NCT03645525

Intratracheal Umbilical Cord-derived Mesenchymal Stem Cell for the Treatment of Bronchopulmonary Dysplasia (BPD)

• Status: Withdrawn
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Children's Hospital of Fudan University · Academic / Other
• Sex: All
• Age: 2 Weeks – 3 Weeks
• Healthy volunteers: Not accepted

Summary

Umbilical Cord-derived Mesenchymal stem cell has been proven effective in the experimental bronchopulmonary dysplasia (BPD).A multi-center study was designed to evaluate the safety and efficacy of the cellular therapy in extremely preterm infants at high risk for BPD.

Detailed description

Brochopulmonary dysplasia is a severe chronic lung disease in extremely preterm infants. The morbidity of BPD is increasing in CHINA. The preventive and therapy methods of BPD are still lacking. Umbilical Cord-derived Mesenchymal stem cell has been proven effective in the experimental bronchopulmonary dysplasia (BPD). A multi-center study was designed to evaluate the safety and efficacy of the cellular therapy in extremely preterm infants at high risk for BPD.

Conditions

• Bronchopulmonary Dysplasia

Interventions

Type	Name	Description
DRUG	Human Umbilical Cord-derived Mesenchymal stem cell	The Human Umbilical Cord-derived Mesenchymal stem cells suspension (2×10\^7/kg per KG of the infant 's weight ) will be instilled once through a catheter into the infant' s endotracheal tube
DRUG	placebo	saline

Timeline

• Start date: 2019-12-01
• Primary completion: 2022-10-30
• Completion: 2023-04-01
• First posted: 2018-08-24
• Last updated: 2023-12-29

Locations

3 sites across 1 country: China