Mechanism of Allogeneic UCB Therapy in Cerebral Palsy
Cerebral Palsy, Child Development
About this trial
This is an interventional treatment trial for Cerebral Palsy focused on measuring Umbilical cord blood transplantation, Cytokine changes
Eligibility Criteria
Inclusion Criteria:
- Diagnosed with cerebral palsy
- Age of ≥10 months and ≤20 years
- Mismatch in HLA-A, B, and DR ≤3, and total nucleated cell count ≥2x107/kg. If the cell count is less than given values, more than 2 units may be used.
- Voluntary decision to participation in the study with informed consent agreed and obtained from the subject's representative.
- Patient and/or representatives are both willing and capable of being hospitalized according to the schedule specified in the protocol and continue the study for 12 months after study entry.
- If the patient has participated in another clinical trial, at least 3 months should have passed since end of the study.
Exclusion Criteria:
- Current aspiration pneumonia
- Known genetic disease
- History of hypersensitivity reaction to any study drugs pertinent to the study
- Patient with severe convulsion disease who has clinical convulsion despite combination therapy with 3 or more agents
- Uncontrolled hypertension defined as systolic blood pressure >115 mmHg and/or diastolic blood pressure >70 mmHg
- Hepatic impairment defined as asparate aminotransferase (AST) >55 IU/L and/or alanine aminotrasferase (ALT) >45 IU/L
- Renal impairment defined as creatinine (Cr) ≥1.3 mg/dL
- Presence of diagnosed or suspected malignant tumor and/or hematologic malignancy
- Non-compliance with study visits specified in the protocol or poor compliance of care-giver.
- Any factors not specified above that the principal investigator determines medically inadequate for participation in this study.
Sites / Locations
- CHA Bundang Medical Center
Arms of the Study
Arm 1
Experimental
allogeneic cord blood transplantation
Intravenous(IV) infusion will be done by the following method A. After 4 hours of fasting, subjects will be sedated with chloral hydrate (Pocral®) syrup B. Intravenous infusion will be conducted in stem cell center, CHA Bundang Medical Center and the therapy will be performed by the Principal Investigator or a physician delegated from the Principal Investigator. The physician conducting the infusion will not participate in the efficacy and result analysis of this study. C. Oxygen saturation will be monitored during therapy.