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Clinical Trials/IRCT20200413047063N1
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.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
5 years ago
Study Type
Interventional
Sex
All

Investigators

Sponsor
Execution of Imam Khomeini's Order

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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