Outcomes of Human Umbilical Cord-derived Mesenchymal Stem Cells Transplantation in the Treatment of Bronchopulmonary Dysplasia
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Enrollment
- 10
- Locations
- 1
- Primary Endpoint
- Adverse events and serious adverse events
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 1 Month to 6 Months (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
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).
Arms & Interventions
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
Intervention: stem cell transplantation (Combination Product)
Outcomes
Primary Outcomes
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 Outcomes
- The lung fibrosis(at 6 months post treatment)