NCT07479043

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)

• Status: Not Yet Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 128 (estimated)
• Sponsor: Breathe Biologics, Inc. · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

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

Interventions

Type	Name	Description
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.
OTHER	Controls will receive two infusions of vehicle solution.	Subjects in the control group will be treated with two IV infusions of vehicle solution.

Timeline

• Start date: 2026-07-01
• Primary completion: 2026-12-01
• Completion: 2026-12-01
• First posted: 2026-03-18
• Last updated: 2026-03-19

Regulatory

• FDA-regulated drug study