Brief Title
Follow-Up Study of Mesenchymal Stem Cells for Bronchopulmonary Dysplasia
Official Title
Follow-Up Study of Safety and Efficacy of Mesenchymal Stem Cells in Preterm Infants With Moderate or Severe Bronchopulmonary Dysplasia
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.
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.
Study Phase
Phase 1
Study Type
Interventional
Primary Outcome
Readmission rate
Secondary Outcome
Rate of Survival
Condition
Bronchopulmonary Dysplasia
Intervention
transplantation of hUC-MSCs
Study Arms / Comparison Groups
Mesenchymal Stem Cell
Description: A single intravenous transplantation of Mesenchymal Stem Cell (Dose A - 1 million cells per kg, Dose B - 5 million cells per kg)
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
30
Start Date
July 1, 2018
Completion Date
December 31, 2020
Primary Completion Date
July 1, 2020
Eligibility 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
Gender
All
Ages
1 Month - 5 Years
Accepts Healthy Volunteers
No
Contacts
Zhou Fu, 13637719980, [email protected]
Location Countries
China
Location Countries
China
Administrative Informations
NCT ID
NCT03873506
Organization ID
yunqiu xia
Responsible Party
Principal Investigator
Study Sponsor
Children's Hospital of Chongqing Medical University
Study Sponsor
Zhou Fu, Study Chair, Children's Hospital of Chongqing Medical University
Verification Date
March 2019