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Clinical Trials/NCT04062136
NCT04062136
Completed
Phase 1

Outcomes of Human Umbilical Cord-derived Mesenchymal Stem Cells Transplantation in the Treatment of Bronchopulmonary Dysplasia

Vinmec Research Institute of Stem Cell and Gene Technology1 site in 1 country10 target enrollmentMarch 1, 2019

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Bronchopulmonary Dysplasia
Sponsor
Vinmec Research Institute of Stem Cell and Gene Technology
Enrollment
10
Locations
1
Primary Endpoint
Adverse events and serious adverse events
Status
Completed
Last Updated
last year

Overview

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

Registry
clinicaltrials.gov
Start Date
March 1, 2019
End Date
November 30, 2020
Last Updated
last year
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

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).

Outcomes

Primary Outcomes

Adverse events and serious adverse events

Time Frame: during 9 months post treatment

Incidence of the adverse events or serious adverse events after transplantation

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 Outcomes

  • The lung fibrosis(at 6 months post treatment)

Study Sites (1)

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