Stem cell therapy for type1 diabetes with transplantation of stem cells into the Omental pouch, peritoneum, and blood, experimental study

INTRODUCTION: Type 1 diabetes is a dreadful autoimmune disease of childhood with incidence of 0.26/1000 children in India. To develop a new, cheap, and effective treatment for this disease, we invented an autologous Stem cell therapy for type 1 diabetes in which stem cells are transplanted into the Omental pouch, peritoneum, and blood. The Omental pouch stem cell operation in the therapy is reported for the first time in the medical literature. MATERIALS AND METHODS: Last 5 years I treated 21 patients of Type 1 diabetes with autologous stem cell therapy and in the same period, a group of 26 patients of Type 1 diabetes with conventional treatment of Insulin injections was put as a control group. Blood sugar fasting and post prandial, Anti Gad antibody titer, Glycosylated Hb and C peptide levels and weight of patient and total Insulin requirement in 24 h were the variables to be measured before the therapy and after the therapy. Stem cells were harvested from patients own bone marrow and separated by density gradient method. An infusion of 20 mg/kg methylprednisolone in 100 ML normal saline given intravenously over 1 h prior to the therapy. The total average numbers of cells harvested were 7.86 × 10(7). One third quantity of isolated stem cells were put into the Omental pouch through no. 7 IFT, another one third into peritoneal cavity through no. 10 IFT and remaining third is given IV in 100 ml normal saline. RESULTS: The minimum follow up was 6 months and maximum of 4 years. In the therapy group, the average weight gain after one year of therapy, daily requirement of Insulin and its drop after therapy, drop in HbA1c levels, drop in fasting and post prandial blood sugar, rise of C peptide levels and drop in Anti-GAD antibody titer were measured and was found to be statistically highly significant. The same parameters were measured in control group and was not statistically significant. There were a few side effects noted after stem cell therapy such as mild skin rash, nausea, and pain in abdomen. DISCUSSION: In autologous bone marrow derived stem cell therapy, cells are transplanted into the Omental pouch, peritoneum, and blood. Cells transplanted in the Omental pouch get vascularized like a split skin graft. Omental surface has far less cellular immunity than blood, hence, if some of these cells get converted into Islets like cells producing Insulin, then they are less vulnerable to damage by the immune system. It means that the Omental pouch may act as a new biological pancreas producing Insulin. Stem cells injected intravenously reach the pancreases and may get differentiate into Islet like cells due to specific growth factors released by pancreas. Stem cells can reverse autoimmunity by their immunomodulatory function. Stem cells transplanted in peritoneum grow longer due to large surface area and little cellular immunity and secrete growth factors and cytokines for a long time which can rejuvenate existing Islets of Langerhans. The therapy group had substantially good results compared to the control group and the difference was statistically highly significant. CONCLUSIONS: Autologous stem cell therapy was safe, and effective for the long term for the treatment of Type 1 diabetes. We need a greater number of cases and a longer follow up to make it better. The therapy creates a lot of hope for Type 1 diabetes patients as it can be easily repeated any number of times.