Lipogems’ Knee Osteoarthritis Trial Now Complete

Lipogems has completed the ARISE I U.S. Food and Drug Administration (FDA) Investigational Device Exemption study of its knee osteoarthritis (OA) treatment.

The double-blinded, randomized controlled trial enrolled 173 subjects across 18 U.S. sites. The primary endpoints evaluate improvement in pain and function at 12 months after injection with microfat. Efficacy and safety results from ARISE studies are expected to be announced later this year.

“We are thrilled to reach this significant milestone,” Lipogems USA CEO Carl Llewellyn said. “This accomplishment brings us one step closer to making Lipogems a mainstream treatment option for patients with knee osteoarthritis that historically have had limited options. The successful conclusion of this trial represents the hard work and dedication of our team, clinical sites, and the patients that have placed their trust in us.”

While the Lipogems device has been FDA-cleared for broad use in orthopedics and arthroscopic surgery for 10 years, the ARISE studies represent the largest clinical trials to date for the company. The ARISE I and II trials aim to help Lipogems obtain a separate indication specifically for knee OA. The data will be analyzed in the coming months to assess the safety and efficacy of a single autologous, intra-articular injection of Lipogems’ proprietary microfat versus corticosteroid injection to treat pain and improve function in patients with moderate Knee OA.

Research has shown that body fat has many properties that are essential to optimize physiological function, including cushioning and support for joints as well as supporting the repair of damaged or injured tissue.

Lipogems International is a privately held medical device company that uses adipose tissue solutions to help maintain or restore patient lifestyles and to improve quality of life and recovery times. Lipogems’ products are used in various specialties, including orthopedics, though the company is exploring applications and indications in several other applicable specialties. Lipogems is available in 29 countries.