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Evaluating Safety and Benefits of Umbilical Cord-Derived Mesenchymal Stem Cell Treatment for Severe Bronchopulmonary Dysplasia in Premature Infants
Led by The Children's Hospital of Zhejiang University School of Medicine · Updated on 2025-01-23
10
Participants Needed
1
Research Sites
N/A
Total Duration
AI-Summary
What this Trial Is About
Bronchopulmonary dysplasia BPD is a chronic lung disease affecting very low and ultra-low preterm infants, often leading to long-term lung function problems, exercise intolerance, and delayed neurodevelopment. This research aims to evaluate the safety and effectiveness of transplanting umbilical cord-derived mesenchymal stem cells MSCs to treat severe BPD in premature infants, hoping to improve survival and long-term outcomes. MSCs are known for their ability to renew themselves, reduce inflammation, and support lung development, with early studies suggesting they may be safe and helpful for children with BPD. The study involves intratracheal administration of MSCs at a dose of 1107 cells per kilogram to participating infants. This is an interventional trial focusing on the direct delivery of stem cells into the lungs of premature babies who have severe BPD and require ongoing ventilator support after hormone therapy and surfactant use. The trial is designed to assess both short-term and long-term safety, as well as the potential benefits of MSCs on lung healing and function. Participants will be monitored until 24 months of corrected age, with measurements including the time to extubation after MSC treatment, frequency and duration of any needed re-intubations, and overall mortality related to BPD. Additional assessments include lung inflammation markers from lavage fluid, lung function tests, chest X-rays, and evaluations for any adverse events such as allergic reactions, infections, brain hemorrhages, neurodevelopmental issues, or tumor formation. This comprehensive follow-up will provide important information about the safety and impact of MSC therapy in this vulnerable population.
CONDITIONS
Brief Title
Safety and Efficacy of Umbilical Cord-derived Mesenchymal Stem Cell(MSC) Transplantation in the Treatment of Bronchopulmonary Dysplasia(BPD) in Premature Infants
Research Team
Y
Yaoqin Hu, MD
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