Abstract
BackgroundDespite increasing clinical investigations emphasizing the safety of mesenchymal stem cell (MSC) therapy in different populations with different diseases, no article has recently reviewed the adverse events in all populations.AimTo evaluate the safety of MSC therapy in all populations receiving MSC therapy and explore the potential heterogeneities influencing the clinical application of MSCs.MethodsThe PubMed, Embase, Web of Science and Scopus databases were searched from onset until 1 March 2021.ResultsAll adverse events are displayed as odds ratios (ORs) and 95% CIs (confidential intervals). In total, 62 randomized clinical trials were included that enrolled 3546 participants diagnosed with various diseases (approximately 20 types of diseases) treated with intravenous or local implantation versus placebo or no treatment. All studies were of high quality, and neither serious publication bias nor serious adverse events (such as death and infection) were discovered across the included studies. The pooled analysis demonstrated that MSC administration was closely associated with transient fever (OR, 3.65, 95% CI 2.05–6.49, p < 0.01), administration site adverse events (OR, 1.98, 95% CI 1.01–3.87, p = 0.05), constipation (OR, 2.45, 95% CI 1.01–5.97, p = 0.05), fatigue (OR, 2.99, 95% CI 1.06–8.44, p = 0.04) and sleeplessness (OR, 5.90, 95% CI 1.04–33.47, p = 0.05). Interestingly, MSC administration trended towards lowering rather than boosting the incidence rate of arrhythmia (OR, 0.62, 95% CI 0.36–1.07, p = 0.09).ConclusionsConclusively, MSC administration was safe in different populations compared with other placebo modalities.
Highlights
Mesenchymal stromal cells (MSCs), a class of highly heterogeneous cells that can be isolated from bone marrow, adipose tissue, the umbilical cord and the placenta, were primarily discovered in 1974 by Friedenstein [1]
Conclusively, MSC administration was safe in different populations compared with other placebo modalities
Outcome definition In total, we reported 17 adverse events that appeared during MSC therapy, of which 9 events were classified as major events, and 8 events were classified as minor events
Summary
Mesenchymal stromal cells (MSCs), a class of highly heterogeneous cells that can be isolated from bone marrow, adipose tissue, the umbilical cord and the placenta, were primarily discovered in 1974 by Friedenstein [1]. MSCs have been applied in many refractory diseases, such as cerebral palsy [8], spinal cord injury [9] and systemic lupus erythematosus [10]. A large number of studies, most of which have enrolled small samples, have investigated the safety of MSC transplantation, but no articles have reviewed these studies to characterize the adverse events closely associated with MSC administration over the past 9 years. Despite increasing clinical investigations emphasizing the safety of mesenchymal stem cell (MSC) therapy in different populations with different diseases, no article has recently reviewed the adverse events in all populations
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