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NOT YET RECRUITING
NCT07058025
PHASE2

Mesenchymal Stromal Cell Therapy to Prevent Bronchopulmonary Dysplasia in Extreme Preterm Infants

Sponsor: Ottawa Hospital Research Institute

View on ClinicalTrials.gov

Summary

This clinical trial aims to evaluate the safety and efficacy of mesenchymal stromal cell (MSC) therapy in extreme preterm infants to prevent bronchopulmonary dysplasia, the main respiratory complication of preterm birth. Study participants will receive either multiple intravenous doses (total of 3 doses) of MSC derived from human donor umbilical cord tissue (intervention group) or no uc-MSC injection (control group) to confirm the safety of IV MSC in extreme preterm infants and evaluate the potential benefit of MSC therapy on their respiratory health as well as on other complications related to preterm birth.

Official title: Mesenchymal Stromal Cells in Extreme Preterm Infants at Risk of Developing Bronchopulmonary Dysplasia - A Phase 2 Multi-Centre Double Blind Randomized Controlled Trial

Key Details

Gender

All

Age Range

4 Days - 14 Days

Study Type

INTERVENTIONAL

Enrollment

168

Start Date

2025-10-01

Completion Date

2038-09-30

Last Updated

2025-07-10

Healthy Volunteers

No

Interventions

BIOLOGICAL

Human Allogenic Umbilical Cord Mesenchymal Stromal Cells

IV administration of uc-MSC every 7 days ± 1 day for 3 weeks. Randomized double blinded

OTHER

Sham procedure control

Sham procedure (mimic IV catheter insertion adn cell product infusion behing a screen). Repeated weekly for 3 weeks

Locations (8)

Royal Alexandra Hospital/Stollery Children's Hospital

Edmonton, Alberta, Canada

McMaster Children's Hospital

Hamilton, Ontario, Canada

The Ottawa Hospital

Ottawa, Ontario, Canada

Sunnybrook Health Sciences Ctr

Toronto, Ontario, Canada

Mount Sinai Hospital

Toronto, Ontario, Canada

CHU Sainte-Justine

Montreal, Quebec, Canada

McGill Montreal Children's Hospital

Montreal, Quebec, Canada

Université Laval

Québec, Quebec, Canada