Allogeneic UCB Therapy With EPO in Children With CP

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 120

Inclusion Criteria

1. Diagnosed with cerebral palsy
2. Age of =10 months and =6 years
3. Mismatch in HLA-A, B, and DR =2, and total nucleated cell count =3x10^7/kg. If the cell count is less than given values, more than 1 unit could be used.
4. Hemoglobin =13.6 g/dL
5. Decision of participation in the study by and acquisition of informed consent from the subject’s representative
6. Willingness and ability to be hospitalized according to the schedule specified in the protocol and continue the study for 12 months after study entry

Exclusion Criteria

1. Current aspiration pneumonia
2. Known genetic disease
3. History of hypersensitivity reaction to any study drugs pertinent to the study
4. History of participation in any other study with stem cell
5. Prior treatment with EPO within 3 months prior to study entry
6. Known coagulopathy with family history of thrombosis or medical history of recurrent thrombosis
7. Patient with severe seizure disease who has clinical convulsion despite combination therapy with 3 or more agents
8. Uncontrolled hypertension defined as systolic blood pressure >115 mmHg and/or diastolic blood pressure >70 mmHg
9. Hepatic impairment defined as asparate aminotransferase (AST) >55 IU/L and/or alanine aminotransferase (ALT) >45 IU/L
10. Renal impairment defined as creatinine (Cr) =1.2 mg/dL
11. Absolute neutrophil count =500/dL
12. Presence of diagnosed or suspected malignant tumor and/or hematologic malignancy
13. Non-compliance with study visits specified in the protocol or unwillingness of care-giver due to lack of understanding of the patient

Study & Design

Study Type: Interventional Study

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Gross Motor Function Measure (GMFM);Gross Motor Performance Measure (GMPM);Bayley Scales of Infant Development-II (BSID-II), mental and motor scale, raw scores

Secondary Outcome Measures

Name	Time	Method
Gross Motor Function Classification System (GMFCS);Functional Independence Measure for Children (WeeFIM);Pediatric Evaluation of Disability Inventory (PEDI);Quality of Upper Extremity Skills Test (QUEST);Visual Motor Integration (VMI);Selective Control Assessment of Lower Extremity (SCALE);Modified Ashworth scale (MAS);Modified Tardieu scale (MTS) of hamstrings;Manual muscle testing (MMT);Brain Diffusion Tensor Imaging (Brain DTI);Brain Positron Emission Tomography (Brain PET);Electroencephalography (EEG);Evoked Potential (EP);Adverse events