Outcomes Data of Adipose Stem Cells to Treat Rheumatoid Arthritis
Autologous Adipose Stromal Vascular Fraction Outcomes in Rheumatoid Arthritis Research Study
2 other identifiers
observational
50
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Jan 2015
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2015
CompletedFirst Submitted
Initial submission to the registry
January 22, 2015
CompletedFirst Posted
Study publicly available on registry
January 28, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2019
CompletedAugust 31, 2018
August 1, 2018
4.3 years
January 22, 2015
August 28, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (3)
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
Eligibility Criteria
Community Sample
You may qualify if:
- 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
You may not qualify if:
- Subjects with addition major health condition/disease diagnoses
- Subjects that are pregnant or breastfeeding
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- StemGenexlead
Study Sites (1)
StemGenex
San Diego, California, 92121, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 22, 2015
First Posted
January 28, 2015
Study Start
January 1, 2015
Primary Completion
May 1, 2019
Study Completion
May 1, 2019
Last Updated
August 31, 2018
Record last verified: 2018-08