Study of Allogeneic Adipose-Derived Mesenchymal Stem Cells for Non-COVID-19 Acute Respiratory Distress Syndrome
Study Details
Study Description
Brief Summary
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.
Condition or Disease | Intervention/Treatment | Phase |
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Phase 2 |
Detailed Description
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.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Experimental: COVI-MSC 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
COVI-MSC are allogeneic culture-expanded adipose-derived mesenchymal stem cells
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Placebo Comparator: Placebo Subjects will receive intravenous infusions of placebo (two vials) on Day 0, Day 2, and Day 4 |
Drug: Placebo
Excipient solution
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Outcome Measures
Primary Outcome Measures
- All-cause mortality rate at Day 28 [Baseline to Day 28]
All-cause mortality rate at Day 28
Secondary Outcome Measures
- All-cause mortality rate at Days 60 and 90 [Baseline to Day 60 and Day 90]
All-cause mortality rate at Days 60 and 90
- Number of ventilator-free days through Day 28 [Baseline through Day 28]
Number of ventilator-free days through Day 28
- Number of ICU days through Day 28 [Baseline through Day 28]
Number of ICU days through Day 28
- Clinical status at Day 28 [Baseline to Day 28]
Clinical status as assessed using the Ordinal Scale for Clinical Improvement (0-8 scale, where lower score means better outcome)
- Change in oxygenation [Baseline to Day 2, Day 4, Day 6, Day 14, Day 28]
Change in oxygenation at Days 2, 4, 6, 14, and 28 as measured using PaO2:FiO2 ratio.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Negative for SARS-CoV-2 infection as determined by an approved polymerase chain reaction (PCR) or an approved antigen test of any specimen
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Hospitalized with non-COVID-19-induced ARDS (any severity) with a PaO2/FiO2 (PF ratio) ≤ 300
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Requires oxygen supplementation at Screening
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Willing to follow contraception guidelines
Exclusion Criteria:
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Current standard of care treatments for ARDS appear to be working and the subject is clinically improving
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A previous stem cell infusion unrelated to this trial
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Pregnant or breast feeding or planning for either during the study
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Suspected uncontrolled active bacterial, fungal, viral, or other infection
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History of a splenectomy, lung transplant or lung lobectomy
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Concurrent participation in another clinical trial involving therapeutic interventions (observational study participation is acceptable)
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Expected survival or time to withdrawal of life-sustaining treatments expected to be < 7 days
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Sorrento Therapeutics, Inc.
Investigators
- Study Director: Mike Royal, MD, Sorrento Therapeutics, Inc.
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- MSC-ARDS-201