NCT03774537

Human Mesenchymal Stem Cells For Infants At High Risk For Bronchopulmonary Dysplasia

Intravenous Human Umbilical-Cord-Derived Mesenchymal Stem Cells For Premature Infants Ａt High Risk For Bronchopulmonary

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Children's Hospital of Chongqing Medical University · Academic / Other
• Sex: All
• Age: 4 Days – 14 Days
• 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 premature infants at high risk for Bronchopulmonary Dysplasia（BPD）

Detailed description

BPD is a chronic lung disease that occur in premature infants receiving prolonged oxygen pulmonary and ventilator therapy. It remains a main complication of extreme prematurity and currently lacks efficient treatment.The mortality rate of one year after birth is still high and the quality of life is not optimistic. 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 at high risk for BPD

Conditions

• Bronchopulmonary Dysplasia

Interventions

Type	Name	Description
DRUG	Transplantation of hUC-MSCs	Preterm infants at high risk for BPD will receive transplantation of hUC-MSCs through intravenous infusion. Dose A - 1 million cells per kg; Dose B - 5 million cells per kg
DRUG	No transplantation of hUC-MSCs	Preterm infants at high risk for BPD will not receive transplantation of hUC-MSCs

Timeline

• Start date: 2019-03-01
• Primary completion: 2020-12-01
• Completion: 2021-12-31
• First posted: 2018-12-13
• Last updated: 2019-03-06

Locations

1 site across 1 country: China