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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
Human umbilical cord-derived mesenchymal stem cells had given to preterm infants through intravenous infusion.
Children's Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, China
RECRUITINGReadmission 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
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