Safety of multiple intravenous infusions of adipose-derived mesenchymal stem cells for hospitalized cases of COVID-19: a randomized controlled trial.

Several human studies show positive signals, while research methods and sample sizes continue to develop.

• Level A · Stronger Clinical Evidence
• Level B · Emerging clinical evidence with positive signals
• Level C · Early human research exploring benefits
• Level D · Scientific groundwork from lab and animal studies
• Emerging · Emerging topic under active research

Abstract (original English)

Objective The purpose of the study was to assess the safety of allogeneic, Hope Biosciences Adipose Derived Mesenchymal Stem Cells (HB-adMSCs) for the treatment of hospitalized subjects with COVID-19. Methods N = 48 patients were randomly assigned to HB-adMSC (100 MM) or placebo group. Four intravenous infusions of HB-adMSCs or saline were administered at days 0, 3, 7, 10. The primary safety endpoint was incidence of adverse and serious adverse events (AE/SAEs); secondary endpoints were incidence of specific AEs and alterations in hematology, biochemistry, and coagulation parameters. Results Majority of AEs were mild in severity. HB-adMSC group showed a higher incidence of cardiopulmonary failure, anemia, anxiety, and diarrhea, while placebo group showed a higher incidence of headaches, fatigue, and chest discomfort (posterior probabilities ≥80%). Deaths were attributed to severe complications due to COVID-19 and were unrelated to study drug. No AEs were attributed to the treatment. Hematology and coagulation panel alterations were not associated with HB-adMSCs. Analyses of inflammatory markers showed increased levels of interleukin-6 and C-reactive protein over time in HB-adMSC group (posterior probabilities ≥78%). Conclusion Multiple infusions of 100MM allogeneic HB-adMSCs were considered safe for the study population. More research is needed to determine the safety of MSC th

Evidence level

Several human studies show positive signals, while research methods and sample sizes continue to develop.

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