A Clinical Study of UC-MSCs for Pediatric Patients with Cerebral Palsy

JRCT ID: jRCT2053210009

Registered date:21/04/2021

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: Pediatric cerebral palsy attributed to PVL
• Date of first enrollment: 15/07/2021
• Target sample size: 6
• Study type: Interventional

Intervention(s)

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.

Outcome(s)

• Primary Outcome: Adverse events appeared in the participants after the treatment.

Secondary Outcome

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

Key inclusion & exclusion criteria

• Age minimum: >= 1age old
• Age maximum: < 2age old
• Gender: Both

Include 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)

Exclude 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

Related Information

• Primary Sponsor: Ookawa Sumito
• Secondary ID(s): NCT04873752