June 28, 2023 is a historic date for regenerative medicine and endocrinology. The Food and Drug Agency (FDA) officially approved cell therapy for type 1 diabetes for the first time in the world. This is a drug containing allogeneic pancreatic cells obtained from deceased donors. The drug was created specially for the treatment of adults in whom it is difficult to normalize the level of glycated hemoglobin due to repeated episodes of acute hypoglycemia. According to Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, the new therapy will allow better management of blood glucose level in diabetic patients and improve their quality of life.
Type 1 diabetes is a chronic autoimmune disease that requires constant treatment, namely lifelong insulin replacement therapy. Nevertheless, it is difficult for many patients to choose the optimal dosage of insulin and maintain a normal blood glucose level. Diabetes is also often complicated by disorders of other organs.
Cell therapy for type 1 diabetes is aimed precisely at restoring insulin production by the pancreas. The FDA-approved cell preparation is given as a single injection into the portal vein, with additional cell infusions as needed.
The safety and effectiveness of the cellular preparation for the treatment of diabetes mellitus has been thoroughly investigated in 2 clinical trials involving 30 patients. In 21 patients, thanks to cell therapy, it was possible to achieve longer periods of independence from insulin, lasting from 1 to 5 years, sometimes patients managed to completely do without insulin.
More than 400 million people in the world suffer from diabetes, and every fourth case is complicated by chronic ulcers of the lower extremities, the so-called “diabetic foot” syndrome. Every 30 seconds in the world, a limb of a diabetic patient is amputated. Therefore, the creation of new effective methods for the treatment of diabetes is one of the most urgent tasks of modern medical science.
In Ukraine, the Institute of Cell Therapy has also developed methods of treating type 1 and type 2 diabetes based on stem cells of umbilical cord blood, umbilical cord, and placenta, which have managed to improve the quality of life of many patients from around the world.
Based on: https://bioinformant.com/cell-therapy-type-1-diabetes/
