administration of autologous mesenchymal stem cell transplan¬tation for treatment of type 1 diabetes mellitus

background: the aim of the present clinical trial was to investigate the efficacy of autologous bone marrow mesenchymal stem cells (bm-mscs) in glycemic control of diabetic patients without using any immunosuppressive drugs over a nine-month period. method: twenty-three patients with t1dm, at 5 to 30 years of age and in both sexes, participated in this study. this trial consisted of two phases; in the end of the first phase (three month after the transplantation), if the patient still needed exogenous insulin to control his/her glycemic state, the second phase of study was performed. in both phases, 100 milliliter of mixed mesenchymal stem cells and normal saline containing 2×10⁶ autologous cells/kg for each patient was delivered to patients through cubital vein. all patients were evaluated at 1, 3, 6 and 9 months after the procedure. result: twenty-one patients underwent a second injection. nine patients (39%) responded positively and 14 patients (61%) responded negatively based on their hba1c levels and insulin requirements in both injections. two patients became insulin-free during two rounds of injections. in responder patients, mean levels of c-peptide and hba1c as well as prescribed insulin dosage significantly decreased compared to baseline measures ( p =0.002, p =0.007 and p <0.001). in the second phase, responder patients did not show significant reduction in c-peptide levels compared to the baseline of the second phase. mean levels of hba1c and prescribed insulin dosage significantly decreased in comparison to the beginning of the study ( p <0.05). conclusion: transplantation of bm-msc can be viewed as a promising, simple, safe, and efficient therapeutic modality for t1dm.