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Trial record 7 of 7699 for:    stem cells

Human Mesenchymal Stem Cells For 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: NCT03558334
Recruitment Status : Recruiting
First Posted : June 15, 2018
Last Update Posted : May 21, 2019
Sponsor:
Information provided by (Responsible Party):
Xia Yunqiu, Children's Hospital of Chongqing Medical University

Tracking Information
First Submitted Date  ICMJE June 4, 2018
First Posted Date  ICMJE June 15, 2018
Last Update Posted Date May 21, 2019
Actual Study Start Date  ICMJE June 28, 2018
Estimated Primary Completion Date December 31, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 14, 2018)
Number of participants with adverse reactions related to infusion after treatment [ Time Frame: 24 hours after administration ]
To evaluate the safety of human umbilical cord -derived mesenchymal stem cells for BPD.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03558334 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 14, 2018)
  • 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 BPD.
  • Changes of temperature in participants [ Time Frame: 3 days after administration ]
    To evaluate the safety of human umbilical cord -derived mesenchymal stem cells for BPD.
  • Changes of blood pressure in participants [ Time Frame: 3 days after administration ]
    To evaluate the safety of human umbilical cord -derived mesenchymal stem cells for BPD. Blood pressure is measured by electronic sphygmomanometer .
  • Changes of heart rate in participants [ Time Frame: 3 days after administration ]
    To evaluate the safety of human umbilical cord -derived mesenchymal stem cells for BPD.
  • Changes of respiratory rate in participants [ Time Frame: 3 days after administration ]
    To evaluate the safety of human umbilical cord -derived mesenchymal stem cells for BPD.
  • Changes of oxygen saturation in participants [ Time Frame: 3 days after administration ]
    To evaluate the safety of human umbilical cord -derived mesenchymal stem cells for BPD.
  • Growth velocity (Z-score) in participants [ Time Frame: within 2 years after administration ]
    To evaluate the safety and efficacy of human umbilical cord -derived mesenchymal stem cells for BPD.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Human Mesenchymal Stem Cells For Bronchopulmonary Dysplasia
Official Title  ICMJE Intravenous Human Umbilical-Cord-Derived Mesenchymal Stem Cells For Moderate and Severe Bronchopulmonary Dysplasia in Premature Infants
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 premature infants for moderate and severe Bronchopulmonary Dysplasia(BPD).
Detailed Description

BPD is a chronic lung disease that occur in premature infants receiving prolonged oxygen pulmonary and ventilator therapy. It remains a main complication of extreme prematurity and currently lacks efficient treatment.The mortality rate of one year after birth is still high and the quality of life is not optimistic.

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 BPD.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-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 preterm infants through intravenous infusion.

    Dose A - 1 million cells per kg Dose B - 5 million cells per kg

    Other Name: Intravenous infusion of mesenchymal stem cell
  • Drug: No transplantation of mesenchymal stem cell
    Human umbilical cord-derived mesenchymal stem cell will be not given to preterm infants through intravenous infusion.
    Other Name: No intravenous infusion of mesenchymal stem cell
Study Arms  ICMJE
  • Experimental: Transplantation of Mesenchymal Stem Cell
    Mesenchymal stem cell will be given to preterm infants with BPD.
    Intervention: Drug: Transplantation of mesenchymal stem cell
  • Active Comparator: No Transplantation of Mesenchymal Stem Cell
    Mesenchymal stem cell will be not given to preterm infants with BPD.
    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 Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 19, 2019)
12
Original Estimated Enrollment  ICMJE
 (submitted: June 14, 2018)
30
Estimated Study Completion Date  ICMJE June 30, 2022
Estimated Primary Completion Date December 31, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. The participants meet the diagnostic criteria for moderate and severe BPD established by the National Institutes of Child Health and Human Development (NICHD) workshop.
  2. The participants have abnormal respiratory manifestations.
  3. Written consent form signed by a legal representative or a parent.

Exclusion Criteria:

  1. Although mechanical ventilation or oxygen is required in participants, there are no signs of dyspnea or BPD-related changes in lung imaging, such as central apnea or diaphragm paralysis.
  2. The participants who have complex congenital heart disease.
  3. The participants who have severe pulmonary hypertension(cardiac ultrasound confirmed) at the time of assessment.
  4. The participants who have severe respiratory tract malformation: pierre-robin syndrome, tracheobronchomalacia, vascular ring syndrome, congenital tracheal stenosis, tracheo-esophageal fistula, pulmonary emphysema, pulmonary sequestration, congenital pulmonary dysplasia, congenital pulmonary cyst, congenital spasm, etc.
  5. The participants who have severe chromosome anomalies :Edward syndrome, Patau syndrome, Down syndrome, etc) or severe congenital malformation (Hydrocephalus, Encephalocele, etc).
  6. The participants who have severe congenital infection(Herpes, Toxoplasmosis, Rubella, Syphilis, AIDS, etc).
  7. The participants who have severe sepsis or shock.
  8. The participants who is going to have surgery 72 hours before/after this study drug administration.
  9. The participants who have surfactant administration within 24 hours before this study drug administration.
  10. The participants who have severe intracranial hemorrhage ≥ grade 3 or 4.
  11. The participants who have active pulmonary hemorrhage or active air leak syndrome at the time of assessment.
  12. The participants who have the history of other clinical studies as a participant.
  13. The participants who is considered inappropriate by the investigators.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Yunqiu Xia 13637719980 sunny_199001@foxmail.com
Contact: Lin Zou 18623121280
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03558334
Other Study ID Numbers  ICMJE XYunqiu
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 May 2019

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