Safety of Multiple Intravenous Infusions of Adipose-Derived Mesenchymal Stem Cells for Hospitalized Cases of COVID-19: A Randomized Controlled Trial

Authors

Constanza de Dios
Ridhima Vij
Hosu Kim
Hyeonggeun Park
Donna Chang

Publication Date

1-1-2023

Journal

Frontiers in Medicine

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:

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.

Keywords

mesenchymal stem cells, adipose-derived, intravenous, safety, COVID-19

Comments

Clinical Trial Registration Identifier NCT04362189.

Supplementary Materials

PMID: 38188343