UDI-001 is administered to pediatric patients with cerebral palsy attributed to periventricular leukomalacia (PVL) multiple times to investigate its safety and efficacy.
This is the first study of UDI-001 to be administered to children. Pediatric patients with cerebral palsy attributed to PVL are enrolled to the study and umbilical cord derived mesenchymal stromal cells (UC-MSCs) are administered to those patients multiple times intravenously. Safety and efficacy of UC-MSCs are evaluated for 52 weeks after the first administration.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
6
2.5 x 10\^6 cells/kg of UDI-001 are administered intravenously. One cycle consists of twice a week administrations.
Osaka City University Hospital
Osaka, Osaka, Japan
Safety: Adverse Event
Adverse events which appear in the participants after the treatment
Time frame: until Week 52
Gross Motor Function Measure Score (GMFM Score)
Difference and change in GMFM score
Time frame: baseline to Week 52
Gross Motor Function Classification System (GMFCS)
Improvement rate of GMFCS
Time frame: baseline to Week 52
Function Independence Measure for Children (WeeFIM)
Change in WeeFIM score
Time frame: baseline to Week 52
Kyoto Scale of Psychological Development Test 2001 (KSPD)
Change in and Improvement rate of KSPD
Time frame: baseline to Week 52
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