Acute Respiratory Distress Syndrome
Conditions
Keywords
Acute Respiratory Distress Syndrome, ARDS, Mesenchymal Stem Cells, Cell Therapy, Regenerative Medicine, Inflammation
Brief summary
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.
Detailed description
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.
Interventions
BIOLOGICALSubjects in the UC-MSC treatment group will receive two intravenous infusions (at day 0 and 3) of 100 million UC-MSC.
Subjects in the UC-MSC treatment group will receive two intravenous infusions (at day 0 and 3) of 100±20 x106 UC-MSC.
OTHERControls will receive two infusions of vehicle solution.
Subjects in the control group will be treated with two IV infusions of vehicle solution.
Sponsors
Breathe Biologics, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Intervention model description
Drug A and a placebo for Drug B
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Patients currently hospitalized 2. Laboratory confirmation of ARDS 3. Aged between 18 and 80 years 4. Willing and able to provide written informed consent, or with a legal representative who can provide informed consent 5. SpO2 \<94% on room air requiring supplemental oxygen above baseline 6. PaO2/FiO2 \<300 mmHg 7. Bilateral infiltrates on frontal chest radiograph or bilateral ground glass opacities on a chest CT scan 8. 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
1. Greater than 96 h since hospitalization at the time of enrollment 2. Greater than 48 h since intubation at the time of enrollment 3. A previous MSC infusion not related to this trial 4. History of Pulmonary Hypertension (WHO Class III/IV) 5. History of left atrial hypertension or decompensated left heart failure. 6. Pregnant or lactating patient 7. Unstable arrhythmia 8. Patients currently receiving immunosuppression with exception of up to 10 mg Prednisone equivalents daily 9. Patients currently receiving chronic dialysis 10. Patients currently receiving Extracorporeal Membrane Oxygenation (ECMO) 11. Presence of any active malignancy (except non-melanoma skin cancer) 12. Moderate to severe liver disease (AST and ALT \>5 X ULN) 13. Severe chronic respiratory disease with a PaCO2 \> 50 mm Hg or the use of home oxygen at rest 14. Septic Shock (with \>1 vasopressor) 15. Multi-organ failure 16. Not expected to survive \> 48 hours
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Participants Alive and Free of Respiratory Failure | 60 days | The proportion of participants who are alive and free of respiratory failure following treatment with UC-MSC therapy. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 1. All-Cause Mortality | 60 Days | Number of Participants Who Died (All-Cause Mortality) |
| 2. Survival Status | 31 Days | Number of Participants Alive at Day 31 |
| 3. Incidence of Serious Adverse Events (SAEs) | 31 Days | Number of Participants Experiencing Serious Adverse Events (SAEs) |
| 4. Serious Adverse Event-Free Survival | 31 Days | Number of Participants Alive Without Serious Adverse Events |
| 5. Time to Clinical Recovery | Up to 60 Days | Time to Clinical Recovery (Days) |
| 6. Time to Oxygen Requirement ≤ 40% | Up to 60 Days | Time to Oxygen Requirement ≤ 40% (Days) |
Outcome results
None listed