An autologous immunogenic composition, method of preparation and applications thereof

An autologous immunogenic composition using a subject's own leukocyte fraction and platelet-rich plasma, without additional chemicals, addresses the limitations of existing vaccines by inducing a specific immune response against various diseases, offering a simplified, cost-effective, and patient-specific treatment solution.

WO2025062408A1PCT designated stage expired Publication Date: 2025-03-27PAIKRAY SITARAM PRASAD +3
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Patent Information

Application Number
PCT/IN2024/050046
Authority / Receiving Office
WO · WO
Patent Type
Applications
Current Assignee / Owner
Priority Date
2023-09-23
Filing Date
2024-01-18
Publication Date
2025-03-27

AI Technical Summary

Technical Problem

Existing autologous vaccines for diseases like cancer, viral infections, autoimmune diseases, and non-communicable diseases require the incorporation of supplementary chemicals and biological substances, leading to complex and costly manufacturing processes, and are limited in their ability to address a broad spectrum of disease conditions.

Method used

An autologous immunogenic composition is developed using a complete leukocyte fraction isolated from a subject's blood sample, optionally including a platelet-rich plasma fraction, and a vehicle, without the need for additional chemicals or biological substances, simplifying the production process and making it cost-effective.

Benefits of technology

The autologous immunogenic composition induces a specific immune response against viral infections, autoimmune diseases, and non-communicable diseases, providing a unique and potent immunogenic effect tailored to each patient's specific antibodies or autoantibodies, leading to effective treatment and potential recovery of lost functions.

✦ Generated by Eureka AI based on patent content.

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Abstract

The present disclosure generally relates to the field of pharmaceuticals and immunology. Specifically, the present disclosure relates to an autologous immunogenic composition and method of preparation of the autologous immunogenic composition for treatment of viral infection, autoimmune disease, or non-communicable disease in a subject. The present disclosure also pertains to a method of increasing the immunogenicity & treatment of a subject against viral infection, autoimmune disease, or non-communicable disease by employing the immunogenic composition of the present disclosure.
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Description

