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

Zhejiang University

Status and phase: Enrolling; Phase 2; Phase 1

Conditions: BPD - Bronchopulmonary Dysplasia

Treatments: Drug: MSC

Study type: Interventional

Funder types: Other

Identifiers

NCT06788470

2019-SC-001

Details and patient eligibility

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.

Enrollment: 10 estimated patients

Sex: All

Ages: 36+ weeks old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

MSC transplantation

Experimental group

Description:

MSCs (1×10\^7/kg) are administered intratracheally to participators.

Treatment:

Drug: MSC