Study of Allogeneic Adipose-Derived Mesenchymal Stem Cells for Non-COVID-19 Acute Respiratory Distress Syndrome

Study Overview
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Brief Summary
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This is a Phase 2 randomized study to assess the safety and efficacy of COVI-MSC in the setting of current standard of care treatments for subjects hospitalized subjects with acute respiratory distress syndrome not related to COVID-19 infection.

Detailed Description
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This is a Phase 2, randomized controlled, multicenter study to assess the safety and efficacy of COVI-MSC in the setting of current standard of care treatments for subjects hospitalized subjects with acute respiratory distress syndrome not related to COVID-19 infection. Subjects will be randomized 2:1 to receive COVI-MSC or placebo. COVI-MSC or placebo will be administered intravenously on Day 0, Day 2, and Day 4.

Official Title
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Treatment of Non-COVID-19 Acute Respiratory Distress Syndrome: A Phase 2 Study of the Efficacy and Safety of Intravenous Allogeneic Adipose-Derived Mesenchymal Stem Cells

Conditions
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Acute Respiratory Distress Syndrome, Ards

Intervention / Treatment
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* Biological: COVI-MSC
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Negative for SARS-CoV-2 infection as determined by an approved polymerase chain reaction (PCR) or an approved antigen test of any specimen Hospitalized with non-COVID-19-induced ARDS (any severity) with a PaO2/FiO2 (PF ratio) ≤ 300 Requires oxygen supplementation at Screening Willing to follow contraception guidelines Exclusion Criteria: Current standard of care treatments for ARDS appear to be working and the subject is clinically improving A previous stem cell infusion unrelated to this trial Pregnant or breast feeding or planning for either during the study Suspected uncontrolled active bacterial, fungal, viral, or other infection History of a splenectomy, lung transplant or lung lobectomy Concurrent participation in another clinical trial involving therapeutic interventions (observational study participation is acceptable) Expected survival or time to withdrawal of life-sustaining treatments expected to be < 7 days

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: COVI-MSC<br>Subjects will receive intravenous infusions of COVI-MSC (two vials or a total of ≈ 30 million cells) on Day 0, Day 2, and Day 4 | Biological: COVI-MSC<br>* COVI-MSC are allogeneic culture-expanded adipose-derived mesenchymal stem cells<br>|
| Placebo Comparator: Placebo<br>Subjects will receive intravenous infusions of placebo (two vials) on Day 0, Day 2, and Day 4 | Drug: Placebo<br>* Excipient solution<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All-cause mortality rate at Day 28 | All-cause mortality rate at Day 28 | Baseline to Day 28 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All-cause mortality rate at Days 60 and 90 | All-cause mortality rate at Days 60 and 90 | Baseline to Day 60 and Day 90 | 
| Number of ventilator-free days through Day 28 | Number of ventilator-free days through Day 28 | Baseline through Day 28 | 
| Number of ICU days through Day 28 | Number of ICU days through Day 28 | Baseline through Day 28 | 
| Clinical status at Day 28 | Clinical status as assessed using the Ordinal Scale for Clinical Improvement (0-8 scale, where lower score means better outcome) | Baseline to Day 28 | 
| Change in oxygenation | Change in oxygenation at Days 2, 4, 6, 14, and 28 as measured using PaO2:FiO2 ratio. | Baseline to Day 2, Day 4, Day 6, Day 14, Day 28 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ARDS