NCT04909879

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• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Sorrento Therapeutics, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Acute Respiratory Distress Syndrome
• Ards

Interventions

Type	Name	Description
BIOLOGICAL	COVI-MSC	COVI-MSC are allogeneic culture-expanded adipose-derived mesenchymal stem cells
DRUG	Placebo	Excipient solution

Timeline

• Start date: 2021-09-01
• Primary completion: 2022-02-01
• Completion: 2022-04-01
• First posted: 2021-06-02
• Last updated: 2021-09-24

Regulatory

• FDA-regulated drug study