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 joint pain and functionality in people with Osteoarthritis (OA). SVF contains components with "regenerative" properties, including stem cells that have shown promise for ameliorating specific disease conditions. This study is designed to evaluate joint pain and functionality changes in individuals with OA for up to 12 months following SVF treatment.
Study Type
OBSERVATIONAL
Enrollment
100
StemGenex
San Diego, California, United States
RECRUITINGChange from Baseline in Overall Knee Assessment Over the Course of a 12 Month Period as Measured by the Knee Injury and Osteoarthritis Outcome Score (KOOS LK 1.0)
The change from baseline over the course of 12 months using participants' assessment of their knee and associated problems. Mean scores will be used for baseline (day 0) and all interviews up to month 12 (months 1, 3, 6, and 12). Answer options are graded on a 5 point Likert scale and each question gets a score from 0 to 4.
Time frame: Baseline, 12 months
Change from Baseline in Overall Hip Assessment Over the Course of a 12 Month Period as Measured by the Hip Dysfunction and Osteoarthritis Outcome Score (HOOS LK 2.0)
The change from baseline over the course of 12 months using participants' assessment of their hip and associated problems. Mean scores will be used for baseline (day 0) and all interviews up to month 12 (months 1, 3, 6, and 12). Answer options are graded on a 5 point Likert scale and each question gets a score from 0 to 4.
Time frame: Baseline, 12 months
Change from Baseline in Knee Pain at Month 12 as Measured by Participants Using the Knee Injury and Osteoarthritis Outcome Score (KOOS LK 1.0) The Pain Subscale
Participant assessment in the change in knee pain from baseline to month 12 using the KOOS pain subscale.
Time frame: Baseline, Month 12
Change from Baseline in Function in Daily Living (ADL) at Month 12 as Measured by Participants Using the Knee Injury and Osteoarthritis Outcome Score (KOOS LK 1.0) The ADL Subscale
Participant assessment in the change in function in daily living from baseline to month 12 using the KOOS ADL subscale.
Time frame: Baseline, Month 12
Change from Baseline in Function in Sport and Recreation at Month 12 as Measured by Participants Using the Knee Injury and Osteoarthritis Outcome Score (KOOS LK 1.0) The Sport/Rec Subscale
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Participant assessment in the change in sport and recreation from baseline to month 12 using the KOOS sport/rec subscale.
Time frame: Baseline, Month 12
Change from Baseline in Knee Related Quality of Life (QOL) at Month 12 as Measured by Participants Using the Knee Injury and Osteoarthritis Outcome Score (KOOS LK 1.0) The Knee Related Quality of Life Subscale
Participant assessment in the change in knee related quality of life from baseline to month 12 using the KOOS QOL subscale.
Time frame: Baseline, Month 12
Change from Baseline in Other Knee Symptoms at Month 12 as Measured by Participants Using the Knee Injury and Osteoarthritis Outcome Score (KOOS LK 1.0) The Other Symptoms Subscale
Participant assessment in the change in other knee symptoms from baseline to month 12 using the KOOS other symptoms subscale.
Time frame: Baseline, Month 12
Change from Baseline in Hip Pain at Month 12 as Measured by Participants Using the Hip Dysfunction and Osteoarthritis Outcome Score (HOOS LK 2.0) The Pain Subscale
Participant assessment in the change in hip pain from baseline to month 12 using the HOOS pain subscale.
Time frame: Baseline, Month 12
Change from Baseline in Function in Daily Living (ADL) at Month 12 as Measured by Participants Using the Hip Dysfunction and Osteoarthritis Outcome Score (HOOS LK 2.0) The ADL Subscale
Participant assessment in the change in function in daily living from baseline to month 12 using the HOOS ADL subscale.
Time frame: Baseline, Month 12
Change from Baseline in Function in Sport and Recreation at Month 12 as Measured by Participants Using the Hip Dysfunction and Osteoarthritis Outcome Score (HOOS LK 2.0) The Sport/Rec Subscale
Participant assessment in the change in function in sport and recreation from baseline to month 12 using the HOOS sport/rec subscale.
Time frame: Baseline, Month 12
Change from Baseline in Hip Related Quality of Life (QOL) at Month 12 as Measured by Participants Using the Hip Dysfunction and Osteoarthritis Outcome Score (HOOS LK 2.0) The QOL Subscale
Participant assessment in the change in hip related quality of life from baseline to month 12 using the HOOS QOL subscale.
Time frame: Baseline, Month 12
Change from Baseline in Other Hip Symptoms at Month 12 as Measured by Participants Using the Hip Dysfunction and Osteoarthritis Outcome Score (HOOS LK 2.0) The Other Symptoms Subscale
Participant assessment in the change in other hip symptoms from baseline to month 12 using the HOOS other symptoms subscale.
Time frame: Baseline, Month 12