Safety and Efficacy of Combined Administration of Erythropoietin in Umbilical Cord Blood Therapy for Stroke Patients
试验速览
- 阶段
- 1 期
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Change of Functional Independence Measure
研究概览
简要总结
This clinical trial is a clinical trial for the evaluation of the safety and efficacy of umbilical cord blood (UCB) therapy, UCB and erythropoietin (EPO) combination therapy in adult stroke patients.
详细描述
UCB is a high-quality source of mesenchymal stem cells, and studies are being actively developed for stroke patients. UCB therapy has a neuroprotective effect through anti-inflammatory effect and anti-apoptosis.
However, UCB alone has not been able to provide sufficient improvement and is being studied for combination therapies with growth factors that can exert its effects. Among the various growth factors, EPO is a powerful factor that can act as a neurotrophic factor in neurons, astrocytes, oligodendrocytes, microglia, endothelial cells, and neural stem/precursor cells.
In our previous study of subacute stroke animal models, investigators confirmed that the combined administration of UCB and EPO improved the behavioral assessment (mNSS, Cylinder test) compared to UCB only administration.
The aim of this study is to investigate the difference in therapeutic effects between UCB alone therapy and UCB and EPO combination 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
- •Adult patients over 20 years old
- •Patients with a stroke lasting from 30 days to less than 9 months
- •After hearing and fully understanding the details of this clinical trial, the person or legal representative has agreed to voluntary participation and has agreed in writing to comply with the notice
排除标准
- •Patients with one or more of the following can not participate in the study.
- •Patients with uncontrolled hypertension
- •A person who has impaired ability of consent, who is not accompanied by a guardian
- •Women who are pregnant, lactating, have a pregnancy plan during the trial, or those who do not use an available contraceptive method (women of childbearing age must be negative in the pregnancy test on baseline visit (0 weeks) .)
- •Those who satisfy the following conditions
- •A person whose ALT / AST is measured at 120 IU / L or more
- •Serum creatinine greater than 1.8 mg / dL
- •Total bilirubin> 1.8 mg / dL
- •Total WBC count less than 3000 / mm3
- •Those with a Hb of 16 g / dL or more
- •Platelet count less than 150,000 / uL or more than 675,000 / uL
- •Clinically significant infections during the screening period (pneumonia, pyelonephritis, sepsis, etc.)
- •Persons with severe medical conditions such as cardiovascular, digestive, respiratory, and endocrine conditions.
- •Any kind of confirmed congenital or acquired immune deficiency syndrome
- •Those who have been diagnosed with malignant carcinoma (excluding complete remission for more than 10 years)
- •If participants have side effects on your medication [Regarding erythropoietin agent]
- •Patients with hypersensitivity to erythropoietin
- •Patients sensitive to mammalian cell-derived drugs or human albumin
- •epileptic patients
- •Patients with a history of seizures
- •Patients on a thrombolytic drug (meaning thrombolytic agent such as Tissue Plasminogen Activator, allowing anti-platelet agents such as aspirin and plavix) [Related to tacrolimus] Patients with hypersensitivity to tacrolimus or macrolide compounds
- •Patients receiving cyclosporine or bosentan
- •Patients receiving potassium-preserving diuretics
- •Other If the investigator determines that participation in this trial is not appropriate
研究组 & 干预措施
UCB infusion and EPO injection group
Take immunosuppressant agents for 1 week. Umbilical cord blood is administered in the treatment room. Afterward, the venous erythropoietin agent injects into the peripheral vein 5 times a total of 5 times a week.
干预措施: Placebo umbilical cord blood infusion (Drug)
UCB infusion and EPO injection group
Take immunosuppressant agents for 1 week. Umbilical cord blood is administered in the treatment room. Afterward, the venous erythropoietin agent injects into the peripheral vein 5 times a total of 5 times a week.
