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

Shanghai Jiao Tong University

Status and phase: Unknown; Early Phase 1

Conditions: Injury of Facial Nerve, Unspecified Side, Initial Encounter

Treatments: Biological: Autologous adipose stem cell therapy; Drug: Mecobalamin

Study type: Interventional

Funder types: Other

Identifiers

NCT02853942

XH-16-012

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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;

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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100 participants in 2 patient groups

Stem cell therapy group

Experimental group

Description:

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.

Treatment:

Biological: Autologous adipose stem cell therapy

Drug: Mecobalamin

Neurotrophic drugs treatment group

Experimental group

Description:

Patients were treated with routine drug therapy，do not inject stem cell to the facial nerve of patient

Treatment:

Drug: Mecobalamin