Human Mesenchymal Stem Cells For Moderate and Severe Bronchopulmonary Dysplasia

January 11, 2019 updated by: Xia Yunqiu, Children's Hospital of Chongqing Medical University

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

57

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 Contact

Study Contact Backup

  • Name: Lin Zou
  • Phone Number: 023-63622066

Study Locations

  • China
    • Chongqing
      • Chongqing, Chongqing, China, 400014
        • Children's Hospital of Chongqing Medical University
        • Contact:

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

4 weeks to 1 year (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Transplantation of Mesenchymal Stem Cell
Mesenchymal stem cell will be given to participants with moderate and severe bronchopulmonary dysplasia.
Drug: Transplantation of mesenchymal stem cell

Human umbilical cord-derived mesenchymal stem cell will be given to participants through intravenous infusion.

Dose A - 1 million cells per kg Dose B - 5 million cells per kg
Active Comparator: No Transplantation of Mesenchymal Stem Cell
Mesenchymal stem cell will be not given to participants with moderate and severe bronchopulmonary dysplasia.
Drug: No Transplantation of Mesenchymal Stem Cell
Human umbilical cord-derived mesenchymal stem cell will be not given to participants through intravenous infusion.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the accumulative duration of oxygen therapy
Time Frame: from the time of diagnosis to the time of stopping oxygen therapy
To evaluate the safety of human umbilical cord -derived mesenchymal stem cells for moderate and severe bronchopulmonary dysplasia.
from the time of diagnosis to the time of stopping oxygen therapy

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes of blood pressure in participants
Time Frame: 24 hours after administration
To evaluate the safety of human umbilical cord -derived mesenchymal stem cells for moderate and severe bronchopulmonary dysplasia. Blood pressure is measured by electronic sphygmomanometer .
24 hours after administration
Changes of heart rate in participants
Time Frame: 24 hours after administration
To evaluate the safety of human umbilical cord -derived mesenchymal stem cells for moderate and severe bronchopulmonary dysplasia.
24 hours after administration

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes of respiratory rate in participants
Time Frame: 24 hours after administration
To evaluate the safety of human umbilical cord -derived mesenchymal stem cells for moderate and severe bronchopulmonary dysplasia.
24 hours after administration
Changes of high-resolution chest CT in participants
Time Frame: within 2 years after administration
To evaluate the safety and efficacy of human umbilical cord -derived mesenchymal stem cells for moderate and severe bronchopulmonary dysplasia.
within 2 years after administration

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 (Anticipated)

July 1, 2019

Primary Completion (Anticipated)

June 1, 2021

Study Completion (Anticipated)

December 31, 2021

Study Registration Dates

First Submitted

July 17, 2018

First Submitted That Met QC Criteria

July 17, 2018

First Posted (Actual)

July 26, 2018

Study Record Updates

Last Update Posted (Actual)

January 15, 2019

Last Update Submitted That Met QC Criteria

January 11, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Xia Yunqiu

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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