To Evaluate 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).

Starting soon · Phase 3 · Has a placebo group

Conditions studied: Acute Respiratory Distress Syndrome

In brief

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.

Key facts

Study ID

NCT07479043

Run by

Breathe Biologics, Inc.

People needed

128

Starts

2026-07-01

Expected to finish

2026-12-01

Last updated by the study team

2026-03-19

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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.
• Pregnant or lactating patient
• Unstable arrhythmia
• Patients currently receiving immunosuppression with exception of up to 10 mg Prednisone equivalents daily
• Patients currently receiving chronic dialysis
• Patients currently receiving Extracorporeal Membrane Oxygenation (ECMO)
• Presence of any active malignancy (except non-melanoma skin cancer)
• Moderate to severe liver disease (AST and ALT >5 X ULN)
• Severe chronic respiratory disease with a PaCO2 > 50 mm Hg or the use of home oxygen at rest
• Septic Shock (with >1 vasopressor)
• Multi-organ failure
• Not expected to survive > 48 hours

Full record on ClinicalTrials.gov

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