Autologous Adipose Stromal Vascular Fraction Outcomes in Rheumatoid Arthritis Research Study
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Rheumatoid Arthritis
- Sponsor
- StemGenex
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- 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)
- Last Updated
- 7 years ago
Overview
Brief Summary
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •Subjects with addition major health condition/disease diagnoses
- •Subjects that are pregnant or breastfeeding
Outcomes
Primary Outcomes
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)
Time Frame: 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.
Secondary Outcomes
- 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)