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

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.

Timeline

Start

2025-10-01

Primary completion

2028-09-30

Completion

2038-09-30

Publications

• Renesme L, Ferretti E, Horth C, Grimwood R, Da Sylva L, Olson V, Cyr-Depauw C, Freund D, Rudiger M, Mobius MA, Hodgins S, Khan S, Courtman D, Fergusson DA, Thebaud B. Helping Underdeveloped Lungs with Cells (HULC-2): mesenchymal stromal cells in extreme preterm infants at risk of developing bronchopulmonary dysplasia - a study protocol of a phase 2 multicentre double blind randomised controlled trial in Canada. BMJ Open. 2026 Jul 6;16(7):e112385. doi: 10.1136/bmjopen-2025-112385.

Drugs

Indications