Autologous Adipose Stromal Vascular Fraction Outcomes in Rheumatoid Arthritis Research Study
试验速览
- 阶段
- 不适用
- 发起方
- StemGenex
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Change from Baseline in Overall Rheumatoid Arthritis Disease Activity Over the Course of a 12 Month Period as Measured by the Patient Activity Scale-II (PAS-II)
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 pain and functionality in people with rheumatoid arthritis (RA). SVF contains multiple cellular components, including stem cells, with both regenerative and anti-inflammatory properties. This therapy has shown promise for ameliorating the symptoms of RA. This study is designed to evaluate changes in pain and functionality in individuals with RA 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects diagnosed with rheumatoid arthritis
- •Subjects scheduled for a stem cell/SVF treatment
- •Subjects willing and able to sign informed consent
- •Subjects willing and able to perform follow-up interviews and surveys
排除标准
- •Subjects with addition major health condition/disease diagnoses
- •Subjects that are pregnant or breastfeeding
结局指标
主要结局
Change from Baseline in Overall Rheumatoid Arthritis Disease Activity Over the Course of a 12 Month Period as Measured by the Patient Activity Scale-II (PAS-II)
时间窗: Baseline, 12 Months
The change from baseline over the course of 12 months using participants' assessment of their overall ability to be active. Mean scores will be used for baseline (day 0) and all interviews up to month 12 (months 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, and 12). Answer options are graded either according to a four point or ten point Likert response scale.
次要结局
- Change from Baseline in Overall Health at Month 12 as Measured by the Participants' Response to the Health Assessment Questionnaire-II (HAQ-II)(Baseline, Month 12)
- Change from Baseline in Overall Pain at Month 12 as Measured by Participants' Response to the Patient Activity Scale-II (PAS-II) Pain Subscale(Baseline, Month 12)
- Change from Baseline in Overall Global Activity at Month 12 as Measured by Participants' Response to the Patient Activity Scale-II (PAS-II) Global Activity Subscale(Baseline, Month 12)