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

NCT ID: NCT06788470

Last Updated: 2025-01-23

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-08-09
• Study Completion Date: 2027-08-09

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.

Conditions

BPD - Bronchopulmonary Dysplasia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

MSC transplantation

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

Group Type: EXPERIMENTAL

MSC

Intervention Type: DRUG

Intratracheal administration of umbilical cord-derived mesenchymal stem cells (MSCs).

Interventions

MSC

Intratracheal administration of umbilical cord-derived mesenchymal stem cells (MSCs).

Intervention Type: DRUG

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.

• Minimum Eligible Age: 36 Weeks
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Children's Hospital of Zhejiang University School of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Shu Qiang

Professor of Pediatrics, Chief surgeon, Principal Investigator, Hospital secretary of Party Committee, Children's Hospital, Zhejiang University School of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

The Children's Hospital of Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

Site Status: RECRUITING

Countries

China

Central Contacts

Yaoqin Hu, MD

Role: CONTACT

huyaoqin@zju.edu.cn

0571-86670704

Facility Contacts

Ruoqiong Huang, Postdoc

Role: primary

huangruoqiong@zju.edu.cn

0571-86670704

Other Identifiers

2019-SC-001

Identifier Type: -

Identifier Source: org_study_id