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.
Acute Respiratory Distress Syndrome (ARDS) is a life-threatening condition characterized by severe inflammatory lung injury, impaired oxygen exchange, and high mortality. Current treatments are primarily supportive and include mechanical ventilation and intensive care management. JadiCell™ is an investigational cellular therapy derived from human umbilical cord tissue. These cells possess immunomodulatory and regenerative properties and may reduce inflammatory lung injury through paracrine signaling, immune regulation, and tissue repair mechanisms. Following intravenous administration, mesenchymal stem cells are known to localize within the pulmonary microvasculature where they interact with immune cells and injured lung tissue. This study will evaluate the safety and potential clinical effects of intravenous JadiCell administration in patients with ARDS.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
128
Subjects in the UC-MSC treatment group will receive two intravenous infusions (at day 0 and 3) of 100±20 x106 UC-MSC.
Subjects 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.
Time frame: 60 days
1. All-Cause Mortality
Number of Participants Who Died (All-Cause Mortality)
Time frame: 60 Days
2. Survival Status
Number of Participants Alive at Day 31
Time frame: 31 Days
3. Incidence of Serious Adverse Events (SAEs)
Number of Participants Experiencing Serious Adverse Events (SAEs)
Time frame: 31 Days
4. Serious Adverse Event-Free Survival
Number of Participants Alive Without Serious Adverse Events
Time frame: 31 Days
5. Time to Clinical Recovery
Time to Clinical Recovery (Days)
Time frame: Up to 60 Days
6. Time to Oxygen Requirement ≤ 40%
Time to Oxygen Requirement ≤ 40% (Days)
Time frame: Up to 60 Days
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