This study evaluates the safety and potential therapeutic activity of JadiCell™, 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.
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
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)
Factorial
Subjects in the UC-MSC treatment group will receive two intravenous infusions (at day 0 and 3) of 100 million UC-MSC.
Biological/VaccineSubjects in the UC-MSC treatment group will receive two intravenous infusions (at day 0 and 3) of 100±20 x106 UC-MSC.
Controls will receive two infusions of vehicle solution.
Other interventionSubjects in the control group will be treated with two IV infusions of vehicle solution.
Proportion of Participants Alive and Free of Respiratory Failure
The proportion of participants who are alive and free of respiratory failure following treatment with UC-MSC therapy.
1. All-Cause Mortality
Number of Participants Who Died (All-Cause Mortality)
2. Survival Status
Number of Participants Alive at Day 31
3. Incidence of Serious Adverse Events (SAEs)
Number of Participants Experiencing Serious Adverse Events (SAEs)
4. Serious Adverse Event-Free Survival
Number of Participants Alive Without Serious Adverse Events
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