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Stem Cells for Bronchopulmonary Dysplasia

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ClinicalTrials.gov Identifier: NCT03378063
Recruitment Status : Recruiting
First Posted : December 19, 2017
Last Update Posted : February 16, 2021
Sponsor:
Collaborators:
Children's Hospital of Chongqing Medical University
Chongqing Maternal and Child Health Hospital
Information provided by (Responsible Party):
Chen Long,MD, Daping Hospital and the Research Institute of Surgery of the Third Military Medical University

Study Description
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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

Condition or disease Intervention/treatment Phase
Bronchopulmonary Dysplasia Drug: transplantation of mesenchymal stem cell Drug: no transplantation of mesenchymal stem cell Early Phase 1

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Stem Cells for Bronchopulmonary Dysplasia: a Cohort Study
Actual Study Start Date : November 1, 2017
Estimated Primary Completion Date : December 30, 2022
Estimated Study Completion Date : December 30, 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. death [ Time Frame: within two years ]
    the infant is dead due to lung disease


Secondary Outcome Measures :
  1. 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


Eligibility Criteria
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Ages Eligible for Study:   1 Month to 3 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • diagnosed with BPD

Exclusion Criteria:

  • parents' rejection
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03378063


Locations
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China, Chongqing
Department of Pediatrics, Daping Hospital, Research Institute of Surgery, Third Military Medical University Recruiting
Chongqing, Chongqing, China, 400042
Contact: Long Chen, MD    8613883559467    neuroclong@126.com   
Contact: Shi Yuan, PhD,MD         
Sponsors and Collaborators
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
Children's Hospital of Chongqing Medical University
Chongqing Maternal and Child Health Hospital
More Information
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Responsible Party: Chen Long,MD, Principal Investigator, Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
ClinicalTrials.gov Identifier: NCT03378063    
Other Study ID Numbers: stem cell for BPD
First Posted: December 19, 2017    Key Record Dates
Last Update Posted: February 16, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Bronchopulmonary Dysplasia
Ventilator-Induced Lung Injury
Lung Injury
Lung Diseases
 Respiratory Tract Diseases
Infant, Premature, Diseases
Infant, Newborn, Diseases