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Clinical Efficacy of Stem Cell Therapy for Diabetes Mellitus: A Meta-Analysis

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PLoS ONE

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      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.

      Methods and Findings

      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.

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      Most cited references 58

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          Meta-analysis of observational studies in epidemiology: a proposal for reporting. Meta-analysis Of Observational Studies in Epidemiology (MOOSE) group.

           T Sipe,  D Rennie,  D Stroup (2000)
          Because of the pressure for timely, informed decisions in public health and clinical practice and the explosion of information in the scientific literature, research results must be synthesized. Meta-analyses are increasingly used to address this problem, and they often evaluate observational studies. A workshop was held in Atlanta, Ga, in April 1997, to examine the reporting of meta-analyses of observational studies and to make recommendations to aid authors, reviewers, editors, and readers. Twenty-seven participants were selected by a steering committee, based on expertise in clinical practice, trials, statistics, epidemiology, social sciences, and biomedical editing. Deliberations of the workshop were open to other interested scientists. Funding for this activity was provided by the Centers for Disease Control and Prevention. We conducted a systematic review of the published literature on the conduct and reporting of meta-analyses in observational studies using MEDLINE, Educational Research Information Center (ERIC), PsycLIT, and the Current Index to Statistics. We also examined reference lists of the 32 studies retrieved and contacted experts in the field. Participants were assigned to small-group discussions on the subjects of bias, searching and abstracting, heterogeneity, study categorization, and statistical methods. From the material presented at the workshop, the authors developed a checklist summarizing recommendations for reporting meta-analyses of observational studies. The checklist and supporting evidence were circulated to all conference attendees and additional experts. All suggestions for revisions were addressed. The proposed checklist contains specifications for reporting of meta-analyses of observational studies in epidemiology, including background, search strategy, methods, results, discussion, and conclusion. Use of the checklist should improve the usefulness of meta-analyses for authors, reviewers, editors, readers, and decision makers. An evaluation plan is suggested and research areas are explored.
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            Author and article information

            Affiliations
            Center of Excellence for Stem Cells and Regenerative Medicine (CESC), Zewail City of Science and Technology, 6 th of October City, Egypt
            University-Hospital of Parma, ITALY
            Author notes

            Competing Interests: The authors have declared that no competing interests exist.

            Conceived and designed the experiments: AEB NEB. Performed the experiments: AEB NEB. Analyzed the data: AEB NEB. Wrote the paper: AEB NEB.

            Contributors
            Role: Editor
            Journal
            PLoS One
            PLoS ONE
            plos
            plosone
            PLoS ONE
            Public Library of Science (San Francisco, CA USA )
            1932-6203
            13 April 2016
            2016
            : 11
            : 4
            27073927 4830527 10.1371/journal.pone.0151938 PONE-D-15-52174
            © 2016 El-Badawy, El-Badri

            This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.

            Counts
            Figures: 5, Tables: 1, Pages: 16
            Product
            Funding
            Funded by: funder-id http://dx.doi.org/10.13039/501100003009, Science and Technology Development Fund;
            Award ID: 5300
            Award Recipient :
            This work is supported by grant #5300, funded by the Science and Technology Development Fund (STDF), Egypt.
            Categories
            Research Article
            Medicine and Health Sciences
            Clinical Genetics
            Stem Cell Therapy
            Medicine and Health Sciences
            Endocrinology
            Endocrine Disorders
            Diabetes Mellitus
            Medicine and Health Sciences
            Metabolic Disorders
            Diabetes Mellitus
            Medicine and Health Sciences
            Endocrinology
            Diabetic Endocrinology
            Insulin
            Biology and Life Sciences
            Biochemistry
            Hormones
            Insulin
            Biology and Life Sciences
            Cell Biology
            Cellular Types
            Animal Cells
            Stem Cells
            Mesenchymal Stem Cells
            Medicine and Health Sciences
            Surgical and Invasive Medical Procedures
            Blood and Lymphatic System Procedures
            Stem Cell Transplantation
            Medicine and Health Sciences
            Surgical and Invasive Medical Procedures
            Transplantation
            Cell Transplantation
            Stem Cell Transplantation
            Medicine and Health Sciences
            Surgical and Invasive Medical Procedures
            Transplantation
            Cell Transplantation
            Islet Transplantation
            Medicine and Health Sciences
            Surgical and Invasive Medical Procedures
            Endocrine System Procedures
            Islet Transplantation
            Medicine and health sciences
            Diagnostic medicine
            Diabetes diagnosis and management
            HbA1c
            Biology and life sciences
            Biochemistry
            Proteins
            Hemoglobin
            HbA1c
            Biology and Life Sciences
            Cell Biology
            Cellular Types
            Animal Cells
            Stem Cells
            Hematopoietic Stem Cells
            Custom metadata
            All relevant data are within the paper and its Supporting Information files.

            Uncategorized

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