NIPH Clinical Trials Search

JRCT ID: jRCT2053210009

Registered date:21/04/2021

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

Basic Information

Recruitment status Not Recruiting
Health condition(s) or Problem(s) studiedPediatric cerebral palsy attributed to PVL
Date of first enrollment15/07/2021
Target sample size6
Countries of recruitment
Study typeInterventional
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.


Primary OutcomeAdverse events appeared in the participants after the treatment.
Secondary Outcome1) 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
Include criteria1) 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 criteria1) 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


Public contact
Name Kazuya Mori
Address 29th Floor Grand Front Osaka Tower B, 3-1 Ofuka-cho, Kita-ku, Osaka Osaka Japan 530-0011
Telephone +81-6-6758-6931
Affiliation ROHTO Pharmaceutical Co., Ltd.
Scientific contact
Name Sumito Ookawa
Address 20th Floor Shiodome Building 1-2-20 Kaigan, Minato-ku, Tokyo Tokyo Japan 105-0022
Telephone +81-3-6832-6014
Affiliation ROHTO Pharmaceutical Co., Ltd.