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 个研究点目标入组 120 人开始时间: 待定最近更新: 2019年3月11日

适应症

试验速览

暂无简介。

•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

•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

发起方

Bundang CHA General Hospital