A Study to Investigate the Safety and Efficacy of UC-MSCs in Pediatric Patients With Cerebral Palsy (NCT04873752) | Clinical Trial Compass
CompletedPhase 1/2
A Study to Investigate the Safety and Efficacy of UC-MSCs in Pediatric Patients With Cerebral Palsy
Japan6 participantsStarted 2021-06-02
Plain-language summary
UDI-001 is administered to pediatric patients with cerebral palsy attributed to periventricular leukomalacia (PVL) multiple times to investigate its safety and efficacy.
Who can participate
Age range12 Months – 24 Months
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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