Actively Recruiting
Safety and Efficacy of Umbilical Cord-derived Mesenchymal Stem Cell Transplantation in the Treatment of 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
On this page
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 1×10^7 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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Born between 23 and 29 weeks of gestation with a birth weight of 500 to 1500 grams
- No improvement or worsening lung condition after hormone therapy and still requiring positive pressure ventilation by tracheal intubation at a corrected gestational age of 36 weeks
- Diagnosed with severe bronchopulmonary dysplasia after early use of pulmonary surfactant
- Parents agree to participate in the clinical trial
You will not qualify if you...
- Premature infants not within the specified gestational age range
- Presence of congenital structural malformations of the trachea, bronchus, or lungs
- Severe congenital heart disease
- Periventricular leukomalacia (PVL)
- Intraventricular hemorrhage (IVH) above level 3
- Septic shock or positive blood culture
- Acute pulmonary hemorrhage
- Intracranial or extracranial diseases affecting respiratory rate and rhythm
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single administration with follow-up until 24 months of corrected age
Participants receive intratracheal administration of umbilical cord-derived mesenchymal stem cells (MSCs).
Initial treatment visit followed by regular assessments
Duration - Up to 24 months of corrected age
Participants are monitored for safety and efficacy outcomes including lung function, inflammatory markers, and neurodevelopmental status.
Regular follow-up visits over 24 months
Trial Site Locations
Total: 1 location
1
The Children's Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, China, 310052
Actively Recruiting
Research Team
Y
Yaoqin Hu, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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