[0001]“AN AUTOLOGOUS IMMUNOGENIC COMPOSITION, METHOD OF PREPARATION AND APPLICATIONS THEREOF” FIELD OF INVENTION: The present disclosure generally relates to the field of pharmaceuticals and immunology. Specifically, the present disclosure relates to an autologous immunogenic composition and method of preparation of the autologous immunogenic composition for treatment of viral infection, autoimmune disease, or non-communicable disease in a subject. The present disclosure also pertains to a methods of increasing the immunogenicity & treatment of a subject against viral infection, autoimmune disease, or non-communicable disease by employing the immunogenic composition of the present disclosure. BACKGROUND AND PRIOR ART OF THE INVENTION: The immune system is a collection of cells, tissues, and organs that protect the body against infection and disease1. There are two main types of immune response: the innate immune response and the adaptive immune response. The innate immune response is the body’s first line of defense against infection. It is a rapid and non-specific response, which means that it is not directed at a particular pathogen. The innate response includes physical and chemical barriers, such as skin and mucosa, as well as specialized cells, such as macrophages and dendritic cells, which work to destroy and eliminate invading pathogens. The adaptive immune response develops more slowly than the innate response but is highly specific for a particular pathogen and provides long-lasting protection. The adaptive response involves the activation of B lymphocytes and T lymphocytes, two types of immune system cells that produce antibodies and specifically recognize and eliminate pathogens. Additionally, the adaptive response has the ability to remember pathogens it has encountered before, allowing for a faster and more efficient response to future encounters with the same pathogen2. The immune system recognizes and remembers pathogens, allowing for a faster response in future encounters. Vaccines leverage this ability by teaching the immune system to recognize and fight specific pathogens. A viral infection disease is a condition caused by the invasion and reproduction of viruses in the human body or living organisms. Viruses are microorganisms that require host cells to multiply and trigger an immune response. When a virus enters the body, it triggers an immune system reaction, which involves defense cells and molecules. Infected cells release signals to alert the immune system, which activates T and B lymphocytes to recognize and attack infected cells, as well as to produce specific antibodies that neutralize the virus. Although this immune response is essential to control viral infection, some viruses evade and weaken the immune system, which leads to persistent or chronic infections in certain cases3. The most representative viral infection diseases worldwide may vary according to the period and regions. However, major viral diseases in order of estimated incidence include: Acute respiratory infections (including common cold, flu, and COVID-19), Hepatitis B, Hepatitis C, HIV / AIDS, Dengue, Herpes simplex (HSV), Chickenpox, Measles, Human papillomavirus (HPV). These viral diseases have significant relevance in terms of global incidence and their impact on public health. However, the situation may change over time and new viral diseases may emerge4. An auto-immune disease is a disorder in which the body's immune system mistakenly attacks and destroys the body's own healthy tissue. Normally, the immune system protects the body against foreign pathogens, such as viruses and bacteria, but in an autoimmune disease, the immune system attacks cells, tissues, and organs in the body as if they were foreign invaders. Autoimmune diseases may affect any part of the body, and there are more than 80 different types. The symptoms of autoimmune diseases can vary depending on the type of disease and the part of the body that is affected, and can include fatigue, pain, inflammation, fever, and skin problems, among others5. It is important to mention that the incidence of autoimmune diseases can vary by geographic region, ethnic group, and other factors. Some of the common autoimmune diseases in order of estimated incidence from highest to lowest include: autoimmune thyroid disease (Hashimoto's thyroiditis and Graves' disease), rheumatoid arthritis, systemic lupus erythematosus, diabetes type 1, Celiac disease, multiple sclerosis, Crohn's disease, ulcerative colitis, psoriasis, Sjogren's syndrome and neutrophilic dermatoses. The incidence of these diseases may vary according to the populations studied and the regional context. Furthermore, some autoimmune diseases may have a similar incidence and may appear in different orders from different sources6-9. The exact cause of autoimmune diseases is not fully known, but it is believed that they are a result of a combination of genetic, environmental, and lifestyle factors. Environmental factors, such as exposure to toxins, viral or bacterial infections, as well as stress and diet, have also been implicated in the development of autoimmune diseases10. Noncommunicable diseases (NCDs) are chronic diseases that are not passed from one person to another. These illnesses can be long lasting and can get worse over time. Major NCDs include cardiovascular diseases, cancer, chronic respiratory diseases, and diabetes. Other NCDs include neurological diseases, mental illnesses, musculoskeletal diseases, and digestive diseases. Common risk factors for NCDs include smoking, excessive alcohol consumption, unhealthy diet, physical inactivity, and exposure to environmental pollution11. The incidence of noncommunicable diseases can vary depending on the region and the population studied, however of some of the most common noncommunicable diseases in order of highest to lowest estimated incidence include: Cardiovascular diseases (such as coronary heart disease and stroke), Type 2 diabetes, Chronic respiratory diseases (such as chronic obstructive pulmonary disease -COPD- and asthma), Cancer (different types, such as lung, breast, prostate, colon, etc.), Neuropsychiatric illnesses (such as dementia and depression), obesity, and chronic kidney diseases. This list is not exhaustive and there are other non- communicable diseases that also have a significant incidence in different populations12-13. Autoimmune diseases and noncommunicable diseases (NCDs) have some similarities and connections. First, both autoimmune and NCD diseases are chronic and may have a common inflammatory basis. In addition, various risk factors for NCDs, such as smoking, excessive alcohol consumption, unhealthy diet, physical inactivity, and exposure to environmental pollution, may also contribute to the development of autoimmune diseases. In addition, people with autoimmune diseases are at increased risk of developing cardiovascular diseases and other NCDs. For example, patients with systemic lupus erythematosus are at increased risk of cardiovascular disease and chronic kidney disease14. Autohemotherapy is a medical procedure in which a certain amount of blood is removed from a patient and then reinjected into their own body. This practice has been used in different ways throughout history. International patent application with publication number WO 2011 / 135393 A1 relates to an autologous biological vaccine against cancer and its preparation method. It teaches a biological vaccine obtained from proteins overexpressed in the serum of cancer patients. However, the vaccine requires addition of immunogenic adjuvants such as an attenuated DNA virus and amino acids in order to provoke an immune response, blocking tumor cells. European patent application with publication number EP 1523989 A1 pertains to a process for the preparation of an anticancer vaccine derived from serum or autologous leukocytes. The preparation method includes coagulating a defined amount of blood from the cancer patient who has not been treated with chemo or radiotherapy, centrifuging said blood with a rotational speed of at least 2000 rpm for 30 seconds, combining the supernatant serum with an aqueous solution of formaldehyde at a temperature of at least 37°C for at least 28 days, treating the product of the above step with phosphoric acid, filtering, treating the precipitate with an aqueous solution of hydrochloric acid to lower the pH at 4, centrifuge the product at a rotational speed of at least 2000 rpm, collect the precipitate, treat and dissolve the precipitate with a buffer solution to raise the pH to a physiological value and repeat the last 8 steps. The blood tissue processing procedure thus requires several steps, coagulation, added chemicals, temperature and pH modifications making the process cumbersome. International patent application with publication number WO 2019 / 175500 A1 relates to an autologous vaccine against cancer, and a method to produce it, which comprises the following steps: a) extracting proteins from a serum or plasma sample obtained from a cancer patient; and b) contacting the proteins extracted in step a) with particles of hydroxyapatite and / or tricalcium phosphate. Thus, the processing procedure requires the alteration of the blood tissue with chemicals. International patent application with publication number WO 2006 / 122914 A2 refers to a drug characterized in that it comprises at least one biocompatible solid support, preferably in powder form, on which at least one active principle is adsorbed or is to be adsorbed, preferably selected from biological materials and / or or biological molecules, preferably without the need for a coupling agent. Said biocompatible solid support is capable of purifying the active substance. The invention also refers to a method for preparing said drug. Thus, the processing procedure requires the addition of biological solids and activators. Thus, the prior art exhibits limitations, primarily in the context of autologous vaccines, as they necessitate the incorporation of supplementary chemicals / biological substances and involve a laborious and intricate manufacturing process. Furthermore, it is worth noting that while autologous vaccines have demonstrated efficacy in combatting cancer, suitable vaccines to address a broader spectrum of disease conditions remains limited. Consequently, there is a need in the art for developing autologous immune composition endowed with potent immunogenic activity against viral diseases, autoimmune diseases, and non-communicable diseases, accompanied by a simplified and cost-effective production method. SUMMARY OF THE INVENTION: This summary is provided to introduce a selection of concepts, in a simplified format, that are further described in the detailed description of the invention. This summary is neither intended to identify key or essential inventive concepts of the invention nor is it intended for determining the scope of the invention. The present disclosure relates to an autologous immunogenic composition for the treatment of a viral infection, an autoimmune disease, or a non-communicable disease in a subject in need thereof, comprising: a) complete leukocyte fraction isolated from a blood sample of the subject; b) optionally comprising a platelet-rich plasma fraction isolated from the blood sample of the subject; and c) a vehicle. The present disclosure also pertains to a method for preparing an autologous immunogenic composition, comprising steps of: - obtaining blood sample from a subject having a viral infection, an autoimmune disease, or a non-communicable disease; - centrifuging the collected blood sample at a speed ranging from about 3000 rpm to about 6000 rpm; - isolating complete leukocyte fraction optionally along with platelet-rich plasma fraction from the centrifuged blood sample; and -mixing the isolated complete leukocyte fraction optionally along with the platelet- rich plasma fraction with a vehicle to obtain the autologous immunogenic composition. The present disclosure further provides an autologous immunogenic composition, obtained by the aforesaid method. The present disclosure also provides for a method for inducing an immune response in subject having a viral infection, an autoimmune disease, or a non-communicable disease, wherein the method comprises administering the autologous immunogenic composition as claimed in any of the preceding claims to the subject in an effective amount to induce the immune response, characterised in that the autologous immunogenic composition is produced from blood sample of the subject post onset of the viral infection, the autoimmune disease, or the non-communicable disease. The present disclosure also pertains to a method for treating a viral infection, an autoimmune disease or a non-communicable disease in a subject in need thereof, wherein the method comprises acts of: - detoxification of the subject, - administering the autologous immunogenic composition as claimed in any of claims 1- 6 to the subject in an effective amount to induce the immune response, characterized in that the autologous immunogenic composition is produced from blood sample of the subject post onset of the viral infection, the autoimmune disease, or the non- communicable disease, - administering the subject with a nutraceutical composition, and - optionally rehabilitating the subject. To further clarify the advantages and features of the present disclosure, a more particular description of the invention will be rendered by reference to specific embodiments thereof. DETAILED DESCRIPTION OF THE INVENTION: The present disclosure aims to address the drawbacks of the art and provides for an effective autologous immunogenic composition for increasing immunogenicity against viral infection, autoimmune disease, or non-communicable disease in a subject. The present disclosure also provides for a simplified and cost-effective method of preparation of the said composition, by employing white blood cells from blood tissue fraction obtained from the subject, without altering the blood tissue sample with chemicals or biological substances to increase the immunogenicity. For the purpose of promoting an understanding of the principles of the invention, reference will now be made to the embodiment illustrated in the drawings and specific language will be used to describe the same. It will nevertheless be understood that no limitation of the scope of the invention is thereby intended, such alterations and further modifications in the illustrated system, and such further applications of the principles of the invention as illustrated therein being contemplated as would normally occur to one skilled in the art to which the invention relates. Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skilled in the art to which this invention belongs. The system, methods, and examples provided herein are illustrative only and not intended to be limiting. Although any methods and materials similar or equivalent to those described herein can also be used in the practice or testing of the present disclosure, the preferred methods and materials are now described. All publications mentioned herein are incorporated herein by reference to disclose and describe the methods and / or materials in connection with which the publications are cited. It must be noted that as used herein and in the appended claims, the singular forms "a", "and", and "the" include plural referents unless the context dictates otherwise. Thus, for example, reference to "a compound" includes a plurality of such compounds, and reference to "the step" includes reference to one or more steps and equivalents thereof known to those skilled in the art, and so forth. The term “some” as used herein is defined as “none, or one, or more than one, or all.” Accordingly, the terms “none,” “one,” “more than one,” “more than one, but not all” or “all” would all fall under the definition of “some.” The term “some embodiments” may refer to no embodiments or to one embodiment or to several embodiments or to all embodiments. Accordingly, the term “some embodiments” is defined as meaning “no embodiment, or one embodiment, or more than one embodiment, or all embodiments.” The terminology and structure employed herein is for describing, teaching and illuminating some embodiments and their specific features and elements and does not limit, restrict or reduce the spirit and scope of the claims or their equivalents. More specifically, any terms used herein such as but not limited to “includes”, “comprises”, “has”, “consists” and grammatical variants thereof is inclusive or open-ended and does not exclude additional, unrecited elements or method steps. The specification will be understood to also include embodiments which have the transitional phrase “consisting of” or “consisting essentially of” in place of the transitional phrase “comprising.” The transitional phrase “consisting of” excludes any element, step, or ingredient not specified in the claim, except for impurities associated therewith. The transitional phrase “consisting essentially of” limits the scope of a claim to the specified materials or steps “and those that do not materially affect the basic and novel characteristic(s)” of the claimed invention. Whether or not a certain feature or element was limited to being used only once, either way it may still be referred to as “one or more features” or “one or more elements” or “at least one feature” or “at least one element.” Furthermore, the use of the terms “one or more” or “at least one” feature or element do NOT preclude there being none of that feature or element, unless otherwise specified by limiting language such as “there NEEDS to be one or more” or “one or more element is REQUIRED.” Unless otherwise defined, all terms, and especially any technical and / or scientific terms, used herein may be taken to have the same meaning as commonly understood by one having an ordinary skill in the art. Use of the phrases and / or terms such as but not limited to “a first embodiment,” “a further embodiment,” “an alternate embodiment,” “one embodiment,” “an embodiment,” “multiple embodiments,” “some embodiments,” “other embodiments,” “further embodiment”, “furthermore embodiment”, “additional embodiment” or variants thereof do NOT necessarily refer to the same embodiments. Unless otherwise specified, one or more particular features and / or elements described in connection with one or more embodiments may be found in one embodiment, or may be found in more than one embodiment, or may be found in all embodiments, or may be found in no embodiments. Although one or more features and / or elements may be described herein in the context of only a single embodiment, or alternatively in the context of more than one embodiment, or further alternatively in the context of all embodiments, the features and / or elements may instead be provided separately or in any appropriate combination or not at all. Conversely, any features and / or elements described in the context of separate embodiments may alternatively be realized as existing together in the context of a single embodiment. The term “patient” or “subject” are used interchangeably and refer to a mammal preferably human. The terms “treat,” “treatment,” and “treating" in the context of the administration of a therapy to a patient refers to the reduction, elimination, or inhibition of the progression and / or duration of a disease or condition, the reduction or amelioration of the severity of a disease or condition, the amelioration of one or more symptoms thereof resulting from the administration of one or more therapies; and / or recovery of functions lost due to a disease or condition. An “effective amount” is an amount sufficient for the composition to accomplish a stated purpose relative to the absence of the composition (e.g. reduce one or more symptoms of a disease or condition). An example of an “effective amount” is an amount sufficient to contribute to the treatment, prevention, delay, inhibition, suppression, or reduction of a symptom or symptoms of a disease or disorder, which could also be referred to as a “therapeutically effective amount.” A “reduction” of a symptom or symptoms (and grammatical equivalents of this phrase) means decreasing of the severity or frequency of the symptom(s), or elimination of the symptom(s). The terms “about” or “approximately” in the context of the present disclosure denote an interval of accuracy that the person skilled in the art will understand to still ensure the technical effect of the feature in question. The term typically indicates deviation from the indicated numerical value of ±20%, preferably ±15%, more preferably ±10%, and even more preferably ±5%. The term “optionally,” as used in the present disclosure, means that a feature or element described as ‘optional’ within the context of the invention is not required for the invention to function as claimed. It indicates that the presence or absence of the described feature or element does not alter the fundamental operation or scope of the invention, and its inclusion or exclusion may be determined based on the specific requirements or preferences of a practitioner skilled in the art or the particular application in question. As used herein the terms “method” and “process” have been used interchangeably. As used herein the terms “autologous” and “autologously” refers to a composition or method that utilizes biological materials, including cells, tissues, or components thereof, obtained from the same individual for whom the composition or method is intended. As used herein the term “complete leukocyte fraction” denotes the entirety of white blood cells present in a given biological sample, encompassing all distinct types of leukocytes, including but not limited to neutrophils, lymphocytes, monocytes, eosinophils, and basophils. It includes a heterogeneous mixture of intracellular material of white blood cells or part of the white cell membrane extracted from the patient’s blood tissue. It signifies a comprehensive representation of the leukocyte population, free from selective exclusion or bias, thus providing a full spectrum of immunological components for use in various applications. As used herein the terms “autologous immunogenic composition”, “immunogenic composition” or “immunogen” have been used interchangeably. The present disclosure broadly pertains to development of an immunogenic composition for the treatment of viral infection, autoimmune disease, or non-communicable disease in a subject in need thereof. In some embodiments, the immunogenic composition of the present disclosure is produced autologously from an injectable suspension of leukocyte heterogeneous intracellular material extracted from a patient’s blood tissue, which is to be administered subcutaneously along with a vehicle, in order to promote an immune response in a patient for the auxiliary treatment of viral diseases, autoimmune diseases and / or non-communicable diseases. The immunogenic composition seeks to induce a specific immune response against the antibodies or autoantibodies related to the disease, without the need for external substances. In some embodiments, the autologous immunogenic composition of the present disclosure comprises: a) a non-specific active biological component from white blood tissue cells which is specifically the complete leukocyte fraction extracted from the patient’s blood tissue; and b) a vehicle. In an embodiment, the immunogenic composition of the present disclosure is an injectable suspension comprising: a) about 20 and 40% of the complete leukocyte fraction extracted from the patient’s blood tissue; and b) the remaining amount is a 100% sterile and injectable hypotonic solution. In some embodiments, the autologous immunogenic composition of the present disclosure further comprises a fraction of platelet-rich plasma isolated from the blood sample of the subject. In an embodiment, the immunogenic composition for the treatment of viral infection, autoimmune disease, and / or non-communicable disease in a subject in need thereof comprises: -complete leukocyte fraction isolated from a blood sample of the subject; - a fraction of platelet-rich plasma isolated from the blood sample of the subject; and - a vehicle, which is preferably a hypotonic solution. In another embodiment of the present disclosure, the immunogenic composition comprises about 20% w / w to about 30% w / w of the complete leukocyte fraction, about 10% w / w to about 25% w / w of the platelet-rich plasma fraction; and about 60% w / w to about 70% w / w of the vehicle. In yet another embodiment, the immunogenic composition comprises about 20% w / w to about 30% w / w of the complete leukocyte fraction, about 10% w / w to about 20% w / w of the platelet-rich plasma fraction; and about 60% w / w to about 70% w / w of the vehicle. Small amounts of plasma in the immunogenic composition of the present disclosure help to stabilize the medium. Plasma, being the natural medium of the cells, acts as a stabilizing medium for the white blood cells obtained from the blood sample, keeping the tissue conditioned until the moment of its application. In some embodiments, the platelet-rich plasma fraction is the fraction closest to the white blood cell fraction surprisingly provide additional benefits to the patient. The present disclosure also pertains to a method for obtaining the immunogenic composition for treatment of viral infection, autoimmune disease, or non-communicable disease. In some embodiments, the method for the preparation of the autologous immunogenic composition of the present disclosure for the treatment of viral infection, autoimmune disease, or non-communicable disease in a subject comprises acts of: - isolating complete leukocyte fraction from a blood sample of the subject having viral infection, autoimmune disease, or non-communicable disease, by centrifugation of the blood sample at a speed ranging from about 3000 rom to about 6000 rpm; and -mixing the isolated complete leukocyte fraction with a vehicle to obtain the immunological composition. In an exemplary embodiment, the method for the preparation of the autologous immunogenic composition of the present disclosure comprises acts of: - About 10 ml to about 20ml of blood tissue sample is taken from a patient having viral infection, autoimmune disease, or non-communicable disease using collectors with anticoagulant (such as but not limiting to EDTA), - Centrifuging the sample at a speed ranging from about 3000 rom to about 6000 rpm for at least 5 minutes, - Collecting the complete leukocyte fraction optionally along with the platelet-rich plasma fraction; - The material thus obtained is mixed with a vehicle, preferably with a hypotonic solution to obtain the autologous immunogenic composition of the present disclosure; and - The composition is optionally packaged in pharmaceutical vial form. The immunogen obtained must be kept at rest for at least 24 hours to guarantee its effectiveness; if it rests for less time, the quality of the immunological response may be lower. The immunogenic composition of the present disclosure is to be kept refrigerated from the time of its preparation until its administration / application. In some embodiments, the composition is stored at a temperature ranging from about 2°C to about 4°C. Temperature lower than 2°C causes freezing and distortion of the medium, and temperature higher than 4°C causes decomposition of the medium. In some embodiments, the blood sample obtained from the patient / subject is stored with an anticoagulant such as EDTA until processing or before the centrifugation process. In some embodiments, the anticoagulant employed in the present disclosure is selected from a group comprising EDTA, Citrate-Phosphate-Dextrose-Adenine (C.P.D.A-1), and Citrate-Phosphate-Dextrose (C.P.D. + Adsol). Centrifugation of the blood tissue sample in the method of the present disclosure is carried out for a period of about 3 to about 7minutes, preferably about 5 minutes for separating the blood fractions without damaging the cells of interest, while extracting the white blood cells optionally along with a fraction of plasma, by maintaining the integrity. In some embodiments, the vehicle employed in the composition of the present disclosure is a hypotonic solution. The hypotonic solution aids in lysis of white blood cells. The white blood cells are required to be completely lysed. The present disclosure also pertains to an autologous immunogenic composition, obtained by the method of the present disclosure. The immunogenic composition and the method for the preparation of the autologous immunogenic composition of the present disclosure is characterized in that: - it does not require altering the blood sample obtained from the subject / patient with additional chemicals, adjuvants, biological molecules / compounds; - the immunological reaction is achieved only on the segments obtained from the white blood cells; - it is important that there is no heating or freezing of the blood sample obtained from the patient before processing it; - the pH of the blood sample obtained from the patient is not altered; - the immunogen has to rest for at least 24 hours to have complete lysis; - the method is aseptic; and / or - employs leukocytes and plasma fraction present during the disease condition of the subject, i.e., the blood sample is obtained from the subject post onset of the disease. Thus, the antibody (whichever is present in the patient) is converted into an antigen in the composition of the present disclosure. The immunogen obtained is thus unique and specific for each patient. In some embodiments, the present disclosure requires that the entire leukocyte fraction is extracted from the patient’s blood sample to guarantee complete immune response. The leukocytes in the blood sample are not subjected to any differentiation or selection. The autologous immunogenic composition of the present disclosure has an antigenic effect and has the capacity to induce a new specific humoral and cellular immune response against the antibodies or autoantibodies that promote the disease to be treated. The specificity of the immunogen comes from the fact that the antibodies of interest are unique to each patient and are present only at the time of suffering from the disease, that is, at the time of taking the blood sample. The present disclosure also pertains to the method for inducing an immune response in a subject in need thereof having a viral infection, an autoimmune disease, or a non- communicable disease, wherein the method comprises administering the autologous immunogenic composition of the present disclosure to the subject in an effective amount to induce the immune response. The immunogenic composition is an injectable suspension which is administered to the subject subcutaneously. In a preferred embodiment, about 10 ml ± 1 of the composition may be administered to the subject in need thereof. In all patients, the required applications supplied are deferred in homogeneous periods. The immunogenic composition of the present disclosure may be used for first choice treatment, second choice treatment, third choice treatment, adjunctive therapy, or a replacement therapy. In a preferred embodiment, the immunogenic composition is administered as an adjunctive therapy / auxiliary treatment. Applications of the autologous immunogenic composition of the present disclosure include: - It is an auxiliary to the immune response to viral infections. - It is an auxiliary to the treatment of autoimmune diseases. - It is an auxiliary to the treatment of non-communicable diseases. - It is an auxiliary to reduce or eliminate the symptoms of viral infection diseases. - It is an auxiliary to reduce or eliminate the symptoms of autoimmune diseases. - It is an auxiliary to reduce or eliminate the symptoms of noncommunicable diseases. - It is an auxiliary in the recovery of functions lost due to viral infection diseases. - It is an auxiliary in the recovery of functions lost due to autoimmune diseases. - It is an auxiliary in the recovery of functions lost due to non-communicable diseases. In some embodiments, the viral infection is selected from a group comprising common cold, flu, COVID-19, hepatitis B, hepatitis C, HIV / AIDS, dengue, tuberculosis, herpes simplex (HSV), chickenpox, measles and human papillomavirus (HPV) or any combination thereof. In some embodiments, the autoimmune disease is selected from a group comprising Hashimoto’s thyroiditis, Graves’ disease, rheumatoid arthritis, systemic lupus erythematosus, diabetes type 1, Celiac disease, Multiple Sclerosis, Crohn’s disease, Ulcerative colitis, Psoriasis, Sjogren’s syndrome and neutrophilic dermatoses or any combination thereof. In some embodiments, the non-communicable disease is selected from a group comprising cardiovascular disease, Type 2 diabetes, Chronic respiratory disease, cancer, neuropsychiatric illnesses, obesity and chronic kidney disease or any combination thereof. In an exemplary and non-limiting embodiment, the advantages of present disclosure are: I. It provides for a simplified and cost-effective method of preparation of the said composition, by employing white blood cells from blood tissue fraction obtained from the subject, without altering the blood tissue sample with chemicals or biological substances to increase the immunogenicity. II. The immunogenic composition obtained is unique and specific for each patient. The specificity of the immunogen comes from the fact that the antibodies of interest are unique to each patient and are present only at the time of suffering from the disease, that is, at the time of taking the blood sample. III. It has higher antigenic effect and has the capacity to induce a new specific humoral and cellular immune response against the antibodies or autoantibodies that promote the disease to be treated. IV. It provides complete immune response to the subject in need thereof. Numbered embodiments of the present disclosure: 1. An autologous immunogenic composition for the treatment of a viral infection, an autoimmune disease, or a non-communicable disease in a subject in need thereof, comprising: a. complete leukocyte fraction isolated from a blood sample of the subject; b. optionally comprising a platelet-rich plasma fraction isolated from the blood sample of the subject; and c. a vehicle. 