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

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

Status
UNKNOWN
Phases
Early Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02853942
Enrollment
100
Registered
2016-08-03
Start date
2016-10-31
Completion date
2017-12-31
Last updated
2016-08-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Injury of Facial Nerve, Unspecified Side, Initial Encounter

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.

Interventions

BIOLOGICALAutologous adipose stem cell therapy

Sponsors

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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;

Design outcomes

Primary

MeasureTime frame
House-Brackmann facial nerve grading scaleup to 3 months

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026