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

Injury of Facial Nerve, Unspecified Side, Initial Encounter Clinical Trial

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.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02853942
• Other study ID #: XH-16-012
• Status: Not yet recruiting
• Phase: Phase 0
• First received: July 14, 2016
• Last updated: August 7, 2016
• Start date: October 2016
• Est. completion date: December 2017

Study information

• Verified date: August 2016
• Source: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: National Health and Family Planning Commission
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: December 2017
• Est. primary completion date: October 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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;

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Facial Nerve Injuries
• Hemifacial Spasm
• Injury of Facial Nerve, Unspecified Side, Initial Encounter

Intervention

Biological:
• Autologous adipose stem cell therapy

Drug:
• Mecobalamin

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	House-Brackmann facial nerve grading scale		up to 3 months	Yes