KCT0000950
Recruiting
未知
Safety and Efficacy of Allogeneic Umbilical Cord Blood Therapy Combined With Erythropoietin in Children With Cerebral Palsy: a Double-blind, Randomized, Placebo-controlled Clinical Trial
Bundang CHA General Hospital0 sites120 target enrollmentTBD
ConditionsDiseases of the nervous system
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Diseases of the nervous system
- Sponsor
- Bundang CHA General Hospital
- Enrollment
- 120
- Status
- Recruiting
- Last Updated
- 7 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Not specified
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