Status:
UNKNOWN
MSC-based Therapy in COVID-19-associated Acute Respiratory Distress Syndrome
Lead Sponsor:
D'Or Institute for Research and Education
Conditions:
Covid19
ARDS, Human
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
Considering the potential of mesenchymal stromal cells (MSCs) in the treatment of lung injuries by COVID-19, this pilot clinical trial evaluates the safety and potential efficacy of the cell therapy, ...
Eligibility Criteria
Inclusion
- Clinical diagnosis of COVID-19 confirmed by RT-PCR;
- Thorax CT image suggestive of viral pneumonia;
- Respiratory failure (SaO2 \<93% with O2 at 5L / min)
- Tracheal intubation (first 48 h);
Exclusion
- Pregnancy or breastfeeding;
- Patients with a history of cancer, chemotherapy in the past 2 years;
- Life expectancy less than 6 months or in exclusive palliative care;
- Severe liver failure, with Child-Pugh score\> 12;
- High probability of death in the following 48 h;
- Previous renal failure: patients who were already on dialysis or patients with RFG \<30ml / min / 1.73 m2;
- Clinical or radiological suspicion of tuberculosis and bacterial pneumonia.
Key Trial Info
Start Date :
July 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 31 2020
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT04525378
Start Date
July 1 2020
End Date
October 31 2020
Last Update
August 26 2020
Active Locations (1)
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1
Hospital São Rafael
Salvador, Estado de Bahia, Brazil, 41253-190