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).

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Acute Respiratory Distress Syndrome
• Intervention / Treatment: Biological: Subjects in the UC-MSC treatment group will receive two intravenous infusions (at day 0 and 3) of 100 million UC-MSC.; Other: Controls will receive two infusions of vehicle solution.

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.

• Study Type: Interventional
• Enrollment (Estimated): 128
• Phase: Phase 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment; 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.; Subjects in the UC-MSC treatment group will receive two intravenous infusions (at day 0 and 3) of 100±20 x106 UC-MSC.
Placebo Comparator: Control; Controls will receive two infusions of vehicle solution.	Other: Controls will receive two infusions of vehicle solution.; Subjects in the control group will be treated with two IV infusions of vehicle solution.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Breathe Biologics, Inc.

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: March 10, 2026
• First Submitted That Met QC Criteria: March 13, 2026
• First Posted (Actual): March 18, 2026

Study Record Updates

• Last Update Posted (Actual): March 19, 2026
• Last Update Submitted That Met QC Criteria: March 17, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Cell Therapy; Inflammation; ARDS; Mesenchymal Stem Cells; Acute Respiratory Distress Syndrome; Regenerative Medicine
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Lung Diseases; Respiration Disorders; Pathological Conditions, Signs and Symptoms; Respiratory Distress Syndrome; Inflammation
• Other Study ID Numbers: BRTH001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No