Stem Cells for Bronchopulmonary Dysplasia

NCT03378063 | Withdrawn Early Phase 1 DMC

• 1 other identifier: stem cell for BPD
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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

Conditions

Bronchopulmonary Dysplasia

Outcome Measures

Primary Outcomes (1)

• death

  the infant is dead due to lung disease

  within two years

Secondary Outcomes (1)

• Bayley Scales of Infant Development

  30 months after birth

Study Arms (2)

transplantation of mesenchymal stem cell

EXPERIMENTAL

transplantation of mesenchymal stem cell will be given to the infants with BPD.

Drug: transplantation of mesenchymal stem cell

no transplantation of mesenchymal stem cell

ACTIVE COMPARATOR

transplantation of mesenchymal stem cell will be not given to the infants with BPD.

Drug: no transplantation of mesenchymal stem cell

Interventions

transplantation of mesenchymal stem cell DRUG

allogeneic human umbilical cord blood (hUCB)-derived mesenchymal stem cell (MSC) transplantation will be given to preterm infants

transplantation of mesenchymal stem cell

no transplantation of mesenchymal stem cell DRUG

MSC transplantation will be not given to preterm infants

no transplantation of mesenchymal stem cell

Eligibility Criteria

• Age: 1 Month - 3 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• diagnosed with BPD

You may not qualify if:

• parents' rejection

Sponsors & Collaborators

• Daping Hospital and the Research Institute of Surgery of the Third Military Medical University: lead
• Children's Hospital of Chongqing Medical University: collaborator
• Chongqing Maternal and Child Health Hospital: collaborator

Study Sites (1)

Department of Pediatrics, Daping Hospital, Research Institute of Surgery, Third Military Medical University

Chongqing, Chongqing Municipality, 400042, China

Location

MeSH Terms

Conditions

Bronchopulmonary Dysplasia

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

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 6, 2017
• First Posted: December 19, 2017
• Study Start: November 1, 2017
• Primary Completion: December 30, 2022
• Study Completion: December 30, 2022
• Last Updated: May 1, 2023

Record last verified: 2021-02

Locations

CN (1)