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).

ConditionAcute Respiratory Distress Syndrome

Trial statusNot yet recruiting

Trial phasePhase 3

Trial typeInterventional

Biological sexAll

Age18-80

SponsorBreathe Biologics, Inc.

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

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)

Trial design

Treatments tested in this trial

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.

Treatment groups

128 Participants

are divided into 2 treatment groups

Locations

This trial has no locations

Sponsors and collaborators

Breathe Biologics, Inc.

Lead sponsor

Source ClinicalTrials.gov