Stem Cells for Bronchopulmonary Dysplasia

April 28, 2023 updated by: Chen Long,MD, Daping Hospital and the Research Institute of Surgery of the Third Military Medical University

Stem Cells for Bronchopulmonary Dysplasia: a Cohort Study

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

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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 Type

Interventional

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Chongqing
      • Chongqing, Chongqing, China, 400042
        • Department of Pediatrics, Daping Hospital, Research Institute of Surgery, Third Military Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 month to 3 months (Child)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • diagnosed with BPD

Exclusion Criteria:

  • parents' rejection

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: transplantation of mesenchymal stem cell
transplantation of mesenchymal stem cell will be given to the infants with BPD.
Drug: transplantation of mesenchymal stem cell
allogeneic human umbilical cord blood (hUCB)-derived mesenchymal stem cell (MSC) transplantation will be given to preterm infants
Active Comparator: no transplantation of mesenchymal stem cell
transplantation of mesenchymal stem cell will be not given to the infants with BPD.
Drug: no transplantation of mesenchymal stem cell
MSC transplantation will be not given to preterm infants

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
death
Time Frame: within two years
the infant is dead due to lung disease
within two years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Bayley Scales of Infant Development
Time Frame: 30 months after birth
scores of Bayley Scales of Infant Development at 2 months old and 2 years old
30 months after birth

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Daping Hospital and the Research Institute of Surgery of the Third Military Medical University

Collaborators

Children's Hospital of Chongqing Medical University
Chongqing Maternal and Child Health Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2017

Primary Completion (Anticipated)

December 30, 2022

Study Completion (Anticipated)

December 30, 2022

Study Registration Dates

First Submitted

December 6, 2017

First Submitted That Met QC Criteria

December 17, 2017

First Posted (Actual)

December 19, 2017

Study Record Updates

Last Update Posted (Actual)

May 1, 2023

Last Update Submitted That Met QC Criteria

April 28, 2023

Last Verified

February 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • stem cell for BPD

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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