FDA Oks IDE Study of Adipose Tissue for Knee OA
The FDA has ok’d a 12-month Investigational Device Exemption (IDE) randomized control study for the use of adipose (fat) tissue as a treatment for knee osteoarthritis (OA)—using as the control for the study, corticosteroids.
The sponsor of the study, Norcross Georgia based Lipogems, which received FDA 510(k) clearance in 2014 for its device, told OTW that its product processes adipose tissue for applications in orthopedics, arthroscopy and nine other specialties. To date Lipogem’s adipose processing system has been studied in more than 115 independent peer reviewed publications.
Carl Llewellyn, CEO of Lipogems USA, stated "We are excited to achieve this milestone to pursue a specific indication in knee OA and have worked closely with the FDA to establish a pathway for Premarket Approval of the Lipogems System in this indication.”
“The decision to pursue this specific indication is based on the positive results seen in 30+ independent peer-reviewed publications with up to 3 years follow-up evaluating pain, function, quality of life, and economic advantages. We anticipate that the approved IDE study will demonstrate compelling safety and efficacy data of Lipogems' Microfragmented Fat in knee osteoarthritis."
Llewellyn told OTW, “As part of the FDA submission, independent labs validated that the Lipogems patented process which preserves the cell and tissue microarchitecture of the Microfragmented Fat, its ability to reduce the inflammatory cytokine cascade, and the improved lubricity compared to commercially available hyaluronic acid. The positive results seen help to further define the function of the Lipogems patented technology and separate it from other processing methods.”
“Even though there are 30+ independent studies supporting the use of Lipogems in knee osteoarthritis, and it has been used in over 50,000 cases worldwide to date, physicians are unable to proactively educate their patients about this beneficial therapy.”
“Lipogems is the only commercially available company in the autologous space to have responsibly collaborated with the FDA to create a pathway and committed the time and substantial resources to achieve this milestone.”
“This is important because by successfully completing the knee OA study and obtaining a specific indication, physicians will be able to directly market to and educate patients about the Lipogems procedure for knee osteoarthritis. This is also the first step on the pathway to reimbursement which will permit more patients suffering from knee OA to receive the long-term relief seen in our clinical studies.”