Placental Mesenchymal Stem Cell Therapy for Acute Respiratory Distress Syndrome in Coronavirus Infection: A Phase 1-2 Clinical Trial

Phase 1

Recruiting

• Conditions: Acute Respiratory Distress Syndrome of COVID-19.; COVID-19; U07.1

• Registration Number: IRCT20200413047063N1
• Lead Sponsor: Execution of Imam Khomeini's Order

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 18 May 2020

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 20

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
Be thought by researchers to be inappropriate to participate in this clinical study (Expected deaths within 48 hours, uncontrolled infections)

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Adverse events assesment. Timepoint: At the same time of each intervention, 24 hours after each intervention, on days 6, 7, 14 and 28 after the first intervention. Method of measurement: Number of participants with treatment-related adverse events as assessed by CTCAE v4.0.;Blood oxygen saturation. Timepoint: At Baseline, simultaneously with each intervention and on days 5, 6, 7, 14 after the first intervention. Method of measurement: Evaluation of Pneumonia Improvement.

Secondary Outcome Measures

Name	Time	Method
Biomarkers concentrations in plasma. Timepoint: At baseline, 7, 14, 28 days after the first intervention. Method of measurement: Biochemical examination.;Respiratory efficacy. Timepoint: From baseline to day 7. Method of measurement: Evaluated by the increase in PaO2/FiO2 ratio.;Intensive care unit-free days. Timepoint: Up to day 8. Method of measurement: Number of day.;Change in clinical symptoms. Timepoint: At Baseline, simultaneously with each intervention and on days 5, 6, 7, 14 after the first intervention. Method of measurement: Evaluation of Pneumonia Improvement.