Clinical trial NCT06788470: Safety and Efficacy of Umbilical Cord-derived Mesenchymal Stem Cell(MSC) Transplantation in the Treatment of Bronchopulmonary Dysplasia(BPD) in Premature Infants
Official title: Safety and Efficacy of Umbilical Cord-derived Mesenchymal Stem Cell Transplantation in the Treatment of Bronchopulmonary Dysplasia in Premature Infants
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
PHASE2
Conditions: BPD - Bronchopulmonary Dysplasia
Keywords: Bronchopulmonary dysplasia (BPD)
Mesenchymal stem cells (MSCs)
Premature infants
Lead sponsor: The Children's Hospital of Zhejiang University School of Medicine
Sponsor class: OTHER
First posted: 2025-01-23
Enrollment: 10
Sex: ALL
Minimum age (years): 36
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Intratracheal administration of umbilical cord-derived mesenchymal stem cells (MSCs) in premature infants with bronchopulmonary dysplasia (BPD).
Primary purpose: TREATMENT

Brief 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-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.


Eligibility criteria: 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.

Primary outcomes:
measure: Extubating time after MSC transplantation
timeFrame: until 24 months of corrected age
measure: The number of times and total duration of re-intubation after extubating
timeFrame: until 24 months of corrected age
measure: Mortality of BPD
timeFrame: until 24 months of corrected age
Secondary outcomes:
measure: Further assess the severity of BPD by detecting the levels of pro-inflammatory cytokine in alveolar lavage fluid, pulmonary function index and chest radiography.
timeFrame: until 24 months of corrected age
measure: Short-term safety assessment of MSC transplantation by whether anaphylaxis and severe infection are observed within 24 hours after MSC transplantation.
timeFrame: within 24 hours after MSC transplantation
measure: long-term safety assessment of MSC transplantation by whether intraventricular hemorrhage, periventricular leukomalacia, neurodevelopmental problems and tumor formation are observed after MSC transplantation until 24 months of corrected age.
timeFrame: until 24 months of corrected age
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: The Children's Hospital of Zhejiang University School of Medicine
state: Zhejiang
Study officials:
References: