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.

Inclusion Criteria:

• Age >= 12 months and < 24 months corrected age at the time of informed consent
• Diagnosed with cerebral palsy
• Diagnosed with PVL
• GMFCS level between II and IV
• Able to obtain written informed consent from parents (legal representative)

Exclusion Criteria:

• Presence of progressive neurological disease
• Presence of congenital anomaly
• Diagnosed with Grade 3 or more severe intraventricular hemorrhage
• Body weight < 5kg
• Profound intellectual disorder
• Complication of serious infection such as sepsis
• Requirement of mechanical ventilation
• Complication of serious organ failure such as kidney, liver or heart diseases or others and considered to be inappropriate
• Diagnosed with or suspected of hypsarrhythmia
• Positive for HBV, HCV, HIV or HTLV-1
• Patients who have received cell therapy
• Patients who have undergone selective dorsal rhizotomy or received botulinum toxin products within a certain period of time