THERAPEUTIC USE OF THE ß2m PROTEIN

Abstract

The use of beta2-microglobulin (β2m) as active ingredient, in particular in pharmaceutical compositions intended for the treatment of autoimmune diseases.

1 - 21 . (canceled) 
     
     
         22 . A pharmaceutical product, characterized in that it consists of β2-microglobulin or of a functional variant of that protein presenting at least 70% identity with the human β2-microglobulin protein, in a pharmaceutically acceptable carrier. 
     
     
         23 . A pharmaceutical product according  claim 22 , wherein said active ingredient is the human β2-microglobulin protein. 
     
     
         24 . A pharmaceutical product according to  claim 22 , wherein said active ingredient is a functional variant of the β2-microglobulin protein presenting at least 80%, and preferably 90% identity with the human β2-microglobulin protein. 
     
     
         25 . A method of treating an autoimmune disease, comprising administering to a subject in need thereof an effective amount of the pharmaceutical product according to  claim 22 . 
     
     
         26 . The method according to  claim 25 , characterized in that the autoimmune disease treated is rheumatoid polyarthritis, systemic lupus erythematosus, Sjögren's syndrome, scleroderma, fibromyalgia, myositis, ankylosing spondylitis, insulin dependent diabetes of type I, Hashimoto's thyroiditis, Addison's disease, Crohn's disease, Celiac's disease, multiple sclerosis or amyotrophic lateral sclerosis. 
     
     
         27 . The method according to  claim 25 , wherein the autoimmune disease treated is amyotrophic lateral sclerosis (ALS). 
     
     
         28 . The method according to  claim 25 , wherein the autoimmune disease treated is multiple sclerosis. 
     
     
         29 . The method according to  claim 25 , wherein the autoimmune disease treated is Crohn's disease. 
     
     
         30 . The method according to  claim 25 , wherein the autoimmune disease treated is rheumatoid polyarthritis. 
     
     
         31 . The method according to  claim 25 , wherein the autoimmune disease treated is insulin dependent diabetes of type I. 
     
     
         32 . A method of increasing the ratio of blood β2-microglobulin to a concentration comprised between 2.5 and 12 mg/l, preferably between 3 and 8 mg/l, more preferably between 3 and 5 mg/l in a patient suffering from an auto-immune disease, comprising administering to said patient an effective amount of the pharmaceutical product according to  claim 22 . 
     
     
         33 . A method of restoring a normal HC/β2-microglobulin molar ratio within the membrane MHC-I complexes in a patient suffering from an auto-immune disease, comprising administering to said patient an effective amount of the pharmaceutical product according to  claim 22 . 
     
     
         34 . A method of preventing a β2-microglobulin deficit from occurring in the MHC-I complexes in a patient suffering from an auto-immune disease, comprising administering to said patient an effective amount of the pharmaceutical product according to  claim 22 . 
     
     
         35 . A pharmaceutical product according  claim 22 , characterized in that it consists of a liposome loaded with β2-microglobulin or with a functional variant of that protein. 
     
     
         36 . A pharmaceutical product according to  claim 22 , characterized in that β2-microglobulin is prepared in saline form and incubated beforehand ex-vivo in contact with the blood, the serum or the lymphocytes of the patient to treat. 
     
     
         37 . A composition comprising a pharmaceutical product according to  claim 22 . 
     
     
         38 . A method of diagnosis of an autoimmune disease, characterized in that it comprises a step consisting of determining the intracellular or membrane HC/β2-microglobulin ratio of the MHC-I complexes in a patient. 
     
     
         39 . A method of diagnosis according to  claim 38 , characterized in that the HC/β2-microglobulin ratio of the MHC-I complexes is a membrane ratio. 
     
     
         40 . A method according to  claim 39 , characterized in that it comprises the steps of:
 i) taking cells from a patient in whom an autoimmune disease is to be screened, preferably lymphocytes;   ii) extracting the MHC-I complexes from those cells;   iii) determining the respective quantities of HC and of β2-microglobulin contained in said MHC-I complexes;   iv) establishing the HC/β2-microglobulin molar ratio of said MHC-I complexes; and   v) comparing the HC/β2-microglobulin ratio obtained with that of a control sample.