Outcomes Data of Adipose Stem Cells to Treat Rheumatoid Arthritis
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02348086|
Recruitment Status : Unknown
Verified August 2018 by StemGenex.
Recruitment status was: Recruiting
First Posted : January 28, 2015
Last Update Posted : August 31, 2018
- Study Details
- Tabular View
- No Results Posted
- How to Read a Study Record
|Condition or disease|
|Study Type :||Observational|
|Estimated Enrollment :||50 participants|
|Official Title:||Autologous Adipose Stromal Vascular Fraction Outcomes in Rheumatoid Arthritis Research Study|
|Study Start Date :||January 2015|
|Estimated Primary Completion Date :||May 2019|
|Estimated Study Completion Date :||May 2019|
- 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.
- Change from Baseline in Overall Health at Month 12 as Measured by the Participants' Response to the Health Assessment Questionnaire-II (HAQ-II) [ Time Frame: Baseline, Month 12 ]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.
- Change from Baseline in Overall Pain at Month 12 as Measured by Participants' Response to the Patient Activity Scale-II (PAS-II) Pain Subscale [ Time Frame: Baseline, Month 12 ]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.
- 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 [ Time Frame: Baseline, Month 12 ]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.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
|Sampling Method:||Non-Probability Sample|
- 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
- Subjects with addition major health condition/disease diagnoses
- Subjects that are pregnant or breastfeeding
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02348086
|Contact: Holly Bergen||800-609-7795|
|United States, California|
|San Diego, California, United States, 92121|
|Other Study ID Numbers:||
ASCRA-01 ( Other Identifier: StemGenex )
|First Posted:||January 28, 2015 Key Record Dates|
|Last Update Posted:||August 31, 2018|
|Last Verified:||August 2018|
Connective Tissue Diseases
Immune System Diseases