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Human Mesenchymal Stem Cells For Moderate and Severe Bronchopulmonary Dysplasia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03601416
Recruitment Status : Not yet recruiting
First Posted : July 26, 2018
Last Update Posted : January 15, 2019
Sponsor:
Information provided by (Responsible Party):
Xia Yunqiu, Children's Hospital of Chongqing Medical University

Study Description
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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.

Condition or disease Intervention/treatment Phase
Bronchopulmonary Dysplasia Drug: Transplantation of mesenchymal stem cell Drug: No Transplantation of Mesenchymal Stem Cell Phase 2

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 57 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Intravenous Human Umbilical-Cord-Derived Mesenchymal Stem Cells For Moderate and Severe Bronchopulmonary Dysplasias in Children
Estimated Study Start Date : July 1, 2019
Estimated Primary Completion Date : June 1, 2021
Estimated Study Completion Date : December 31, 2021

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Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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 .

  2. 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.


Other Outcome Measures:
  1. 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.

  2. 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.


Eligibility Criteria
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Ages Eligible for Study:   up to 1 Year   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03601416


Contacts
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Contact: Yunqiu Xia 023-63622066 sunny_199001@foxmail.com
Contact: Lin Zou 023-63622066

Locations
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China, Chongqing
Children's Hospital of Chongqing Medical University
Chongqing, Chongqing, China, 400014
Contact: Yunqiu Xia    13637719980    sunny_199001@foxmail.com   
Sponsors and Collaborators
Children's Hospital of Chongqing Medical University
Investigators
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Study Chair: Zhou Fu Children's Hospital of Chongqing Medical University
More Information
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Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Xia Yunqiu, doctor, Children's Hospital of Chongqing Medical University
ClinicalTrials.gov Identifier: NCT03601416    
Other Study ID Numbers: Xia Yunqiu
First Posted: July 26, 2018    Key Record Dates
Last Update Posted: January 15, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Xia Yunqiu, Children's Hospital of Chongqing Medical University:
human umbilical cord -derived mesenchymal stem cells
moderate and severe bronchopulmonary dysplasia
Additional relevant MeSH terms:
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Bronchopulmonary Dysplasia
Hyperplasia
Pathologic Processes
Ventilator-Induced Lung Injury
Lung Injury
 Lung Diseases
Respiratory Tract Diseases
Infant, Premature, Diseases
Infant, Newborn, Diseases