Efficacy of intravenous infusions of UC-derived MSCs for the treatment of COVID-19: A structured summary of a phase II double blinded, randomized controlled clinical trial [post]

Muhammad Ali, Azra Mehmood, Moazzam Nazeer Tarar, John D Gottsch, Zafar Nawaz, S. Amer Riazuddin, Aisha Khan, Sheikh Riazuddin
2020 unpublished
In this clinical research project, we will conduct a highly rigorous clinical trial where we randomize the patients between umbilical cord (UC)-derived mesenchymal stem cell (MSC) and standard of care (SOC). This study will ask the question whether the allogenic MSCs are effective in reducing death and/or progression of COVID-19 disease when administered to patients with moderate to severe symptoms. MSCs are unique group of cells with minimal immune reactivity and produce multiple beneficial
more » ... tiple beneficial effects, which include reduction of severe inflammatory reaction. There is convincing evidence from human studies that intravenous (IV) delivery of MSCs can directly impact the hyper-inflammatory responses of COVID-19 induced injury of the heart and lungs. Our study will evaluate the safety and efficacy of allogenic UC-derived MSCs administered intravenously to COVID-19 patients with moderate to severe symptom in a randomized, controlled clinical trial. In addition, we will determine whether : (i) UC-derived MSCs are effective in reducing 30-day all-cause mortality (primary endpoint) and (ii) UC-derived MSCs are effective in preventing progression to mechanical ventilation, and/or reducing an inflammatory response, and/or improving overall patient condition (secondary endpoints).
doi:10.21203/rs.3.rs-92995/v1 fatcat:kpvc76knmnfxbnqnmgjy4xdyui