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

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.

NCT Number	NCT07058025
Lead Sponsor	Ottawa Hospital Research Institute Collaborators: Canadian Institutes of Health Research (CIHR), Stem Cell Network
Conditions	Bronchopulmonary Dysplasia (BPD), ELGAN (22-28SA)
Enrollment	168 participants
Start Date	2025-10-01
Primary Completion	2028-09-30 (estimated)
Study Completion	2038-09-30 (estimated)
Updated on ClinicalTrials.gov	2025-07-10