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
About this trial
This is an interventional treatment trial for Injury of Facial Nerve, Unspecified Side, Initial Encounter
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;
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
NCT ID
NCT02853942
First Posted
July 14, 2016
Last Updated
August 7, 2016
Sponsor
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
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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