Mesenchymal Stromal Cells for the Treatment of SARS-CoV-2 Induced Acute Respiratory Failure (COVID-19 Disease)

Plain-language summary

This study evaluated mesenchymal stromal cell therapy, together with supportive care, in adults with acute respiratory failure caused by SARS-CoV-2 (COVID-19 disease). To join, patients had to be 18 or older with confirmed SARS-CoV-2 infection and moderate or severe acute respiratory distress syndrome (ARDS). The study was conducted in Phase 1/Phase 2 and has been completed.

The summary above is a plain-language rendering of the official record. The original English title is shown for reference.

Trial details

Phase

PHASE1/PHASE2

Status

Completed

Sponsor

Baylor College of Medicine

Intervention

Mesenchymal Stromal Cells, Supportive Care

Start date

2/12/2021

Estimated completion

1/10/2023

Countries

United States

Related genes

Locations

• Houston, United States

Eligibility criteria

Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.

Inclusion Criteria:

1. 18 years or older
2. Confirmed SARS-CoV2 infection real-time reverse transcription polymerase chain reaction (RT-PCR) assay
3. Moderate OR severe ARDS, based on the degree of impairment of oxygenation as defined by the ratio of arterial oxygen tension to fraction of inspired oxygen (PaO2/FiO2):

   1. Moderate ARDS: PaO2/FiO2 100-200 mmHg OR
   2. Severe ARDS: PaO2/FiO2 ≤100 mmHg
4. If on invasive or noninvasive (BiPAP) mechanical ventilator, PEEP ≥5 cm H2O
5. Bilateral opacities present on chest radiograph or computed tomographic (CT) scan, that are not fully explained by pleural effusions, lung collapse, or lung nodules.

Exclusion Criteria:

1. Currently receiving extracorporeal membrane oxygenation (ECMO)
2. Severe chronic respiratory disease requiring use of home oxygen
3. Pregnant or lactating
4. Known hypersensitivity to dimethyl sulfoxide (DMSO)
5. Unstable hemodynamics as deemed by the treating physician/investigator including but not limited to unstable, ventricular tachycardia or new cardiac arrythmia requiring cardioversion.
6. Uncontrolled bacterial or fungal co-infection
7. Any end-stage organ disease or condition, which in the opinion of the Investigator, makes the patient an unsuitable candidate for treatment
8. Inability to obtain informed consent (from patient or legally appropriate proxy)
9. Presence of any contraindication to receiving prophylactic low dose unfractionated or low molecular weight heparin.
10. Respiratory failure not fully explained by cardiac failure or fluid overload.