Autologous Cord Blood Mononuclear Cells for Bronchopulmonary Dysplasia in Very Preterm Neonates

October 26, 2021 updated by: yang jie, Guangdong Women and Children Hospital

Rationale: Pre-clinical animal studies provide robust evidence regarding the beneficial effect of cord blood-derived mononuclear cells (MNCs) for experimental bronchopulmonary dysplasia (BPD).

This single-center, non-randomized, controlled, blinded trial assessed the effect of a single intravenous infusion of autologous cord blood MNCs (ACBMNCs) in preventing BPD in very preterm neonates, a high-risk population.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

62

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 511442
        • Jie Yang

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 second to 7 months (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria: (1) born at the study hospital; (2) singleton birth; (3) GA <32 weeks; (4) free of severe congenital anomalies or genetic syndromes; (5) without clinical chorioamnionitis; (6) the mother was negative for hepatitis B (HBsAg and/or HBeAg), hepatitis C (anti-HCV), syphilis, HIV (anti-HIV-1 and -2), and IgM against cytomegalovirus, rubella, toxoplasma, and herpes simplex viruses; (7) consent was obtained from the parents or guardians; and (8) after processing, UCB cells were available.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: control
Experimental: Autologous cord blood mononuclear cells
Autologous Umbilical Cord Blood Mononuclear Cells Therapy 24 hours after birth ,dose is 50 million cells/kg
Other: Autologous Umbilical Cord Blood Mononuclear Cells Therapy
Autologous Umbilical Cord Blood Mononuclear Cells Therapy in preterm for prevention of infection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
bronchopulmonary dysplasia at 36 weeks of postmenstrual age or the discharge home
Time Frame: 36 weeks of postmenstrual age or the discharge
bronchopulmonary dysplasia rate
36 weeks of postmenstrual age or the discharge

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
number of patients with severe BPD in survivors
Time Frame: 36 weeks of postmenstrual age or the discharge
severe BPD in survivors
36 weeks of postmenstrual age or the discharge
number of patients died before discharge from hospital
Time Frame: before discharge from hospital
mortality before discharge from hospital
before discharge from hospital
the duration of mechanical ventilation
Time Frame: before discharge from hospital
Other outcomes
before discharge from hospital

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Guangdong Women and Children Hospital

Investigators

  • Principal Investigator: Jie Yang, PHD, Guangdong Women and Children Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2018

Primary Completion (Actual)

January 1, 2020

Study Completion (Actual)

January 1, 2020

Study Registration Dates

First Submitted

December 3, 2016

First Submitted That Met QC Criteria

December 17, 2016

First Posted (Estimate)

December 21, 2016

Study Record Updates

Last Update Posted (Actual)

November 2, 2021

Last Update Submitted That Met QC Criteria

October 26, 2021

Last Verified

October 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Guangdong M And C

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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