Injectable and localized biotechnological mesotherapy solution for scalp containing a micro-RNA / exosome / stem cell cocktail and active ingredients suitable for regional needs and production method thereof

Abstract

The invention relates to a sterile biotechnological solution for use in the medical aesthetics sector, enriched with stem cells incorporating micro-RNA technology, amino acids, hyaluronic acid, peptides, and vitamins; which nourishes hair follicles to support hair growth, helps prevent hair loss, and improves scalp quality, and a production method thereof.

Description

[0001] INJECTABLE AND LOCALIZED BIOTECHNOLOGICAL MESOTHERAPY SOLUTION FOR SCALP CONTAINING A MICRO-RNA / EXOSOME / STEM CELL COCKTAIL AND ACTIVE INGREDIENTS SUITABLE FOR REGIONAL NEEDS AND PRODUCTION METHOD THEREOF

[0002] Technical Field

[0003] The invention relates to a sterile biotechnological solution for use in the medical aesthetics sector, enriched with stem cells incorporating micro-RNA technology, amino acids, hyaluronic acid, peptides, and vitamins; which nourishes hair follicles to support hair growth, helps prevent hair loss, and improves scalp quality, and a production method thereof.

[0004] State of the Art

[0005] Hair is a protein fiber that grows from hair follicles in the skin. Since hair significantly affects a person's appearance, quick solutions are sought for hair problems.

[0006] In the current practice, there are many different brands of mesotherapy solutions available on the market. Only a portion of these products are licensed in accordance with Medical Device Class 3 regulations. Meanwhile, the remaining products are generally sold for topical use. However, despite being labeled for 'topical use,' these products are injected into the skin by healthcare professionals. In addition, there are a variety of unofficial and unregulated products on the market. These products pose a risk in terms of health.

[0007] In current practice, mesotherapy products on the market have a limited number of raw materials. This also leads to a prolonged start of effect for the products.

[0008] As a result of the research on the subject, an application with the number TR2024 / 001159 titled "QE§iTLi SAQ PROBLEMLERiNE YONELiK BiR SAQ SERUMU" was found. This application mentions a hair serum that is effective against eczema, dandruff, itching, hair breakage and shedding, hair loss problems and helpshair grow fast. Said hair serum comprises various oils and has the disadvantage of showing its effects only over a long period of time in the present art.

[0009] As a result of research on the subject, a product encountered was found to contain hyaluronic acid, vitamins, and amino acids. This product nourishes the hair follicles. However, due to the limited amount of potent and effective ingredients in the product, its effects can only be seen with long-term use. This situation fails to deliver the desired results in the short term due to the formulation not being sufficiently rich and targeted.

[0010] Another product found as a result of the research on the subject was found to contain copper peptide, vitamin B complex, pyridoxine, and capsaicin. However, due to the limited amount of potent and effective ingredients in the product, its effects can only be seen with long-term use. This situation fails to deliver the desired results in the short term due to the formulation not being sufficiently rich and targeted.

[0011] As a result, it has become necessary to make an improvement in the relevant technical field due to the above-mentioned disadvantages and the inadequacy of the existing solutions on the subject.

[0012] Object of the Invention

[0013] The invention was designed based on current circumstances and aims to resolve the aforementioned issues.

[0014] The main object of the invention is to introduce a sterile biotechnological solution that promotes hair growth by nourishing hair follicles, helps prevent hair loss, and improves scalp quality, and the production method thereof.

[0015] Another object of the invention is to introduce a solution that increases the moisture balance of the scalp and makes the hair look fuller and shinier.

[0016] Another object of the invention is to introduce a solution that reduces hair loss by strengthening the hair follicles.Another object of the invention is to introduce a solution that strengthens hair through plant stem cells and a targeted approach.

[0017] Another object of the invention is to provide a hair care solution that works in a short time.

[0018] The structural and characteristic features of the invention and all advantages thereof will be understood more clearly with the figures given below and the detailed description provided with reference to these figures, therefore, evaluation must be made by taking these figures and detailed description into account.

