Status:
TERMINATED
hCT-MSCs for COVID19 ARDS
Lead Sponsor:
Joanne Kurtzberg, MD
Collaborating Sponsors:
The Marcus Foundation
Conditions:
COVID
Corona Virus Infection
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
This is a 50 patient, Phase 1/2a multi-center pilot study to test the safety and to describe the preliminary efficacy of intravenous administration of allogenic human cord tissue mesenchymal stromal c...
Detailed Description
This is a 50 patient, Phase 1/2a multi-center pilot study to test the safety and to describe the preliminary efficacy of intravenous administration of allogenic human cord tissue mesenchymal stromal c...
Eligibility Criteria
Inclusion
- The patient or legally authorized representative (LAR) must have the ability to understand and the willingness to provide a signed and dated informed consent form.
- Age 18 years and over
- The patient agrees to use adequate contraception for the duration of the treatment protocol and for 6 months post treatment.
- Positive RT- PCR testing for COVID-19 nucleic acid using nasopharyngeal swabbing or any other site
- Patient meets ARDS criteria and is on non-invasive or mechanical ventilation or high flow nasal cannula
- bilateral opacities on chest imaging consistent with pulmonary edema
- A need for positive pressure ventilation or high flow nasal cannula
- PaO2/FiO2 ratio ≤ 300 mmHg by arterial blood gas or SpO2/FiO2 imputation.
- Infiltrates not fully explained by cardiac failure or fluid overload in the physician's best clinical judgement
- Subjects requiring dialysis as a result of a COVID-19 infection will not be excluded.
Exclusion
- Evidence of multiorgan failure involving one or more organs, excluding the lungs as defined below:
- Presence of shock, defined as MAP \< 65 mmHg with signs of peripheral hypoperfusion, or continuous infusion of 2 or more vasopressor or inotrope agents to maintain MAP ≥ 65 mmHg.
- Serum bilirubin \> 10 mg/dl
- Platelet count \< 50,000/ml
- Subjects requiring dialysis as a result of anything other than a COVID-19 infection will be excluded
- Evidence of acquired or congenital immunodeficiency (due to immunosuppressive therapy excluding steroid use for treatment of COVID-19 acute respiratory failure, HIV, previous treatment for cancer, etc.)
- History of metastatic cancer diagnosis or treatment in the past 1 year
- History of previous treatments with MSCs or other cell therapies
- Patient is co-enrolled in any other IND-sponsored clinical trials for COVID-19 or ARDs. Drugs that are administered under emergency use authorizations (EUA) by the FDA are permitted.
- Evidence of pregnancy or lactation
- Moribund patient not expected to survive \>24 hours
- Unable/unwilling to deliver lung protective ventilation
- Patient is receiving Extracorporeal Membrane Oxygenation (ECMO)
Key Trial Info
Start Date :
June 18 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 16 2022
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT04399889
Start Date
June 18 2020
End Date
February 16 2022
Last Update
December 20 2022
Active Locations (5)
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1
Boca Raton Regional Hospital
Boca Raton, Florida, United States, 33486
2
Jackson Memorial Hospital
Miami, Florida, United States, 33136
3
University of Miami Hospital
Miami, Florida, United States, 33136
4
New York Medical College
Valhalla, New York, United States, 10595