Ignite Creation Date:
2024-05-06 @ 2:33 PM
Last Modification Date:
2024-10-26 @ 1:33 PM
Study NCT ID:
NCT04352803
Status:
NOT_YET_RECRUITING
Last Update Posted:
2020-04-21
First Post:
2020-04-16
Brief Title:
Adipose Mesenchymal Cells for Abatement of SARS-CoV-2 Respiratory Compromise in COVID-19 Disease
Sponsor:
Regeneris Medical
Organization:
Regeneris Medical
Study Overview
Official Title:
IV Infusion of Autologous Adipose Derived Mesenchymal Cells for Abatement of Respiratory Compromise in SARS-CoV-2 Pandemic COVID-19
Status:
NOT_YET_RECRUITING
Status Verified Date:
2020-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
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
Detailed Description:
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None