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Follow-Up Study of Mesenchymal Stem Cells for Bronchopulmonary Dysplasia

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ClinicalTrials.gov Identifier: NCT03873506
Recruitment Status : Recruiting
First Posted : March 13, 2019
Last Update Posted : March 13, 2019
Sponsor:
Information provided by (Responsible Party):
Xia Yunqiu, Children's Hospital of Chongqing Medical University

Brief Summary:
This is a follow-up study to investigate the long-term safety and efficacy of human umbilical cord -derived mesenchymal stem cells (hUC-MSCs), for the treatment of BPD in premature infants. Subjects who participated in and completed the initial stage of the PhaseⅠtrial (NCT03558334 ) will be followed-up until 48 months after the hUC-MSCs transplantation.

Condition or disease Intervention/treatment Phase
Bronchopulmonary Dysplasia Drug: transplantation of hUC-MSCs Phase 1

Detailed Description:
Subjects who completed the initial stage of the PhaseⅠclinical trial will be followed-up at 5 additional visits: 1, 3, 6, 12 and 24 months after the hUC-MSCs transplantation.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Follow-Up Study of Safety and Efficacy of Mesenchymal Stem Cells in Preterm Infants With Moderate or Severe Bronchopulmonary Dysplasia
Actual Study Start Date : July 1, 2018
Estimated Primary Completion Date : July 1, 2020
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Mesenchymal Stem Cell
A single intravenous transplantation of Mesenchymal Stem Cell (Dose A - 1 million cells per kg, Dose B - 5 million cells per kg)
Drug: transplantation of hUC-MSCs
Human umbilical cord-derived mesenchymal stem cells had given to preterm infants through intravenous infusion.
Other Name: intravenous infusion of hUC-MSCs




Primary Outcome Measures :
  1. Readmission rate [ Time Frame: within two years ]
  2. Duration of the hospital stay due to respiratory infection [ Time Frame: within two years ]

Secondary Outcome Measures :
  1. Rate of Survival [ Time Frame: within two years ]
  2. Incidence of Tumorigenicity [ Time Frame: within two years ]
  3. Growth measured by Z-score [ Time Frame: within two years ]
  4. Number of neurological developmental delay [ Time Frame: within two years ]
  5. Number of blindness and deafness [ Time Frame: within two years ]


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Ages Eligible for Study:   1 Month to 5 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Subject who completed the safety and efficacy evaluations in hUC-MSCs PhaseⅠ clinical trial
  2. Subject with a written consent form signed by a legal representative or a parent

Exclusion Criteria:

  1. Subject whose parent or legal representative does not agree to participate in the study
  2. subject who is considered inappropriate to participate the study by the investigator

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): NCT03873506


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: NCT03873506     History of Changes
Other Study ID Numbers: yunqiu xia
First Posted: March 13, 2019    Key Record Dates
Last Update Posted: March 13, 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:
Bronchopulmonary Dysplasia
human umbilical cord -derived mesenchymal stem cells
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