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

Constanza de Dios; Ridhima Vij; Hosu Kim; Hyeonggeun Park; Donna Chang

doi:10.3389/fmed.2023.1321303

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

Front Med (Lausanne). 2023 Dec 22:10:1321303. doi: 10.3389/fmed.2023.1321303. eCollection 2023.

Authors

Constanza de Dios^#¹, Ridhima Vij^#², Hosu Kim³, Hyeonggeun Park³, Donna Chang^{2

3}

Affiliations

¹ Department of Psychiatry and Behavioral Sciences, University of Texas Health Science Center, Houston, TX, United States.
² Hope Biosciences Research Foundation, Sugar Land, TX, United States.
³ Hope Biosciences, Sugar Land, TX, United States.

^# Contributed equally.

Abstract

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 therapy.

Clinical trial registration: (www.ClinicalTrials.gov) identifier NCT04362189.

Keywords: COVID-19; adipose-derived; intravenous; mesenchymal stem cells; safety.

Associated data

ClinicalTrials.gov/NCT04362189

Grants and funding

The author(s) declare financial support was received for the research, authorship, and/or publication of this article. This study was funded in whole by Hope Biosciences Research Foundation and Hope Biosciences LLC provided the investigational drug.