To Evaluate the Safety and Potential Therapeutic Activity of JadiCell™, an Investigational Umbili… (NCT07479043) | Clinical Trial Compass
Not Yet RecruitingPhase 3
To Evaluate the Safety and Potential Therapeutic Activity of JadiCellâ„¢, an Investigational Umbilical Cord-Derived Mesenchymal Stem Cell Therapy, in Patients Diagnosed With Acute Respiratory Distress Syndrome (ARDS).
128 participantsStarted 2026-07
Plain-language summary
This study evaluates the safety and potential therapeutic activity of JadiCellâ„¢, an investigational umbilical cord-derived mesenchymal stem cell therapy, in patients diagnosed with Acute Respiratory Distress Syndrome (ARDS). JadiCells are administered intravenously and are intended to modulate inflammatory responses and promote tissue repair in injured lung tissue.
Who can participate
Age range18 Years – 80 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Patients currently hospitalized
✓. Laboratory confirmation of ARDS
✓. Aged between 18 and 80 years
✓. Willing and able to provide written informed consent, or with a legal representative who can provide informed consent
✓. SpO2 \<94% on room air requiring supplemental oxygen above baseline
✓. PaO2/FiO2 \<300 mmHg
✓. Bilateral infiltrates on frontal chest radiograph or bilateral ground glass opacities on a chest CT scan
✓. Requiring one of the following ï High Flow Oxygen Therapy ï Non-invasive Positive Pressure Ventilation (NIPPV, e.g. BiPAP and CPAP) ï Invasive Mechanical Ventilation (INV = intubated)
Exclusion criteria
✕. Greater than 96 h since hospitalization at the time of enrollment
✕. Greater than 48 h since intubation at the time of enrollment
✕. A previous MSC infusion not related to this trial
✕. History of Pulmonary Hypertension (WHO Class III/IV)
✕. History of left atrial hypertension or decompensated left heart failure.
What they're measuring
1
Proportion of Participants Alive and Free of Respiratory Failure