Pediatric cerebral palsy attributed to PVL
Conditions
Interventions
2.5 x 10^6 cells/kg of UDI-001 are administered intravenously.
One cycle consists of twice a week administrations and 4 cycles with 8 administrations are conducted.
Sponsors
Ookawa Sumito
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Age >= 12 months and < 24 months corrected age at the time of informed consent 2) Diagnosed with cerebral palsy 3) Diagnosed with PVL 4) GMFCS level between II and IV 5) Able to obtain written infomed consent from parents (legal representative)
Exclusion criteria
Exclusion criteria: 1) Presence of progressive neurological disease 2) Presence of congenital anomaly 3) Diagnosed with Grade 3 or more severe IVH 4) Body weight < 5kg 5) Profound intellectual disorder 6) Complication of serious infection such as sepsis 7) Requirement of mechanical ventilation 8) Complication of serious organ failure such as kidney, liver or heart diseases or others and considered to be inappropriate 9) Diagnosed with or suspected of hypsarrhythmia 10) Positive for HBV, HCV, HIV or HTLV-1 11) Patients who have recived cell therapy 12) Patients who have undergone SDR or received botulinum toxin products within a certain period of time
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adverse events appeared in the participants after the treatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Difference and change in GMFM score 2) Improvement rate of GMFCS 3) Change in WeeFIM score 4) Change in and improvement rate of KSPD | — |
Contacts
Public ContactKazuya Mori
ROHTO Pharmaceutical Co., Ltd.
Outcome results
None listed