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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
20
Autologous Adipose Derived Mesenchymal Cells 500,000/kg IV
Safety - Incidence of unexpected adverse events
Incidence of unexpected adverse events within 28 days following IV administration of MSCs.
Time frame: up to 28 days
Efficacy - Frequency of progression to mechanical ventilation
Changes in progression or rate of subjects progressing to mechanical ventilation
Time frame: up to 28 days
Efficacy - Changes in length of mechanical ventilation
Changes in time subjects remain on mechanical ventilation
Time frame: up to 28 days
Efficacy - Changes in length of weaning of mechanical ventilation
Changes in length of time subjects wean off of mechanical ventilation
Time frame: up to 28 days
Efficacy - Changes in length of hospital stay
Length of Hospital Stay
Time frame: up to 28 days
Efficacy - Changes in mortality rate
Mortality rate from all causes
Time frame: up to 28 days
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.