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

Phase 2

Withdrawn

• Conditions: Acute Respiratory Distress Syndrome; Ards
• Interventions: Biological: COVI-MSC; Drug: Placebo

• Registration Number: NCT04909879
• Lead Sponsor: Sorrento Therapeutics, Inc.

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.

Study Timeline

• Study First Submitted: 2021-05-29
• Study First Submitted QC: 2021-05-29
• Study First Posted: 2021-06-02
• Status Verified: 2021-09
• Study Start: 2021-09
• Last Update Submitted: 2021-09-17
• Last Update Posted: 2021-09-24
• Primary Completion: 2022-02
• Study Completion: 2022-04

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
COVI-MSC	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
Placebo	Placebo	Subjects will receive intravenous infusions of placebo (two vials) on Day 0, Day 2, and Day 4

Primary Outcome Measures

Name	Time	Method
All-cause mortality rate at Day 28	Baseline to Day 28	All-cause mortality rate at Day 28

Secondary Outcome Measures

Name	Time	Method
Number of ventilator-free days through Day 28	Baseline through Day 28	Number of ventilator-free 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)
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
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.
Number of ICU days through Day 28	Baseline through Day 28	Number of ICU days through Day 28