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Trial record 2 of 4 for:    stromal vascular fraction for rheumatoid arthritis

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
Sponsor:
Information provided by (Responsible Party):
StemGenex

Tracking Information
First Submitted Date January 22, 2015
First Posted Date January 28, 2015
Last Update Posted Date August 31, 2018
Study Start Date January 2015
Estimated Primary Completion Date May 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: January 22, 2015)
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.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: January 22, 2015)
  • 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.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Outcomes Data of Adipose Stem Cells to Treat Rheumatoid Arthritis
Official Title Autologous Adipose Stromal Vascular Fraction Outcomes in Rheumatoid Arthritis Research Study
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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Community Sample
Condition Rheumatoid Arthritis
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: January 22, 2015)
50
Original Estimated Enrollment Same as current
Estimated Study Completion Date May 2019
Estimated Primary Completion Date May 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria

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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT02348086
Other Study ID Numbers SVF01RA
ASCRA-01 ( Other Identifier: StemGenex )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Current Responsible Party StemGenex
Original Responsible Party Same as current
Current Study Sponsor StemGenex
Original Study Sponsor Same as current
Collaborators Not Provided
Investigators Not Provided
PRS Account StemGenex
Verification Date August 2018