Outcomes Data of Adipose Stem Cells to Treat Rheumatoid Arthritis

Rheumatoid Arthritis Clinical Trial

Official title:

Autologous Adipose Stromal Vascular Fraction Outcomes in Rheumatoid Arthritis Research Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02348086
• Other study ID #: SVF01RA
• Secondary ID: ASCRA-01
• Status: Recruiting
• Start date: January 2015
• Est. completion date: May 2019

Study information

• Verified date: August 2018
• Source: StemGenex
• Contact: Holly Bergen
• Phone: 800-609-7795
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: May 2019
• Est. primary completion date: May 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Locations

Country	Name	City	State
United States	StemGenex	San Diego	California

Sponsors (1)

Lead Sponsor	Collaborator
StemGenex

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change from Baseline in Overall Health at Month 12 as Measured by the Participants' Response to the Health Assessment Questionnaire-II (HAQ-II)	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.	Baseline, Month 12
Secondary	Change from Baseline in Overall Pain at Month 12 as Measured by Participants' Response to the Patient Activity Scale-II (PAS-II) Pain Subscale	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.	Baseline, Month 12
Secondary	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	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.	Baseline, Month 12