Status:
UNKNOWN
Mesenchymal Stem Cell Therapy for SARS-CoV-2-related Acute Respiratory Distress Syndrome
Lead Sponsor:
Royan Institute
Collaborating Sponsors:
Tehran University of Medical Sciences
Shahid Beheshti University of Medical Sciences
Conditions:
Covid-19
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
PHASE3
Brief Summary
Acute Respiratory Distress Syndrome (ARDS) is the major cause of death in the COVID-19 pandemic. In this trial, the safety and efficacy of Mesenchymal Stem Cells (MSC) for the treatment of ARDS in COV...
Detailed Description
Acute respiratory distress syndrome (ARDS) is the major cause of death in the COVID 19 infection pandemic. It is a devastating clinical condition, caused by an acute and diffuse lung injury that requi...
Eligibility Criteria
Inclusion
- Confirmation of 2019-nCoV infection by RT-PCR
- Diagnosis of ARDS according to the Berlin definition of ARDS
- Requiring supplemental oxygen
- Pneumonia that is judged by chest radiograph or CT
- PaO2/oxygen absorption concentration (FiO2) ≤ 300MMHG
- Pulmonary imaging shows that the focused progress \> 50% in 24-48 hours
- Mild to Moderate 2019-nCoV pneumonia/ stay in the ICU \<48 hours
- SOFA score between 2-3 point
Exclusion
- Severe allergies or allergies after 1st injection to stem cell preparations and their components
- Patients with a malignant tumor, other serious systemic diseases, and psychosis
- Co-Infection of HIV, tuberculosis, influenza virus, adenovirus, and other respiratory infection viruses
- Patients with a previous history of pulmonary embolism
- Be thought by researchers to be inappropriate to participate in this clinical study (Expected deaths within 48 hours, uncontrolled infections)
- Liver or kidney SOFA score of more than 3 points; combined with other organ failures (need organ support), Stage 4 severe chronic kidney disease or requiring dialysis (i.e. estimated glomerular filtration rate (eGFR) \< 30)
- Pulmonary obstructive pneumonia, severe pulmonary interstitial fibrosis, alveolar proteinosis, allergic alveolitis, and other known viral pneumonia or bacterial pneumonia
- Continuous use of immunosuppressive agents or organ transplants in the past 6 months
- In vitro life support (ECMO, ECCO2R, RRT)
- Pregnant or lactating women
- Uncontrolled underlying disease
Key Trial Info
Start Date :
April 5 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 10 2020
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT04366063
Start Date
April 5 2020
End Date
December 10 2020
Last Update
April 30 2020
Active Locations (1)
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1
Royan Institute
Tehran, Iran, 16635148