Human Mesenchymal Stem Cells For Moderate and Severe Bronchopulmonary Dysplasia

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Brief Title

Human Mesenchymal Stem Cells For Moderate and Severe Bronchopulmonary Dysplasia

Official Title

Intravenous Human Umbilical-Cord-Derived Mesenchymal Stem Cells For Moderate and Severe Bronchopulmonary Dysplasias in Children

Brief 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 children with
      moderate and severe bronchopulmonary dysplasia.

Detailed Description

      Bronchopulmonary dysplasia (BPD) is one of the most common chronic lung diseases with poor
      prognosis, especially in preterm infants with moderate and severe BPD. However, there is lack
      of effective therapies for this disease.

      hUC-MSCs are widely used in clinic due to their low immunogenicity and convenient to get.Many
      animal study had shown that hUC-MSCs had therapeutic effects on a variety of animal models of
      lung disease.Furthermore,there are a large number of clinical trials of MSCs applied to
      various system diseases and the safety was verified.So,the main purpose of this study is to
      evaluate the safety and efficacy of hUC-MSCs in participants with moderate and severe
      bronchopulmonary dysplasia.

Study Phase

Phase 2

Study Type

Interventional

Primary Outcome

the accumulative duration of oxygen therapy

Secondary Outcome

 Changes of blood pressure in participants

Condition

Bronchopulmonary Dysplasia

Intervention

Transplantation of mesenchymal stem cell

Study Arms / Comparison Groups

 Transplantation of Mesenchymal Stem Cell
Description:  Mesenchymal stem cell will be given to participants with moderate and severe bronchopulmonary dysplasia.

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

57

Start Date

July 1, 2019

Completion Date

December 31, 2021

Primary Completion Date

June 1, 2021

Eligibility Criteria

        Inclusion Criteria:

          1. Participants with moderate and severe bronchopulmonary dysplasia are not well treated
             by routine therapy

          2. The legal representative or the participant had signed consent.

        Exclusion Criteria:

          -  1. Severe underlying diseases (e.g. systemic and hematological malignancies, heart
             failure, liver and kidney failure, immune deficiency, severe infectious diseases,
             III-IV grade pulmonary hypertension, Lung transplantation, current indications of
             acute surgery after lung transplantation) 2. Participants whose age is more than 1
             year old.

Gender

All

Ages

N/A - 1 Year

Accepts Healthy Volunteers

No

Contacts

Zhou Fu, 023-63622066, [email protected]

Location Countries

China

Location Countries

China

Administrative Informations

NCT ID

NCT03601416

Organization ID

Xia Yunqiu

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

January 2019