干预措施: Placebo erythropoietin injection (Drug)
UCB infusion and EPO injection group
Take immunosuppressant agents for 1 week. Umbilical cord blood is administered in the treatment room. Afterward, the venous erythropoietin agent injects into the peripheral vein 5 times a total of 5 times a week.
干预措施: Active rehabilitation (Procedure)
UCB infusion and placebo EPO injection group
Take immunosuppressant agents for 1 week. Umbilical cord blood is administered in the treatment room. Afterward, the venous erythropoietin placebo injects into the peripheral vein 5 times a total of 5 times a week.
干预措施: Umbilical cord blood infusion (Drug)
UCB infusion and placebo EPO injection group
Take immunosuppressant agents for 1 week. Umbilical cord blood is administered in the treatment room. Afterward, the venous erythropoietin placebo injects into the peripheral vein 5 times a total of 5 times a week.
干预措施: Placebo erythropoietin injection (Drug)
UCB infusion and placebo EPO injection group
Take immunosuppressant agents for 1 week. Umbilical cord blood is administered in the treatment room. Afterward, the venous erythropoietin placebo injects into the peripheral vein 5 times a total of 5 times a week.
干预措施: Active rehabilitation (Procedure)
Placebo UCB infusion and placebo EPO injection group
Take immunosuppressant placebo for 1 week with the same schedule as the experimental group. As in the experimental group, placebo umbilical cord blood is administered in the treatment room and stay in the treatment room for the same time. Afterward, the venous erythropoietin placebo injects into the peripheral vein 5 times a total of 5 times a week. Other inspection schedules proceed with other groups.
干预措施: Umbilical cord blood infusion (Drug)
Placebo UCB infusion and placebo EPO injection group
Take immunosuppressant placebo for 1 week with the same schedule as the experimental group. As in the experimental group, placebo umbilical cord blood is administered in the treatment room and stay in the treatment room for the same time. Afterward, the venous erythropoietin placebo injects into the peripheral vein 5 times a total of 5 times a week. Other inspection schedules proceed with other groups.
干预措施: Erythropoietin injection (Drug)
Placebo UCB infusion and placebo EPO injection group
Take immunosuppressant placebo for 1 week with the same schedule as the experimental group. As in the experimental group, placebo umbilical cord blood is administered in the treatment room and stay in the treatment room for the same time. Afterward, the venous erythropoietin placebo injects into the peripheral vein 5 times a total of 5 times a week. Other inspection schedules proceed with other groups.
干预措施: Active rehabilitation (Procedure)
结局指标
主要结局
Change of Functional Independence Measure
时间窗: baseline - 3 months - 6 months
The difference in the FIM (Functional Independence Measure)score between the three groups at baseline, 90 days, and 180 days was confirmed by comparing differences in scores (total score\[18\~126\], motor score\[13\~90\], and cognition score\[5\~35\]. The total score is the sum of the motor score and the cognition score. The higher scores represent a better outcome )
次要结局
- Change of Manual Function Test(baseline - 3 months - 6 months)
- Change of Fugl-Meyer Assessment(baseline - 3 months - 6 months)
- Change of Berg Balance Scale(baseline - 3 months - 6 months)
- Change of Trunk Imbalance Scale(baseline - 3 months - 6 months)
- Change of Medical research council(baseline - 3 months - 6 months)
- Change of National Institutes of Health Stroke Scale(baseline - 3 months - 6 months)
- Change of Korean Mini Mental State Exam(baseline - 3 months - 6 months)
- Change of Korean Wechsler adult intelligence scale-IV(baseline - 3 months - 6 months)
- Change of Korean version of the Western Aphasia Battery(baseline - 3 months - 6 months)
- Change of Brain imaging(baseline - 6 months)
- Change of Biomarkers(baseline - 1 day - 15 days - 1 month - 3 months - 6 months)
研究者
MinYoung Kim, MD, PhD
Head of Rehabilitation Medicine Department, Professor, Principal Investigator
Bundang CHA Hospital