Placenta Derived Mesenchymal Stem Cells Transplantation in Type 1 Diabetes: Preliminary Report of Phase 1 Clinical Trial Publisher



Madani S¹ ; Setudeh A² ; Aghayan HR³ ; Alavimoghadam S³ ; Rouhifard M⁴ ; Rezaei N⁴ ; Rostami P² ; Mohsenipour R² ; Amirkashani D⁵ ; Bandarian F¹ ; Arjmand B³ ; Larijani B⁶ Show Affiliations
Source: Journal of Diabetes and Metabolic Disorders Published:2021

Abstract

Introduction: Type 1 Diabetes Mellitus (T1DM) is an auto immune reaction against insulin secreting beta cells. Exogenous insulin administration is the only standard treatment for T1DM. However, despite tight glycemic control many patients will develop chronic life-threatening complications. Recently, stem cell transplantation has been suggested as a novel treatment for eliminating the beta cell damage and promoting their regeneration by modulating auto-immunity. To our knowledge; this is the first preliminary report of placenta derived MSCs (PLMSCs) transplantation in juvenile T1DM. Method: An Open label non-randomized phase 1 clinical trial was designed to evaluate the safety of PLMSCs transplantation in new onset juvenile T1DM (IRCT20171021036903N2). PLMSCs were manufactured in our clean room facility using a Xeno-free/GMP compliant protocol. The first series of patients (n = 4) received one dose of1 × 106 PLMSCs/kg intravenously. Diabetic clinical and laboratory parameters and side effects were evaluated weekly for the first month, monthly for 6 months, and then every 3 month till 1 year. Results: Serious adverse events were not seen during 1 year follow-up. Partial remission and hypoglycemic attacks were happened one month after transplantation in two patients. ZnT8-Ab decreased till month 3 and then increased again in all patients. Anti Gad-Ab decreased till month 3 of follow up then increased. Discussion: This preliminary report of our phase I clinical trial demonstrated the short term safety of PLMSCs transplantation in juvenile T1DM. To prove the long term safety and probable efficacy of this treatment more investigations are needed. Trial registration: Iranian Registry of Clinical Trials: IRCT20171021036903N2 © 2021, Springer Nature Switzerland AG.