Mesenchymal Stromal Cells for COVID-19 and Viral Pneumonias (NCT05286255) | Clinical Trial Compass
WithdrawnPhase 1
Mesenchymal Stromal Cells for COVID-19 and Viral Pneumonias
Stopped: Funding
United States0Started 2024-10-01
Plain-language summary
This is an open-label phase 1 clinical trial of allogeneic umbilical cord derived mesenchymal stromal cells (MSCs) for hospitalized individuals with COVID-19 or other viral pneumonias. Hospitalized individuals who are within 7 days of the onset of a viral pneumonia will be given 2 doses of MSCs at days 1 and 3 after consent. The safety of intravenous infusion will be tested and course of the oxygen response to treatment over 90 days will be evaluated.
Who can participate
Age range18 Years – 80 Years
SexALL
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Inclusion criteria
✓. Hospitalized with COVID-19 respiratory symptoms and confirmation via COVID-19 SARS-CoV-2 RT-PCR testing.
✓. Patient or their surrogate is willing and able to provide written informed consent and comply with all protocol requirements.
✓. Diagnosis with Mild or Moderate Pneumonia not requiring mechanical ventilation: Patient must have at least one of the following features:
✓. Patient agrees to storage of specimens for future testing.
✓. Willingness to undergo mechanical ventilation for worsening
Exclusion criteria
✕. Intubation with mechanical ventilation prior to study enrolment. High flow nasal cannula and non-invasive mechanical ventilation is allowed.
✕. Pneumonia caused by bacteria, mycoplasma, chlamydia, legionella, fungi or other viruses
✕. Obstructive pneumonia induced by lung cancer or other known causes
✕. Significant comorbid illness likely to impact the outcome of COVID-19 including but not limited to active malignancy other than skin cancer.
✕. Patients who are participating in other therapeutic clinical trials within 30 days of consent.
✕. History of long-term use of immunosuppressive agents including prednisone dose \>5mg daily over the 30 days prior to enrollment.