2. The immunogenic composition as disclosed in embodiment 1, wherein the vehicle is a hypotonic solution. 3. The immunogenic composition as disclosed in any of embodiments 1 to 2, wherein the composition is stored at a temperature ranging from about 2°C to about 4°C. 4. The immunogenic composition as disclosed in any of embodiments 1 to 3, wherein the composition is in the form of a suspension. 5. The immunogenic composition as disclosed in any of embodiments 1 to 4, wherein the immunogenic composition does not comprise any added preservative. 6. The immunogenic composition as disclosed in any of embodiments 1 to 5, wherein the immunogenic composition comprises about 20% w / w to about 30% w / w of the complete leukocyte fraction. 7. The immunogenic composition as disclosed in any of embodiments 1 to 6, wherein the immunogenic composition comprises about 10% w / w to about 25% w / w of the platelet-rich plasma fraction. 8. The immunogenic composition as disclosed in any of embodiments 1 to 7, wherein immunogenic composition comprises about 60% w / w to about 70% w / w of the vehicle. 9. The immunogenic composition as disclosed in any of embodiments 1 to 8, wherein the subject is a mammal, preferably human. 10. The immunogenic composition as disclosed in any of embodiments 1 to 9, wherein the immunogenic composition is subject specific. 11. The immunogenic composition as disclosed in any of embodiments 1 to 10, wherein the immunogenic composition is used for first choice treatment, second choice treatment, third choice treatment, adjunctive therapy, or a replacement therapy, preferably an adjunctive therapy. 12. The immunogenic composition as disclosed in any of embodiments 1 to 11, wherein the viral infection is selected from a group comprising common cold, flu, COVID-19, hepatitis B, hepatitis C, HIV / AIDS, dengue, tuberculosis, herpes simplex (HSV), chickenpox, measles and human papillomavirus (HPV) or any combination thereof. 13. The immunogenic composition as disclosed in any of embodiments 1 to 11, wherein the autoimmune disease is selected from a group comprising Hashimoto's thyroiditis, Graves' disease, rheumatoid arthritis, systemic lupus erythematosus, diabetes type 1, Celiac disease, Multiple Sclerosis, Crohn's disease, Ulcerative colitis, Psoriasis, Sjogren's syndrome and neutrophilic dermatoses or any combination thereof. 14. The immunogenic composition as disclosed in any of embodiments 1 to 11, wherein and the non-communicable disease is selected from a group comprising cardiovascular disease, Type 2 diabetes, Chronic respiratory disease, cancer, neuropsychiatric illnesses, obesity and chronic kidney disease or any combination thereof. 15. The immunogenic composition as disclosed in any of embodiments 1 to 14, wherein the complete leukocyte fraction isolated from the blood sample of the subject are those that are active as a consequence of an immunological or an autoimmune response corresponding to the disease to be treated in said subject. 16. The immunogenic composition as disclosed in any of embodiments 1 to 15, wherein the composition has an antigenic effect and has the capacity to induce a new specific humoral and / or cellular immune response against the antibodies or autoantibodies that promote the disease to be treated. 17. A method for preparing an autologous immunogenic composition as disclosed in any of embodiments 1 to 16, comprising steps of: - obtaining blood sample from a subject having a viral infection, an autoimmune disease, or a non-communicable disease; - centrifuging the collected blood sample at a speed ranging from about 3000 rpm to about 6000 rpm; - isolating complete leukocyte fraction optionally along with platelet-rich plasma fraction from the centrifuged blood sample; and -mixing the isolated complete leukocyte fraction optionally along with the platelet- rich plasma fraction with a vehicle to obtain the autologous immunogenic composition. 18. The method as disclosed in embodiment 17, wherein the vehicle is a hypotonic solution. 19. The method as disclosed in embodiments 17 or 18, wherein the composition is stored at a temperature ranging from about 2°C to about 4°C. 20. The method as disclosed in any of embodiments 17 to 19, wherein the immunogenic composition is packaged in a pharmaceutical vial. 21. The method as disclosed in any of embodiments 17 to 20, wherein the composition is in the form of a suspension. 22. The method as disclosed in any of embodiments 17 to 21, wherein the immunogenic composition does not comprise any preservative. 23. The method as disclosed in any of embodiments 17 to 22, wherein the immunogenic composition comprises about 20% w / w to about 30% w / w of the complete leukocyte fraction. 24. The method as disclosed in any of embodiments 17 to 23, wherein the immunogenic composition comprises about 10% w / w to about 25% w / w of the platelet-rich plasma fraction; preferably about 10% w / w to about 20% w / w of the platelet-rich plasma fraction. 25. The method as disclosed in any of embodiments 17 to 24, wherein the immunogenic composition comprises about 60% w / w to about 70% w / w of the vehicle. 26. The method as disclosed in any of embodiments 17 to 25, wherein the centrifugation is carried out for a period of about 3 to about 7 minutes, preferably about 5 minutes. 27. The method as disclosed in any of the embodiments 17 to 25, wherein the blood sample obtained from the subject is mixed and / or stored with an anticoagulant selected from a group comprising ethylenediamine tetraacetic acid, Citrate-Phosphate- Dextrose-Adenine (C.P.D.A-1), and Citrate-Phosphate-Dextrose (C.P.D. + Adsol). 28. The method as disclosed in any of the embodiments 17 to 27, wherein the subject is a mammal, preferably human. 29. The method as disclosed in any of embodiments 17 to 28, wherein the autologous immunogenic composition is subject specific. 30. The method as disclosed in any of embodiments 17 to 29, wherein the immunogenic composition is used for first choice treatment, second choice treatment, third choice treatment, adjunctive therapy, or a replacement therapy, preferably an adjunctive therapy. 31. The method as disclosed in any of embodiments 17 to 30, wherein the complete leukocyte fraction isolated from the blood sample are those that are active as a consequence of an immunological or an autoimmune response corresponding to the disease to be treated. 32. The method as disclosed in any of embodiments 17 to 31, wherein the composition has an antigenic effect and has the capacity to induce a new specific humoral and / or cellular immune response against the antibodies or autoantibodies that promote the disease to be treated. 33. The method as disclosed in any of embodiments 17-32, wherein the disease to be treated is selected from a group comprising a viral infection, an autoimmune disease, or a non-communicable disease or a combination thereof. 34. The method as disclosed in any of embodiments 17-33, wherein the viral infection is selected from a group comprising common cold, flu, COVID-19, hepatitis B, hepatitis C, HIV / AIDS, dengue, tuberculosis, herpes simplex (HSV), chickenpox, measles and human papillomavirus (HPV) or any combination thereof. 35. The method as disclosed in any of embodiments 17-33, wherein the autoimmune disease is selected from a group comprising Hashimoto’s thyroiditis, Graves’ disease, rheumatoid arthritis, systemic lupus erythematosus, diabetes type 1, Celiac disease, Multiple Sclerosis, Crohn’s disease, Ulcerative colitis, Psoriasis, Sjogren’s syndrome and neutrophilic dermatoses or any combination thereof. 36. The method as disclosed in any of embodiments 17-33, wherein the non- communicable disease is selected from a group comprising cardiovascular disease, Type 2 diabetes, Chronic respiratory disease, cancer, neuropsychiatric illnesses, obesity and chronic kidney disease or any combination thereof. 37. An autologous immunogenic composition, obtained by the method of any of embodiments 17-36. 38. The autologous immunogenic composition of embodiment 37, is for the treatment of a viral infection, an autoimmune disease, or a non-communicable disease in a subject in need thereof; and comprises complete leukocyte fraction isolated from a blood sample of the subject; optionally comprising a platelet-rich plasma fraction isolated from the blood sample of the subject; and a vehicle. 39. The autologous immunogenic composition of embodiment 37 or 38, wherein the vehicle is a hypotonic solution; wherein the composition is stored at a temperature ranging from about 2°C to about 4°C; wherein the composition is in the form of a suspension; wherein the immunogenic composition does not comprise any added preservative; wherein the composition comprises about 20% w / w to about 30% w / w of the complete leukocyte fraction; wherein the immunogenic composition comprises about 10% w / w to about 25% w / w of the platelet-rich plasma fraction; wherein immunogenic composition comprises about 60% w / w to about 70% w / w of the vehicle; wherein the complete leukocyte fraction isolated from the blood sample of the subject are those that are active as a consequence of an immunological or an autoimmune response corresponding to the disease to be treated in said subject; and / or wherein the composition has an antigenic effect and has the capacity to induce a new specific humoral and / or cellular immune response against the antibodies or autoantibodies that promote the disease to be treated. 40. A method for inducing an immune response in subject having a viral infection, an autoimmune disease, or a non-communicable disease, wherein the method comprises: administering the autologous immunogenic composition as disclosed in any of embodiments 1 to 16 or 37-39 to the subject in an effective amount to induce the immune response, characterised in that the autologous immunogenic composition is produced from blood sample of the subject post onset of the viral infection, the autoimmune disease, or the non-communicable disease. 41. The method as disclosed in embodiment 40, wherein the subject is administered with about 10 ml to about 12 ml of the autologous immunogenic composition. 42. The method as disclosed in embodiment 40 or 41, wherein the composition is administered subcutaneously. 43. The method as disclosed in any of embodiments 40 to 42, wherein the subject is a mammal, preferably human. 44. The method as disclosed in any of embodiments 40 to 43, wherein the immunogenic composition is used for first choice treatment, second choice treatment, third choice treatment, adjunctive therapy, or a replacement therapy. 45. The method as disclosed in any of embodiments 40 to 44, wherein the immunogenic composition is an adjunctive therapy. 46. The method as disclosed in any of embodiments 40 to 45, wherein the complete leukocyte fraction isolated from the blood sample are those that are active as a consequence of an immunological or an autoimmune response corresponding to the disease to be treated. 47. The method as disclosed in any of embodiments 40 to 46, wherein the composition has an antigenic effect and has the capacity to induce a new specific humoral and / or cellular immune response against the antibodies or autoantibodies that promote the disease to be treated. 48. The method as disclosed in any of embodiments 40 to 47, wherein the viral infection is selected from a group comprising common cold, flu, COVID-19, hepatitis B, hepatitis C, HIV / AIDS, dengue, tuberculosis, herpes simplex (HSV), chickenpox, measles and human papillomavirus (HPV). 49. The method as disclosed in any of embodiments 40 to 47, wherein the autoimmune disease is selected from a group comprising Hashimoto's thyroiditis, Graves' disease, rheumatoid arthritis, systemic lupus erythematosus, diabetes type 1, Celiac disease, Multiple Sclerosis, Crohn's disease, Ulcerative colitis, Psoriasis, Sjogren's syndrome and neutrophilic dermatoses. 50. The method as disclosed in any of embodiments 40 to 47, wherein the non- communicable disease is selected from a group comprising cardiovascular disease, Type 2 diabetes, Chronic respiratory disease, cancer, neuropsychiatric illnesses, obesity and chronic kidney disease. 51. An autologous immunogenic composition as disclosed in any of the preceding embodiments, for use in inducing an immune response in a subject having a viral infection, an autoimmune disease, or a non-communicable disease by administering the autologous immunogenic composition in an effective amount to induce the immune response, characterised in that the autologous immunogenic composition is produced from blood sample of the subject post onset of the viral infection, the autoimmune disease, or the non-communicable disease. 52. Use of the autologous immunogenic composition as disclosed in any of the preceding embodiments, for inducing an immune response in a subject having a viral infection, an autoimmune disease, or a non-communicable disease by administering the autologous immunogenic composition in an effective amount to induce the immune response, characterised in that the autologous immunogenic composition is produced from blood sample of the subject post onset of the viral infection, the autoimmune disease, or the non-communicable disease. 53. A method for treating a viral infection, an autoimmune disease or a non-communicable disease in a subject in need thereof, wherein the method comprises acts of: - detoxification of the subject, - administering the autologous immunogenic composition as described in any of embodiments 1-16 and 37-39 to the subject in an effective amount to induce the immune response, characterized in that the autologous immunogenic composition is produced from blood sample of the subject post onset of the viral infection, the autoimmune disease, or the non-communicable disease, - administering the subject with a nutraceutical composition, and - optionally rehabilitating the subject. 54. The method as disclosed in embodiment 53, wherein the detoxification is carried out by employing one or more natural approaches comprising steam shower, digestive cleansing, ionic foot bath, mineral solutions, acid solutions, herbal extracts, or removal of cavities and amalgams. 55. The method as disclosed in embodiment 53 or 54, wherein the subject is administered with about 10 ml to about 12 ml of the autologous immunogenic composition. 56. The method as disclosed in any of embodiment 53-55, wherein the immunogenic composition is preferably administered subcutaneously. 57. The method as disclosed in any of embodiment 53-57, wherein the nutraceutical composition is selected from a group comprising extracts of medicinal mushrooms, amino acids and herbal extracts. 58. The method as disclosed in any of embodiment 53-57, wherein the nutraceutical composition is administered orally. 59. The method as disclosed in any of embodiment 53-58, wherein the rehabilitation comprises activities selected from group comprising physiotherapy, yoga, meditation and / or psychological therapy. 