Status:
COMPLETED
A Study to Investigate the Safety and Efficacy of UC-MSCs in Pediatric Patients With Cerebral Palsy
Lead Sponsor:
Rohto Pharmaceutical Co., Ltd.
Conditions:
Cerebral Palsy
Periventricular Leukomalacia
Eligibility:
All Genders
12-24 years
Phase:
PHASE1
PHASE2
Brief Summary
UDI-001 is administered to pediatric patients with cerebral palsy attributed to periventricular leukomalacia (PVL) multiple times to investigate its safety and efficacy.
Detailed Description
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 cel...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 2 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 15 2024
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT04873752
Start Date
June 2 2021
End Date
February 15 2024
Last Update
April 6 2025
Active Locations (1)
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1
Osaka City University Hospital
Osaka, Osaka, Japan, 545-8586