1. Clinical efficacy on glycemic control and safety of mesenchymal stem cells in patients with diabetes mellitus: Systematic review and meta-analysis of RCT data
- Author
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Asiamah Ernest Amponsah, Desheng Kong, Ruiyun Guo, Zhifen Yang, Jun Ma, Baofeng Feng, Aijing Liu, Timothy O'Brien, Huixian Cui, Xiaolin Zhang, Wei Zhang, and Jingjing He
- Subjects
Blood Glucose ,0301 basic medicine ,Cochrane Library ,Biochemistry ,law.invention ,Endocrinology ,Medical Conditions ,Mathematical and Statistical Techniques ,0302 clinical medicine ,Randomized controlled trial ,Animal Cells ,law ,Medicine and Health Sciences ,Diabetes diagnosis and management ,Insulin ,Medicine ,Randomized Controlled Trials as Topic ,Multidisciplinary ,C-Peptide ,Stem Cells ,Stem Cell Therapy ,Statistics ,Fasting ,Metaanalysis ,Treatment Outcome ,Research Design ,Meta-analysis ,Physical Sciences ,Cellular Types ,Research Article ,medicine.medical_specialty ,Drug Research and Development ,HbA1c ,Endocrine Disorders ,Clinical Research Design ,Science ,030209 endocrinology & metabolism ,Glycemic Control ,Hypoglycemia ,Mesenchymal Stem Cell Transplantation ,Research and Analysis Methods ,03 medical and health sciences ,Diabetes mellitus ,Internal medicine ,Diabetes Mellitus ,Humans ,Clinical Trials ,Hemoglobin ,Statistical Methods ,Adverse effect ,Glycated Hemoglobin ,Clinical Genetics ,Diabetic Endocrinology ,Pharmacology ,business.industry ,Biology and Life Sciences ,Proteins ,Mesenchymal Stem Cells ,Cell Biology ,medicine.disease ,Hormones ,Randomized Controlled Trials ,Diagnostic medicine ,Clinical trial ,Diabetes Mellitus, Type 1 ,030104 developmental biology ,Diabetes Mellitus, Type 2 ,Metabolic Disorders ,Relative risk ,Adverse Events ,Clinical Medicine ,business ,Mathematics - Abstract
Background Diabetes mellitus as a chronic metabolic disease is threatening human health seriously. Although numerous clinical trials have been registered for the treatment of diabetes with stem cells, no articles have been published to summarize the efficacy and safety of mesenchymal stem cells (MSCs) in randomized controlled trials (RCTs). Methods and findings The aim of this study was to systematically review the evidence from RCTs and, where possible, conduct meta-analyses to provide a reliable numerical summary and the most comprehensive assessment of therapeutic efficacy and safety with MSCs in diabetes. PubMed, Web of Science, Ovid, the Cochrane Library and CNKI were searched. The retrieval time was from establishment of these databases to January 4, 2020. Seven RCTs were eligible for analysis, including 413 participants. Meta-analysis results showed that there were no significant differences in the reduction of fasting plasma glucose (FPG) compared to the baseline [mean difference (MD) = -1.05, 95% confidence interval (CI) (-2.26,0.16), P2 = 94%] and the control group [MD = -0.62, 95%CI (-1.46,0.23), P2 = 87%]. The MSCs treatment group showed a significant decrease in hemoglobin (Hb) A1c [random-effects, MD = -1.32, 95%CI (-2.06, -0.57), P2 = 90%] after treatment. Additionally, HbA1c reduced more significantly in MSC treatment group than in control group [random-effects, MD = -0.87, 95%CI (-1.53, -0.22), P2 = 82%] at the end of follow-up. However, as for fasting C-peptide levels, the estimated pooled MD showed that there was no significant increase [MD = -0.07, 95%CI (-0.30, 0.16), P2 = 94%] in MSCs treatment group compared with that in control group. Notably, there was no significant difference in the incidence of adverse events between MSCs treatment group and control group [relative risk (RR) = 0.98, 95%CI (0.72, 1.32), P = 0.02, I2 = 70%]. The most commonly observed adverse reaction in the MSC treatment group was hypoglycemia (29.95%). Conclusions This meta-analysis revealed MSCs therapy may be an effective and safe intervention in subjects with diabetes. However, due to the limited studies, a number of high-quality as well as large-scale RCTs should be performed to confirm these conclusions.
- Published
- 2021