[0019] Detailed Description of the Invention

[0020] In this detailed description, the preferred embodiments of the inventive injectable and local solution comprising micro-RNA / exosomes / stem cells cocktail and traditional active ingredients for use in hair mesotherapy and the production method thereof are described only for a better understanding of the subject matter.

[0021] The stem cell cocktails in the formulation were developed using micro-RNA technology and this innovative invention was applied for the first time in the medical aesthetic sector. Micro-RNA technology increases the efficiency of the active substances in plants, making treatment processes more effective. The combination of plant-derived stem cells and micro-RNAs targets the treatment of skin diseases and tissue regeneration. This approach allows exosomal micro-RNAs to be efficiently delivered to target tissues and maintain their biological activity thanks to their high stability. It also promotes collagen and elastin production, accelerating the healing process and supporting skin health. These versatile features are breaking new ground in treatment and renewal processes.

[0022] The inventive biotechnological solution for use in the medical aesthetic sector, enriched with stem cells containing micro-RNA technology, amino acids, hyaluronic acid, peptides, and vitamins, enabling hair growth, reducing hair loss, strengthening the hair and increasing the moisture of the hair comprises, by weight,

[0023] • phosphate buffer in a proportion of 50% to 90%,• hyaluronic acid 1.8 in a proportion of 0.2% to 3%,

[0024] • biotin (B7) in a proportion of 0.02% to 5%

[0025] • D-panthenol (B5) in a proportion of 0.02% to 5%

[0026] • niacinamide (B3) in a proportion of 0.02% to 5%,

[0027] • pyridoxine (B6) in a proportion of 0.02% to 5%

[0028] • copper tripeptide-34 in a proportion of 0.001% to 0.05%,

[0029] • decapeptide-28 in a proportion of 0.001 % to 0.05%,

[0030] • oligopeptide-54 in a proportion of 0.001 % to 0.05%,

[0031] • quince (Cydonia oblonga) seed stem cell cocktail in a proportion of 0.1% to 2%, • mallow (Malva sylvestris) stem cell cocktail in a proportion of 0.1% to 2%,

[0032] • L-arginine in a proportion of 0.1% to 3%,

[0033] • L-arginine HCI in a proportion of 0.1% to 3%,

[0034] • L-isoleucine in a proportion of 0.1% to 3%,

[0035] • L-leucine in a proportion of 0.1% to 3%,

[0036] • L-proline in a proportion of 0.1% to 3%,

[0037] • L-alanine in a proportion of 0.1% to 3%,

[0038] • L-serine in a proportion of 0.1% to 3%,

[0039] • L-histidine in a proportion of 0.1% to 3%,

[0040] • L-lysine in a proportion of 0.1% to 3%,

[0041] • L-phenylalanine in a proportion of 0.1% to 3%,

[0042] • L-threonine in a proportion of 0.1% to 3%,

[0043] • L-valine in a proportion of 0.1% to 3%.

[0044] The alternative embodiment of the inventive solution comprises, by weight, phosphate buffer in a proportion of 85.85%, hyaluronic acid 1.8 in a proportion of 0.6%, biotin in a proportion of 0.05%, D-panthenol in a proportion of 1.07%, niacinamide in a proportion of 1.61%, pyridoxine in a proportion of 0.6%, copper tripeptide-34 in a proportion of 0.01%, decapeptide-28 in a proportion of 0.01%, oligopeptide-54 in a proportion of 0.01%, quince seed stem cell cocktail in a proportion of 0.86%, mallow stem cell cocktail in a proportion of 0.86%, L-arginine in a proportion of 0.86%, L-arginine HCI in a proportion of 0.86%, L-isoleucine in a proportion of 0.64%, L-leucine in a proportion of 0.64%, L-proline in a proportion of 0.54%, L-alanine in a proportion of 0.86%, L-serine in a proportion of 0.54%, L-histidine in a proportion of 0.64%, L-lysine in aproportion of 0.86%, L-phenylalanine in a proportion of 0.64%, L-threonine in a proportion of 0.64%, and L-valine in a proportion of 0.75%.

