Autologous Adipose Mesenchymal Stem Cell Transplantation in the Treatment of Patients With Hemifacial Spasm
|ClinicalTrials.gov Identifier: NCT02853942|
Recruitment Status : Unknown
Verified August 2016 by Shiting Li, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine.
Recruitment status was: Not yet recruiting
First Posted : August 3, 2016
Last Update Posted : August 9, 2016
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.
|Condition or disease||Intervention/treatment||Phase|
|Injury of Facial Nerve, Unspecified Side, Initial Encounter||Biological: Autologous adipose stem cell therapy Drug: Mecobalamin||Early Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|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.|
|Study Start Date :||October 2016|
|Estimated Primary Completion Date :||October 2017|
|Estimated Study Completion Date :||December 2017|
Experimental: 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.
Biological: Autologous adipose stem cell therapy
Experimental: Neurotrophic drugs treatment group
Patients were treated with routine drug therapy，do not inject stem cell to the facial nerve of patient
- House-Brackmann facial nerve grading scale [ Time Frame: up to 3 months ]