Follow-Up Study of Mesenchymal Stem Cells for Bronchopulmonary Dysplasia

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Bronchopulmonary dysplasia
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Brief Title

Follow-Up Study of Mesenchymal Stem Cells for Bronchopulmonary Dysplasia

Official Title

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

Brief Summary

      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.

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 Phase

Phase 1

Study Type

Interventional

Primary Outcome

Readmission rate

Secondary Outcome

 Rate of Survival

Condition

Bronchopulmonary Dysplasia

Intervention

transplantation of hUC-MSCs

Study Arms / Comparison Groups

 Mesenchymal Stem Cell
Description:  A single intravenous transplantation of Mesenchymal Stem Cell (Dose A - 1 million cells per kg, Dose B - 5 million cells per kg)

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status

Drug

Estimated Enrollment

30

Start Date

July 1, 2018

Completion Date

December 31, 2020

Primary Completion Date

July 1, 2020

Eligibility Criteria

        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

Gender

All

Ages

1 Month - 5 Years

Accepts Healthy Volunteers

No

Contacts

Zhou Fu, 13637719980, [email protected]

Location Countries

China

Location Countries

China

Administrative Informations

NCT ID

NCT03873506

Organization ID

yunqiu xia

Responsible Party

Principal Investigator

Study Sponsor

Children's Hospital of Chongqing Medical University

Study Sponsor

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

Verification Date

March 2019