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

Phase 1

Completed

• Conditions: Bronchopulmonary Dysplasia
• Interventions: Combination Product: stem cell transplantation

• Registration Number: NCT04062136
• Lead Sponsor: Vinmec Research Institute of Stem Cell and Gene Technology

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

Study Timeline

• Study Start: 2019-03-01
• Study First Submitted: 2019-03-27
• Study First Submitted QC: 2019-08-19
• Study First Posted: 2019-08-20
• Primary Completion: 2020-11-30
• Study Completion: 2020-11-30
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-03
• Last Update Posted: 2024-06-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Stem cell transplantation	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

Primary Outcome Measures

Name	Time	Method
Adverse events and serious adverse events	during 9 months post treatment	Incidence of the adverse events or serious adverse events after transplantation
The proportion of patients win from oxygen	during 9 months post treatment	To identify the proportion of patient with Bronchopulmonary Dysplasia win from oxygen after stem cell transplantation.

Secondary Outcome Measures

Name	Time	Method
The lung fibrosis	at 6 months post treatment	Changes of the lung fibrosis on chest CT at 6 months compared with baseline

Trial Locations

Locations (1)

Vinmec Research Institute of Stem Cell and Gene Technology; 🇻🇳 Hanoi, Vietnam