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

August 7, 2016 updated by: Shiting Li, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

The Research of Autologous Adipose Mesenchymal Stem Cell Transplantation for Treatment of Facial 、Auditory Nerve Dysfunction of Patients With Hemifacial Spasm After Microvascular Decompression.

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Early Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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.
Drug: Mecobalamin
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
Drug: Mecobalamin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
House-Brackmann facial nerve grading scale
Time Frame: up to 3 months
up to 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2016

Primary Completion (Anticipated)

October 1, 2017

Study Completion (Anticipated)

December 1, 2017

Study Registration Dates

First Submitted

July 14, 2016

First Submitted That Met QC Criteria

July 31, 2016

First Posted (Estimate)

August 3, 2016

Study Record Updates

Last Update Posted (Estimate)

August 9, 2016

Last Update Submitted That Met QC Criteria

August 7, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • XH-16-012

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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