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Oral composition with immunomodulating effect on natural killer cells

a technology of immunomodulating effect and oral composition, which is applied in the field of oral compositions, can solve the problems of inability to re-inject intralipid®, and inability to re-inject intralipid®, and achieve the effects of preventing immune-mediated sub-fertility, considerable social, psychological and economic impa

Inactive Publication Date: 2019-10-31
GELADAKI VARVARA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Benefits of technology

The present invention is about a combination of fatty acids or esters thereof that can be used by women who have repeated spontaneous abortions or implantation failures during in vitro fertilization. This invention aims to prevent immune-mediated sub-fertility in a significant cohort of couples who are facing these problems. It can have social, psychological, and economical impact on the couples.

Problems solved by technology

Furthermore intravenous infusion of Intralipid® may cause several side effects such as bladder pain, bloody or cloudy urine, chills, difficult, burning, or painful urination, fever, frequent urge to urinate, lower back or side pain, sore throat and vomiting.
Furthermore, since the patients are hospitalized, they may be exposed to hospital-acquired infections.
In addition, these methods are associated with the risks and side effects of intervention treatments (including life-threatening ones such sepsis from human derived products, hyper-coagulation from fat emulsion infusions).
In addition, these treatments are associated with serious side effects.

Method used

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Examples

Experimental program
Comparison scheme
Effect test

example 1

[0057]A group of 15 women was treated once per day with oral composition 1 in the form of oral solution comprising the active ingredients shown in Table 1a. The fatty acids of the composition were in the form of glycerides. The amount of the administered composition was such that the total amount of fatty acids administered per day was 0.25 g / kg of body weight. Blood samples were collected and tested prior to and 45 days after the initiation of the treatment.

TABLE 1a% Active substancesLCFA 97.64%SFA 14.74%Miristic acid0.20%Palmitic acid4.50%Stearic acid10.04%MUFA 23.39%Oleic acid21.39%Docosahexaenoid acid (DHA)0.50%Eicosapentaenoic acid(EPA)1.50%PUFA 59.51%Linoleic acid49.27%γ-linolenic0.50%α-linolenic9.74%Vitamins 1.64%B10.02%B20.02%B30.02%B60.01%D3 (15 μg-600 IU)0.48%Folic Acid0.03%Myo-inositol1.06%Metal ions 0.10%Cooper0.01%Zinc0.02%Magnesium0.06%Manganium0.01%AminoacidsL-Glutamin0.62%

[0058]The results of the numbers and activity of peripheral blood NK cells are shown in Table 1 ...

example 2

[0065]A group of 6 women were tested at day 0 and at day 70 for NK cell number and activity after administration of oral composition 2 once per day. The composition was in the form of oral solution comprising the active ingredients shown in Table 2a. The fatty acids of the composition were in the form of glycerides. The amount of the administered composition was such that the total amount of fatty acids administered per day was 0.25 g / kg of body weight.

TABLE 2a% active substancesLCFA 97.84%SFA 11.29%Miristic acid3.05%Palmitic acid6.84%Steatic acid1.40%MUFA 35.85%Oleic acid28.85%Docosahexaenoid acid (DHA)1.80%Eicosapentaenoic acid(EPA)5.20%PUFA 50.70%Linoleic acid29.28%γ-linolenic18.69%α-linolenic2.73%MCFA 2%Capric acid0.50%Caprilyc acid0.50%Lauric acid1.00%Vitamins 0.16%D30.10%Folic acid0.03%Myo-inositol0.03%

[0066]The results of the numbers and activity of peripheral blood NK cells are shown in Table 2b.

TABLE 2bDay 0Day 70Day 0Day 70NK %NK %NK %NK %MeannumbernumberMeanMeanMeanactivi...

example 3

[0069]In this group 6 patient's blood samples were collected and tested prior to and at 45 days after administration of oral composition 3 once per day. The composition was in the form of oral solution comprising the active ingredients shown in Table 3a. The fatty acids of the composition were in the form of glycerides. The amount of the administered composition was such that the total amount of fatty acids administered per day was 0.25 g / kg of body weight.

TABLE 3a% active substancesLCFA 100%SFA 25%Miristic acid10%Palmitic acid10%Steatic acid 5%MUFA 50%Oleic acid22%Docosahexaenoid acid (DHA) 6%Eicosapentaenoic acid(EPA)19%Miristoleic acid0.2% Palmitoleic acid2.6% Sapienic acid0.2% PUFA 25%Linoleic acid12%γ-linolenic 5%α-linolenic 8%

[0070]The results of the numbers and activity of peripheral blood NK cells are shown in Table 3b.

TABLE 3bDay 0Day 45Day 0Day 45NK %NK %NK %NK %MeannumbernumberMeanActivityActivityactivity(mean)(mean)Decline %Day 0Day 70Decline %Subjects 617.8412.4030.4836...

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Abstract

An oral composition comprising, as active ingredients, a combination of fatty acids or esters thereof for use in a method for the treatment of repeated spontaneous abortions or repeated implantation failures after in vitro fertilization in sub-fertile women has increased the number and / or the cytotoxicity of NK cells. The oral compositions is administered in specified amounts for a specified period of time.

Description

FIELD OF THE INVENTION[0001]The present invention relates to oral compositions for use in a method for the treatment of repeated spontaneous abortions (RSA) or repeated implantation failures (RIF) after in vitro fertilization (IVF) in sub-fertile human female subjects having increased number and / or cytotoxicity of NK cells.BACKGROUND OF THE INVENTION[0002]Natural Killer (NK) cells are a specific group of large granular lymphocytes (LGL) which play a major role in innate immune responses but are also important in influencing adaptive immune responses and in immune regulation (Herberman R B. Role of human natural killer cell responses in health and disease. Olin Diagn Lab Immunol 1994; 1:125-33). They form 1-2% of lymphoid tissue found mainly in spleen. In the peripheral blood, NK cells make up 5-15% of all lymphocytes and 70-95% of LGLs (Stites D P, Terr A I, Parslow T G. Basic and clinical immunology. 8th edition, Appleton and Lange, Norwalk, Conn., 1994).[0003]NK cells express on t...

Claims

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Application Information

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IPC IPC(8): A61K31/202A61K9/00A61K31/20A61K31/201A61K33/30A61K33/32A61K33/06A61K31/198A61K31/194A61K31/05A61K31/51A61K31/525A61K31/4415A61K31/455A61K31/7004A61K33/34A61P37/06A61P15/06
CPCA61K33/30A61K33/34A61K31/4415A61K33/06A61K31/525A61K31/7004A61K31/20A61K31/194A61K9/0053A61K31/198A61K31/455A61K31/05A61P15/06A61K31/202A61K33/32A61K31/201A61K31/51A61P37/06A61K45/06A61K31/047A61K31/519A61K31/593A61K9/0095A61K2300/00A61K31/23
Inventor GELADAKI, VARVARA
Owner GELADAKI VARVARA
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