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Could umbilical cord stem cells help ARDS patients breathe again?

NCT ID NCT07479043

Disease control Sponsor: Breathe Biologics, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests a new treatment called JadiCell, made from stem cells from donated umbilical cords, for people with severe lung failure (ARDS). The goal is to see if a single IV dose can calm inflammation and help the lungs heal, so patients need less breathing support. About 128 adults in the hospital will take part. The main focus is safety and whether more patients survive without needing a ventilator.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 128 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Jul 2026

An estimate. Start dates often move.

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 80 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

acute respiratory distress syndrome adult acute respiratory distress syndrome Inflammation

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Acute respiratory distress syndrome

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The official record

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

    Open the record ↗

  2. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

More trials for these conditions

Other studies related to the condition(s) this trial covers.