Acute Respiratory Distress SyndromePhase 3NCT07479043

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).

A Phase 3 study testing Subjects in the UC-MSC treatment group will receive two intravenous infusions (at day 0 and 3) of 100 million UC-MSC. in people with Acute Respiratory Distress Syndrome, run by Breathe Biologics, Inc..

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Official record

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Trial summary

Who is it for?: Ages 18 to 80 years
Conditions the study is for: Acute Respiratory Distress Syndrome
What is being tested?: Subjects in the UC-MSC treatment group will receive two intravenous infusions (at day 0 and 3) of 100 million UC-MSC.
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 128 participants
Where: No sites listed yet
Study dates: 1 Mar 2027to Dec 2027
Phase: Phase 3
Are there results?: Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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)

Who cannot join

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

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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

About this study

Official title: Phase III Clinical Study of JadiCell™ (Umbilical Cord-Derived Mesenchymal Stem Cells) for the Treatment of Acute Respiratory Distress Syndrome (ARDS)

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.

Read the 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.

Conditions: Acute Respiratory Distress Syndrome
Being tested: Subjects in the UC-MSC treatment group will receive two intravenous infusions (at day 0 and 3) of 100 million UC-MSC., Controls will receive two infusions of vehicle solution.
Keywords: Acute Respiratory Distress Syndrome, ARDS, Mesenchymal Stem Cells, Cell Therapy, Regenerative Medicine, Inflammation
Medical subject headings: Respiratory Distress Syndrome, Inflammation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Subjects in the UC-MSC treatment group will receive two intravenous infusions (at day 0 and 3) of 100 million UC-MSC.Biological
Subjects 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
Subjects in the control group will be treated with two IV infusions of vehicle solution.

Study groups in NCT07479043
Study group	Role	What they receive
Treatment	Experimental	Subjects in the UC-MSC treatment group will receive two intravenous infusions (at day 0 and 3) of 100±20 x106 UC-MSC. Receives: Biological: Subjects in the UC-MSC treatment group will receive two intravenous infusions (at day 0 and 3) of 100 million UC-MSC.
Control	Placebo comparator	Controls will receive two infusions of vehicle solution. Receives: Other: Controls will receive two infusions of vehicle solution.

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 60 days

Secondary outcomes (6)

1. All-Cause Mortality
Number of Participants Who Died (All-Cause Mortality)
Measured: 60 Days
2. Survival Status
Number of Participants Alive at Day 31
Measured: 31 Days
3. Incidence of Serious Adverse Events (SAEs)
Number of Participants Experiencing Serious Adverse Events (SAEs)
Measured: 31 Days
4. Serious Adverse Event-Free Survival
Number of Participants Alive Without Serious Adverse Events
Measured: 31 Days
5. Time to Clinical Recovery
Time to Clinical Recovery (Days)
Measured: Up to 60 Days
6. Time to Oxygen Requirement ≤ 40%
Time to Oxygen Requirement ≤ 40% (Days)
Measured: Up to 60 Days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Mar 2027Dec 2027

First posted18 Mar 2026
Study start1 Mar 2027 (estimated)
Primary completion31 Oct 2027 (estimated)
Study completionDec 2027 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Acute Respiratory Distress SyndromeStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Factorial
Model description: Drug A and a placebo for Drug B
Masking: Single blind
Who is masked: Participant
Enrolment: 128 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07479043
Sponsor's protocol ID: BRTH001
Status last verified: Sep 2026
First submitted: 10 Mar 2026
Last updated: 1 Oct 2026
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Undecided

Interested in taking part?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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All Acute Respiratory Distress Syndrome trials

Study at a glance

From the registry record, last updated by the sponsor on 1 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Phase III Clinical Study of JadiCell™ (Umbilical Cord-Derived Mesenchymal Stem Cells) for the Treatment of Acute Respiratory Distress Syndrome (ARDS)
ClinicalTrials.gov ID: NCT07479043
Acronym / sponsor ID: BRTH001
Conditions: Acute Respiratory Distress Syndrome
Keywords: Acute Respiratory Distress Syndrome, ARDS, Mesenchymal Stem Cells, Cell Therapy, Regenerative Medicine, Inflammation
Phase: Phase 3
Study type: Interventional
Recruitment status: Not yet recruiting
Enrolment: 128 participants (estimated)
Lead sponsor: Breathe Biologics, Inc.Industry (pharma, biotech, devices)
Study start: 1 Mar 2027 (estimated)
Primary completion: 31 Oct 2027 (estimated)
Study completion: Dec 2027 (estimated)
First posted: 18 Mar 2026 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

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 design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Factorial
Masking: Single blind (participant)
Number of arms: 2
Model description: Drug A and a placebo for Drug B

Arm	Type	Receives
Treatment	Experimental	Biological: Subjects 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.
Control	Placebo comparator	Other: Controls will receive two infusions of vehicle solution.Controls will receive two infusions of vehicle solution.

Who may qualify

Ages: 18 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

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

Key exclusion criteria (16 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Subjects 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.	Biological	Treatment
Controls will receive two infusions of vehicle solution.Subjects in the control group will be treated with two IV infusions of vehicle solution.	Other	Control

Primary outcome

Proportion of Participants Alive and Free of Respiratory Failure
Time frame: 60 days
The proportion of participants who are alive and free of respiratory failure following treatment with UC-MSC therapy.

6 secondary outcomes

1. All-Cause Mortality
Time frame: 60 Days
2. Survival Status
Time frame: 31 Days
3. Incidence of Serious Adverse Events (SAEs)
Time frame: 31 Days
4. Serious Adverse Event-Free Survival
Time frame: 31 Days
5. Time to Clinical Recovery
Time frame: Up to 60 Days
6. Time to Oxygen Requirement ≤ 40%
Time frame: Up to 60 Days

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2026.
Individual participant dataSharing planned: Undecided

Related trials for Acute Respiratory Distress Syndrome

Enrolling by invitation
Personalized Ventilator Settings for Patients on ECMO
Acute Respiratory Distress Syndrome (ARDS), Extracorporeal Membrane Oxygenation
Active, not recruiting
CT for Personalized Mechanical Ventilation
Ventilator-Induced Lung Injury, Sepsis Syndrome
Not yet recruitingObservational study
Development and Multicenter Validation of an Explainable System for Neonatal ARDS-Compatible Phenotyping
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RecruitingObservational study
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Recruiting
Comparing Surfactant Administration Through Supraglottic Airway and Thin Catheter for Preterm Infants
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.

The record lists no contact. Use the official record to reach the sponsor.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 1 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of Participants Alive and Free of Respiratory Failure (time frame: 60 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07479043.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2026.