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临床试验/NCT02853942
NCT02853942Unknown早期 1 期

The Research of Autologous Adipose Mesenchymal Stem Cell Transplantation for Treatment of Facial 、Auditory Nerve Dysfunction of Patients With Hemifacial Spasm After Microvascular Decompression.

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine0 个研究点目标入组 100 人开始时间: 2016年10月最近更新:
适应症
干预措施
相关药物

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

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

Experimental

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

Experimental

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

Experimental

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

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

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