We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04062136
Recruitment Status : Unknown
Verified August 2019 by Vinmec Research Institute of Stem Cell and Gene Technology.
Recruitment status was:  Recruiting
First Posted : August 20, 2019
Last Update Posted : August 20, 2019
Sponsor:
Information provided by (Responsible Party):
Vinmec Research Institute of Stem Cell and Gene Technology

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
To evaluate the safety and efficacy of human umbilical cord mesenchymal stem cells transplantation in patients with bronchopulmonary dysplasia

Condition or disease Intervention/treatment Phase
Bronchopulmonary Dysplasia Combination Product: stem cell transplantation Phase 1

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
Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Outcomes of Human Umbilical Cord-derived Mesenchymal Stem Cells Transplantation in the Treatment of Bronchopulmonary Dysplasia
Actual Study Start Date : March 1, 2019
Estimated Primary Completion Date : November 30, 2020
Estimated Study Completion Date : November 30, 2020

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: Stem cell transplantation
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
 Combination Product: stem cell transplantation
Transplantation of umbilical cord mesenchymal stem cells


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Adverse events and serious adverse events [ Time Frame: during 9 months post treatment ]
    Incidence of the adverse events or serious adverse events after transplantation

  2. The proportion of patients win from oxygen [ Time Frame: during 9 months post treatment ]
    To identify the proportion of patient with Bronchopulmonary Dysplasia win from oxygen after stem cell transplantation.


Secondary Outcome Measures :
  1. The lung fibrosis [ Time Frame: at 6 months post treatment ]
    Changes of the lung fibrosis on chest CT at 6 months compared with baseline


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   1 Month to 6 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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): NCT04062136


Contacts
Layout table for location contacts
Contact: Liem T Nguyen, MD., PhD (+844)39743556 ext 1420 v.liemnt@vinmec.com
Contact: Thai H Trieu Thi, MD (+8424) 3974 3556 v.thaitth@vinmec.com

Locations
Layout table for location information
Vietnam
Vinmec Research Institute of Stem Cell and Gene Technology Recruiting
Hanoi, Vietnam, 100000
Contact: Liem T Nguyen, MD., PhD    (+844)39743556 ext 1420    v.liemnt@vinmec.com   
Vinmec Research Institute of Stem Cell and Gene Technology Recruiting
Hanoi, Vietnam, 100000
Contact: Nguyen Thanh Liem, Prof         
Sponsors and Collaborators
Vinmec Research Institute of Stem Cell and Gene Technology
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications of Results:

Layout table for additonal information
Responsible Party: Vinmec Research Institute of Stem Cell and Gene Technology
ClinicalTrials.gov Identifier: NCT04062136    
Other Study ID Numbers: VinmecISC1915
First Posted: August 20, 2019    Key Record Dates
Last Update Posted: August 20, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Vinmec Research Institute of Stem Cell and Gene Technology:
Bronchopulmonary dysplasia
umbilical cord mesenchymal stem cells
Additional relevant MeSH terms:
Layout table for MeSH terms
Bronchopulmonary Dysplasia
Hyperplasia
Pathologic Processes
Ventilator-Induced Lung Injury
Lung Injury
 Lung Diseases
Respiratory Tract Diseases
Infant, Premature, Diseases
Infant, Newborn, Diseases