Safety and Efficacy Investigation of Patients With Hypoxic Ischemic Encephalopathy by Transplantation of Umbilical Cord Derived Mesenchymal Stem Cells
试验速览
- 阶段
- 1 期
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- National Institutes of Health Stroke Scale (NIHSS) scores.
研究概览
简要总结
This study is to evaluate the safety and efficacy of Umbilical Cord Derived Mesenchymal Stem Cells transplantation in hypoxic ischemic encephalopathy.
详细描述
To date,hypoxic ischemic encephalopathy is refractory, including after carbon monoxide poisoning, cardiopulmonary resuscitation,hemorrhagic shock and cerebral infarction etc. We used Mesenchymal Stem Cells via portal vein infusion method to treat hypoxic ischemic encephalopathy. With different durations of follow-up, we cleared therapeutic effect, the quality of life and prognostic implications of the cord blood stem cell infusion on hypoxic ischemic encephalopathy, and evaluated the adverse reactions, through the neurological function score (NIHSS，Barthel Index), cognitive score (MoCA, MMSE),and the international uniform Parkinson Rating Scale score (UPDRS). Here, we seek new means for the treatment of hypoxic ischemic encephalopathy, and provide the basis for clinical for further application of umbilical cord blood derived Mesenchymal stem cells.
On the basis of conventional therapy, at the same time, selected patients were given by intravenous infusion of umbilical cord blood stem cells 100-800 million. All patients before treatment, after treatment for 15days, 90days and 180 days were evaluated respectively the curative effect. The neurological function score (NIHSS score, Barthel Index) was observed in patients with the ability to live independently and prognosis; MoCA, MMSE were used in the evaluation of cognitive function ；UPDRS was used in the evaluation of extrapyramidal tract function.
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
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients are screened foe enrollment in the study if both clinal signs and laboratory tests meet the diagnosis standards recommended by International Classification of Diseases-10 about hypoxic ischemic encephalopathy.
排除标准
- •Exclusion Criteria are any clinically significant diseases in liver,kidney,and heart. additional exclusion criteria are no pregnancy,no immunosuppressive medication, no tumor, no viral diseases or diseases associated with immunodeficiency.
研究组 & 干预措施
mesenchymal stem cells
Umbilical Cord Derived Mesenchymal Stem Cells at a dose of 100-800 million by intravenous infusion
干预措施: mesenchymal stem cells (Biological)
结局指标
主要结局
National Institutes of Health Stroke Scale (NIHSS) scores.
时间窗: 180 days
The NIHSS is a systematic assessment tool that provides a quantitative measure of stroke-related neurologic deficit. Values range from 0 (no deficit) to 42 (dead).
次要结局
- The Barthel Index(before treatment and post cell transplantation:15,90,180 days)
- The Mini-Mental State Examination (MMSE)(before treatment and post cell transplantation:15,90,180 days)
- The Montreal Cognitive Assessment(MoCA)(before treatment and post cell transplantation:15,90,180 days)
- Unified Parkinson's Disease Rating Scale (UPDRS)(before treatment and post cell transplantation:15,90,180 days.)
- adverse reaction(post cell transplantation:15,90,180 days)
研究者
Quanhai Li
Director of Cell Thearpy Center, the First Hospital of HeibeiMU
Hebei Medical University