An observational study in Rheumatoid Arthritis, sponsored by StemGenex. Status unknown at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-08-31.
Sponsored by StemGenex · Observational
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.
3,554 studies on the registry are indexed under Arthritis; 317 are open to participants now.
This study's planned enrollment of 50 is below the median of 155 across 1,057 observational studies indexed under Arthritis.
Browse Arthritis studies →StemGenex is the lead sponsor of 5 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Community Sample
Exclusion Criteria:
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.
Time frame: Baseline, 12 Months
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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline, Month 12
This study is status unknown, as verified in Aug 2018. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
StemGenex