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Trial record 2 of 20 for:    MSC | Bronchopulmonary Dysplasia

Human Mesenchymal Stem Cells For Infants At High Risk 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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03774537
Recruitment Status : Unknown
Verified March 2019 by Xia Yunqiu, Children's Hospital of Chongqing Medical University.
Recruitment status was:  Recruiting
First Posted : December 13, 2018
Last Update Posted : March 6, 2019
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 at high risk for Bronchopulmonary Dysplasia(BPD)

Condition or disease Intervention/treatment Phase
Bronchopulmonary Dysplasia Drug: Transplantation of hUC-MSCs Drug: No transplantation of hUC-MSCs 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 at high risk for BPD

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 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 Premature Infants At High Risk For Bronchopulmonary
Actual Study Start Date : March 1, 2019
Estimated Primary Completion Date : December 1, 2020
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Transplantation of hUC-MSCs
Preterm infants at high risk for BPD will receive transplantation of hUC-MSCs.
Drug: Transplantation of hUC-MSCs
Preterm infants at high risk for BPD will receive transplantation of hUC-MSCs through intravenous infusion. Dose A - 1 million cells per kg; Dose B - 5 million cells per kg
Other Name: Intravenous infusion of hUC-MSCs

No transplantation of hUC-MSCs
Preterm infants at high risk for BPD will not receive transplantation of hUC-MSCs
Drug: No transplantation of hUC-MSCs
Preterm infants at high risk for BPD will not receive transplantation of hUC-MSCs
Other Name: No intravenous infusion of hUC-MSCs




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 hUC-MSCs for BPD.


Secondary Outcome Measures :
  1. The incidence and severity of BPD defined by the National Institutes of Child Health and Human Development (NICHD) workshop. [ Time Frame: at the corrected gestational age of 36 weeks ]
    To evaluate the efficacy of hUC-MSCs to prevent preterm infants at high risk of BPD from developing BPD

  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 BPDmesenchymal stem cells for BPD.

  3. 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.mesenchymal stem cells for BPD.

  4. 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.

  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.



Information from the National Library of Medicine

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Ages Eligible for Study:   up to 14 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. An infant whose postnatal age is 3 to 14 days, inclusive (for treatment between 5 and 14 days after birth)
  2. Gestational age is between 23 and 28 weeks (23 weeks ≤ gestational age (GA) < 28 weeks)
  3. Birth weight is between 500g and 1000g, inclusive
  4. Being intubated and receiving mechanical ventilation within 5-14 days after birth, with a fraction of inspired oxygen (FiO2) of 0.25 or greater at Screening
  5. 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): NCT03774537


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

Locations
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China, Chongqing
Children's Hospital of Chongqing Medical University Recruiting
Chongqing, Chongqing, China
Contact: Yunqiu Xia    13637719980      
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
Publications:

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Responsible Party: Xia Yunqiu, Director, Children's Hospital of Chongqing Medical University
ClinicalTrials.gov Identifier: NCT03774537    
Other Study ID Numbers: XiaYQ
First Posted: December 13, 2018    Key Record Dates
Last Update Posted: March 6, 2019
Last Verified: March 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:
high risk; Bronchopulmonary Dysplasia;hUC-MSCs
Additional relevant MeSH terms:
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Bronchopulmonary Dysplasia
Ventilator-Induced Lung Injury
Lung Injury
Lung Diseases
Respiratory Tract Diseases
Infant, Premature, Diseases
Infant, Newborn, Diseases