NCT04865107

Cellular Immuno-Therapy for COVID-19 ARDS Randomized Clinical Trial

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 22 (actual)
• Sponsor: Ottawa Hospital Research Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase 2 multicenter randomized (2:1), placebo-controlled trial to evaluate early signs of efficacy of allogeneic, umbilical cord-derived (UC) mesenchymal stromal cells (MSCs) in patients with COVID-19 and Acute Respiratory Distress Syndrome (ARDS). Randomized participants (N=54) will receive 3 daily doses of up to 90-million cells/unit dose (cumulative dose of up to 270 million UC-MSCs) or blinded placebo. The MSC product will be provided as 2.5 million cells/ml suspended in PlasmaLyte A containing 5% Human Albumin. The appearance-matched placebo product contains the same excipients, PlasmaLyte A and 5% Human Albumin, as the UC-MSCs.

Conditions

• Covid19
• Acute Respiratory Distress Syndrome

Interventions

Type	Name	Description
BIOLOGICAL	UC-MSCs	3 daily doses of up to 90-million cells/unit dose (cumulative dose of up to 270 million UC-MSCs)
BIOLOGICAL	Placebo	PlasmaLyte A and 5% Human Albumin

Timeline

• Start date: 2021-04-27
• Primary completion: 2022-04-01
• Completion: 2022-04-01
• First posted: 2021-04-29
• Last updated: 2025-07-31

Locations

4 sites across 1 country: Canada