NCT04202783

The Use of Exosomes In Craniofacial Neuralgia

• Status: Suspended
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Neurological Associates of West Los Angeles · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Neuralgia

Interventions

Type	Name	Description
OTHER	Exosomes	Focused ultrasound delivery of intravenously-infused exosomes

Timeline

• Start date: 2023-12-01
• Primary completion: 2024-12-01
• Completion: 2024-12-01
• First posted: 2019-12-18
• Last updated: 2022-09-28

Locations

1 site across 1 country: United States