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Follow-Up Study of Mesenchymal Stem Cells for Bronchopulmonary Dysplasia

Primary Purpose

Bronchopulmonary Dysplasia

Status
Unknown status
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
transplantation of hUC-MSCs
Sponsored by
Children's Hospital of Chongqing Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bronchopulmonary Dysplasia focused on measuring Bronchopulmonary Dysplasia, human umbilical cord -derived mesenchymal stem cells

Eligibility Criteria

1 Month - 5 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Subject who completed the safety and efficacy evaluations in hUC-MSCs PhaseⅠ clinical trial
  2. Subject with a written consent form signed by a legal representative or a parent

Exclusion Criteria:

  1. Subject whose parent or legal representative does not agree to participate in the study
  2. subject who is considered inappropriate to participate the study by the investigator

Sites / Locations

  • Children's Hospital of Chongqing Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Mesenchymal Stem Cell

Arm Description

A single intravenous transplantation of Mesenchymal Stem Cell (Dose A - 1 million cells per kg, Dose B - 5 million cells per kg)

Outcomes

Primary Outcome Measures

Readmission rate
Duration of the hospital stay due to respiratory infection

Secondary Outcome Measures

Rate of Survival
Incidence of Tumorigenicity
Growth measured by Z-score
Number of neurological developmental delay
Number of blindness and deafness

Full Information

First Posted
February 20, 2019
Last Updated
March 12, 2019
Sponsor
Children's Hospital of Chongqing Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT03873506
Brief Title
Follow-Up Study of Mesenchymal Stem Cells for Bronchopulmonary Dysplasia
Official Title
Follow-Up Study of Safety and Efficacy of Mesenchymal Stem Cells in Preterm Infants With Moderate or Severe Bronchopulmonary Dysplasia
Study Type
Interventional

2. Study Status

Record Verification Date
March 2019
Overall Recruitment Status
Unknown status
Study Start Date
July 1, 2018 (Actual)
Primary Completion Date
July 1, 2020 (Anticipated)
Study Completion Date
December 31, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Children's Hospital of Chongqing Medical University

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
This is a follow-up study to investigate the long-term safety and efficacy of human umbilical cord -derived mesenchymal stem cells (hUC-MSCs), for the treatment of BPD in premature infants. Subjects who participated in and completed the initial stage of the PhaseⅠtrial (NCT03558334 ) will be followed-up until 48 months after the hUC-MSCs transplantation.
Detailed Description
Subjects who completed the initial stage of the PhaseⅠclinical trial will be followed-up at 5 additional visits: 1, 3, 6, 12 and 24 months after the hUC-MSCs transplantation.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bronchopulmonary Dysplasia
Keywords
Bronchopulmonary Dysplasia, human umbilical cord -derived mesenchymal stem cells

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Mesenchymal Stem Cell
Arm Type
Experimental
Arm Description
A single intravenous transplantation of Mesenchymal Stem Cell (Dose A - 1 million cells per kg, Dose B - 5 million cells per kg)
Intervention Type
Drug
Intervention Name(s)
transplantation of hUC-MSCs
Other Intervention Name(s)
intravenous infusion of hUC-MSCs
Intervention Description
Human umbilical cord-derived mesenchymal stem cells had given to preterm infants through intravenous infusion.
Primary Outcome Measure Information:
Title
Readmission rate
Time Frame
within two years
Title
Duration of the hospital stay due to respiratory infection
Time Frame
within two years
Secondary Outcome Measure Information:
Title
Rate of Survival
Time Frame
within two years
Title
Incidence of Tumorigenicity
Time Frame
within two years
Title
Growth measured by Z-score
Time Frame
within two years
Title
Number of neurological developmental delay
Time Frame
within two years
Title
Number of blindness and deafness
Time Frame
within two years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Month
Maximum Age & Unit of Time
5 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Subject who completed the safety and efficacy evaluations in hUC-MSCs PhaseⅠ clinical trial Subject with a written consent form signed by a legal representative or a parent Exclusion Criteria: Subject whose parent or legal representative does not agree to participate in the study subject who is considered inappropriate to participate the study by the investigator
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yunqiu Xia
Phone
13637719980
Email
sunny_199001@foxmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Lin Zou
Phone
18623121280
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zhou Fu
Organizational Affiliation
Children's Hospital of Chongqing Medical University
Official's Role
Study Chair
Facility Information:
Facility Name
Children's Hospital of Chongqing Medical University
City
Chongqing
State/Province
Chongqing
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yunqiu Xia
Phone
13637719980

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
24508444
Citation
Chang YS, Ahn SY, Yoo HS, Sung SI, Choi SJ, Oh WI, Park WS. Mesenchymal stem cells for bronchopulmonary dysplasia: phase 1 dose-escalation clinical trial. J Pediatr. 2014 May;164(5):966-972.e6. doi: 10.1016/j.jpeds.2013.12.011. Epub 2014 Feb 6.
Results Reference
background
PubMed Identifier
28341525
Citation
Ahn SY, Chang YS, Kim JH, Sung SI, Park WS. Two-Year Follow-Up Outcomes of Premature Infants Enrolled in the Phase I Trial of Mesenchymal Stem Cells Transplantation for Bronchopulmonary Dysplasia. J Pediatr. 2017 Jun;185:49-54.e2. doi: 10.1016/j.jpeds.2017.02.061. Epub 2017 Mar 21.
Results Reference
background

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Follow-Up Study of Mesenchymal Stem Cells for Bronchopulmonary Dysplasia

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