Bronchopulmonary Dysplasia
Conditions
Keywords
Bronchopulmonary Dysplasia, human umbilical cord -derived mesenchymal stem cells
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.
Interventions
Human umbilical cord-derived mesenchymal stem cells had given to preterm infants through intravenous infusion.
Sponsors
Children's Hospital of Chongqing Medical University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
1 Months to 5 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Readmission rate | within two years |
| Duration of the hospital stay due to respiratory infection | within two years |
Secondary
| Measure | Time frame |
|---|---|
| Growth measured by Z-score | within two years |
| Rate of Survival | within two years |
| Number of blindness and deafness | within two years |
| Number of neurological developmental delay | within two years |
| Incidence of Tumorigenicity | within two years |
Countries
China
Contacts
Primary ContactYunqiu Xia
Backup ContactLin Zou
Outcome results
None listed