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

Early Phase 1

• Conditions: Injury of Facial Nerve, Unspecified Side, Initial Encounter
• Interventions: Biological: Autologous adipose stem cell therapy; Drug: Mecobalamin

• Registration Number: NCT02853942
• Lead Sponsor: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-07-14
• Study First Submitted QC: 2016-07-31
• Status Verified: 2016-08
• Study First Posted: 2016-08-03
• Last Update Submitted: 2016-08-07
• Last Update Posted: 2016-08-09
• Study Start: 2016-10
• Primary Completion: 2017-10
• Study Completion: 2017-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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;

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Stem cell therapy group	Autologous adipose stem cell therapy	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.
Stem cell therapy group	Mecobalamin	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.
Neurotrophic drugs treatment group	Mecobalamin	Patients were treated with routine drug therapy，do not inject stem cell to the facial nerve of patient

Primary Outcome Measures

Name	Time	Method
House-Brackmann facial nerve grading scale	up to 3 months