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

NCT02853942 | Unknown Early Phase 1

• 1 other identifier: XH-16-012
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Injury of Facial Nerve, Unspecified Side, Initial Encounter

Outcome Measures

Primary Outcomes (1)

• House-Brackmann facial nerve grading scale

  up to 3 months

Study Arms (2)

Stem cell therapy group

EXPERIMENTAL

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

Neurotrophic drugs treatment group

EXPERIMENTAL

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

Drug: Mecobalamin

Interventions

Autologous adipose stem cell therapy BIOLOGICAL

Stem cell therapy group

Mecobalamin DRUG

Neurotrophic drugs treatment group; Stem cell therapy group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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;

Sponsors & Collaborators

• Xinhua Hospital, Shanghai Jiao Tong University School of Medicine: lead

MeSH Terms

Conditions

Facial Nerve Injuries

Interventions

mecobalamin

Condition Hierarchy (Ancestors)

Facial Nerve Diseases; Mouth Diseases; Stomatognathic Diseases; Cranial Nerve Injuries; Cranial Nerve Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Office of clinical research of Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Study Record Dates

• First Submitted: July 14, 2016
• First Posted: August 3, 2016
• Study Start: October 1, 2016
• Primary Completion: October 1, 2017
• Study Completion: December 1, 2017
• Last Updated: August 9, 2016

Record last verified: 2016-08

Data Sharing

• IPD Sharing: Will share