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

NCT03774537 · Status: UNKNOWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2019-03-06

No results posted yet for this study

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）

Conditions

  • Bronchopulmonary Dysplasia

Interventions

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

Sponsors & Collaborators

  • Children's Hospital of Chongqing Medical University

    lead OTHER

Principal Investigators

  • Zhou Fu · Children's Hospital of Chongqing Medical University

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
4 Days
Max Age
14 Days
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-03-01
Primary Completion
2020-12-01
Completion
2021-12-31

Countries

  • China

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 NCT03774537 on ClinicalTrials.gov