Actively Recruiting
Safety and Efficacy of Umbilical Cord-derived Mesenchymal Stem Cell(MSC) Transplantation in the Treatment of Bronchopulmonary Dysplasia(BPD) 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, 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 shown that MSCs can alleviate BPD by improving alveolar and pulmonary vascular development, and reducing pulmonary fibrosis. Several phase I clinical studies have demonstrated that intratracheal transplantation of human umbilical cord blood-derived mesenchymal stem cells for children with BPD is safe and feasible. This study aims to further evaluate the safety and efficacy of umbilical cord-derived mesenchymal stem cell transplantation in the treatment of severe BPD in premature infants, in the hope of increasing the survival rate and improving the prognosis of severe BPD.
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
Complete this quick 3-step screening to check your eligibility
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
CONTACT
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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