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

• Sponsor: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT02853942
• Collaborator: (none)
• Enrollment: 100
• Arms: 2
• Duration (Months): 14

Study Details

Study Description

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.

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 100 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• 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: Oct 1, 2016
• Anticipated Primary Completion Date: Oct 1, 2017
• Anticipated Study Completion Date: Dec 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
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; Drug: Mecobalamin
Experimental: Neurotrophic drugs treatment group Patients were treated with routine drug therapy，do not inject stem cell to the facial nerve of patient	Drug: Mecobalamin

Outcome Measures

Primary Outcome Measures

1. House-Brackmann facial nerve grading scale [up to 3 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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;

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Shiting Li, Office of clinical research of Xinhua Hospital, Shanghai Jiao Tong University School of Medicine, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
• ClinicalTrials.gov Identifier: NCT02853942
• Other Study ID Numbers: XH-16-012
• First Posted: Aug 3, 2016
• Last Update Posted: Aug 9, 2016
• Last Verified: Aug 1, 2016

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Additional relevant MeSH terms: Hemifacial Spasm; Facial Nerve Injuries

Study Results

No Results Posted as of Aug 9, 2016