Adipose Mesenchymal Cells for Abatement of SARS-CoV-2 Respiratory Compromise in COVID-19 Disease
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|ClinicalTrials.gov Identifier: NCT04352803|
Recruitment Status : Not yet recruiting
First Posted : April 20, 2020
Last Update Posted : April 21, 2020
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.
|Condition or disease||Intervention/treatment||Phase|
|Covid-19 Pneumonia Cyotokine Storm||Biological: Autologous Adipose MSC's||Phase 1|
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 (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Sequential Assignment|
|Intervention Model Description:||This is an Interventional, Prospective, Open label (Voluntary Assignment), single to multiple center expansion, unmatched controlled, Sequentially Interim analysis tested Trial|
|Masking:||None (Open Label)|
|Official Title:||IV Infusion of Autologous Adipose Derived Mesenchymal Cells for Abatement of Respiratory Compromise in SARS-CoV-2 Pandemic (COVID-19)|
|Estimated Study Start Date :||April 2020|
|Estimated Primary Completion Date :||April 2024|
|Estimated Study Completion Date :||April 2026|
Experimental: Autologous Adipose Derived Mesenchymal Cells
Conventional treatment plus MSC's IV
Biological: Autologous Adipose MSC's
Autologous Adipose Derived Mesenchymal Cells 500,000/kg IV
No Intervention: Untreated
Conventional treatment only
- Safety - Incidence of unexpected adverse events [ Time Frame: up to 28 days ]Incidence of unexpected adverse events within 28 days following IV administration of MSCs.
- Efficacy - Frequency of progression to mechanical ventilation [ Time Frame: up to 28 days ]Changes in progression or rate of subjects progressing to mechanical ventilation
- Efficacy - Changes in length of mechanical ventilation [ Time Frame: up to 28 days ]Changes in time subjects remain on mechanical ventilation
- Efficacy - Changes in length of weaning of mechanical ventilation [ Time Frame: up to 28 days ]Changes in length of time subjects wean off of mechanical ventilation
- Efficacy - Changes in length of hospital stay [ Time Frame: up to 28 days ]Length of Hospital Stay
- Efficacy - Changes in mortality rate [ Time Frame: up to 28 days ]Mortality rate from all causes
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04352803
|Contact: Ryan Welter, MD PhD||(508) email@example.com|