title: Clinical Efficacy of Stem Cell Therapy for Diabetes Mellitus: A Meta-Analysis.
abstract: BACKGROUND
  Stem cell therapy is a promising therapeutic modality for advanced diabetes mellitus (DM). This study presents a meta-analysis of relevant clinical trials to determine the efficacy of stem cell therapy in DM. We aim to critically evaluate and synthesize clinical evidence on the safety and efficiency of different types of stem cell therapy for both T1DM and T2DM.
  
  
  RESULTS
  We pooled participant-level data from twenty-two eligible clinical trials that satisfied our inclusion criteria, with a total of 524 patients. There were significant differences in the outcome based on the type and source of the infused cells. Out of all T1DM patients who received CD34+ hematopoietic stem cell (HSC) infusion, 58.9% became insulin independent for a mean period of 16 months, whereas the results were uniformly negative in patients who received umbilical cord blood (UCB). Infusion of umbilical cord mesenchymal stem cells (UC-MSCs) provided significantly beneficial outcome in T1DM, when compared to bone-marrow mesenchymal stem cells (BM-MSCs) (P<0.0001 and P = 0.1557). Administration of stem cell therapy early after DM diagnosis was more effective than intervention at later stages (relative risk = 2.0, P = 0.0008). Adverse effects were observed in only 21.72% of both T1DM and T2DM stem cell recipients with no reported mortality. Out of all poor responders, 79.5% were diagnosed with diabetic ketoacidosis.
  
  
  CONCLUSIONS
  Stem cell transplantation can represent a safe and effective treatment for selected patients with DM. In this cohort of trials, the best therapeutic outcome was achieved with CD34+ HSC therapy for T1DM, while the poorest outcome was observed with HUCB for T1DM. Diabetic ketoacidosis impedes therapeutic efficacy.
authors.affiliation: Center of Excellence for Stem Cells and Regenerative Medicine (CESC), Zewail City of Science and Technology, 6th of October City, Egypt.
authors.forename: Ahmed
authors.initials: A
authors.lastname: El-Badawy
authors.affiliation: Center of Excellence for Stem Cells and Regenerative Medicine (CESC), Zewail City of Science and Technology, 6th of October City, Egypt.
authors.forename: Nagwa
authors.initials: N
authors.lastname: El-Badri
mesh_terms: D064591:Allografts; D064987:Cell- and Tissue-Based Therapy / Q000009:adverse effects / Q000379:methods*; D002986:Clinical Trials as Topic; D003922:Diabetes Mellitus, Type 1 / Q000628:therapy*; D003924:Diabetes Mellitus, Type 2 / Q000628:therapy*; D006801:Humans; D033581:Stem Cell Transplantation / Q000009:adverse effects / Q000379:methods*; D013997:Time Factors