Study of Allogeneic Adipose-Derived Mesenchymal Stem Cells for Non-COVID-19 Acute Respiratory Distress Syndrome
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|ClinicalTrials.gov Identifier: NCT04909879|
Recruitment Status : Withdrawn (Replaced by a different protocol.)
First Posted : June 2, 2021
Last Update Posted : September 24, 2021
|Condition or disease||Intervention/treatment||Phase|
|Acute Respiratory Distress Syndrome Ards||Biological: COVI-MSC Drug: Placebo||Phase 2|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||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|
|Estimated Study Start Date :||September 2021|
|Estimated Primary Completion Date :||February 2022|
|Estimated Study Completion Date :||April 2022|
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
COVI-MSC are allogeneic culture-expanded adipose-derived mesenchymal stem cells
Placebo Comparator: Placebo
Subjects will receive intravenous infusions of placebo (two vials) on Day 0, Day 2, and Day 4
- All-cause mortality rate at Day 28 [ Time Frame: Baseline to Day 28 ]All-cause mortality rate at Day 28
- All-cause mortality rate at Days 60 and 90 [ Time Frame: Baseline to Day 60 and Day 90 ]All-cause mortality rate at Days 60 and 90
- Number of ventilator-free days through Day 28 [ Time Frame: Baseline through Day 28 ]Number of ventilator-free days through Day 28
- Number of ICU days through Day 28 [ Time Frame: Baseline through Day 28 ]Number of ICU days through Day 28
- Clinical status at Day 28 [ Time Frame: 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 [ Time Frame: 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04909879
|Study Director:||Mike Royal, MD||Sorrento Therapeutics, Inc.|