Recruiting

Adipose Stem Cells

Sponsor:

StemGenex

Code:

NCT02348086

Conditions

Rheumatoid Arthritis

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Study Details

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.

Conditions

Rheumatoid Arthritis

Study ID

NCT02348086

Start date

Jan, 2015

Status verified date

Aug, 2018

Completion date

May, 2019

Anticipated

Primary completion date

May, 2019

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

50 participants

Anticipated

Interventions and Outcome Measures

Primary outcome measure

  • 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 ]

Central Contacts and Locations

Central contacts

Holly Bergen

800-609-7795

Locations

StemGenex

Recruiting

San Diego, California, United States, 92121

Contacts

855-742-7836

More Information

Sponsor

StemGenex

Last update posted

Aug 31, 2018

Last verified

Aug, 2018

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by StemGenex on 2018-08-31.