A Phase 1 interventional study of transplantation of hUC-MSCs in Bronchopulmonary Dysplasia, sponsored by Children's Hospital of Chongqing Medical University. Status unknown at 1 site in China. Open to participants aged 1 Month to 5 Years. Per ClinicalTrials.gov, last updated 2019-03-14.
Sponsored by Children's Hospital of Chongqing Medical University · Phase 1, Interventional, and Treatment
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.
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.
339 studies on the registry are indexed under Bronchopulmonary Dysplasia; 80 are open to participants now.
This study's planned enrollment of 30 is below the median of 70 across 228 interventional studies indexed under Bronchopulmonary Dysplasia.
Browse Bronchopulmonary Dysplasia studies →Children's Hospital of Chongqing Medical University is the lead sponsor of 35 studies on the registry; 13 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
Also known as: intravenous infusion of hUC-MSCs
Readmission rate
Time frame: within two years
Duration of the hospital stay due to respiratory infection
Time frame: within two years
Rate of Survival
Time frame: within two years
Incidence of Tumorigenicity
Time frame: within two years
Growth measured by Z-score
Time frame: within two years
Number of neurological developmental delay
Time frame: within two years
Number of blindness and deafness
Time frame: within two years
Plan to share: No
This study is status unknown, as verified in Mar 2019. You cannot join it, but the record below documents what was studied.
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Children's Hospital of Chongqing Medical University