SuspendedNot Applicable

The Use of Exosomes In Craniofacial Neuralgia

Stopped: Pending COVID-19 pandemic; pending product development

United States100 participantsStarted 2023-12-01

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Brief Pain Inventory (BPI)

Timeframe: 8 weeks from baseline

Patient Health Questionnaire (PHQ-9)

Timeframe: 8 weeks from baseline

Adverse Event Reporting

Timeframe: Baseline to 24 weeks

Trial details

NCT IDNCT04202783

SponsorNeurological Associates of West Los Angeles

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-12-01

View on ClinicalTrials.gov More Neuralgia trials

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.