IRCT20200413047063N1
Recruiting
Phase 1
Placental Mesenchymal Stem cells for treatment of ARDS in Coronavirus infection, Phase 1 and 2 Clinical Trials
Execution of Imam Khomeini's Order0 sites20 target enrollmentTBD
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Acute Respiratory Distress Syndrome of COVID-19.
- Sponsor
- Execution of Imam Khomeini's Order
- Enrollment
- 20
- Status
- Recruiting
- Last Updated
- 5 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Confirmation of 2019\-nCoV infection by RT\-PCR
- •Diagnosis of ARDS according to the Berlin definition of ARDS
- •Requiring supplemental oxygen,
- •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
- •Pneumonia that is judged by chest radiograph or CT
Exclusion Criteria
- •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 virus
- •Patients with previous history of pulmonary embolism
- •Liver or kidney SOFA score of more than 3 points; combined with other organ failure (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
Outcomes
Primary Outcomes
Not specified
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