Clinical trial NCT04202783: The Use of Exosomes In Craniofacial Neuralgia
Official title: The Use of Exosomes In Craniofacial Neuralgia
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: NA
Conditions: Neuralgia
Lead sponsor: Neurological Associates of West Los Angeles
Sponsor class: OTHER
First posted: 2019-12-18
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: The present study is being undertaken as an open label study to evaluate the safety and feasibility of exosomes as an intervention for patients with craniofacial neuralgia. Baseline and outcome measures in this study utilize validated tests that are appropriate for repeated measures. The present study can be easily implemented because the neuropsychological testing instruments have been in routine clinical deployment providing for a high degree of availability and reliability. Quality assurance is tightly controlled. The study population is sufficiently broad and the conditions of interest are sufficiently prevalent so that recruitment of subjects is not a limiting factor.
Primary purpose: TREATMENT

Brief summary: This study is designed to evaluate the safety and efficacy of exosome deployment in patients with Craniofacial Neuralgia. Secondarily, this study is designed to rigorously evaluate for any adverse events that may be related to the administration and reception of exosomes.

Detailed description: The present study is designed to amplify the delivery of growth factors and anti-inflammatory agents to localized targets (determined by specific condition) by using focused transcranial ultrasound prior to intravenous infusion of exosomes. Exosomes delivered intravenously can be demonstrated to cross the blood brain barrier naturally. Exosomes are thought to play a normal physiological role in intercellular signaling, and demonstrate anti-inflammatory and pro-growth effects in preclinical models and clinical cases reports. Clinical trials have deployed exosomes intravenously and with intracerebral and intrathecal injection, and have claimed safety and clinical efficacy.

Focused ultrasound has been shown to enhance local blood flow and has been presented as a non-invasive means of targeting delivery of therapeutic agents.

Eligibility criteria: Inclusion Criteria:

* Male or Female at least 18 years of age
* Clinical diagnosis of craniofacial neuralgia

Exclusion Criteria:

* Subjects unable to give informed consent
* Subjects who would not be able to lay down without excessive movement in a calm environment sufficiently long enough to be able to achieve sleep
* Recent surgery or dental work within 3 months of the scheduled procedure.
* Pregnancy, women who may become pregnant or are breastfeeding
* Advanced terminal illness
* Any active cancer or chemotherapy
* Bone marrow disorder
* Myeloproliferative disorder
* Sickle cell disease
* Primary pulmonary hypertension
* Immunocompromising conditions and/or immunosuppressive therapies
* Macular degeneration
* Subjects with scalp rash or open wounds on the scalp (for example from treatment of squamous cell cancer)
* Advanced kidney, pulmonary, cardiac or liver failure
* Subjects with vascular causes of dementia
* Bleeding disorder, untreated

Primary outcomes:
measure: Brief Pain Inventory (BPI)
timeFrame: 8 weeks from baseline
measure: Patient Health Questionnaire (PHQ-9)
timeFrame: 8 weeks from baseline
measure: Adverse Event Reporting
timeFrame: Baseline to 24 weeks
Secondary outcomes:
measure: Global Rating of Change (GRC)
timeFrame: 8 weeks from baseline
measure: Brief Pain Inventory (BPI)
timeFrame: 24 weeks from baseline
measure: Patient Health Questionnaire (PHQ-9)
timeFrame: 24 weeks from baseline
Other outcomes:
Locations:
city: Santa Monica
country: United States
facility: Neurological Associates of West LA
state: California
Study officials:
affiliation: Neurological Associates of West Los Angeles
name: Sheldon Jordan, MD
role: PRINCIPAL_INVESTIGATOR
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