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

Primary Purpose

Injury of Facial Nerve, Unspecified Side, Initial Encounter

Status
Unknown status
Phase
Early Phase 1
Locations
Study Type
Interventional
Intervention
Autologous adipose stem cell therapy
Mecobalamin
Sponsored by
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Injury of Facial Nerve, Unspecified Side, Initial Encounter

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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;

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    Stem cell therapy group

    Neurotrophic drugs treatment group

    Arm 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.

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

    Outcomes

    Primary Outcome Measures

    House-Brackmann facial nerve grading scale

    Secondary Outcome Measures

    Full Information

    First Posted
    July 14, 2016
    Last Updated
    August 7, 2016
    Sponsor
    Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02853942
    Brief Title
    Autologous Adipose Mesenchymal Stem Cell Transplantation in the Treatment of Patients With Hemifacial Spasm
    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 Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2016
    Overall Recruitment Status
    Unknown status
    Study Start Date
    October 2016 (undefined)
    Primary Completion Date
    October 2017 (Anticipated)
    Study Completion Date
    December 2017 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

    4. Oversight

    Data Monitoring Committee
    No

    5. 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Injury of Facial Nerve, Unspecified Side, Initial Encounter

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Early Phase 1
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    100 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Stem cell therapy group
    Arm Type
    Experimental
    Arm 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.
    Arm Title
    Neurotrophic drugs treatment group
    Arm Type
    Experimental
    Arm Description
    Patients were treated with routine drug therapy,do not inject stem cell to the facial nerve of patient
    Intervention Type
    Biological
    Intervention Name(s)
    Autologous adipose stem cell therapy
    Intervention Type
    Drug
    Intervention Name(s)
    Mecobalamin
    Primary Outcome Measure Information:
    Title
    House-Brackmann facial nerve grading scale
    Time Frame
    up to 3 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: the age of 18 ~ 80 years old; no surgical contraindications, accept facial nerve microvascular decompression surgery; to enter into the group's informed consent and sign the consent form for clinical research. patients with preoperative facial nerve electrophysiology examination without facial paralysis patients with preoperative electrical testing without hearing impairment Exclusion Criteria: patients with poor compliance; major surgical complications and interruption of treatment; brain magnetic resonance examination or blood test results abnormal and clinical significance; clinical trials of other drugs within 30 days; the unintended side effects;

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes

    Learn more about this trial

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

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