Status:
COMPLETED
Study of Decidual Stromal Cells to Treat COVID-19 Respiratory Failure
Lead Sponsor:
University Health Network, Toronto
Collaborating Sponsors:
Oslo University Hospital
Conditions:
COVID-19
Acute Respiratory Distress Syndrome
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief Summary
This is a research study to see how safe and effective decidual stromal cells are in treating patients with respiratory failure (breathing problem where not enough oxygen is passed from the lungs into...
Detailed Description
COVID-19 viral infectious disease that has lead to high numbers of critically ill patients or death due to respiratory failure. Decidual Stromal Cells (DSC) may be useful in the treatment of acute re...
Eligibility Criteria
Inclusion
- Able to provide informed consent for participation in the study, either by the participant themselves or by the legally acceptable representative (LAR)
- Virological diagnosis of SARS-CoV-2 infection (PCR)
- Acute respiratory distress syndrome (ARDS) not due to cardiac causes
- Receiving mechanical ventilation
Exclusion
- Severe comorbidity with life expectancy \<3 months according to investigators assessment
- Currently receiving extracorporeal membrane oxygenation (ECMO)
- Patients with established positive bacterial blood cultures prior to enrollment or suspicion of superimposed bacterial pneumonia
- Patients with diagnosed significant pulmonary embolism or deep vein thrombosis in the previous 3 months
- Patients who have been intubated for more than 48 hours
- Known hypersensitivity to dimethyl sulfoxide (DMSO) or to porcine or bovine proteins
- Acute co-morbidity within 7 days before inclusion such as stroke
- History of severe chronic history of heart disease, recent myocardial infarction or unstable angina, lung disease (requiring home oxygen), pulmonary hypertension, or liver comorbidities
- Malignancy that requires treatment in the previous two years (excluding non-melanoma skin malignancies treated by excision, or cryotherapy)
- History of immunosuppression (immunomodulators or anti-rejection drugs in past year, or active disease, autoimmune disease on treatment, transplant recipients) or anaphylaxis
- Refusal of blood products
- Severe co-morbidity/co-morbidities which in the opinion of the investigators would compromise safety assessments
- Pregnant or breast-feeding
- Actively participating on another trial of an investigational agent for ARDS
- Unacceptable laboratory blood tests for alanine aminotransferase (ALT)/aspartate aminotransferase (AST), neutrophils, or platelets
Key Trial Info
Start Date :
September 25 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 7 2023
Estimated Enrollment :
19 Patients enrolled
Trial Details
Trial ID
NCT04451291
Start Date
September 25 2020
End Date
November 7 2023
Last Update
February 5 2024
Active Locations (3)
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1
Brampton Civic Hospital
Brampton, Ontario, Canada, L6R 3J7
2
Etobicoke General Hospital
Etobicoke, Ontario, Canada, M9V 1R8
3
Toronto General Hospital
Toronto, Ontario, Canada, M5G 2C4