Phase III Trial of Umbilical Cord-derived Mesenchymal Stem Cells for Patients
with Acute Respiratory Distress Syndrome (“UC-MSC for ARDS”) IND #19757

This is a double-blind, phase 2b/3, randomized, controlled, multi-center trial of 128 subjects with moderate to severe ARDS. Allocation to UC- MSC treatment group or control group will be based on 1:1 randomization: 64 subjects will be allocated to UC-MSC treatment group, 64 subjects to control group. Randomization will be stratified by site and by type of oxygen therapy (High Flow Oxygen/NIPPV versus mechanical ventilation). The study will test the hypothesis that UC-MSC treatment leads to an increase of the proportion of patients alive and free of respiratory failure at day 60 after randomization. The study will also estimate effects on survival, on the occurrence of Serious Adverse Events (SAEs), and on time to recovery.

The overall objective of this protocol is to confirm safety and determine effectiveness of “JadiCell” Umbilical Cord Mesenchymal Stem Cell (UC-MSC) infusions in subjects with ARDS.

The primary objective will be to assess effectiveness of UC-MSC treatment on proportion of patients alive and free of respiratory failure at Day 60 after randomization. 

The secondary objectives will be to assess all-cause mortality at Day 60, survival at day 31, number of subjects experiencing serious adverse events (SAEs) by day 31, SAE-free survival, time to recovery (evaluated until day 60), and time to oxygen requirement equal or below 40% oxygen.

The primary endpoint will be:

Proportion of patients alive and free of respiratory failure at Day 60 after randomization comparing UC-MSC therapy group versus Control group.

The secondary endpoints will be:

– All-cause mortality at Day 60

– Survival at day 31,

– Number of subjects experiencing Serious Adverse Events by day 31,

– SAE-free survival

– Time to Recovery (evaluated until day 60).

– Time to oxygen requirement 40% oxygen or below

128 hospitalized subjects diagnosed with ARDS will be enrolled. Subjects of any gender, with age between 18 and 80 years, will be eligible for enrollment.

Eligibility criteria include respiratory failure requiring either High Flow Oxygen Therapy, Non-Invasive Positive Pressure Ventilation (NIPPV), or Invasive Mechanical Ventilation (IMV).

Up to 6 U.S. sites and locations will enroll participants. The study is not intended to include sites outside of the United States. Subjects in the UC-MSC treatment group will receive two intravenous infusions (at day 0 and 3) of 100±20 x106 UC-MSC, controls will receive two infusions of vehicle solution. Both groups will receive best standard of care.

We anticipate that the trial and data analysis will be completed within 1 year. Primary endpoint analysis will be completed in approximately 3 months after completion of enrollment. The follow-up time is 6 months (180 +/- 7 days).