Actively Recruiting
Safety and Efficacy of Umbilical Cord-Derived Mesenchymal Stem Cell Transplantation in Treating 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
156 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Bronchopulmonary dysplasia (BPD) is a chronic lung disease mainly affecting very low and ultra-low birth weight premature infants. Severe cases of BPD can lead to long-term problems such as poor lung function, difficulty with exercise in childhood, and delayed neurodevelopment, which significantly impact quality of life and create burdens for families and society. The disease involves complex issues like lung vessel abnormalities, inflammation, and poor lung development. Currently, no specific drug can cure BPD. Mesenchymal stem cells (MSCs), which can renew themselves and reduce inflammation, have shown promise in early studies for improving lung development and reducing lung scarring in BPD. This research evaluates the safety and effectiveness of transplanting umbilical cord-derived MSCs into the lungs of premature infants with severe BPD. The MSCs are given directly through the windpipe (intratracheal administration). The study is a combined Phase 1 and Phase 2 trial aimed at improving survival and outcomes in these infants. It builds on prior early-phase studies that suggested this treatment is safe and feasible. Participants will be closely monitored until they reach 24 months of corrected age. Researchers will measure how long infants need breathing support after MSC treatment, the number and length of any re-intubations, and survival rates related to BPD. Parents will provide consent, and infants will be observed for safety and treatment effects during this follow-up period to assess both benefits and potential risks of the MSC transplantation.
CONDITIONS
Official 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
- Lung condition not improving or worsening after hormone therapy (DART), requiring positive pressure ventilation via tracheal intubation at 36 weeks corrected gestational age
- Diagnosed with severe bronchopulmonary dysplasia after early surfactant therapy
- Parents agree to participate in the clinical trial
You will not qualify if you...
- Premature infants not within the specified gestational age range
- Congenital structural malformations of the trachea, bronchi, or lungs
- Presence of severe congenital heart disease
- Presence of periventricular leukomalacia (PVL)
- Intraventricular hemorrhage (IVH) grade 3 or higher
- Septic shock or positive blood culture
- Acute pulmonary hemorrhage
- Intracranial or extracranial diseases affecting breathing rate or rhythm
AI-Screening
AI-Powered Screening
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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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