The Research of Autologous Adipose Mesenchymal Stem Cell Transplantation for Treatment of Facial 、Auditory Nerve Dysfunction of Patients With Hemifacial Spasm After Microvascular Decompression.
试验速览
- 阶段
- 早期 1 期
- 入组人数
- 100
- 主要终点
- House-Brackmann facial nerve grading scale
研究概览
简要总结
Main purpose:In the face of listening to nerve injury at early stage, utilizing autologous adipose stem cell transplantation in the treatment of makes the acceptance micro vascular decompression hemifacial spasm patients to nerve function to obtain a better recovery.
Secondary purpose :To clarify the efficacy of stem cells in the treatment of cranial nerve dysfunction, and to provide evidence for the treatment of other cranial nerve dysfunction.
Cases in group:Appearing on the surface of microvascular decompression for hemifacial spasm to decrease neural electrophysiological index of patients research design:Single center, prospective, randomized, double-blind, controlled Observation index:Facial nerve clinical score, facial nerve muscle compound action potential, electrical measurement, cerebrospinal fluid index Evaluation of therapeutic effect:Facial nerve function evaluation (House-Brackmann classification, facial nerve function classification scale SFGS), facial nerve electrophysiology evaluation (facial nerve muscle compound action potential), electric measurement Safety evaluation:Clear evaluation of hemifacial spasm and micro vascular decompression were listening to nerve in intracranial segment wrapped around the autologous fat stem cell therapy overall safety and evaluation methods including adverse events, laboratory tests, vital signs, electrocardiogram.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 80 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •the age of 18 ~ 80 years old;
- •no surgical contraindications, accept facial nerve microvascular decompression surgery;
- •to enter into the group's informed consent and sign the consent form for clinical research.
- •patients with preoperative facial nerve electrophysiology examination without facial paralysis
- •patients with preoperative electrical testing without hearing impairment
排除标准
- •patients with poor compliance;
- •major surgical complications and interruption of treatment;
- •brain magnetic resonance examination or blood test results abnormal and clinical significance;
- •clinical trials of other drugs within 30 days;
- •the unintended side effects;
研究组 & 干预措施
Stem cell therapy group
Using the international standard 14G (diameter 1.54mm) needle inject autologous adipose derived mesenchymal stem cells 2ml to facial nerve, the effective release of the concentration is 100 million stem cells / ml.
干预措施: Autologous adipose stem cell therapy (Biological)
Stem cell therapy group
Using the international standard 14G (diameter 1.54mm) needle inject autologous adipose derived mesenchymal stem cells 2ml to facial nerve, the effective release of the concentration is 100 million stem cells / ml.
干预措施: Mecobalamin (Drug)
Neurotrophic drugs treatment group
Patients were treated with routine drug therapy,do not inject stem cell to the facial nerve of patient
干预措施: Mecobalamin (Drug)
结局指标
主要结局
House-Brackmann facial nerve grading scale
时间窗: up to 3 months
次要结局
未报告次要终点
研究者
Shiting Li
Office of clinical research of Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
