NCT03601416

Human Mesenchymal Stem Cells For Moderate and Severe Bronchopulmonary Dysplasia

Intravenous Human Umbilical-Cord-Derived Mesenchymal Stem Cells For Moderate and Severe Bronchopulmonary Dysplasias in Children

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 57 (estimated)
• Sponsor: Children's Hospital of Chongqing Medical University · Academic / Other
• Sex: All
• Age: 28 Days – 1 Year
• Healthy volunteers: Not accepted

Summary

This study is an open-label, single-center, dose escalation study to evaluate of safety and efficacy of human umbilical cord -derived mesenchymal stem cells (hUC-MSCs) in children with moderate and severe bronchopulmonary dysplasia.

Detailed description

Bronchopulmonary dysplasia (BPD) is one of the most common chronic lung diseases with poor prognosis, especially in preterm infants with moderate and severe BPD. However, there is lack of effective therapies for this disease. hUC-MSCs are widely used in clinic due to their low immunogenicity and convenient to get.Many animal study had shown that hUC-MSCs had therapeutic effects on a variety of animal models of lung disease.Furthermore,there are a large number of clinical trials of MSCs applied to various system diseases and the safety was verified.So,the main purpose of this study is to evaluate the safety and efficacy of hUC-MSCs in participants with moderate and severe bronchopulmonary dysplasia.

Conditions

• Bronchopulmonary Dysplasia

Interventions

Type	Name	Description
DRUG	Transplantation of mesenchymal stem cell	Human umbilical cord-derived mesenchymal stem cell will be given to participants through intravenous infusion. Dose A - 1 million cells per kg Dose B - 5 million cells per kg
DRUG	No Transplantation of Mesenchymal Stem Cell	Human umbilical cord-derived mesenchymal stem cell will be not given to participants through intravenous infusion.

Timeline

• Start date: 2019-07-01
• Primary completion: 2021-06-01
• Completion: 2021-12-31
• First posted: 2018-07-26
• Last updated: 2019-01-15

Locations

1 site across 1 country: China