Outcomes Data of Adipose Stem Cells to Treat Rheumatoid Arthritis

Study Overview
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Brief Summary
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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.

Official Title
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Autologous Adipose Stromal Vascular Fraction Outcomes in Rheumatoid Arthritis Research Study

Conditions
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Rheumatoid Arthritis

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 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. | Baseline, 12 Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline in Overall Health at Month 12 as Measured by the Participants' Response to the Health Assessment Questionnaire-II (HAQ-II) | Participant assessment of the change in their overall health from baseline to month 12 using the HAQ-II. Answer options are given as a four point Likert response scale. | 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 | Participant assessment of the change in their overall pain from baseline to month 12 using the PAS-II pain subscale. Answer options are given as a ten point Likert response scale. | 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 | Participant assessment of the change in their overall global activity from baseline to month 12 using the PAS-II global activity subscale. Answer options are given as a ten point Likert response scale. | Baseline, Month 12 |