NCT02348086|Unknown
Outcomes Data of Adipose Stem Cells to Treat Rheumatoid Arthritis
Autologous Adipose Stromal Vascular Fraction Outcomes in Rheumatoid Arthritis Research Study
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Autologous Adipose Stromal Vascular Fraction Outcomes in Rheumatoid Arthritis Research Study
Sponsor study identifier
Secondary identifiers
OTHER · StemGenex
observational
50
1 country
1
Study Start
January 2015
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
May 2019
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
May 2019
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
May 2019
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 2015
Date type not reportedThis date has not been verified as actual or estimated.
January 22, 2015
Actual (reported)January 28, 2015
Actual (reported)May 2019
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
May 2019
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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
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
Community Sample
StemGenex
San Diego, California, 92121, United States
First Submitted
January 22, 2015
First Posted
January 28, 2015
Study Start
January 2015
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
May 2019
Estimated (date passed)Curcuma Longa L in Rheumatoid Arthritis
Contact the study team to confirm eligibility.
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
May 2019
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
August 31, 2018
Record last verified: 2018-08
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Source: ClinicalTrials.gov.
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