[0045] The hair biotechnological solution developed with cocktail formulation and stem cells is enriched with hyaluronic acid, biotin, panthenol, niacinamide, pyridoxine, 12 different amino acids, and 3 different biomimetic peptides. With this special formulation, the hair structure is supported and the quality of hair follicles is improved by activating stem cells. The aim is to increase the moisture balance of the scalp and make the hair look fuller and shinier. By strengthening the hair, it contributes to its healthy growth. With the developed formula, an effective result is expected in hair mesotherapy applications.

[0046] The production method of the inventive injectable and localized solution comprising micro-RNA / exosomes / stem cells and traditional active ingredients for use in hair mesotherapy comprises the process steps of:

[0047] • subjecting low molecular weight hyaluronic acid 1.8 to molecular dissolution in a phosphate buffer solution prepared at 37 13, not exceeding 40 O, after solubilization is complete, measuring viscosity and pH (preferably hyaluronic acid 1.8 in a proportion of 0.2% to 3% into phosphate buffer solution in a proportion of 50% to 90% by weight)

[0048] • adding niacinamide, pyridoxine, D-panthenol, biotin into the solution, solubilizing for 1 hour, and checking the homogeneity of the solution (preferably niacinamide in a proportion of 0.02% to 5%, pyridoxine in a proportion of 0.02% to 5%, D-panthenol in a proportion of 0.02% to 5%, biotin in a proportion of 0.02% to 5% by weight),

[0049] • adding amino acids (L-arginine, L-arginine HCI, L-isoleucine, L-leucine, L- proline, L-alanine, L-serine, L-histidine, L-lysine, L-phenylalanine, L-threonine, and L-valine) into the solution, solubilizing for 1 hour, and checking the homogeneity of the solution (preferably, L-arginine in a proportion of 0.1% to 3%, L-arginine HCI in a proportion of 0.1% to 3%, L-isoleucine in a proportion of 0.1% to 3%, L-leucine in a proportion of 0.1% to 3%, L-proline in a proportion of 0.1% to 3%, L-alanine in a proportion of 0.1% to 3%, L-serine in a proportion of 0.1% to 3%, L-histidine in a proportion of 0.1% to 3%, L-lysine in a proportion of 0.1% to 3%, L-phenylalanine in a proportion of 0.1% to 3%, L-threonine in a proportion of 0.1% to 3%, and L-valine in a proportion of 0.1% to 3% by weight),• adding peptides (copper tripeptide-34, decapeptide-28, oligopeptide-54) and stem cell cocktails (quince seed stem cell cocktail and mallow stem cell cocktail) into the solution, solubilizing for 1 hour, and checking the homogeneity of the solution (preferably, copper tripeptide-34 in a proportion of 0.001% to 0.05%, decapeptide-28 in a proportion of 0.001% to 0.05%, oligopeptide-54 in a proportion of 0.001% to 0.5%, quince seed stem) cell cocktail in a proportion of 0.1% to 2%, and mallow stem cell cocktail in a proportion of 0.1% to 2% by weight),

[0050] • sampling the mixture for physicochemical analysis after all stages are completed,

[0051] • filtering the mixture with the help of 0.22 micron PES filters and obtaining the solution,

[0052] • finalizing the product using sterile vials, stoppers, and caps.

[0053] No further raw material should be added until the molecular solubilization of hyaluronic acid is complete. Stem cells should be weighed under a sterile cabinet as they may be contaminated. Peptides are available in powder form but must be dissolved in distilled water before being added into the solution.

[0054] Hyaluronic acid has effects such as moisturizing the skin, restructuring, plumping, and reducing the appearance of wrinkles. It is injected into the dermis layer with mesotherapy applications.

[0055] Peptides used in mesotherapy, collagen peptides improve skin elasticity and firmness, oligopeptides help moisturize the skin, reduce the appearance of wrinkles and fine lines, provide a smooth appearance, growth factor peptides support collagen and elastin production in the skin. Soothing peptides reduce irritation, relieve redness.

