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NCT04062136 Clinical Trial

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

Bronchopulmonary Dysplasia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04062136
Other study ID # VinmecISC1915
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
Start date March 1, 2019
Est. completion date November 30, 2020

Study information
Verified date June 2024
Source Vinmec Research Institute of Stem Cell and Gene Technology
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility
Status Completed
Enrollment 10
Est. completion date November 30, 2020
Est. primary completion date November 30, 2020
Accepts healthy volunteers No
Gender All
Age group 1 Month to 6 Months
Eligibility 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).

Study Design

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
Vietnam Vinmec Research Institute of Stem Cell and Gene Technology Hanoi

Sponsors (1)
Lead Sponsor Collaborator
Vinmec Research Institute of Stem Cell and Gene Technology

Country where clinical trial is conducted

Vietnam, 

References & Publications (3)

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 in — View Citation

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. — View Citation

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. doi: 10.12659/ajcr.905244. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Adverse events and serious adverse events Incidence of the adverse events or serious adverse events after transplantation during 9 months post treatment
Primary The proportion of patients win from oxygen To identify the proportion of patient with Bronchopulmonary Dysplasia win from oxygen after stem cell transplantation. during 9 months post treatment
Secondary The lung fibrosis Changes of the lung fibrosis on chest CT at 6 months compared with baseline at 6 months post treatment
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