Safety and efficacy of stem cell therapy: an overview protocol on published meta-analyses and evidence mapping

Stem cell therapy (SCT) is an emerging and promising treatment measure for many conditions (e.g., chronic liver disease, diabetes mellitus, and knee osteoarthritis). Although there are numerous meta-analyses (MAs) concerning SCT, the quality of these MAs and the efficacy and safety data for SCT reported in these MAs remain unknown. Therefore, it is of utmost importance to conduct an overview of existing MAs concerning SCT for evaluating these parameters.

We will systematically search PubMed and EMBASE databases from inception to October 2020 for identifying MAs of SCT published in English. Two independent reviewers will select appropriate MAs against the predefined eligibility criteria. The efficacy and safety data of SCT reported in MAs will be descriptively summarized. Following this, the reporting quality and methodological quality of included MAs will be appraised using Preferred Reporting Items for Systematic reviews and Meta-analyses (PRISMA) and A Measurement Tool to Assess Systematic Reviews 2 (AMSTAR-2) tools by two reviewers, respectively. Further, the evidence mapping method will be used to present assessment results. The key information will also be extracted by two independent reviewers. The Spearman's correlation coefficient will be used to explore the association between reporting quality and methodological quality. The factors influencing the quality will be assessed through linear regression analyses. The sensitivity analysis will also be conducted. Data analyses will be performed using Stata 16.0 and Excel 2016. P<0.05 will be considered statistically significant.

This overview of MAs concerning SCTs will provide comprehensive evidence on the quality of MAs and data of interest reported in MAs. Further, these data can be used to guide clinical practice and future research.

International Prospective Register of Systematic Reviews (PROSPERO): CRD42020206642.