Bronchopulmonary Dysplasia
Conditions
Keywords
Bronchopulmonary dysplasia, umbilical cord mesenchymal stem cells
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
Interventions
COMBINATION_PRODUCTstem cell transplantation
Transplantation of umbilical cord mesenchymal stem cells
Sponsors
Vinmec Research Institute of Stem Cell and Gene Technology
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
1 Months to 6 Months
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| The lung fibrosis | at 6 months post treatment | Changes of the lung fibrosis on chest CT at 6 months compared with baseline |
Countries
Vietnam
Outcome results
None listed