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Mesenchymal Stromal Cell Therapy to Prevent Bronchopulmonary Dysplasia in Extreme Preterm Infants
Sponsor: Ottawa Hospital Research Institute
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
Human Allogenic Umbilical Cord Mesenchymal Stromal Cells
IV administration of uc-MSC every 7 days ± 1 day for 3 weeks. Randomized double blinded
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