Stem Cells for Bronchopulmonary Dysplasia

Early Phase 1

Withdrawn

• Conditions: Bronchopulmonary Dysplasia
• Interventions: Drug: transplantation of mesenchymal stem cell; Drug: no transplantation of mesenchymal stem cell

• Registration Number: NCT03378063
• Lead Sponsor: Daping Hospital and the Research Institute of Surgery of the Third Military Medical University

Brief Summary

Very preterm infants are at high risk to develop to bronchopulmonary dysplasia (BPD) for the lack of effective measures to prevent or ameliorate this common and serious disorder. BPD remains a major cause of mortality and lifelong morbidity in preterm infants

Detailed Description

Several studies have shown that transplantation of mesenchymal stem cells (MSCs) in immunocompetent animals attenuates lung injury, such as impaired alveolarization, inflammatory response, increased apoptosis, and fibrosis. Human umbilical cord blood (hUCB) is considered a better source of MSCs because of their ready availability and greater proliferative capacity and less antigenicity than other cell types.

transplantation of hUCB-derived MSCs should be effective in treating BPD. The safety and efficacy of MSC transplantation for prevention of BPD has not been tested previously, however.

Study Timeline

• Study Start: 2017-11-01
• Study First Submitted: 2017-12-06
• Study First Submitted QC: 2017-12-17
• Study First Posted: 2017-12-19
• Status Verified: 2021-02
• Primary Completion: 2022-12-30
• Study Completion: 2022-12-30
• Last Update Submitted: 2023-04-28
• Last Update Posted: 2023-05-01

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• diagnosed with BPD

Exclusion Criteria

• parents' rejection

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
transplantation of mesenchymal stem cell	transplantation of mesenchymal stem cell	transplantation of mesenchymal stem cell will be given to the infants with BPD.
no transplantation of mesenchymal stem cell	no transplantation of mesenchymal stem cell	transplantation of mesenchymal stem cell will be not given to the infants with BPD.

Primary Outcome Measures

Name	Time	Method
death	within two years	the infant is dead due to lung disease

Secondary Outcome Measures

Name	Time	Method
Bayley Scales of Infant Development	30 months after birth	scores of Bayley Scales of Infant Development at 2 months old and 2 years old

Trial Locations

Locations (1)

Department of Pediatrics, Daping Hospital, Research Institute of Surgery, Third Military Medical University; 🇨🇳 Chongqing, Chongqing, China