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Human Mesenchymal Stem Cells For Bronchopulmonary Dysplasia

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ClinicalTrials.gov Identifier: NCT03558334
Recruitment Status : Recruiting
First Posted : June 15, 2018
Last Update Posted : June 15, 2018
Sponsor:
Information provided by (Responsible Party):
Xia Yunqiu, Children's Hospital of Chongqing Medical University

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 severe Bronchopulmonary Dysplasia(BPD).

Condition or disease Intervention/treatment Phase
Bronchopulmonary Dysplasia Drug: Transplantation of mesenchymal stem cell Drug: No transplantation of mesenchymal stem cell Phase 1 Phase 2

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 severe BPD.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Intravenous Human Umbilical-Cord-Derived Mesenchymal Stem Cells For Severe Bronchopulmonary Dysplasia in Premature Infants
Actual Study Start Date : March 1, 2016
Estimated Primary Completion Date : December 1, 2018
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Transplantation of Mesenchymal Stem Cell
Mesenchymal stem cell will be given to preterm infants with BPD.
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

Active Comparator: No Transplantation of Mesenchymal Stem Cell
Mesenchymal stem cell will be not given to preterm infants with BPD.
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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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 .

  4. 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.

  5. 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.

  6. 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.

  7. 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.



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. The participants meet the diagnostic criteria for 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.

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): NCT03558334


Contacts
Contact: Yunqiu Xia 13637719980 sunny_199001@foxmail.com
Contact: Lin Zou 18623121280

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

Publications:

Responsible Party: Xia Yunqiu, doctor, Children's Hospital of Chongqing Medical University
ClinicalTrials.gov Identifier: NCT03558334     History of Changes
Other Study ID Numbers: XYunqiu
First Posted: June 15, 2018    Key Record Dates
Last Update Posted: June 15, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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:
Bronchopulmonary Dysplasia
human umbilical cord -derived mesenchymal stem cells

Additional relevant MeSH terms:
Hyperplasia
Bronchopulmonary Dysplasia
Pathologic Processes
Ventilator-Induced Lung Injury
Lung Injury
Lung Diseases
Respiratory Tract Diseases
Infant, Premature, Diseases
Infant, Newborn, Diseases