[0056] Various vitamins are used in mesotherapy applications to support collagen production, regulate skin tone, reduce the appearance of wrinkles and adjust the moisture balance of the skin. B Vitamins are used to support skin health. As vitamin B3, niacinamide increases the skin's moisture retention capacity, strengthens the skin barrier and evens skin tone. Pantothenic acid as vitamin B5 maintains the skin's moisture balance while reducing the appearance of wrinkles. Biotin as vitamin B7 promotes hair growth, strengthens hair and improves its quality. Thus, it reduces hair loss.Non-crosslinked hyaluronic acid provides easy handling with a low viscosity value. It is used in mesotherapy applications for its skin rejuvenation and repair effects. It has been found to be effective in fine lines. It has the effects of reducing skin wrinkles, providing firmness, smoothing imperfections, minimizing pores and moisturizing. It gives the skin elasticity and glow. It balances skin pH and sebum production. It is used with the intent of providing the skin with intense moisture and stimulating the skin's natural renewal processes. It stimulates the skin's metabolism and increases collagen production.

[0057] Biotin (vitamin B7) is a water-soluble B-complex vitamin. Biotin acts as a coenzyme for carboxylase enzymes that assist in various metabolic reactions involved in carbon dioxide transfer. Biotin plays an important role in fatty acid synthesis, branched-chain amino acid catabolism, and gluconeogenesis, which are important for healthy skin and hair care. Biotin is often used as a dietary supplement to strengthen hair and nails. Biotin can be taken as a supplement, but biotin is also found in many health and beauty products as an alternative. Symptoms of biotin deficiency include hair loss (alopecia), conjunctivitis, dermatitis in the form of scaly, red rashes around the eyes, nose and mouth.

[0058] D-panthenol (provitamin B5) is the alcohol analog of the vitamin pantothenic acid (vitamin B3) and is frequently used in various commercial skin creams, lipsticks, aftershave lotions and hair preparations for its anti-inflammatory, skin softening, regenerating and hair care properties. Skin irritation and sensitization studies of cosmetic products at concentrations of up to 0.5% have shown that they do not cause allergic sensitization. Panthenol is converted into pantothenic acid, an important component of coenzyme A, which is necessary for the normal metabolic process of cells in the skin. Panthenol is an active ingredient used in dermatology to maintain skin health and treat defects in the morphology of the stratum corneum, while in cosmetology it is used for its skin moisturizing, softening and barrier function properties.

[0059] Niacinamide plays a role in biochemical reactions in the cell with its antioxidant and anti-inflammatory properties. It is also effective against bacteria with its antimicrobial activity. With these properties, it is effective in eliminating acne, controlling sebumproduction, and reducing hyperpigmentation. Niacinamide supports the integrity of the extracellular matrix by promoting collagen and elastin production. This helps the skin look younger and firmer. It strengthens the overall structure of the skin.

[0060] Pyridoxine supports the reduction of intracellular oxidative stress and reduces inflammation in the skin. It supports the epidermal function of the skin. It slows down the aging of the skin with its antioxidant properties. It helps repair and renew skin cells, thereby improving skin damage. It nourishes the skin and improves skin health. It helps regulate the sebaceous glands and supports the removal of acne and imperfections on the skin.

[0061] Amino acids are the building blocks of proteins, each amino acid contains an amino group (-NH2), a carboxyl group (-COOH), and a side chain that determines the property of the amino acid. The human body naturally comprises 20 different amino acids. In the body, these amino acids are involved in various biochemical processes and are also used as building blocks. Its general functions include strengthening the immune system, nerve transmission, strengthening the immune system, and the production of hormones and enzymes. Amino acids used in medical aesthetic applications play an important role in skin renewal. It supports skin collagen and elastin production. In addition, amino acids promote moisture balance in the skin, improve overall skin health, and reduce oxidative stress.

