Repair the worn knee from arthritis with stem cells obtained from the patient’s fat. This is the goal of a clinical study for which the Italian company Lipogems International Spa received the green light from the American Food and Drug Administration. “We are very proud of this milestone achieved after more than 2 years of working with the Fda”, declares Giorgio Ninzoli, Group CEO of Lipogems, a multinational company based in Milan that operates in the sector of biotechnology and regenerative medicine, established in 2012 by Camillo Ricordi , director of the Diabetes Research Institute in Miami, and Carlo Tremolada, plastic surgeon. The trial will be conducted in the States and represents “the fundamental step to obtain reimbursement in the US for the treatment of osteoarthritis of the knee, one of the most common diseases that affects millions of people every year”, Ninzoli underlines, certain that “this approval will have a strong impact for Lipogems all over the world “. The company – explains a note – produces and markets an innovative medical device used to process and micro fragment adipose tissue used in orthopedics, colorectal surgery, chronic wound care and other specialties. Lipogems boasts over 100 publications in peer reviewed journals and its device has been used to date for over 50 thousand procedures worldwide.The medical device developed and patented by Lipgems – details the note – is certified and authorized for collection and processing of adipose tissue. The minimally invasive procedure can be completed in under an hour both in the operating room and in a surgery room. It involves a small sampling of grease, the processing of the sample and the subsequent grafting of the material obtained. The processing carried out by the device is a micro fragmentation process that simulates tissue damage and therefore triggers the natural repair processes: in particular, it activates the transformation of the pericyte, an undifferentiated cell type, into a mesenchymal stem cell Msc. The product thus obtained is a micro-fragmented adipose tissue intended for autologous grafting, with high concentrations of active pericytes and mesenchymal cells that favor the natural regenerative process. The fields of application are numerous, the company lists: osteoarthritis of the knee, hip and shoulder, diabetic foot ulcer, perianal fistula from Crohn’s disease and, under experimentation, the possibility of use as a vehicle for the administration of drugs in the treatment of tumors and infections.
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