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Completed

NCT Number: NCT04062136

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

To evaluate the safety and efficacy of human umbilical cord mesenchymal stem cells transplantation in patients with bronchopulmonary dysplasia

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Key information

Conditions

Bronchopulmonary Dysplasia Congenital, Hereditary, and Neonatal Diseases and Abnormalities Infant, Newborn, Diseases Infant, Premature, Diseases Lung Diseases Lung Injury Respiratory Tract Diseases Ventilator-Induced Lung Injury

Age range

1 month–6 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Vinmec Research Institute of Stem Cell and Gene Technology

Hanoi, 100000, Vietnam

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Stem cell transplantation

Combination Product

Transplantation of umbilical cord mesenchymal stem cells

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Vinmec Research Institute of Stem Cell and Gene Technology

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Aug 20, 2019
Registry last updated
Jun 4, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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