Autologous Adipose Stromal Vascular Fraction Outcomes Research Study
试验速览
- 阶段
- 不适用
- 发起方
- StemGenex
- 入组人数
- 221
- 试验地点
- 1
- 主要终点
- Change from Baseline in Overall Quality of Life Over the Course of a 12 Month Period as Measured by the Multiple Sclerosis Quality of Life Inventory (MSQLI)
研究概览
简要总结
The purpose of this study is to determine the impact that treatment with a cellular concentrate derived from an individual's own fat, known as the stromal vascular fraction (SVF), has on the quality of life of people with multiple sclerosis (MS). SVF contains components with "regenerative" properties, including stem cells that may be capable of ameliorating specific disease conditions. This study is designed to evaluate quality of life changes in individuals with MS for up to 12 months following SVF treatment.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects scheduled for a stem cell/SVF treatment
- •Subjects diagnosed with some form of multiple sclerosis
- •Subjects between the ages of 18 and 65
- •Subjects willing and able to sign informed consent
- •Subjects willing and able to perform follow up interviews and surveys
排除标准
- •Subjects for whom baseline data is not available
- •Subjects with additional major health diagnoses
- •Subjects that are pregnant or breastfeeding
结局指标
主要结局
Change from Baseline in Overall Quality of Life Over the Course of a 12 Month Period as Measured by the Multiple Sclerosis Quality of Life Inventory (MSQLI)
时间窗: Baseline, 12 months
The change from baseline over the course of 12 months using participants' assessment of their quality of life. Mean scores will be used for baseline (day 0) and all interviews up to month 12 (months 1, 3, 6, and 12). Answer options are graded on a multiple point Likert scale.
次要结局
- Change from Baseline in Overall General Quality of Life Over the Course of a 12 Month Period as Measured by the Health Status Questionnaire (SF-36)(Baseline, Month 12)
- Change from Baseline in Fatigue Over the Course of a 12 Month Period as Measured by the Modified Fatigue Impact Scale (MFIS)(Baseline, Month 12)
- Change from Baseline in Cognitive Problems Over the Course of a 12 Month Period as Measured by the Perceived Deficits Questionnaire (PDQ)(Baseline, Month 12)
- Change from Baseline in Pain and Other Sensory Symptoms Over the Course of a 12 Month Period as Measured by the MOS Pain Effects Scale (PES)(Baseline, Month 12)
- Change from Baseline in Sexual Satisfaction Over the Course of a 12 Month Period as Measured by the Sexual Satisfaction Scale (SSS)(Baseline, Month 12)
- Change from Baseline in Bladder Control Over the Course of a 12 Month Period as Measured by the Bladder Control Scale (BLCS)(Baseline, Month 12)
- Change from Baseline in Bowel Control Over the Course of a 12 Month Period as Measured by the Bowel Control Scale (BWCS)(Baseline, Month 12)
- Change from Baseline in Visual Problems Over the Course of a 12 Month Period as Measured by the Impact of Visual Impairment Scale (IVIS)(Baseline, Month 12)
- Change from Baseline in Emotional Distress Over the Course of a 12 Month Period as Measured by the Mental Health Inventory (MHI)(Baseline, Month 12)
- Change from Baseline in Social Support Over the Course of a 12 Month Period as Measured by the Modified MOS Social Support Survey (MSSS)(Baseline, Month 12)