Cell-based composition and use thereof for treatment of diabetes and associated metabolic disorders and for amelioration of insulin resistance in pre-diabetes

Abstract

The present invention relates to a cell-based composition comprising a suspension of mesenchymal stem cells in crystalloid with a cellular concentration from 0.01 million to 3.0 million cells/ml. The cell-based composition is used in a form of medicament for treatment of diabetes and its associated metabolic disorders and complications.

1 . A cell-based composition comprising a suspension of mesenchymal stem cells in crystalloid with a cellular concentration from 0.01 million to 3.0 million cells/ml. 
     
     
         2 . The cell-based composition as claimed in  claim 1  wherein the suspension of mesenchymal stem cells is derived from cryopreserved mesenchymal stem cells comprising from 25 to 35 million cells per cryovial. 
     
     
         3 . The cell-based composition as claimed in  claim 1  wherein the suspension mesenchymal stem cells is derived from human umbilical cord, bone marrow, fat tissue, peripheral blood or tooth pulp. 
     
     
         4 . The cell-based composition as claimed in  claim 1  wherein the suspension of mesenchymal stem cells is positive for a selected group of surface markers including CD73, CD90, and CD105, and negative for a selected group of surface markers including CD34, CD45, and HLA-DR. 
     
     
         5 . A method for the treatment of diabetes and its associated metabolic disorders and complications and for amelioration of insulin resistance in pre-diabetes in a subject, said method comprising administering to said subject an effective amount of a cell-based composition as claimed in  claim 1 . 
     
     
         6 . The method as claimed in  claim 5 , includes a step of administering the cell-based composition in a therapeutically effective amount into a subject by way of intravenous infusion. 
     
     
         7 . The method as claimed in  claim 5 , wherein the associated metabolic disorders and complications is selected from a group including nephropathy, dyslipidaemia, diabetes foot ulcer, macular oedema, cardiomyopathy or stroke. 
     
     
         8 . The method as claimed in  claim 6 , wherein the therapeutically effective amount is from 0.25 million to 3.0 million cells/kg body weight. 
     
     
         9 . The method as claimed in  claim 6 , wherein the infusion is carried out in a period ranging from 30 minutes to 2 hours. 
     
     
         10 . A method for the treatment of diabetes and its associated metabolic disorders and complications and for amelioration of insulin resistance in pre-diabetes in a subject, said method comprising administering to said subject an effective amount of a cell-based composition as claimed in  claim 2 . 
     
     
         11 . The method as claimed in  claim 10 , includes a step of administering the cell-based composition in a therapeutically effective amount into a subject by way of intravenous infusion. 
     
     
         12 . The method as claimed in  claim 10 , wherein the associated metabolic disorders and complications is selected from a group including nephropathy, dyslipidaemia, diabetes foot ulcer, macular oedema, cardiomyopathy or stroke. 
     
     
         13 . The method as claimed in  claim 11 , wherein the therapeutically effective amount is from 0.25 million to 3.0 million cells/kg body weight. 
     
     
         14 . The method as claimed in  claim 11 , wherein the infusion is carried out in a period ranging from 30 minutes to 2 hours. 
     
     
         15 . A method for the treatment of diabetes and its associated metabolic disorders and complications and for amelioration of insulin resistance in pre-diabetes in a subject, said method comprising administering to said subject an effective amount of a cell-based composition as claimed in  claim 3 . 
     
     
         16 . The method as claimed in  claim 15 , includes a step of administering the cell-based composition in a therapeutically effective amount into a subject by way of intravenous infusion. 
     
     
         17 . The method as claimed in  claim 15 , wherein the associated metabolic disorders and complications is selected from a group including nephropathy, dyslipidaemia, diabetes foot ulcer, macular oedema, cardiomyopathy or stroke. 
     
     
         18 . The method as claimed in  claim 16 , wherein the therapeutically effective amount is from 0.25 million to 3.0 million cells/kg body weight. 
     
     
         19 . The method as claimed in  claim 16 , wherein the infusion is carried out in a period ranging from 30 minutes to 2 hours. 
     
     
         20 . A method for the treatment of diabetes and its associated metabolic disorders and complications and for amelioration of insulin resistance in pre-diabetes in a subject, said method comprising administering to said subject an effective amount of a cell-based composition as claimed in  claim 4 . 
     
     
         21 . The method as claimed in  claim 20 , includes a step of administering the cell-based composition in a therapeutically effective amount into a subject by way of intravenous infusion. 
     
     
         22 . The method as claimed in  claim 20 , wherein the associated metabolic disorders and complications is selected from a group including nephropathy, dyslipidaemia, diabetes foot ulcer, macular oedema, cardiomyopathy or stroke. 
     
     
         23 . The method as claimed in  claim 21 , wherein the therapeutically effective amount is from 0.25 million to 3.0 million cells/kg body weight. 
     
     
         24 . The method as claimed in  claim 21 , wherein the infusion is carried out in a period ranging from 30 minutes to 2 hours.