ENDOCRINOLOGY. DIABETES MELLITUS TYPE II
Assessment of the safety and efficacy of the use of cultured autologous (allogenic) multipotent mesenchymal stromal cells from adipose tissue in patients with type 2 diabetes mellitus.
To evaluate the safety and efficacy of transplantation of autologous (allogeneic) cultured multipotent mesenchymal stromal cells from human adipose tissue in patients with type 2 diabetes mellitus.
The medical product of cultured autologous (allogeneic) multipotent mesenchymal stromal cells from human adipose tissue is a cellular graft in the form of a cell suspension in a physiological solution.
The number of transplanted cells is determined individually for each patient in the calculation: at least 106 cells per kilogram of body weight.
The material for the preparation of autologous multipotent mesenchymal stromal cells is derived from the adipose tissue of the patients. The culture of autologous MMSCs is prepared in vitro according to a special methodology. Transplantation of autologous (allogenic) MMSCs to patients with type 2 diabetes mellitus is performed by intravenous drip infusion.
Achievement of target levels of carbohydrate metabolism and insulin resistance:
- the level of glycemia is not higher than 7.0 mmol/L;
- HbA1C ≤ 7%;
- HOMA-IR – 20-30 in 12 months after transplantation.