An Open-label, Safety and Efficacy Assessment of Autologous Bone-marrow Derived Mesenchymal Stem Cell Therapy in Anoxic (or Hypoxic) Brain Injury.
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 4
- 试验地点
- 2
- 主要终点
- safety assessment
研究概览
简要总结
The purpose of study is to evaluate the safety and efficacy of autologous bone marrow-derived stem cells therapy in patients with anaerobic (hypoxic) brain injury. Stem cell therapy is an emerging alternative treatment modality in incurable and intractable neurological disorders. This pilot study aims to evaluate the feasibility and safety of stem cells in anaerobic brain injury.
详细描述
Various treatment modalities to minimize the neurological deficits of anoxic brain injury, including lower consciousness, abnormal movement disorders, and abnormal behavior, have been tried, but so far there have been no effective proven method for chronic patients.
This study is the investigator initiated trial to verify the safety and feasibility of stem cells therapy in patients with anoxic brain injury.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients older than 14 days after the index event occurs in an oxygen-free brain injury patients
- •Severe disability or moderate due to anoxic brain injury
- •18 years to 75 years
- •Patients was 7 points less than Glasgow coma scale (GCS) After the resumption of blood flow circulation.
- •anaerobic unexpected (hypoxic) cerebral ischemia Encephalopathy (It should not be a hypoxic brain ischemia was induced due to heart surgery, which is scheduled)
- •Subjects agreed in writing that it will be participating in clinical research, as viewed from the legal representative (patient)
排除标准
- •Patients who require ventilator continued
- •Patients who had extracorporeal membrane oxygenation(ECMO) index event occurs at the time
- •Patients who had a history of cardiac arrest prior to the occurrence of Index event
- •End-stage people of less than 12 months is expected (incurable) disease patients
- •Patients with cardiac arrest occurred due to brain trauma severe
- •Patients with damage to other organs of severe
- •Patients with bleeding or malignant current
- •Pregnant patient
- •Patients with central nervous system tumors undergoing radiation therapy or chemotherapy
- •If the patient or are participating in other clinical trials, you are planning to participate, or patients three months after the end is not passed to participate in other clinical trials
研究组 & 干预措施
Single arm
Experimental: HYNR-CS inj.
Treatment group with HYNR-CS inj.
干预措施: HYNR-CS inj. (Biological)
结局指标
主要结局
safety assessment
时间窗: week 1, 3, 4, 5, 7
Each visit physical examination, neurological examination, and adverse reactions through the follow-up to the expression of new symptoms. week 1,3,5,7 conducted Hematological week 4,7 conducted MRI, PET
次要结局
- Glasgow Coma Scale(GCS)(Week 1, 4, 5, 6, 7)
- Cerebral Performance Category(CPC)scale(Week 1, 4, 5, 6, 7)
- FOUR score(Week 1, 4, 5, 6, 7)
- Functional Independence Measure(FIM)(Week 1, 4, 5, 6, 7)
- Disability Rating Scale(DRS)(Week 1, 4, 5, 6, 7)
研究者
Hyun Young Kim
seong joon kwon
Hanyang University Seoul Hospital