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Mesenchymal Stem Cells for Prevention of Bronchopulmonary Dysplasia in Infants

NCT03631420 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 9

Last updated 2023-12-04

No results posted yet for this study

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.

Conditions

  • Bronchopulmonary Dysplasia

Interventions

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

Sponsors & Collaborators

  • Meridigen Biotech Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
3 Days
Max Age
51 Days
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-10-26
Primary Completion
2025-12-31
Completion
2027-07-31
FDA Drug
Yes

Countries

  • Taiwan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03631420 on ClinicalTrials.gov