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Stem Cells for Bronchopulmonary Dysplasia

Primary Purpose

Bronchopulmonary Dysplasia

Status
Withdrawn
Phase
Early Phase 1
Locations
China
Study Type
Interventional
Intervention
transplantation of mesenchymal stem cell
no transplantation of mesenchymal stem cell
Sponsored by
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bronchopulmonary Dysplasia

Eligibility Criteria

1 Month - 3 Months (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • diagnosed with BPD

Exclusion Criteria:

  • parents' rejection

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

transplantation of mesenchymal stem cell

no transplantation of mesenchymal stem cell

Arm Description

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

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

Outcomes

Primary Outcome Measures

death
the infant is dead due to lung disease

Secondary Outcome Measures

Bayley Scales of Infant Development
scores of Bayley Scales of Infant Development at 2 months old and 2 years old

Full Information

First Posted
December 6, 2017
Last Updated
April 28, 2023
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
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1. Study Identification

Unique Protocol Identification Number
NCT03378063
Brief Title
Stem Cells for Bronchopulmonary Dysplasia
Official Title
Stem Cells for Bronchopulmonary Dysplasia: a Cohort Study
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Withdrawn
Why Stopped
no stell cell accessed
Study Start Date
November 1, 2017 (Actual)
Primary Completion Date
December 30, 2022 (Anticipated)
Study Completion Date
December 30, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the 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

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bronchopulmonary Dysplasia

7. Study Design

Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
transplantation of mesenchymal stem cell
Arm Type
Experimental
Arm Description
transplantation of mesenchymal stem cell will be given to the infants with BPD.
Arm Title
no transplantation of mesenchymal stem cell
Arm Type
Active Comparator
Arm Description
transplantation of mesenchymal stem cell will be not given to the infants with BPD.
Intervention Type
Drug
Intervention Name(s)
transplantation of mesenchymal stem cell
Intervention Description
allogeneic human umbilical cord blood (hUCB)-derived mesenchymal stem cell (MSC) transplantation will be given to preterm infants
Intervention Type
Drug
Intervention Name(s)
no transplantation of mesenchymal stem cell
Intervention Description
MSC transplantation will be not given to preterm infants
Primary Outcome Measure Information:
Title
death
Description
the infant is dead due to lung disease
Time Frame
within two years
Secondary Outcome Measure Information:
Title
Bayley Scales of Infant Development
Description
scores of Bayley Scales of Infant Development at 2 months old and 2 years old
Time Frame
30 months after birth

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Month
Maximum Age & Unit of Time
3 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: diagnosed with BPD Exclusion Criteria: parents' rejection
Facility Information:
Facility Name
Department of Pediatrics, Daping Hospital, Research Institute of Surgery, Third Military Medical University
City
Chongqing
State/Province
Chongqing
ZIP/Postal Code
400042
Country
China

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

Stem Cells for Bronchopulmonary Dysplasia

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