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Clinical Trials/NCT02853942
NCT02853942
Unknown
Early Phase 1

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

Overview

Phase
Early Phase 1
Intervention
Autologous adipose stem cell therapy
Conditions
Injury of Facial Nerve, Unspecified Side, Initial Encounter
Sponsor
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Enrollment
100
Primary Endpoint
House-Brackmann facial nerve grading scale
Last Updated
9 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
October 2016
End Date
December 2017
Last Updated
9 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

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

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;

Arms & Interventions

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.

Intervention: Autologous adipose stem cell therapy

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.

Intervention: Mecobalamin

Neurotrophic drugs treatment group

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

Intervention: Mecobalamin

Outcomes

Primary Outcomes

House-Brackmann facial nerve grading scale

Time Frame: up to 3 months

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