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

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

Status

Withdrawn

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04909879

Enrollment

Registered

2021-06-02

Start date

2021-09-30

Completion date

2022-04-30

Last updated

2021-09-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Respiratory Distress Syndrome, Ards

Keywords

ARDS

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.

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.

Interventions

BIOLOGICALCOVI-MSC

COVI-MSC are allogeneic culture-expanded adipose-derived mesenchymal stem cells

DRUGPlacebo

Excipient solution

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
All-cause mortality rate at Day 28	Baseline to Day 28	All-cause mortality rate at Day 28

Secondary

Measure	Time frame	Description
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.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026