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
• Status: Completed
• Phase: Phase 1
• 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
• 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).

Related Conditions & MeSH terms

• Bronchopulmonary Dysplasia
• Hyperplasia

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