NCT04869397

Treatment of Respiratory Complications Associated With COVID-19 Using Umbilical Cord Mesenchymal Stromal Cells

Treatment of Respiratory Complications Associated With COVID-19 Infection Using Wharton's Jelly (WJ)-Umbilical Cord (UC) Mesenchymal Stromal Cells (ProTrans®): a Randomized Phase II Controlled Clinical Trial

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 19 (actual)
• Sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a randomized phase II placebo controlled clinical trial. Active arm: Allogeneic Wharton's jelly derived MSCs (WJ-MSCs). Both groups will receive standard of care treatment for COVID (e.g. dexamethasone)

Detailed description

Allogeneic Wharton's jelly-MSCs (WJ-MSC) will be provided by NextCell Pharma under the commercial name of ProTrans®. ProTrans® will be administered at a fixed dose of 100 million cells per patient in a single infusion at bedside. Placebo: Sodium chloride buffer supplemented with 5% HSA and 10% DMSO same volume and mode of administration as treatment group (NextCell Pharma).

Conditions

• Covid19

Interventions

Type	Name	Description
BIOLOGICAL	Allogeneic Wharton's jelly-MSCs (WJ-MSC)	The product is provided cryopreserved by NextCell Pharma. The cells are frozen in cryobags at a concentration of 2 × 107 cells/ml in 5% Human Serum Albumin (HSA) and 10% dimethylsulfoxide (DMSO). One cryobag contains one dose. The bags are frozen in a controlled rate freezer and directly transferred to -190 ºC for storage until the time of infusion. Cryobags are thawed at bedside and diluted in 100 ml of saline prior to administration. Cells will be delivered at a rate of 5 million cells per minute over a total of 20 minutes.
OTHER	Placebo	Sodium chloride buffer supplemented with 5% HSA and 10% DMSO same volume and mode of administration as treatment group

Timeline

• Start date: 2021-06-14
• Primary completion: 2023-05-26
• Completion: 2023-05-26
• First posted: 2021-05-03
• Last updated: 2025-09-08

Locations

1 site across 1 country: Canada