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Studies

Interventional Not yet recruiting Phase 2

NCT07058025 on ClinicalTrials.gov

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

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

  • Sponsor: Ottawa Hospital
  • Collaborators: Canadian Institutes of Health Research (CIHR), Stem Cell Network
  • Enrollment: 168 (Estimated)
  • Study start: 2025-10-01 (Estimated)
  • Primary completion: 2028-09-30 (Estimated)
  • Study completion: 2038-09-30 (Estimated)
  • Allocation: Randomized
  • InterventionModel: Parallel
  • InterventionModelDescription: Intervention group: Participants allocated in the intervention group will receive multidose of UC-MSCs as follow: * Dose: each dose consists of 10x 106 cells/kilograms of bodyweight. * Administration protocol: weekly IV dose of UC-MSCs for 3 weeks (total of 3 doses) * Route of administration: IV infusion on peripheral intravenous catheter. The UC-MSC solution will be infused using a syringe pump over 15 minutes, and after the UCMSC infusion, an additional volume of normal saline will be infused using a syringe pump over 15 minutes. Control group: Participants allocated in the control group will receive a sham procedure weekly for 3 weeks. A syringe of normal saline brought to bedside, but it will not be administered. The physician and bedside nurse will perform the sham procedure behind a screen (they will mimic IV catheter insertion and cell product injection)
  • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • PrimaryPurpose: Prevention

Brief 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.

Conditions

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

Intervention / Treatment

  • Biological: Human Allogenic Umbilical Cord Mesenchymal Stromal Cells
  • Other: Sham procedure control

Primary Outcome Measures

  • Number of mechanical ventilation-free days accounting for mortality (120 days)
    The study primary outcome is the number of mechanical ventilation-free days accounting for mortality. Mechanical ventilation is defined by artificial ventilation using an endotracheal tube. For study purpose, this outcome will be measured at 120 days after randomization. To account for mortality, any death within 120 days post randomization will be counted as "0" mechanical ventilation-free day (worse outcome).

Countries

Canada

Locations and Investigators

  • Royal Alexandra Hospital/Stollery Children's Hospital, Edmonton, Canada
  • McMaster Children's Hospital, Hamilton, Canada
    • Amit Mukerji
    • Amit Mukerji (Principal Investigator)
  • The Ottawa Hospital, Ottawa, Canada
  • Sunnybrook Health Sciences Ctr, Toronto, Canada
    • Maher Shahroor, MD, RCPSC
    • Maher Shahroor, MD, RCPSC (Principal Investigator)
    • Elizabeth Asztalos, MD, MSc, FRCPC
  • Mount Sinai Hospital, Toronto, Canada
    • Prakesh Shah
    • Prakesh Shah, MD (Principal Investigator)
  • CHU Sainte-Justine, Montreal, Canada
    • Anne-Monique Nuyt
    • Anne-Monique Nuyt (Principal Investigator)
  • McGill Montreal Children's Hospital, Montreal, Canada
    • Marc Beltempo, MD, M.Sc., FRCPC
    • Marc Beltempo, MD, M.Sc., FRCPC (Principal Investigator)
  • Université Laval, Québec City, Canada
    • Mireille Guillot, MD
    • Mireille Guillot (Principal Investigator)

Study Officials