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Effect of Autologous Cord Blood Mononuclear Cells for Treatment of Bronchopulmonary Dysplasia in Extremely Preterm Neonates

NCT05071638 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 76

Last updated 2021-10-08

No results posted yet for this study

Summary

This is a non-randomized, case-controlled trial that evaluates the efficacy of autologous cord blood mononuclear cells(ACBMNC) infusion as a Treatment for BPD. The results of this trial will provide valuable clinical evidence for recommendations on the treatment of BPD in extremely preterm infants. Informed consent before birth is signed. In this prospective clinical trial, preterm neonates less than 28 weeks who previously stored ACBMNC and then suffer BPD will be assigned to be ACBMNC infusion group, while those who do not previously stored ACBMNC or then refuse ACBMNC infusion and suffer BPD will be assigned to be control group. In the ACBMNC infusion group, when BPD occurred, the pre-stored ACBMNC will be removed and rewarmed, and then ACBMNC(5×107 cells /kg) will be intravenously injected within 24 hours. The control group receives standardized treatment without special treatment. The total number of participants is 76 and the same in both groups. The primary outcome is the rate of mortality or ratio of severe BPD at 36 weeks of postmenstrual age or discharge home. The secondary outcomes will include other common preterm complication rate and the number of hospitalizations due to pneumonia within 1 year of postmenstrual age.

Conditions

  • BPD

Interventions

BIOLOGICAL

autologous cord blood mononuclear cells

preterm neonates less than 28 weeks who suffer BPD and also stored cord blood are assigned to receive intravenous autologous cord blood mononuclear cells infusion (5×107cells/kg).

Sponsors & Collaborators

  • Guangdong Women and Children Hospital

    lead OTHER

Principal Investigators

  • Jie Yang, PhD · Guangdong Women and Children Hospital

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Max Age
28 Weeks
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-10-01
Primary Completion
2023-03-31
Completion
2023-09-30

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 NCT05071638 on ClinicalTrials.gov