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

NCT03645525 · Status: WITHDRAWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL

Last updated 2023-12-29

No results posted yet for this study

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.

Conditions

  • Bronchopulmonary Dysplasia

Interventions

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

Sponsors & Collaborators

  • Children's Hospital of Fudan University

    lead OTHER

Principal Investigators

  • Chen Chao, PhD,MD · Chiledren's Hospital of Fudan University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
2 Weeks
Max Age
3 Weeks
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-12-01
Primary Completion
2022-10-30
Completion
2023-04-01

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

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 NCT03645525 on ClinicalTrials.gov