Autologous Adipose Mesenchymal Stem Cell Transplantation in the Treatment of Patients With Hemifacial Spasm

Study Overview
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Brief Summary
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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.

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

Conditions
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Injury of Facial Nerve, Unspecified Side, Initial Encounter

Intervention / Treatment
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* Biological: Autologous adipose stem cell therapy
* Drug: Mecobalamin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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;

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Stem cell therapy group<br>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. | Biological: Autologous adipose stem cell therapy<br> <br> Drug: Mecobalamin<br> <br> |
| Experimental: Neurotrophic drugs treatment group<br>Patients were treated with routine drug therapy，do not inject stem cell to the facial nerve of patient | Drug: Mecobalamin<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| House-Brackmann facial nerve grading scale |  | up to 3 months |