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Trial record 6 of 7597 for:    stem cells

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

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ClinicalTrials.gov Identifier: NCT04062136
Recruitment Status : 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

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
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


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




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



Information from the National Library of Medicine

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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).

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
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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
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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

Publications of Results:
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Responsible Party: Vinmec Research Institute of Stem Cell and Gene Technology
ClinicalTrials.gov Identifier: NCT04062136     History of Changes
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

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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:
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Bronchopulmonary Dysplasia
Hyperplasia
Pathologic Processes
Ventilator-Induced Lung Injury
Lung Injury
Lung Diseases
Respiratory Tract Diseases
Infant, Premature, Diseases
Infant, Newborn, Diseases