Clinical trial NCT02241408: Outcomes Data of Adipose Stem Cells to Treat Osteoarthritis
Official title: Autologous Adipose Stromal Vascular Fraction Outcomes in Osteoarthritis Research Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Osteoarthritis
Lead sponsor: StemGenex
Sponsor class: INDUSTRY
First posted: 2014-09-16
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Community Sample

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 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.


Eligibility criteria: Inclusion Criteria:

* Fluent in English
* Over the age of 18
* Diagnosed with OA of the knee and/or hip
* Scheduled for intravenous and intra-articular administrations of autologous SVF
* Capable of understanding and willing to sign informed consent
* Willing and able to complete brief phone interviews
* Willing and able to complete online surveys

Exclusion Criteria:

* Co-morbidity with an autoimmune disorder
* Pregnant, may become pregnant, or breastfeeding
* Subjects for which baseline data is not available

Primary outcomes:
measure: Change 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)
timeFrame: Baseline, 12 months
measure: 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)
timeFrame: Baseline, 12 months
Secondary outcomes:
measure: 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
timeFrame: Baseline, Month 12
measure: 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
timeFrame: Baseline, Month 12
measure: 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
timeFrame: Baseline, Month 12
measure: 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
timeFrame: Baseline, Month 12
measure: 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
timeFrame: Baseline, Month 12
measure: 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
timeFrame: Baseline, Month 12
measure: 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
timeFrame: Baseline, Month 12
measure: 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
timeFrame: Baseline, Month 12
measure: 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
timeFrame: Baseline, Month 12
measure: 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
timeFrame: Baseline, Month 12
Other outcomes:
Locations:
city: San Diego
country: United States
facility: StemGenex
state: California
Study officials:
References: