Safety and Efficacy of Umbilical Cord-derived Mesenchymal Stem Cell(MSC) Transplantation i
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
| Condition(s) | BPD - Bronchopulmonary Dysplasia |
|---|---|
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Study type | Interventional |
| Summary | 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-directiona |
| Who can participate | 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 hemorrhag |
| Ages | 36 Weeks |
| Sex | All |
| Lead sponsor | The Children's Hospital of Zhejiang University School of Medicine |
| Locations | Hangzhou, Zhejiang, China |
| Start date | 2024-08-09 |
| NCT ID | NCT06788470 |
| Official listing | https://clinicaltrials.gov/study/NCT06788470 |