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Human Mesenchymal Stem Cells For Moderate and Severe Bronchopulmonary Dysplasia

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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

Tracking Information
First Submitted Date  ICMJE July 17, 2018
First Posted Date  ICMJE July 26, 2018
Last Update Posted Date January 15, 2019
Estimated Study Start Date  ICMJE July 1, 2019
Estimated Primary Completion Date June 1, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 11, 2019)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: July 17, 2018)
Number of participants with adverse reactions after treatment [ Time Frame: 24 hours after administration ]
To evaluate the safety of human umbilical cord -derived mesenchymal stem cells for refractory pulmonary diseases.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 11, 2019)
  • 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 .
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: July 17, 2018)
  • 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 refractory pulmonary diseases. Blood pressure is measured by electronic sphygmomanometer .
  • 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 refractory pulmonary diseases.
Current Other Pre-specified Outcome Measures
 (submitted: January 11, 2019)
  • 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.
  • 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.
Original Other Pre-specified Outcome Measures
 (submitted: July 17, 2018)
  • 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 refractory pulmonary diseases.
  • 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 refractory pulmonary diseases.
 
Descriptive Information
Brief Title  ICMJE Human Mesenchymal Stem Cells For Moderate and Severe Bronchopulmonary Dysplasia
Official Title  ICMJE 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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Bronchopulmonary Dysplasia
Intervention  ICMJE
  • 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

  • Drug: No Transplantation of Mesenchymal Stem Cell
    Human umbilical cord-derived mesenchymal stem cell will be not given to participants through intravenous infusion.
Study Arms  ICMJE
  • Experimental: Transplantation of Mesenchymal Stem Cell
    Mesenchymal stem cell will be given to participants with moderate and severe bronchopulmonary dysplasia.
    Intervention: Drug: Transplantation of mesenchymal stem cell
  • Active Comparator: No Transplantation of Mesenchymal Stem Cell
    Mesenchymal stem cell will be not given to participants with moderate and severe bronchopulmonary dysplasia.
    Intervention: Drug: No Transplantation of Mesenchymal Stem Cell
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: January 11, 2019)
57
Original Estimated Enrollment  ICMJE
 (submitted: July 17, 2018)
30
Estimated Study Completion Date  ICMJE December 31, 2021
Estimated Primary Completion Date June 1, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE up to 1 Year   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Yunqiu Xia 023-63622066 sunny_199001@foxmail.com
Contact: Lin Zou 023-63622066
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03601416
Other Study ID Numbers  ICMJE Xia Yunqiu
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Xia Yunqiu, Children's Hospital of Chongqing Medical University
Study Sponsor  ICMJE Children's Hospital of Chongqing Medical University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Zhou Fu Children's Hospital of Chongqing Medical University
PRS Account Children's Hospital of Chongqing Medical University
Verification Date January 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP