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Safety and Efficacy of Umbilical Cord-derived Mesenchymal Stem Cell(MSC) Transplantation in the Treatment of Bronchopulmonary Dysplasia(BPD) in Premature Infants

RecruitingPhase 1, Phase 2Ages 36 Weeks - anyAllThe Children's Hospital of Zhejiang University Sc…
NCT06788470 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

Bronchopulmonary dysplasia (BPD) is a chronic lung disease, which is a major complication of very low and ultra-low preterm infants. Moderate and severe BPD survivors are prone to adverse outcomes such as impaired lung function, childhood exercise intolerance, and neurodevelopmental retardation in the long term, which seriously affects their quality of life and brings a heavy burden to society and families. However, the pathogenesis of BPD is complex, including pulmonary vascular dysplasia, lung inflammation, and impaired alveolar development. There is currently no specific clinical drug to cure BPD. Mesenchymal stem cells (MSCs) are a kind of multipotent stem cells that exist in almost all organs and tissues of individuals. MSCs have the properties including self-renewal, multi-directional differentiation, and immunosuppressive and anti-inflammatory abilities. Preclinical studies have s

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📋 Eligibility rules (as published)
Inclusion Criteria: 1. 23-29 weeks of gestation, birth weight 500-1500g; 2. For patients with no improvement or aggravation of lung condition after DART hormone therapy, and positive pressure ventilation by tracheal intubation is still required at a correct gestational age of 36 weeks. 3. Children with severe BPD after early use of PS 4. Parents agree to participate in clinical trials. Exclusion Criteria: 1. Premature infants not suitable for the given gestational age; 2. Other congenital structural malformations of trachea, bronchus and lungs; 3. Complicated with severe congenital heart disease; 4. Complicated with Periventricular Leukomalacia (PVL); 5. Complicated with intraventricular hemorrhage (IVH) above level 3; 6. Septic shock or positive blood culture; 7. Acute pulmonary hemorrhage; 8. Intracranial and extracranial diseases affecting respiratory rate and rhythm.
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What it tests

  • MSC
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Where

1 site
The Children's Hospital of Zhejiang University School of Medicine
Hangzhou, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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