The Use of Exosomes In Craniofacial Neuralgia
试验速览
- 阶段
- 不适用
- 状态
- 暂停
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Brief Pain Inventory (BPI)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or Female at least 18 years of age
- •Clinical diagnosis of craniofacial neuralgia
排除标准
- •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
结局指标
主要结局
Brief Pain Inventory (BPI)
时间窗: 8 weeks from baseline
The BPI is a 9 item self-report questionnaire used to evaluate the severity of a patient's pain and the impact of this pain on the patient's daily functioning. Self-report measure containing a composite pain score and functional interference score. The pain subscale contains 4 questions, each with answers ranging from 0 'no pain' to 10 'pain as bad as you can imagine.' Total possible score for the pain subscale is 40 points. The functional/interference subscale contains 7 questions, with each answer ranging from 0 'does not interfere' to 10 'completely interferes.' The maximum possible score for the interference subscale is 70 points. The total overall composite BPI score is out of 100 maximum points. A clinical improvement is considered a decrease in BPI overall composite score by at least 30% from baseline.
Patient Health Questionnaire (PHQ-9)
时间窗: 8 weeks from baseline
The Patient Health Questionnaire (PHQ) is a self-administered version of the PRIME-MD diagnostic instrument for common mental disorders. The PHQ-9 is the depression module, which scores each of the 9 DSM-IV criteria as "0" (not at all) to "3" (nearly every day). Total possible score is 27 points. A clinical improvement is considered a decrease in BPI overall composite score by at least 30% from baseline.
Adverse Event Reporting
时间窗: Baseline to 24 weeks
Adverse events (AEs) and any other untoward signs or symptoms were collected at each study timepoint starting at the treatment injection. Serious adverse events (SAEs) determined by the investigator to be related to the study treatment were formally recorded.
次要结局
- Global Rating of Change (GRC)(8 weeks from baseline)
- Patient Health Questionnaire (PHQ-9)(24 weeks from baseline)
- Brief Pain Inventory (BPI)(24 weeks from baseline)