Establishment of Clinical Basis for Hematopoietic Growth Factors Therapy in Brain Injury
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Chest and Heart Evaluation
研究概览
简要总结
The purpose of our study is to determine the safety and efficacy of the combination of erythropoietin (EPO) and granulocyte-colony stimulating factors (G-CSF) in patients with neurological diseases. To be specific, our clinical study is expected that the combination injection of EPO and G-CSF shows neurotrophic and neuroprotective effects by facilitating endogenous repair process in patients with neurological diseases including stroke, cerebral palsy, or atypical parkinsonism. Therefore, we will apply our original treatment technique in patients with neurological diseases, which is expected to overcome current ethical and technical limitations of less evidenced functional recovery, hematological changes, and side effects. Eventually, We will establish a comprehensive clinical background about neurotrophic and neuroprotective effects of this hematopoietic growth factors therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Over 20 years old
- •Voluntary participants
- •Neurological diseases including stroke, cerebral palsy, or atypical parkinsonism, at least 3 months after their onset
- •Participants who got previous EPO+GCSF injection at least 6 months ago.
排除标准
- •Under 20 years old
- •Participants who can not voluntarily consent
- •Encephalopathy including brain tumor and infection
- •Warfarin (coumadin) medications
- •Leukopenia, Thrombocytopenia, Polycythemia
- •Malignant diseases, Malignant hypertension, Myeloproliferative disorder, Septic embolism, Hyperkalemia
- •Hepatic or Renal dysfunction, Serum creatinine>3mg/dl
- •Allergic reactions against to exogenous EPO and G-CSF
- •Involved in a exclusion criteria for MRI test
- •A women who is pregnant or on breast feeding
- •Body temperature over 38°C
- •Blood pressure over 140/90 mmHg at pre-treatment
- •Blood pressure over 160/100 mmHg during intervention
- •Hb > 15 g/dL at pre-treatment
- •Hb > 17 g/dL during intervention
- •Pneumonia detected by X-ray test
- •Recurrent history of aspiration pneumonia
研究组 & 干预措施
Intervention
Intervention Group
干预措施: Combination injection of EPO and G-CSF (Drug)
Control
Control Group
干预措施: Injection of normal saline (Drug)
结局指标
主要结局
Chest and Heart Evaluation
时间窗: at pre-treatment and 6 months after pretest
(1) Chest X-ray finding at pre-treatment and 6 months after pretest, (2) Electrocardiography finding at pre-treatment and 6 months after pretest. Chest and Heart Evaluation is tested to confirm the safety of the combination of EPO and G-CSF.
Vital Sign
时间窗: 5th day, 30th day during a cycle, and 6 months after pretest
(1) Value of Systolic and Diastolic Blood Pressure, (2) Value of Pulse Rate, (3) Value of Respiratory Rate, (4) Value of Body Temperature. Vital Sign is tested to confirm the safety of the combination of EPO and G-CSF.
Hematological Test
时间窗: 5th day, 30th day during a cycle, and 6 months after pretest
(1) Value of Complete Blood Cells at pre-treatment, 5th day, 30th day during a cycle (total three cycles), and 6 months after pretest, (2) Value of Reticulocyte at pre-treatment, 5th day, 30th day during a cycle (total three cycles), and 6 months after pretest, (3) Value of Erythrocyte Sedimentation Rate at pre-treatment, 5th day, 30th day during a cycle (total three cycles), and 6 months after pretest, (4) Value of C-Reactive Protein at pre-treatment, 5th day, 30th day during a cycle (total three cycles), and 6 months after pretest, (5) Value of Electrolyte and Routine Chemistry at pre-treatment, 5th day, 30th day during a cycle (total three cycles), and 6 months after pretest, (6) Value of Prothrombin Time and Activated Partial Thromboplastin Time at pre-treatment, 5th day, 30th day during a cycle (total three cycles), and 6 months after pretest. Hematological Test is tested to confirm the safety of the combination of EPO and G-CSF.
次要结局
- Hematological Test(5th day, 30th day during a cycle, and 6 months after pretest)
- Occupational Assessment(at pre-treatment, 3 months, and 6 months after pretest)
- Psychological Assessment(at pre-treatment and 6 months after pretest)
- Verbal Assessment(at pre-treatment and 6 months after pretest)
- Physical Assessment(at pre-treatment, 3 months, and 6 months after pretest)