Injury of Facial Nerve, Unspecified Side, Initial Encounter Clinical Trial
Official title:
The Research of Autologous Adipose Mesenchymal Stem Cell Transplantation for Treatment of Facial 、Auditory Nerve Dysfunction of Patients With Hemifacial Spasm After Microvascular Decompression.
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.
Status | Not yet recruiting |
Enrollment | 100 |
Est. completion date | December 2017 |
Est. primary completion date | October 2017 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 80 Years |
Eligibility |
Inclusion Criteria: 1. the age of 18 ~ 80 years old; 2. no surgical contraindications, accept facial nerve microvascular decompression surgery; 3. to enter into the group's informed consent and sign the consent form for clinical research. 4. patients with preoperative facial nerve electrophysiology examination without facial paralysis 5. patients with preoperative electrical testing without hearing impairment Exclusion Criteria: 1. patients with poor compliance; 2. major surgical complications and interruption of treatment; 3. brain magnetic resonance examination or blood test results abnormal and clinical significance; 4. clinical trials of other drugs within 30 days; 5. the unintended side effects; |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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Xinhua Hospital, Shanghai Jiao Tong University School of Medicine |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | House-Brackmann facial nerve grading scale | up to 3 months | Yes |