Status:
UNKNOWN
Follow-Up Study of Mesenchymal Stem Cells for Bronchopulmonary Dysplasia
Lead Sponsor:
Children's Hospital of Chongqing Medical University
Conditions:
Bronchopulmonary Dysplasia
Eligibility:
All Genders
1-5 years
Phase:
PHASE1
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 w...
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.
Eligibility Criteria
Inclusion
- Subject who completed the safety and efficacy evaluations in hUC-MSCs PhaseⅠ clinical trial
- Subject with a written consent form signed by a legal representative or a parent
Exclusion
- Subject whose parent or legal representative does not agree to participate in the study
- subject who is considered inappropriate to participate the study by the investigator
Key Trial Info
Start Date :
July 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2020
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT03873506
Start Date
July 1 2018
End Date
December 31 2020
Last Update
March 14 2019
Active Locations (1)
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1
Children's Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, China