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.
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.
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.
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.
Iranian Registry of Clinical Trials: IRCT20171021036903N2
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The authors should thank Mrs. Fatemeh vakili for her assistance in placenta procurement, Mrs. Zahra Azizkhani, the head nurse of pediatric endocrinology ward, and other nurses of the endocrinology ward of children medical center of Tehran who survived the patients.
This study funding has been provided by Endocrine and Metabolism research Institute of Tehran University of Medical Science. The sponsor of the research has no role in the collection, analysis, and interpretation of data; in the writing of the report; and in the decision to submit the paper for publication. The funder will pay no funding for paper publication.
Conflict of interest
No conflict of interest exists for none of the authors of this study.
Ethical approval for this study was obtained from *Tehran University Ethics Committee Review Board (APPROVAL NUMBER/ID: IR.TUMS.VCR.REC.1396-4367)*.
Written informed consent was obtained from all placenta donor subjects before the study, from all diabetic subjects before the study, and also from all diabetic children's legally authorized representatives before the study.
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Madani, S., Setudeh, A., Aghayan, H.R. et al. Placenta derived Mesenchymal Stem Cells transplantation in Type 1 diabetes: preliminary report of phase 1 clinical trial. J Diabetes Metab Disord 20, 1179–1189 (2021). https://doi.org/10.1007/s40200-021-00837-9
- Cell transplantation
- Mesenchymal stem cell