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).

NCT07479043 | Not Yet Recruiting Phase 3 DMC FDA Drug

• 1 other identifier: BRTH001
• Study Type: interventional
• Target: 128
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Acute Respiratory Distress Syndrome

Keywords

Acute Respiratory Distress Syndrome; ARDS; Mesenchymal Stem Cells; Cell Therapy; Regenerative Medicine; Inflammation

Outcome Measures

Primary Outcomes (1)

• 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.

  60 days

Secondary Outcomes (6)

• 1. All-Cause Mortality

  60 Days

• 2. Survival Status

  31 Days

• 3. Incidence of Serious Adverse Events (SAEs)

  31 Days

• 4. Serious Adverse Event-Free Survival

  31 Days

• 5. Time to Clinical Recovery

  Up to 60 Days

Study Arms (2)

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.

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.

Other: Controls will receive two infusions of vehicle solution.

Interventions

Controls will receive two infusions of vehicle solution. OTHER

Subjects in the control group will be treated with two IV infusions of vehicle solution.

Control

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.

Treatment

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Breathe Biologics, Inc.: lead

MeSH Terms

Conditions

Respiratory Distress Syndrome; Inflammation

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiration Disorders; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Drug A and a placebo for Drug B

Study Record Dates

• First Submitted: March 10, 2026
• First Posted: March 18, 2026
• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: March 19, 2026

Record last verified: 2026-03