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

NCT ID: NCT02853942

Last Updated: 2016-08-09

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-10-31
• Study Completion Date: 2017-12-31

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.

Conditions

Injury of Facial Nerve, Unspecified Side, Initial Encounter

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Autologous adipose stem cell therapy

Intervention Type: BIOLOGICAL

Mecobalamin

Intervention Type: DRUG

Neurotrophic drugs treatment group

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

Group Type: EXPERIMENTAL

Mecobalamin

Intervention Type: DRUG

Interventions

Autologous adipose stem cell therapy

Intervention Type: BIOLOGICAL

Mecobalamin

Intervention Type: DRUG

Eligibility Criteria

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;

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Shiting Li

Office of clinical research of Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

XH-16-012

Identifier Type: -

Identifier Source: org_study_id