MSC-based Therapy in COVID-19-associated Acute Respiratory Distress Syndrome

Last updated: August 24, 2020
Sponsor: D'Or Institute for Research and Education
Overall Status: Active - Recruiting

Phase

1

Condition

Lung Injury

Acute Respiratory Distress Syndrome (Ards)

Treatment

N/A

Clinical Study ID

NCT04525378
PCL02/2020
  • Ages > 18
  • All Genders

Study 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, administered intravenously, in patients with pneumonia associated with COVID-19-associated acute respiratory distress syndrome.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.

Study Design

Total Participants: 20
Study Start date:
July 01, 2020
Estimated Completion Date:
October 31, 2020

Connect with a study center

  • Hospital São Rafael

    Salvador, Bahia 41253-190
    Brazil

    Active - Recruiting

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