(SVF) Treatment for Knee Osteoarthritis

STUDY BASICS

Are you between ages 35 and 85 with osteoarthritic knees? You may be eligible to participate in a research study that intends to determine if an injection of stromal vascular fraction (SVF) cells derived from your own fat will relieve pain and increase function in one of your osteoarthritic knees. Compensation is provided.

STUDY PURPOSE

The purpose of this study is to determine whether treatment of stromal vascular fraction cells for osteoarthritis of the knee relieves pain and increases function. The GID Group has created a single use, disposable device which can take liposuctioned fat and in approximately an hour isolate and concentrate the stromal vascular fraction cells. The device is called the GID SVF-2. This device is considered investigational. "Investigational" means that the device being tested has not been approved by the United States Food and Drug Administration (FDA). 

This study may result in reduced pain associated with osteoarthritis of the knee. Even if you don't directly benefit from the study, the information learned from the study may help other people in the future. 

COULD THIS STUDY BE RIGHT FOR YOU?

Eligible participants are:

• Ages 35-85 
• Previously diagnosed with knee osteoarthritis
• Willing to undergo an MRI, X-Ray, and injection procedure

WHAT PARTICIPANTS CAN EXPECT

Pre-screening will require completing 3 questionnaires and an MRI and X-Ray of one of your knees. Participants will be randomly selected to be in 1 of 2 groups: the Stromal Vascular Fraction Treatment Group and the Placebo Group. You and your doctor will not know which group you are in until the study is over. You will have a 75% chance of receiving stromal vascular fraction treatment and 25% chance of receiving the placebo treatment.

You will have a small amount of fat liposuctioned from your stomach or flanks. This tissue is then processed to isolate and concentrate the stromal vascular cells. Approximately 1.5 hours after liposuction you will be given an injection in one of your knees of either the stromal vascular cell treatment or placebo treatment that was randomly assigned.