AllogeneiC Expanded Human MSC Therapy in Patients Recovering From COVID-19 Acute Respiratory Dist… (NCT05491681) | Clinical Trial Compass
WithdrawnPhase 1
AllogeneiC Expanded Human MSC Therapy in Patients Recovering From COVID-19 Acute Respiratory Distress Trial
Stopped: With available funding it was necessary for Sponsor to prioritize other studies. No study participants were consented or enrolled and no study sites were activated.
0Started 2026-01-04
Plain-language summary
Allogeneic culture-expanded bone marrow-derived human mesenchymal stem cells (MSC) are the subject of the current study as they are supported by preclinical and clinical data for potential to provide a safe and effective treatment for patients with acute respiratory distress.
Who can participate
Age range18 Years – 80 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Patient \> 18 years and ≤ 80 at age at consent
✓. Patient must have:
✓. PaO2/FiO2 \> 100 to \<200 mmHg with PEEP\>5cm H2O
✓. Patient or legally authorized representative (LAR) provides written informed consent, except as noted in 21 CFR 50.23
✓. Understands and agrees to comply with planned study procedures
✓. Available for clinical follow-up for duration of the treatment and follow-up period
✓. Woman of childbearing potential must have a negative pregnancy test at admission or within 24 hours before starting treatment
✓. Agree not to become pregnant during treatment and for 1 months after receiving treatment
Exclusion criteria
✕. Severe chronic respiratory disease with a PaCO2 \> 50 mm Hg or the use of home oxygen (chronic obstructive pulmonary disease or pulmonary fibrosis)
✕. Be an organ transplant recipient
✕. ALT/AST ≥ 5 times the upper limit of normal
✕. BMI \> 40
✕. Stage 4 severe kidney disease or requiring dialysis (i.e. eGFR \<30)
What they're measuring
1
Number of product related adverse events through the duration of the study.