The Italian company leads a trial to certify the effectiveness of processed adipose tissue in knee osteoarthritis
Milan, February 2, 2023 – Lipogems International SpA, the Italian SME leader in the use of adipose tissue in regenerative medicine, announces the enrollment of the first patient in the ARISE study in the United States. The study compares the use of microfragmented adipose tissue processed by the LIPOGEMS device versus the use of corticosteroids in patients suffering from knee osteoarthritis (OA). In June 2022, the Food and Drug Administration (FDA) approved the start of the clinical trial to certify the validity of the treatment, and today, with the enrollment of the first patient, another important step is taken towards certifying the use of adipose tissue for the treatment of knee osteoarthritis.
“We selected the first patient on December 30, 2022, and for us, it is an extraordinary moment,” said Dr. Yogesh Mittal, Board-Certified and Fellowship Training Total Joint Surgeon at the Orthopedic Clinic of Tulsa, Oklahoma, home of NextStage Clinical Research. “For my patients with knee OA, I can offer very limited treatment options that do not go beyond conservative therapies such as the use of corticosteroids, hyaluronic acid injections, physical therapy, and lifestyle advice. The LIPOGEMS device involves a single transplant of autologous adipose tissue in the patient, which can help treat their knee OA and delay TKA.”
Patients with knee OA treated with conservative options, deriving limited benefit, can suffer from debilitating pain, reduced quality of life, and may develop other chronic diseases linked to inactivity and may be subject to depression.
The LIPOGEMS ARISE study will involve up to 20 centers in the USA to certify, according to the FDA-approved protocol, the safety and efficacy of the LIPOGEMS system and thus obtain a specific clinical indication in knee OA.
“The goal of the ARISE study is to demonstrate that we can effectively help patients with knee OA, allowing them to prolong their active life, even in old age,” said Giorgio Ninzoli, CEO of Lipogems International SpA, who continues: “Thanks to numerous clinical evidences, Lipogems International SpA has established itself as a world leader in the autologous transplant of adipose tissue in orthopedics, and a specific indication for use in knee OA will allow us to treat, in the USA, more and more patients suffering from this debilitating disease, helping them improve their quality of life.”