Overview
Follow-Up Study of Mesenchymal Stem Cells for Bronchopulmonary Dysplasia
Status:
Unknown status
Unknown status
Trial end date:
2020-12-31
2020-12-31
Target enrollment:
0
0
Participant gender:
All
All
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.Phase:
Phase 1Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
Children's Hospital of Chongqing Medical University
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