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

Vinmec Research Institute of Stem Cell and Gene Technology

Status and phase: Completed; Phase 1

Conditions: Bronchopulmonary Dysplasia

Treatments: Combination Product: stem cell transplantation

Study type: Interventional

Funder types: Other

Identifiers

NCT04062136

VinmecISC1915

Details and patient eligibility

About

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

Full 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

Enrollment: 10 patients

Sex: All

Ages: 1 to 6 months old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

Stem cell transplantation

Experimental group

Description:

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

Treatment:

Combination Product: stem cell transplantation