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

NCT06788470 | Recruiting Phase 1

• 1 other identifier: 2019-SC-001
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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

Keywords

Bronchopulmonary dysplasia (BPD); Mesenchymal stem cells (MSCs); Premature infants

Outcome Measures

Primary Outcomes (3)

• Extubating time after MSC transplantation

  Record how long it takes for the participants' tracheal tubes to be removed after MSC transplantation.

  until 24 months of corrected age

• The number of times and total duration of re-intubation after extubating

  If the participants' tracheal tubes are removed after MSC transplantation, record the number of times and total duration of tracheal re-intubation until discharge and 24 months of corrected age.

  until 24 months of corrected age

• Mortality of BPD

  Record the number of participants who died from BPD.

  until 24 months of corrected age

Secondary Outcomes (3)

• Further assess the severity of BPD by detecting the levels of pro-inflammatory cytokine in alveolar lavage fluid, pulmonary function index and chest radiography.

  until 24 months of corrected age

• Short-term safety assessment of MSC transplantation by whether anaphylaxis and severe infection are observed within 24 hours after MSC transplantation.

  within 24 hours after MSC transplantation

• 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.

  until 24 months of corrected age

Study Arms (1)

MSC transplantation

EXPERIMENTAL

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

Drug: MSC

Interventions

MSC DRUG

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

MSC transplantation

Eligibility Criteria

• Age: 36 Weeks+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• weeks of gestation, birth weight 500-1500g;
• 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.
• Children with severe BPD after early use of PS
• Parents agree to participate in clinical trials.

You may not qualify if:

• Premature infants not suitable for the given gestational age;
• Other congenital structural malformations of trachea, bronchus and lungs;
• Complicated with severe congenital heart disease;
• Complicated with Periventricular Leukomalacia (PVL);
• Complicated with intraventricular hemorrhage (IVH) above level 3;
• Septic shock or positive blood culture;
• Acute pulmonary hemorrhage;
• Intracranial and extracranial diseases affecting respiratory rate and rhythm.

Sponsors & Collaborators

• The Children's Hospital of Zhejiang University School of Medicine: lead

Study Sites (1)

The Children's Hospital of Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310052, China

RECRUITING

MeSH Terms

Conditions

Bronchopulmonary Dysplasia; Premature Birth

Condition Hierarchy (Ancestors)

Ventilator-Induced Lung Injury; Lung Injury; Lung Diseases; Respiratory Tract Diseases; Infant, Premature, Diseases; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Central Study Contacts

Yaoqin Hu, MD

CONTACT

0571-86670704; huyaoqin@zju.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Pediatrics, Chief surgeon, Principal Investigator, Hospital secretary of Party Committee, Children's Hospital, Zhejiang University School of Medicine

Model Details: Intratracheal administration of umbilical cord-derived mesenchymal stem cells (MSCs) in premature infants with bronchopulmonary dysplasia (BPD).

Study Record Dates

• First Submitted: January 6, 2025
• First Posted: January 23, 2025
• Study Start: August 9, 2024
• Primary Completion (Estimated): August 9, 2027
• Study Completion (Estimated): August 9, 2027
• Last Updated: January 23, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)