60. The method as disclosed in any of embodiment 53-59, wherein the subject is a mammal, preferably human; wherein the viral infection is selected from a group comprising common cold, flu, COVID-19, hepatitis B, hepatitis C, HIV / AIDS, dengue, tuberculosis, herpes simplex (HSV), chickenpox, measles and human papillomavirus (HPV); wherein the autoimmune disease is selected from a group comprising Hashimoto's thyroiditis, Graves' disease, rheumatoid arthritis, systemic lupus erythematosus, diabetes type 1, Celiac disease, Multiple Sclerosis, Crohn's disease, Ulcerative colitis, Psoriasis, Sjogren's syndrome and neutrophilic dermatoses; wherein the non-communicable disease is selected from a group comprising cardiovascular disease, Type 2 diabetes, Chronic respiratory disease, cancer, neuropsychiatric illnesses, obesity and chronic kidney disease. The present disclosure is further illustrated by reference to the following examples which is for illustrative purpose only and does not limit the scope of the invention in any way. These examples are not intended to be inclusive of all aspects of the subject matter disclosed herein, but rather to illustrate representative features, methods, compositions, and results. These examples are not intended to exclude equivalents and variations of the present disclosure, which are apparent to one skilled in the art. EXAMPLES: Example 1: Method of Preparing Autologous Immunogenic Composition 10 ml to 20 ml of blood tissue sample was taken from the patient using collectors with anticoagulant Ethylenediaminetetraacetic acid (EDTA). The sample is not subjected to any heating or freezing step prior to its processing. The collected blood tissue sample was subjected to centrifugation between 3000 and 6000 rpm for about 5 minutes. Once the blood tissue was centrifuged, the leukocyte material was carefully collected. The obtained leukocyte material is mixed with about 5 to 10 ml of sterile hypotonic injectable solution, to obtain the immunogenic composition. The resulting immunogenic composition was packaged in pharmaceutical vial and stored at a temperature of 2 to 4°C. The immunogenic composition is kept refrigerated from its preparation until its administration to the patient from whom it was originally derived. The immunogenic composition obtained must be kept at rest for at least 24 hours to guarantee its effectiveness; if it rests for less time, the quality of the immunogenic response may be lower. Example 2: Application of the Autologous Immunogenic Composition in Patients The autologous immunogenic composition obtained as per Example 1 was subcutaneously administered to patients with different health conditions. Each administration of the immunogenic composition entailed the delivery of about 10 ml ± 1 of the composition. In all cases, the required applications were supplied in homogeneous periods, which are mentioned in each case presented below. For each respective health condition, the specific diagnostic and monitoring procedures, both laboratory and imaging analysis, required to obtain a diagnosis and follow up on changes in each patient are also detailed. The tests required vary from one patient to another, depending on their condition. General objective of the Studies: To generate an improvement in the health of patients of all ages who suffer from chronic-degenerative diseases, using verifiable outpatient and natural methods, which enrich medical and scientific information with the results obtained. Diagnosis and initial evaluation of the patient: 1. File registration: Full name, age, sex. 2. Collection of clinical history (verbal interview): reason for the consultation. General physical examination: Weight, temperature, pressure, vision, onychomycosis, dental conditions, signs of infection may be monitored. a. Type I diabetes, type II diabetes, gestational diabetes: presence of acanthosis nigricans, cases of amputation. b. Arthritis: Inflammation of joints, functional limitation. c. Asthma: wheezing, vesicular murmur alterations. d. Hyperthyroidism, hypothyroidism: tremors, anxiety states, hair, nail and skin conditions, general thyroid condition. e. Breast cancer: presence of tumor mass, inflammation of lymph nodes, skin alterations, sensitivity alterations. f. Prostate cancer: state of prostate growth (DRE or ultrasound), degree of urinary retention. Treatment protocol: The treatment protocol comprises detoxification, immune reprogramming, immune strengthening and rehabilitation, and the protocol is followed by combining Aryuveda methods, physiotherapy, yoga and / or meditation, psychological therapies, and the consumption of natural products and nutraceuticals. During this treatment, the patients also take modern medicines along with treatments in parallel. - Detoxification: To eliminate toxins, microbes, chemicals, radiation and heavy metals. In addition, changes in diet plan and certain habits may be suggested to the patients. Detoxification is to be carried out prior to immune reprogramming, by techniques selected from a group comprising: steam shower, digestive cleansing, ionic foot bath, mineral solutions, acid solutions, herbal extracts, or removal of cavities and amalgams. The techniques are selected in case of symptoms of general intoxication, presence of infection or bacteria, chronic constipation, heavy metal poisoning, exposition to ammonium and ammonia, histamine and / or ionizing radiation. presence of onychomycosis, mercury poisoning or caries damage. • Immune reprogramming: For rectifying the immune response, an autologous immunogen as per the present disclosure is used, with origin derived from autohemotherapy, where the patient's blood is taken, and the immunological information of the sample is used to be processed and applied back to the same patient, without using chemicals or biological elements from any other individual. Administered subcutaneously. The immunogen is allowed to rest for at least 24 hours before its first application. • Cellular and immune strengthening: For recovering cellular strength and efficiency, both in white blood cells and in general tissues, extracts of medicinal mushrooms, plant extracts and nutraceuticals are used, such as amino acids. • Rehabilitation: With the purpose of recovering the lost function as the case may be, in addition to returning the patient to a mental state of tranquility and stability, physiotherapy, yoga, meditation and / or psychological therapy may be required. Treatment schedule: The entire treatment is handled in iterations lasting two months each. The restart of a next iteration and the definition of the needs of that cycle are defined before starting it, based on an analysis of the results obtained so far. The number of iterations can vary from one to twelve, if necessary. Special considerations and contraindications: • The patient's alternate medication must be monitored to regulate the doses required. • In the case of pregnant women, begin treatment once the pregnancy has ended. • If alternative medical treatments are used, verify the contraindication of the methods to be used. • If you have alternative pathologies, adapt the treatment for adequate care that also covers these needs. Patient education: The effect and application of each element of the treatment will be explained, as well as the importance of its comprehensive and correct follow-up. Monitoring instructions and specifications of the studies to be carried out will be given. Example 3: Application of the Immunogenic Composition in Patients with Asthma Asthma treated patients: >60 Objectives of disease treatment for Asthma: • Generate immunological desensitization to the primary antigen. • Avoid collapse or narrowing of the airways. • Avoid, as far as possible, the risk of lethal asthma attacks. A group of asthma patients were selected for this study. Table 1 depicts the studies used for the diagnosis of patients with asthma. The autologous immunogenic composition, prepared as per Example 1, was administered subcutaneously to each patient. Following the first application of the immunogenic composition, majority of patients showed remission of asthma symptoms. About 15% of the patients required a second reinforcement application. About 97% of the patients followed the immunogen application adequately and obtained favorable results. Table 1. Reference studies used for the diagnosis of patients with asthma as per standard protocols. Lab tests Imaging tests Arterial blood gases Bone scan Blood count Lung function tests Allergy tests Peak flow measurements Chest tele Gasometry Example 3.1: • Patient’s identification number: ox004709p1 • Date of birth: 1 / 4 / 1979 • Sex: female • Initial conditions: asthma. Medication for bronchodilation. Corticosteroid medication. • Initial values*: does not apply • Treatment: traditional detoxification methods. Immunogen. Medicinal herbs and mushrooms. • Months of treatment: 4 • Results: crises disappear. No bronchodilation medication. No corticosteroid medication. • Final values*: does not apply • FOLLOW-UP: Discharge. • Notes: * The presented values indicate the result obtained with the reference to which it must be compared in parenthesis. In the cases where “Does not apply” is indicated, the results are either visible by photograph or there are no laboratory tests for the case. Example 3.2: • Patient’s identification number: MC004436P0 • Date of birth: 4 / 3 / 2004 • Sex: female • Initial conditions: asthma. Medication for bronchodilation. • Treatment: traditional detoxification methods. Immunogen. Medicinal herbs and mushrooms. • Months of treatment: 4 • Follow-up: discharge • Notes: • Results: crises disappear. No bronchodilation medication. Example 3.3: • Patient’s identification number: MC004487P8 • Date of birth: 12 / 12 / 1989 • Sex: female • Initial conditions: asthma. Medication for bronchodilation. • Treatment: traditional detoxification methods. Immunogen. Medicinal herbs and mushrooms. • Months of treatment: 8 • Results: crises disappear. No bronchodilation medication. Example 3.4: • Patient’s identification number: OX004709P1 • Date of birth: 1 / 4 / 1979 • Sex: female • Initial conditions: asthma. Medication for bronchodilation. Corticosteroid medication. • Treatment: traditional detoxification methods. Immunogen. Medicinal herbs and mushrooms. • Months of treatment: 4 • Results: crises disappear. No bronchodilation medication. No corticosteroid medication. Example 3.5: • Patient’s identification number: OX005801P5 • Date of birth: 6 / 21 / 2011 • Sex: male • Initial conditions: asthma. Medication for bronchodilation. • Treatment: traditional detoxification methods. Immunogen. Medicinal herbs and mushrooms. • Months of treatment: 2 • Results: crises disappear. No bronchodilation medication. Example 3.6: • Patient’s identification number: SN003514P9 • Date of birth: 2 / 25 / 2008 • Sex: female • Initial conditions: asthma. Corticosteroid medication. • Treatment: traditional detoxification methods. Immunogen. Medicinal herbs and mushrooms. • Months of treatment: 2 • Results: crises disappear. No corticosteroid medication. Example 3.7: • Patient’s identification number: SN004162P2 • Date of birth: 9 / 1 / 1992 • Sex: female • Initial conditions: asthma. Recurrent respiratory infections. Ice cream intolerance. • Treatment: traditional detoxification methods. Immunogen. Medicinal herbs and mushrooms. • Months of treatment: 6 • Results: no recurrent respiratory infections. No intolerance to ice cream. Example 3.8: • Patient’s identification number: SN004269P4 • Date of birth: 8 / 23 / 2012 • Sex: female • Initial conditions: asthma. Recurrent respiratory infections. Need for nebulizations • Treatment: traditional detoxification methods. Immunogen. Medicinal herbs and mushrooms. • Months of treatment: 2 • Results: no recurrent respiratory infections. No need for mists Example 4: Application of Immunogenic Composition in patients with Diabetes Objectives of disease treatment for Type I diabetes, type II diabetes, gestational diabetes: • Identify if there is no insulin production or if there is insulin resistance. • Obtain insulin production when the pancreas did not produce it. • Eliminate insulin resistance by receptors. • Promote the possibility of eliminating the need for conventional medications. • Prevent vision alterations, kidney deterioration. • Correct neuropathies, polydipsia, polyuria, polyphagia, asthenia and adynamia, and vascular compromise in general, and other symptoms derived from the initial disease. • Avoid the side effects of conventional medications. Diabetes Type I treated patients: >10. A group of diabetes Type I treated patients were selected for this study. Table 2 depicts the studies used for the diagnosis of patients with diabetes Type I treated. The autologous immunogenic composition, prepared as per Example 1, was administered subcutaneously to each patient. Following the first application of the immunogenic composition, 60% of the treated patients began to produce insulin. The patients who showed resistance obtained normal levels of insulin production in a maximum of four applications. About 80% of the patients followed the immunogenic application adequately and obtained favorable results. Diabetes Type II treated patients: >500 A group of diabetes Type II treated patients were selected for this study. Table 2 depicts the studies used for the diagnosis of patients with diabetes Type II treated. The autologous immunogenic composition, prepared as per Example 1, was administered subcutaneously to each patient. Following the first application of the immunogenic composition, 20% of the treated patients showed a drop in blood glucose. About 50% showed healthy glucose levels after four applications. About 10% showed healthy glucose levels after twelve applications. About 80% of the patients followed the immunogenic application adequately and obtained favorable results. Gestational diabetes treated patients: >10. A group of gestational diabetes treated patients were selected for this study. Table 2 depicts the studies used for the diagnosis of patients with gestation treated. The autologous immunogenic composition, prepared as per Example 1, was administered subcutaneously to each patient. About 80% of the patients showed healthy glucose levels during the second application. Table 2. Reference studies used for the diagnosis of patients with diabetes as per standard protocols. Lab tests Imaging tests Serum insulin Tomography Peptide C Magnetic resonance Glycosylated hemoglobin Ultrasound EGO Blood glucose measurement Blood chemistry General urinalysis Example 4.1: • Patient’s identification number: gr006028p6 • Date of birth: 8 / 27 / 1979 • Sex: male • Initial conditions: diabetes. Insulin resistance. Glucosuria. High glycosylated hemoglobin. Hypertension. High glucose. Diabetes medication. Pressure medication. Neuropathy • Initial values*: insulin: 8.1uiu / ml (5-25). Glycosylated hemoglobin: 9.6% (2.5-8). Pressure: 118 / 83mmhg (120 / 80). Glucose: 305mg / dl (70-120). Glycosuria: 500mg / dl (negative). Metformin: 2.55g daily. Losartan: 50mg daily. • Treatment: traditional detoxification methods. Immunogen. Medicinal herbs and mushrooms. • Months of treatment: 6 • Results: no insulin resistance. No glucosuria. Normal glycosylated hemoglobin. Normal pressure. Normal glucose. No diabetes medication. No blood pressure medication. No neuropathy • Final values*: insulin: 8.1uiu / ml (5-25). Glycosylated hemoglobin: 7% (2.5-8). Pressure: 119 / 83mmhg (120 / 80). Glucose: 131mg / dl (70-120). Glycosuria: negative (negative). Metformin: 0. Losartan: 0. • Follow-up: discharge. * The presented values indicate the result obtained with the reference to which it must be compared in parenthesis. In the cases where “Does not apply” is indicated, the results are either visible by photograph or there are no laboratory tests for the case. Example 4.2: • Patient’s identification number: jl006431p6 • Date of birth: 9 / 3 / 1949 • Sex: female • Initial conditions: diabetes. Insulin resistance. Hypertension. Scleroderma. Ankylosing spondylitis. Onychomycosis. Insulin use. Pressure medication. • Initial values*: serum insulin: 11.5 uu / ml (6-22). Insulin use: 28 units. Glucose: 117 mg / dl (70-120). Pressure: 138 / 80 mmhg (120 / 80). • Treatment: traditional detoxification methods. Immunogen. Medicinal herbs and mushrooms. • Months of treatment: 8 • Results: no insulin resistance. Normal pressure. No joint pain. No onychomycosis. No use of insulin. No blood pressure medication. • Final values*: serum insulin: 11.5 uu / ml (6-22). Insulin use: 0 units. Glucose: 119 mg / dl (70-120). Pressure: 122 / 73 mmhg (120 / 80). • Follow-up: discharge. * The presented values indicate the result obtained with the reference to which it must be compared in parenthesis. Example 4.3: • Patient’s identification number: mx006424p5 • Date of birth: 5 / 1 / 1976 • Sex: female • Initial conditions: diabetes. Produces little insulin. Onychomycosis. High glucose. Elevated glycosylated hemoglobin. Diabetes medication. Glucosuria. • Initial values*: serum insulin: 4.97 uiu / ml (1.9-23). Glucose: 288 mg / dl (70-120). Glycosylated hemoglobin: 12% (4-6). Glycosuria: 1000mg / dl (negative). Metformin 1.5gr daily. • Treatment: traditional detoxification methods. Immunogen. Medicinal herbs and mushrooms. • Months of treatment: 6 • Results: it already produces insulin. Normal glucose. Normal glycosylated hemoglobin. No diabetes medication. No glucosuria. • Final values*: serum insulin: 7.33 uiu / ml (1.9-23). Glucose: 140 mg / dl (70-120). Glycosylated hemoglobin: 7% (4-6). Glycosuria: negative (negative). Metformin:0. • Follow-up: suspension of treatment. * The presented values indicate the result obtained with the reference to which it must be compared in parenthesis. Example 