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Trial record 2 of 4 for:    stromal vascular fraction for rheumatoid arthritis
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Outcomes Data of Adipose Stem Cells to Treat Rheumatoid Arthritis

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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

Study Description
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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.

Condition or disease
Rheumatoid Arthritis

Study Design
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Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Cohort
Time Perspective: Prospective
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

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Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  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) [ 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.


Eligibility Criteria
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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
Study Population
Community Sample
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
Contacts and Locations
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Information from the National Library of Medicine

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


Contacts
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Contact: Holly Bergen 800-609-7795

Locations
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United States, California
StemGenex Recruiting
San Diego, California, United States, 92121
Contact    855-742-7836      
Sponsors and Collaborators
StemGenex
More Information
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Responsible Party: StemGenex
ClinicalTrials.gov Identifier: NCT02348086    
Other Study ID Numbers: SVF01RA
ASCRA-01 ( Other Identifier: StemGenex )
First Posted: January 28, 2015    Key Record Dates
Last Update Posted: August 31, 2018
Last Verified: August 2018
Additional relevant MeSH terms:
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Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
 Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases