Status:
TERMINATED
Safety and Efficacy of Intravenous Wharton's Jelly Derived Mesenchymal Stem Cells in Acute Respiratory Distress Syndrome Due to COVID 19
Lead Sponsor:
BioXcellerator
Conditions:
Acute Respiratory Distress Syndrome
Eligibility:
All Genders
18-80 years
Phase:
PHASE1
PHASE2
Brief Summary
Recent COVID 19 pandemic has overwhelmed health services all around the world, and humanity has yet to find a cure or a vaccine for the treatment of patients, mainly the severe ones, who pose a therap...
Detailed Description
SARS-CoV-2, virus culprit of the COVID 19 that emerged in China, has become now a worldwide problem, with more than three million cases al around the world as reported by the World Health Organization...
Eligibility Criteria
Inclusion
- SARS-CoV-2 positive Real Time - Polymerase Chain Reaction
- Moderate to severe Acute respiratory distress syndrome according to Murray classification.
- PaO2/FiO2 less than 200 mmHg.
- Within 36 hours of orotracheal intubation.
- Absence of response with previous standard therapy.
- Willing to participate in the study expressed by patient or responsible caregiver.
- Not being in other clinical trial.
Exclusion
- Current pregnancy.
- Cardiac rhythm abnormalities with instability.
- Acute congestive heart failure/cardiogenic shock.
- Severe comorbidities affecting mortality as defined by research group.
- Cancer history in the past 5 years.
- HIV, syphilis, hepatitis B or C.
- Concomitant use of immunosuppressive therapy with contraindication to MSC.
- Fivefold elevation of liver enzymes (ALT, AST).
- Chronic kidney disease with glomerular filtration rate below 30ml/min or dialytic needs.
Key Trial Info
Start Date :
January 13 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 3 2022
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT04390152
Start Date
January 13 2020
End Date
March 3 2022
Last Update
August 27 2024
Active Locations (2)
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1
Clinical Somer
Rionegro, Antioquia, Colombia
2
BioXcellerator
Medellín, Antioquia-CO, Colombia, 050022