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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 · Status: NOT_YET_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 128

Last updated 2026-03-19

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Breathe Biologics, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
FACTORIAL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-07-31
Primary Completion
2026-12-31
Completion
2026-12-31
FDA Drug
Yes

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07479043 on ClinicalTrials.gov