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

Overview

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

Full Title of Study: “Outcomes of Human Umbilical Cord-derived Mesenchymal Stem Cells Transplantation in the Treatment of Bronchopulmonary Dysplasia”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: November 30, 2020

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

Interventions

  • Combination Product: stem cell transplantation
    • Transplantation of umbilical cord mesenchymal stem cells

Arms, Groups and Cohorts

  • 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

Clinical Trial Outcome Measures

Primary Measures

  • 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 Measures

  • The lung fibrosis
    • Time Frame: at 6 months post treatment
    • Changes of the lung fibrosis on chest CT at 6 months compared with baseline

Participating in This Clinical Trial

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).

Gender Eligibility: All

Minimum Age: 1 Month

Maximum Age: 6 Months

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Vinmec Research Institute of Stem Cell and Gene Technology
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Contact(s)
    • Liem T Nguyen, MD., PhD, (+844)39743556, v.liemnt@vinmec.com

Citations Reporting on Results

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.

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.

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.

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