NCT03631420

Mesenchymal Stem Cells for Prevention of Bronchopulmonary Dysplasia in Infants

The Safety and Feasibility of UMC119-01 Cell Therapy in Infants at High Risk for Bronchopulmonary Dysplasia

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 9 (estimated)
• Sponsor: Meridigen Biotech Co., Ltd. · Industry
• Sex: All
• Age: 3 Days – 51 Days
• Healthy volunteers: Not accepted

Summary

The clinical study with UMC119-01 is designed to investigate the safety in patients with bronchopulmonary dysplasia ("BPD"). This will be a dose escalation, open-label, single-center study in infants at high risk for BPD.

Detailed description

UMC119-01 is ex vivo cultured human umbilical cord tissue-derived mensenchymal stem cells product which is intended for prevention of Bronchopulmonary dysplasia.

Conditions

• Bronchopulmonary Dysplasia

Interventions

Type	Name	Description
BIOLOGICAL	Human Umbilical Cord Derived-Mesenchymal Stem Cells	Cohort 1 : 3 million cells/kg ; Cohort 2 : 10 million cells/kg ; Cohort 3 : 30 million cells/kg

Timeline

• Start date: 2018-10-26
• Primary completion: 2025-12-31
• Completion: 2027-07-31
• First posted: 2018-08-15
• Last updated: 2023-12-04

Locations

1 site across 1 country: Taiwan

Regulatory

• FDA-regulated drug study