Follow-Up Study of Mesenchymal Stem Cells for Bronchopulmonary Dysplasia

March 12, 2019 updated by: Xia Yunqiu, Children's Hospital of Chongqing Medical University

Follow-Up Study of Safety and Efficacy of Mesenchymal Stem Cells in Preterm Infants With Moderate or Severe Bronchopulmonary Dysplasia

This is a follow-up study to investigate the long-term safety and efficacy of human umbilical cord -derived mesenchymal stem cells (hUC-MSCs), for the treatment of BPD in premature infants. Subjects who participated in and completed the initial stage of the PhaseⅠtrial (NCT03558334 ) will be followed-up until 48 months after the hUC-MSCs transplantation.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Subjects who completed the initial stage of the PhaseⅠclinical trial will be followed-up at 5 additional visits: 1, 3, 6, 12 and 24 months after the hUC-MSCs transplantation.

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Phase 1

Contacts and Locations

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

Study Contact

Study Contact Backup

  • Name: Lin Zou
  • Phone Number: 18623121280

Study Locations

  • China
    • Chongqing
      • Chongqing, Chongqing, China
        • Recruiting
        • Children's Hospital of Chongqing Medical University
        • Contact:
          • Yunqiu Xia
          • Phone Number: 13637719980

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 month to 5 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Subject who completed the safety and efficacy evaluations in hUC-MSCs PhaseⅠ clinical trial
  2. Subject with a written consent form signed by a legal representative or a parent

Exclusion Criteria:

  1. Subject whose parent or legal representative does not agree to participate in the study
  2. subject who is considered inappropriate to participate the study by the investigator

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: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Mesenchymal Stem Cell
A single intravenous transplantation of Mesenchymal Stem Cell (Dose A - 1 million cells per kg, Dose B - 5 million cells per kg)
Drug: transplantation of hUC-MSCs
Human umbilical cord-derived mesenchymal stem cells had given to preterm infants through intravenous infusion.
Other Names:
  • intravenous infusion of hUC-MSCs

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Readmission rate
Time Frame: within two years
within two years
Duration of the hospital stay due to respiratory infection
Time Frame: within two years
within two years

Secondary Outcome Measures

Outcome Measure
Time Frame
Rate of Survival
Time Frame: within two years
within two years
Incidence of Tumorigenicity
Time Frame: within two years
within two years
Growth measured by Z-score
Time Frame: within two years
within two years
Number of neurological developmental delay
Time Frame: within two years
within two years
Number of blindness and deafness
Time Frame: within two years
within two years

Collaborators and Investigators

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

Sponsor

Children's Hospital of Chongqing Medical University

Investigators

  • Study Chair: Zhou Fu, Children's Hospital of Chongqing Medical University

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 (Anticipated)

July 1, 2020

Study Completion (Anticipated)

December 31, 2020

Study Registration Dates

First Submitted

February 20, 2019

First Submitted That Met QC Criteria

March 12, 2019

First Posted (Actual)

March 13, 2019

Study Record Updates

Last Update Posted (Actual)

March 14, 2019

Last Update Submitted That Met QC Criteria

March 12, 2019

Last Verified

March 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • yunqiu xia

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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