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

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ClinicalTrials.gov Identifier: NCT02853942
Recruitment Status : Unknown
Verified August 2016 by Shiting Li, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine.
Recruitment status was:  Not yet recruiting
First Posted : August 3, 2016
Last Update Posted : August 9, 2016
Sponsor:
Information provided by (Responsible Party):
Shiting Li, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

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

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Study Type : Interventional  (Clinical Trial)
Estimated 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 : October 2016
Estimated Primary Completion Date : October 2017
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Muscle Cramps

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



Primary Outcome Measures :
  1. House-Brackmann facial nerve grading scale [ Time Frame: up to 3 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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;
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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: August 3, 2016    Key Record Dates
Last Update Posted: August 9, 2016
Last Verified: August 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Additional relevant MeSH terms:
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Hemifacial Spasm
Facial Nerve Injuries
Mouth Diseases
Stomatognathic Diseases
Spasm
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Facial Nerve Diseases
Cranial Nerve Injuries
Cranial Nerve Diseases
Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries