Covid-19 Pneumonia Clinical Trial
Official title:
IV Infusion of Autologous Adipose Derived Mesenchymal Cells for Abatement of Respiratory Compromise in SARS-CoV-2 Pandemic (COVID-19)
The aim of this study is to evaluate the safety and efficacy of autologous adipose-derived
mesenchymal cells for treating confirmed or suspected patients with SARS-CoV-2 and
compromised respiratory function requiring hospitalization.
The hypothesis of the Study is autologous adipose-derived mesenchymal cells given IV to
eligible patients will improve clinical outcomes of COVID 19 positive patients with severe
pneumonia or ARDS by reducing or avoiding cytokine storm.
While most patients with SARS-CoV-2 present with mild respiratory disease with the most
common symptoms of fever and cough, approximately 14 % progress to severe pneumonia and ARDS.
The overall mortality rate is 2% but varies by country and age of the patient.
In COVID-19 ARDS standard supportive care and treatment for underlying illnesses remain the
mainstay with limited success.
Numerous antiviral medications including remdesivir, lopinavir-ritonavir or
lopinavir-ritonavir and interferon Beta-1a are in clinical trials but safety and efficacy
remain unclear.
Inflammation associated with a cytokine storm begins at a local site and spreads throughout
the body via systemic circulation. The lungs and other organs are damaged with progressive
inflammation.
Mesenchymal cells offer the potential to treat viral infection both directly and through
reducing the immune response. MSCs play a role as an immunomodulator, which is safe and
effective as demonstrated in numerous clinical trials.
Mesenchymal cells are a potential privileged cell-based therapy in SARS-CoV-2. MSCs derived
extracellular vesicles have demonstrated comparable and sometimes more effective effects in
ameliorating lung inflammation and injury.
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