AUTHOR=de Dios Constanza , Vij Ridhima , Kim Hosu , Park Hyeonggeun , Chang Donna 

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

JOURNAL=Frontiers in Medicine

VOLUME=10

YEAR=2023

URL=https://www.frontiersin.org/journals/medicine/articles/10.3389/fmed.2023.1321303

DOI=10.3389/fmed.2023.1321303

ISSN=2296-858X

ABSTRACT=<sec id="sec1"><title>Objective</title><p>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.</p></sec><sec id="sec2"><title>Methods</title><p><italic>N</italic> = 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.</p></sec><sec id="sec3"><title>Results</title><p>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%).</p></sec><sec id="sec4"><title>Conclusion</title><p>Multiple infusions of 100MM allogeneic HB-adMSCs were considered safe for the study population. More research is needed to determine the safety of MSC therapy.</p></sec><sec id="sec004"><title>Clinical trial registration</title><p>(<ext-link xlink:href="http://www.ClinicalTrials.gov/" ext-link-type="uri" xmlns:xlink="http://www.w3.org/1999/xlink">www.ClinicalTrials.gov</ext-link>) identifier NCT04362189.</p></sec>