NCT07058025

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

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

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 168 (estimated)
• Sponsor: Ottawa Hospital Research Institute · Academic / Other
• Sex: All
• Age: 4 Days – 14 Days
• Healthy volunteers: Not accepted

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.

Detailed description

Include Background...

Conditions

• Bronchopulmonary Dysplasia (BPD)
• ELGAN (22-28SA)

Interventions

Type	Name	Description
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

Timeline

• Start date: 2025-10-01
• Primary completion: 2028-09-30
• Completion: 2038-09-30
• First posted: 2025-07-10
• Last updated: 2025-07-10

Locations

8 sites across 1 country: Canada