4.4: • Patient’s identification number: sn003370p2 • Date of birth: 7 / 22 / 1988 • sex: male • Initial conditions: diabetes. Does not produce insulin. Neuropathy. Chronic fatigue. Insulin use. Glucosuria. Proteinuria. • Initial values*: serum insulin: <2 uiu / ml (0-17). Insulin use: 15u rapid daily + 35u medium daily. Proteinuria: 30mg / dl (negative). Glycosuria: 2.09g / dl (negative). • Treatment: traditional detoxification methods. Immunogen. Medicinal herbs and mushrooms. • Months of treatment: 6 • Results: it already produces insulin. No neuropathy. No chronic fatigue. No use of insulin. No proteinuria. • Final values*: serum insulin: 13.9 uiu / ml (2.6-24.9). Insulin use: 0. Proteinuria: negative (negative). Glycosuria: 1g / dl (negative). • Follow-up: suspension of treatment. * The presented values indicate the result obtained with the reference to which it must be compared in parenthesis. Example 4.5: • Patient’s identification number: mx006419p2 • Date of birth: 6 / 21 / 2010 • Sex: female • Initial conditions: diabetes. Insulin resistance. Insulin use. High glycosylated hemoglobin. • Initial values*: serum insulin: 8.0 uiu / ml (2.6-24.9). Insulin use: 44 units. Glucose: 91 mg / dl (70-120). Glycosylated hemoglobin: 7.92% (4-6). • Treatment: traditional detoxification methods. Immunogen. Medicinal herbs and mushrooms. • Months of treatment: 6 • Results: no insulin resistance. No use of insulin. Normal glycosylated hemoglobin. • Final values*: serum insulin: 8.0 uiu / ml (2.6-24.9). Insulin use: 0 units. Glucose: 89.5 mg / dl (70-120). Glycosylated hemoglobin: 5.53% (4-6). • Follow-up: discharge. * The presented values indicate the result obtained with the reference to which it must be compared in parenthesis. Example 4.6: • Patient’s identification number: ox004605p6 • Date of birth: 9 / 13 / 2008 • Sex: female • Initial conditions: diabetes insipidus. Supracellar arachnoidocele. Constant urination. Medication to control urination. • Initial values*: desmopressin: 0.2mg daily. • Treatment: traditional detoxification methods. Immunogen. Medicinal herbs and mushrooms. • Months of treatment: 36 • Results: no constant urination. No medication to control urination. • Final values*: desmopressin: 0. • Follow-up: discharge. * The presented values indicate the result obtained with the reference to which it must be compared in parenthesis. Example 4.7: • Patient’s identification number: MC006622P9 • Date of birth: 7 / 17 / 1974•Sex: male • Initial conditions: diabetes. Proteinuria. Diabetes medication. Has Pressure medication. Onychomycosis. Obesity • Treatment: traditional detoxification methods. Immunogen. Medicinal herbs and mushrooms. • Months of treatment: 4 • Results: no proteinuria. No diabetes medication. Weight reduction. Follow-up: in treatment Example 4.8: • Patient’s identification number: JL005300P6•Date of birth: 2 / 2 / 1948 • Sex: male • Initial conditions: diabetes. Discharge glucose. Low insulin. Onychomycosis. Pain in legs. Dizziness diabetes medication. Pressure medication. Glycosuria. Proteinuria. • Treatment: traditional detoxification methods. Immunogen. Medicinal herbs and mushrooms. • Months of treatment: 16 • Results: normal glucose. Normal insulin. Onychomycosis almost eliminated. No leg pain. No dizziness. No diabetes medication. Reduction of blood pressure medication. No glycosuria. No proteinuria.•Follow-up: in treatment. To eliminate onychomycosis and pressure medication. Example 4.9: • Patient’s identification number: CM004841P0•Date of birth: 1 / 7 / 1961 • Sex: female • Initial conditions: diabetes. Discharge glucose. Diabetes medication. Discharge pressure. Pressure medication. Onychomycosis. • Treatment: traditional detoxification methods. Immunogen. Medicinal herbs and mushrooms. • Months of treatment: 24•Results: normal glucose. No diabetes medication. Normal pressure. No blood pressure medication. No onychomycosis. • Follow-up: discharge Example 4.10: • Patient’s identification number: SN003947P6 • Date of birth: 7 / 25 / 1942 • Sex: female • Initial conditions: diabetes. Low insulin. Pressure medication. Glucose medication. • Treatment: traditional detoxification methods. Immunogen. Medicinal herbs and mushrooms. • Months of treatment: 18 • Results: normal insulin. No blood pressure medication. • Follow-up: discharge Example 5: Application of Immunogenic Composition in patients with Thyroid diseases Objectives of disease treatment for Hyperthyroidism, hypothyroidism: • Identify if the damage is glandular or hormonal. • Regulate the production of thyroid hormones. • Promote the possibility of eliminating the need for conventional medications. • Correct, in case of hypothyroidism, fatigue, apathy or depression, intolerance to temperature changes, decreased concentration, dry skin, deterioration or loss of hair, deterioration of nails, weight gain, gastrointestinal disorders, excessive sleepiness, and others symptoms derived from the initial illness. • Correct, in case of hyperthyroidism, excessive nervousness, insomnia, palpitations, unexplained tiredness, sweating, heat intolerance, hand tremors, weight loss, gastrointestinal disorders, excessive drowsiness, and other symptoms derived from the initial illness. • Avoid the side effects of conventional medications. Hypothyroidism treated patients: >70. A group of hypothyroidisms treated patients were selected for this study. Table 3 depicts the studies used for the diagnosis of patients with hypothyroidism treated. The autologous composition, prepared as per Example 1, was administered subcutaneously to each patient. The average patient required between four and five immunogenic applications, having an autonomous increase in hormone production. Antiperoxidase antibodies and / or antithyroglobulin antibodies disappeared in about 50% of the cases. About 80% of the patients followed the immunogenic application adequately, and patients with hypothyroidism had stopped requiring complementary medication and obtained favorable results, both in studies and in qualitative symptoms of hypothyroidism. Hyperthyroidism treated patients: >10. A group of hyperthyroidisms treated patients were selected for this study. Table 3 depicts the studies used for the diagnosis of patients with hyperthyroidism treated. The autologous immunogenic composition, prepared as per Example 1, was administered subcutaneously to each patient. There was variability between four and six immunogenic applications per patient, where hormone production was decreased without the use of radioactive iodine or surgery. About 70% of the patients followed the immunogenic application adequately, and stopped requiring complementary medication and obtained favorable results, both in studies and in qualitative symptoms of hyperthyroidism. Table 3. Reference studies used for the diagnosis of patients with thyroid diseases as per standard protocols. Lab tests Imaging tests Ac. antiperoxidase Ultrasound Thyroid profile (TSH, free T3, T4) Ac. antithyroglobulin Radioactive iodine uptake Antithyroid antibodies Example 5.1: • Patient’s identification number: ox004890p0 • Date of birth: 1 / 23 / 1996 • Sex: female • Initial conditions: hyperthyroidism. Elevated antithyroid antibodies. Thyroid medication. Thyroid profile with high values. • Initial values*: ac. Antiperoxidase: 303.84 iu / ml (0-5.61). Thiamazol: 30mg daily. Thyroid stimulating hormone: <0.01 uiu / ml (0.3-4.5). Free t3: 5.57 pg / ml (1.5-4.1). Free t4: 1.88 ng / dl (0.89-1.76). • Treatment: traditional detoxification methods. Immunogen. Medicinal herbs and mushrooms. • Months of treatment: 24 • Results: normal antithyroid antibodies. No thyroid medication. Thyroid profile with normal values. • Final values*: ac. Antiperoxidase: 198.57 iu / ml (0-5.61). Thiamazol: 0. Thyroid- stimulating hormone: 0.48 uui / ml (0.3-4.5). Free t3: 2.93 pg / ml 2-4.2). Free t4: 1.72 ng / dl (0.89-1.72). • Follow-up: discharge. * The presented values indicate the result obtained with the reference to which it must be compared in parenthesis. In the cases where “does not apply” is indicated, the results are either visible by photograph or there are no laboratory tests for the case. Example 6: Application of Immunogenic Composition in patients with Systemic diseases Rheumatoid arthritis treated patients: >150 Objectives of disease treatment for Arthritis: • Identify the presence of antistreptolysins and inflammatory markers. • Promote the reduction of inflammation of the affected parts. • Reduce the patient's functional limitation. • Reduce the possibility of suffering similar future injuries. • Avoid the side effects of conventional medications. A group of rheumatoid arthritis treated patients were selected for this study. Table 4 depicts the studies used for the diagnosis of patients with rheumatoid arthritis treated. The autologous immunogenic composition, prepared as per Example 1, was administered subcutaneously to each patient. Following the first application of the immunogenic composition, there was remission of symptoms. till reaching the sixth immunogenic application in patients with more resistance. About 90% of the patients followed the immunogenic application adequately, showed favorable changes such as decreased inflammation of the joints and recovery of functional limitation, enough to be discharged from the medical service. Systemic lupus erythematosus treated patients: > 20 A group of systemic lupus erythematosus treated patients were selected for this study. Table 4 depicts the studies used for the diagnosis of patients with systemic lupus erythematosus treated. The autologous immunogenic composition, prepared as per Example 1, was administered subcutaneously to each patient. All the Systemic lupus patients treated with immunogenic composition showed functional improvement from the first immunogenic application, with remission of symptoms after four to six immunogenic applications. About 60% of the patients followed the immunogenic application adequately, with an increase in its functionality and with negativity in the presence of specific antibodies. Scleroderma treated patients: >10 A group of scleroderma treated patients were selected for this study. Table 4 depicts the studies used for the diagnosis of patients with scleroderma treated. The autologous immunogenic composition, prepared as per Example 1, was administered subcutaneously to each patient. In the case of biopsies in Barrett's esophagus, frank inflammation reduction and recovery of esophageal functionality were found. About 55% of the patients followed the immunogenic application adequately and the disappearance of specific antibodies was achieved, in addition to presenting a decrease in CREST syndrome (Calcinosis, Reynaud's phenomenon, Esophageal dysfunction, Sclerodactyly, Telangiectasia). Table 4. Reference studies used for the diagnosis of patients with systemic diseases as per standard protocols. Lab tests Imaging tests Complete blood count Ultrasound C-reactive protein Magnetic resonance Erythrocyte sedimentation rate Bone scan Rheumatoid factor Tomography Rheumatic profile with streptomycins Synovial fluid analysis Ac. anti collagen Ac. antinuclear Ac. anticentromere Ac. Anti-SCL 70 Ac. anti-double-stranded DNA Ac. Antiphospholipids Ac. anti smith Biopsy Ac. Anti-SSA or anti-SSB Erythrocyte sedimentation rate Example 6.1: Patient’s identification number: pb002974p6 • Date of birth: 1 / 21 / 1984 • Sex: female • Initial conditions: arthritis. Non-steroidal anti-inflammatory drug. He can't walk. High rheumatoid factor. Microbacterial infections. • Initial values*: rheumatoid factor: 2560iu / ml (<=20). C-reactive protein: 96mg / l (<=6). • Treatment: traditional detoxification methods. Immunogen. Medicinal herbs and mushrooms. • Months of treatment:24 • Results: no non-steroidal anti-inflammatory medication. He can walk now. Normal rheumatoid factor. No microbacterial infections. • Final values*: rheumatoid factor: 128mg / dl(<=8). C-reactive protein: 6mg / dl. (<=6). • Follow-up: discharge. * The presented values indicate the result obtained with the reference to which it must be compared in parenthesis. In the cases where “does not apply” is indicated, the results are either visible by photograph or there are no laboratory tests for the case. Example 7: Application of Immunogenic Composition for the treatment of patients with Chronic renal failure Chronic renal failure treated patients: >70. A group of chronic renal failure treated patients were selected for this study. Table 5 depicts the studies used for the diagnosis of patients with chronic renal failure treated. The autologous immunogenic composition, prepared as per Example 1, was administered subcutaneously to each patient. Between four and six immunogenic applications per patient, improvement in their symptoms was achieved, for example, the decrease in edema in the legs, and improvement in laboratory results was observed. About 75% of the patients followed the immunogenic application adequately, and obtained favorable results, recovering renal function up to the 80%. Table 5. Reference studies used for the diagnosis of patients with chronic renal failure as per standard protocols. Lab tests Imaging tests Renal filtration percentage Tomography EGO Magnetic resonance Blood chemistry Biopsy Ac. antinuclear Ac. Anti-glomerular basement membrane Example 7.1: • Patient’s identification number: df001016p1 • Date of birth: 6 / 20 / 1947 • sex: female • Initial conditions: chronic renal failure. Dialysis. High urea. High creatinine. Low microproteins. Diabetes. insulin use. Hypertension. Pressure medication. High anti- chickenpox antibodies. Medication for dyslipidemia. Cortisone. • Initial values*: dialysis: 3 times a week. Urea: 177mg / dl (15-38). Creatinine: 2.1 mg / dl (0.6-1.3). Microproteins 13.6mg / dl (60-133). Anti-varisella ac: 4512 iu / ml (negative). Injected insulin: 12u daily. Furosemide: 40mg daily. Nifedipine: 30mg daily. Clonazepam: 5mg daily. Bezafibrate: 200mg daily. Cortizone: 50mg daily. • Treatment: traditional detoxification methods. Immunogen. Medicinal herbs and mushrooms. • Months of treatment: 24 • Results: no dialysis. Urea decreases. Creatinine decreases. Normal microproteins. No use of insulin. Normal pressure. No blood pressure medication. Normal anti-chickenpox antibodies. No medication for dyslipidemia. No cortisone. • Final values*: dialysis: 0. Urea: 113mg / dl (15-38). Creatinine: 1.8mg / dl (0.6-1.3). Microproteins 161 mg / dl (60-133). Anti-varisella ac: <150 iu / ml (negative). Injected insulin: 0. Furosemide: 0. Nifedipine replaced by adalat: 10 mg daily. Clonazepam: 5mg daily. Bezafibrate: 200mg daily. Cortizone: 0. • Follow-up: discharge. * The presented values indicate the result obtained with the reference to which it must be compared in parenthesis. In the cases where “does not apply” is indicated, the results are either visible by photograph or there are no laboratory tests for the case. Example 8: Application of Immunogenic Composition in patients with liver diseases Autoimmune hepatitis treated patients: >10. A group of autoimmune hepatitis treated patients were selected for this study. Table 6 depicts the studies used for the diagnosis of patients with autoimmune hepatitis treated. The autologous immunogenic composition, prepared as per Example 1, was administered subcutaneously to each patient. Following from the immunogenic application, remission of symptoms occurred, and concluded with four applications in total. The Acs disappeared. Anti-smooth muscle I and showed normal liver function tests. About 100% of the patients followed the immunogenic application adequately and obtained favorable results. Hepatitis C. treated patients: >10. A group of hepatitis C. treated patients were selected for this study. Table 6 depicts the studies used for the diagnosis of patients with hepatitis C. treated. The autologous immunogenic composition, prepared as per Example 1, was administered subcutaneously to each patient. Improvement of symptoms showed from the second immunogenic application, and about 40% of patients received up to 10 immunogenic applications. A decrease in quantity and size of esophageal varices was observed. About 80% of the patients followed the immunogenic application adequately, and obtained favorable results, with disappearance of the hepatic alteration. Table 6. Reference studies used for the diagnosis of patients with liver diseases as per standard protocols. Lab tests Imaging tests Ac. Anti smooth muscle I Tomography Liver function profile Magnetic resonance Biopsy Ultrasound Ac. antinuclear Ac. Antimitochondrials Serum IgG Example 9: Application of Immunogenic Composition in patients with Nonspecific chronic ulcerative colitis and Crohn's disease Treated patients: >10. A group of nonspecific chronic ulcerative