[0062] Cydonia oblonga (Quince seed) is of interest for the phenolic compounds in its mucilage and its anti-inflammatory, antimicrobial and antioxidant capacity. It provides relief of pain and inflammation and accelerates wound healing by re-epithelializing the skin. It creates a soothing and softening effect. It supports repair by eliminating free radicals in the wound area. It increases collagen and fibroblast synthesis by inhibiting lipid peroxidation. Thus, it promotes cell proliferation and migration by increasing growth factors in the wound healing process. Quince seed mucilage provides moisture as it has a high water absorption capacity. Quince seed stem cell cocktail is developed from quince stem cells and contains plant stem cells and micro-RNAs in exosomes. Micro-RNAs can regulate the silencing of target genes. Quince seed stem cell cocktail stimulates genes involved in antioxidant action, cell proliferation, and collagen synthesis. It stimulates senescence cells to promote collagen synthesis, resulting in afirmer skin appearance. It reduces wrinkles by increasing elasticity and hydration in the skin.

[0063] The use of hibiscus in traditional medicine dates back to BC. 3000s. Today, it is known for its antioxidant, anticancer, anti-ulcer, anti-inflammatory and skin tissue integrity protection functions. When observing its effect on hair applications, it strengthens hair follicles and reduces hair loss by supporting the nutrition of hair follicles. It stimulates the hair follicles and thus promotes new hair growth.

[0064] Copper tripeptide-34 (copper peptide GHK-Cu) is a naturally occurring copper complex of the tripeptide glycyl-L-histidyl-L-lysine. Tripeptide was first isolated from human plasma. It can also be found in saliva and urine. In humans, copper tripeptide-34 promotes the attraction of immune cells, antioxidant and anti-inflammatory effects, stimulation of collagen and glycosaminoglycan synthesis in skin fibroblasts, and growth of blood vessels. Synthetically produced copper tripeptide-34 is used in cosmetics as a restorative and anti-aging component. Some controlled facial studies conducted with copper tripeptide-34 have confirmed the anti-aging, firming, and anti-wrinkle activities of copper tripeptide-34.

[0065] Oligopeptide-54 is a peptide combination developed to support the structure and function of the skin, typically used in skin care to reduce signs of aging and improve skin health. In general, it promotes collagen and elastin production, supports the skin's natural barrier function, protects the skin against external factors, and thus provides a healthier and balanced skin structure.

[0066] Decapeptide-28 is a double-encapsulated biomimetic peptide that promotes hair growth and helps prevent hair loss. It consists of the amino acids alanine, arginine, cysteine, glutamic acid and lysine and reduces hair loss by activating the anagen phase (growth phase) of hair follicles. Decapeptide-28 mimics hair growth pathways and improves hair growth by stimulating stem cells. It also delays the stagnation phase to contribute to the prevention of hair loss.

Claims

CLAIMS1. A biotechnological solution that supports hair growth, reduces hair loss, strengthens the hair, and increases the moisture of the hair in the medical aesthetic sector, characterized in that it comprises, by weight,• phosphate buffer in a proportion of 50% to 90%,• hyaluronic acid 1.8 in a proportion of 0.2% to 3%,• biotin in a proportion of 0.02% to 5%,• D-panthenol in a proportion of 0.02% to 5%,• niacinamide in a proportion of 0.02% to 5%,• pyridoxine in a proportion of 0.02% to 5%,• copper tripeptide-34 in a proportion of 0.001% to 0.05%,• decapeptide-28 in a proportion of 0.001 % to 0.05%,• oligopeptide-54 in a proportion of 0.001 % to 0.05%,• quince seed stem cell cocktail in a proportion of 0.1% to 2%,• mallow stem cell cocktail in a proportion of 0.1% to 2%,• L-arginine in a proportion of 0.1% to 3%,• L-arginine HCI in a proportion of 0.1% to 3%,• L-isoleucine in a proportion of 0.1% to 3%,• L-leucine in a proportion of 0.1% to 3%,• L-proline in a proportion of 0.1% to 3%,• L-alanine in a proportion of 0.1% to 3%,• L-serine in a proportion of 0.1% to 3%,• L-histidine in a proportion of 0.1% to 3%,• L-lysine in a proportion of 0.1% to 3%,• L-phenylalanine in a proportion of 0.1% to 3%,• L-threonine in a proportion of 0.1% to 3%,• L-valine in a proportion of 0.1% to 3%.

2. The solution according to claim 1 , characterized in that it comprises, by weight, phosphate buffer in a proportion of 85.85%, hyaluronic acid 1.8 in a proportion of 0.6%, biotin in a proportion of 0.05%, D-panthenol in a proportion of 1.07%, niacinamide in a proportion of 1.61%, pyridoxine in a proportion of 0.6%, coppertripeptide-34 in a proportion of 0.01%, decapeptide-28 in a proportion of 0.01%, oligopeptide-54 in a proportion of 0.01%, quince seed stem cell cocktail in a proportion of 0.86%, mallow stem cell cocktail in a proportion of 0.86%, L-arginine in a proportion of 0.86%, L-arginine HCI in a proportion of 0.86%, L-isoleucine in a proportion of 0.64%, L-leucine in a proportion of 0.64%, L-proline in a proportion of 0.54%, L-alanine in a proportion of 0.86%, L-serine in a proportion of 0.54%, L- histidine in a proportion of 0.64%, L-lysine in a proportion of 0.86%, L- phenylalanine in a proportion of 0.64%, L-threonine in a proportion of 0.64%, and L- valine in a proportion of 0.75%.

3. A production method of the biotechnological solution that promotes hair growth, reduces hair loss, strengthens the hair, and increases the moisture of the hair in the medical aesthetic sector, characterized in that it comprises the process steps of:• subjecting hyaluronic acid 1.8 to molecular dissolution in a phosphate buffer solution prepared at 37 ID and, after solubilizatio n is complete, measuring viscosity and pH,• adding niacinamide, pyridoxine, D-panthenol, biotin into the solution, solubilizing for 1 hour, and checking the homogeneity of the solution,• adding L-arginine, L-arginine HCI, L-isoleucine, L-leucine, L-proline, L-alanine, L-serine, L-histidine, L-lysine, L-phenylalanine, L-threonine and L-valine into the solution, solubilizing for 1 hour, and checking the homogeneity of the solution • adding copper tripeptide-34, decapeptide-28, oligopeptide - 54, quince seed? stem cell cocktail, and mallow stem cell cocktail into the solution, solubilizing for 1 hour, and checking the homogeneity of the solution,• filtering the mixture with the help of 0.22 micron PES filters and obtaining the solution.

4. The method according to claim 3, characterized in that it comprises the process step of adding hyaluronic acid 1.8 in a proportion of 0.2% to 3% into phosphate buffer solution in a proportion of 50% to 90% by weight.

5. The method according to claim 3, characterized in that it comprises the process step of adding niacinamide in a proportion of 0.02% to 5%, pyridoxine in aproportion of 0.02% to 5%, D-panthenol in a proportion of 0.02 to 5%, and biotin in a proportion of 0.02% to 5% by weight into the solution.

6. The method according to claim 3, characterized in that it comprises the process step of adding, by weight, L-arginine in a proportion of 0.1% to 3%, L-arginine HCI in a proportion of 0.1% to 3%, L-isoleucine in a proportion of 0.1% to 3%, L-leucine in a proportion of 0.1% to 3%, L-proline in a proportion of 0.1% to 3%, L-alanine in a proportion of 0.1% to 3%, L-serine in a proportion of 0.1% to 3%, L-histidine in a proportion of 0.1% to 3%, L-lysine in a proportion of 0.1% to 3%, L-phenylalanine in a proportion of 0.1% to 3%, L-threonine in a proportion of 0.1% to 3%, and L-valine in a proportion of 0.1% to 3% into the solution.

7. The method according to claim 3, characterized in that it comprises the process step of adding, by weight, oligopeptide-54 in a proportion of 0.001% to 0.05%, copper tripeptide-34 in a proportion of 0.001% to 0.05%, decapeptide-28 in a proportion of 0.001% to 0.05%, quince seed stem cell cocktail in a proportion of 0.1% to 2%, and mallow stem cell cocktail in a proportion of 0.1% to 2% into the solution.