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Umbilical Cord Mesenchymal Stem Cells Transplantation in the Treatment of Bronchopulmonary Dysplasia

Primary Purpose

Bronchopulmonary Dysplasia

Status
Unknown status
Phase
Phase 1
Locations
Vietnam
Study Type
Interventional
Intervention
stem cell transplantation
Sponsored by
Vinmec Research Institute of Stem Cell and Gene Technology
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

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

Eligibility Criteria

1 Month - 6 Months (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • The patient is diagnosis Bronchopulmonary Dysplasia (premature and depends on oxygen until 28 days old
  • Gender: either sex
  • Year old < 6 months
  • Weight ≥ 2 kg
  • Agree to participate in the study.

Exclusion Criteria:

  • Severe congenital malformation.
  • Other severe conditions (active pulmonary bleeding, evidence of active infections).

Sites / Locations

  • Vinmec Research Institute of Stem Cell and Gene TechnologyRecruiting
  • Vinmec Research Institute of Stem Cell and Gene TechnologyRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Stem cell transplantation

Arm Description

1 million umbilical Cord Mesenchymal Stem Cells per body kg will transplant via the intravenous at baseline, and the second transplantation will be performed 1 week after the first transplantation

Outcomes

Primary Outcome Measures

Adverse events and serious adverse events
Incidence of the adverse events or serious adverse events after transplantation
The proportion of patients win from oxygen
To identify the proportion of patient with Bronchopulmonary Dysplasia win from oxygen after stem cell transplantation.

Secondary Outcome Measures

The lung fibrosis
Changes of the lung fibrosis on chest CT at 6 months compared with baseline

Full Information

First Posted
March 27, 2019
Last Updated
August 19, 2019
Sponsor
Vinmec Research Institute of Stem Cell and Gene Technology
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1. Study Identification

Unique Protocol Identification Number
NCT04062136
Brief Title
Umbilical Cord Mesenchymal Stem Cells Transplantation in the Treatment of Bronchopulmonary Dysplasia
Official Title
Outcomes of Human Umbilical Cord-derived Mesenchymal Stem Cells Transplantation in the Treatment of Bronchopulmonary Dysplasia
Study Type
Interventional

2. Study Status

Record Verification Date
August 2019
Overall Recruitment Status
Unknown status
Study Start Date
March 1, 2019 (Actual)
Primary Completion Date
November 30, 2020 (Anticipated)
Study Completion Date
November 30, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Vinmec Research Institute of Stem Cell and Gene Technology

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
To evaluate the safety and efficacy of human umbilical cord mesenchymal stem cells transplantation in patients with bronchopulmonary dysplasia
Detailed Description
The purpose of this study is to evaluate the safety and effectiveness of human umbilical cord mesenchymal stem cells in 10 patients with bronchopulmonary dysplasia at Vinmec International Hospital, Hanoi, Vietnam

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bronchopulmonary Dysplasia
Keywords
Bronchopulmonary dysplasia, umbilical cord 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
10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Stem cell transplantation
Arm Type
Experimental
Arm Description
1 million umbilical Cord Mesenchymal Stem Cells per body kg will transplant via the intravenous at baseline, and the second transplantation will be performed 1 week after the first transplantation
Intervention Type
Combination Product
Intervention Name(s)
stem cell transplantation
Intervention Description
Transplantation of umbilical cord mesenchymal stem cells
Primary Outcome Measure Information:
Title
Adverse events and serious adverse events
Description
Incidence of the adverse events or serious adverse events after transplantation
Time Frame
during 9 months post treatment
Title
The proportion of patients win from oxygen
Description
To identify the proportion of patient with Bronchopulmonary Dysplasia win from oxygen after stem cell transplantation.
Time Frame
during 9 months post treatment
Secondary Outcome Measure Information:
Title
The lung fibrosis
Description
Changes of the lung fibrosis on chest CT at 6 months compared with baseline
Time Frame
at 6 months post treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Month
Maximum Age & Unit of Time
6 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: The patient is diagnosis Bronchopulmonary Dysplasia (premature and depends on oxygen until 28 days old Gender: either sex Year old < 6 months Weight ≥ 2 kg Agree to participate in the study. Exclusion Criteria: Severe congenital malformation. Other severe conditions (active pulmonary bleeding, evidence of active infections).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Liem T Nguyen, MD., PhD
Phone
(+844)39743556
Ext
1420
Email
v.liemnt@vinmec.com
First Name & Middle Initial & Last Name or Official Title & Degree
Thai H Trieu Thi, MD
Phone
(+8424) 3974 3556
Email
v.thaitth@vinmec.com
Facility Information:
Facility Name
Vinmec Research Institute of Stem Cell and Gene Technology
City
Hanoi
ZIP/Postal Code
100000
Country
Vietnam
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Liem T Nguyen, MD., PhD
Phone
(+844)39743556
Ext
1420
Email
v.liemnt@vinmec.com
Facility Name
Vinmec Research Institute of Stem Cell and Gene Technology
City
Hanoi
ZIP/Postal Code
100000
Country
Vietnam
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nguyen Thanh Liem, Prof

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
23364976
Citation
Ahn SY, Chang YS, Kim SY, Sung DK, Kim ES, Rime SY, Yu WJ, Choi SJ, Oh WI, Park WS. Long-term (postnatal day 70) outcome and safety of intratracheal transplantation of human umbilical cord blood-derived mesenchymal stem cells in neonatal hyperoxic lung injury. Yonsei Med J. 2013 Mar 1;54(2):416-24. doi: 10.3349/ymj.2013.54.2.416.
Results Reference
result
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
result
PubMed Identifier
29021519
Citation
Liem NT, Anh TL, Thai TTH, Anh BV. Bone Marrow Mononuclear Cells Transplantation in Treatment of Established Bronchopulmonary Dysplasia: A Case Report. Am J Case Rep. 2017 Oct 12;18:1090-1094. doi: 10.12659/ajcr.905244.
Results Reference
result

Learn more about this trial

Umbilical Cord Mesenchymal Stem Cells Transplantation in the Treatment of Bronchopulmonary Dysplasia

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