colitis and Crohn's disease treated patients were selected for this study. Table 7 depicts the studies used for the diagnosis of patients treated with nonspecific chronic ulcerative colitis and Crohn's disease. The autologous immunogenic composition, prepared as per Example 1, was administered subcutaneously to each patient. All the patients suffered with nonspecific chronic ulcerative colitis and Crohn's disease showed a decrease in intestinal inflammation and digestive tract bleeding from the first immunogenic application, and the digestive function such as diarrhea, flow, tenesmus, mucus began to normalize. About 20% needed four immunogenic applications. About 90% of the patients followed the immunogenic application adequately, and obtained favorable results, showing full recovery in imaging and laboratory tests. Table 7. Reference studies used for the diagnosis of patients with Nonspecific chronic ulcerative colitis and Crohn's disease as per standard protocols. Lab tests Imaging tests Occult blood in feces Endoscopy Blood count Tomography Biopsy Magnetic resonance Example 10: Application of Immunogenic Composition patients with Cancer Prostate cancer treated patients: >10. Objectives of disease treatment for Prostate cancer: • Measure the presence and behavior of tumor markers. • Stop, as far as possible, the degenerative process. • Avoid general metastasis. • Promote, as far as possible, the elimination of the tumor. • Avoid, as far as possible, the need for more aggressive therapies. • Reduce the negative effect of alternative therapies. A group of prostate cancer treated patients were selected for this study. Table 8 depicts the studies used for the diagnosis of patients with prostate cancer treated. The autologous immunogenic composition, prepared as per Example 1, was administered subcutaneously to each patient. Following the first application of immunogenic composition, relief in inflammation was observed, with fluctuation of tumor markers. In the second immunogenic application, a consistent decrease in tumor markers was observed. Up to the six immunogenic applications, about 90% of the patients followed the immunogenic application adequately and were discharged with markers at normal levels and without urinary symptoms. Table 8. Reference studies used for the diagnosis of patients with prostate cancer as per standard protocols. Lab tests Imaging tests Prostate specific antigen Ultrasound Biopsy Breast cancer treated patients: >10. Objectives of disease treatment for breast cancer: • Measure the presence and behavior of tumor markers. • Stop, as far as possible, the degenerative process. • Avoid general metastasis and contralateral organ. • Promote, as far as possible, the elimination of the tumor. • Avoid, as far as possible, the need for more aggressive therapies. • Reduce the negative effect of alternative therapies. A group of Brest cancer treated patients were selected for this study. Table 9 depicts the studies used for the diagnosis of patients with Brest cancer treated. The autologous immunogenic composition, prepared as per Example 1, was administered subcutaneously to each patient. With the first immunogenic application, a decrease in tumor markers was observed, with a fluctuation between four and twelve immunogenic applications. Results on tumor varied; in different cases calcification, expulsion, dissectation of the affected tissue, possibility of extirpation of the tumor tissue was observed. About 70% of the patients followed the immunogenic application adequately, and obtained favorable results. Tumor markers were obtained below the reference limit. Table 9. Reference studies used for the diagnosis of patients with breast cancer as per standard protocols. Lab tests Imaging tests Tumor markers Ultrasound Biopsy Mammography Colon cancer treated patients: >10. A group of colon cancer treated patients were selected for this study. Table 10 depicts the studies used for the diagnosis of patients with colon cancer treated. The autologous immunogenic composition, prepared as per Example 1, was administered subcutaneously to each patient. Between two and eight immunogenic applications, a decrease in pain and bleeding in the digestive tract was observed, and the volume of the tumors decreased in size as the treatment progressed; the adenomegaly also disappeared, the patients showed weight gain, and regularization of their digestive functions. About 80% of the patients followed the immunogenic application adequately and were discharged with markers at normal levels and a remission of the symptoms. Table 10. Reference studies used for the diagnosis of patients with colon cancer as per standard protocols. Lab tests Imaging Test Tumor markers Endoscopy Biopsy Tomography Magnetic resonance Example 10.1: • Patient’s identification number: mr005716p2 • Date of birth: 5 / 19 / 1954 • sex: female • Initial conditions: colon cancer. Tumor. Cuci. Daily bleeding. Elevated carcinoembryonic antigen. Onychomycosis. Articulations pain. Positive febrile reactions. Arthritis. Elevated c-reactive protein. • Initial values*: carcinoembryonic ag: 13.33ng / ml (<5). Erythrocyte sedimentation rate: 36mm / hr (0-15). • Treatment: traditional detoxification methods. Immunogen. Medicinal herbs and mushrooms. • Months of treatment: 24 • Results: no bleeding. Normal carcinoembryonic antigen. No joint pain. Negative febrile reactions. Normal creactive protein. • Final values*: carcinoembryonic ag: 0.79ng / ml (<5). C-reactive protein: 6 mg / l (<6). • Follow-up: in treatment. * The presented values indicate the result obtained with the reference to which it must be compared in parenthesis. In the cases where “does not apply” is indicated, the results are either visible by photograph or there are no laboratory tests for the case. Example 10.2: • Patient’s identification number: mx006530p6 • Date of birth: 11 / 27 / 1997 • Sex: female • Initial conditions: cancer. Myelodysplasia. Low leukocytes. Low platelets, low erythrocytes. Psychomotor delay. Convulsive crisis. Medication for seizures. • Initial values*: leukocytes: 1600 mm3 (4500-11000). Platelets: 67,000 mm3 / ul (150,000- 450,000) erythrocytes: 1.47 mill / ul (3.8-5.8). Clonazepam: 2mg daily. Lacosamide: 250mr daily. Levetiracetam: 1g daily. Temperator: 1.2gr daily. Topiramate: 300mg daily. • Treatment: traditional detoxification methods. Immunogen. Medicinal herbs and mushrooms. • Months of treatment: 2 • Results: normal leukocytes. Normal platelets. Normal erythrocytes. No seizures. Reduce medication for seizures. • Final values*: leukocytes: 6.24 thousands / ul (3.6-11). Platelets: 222 miles / ul (150,500). Erythrocytes: 4.27 mill / ul (4.5-5.2). Clonazepam: 0. Lacosamide: 150mr daily. Levetiracetam: 1g daily. Topiramate: 300mg daily. • Follow-up: discharge. * The presented values indicate the result obtained with the reference to which it must be compared in parenthesis. Example 10.3: • Patient’s identification number: mr002459p0 • Date of birth: 3 / 22 / 1973 • Sex: female • Initial conditions: multiple myeloma. High tumor marker. High inflammation marker. Bone tumor. Motor disability. Cerebellar syndrome. Medication for spasms. • Initial values*: b2-microglobulin: 2263 mg / l (0.2-5.8). Igg: 55900 g / l (7000-16000) • Treatment: traditional detoxification methods. Immunogen. Medicinal herbs and mushrooms. • Months of treatment: 24 • Results: normal tumor marker. Normal inflammation marker. No bone tumor. Without motor disability. Without cerebellar syndrome. No spasm medication. • Final values*: b2-microglobulin: 1.94 mg / l (1.59-2.53). Igg: 8080 g / l (7000-16000) • Follow-up: discharge. • Notes: * The presented values indicate the result obtained with the reference to which it must be compared in parenthesis. Example 11: Application of Immunogenic Composition in patients with diseases due to Viral infection Human papillomavirus treated patients: >10. A group of human papilloma virus treated patients were selected for this study. Table 11 depicts the studies used for the diagnosis of patients with human papillomavirus treated. The autologous immunogenic composition, prepared as per Example 1, was administered subcutaneously to each patient. Improvements was observed between one and five immunogenic applications, with disappearance of visible lesions by colposcopy and correction of condylomas (genital warts). About 80% of the patients adequately followed the application of the immunogenic composition and were discharged without lesions and negative results in the PCR lab test. Table 11. Reference studies used for the diagnosis of patients with human papilloma virus as per standard protocols. Lab tests Imaging tests PCR for HPV Colposcopy Immunoglobulin G (IgG) Covid 19 treated patients: >400. A group of Covid 19 treated patients were selected for this study. Table 12 depicts the studies used for the diagnosis of patients with Covid 19 treated. The autologous immunogenic composition, prepared as per Example 1, was administered subcutaneously to each patient. With the first application, disseminated vascular coagulation was avoided, and patients did not suffer from sudden death. Once the active infection disappeared, the patients required up to 3 more immunogenic applications to eliminate the sequelae developed post infection. About 98.5% of the patients adequately followed the immunogenic application and obtained favorable results, avoiding death and eliminating sequelae. Table 12. Reference studies used for the diagnosis of patients with Covid 19 as per standard protocols. Lab tests PCR for Covid 19 Immunoglobulin G (IgG) HIV / AIDS treated patients: >5. A group of HIV / AIDS treated patients were selected for this study. Table 13 depicts the studies used for the diagnosis of patients with HIV / AIDS treated. The autologous immunogenic composition, prepared as per Example 1, was administered subcutaneously to each patient. Between two and six immunogenic applications, a decrease in viral loads was observed, and correction of lymphocyte subpopulations was observed. About 85% of the patients adequately followed the immunogenic application and were discharged with undetectable viral loads and remission of symptoms. Table 13. Reference studies used for the diagnosis of patients with HIV AIDS as per standard protocols. Lab tests Anti-HIV antibodies Western blot test Viral load Lymphocyte subpopulations Example 11.1: • Patient’s identification number: mx002223p7 • Date of birth: 12 / 20 / 1961 • Sex: male • Initial conditions: positive anti hiv antibodies. High viral load. Low cd4. • Initial values*: viral load: 46 (negative). Cd4: 1020 cells / mm3 (500-1700). • Treatment: traditional detoxification methods. Immunogen. Medicinal herbs and mushrooms. • Months of treatment: 12 • Results: undetectable viral load. High cd4. No manifestations of disease. • Final values*: viral load: not detected (negative). Cd4: 1020 cells / mm3 (500-1700). • Follow-up: discharge. • Notes: * The presented values indicate the result obtained with the reference to which it must be compared in parenthesis. Example 11.2: • Patient’s identification number: df002093p5 • Date of birth: 7 / 27 / 1943 • Sex: male • Initial conditions: positive anti-HIV antibodies. High viral load. Low cd4. Hepatitis c positive. • Initial values*: hiv viral load: 166,267 copies / ml (<40). Cd4: <20 cells / ul (490-1740). Hepatitis c viral load: positive. • Treatment: traditional detoxification methods. Immunogen. Medicinal herbs and mushrooms. • Months of treatment: 12 • Results: undetectable viral load. High cd4. No manifestations of disease. Normal glucose. • Final values*: hiv viral load: <40 undetectable (<40). Cd4: 238 cells / ul (457-1536). Hepatitis c viral load: <12 iu / ml (<12). • Follow-up: in treatment. * The presented values indicate the result obtained with the reference to which it must be compared in parenthesis. Example 12: Multiple Sclerosis • Patient’s identification number: mx004647p1 • Date of birth: 12 / 23 / 1990 • Sex: female • Initial conditions: multiple sclerosis. Medication for depression. Back pain. Inability to move. Muscle spasms. Fatigue. Positive antimyelin antibodies. Chickenpox antibodies. • Initial values*: fluoxetine: 30mg. Ac. Antimyelin: 12.8 mom (0-1.9). Anti-varicella zoster igg antibody: 375.46 iu / l (<80). Ac antivaricella zoster igm: 1.19 c (<0.8). • Treatment: traditional detoxification methods. Immunogen. Medicinal herbs and mushrooms. • Months of treatment: 22 • Results: no depression medication. No back pain. No inability to move. No muscle spasms. Without fatigue. Minimal antimyelin antibodies. Chickenpox antibodies negative. • Final values*: fluoxetine: 0. Ac. Antimyelin: 6.2 mom (0-1.9). Anti-varicella zoster igg antibody: 50 iu / l (<80). • Ac antivaricella zoster igm: 0.7 c (<0.8). • Follow-up: discharge. * The presented values indicate the result obtained with the reference to which it must be compared in parenthesis. Example 13: Sweet Syndrome (acute febrile neutrophilic dermatoses) • Patient’s identification number: cc005405p6 • Date of birth: 9 / 21 / 1954 • Sex: female • Initial conditions: sweet syndrome. High neutrophils. Proteinuria. Ketonuria. Myxedema. Erythematous plaques and nodules. • Initial values*: neutrophils: 10.19 thousands / ul (1.69-7.16) proteinuria: 25 mg / dl (negative). Ketonuria: 15mg / dl (negative). • Treatment: traditional detoxification methods. Immunogen. Medicinal herbs and mushrooms. • Months of treatment: 18 • Results: normal neutrophils. No proteinuria. No ketonuria. No myxedema. Without erythematous plaques and nodules. • Final values*: neutrophils: 2448 mm3 (2000-6300). Proteinuria: negative (negative). Ketonuria: negative (negative). • Follow-up: discharge. * The presented values indicate the result obtained with the reference to which it must be compared in parenthesis. References: 1. Alberts, B., Johnson, A., Lewis, J., Raff, M., Roberts, K., & Walter, P. (2002). Molecular Biology of the Cell. Garland Science. https: / / www.ncbi.nlm.nih.gov / books / NBK26876 / National of Allergy and Infectious Diseases. (2020). Understanding the Immune System: Institute How It Works. https: / / www.niaid.nih.gov / research / immune-system-how-it-works. 2. (Abbas AK, Lichtman AH, Pillai S. Cellular and Molecular Immunology. 9th ed. Elsevier; 2018.Janeway CA Jr, Travers P, Walport M, et al. Immunobiology: The Immune System in Health and Disease. 5thed. Garland Science; 2001. Chapter 1, Introduction to the Immune System. Available at: 3. Knipe, D.M., & Howley, P.M. (Eds.). (2013). Fields virology (6th ed.). Lippincott Williams & Wilkins. 4. World Health Organization (WHO). https: / / www.who.int / es / news-room / fact- sheets / detail / 5. American Autoimmune Related Diseases Association. (2021). Autoimmune Information. https: / / www.aarda.org / diseaselist / National Institute of Allergy and Infectious Diseases. (2020). Autoimmune Diseases. https: / / www.niaid.nih.gov / diseases-conditions / autoimmune-diseases 6. American Autoimmune Related Diseases Association. Autoimmune Diseases. 7. Jacobson DL, Gange SJ, Rose NR, Graham NM. Epidemiology and estimated population burden of selected autoimmune diseases in the United States. Clin Immunol Immunopathol.1997;84(3):223-243. doi:10.1006 / clin.1997.4412 8. Eaton WW, Rose NR, Kalaydjian A, Pedersen MG, Mortensen PB. Epidemiology of autoimmune diseases in Denmark. J Autoimmune. 2007;29(1):1-9. doi:10.1016 / j.jaut.2007.05.002 9. Witebsky E, Rose NR, Terplan K, Paine JR, Egan RW. Chronic thyroiditis and autoimmunization. NEVER. 1957;164(13):1439-1447. doi:10.1001 / jama.1957.02980130005002 10. Cooper GS, Bynum ML, Somers EC. Recent insights in the epidemiology of autoimmune diseases: Improved prevalence estimates and understanding of clustering of diseases. J Autoimmune.2009;33(3-4):197-207. doi:10.1016 / j.jaut.2009.09.008 Prevention and control World Health Organization (WHO). (2022). Non- communicable diseases. https: / / www.who.int / es / news-room / fact- sheets / detail / noncommunicable-diseases World Health Organization (WHO). Noncommunicable diseases. https: / / www.who.int / news-room / fact-sheets / detail / noncommunicable-diseases Mendis S, Puska P, Norrving B; World Health Organization. Global Atlas on Cardiovascular Disease Prevention and Control. World Health Organization; 2011. Available at: https: / / apps.who.int / iris / handle / 10665 / 44701 Rheumatoid arthritis patients are also at increased risk of cardiovascular disease. American College of Rheumatology. (2021). Cardiovascular disease and rheumatic diseases.https: / / www.rheumatology.org / I-Am-A / Patient-Caregiver / Diseases- National Institute of Arthritis and Musculoskeletal and Skin Diseases. (2021), Autoimmune Diseases. https: / / www.niams.nih.gov / health- topics / autoimmune-diseases

