Children with Cerebral Palsy

Primary objectives:  To assess the safety and tolerability of allogeneic human umbilical cord blood (hUCB) infusion in children with cerebral palsy (CP) Secondary objective:  To evaluate the efficacy of hUCB infusion in children with CP Exploratory objective:  To assess the change in biomarkers of hUCB infusion in children with CP

injection

hUCB

242

>5*10^8 TNC/bag

Primary endpoint
 Frequency and incidence of treatment-emergent adverse events (TEAEs).

Inclusion criteria
1. Male or female aged ≥ 2 and ≤ 6 years at the time of screening.
2. With a confirmed diagnosis of CP and had clinical evidence of a non-progressive
motor disability due to brain dysfunction.
3. Gross Motor Function Classification Score (GMFCS) levels II-V.
4. Review of brain Magnetic Resonance Imaging (MRI) does not suggest a genetic
condition or brain malformation.
5. Is receiving continuous rehabilitation and has received such rehabilitation for at
least 24 weeks before screening visit without significantly functional improvement
at the Investigator's discretion.
6. Subjects being treated for cerebral palsy must be on a stable regimen for at least 12
weeks before screening visit.
7. At least 3 packages of human leukocyte antigen (HLA) matched (≥ 4:6 to a specific
subject) and ABO/Rh matched hUCB are available for the subject.
8. Has stable electroencephalogram (EEG) recording at screening. Subject whose
results are abnormal but clinically insignificant may be enrolled, if determined by
the Investigator that the subject’s safety and trial evaluation will be unaffected.
9. Has stable clinical electrocardiogram (ECG) results at resting state at the time of
screening. Subject whose results are abnormal but clinically insignificant may be
enrolled, if determined by the Investigator that the subject’s safety and trial
evaluation will be unaffected.
10. Decision of participation in the study by and acquisition of informed consent from
the subject's legal representatives, willing and able to participate in all aspects of
the study, including completion of subjective evaluations, attendance at scheduled
clinic visits, and compliance with all protocol requirements as evidenced by
providing a written informed consent.

1. With clinically significant renal, cardiovascular, liver diseases, psychiatric disorders
or other circumstances (as follows), as judged by the Investigator, which may
increase the risk by participating.
a. Hematology test:
 Absolute neutrophil count (ANC) <1500/μL
 White blood cells (WBC) <3.6 x 103/μL
 Platelet counts <150 x 103/μL
 Hemoglobin <10 g/dL
b. Coagulation:
 International normalized ratio (INR) >1.5 x upper limit of normal (ULN)
c. Liver function:
 Alanine aminotransferase (ALT) >3 x ULN
 Aspartate aminotransferase (AST) >3 x ULN
 Total bilirubin >1.5 mg/dL
d. Kidney function:
 Creatinine >2.0 mg/dL
 Estimated glomerular filtration rate (eGFR) <60 mL/min/1.73m2
2. Has any clinically significant medical conditions or infections (including but not
limited to human immunodeficiency virus [HIV], or uncontrolled bacterial, viral, or
fungal infection[s]), as determined by the Investigator, which may interfere or affect
trial participation.
3. With hereditary diseases.
4. With pulmonary dysfunction or active pneumonia (both treated and untreated).
5. With cancer or a terminal illness.
6. With uncontrolled epileptic seizure of all types.
7. With immunodeficiency or is receiving chemotherapy or immunosuppressive
therapy.
8. Is currently participating in an investigational study or has been taking an
investigational product within 4 weeks or 5 half-lives, whichever is longer, prior to
screening, or receiving any cell therapy within 1 year prior to screening.
9. With a known history of severe infusion reactions.
10. With known allergic reaction or hypersensitivity to any component of the study
product.
11. Judged by the Investigator to be not suitable/eligible for study participation.