Claims

We Claim:

1. An autologous immunogenic composition for the treatment of a viral infection, an autoimmune disease, or a non-communicable disease in a subject in need thereof, comprising: a. complete leukocyte fraction isolated from a blood sample of the subject; b. optionally comprising a platelet-rich plasma fraction isolated from the blood sample of the subject; and c. a vehicle.

2. The immunogenic composition as claimed in claim 1, wherein the vehicle is a hypotonic solution; wherein the composition is stored at a temperature ranging from about 2°C to about 4°C; wherein the composition is in the form of a suspension; and / or wherein the immunogenic composition does not comprise any preservative.

3. The immunogenic composition as claimed in claim 1 or claim 2, wherein the immunogenic composition comprises about 20% w / w to about 30% w / w of the complete leukocyte fraction, about 10% w / w to about 25% w / w of the platelet-rich plasma fraction; and about 60% w / w to about 70% w / w of the vehicle.

4. The immunogenic composition as claimed in any of claims 1-3, wherein the subject is a mammal, preferably human; wherein the immunogenic composition is subject specific.

5. The immunogenic composition as claimed in claims 1 to 4, wherein the immunogenic composition is used for first choice treatment, second choice treatment, third choice treatment, adjunctive therapy, or a replacement therapy, preferably an adjunctive therapy.

6. The immunogenic composition as claimed in any of claims 1 to 5, wherein the viral infection is selected from a group comprising common cold, flu, COVID-19, hepatitis B, hepatitis C, HIV / AIDS, dengue, tuberculosis, herpes simplex (HSV), chickenpox, measles and human papillomavirus (HPV) or any combination thereof; the autoimmune disease is selected from a group comprising Hashimoto's thyroiditis, Graves' disease, rheumatoid arthritis, systemic lupus erythematosus, diabetes type 1, Celiac disease, Multiple Sclerosis, Crohn's disease, Ulcerative colitis, Psoriasis, Sjogren's syndrome and neutrophilic dermatoses or any combination thereof; and the non-communicable disease is selected from a group comprising cardiovascular disease, Type 2 diabetes, Chronic respiratory disease, cancer, neuropsychiatric illnesses, obesity and chronic kidney disease or any combination thereof.

7. The immunogenic composition as claimed in any of claims 1 to 6, wherein the complete leukocyte fraction isolated from the blood sample are those that are active as a consequence of an immunological or an autoimmune response corresponding to the disease to be treated; and / or wherein the composition has an antigenic effect and has the capacity to induce a new specific humoral and / or cellular immune response against the antibodies or autoantibodies that promote the disease to be treated.

8. A method for preparing an autologous immunogenic composition, comprising steps of: - obtaining blood sample from a subject having a viral infection, an autoimmune disease, or a non-communicable disease; - centrifuging the collected blood sample at a speed ranging from about 3000 rpm to about 6000 rpm; - isolating complete leukocyte fraction optionally along with platelet-rich plasma fraction from the centrifuged blood sample; and - mixing the isolated complete leukocyte fraction optionally along with the platelet-rich plasma fraction with a vehicle to obtain the autologous immunogenic composition.

9. The method as claimed in claim 8, wherein the vehicle is a hypotonic solution; wherein the composition is stored at a temperature ranging from about 2°C to about 4°C; wherein the immunogenic composition is packaged in a pharmaceutical vial form; wherein the composition is in the form of a suspension; and / or wherein the immunogenic composition does not comprise any preservative.

10. The method as claimed in claim 8 or claim 9, wherein the immunogenic composition comprises about 20% w / w to about 30% w / w of the complete leukocyte fraction, about 10% w / w to about 25% w / w of the platelet-rich plasma fraction; and about 60% w / w to about 70% w / w of the vehicle.

11. The method as claimed in claim 9, wherein the centrifugation is carried out for a period of about 3 to about 7 minutes, preferably about 5 minutes; and / or wherein the blood sample obtained from the subject is mixed with an anticoagulant selected from a group comprising ethylenediamine tetraacetic acid, Citrate-Phosphate-Dextrose-Adenine (C.P.D.A-1), and Citrate-Phosphate-Dextrose (C.P.D. + Adsol).

12. The method as claimed in any of claims 8-11, wherein the subject is a mammal, preferably human; wherein the immunogenic composition is subject specific; wherein the immunogenic composition is used for first choice treatment, second choice treatment, third choice treatment, adjunctive therapy, or a replacement therapy, preferably an adjunctive therapy; wherein the complete leukocyte fraction isolated from the bloodsample are those that are active as a consequence of an immunological or an autoimmune response corresponding to the disease to be treated; and / or wherein the composition has an antigenic effect and has the capacity to induce a new specific humoral and / or cellular immune response against the antibodies or autoantibodies that promote the disease to be treated.

13. The method as claimed in any of claims 8-12, wherein the disease to be treated is selected from a group comprising a viral infection, an autoimmune disease, or a non-communicable disease or a combination thereof; wherein the viral infection is selected from a group comprising common cold, flu, COVID-19, hepatitis B, hepatitis C, HIV / AIDS, dengue, tuberculosis, herpes simplex (HSV), chickenpox, measles and human papillomavirus (HPV) or any combination thereof; wherein the autoimmune disease is selected from a group comprising Hashimoto’s thyroiditis, Graves’ disease, rheumatoid arthritis, systemic lupus erythematosus, diabetes type 1, Celiac disease, Multiple Sclerosis, Crohn’s disease, Ulcerative colitis, Psoriasis, Sjogren’s syndrome and neutrophilic dermatoses or any combination thereof; and / or wherein the non-communicable disease is selected from a group comprising cardiovascular disease, Type 2 diabetes, Chronic respiratory disease, cancer, neuropsychiatric illnesses, obesity and chronic kidney disease or any combination thereof.

14. An autologous immunogenic composition, obtained by the method as claimed in any of claims 1-13.

15. A method for inducing an immune response in subject having a viral infection, an autoimmune disease, or a non-communicable disease, wherein the method comprises: administering the autologous immunogenic composition as claimed in any of claims 1-6 to the subject in an effective amount to induce the immune response, characterised in that the autologous immunogenic composition is produced from blood sample of the subject post onset of the viral infection, the autoimmune disease, or the non-communicable disease.

16. The method as claimed in claim 15, wherein the subject is administered with about 10 ml to about 12 ml of the autologous immunogenic composition; wherein the composition is preferably administered subcutaneously; wherein the subject is a mammal, preferably human; wherein the immunogenic composition is used for first choice treatment, second choice treatment, third choice treatment, adjunctive therapy, or a replacement therapy, preferably an adjunctive therapy; wherein the complete leukocyte fraction isolated from the blood sample are those that are active as a consequence of an immunological or anautoimmune response corresponding to the disease to be treated; and / or wherein the composition has an antigenic effect and has the capacity to induce a new specific humoral and / or cellular immune response against the antibodies or autoantibodies that promote the disease to be treated.

17. The method as claimed in claim 15 or 16, wherein the viral infection is selected from a group comprising common cold, flu, COVID-19, hepatitis B, hepatitis C, HIV / AIDS, dengue, tuberculosis, herpes simplex (HSV), chickenpox, measles and human papillomavirus (HPV); wherein the autoimmune disease is selected from a group comprising Hashimoto's thyroiditis, Graves' disease, rheumatoid arthritis, systemic lupus erythematosus, diabetes type 1, Celiac disease, Multiple Sclerosis, Crohn's disease, Ulcerative colitis, Psoriasis, Sjogren's syndrome and neutrophilic dermatoses; wherein the non-communicable disease is selected from a group comprising cardiovascular disease, Type 2 diabetes, Chronic respiratory disease, cancer, neuropsychiatric illnesses, obesity and chronic kidney disease.

18. A method for treating a viral infection, an autoimmune disease or a non-communicable disease in a subject in need thereof, wherein the method comprises acts of: - detoxification of the subject, - administering the autologous immunogenic composition as claimed in any of claims 1- 6 to the subject in an effective amount to induce the immune response, characterized in that the autologous immunogenic composition is produced from blood sample of the subject post onset of the viral infection, the autoimmune disease, or the non- communicable disease, - administering the subject with a nutraceutical composition, and - optionally rehabilitating the subject.

19. The method as claimed in claim 18, wherein the detoxification is carried out by employing one or more of steam shower, digestive cleansing, ionic foot bath, mineral solutions, acid solutions, herbal extracts, or removal of cavities and amalgams; wherein the subject is administered with about 10 ml to about 12 ml of the autologous immunogenic composition; wherein the immunogenic composition is preferably administered subcutaneously; wherein the nutraceutical composition is selected from a group comprising extracts of medicinal mushrooms, plant extracts and nutraceuticals are used, such as amino acids; wherein the nutraceutical composition is administered orally; and / or wherein the rehabilitation comprises activities selected from group comprising physiotherapy, yoga, meditation and / or psychological therapy.

20. The method as claimed in claim 15 or 16, wherein the subject is a mammal, preferably human; wherein the viral infection is selected from a group comprising common cold, flu, COVID-19, hepatitis B, hepatitis C, HIV / AIDS, dengue, tuberculosis, herpes simplex (HSV), chickenpox, measles and human papillomavirus (HPV); wherein the autoimmune disease is selected from a group comprising Hashimoto's thyroiditis, Graves' disease, rheumatoid arthritis, systemic lupus erythematosus, diabetes type 1, Celiac disease, Multiple Sclerosis, Crohn's disease, Ulcerative colitis, Psoriasis and Sjogren's syndrome; wherein the non-communicable disease is selected from a group comprising cardiovascular disease, Type 2 diabetes, Chronic respiratory disease, cancer, neuropsychiatric illnesses, obesity and chronic kidney disease.

Citation Information

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