First patients enrolled to evaluate the efficacy of autologous adipose tissue transplant using the Lipogems device
The IRCCS Sant’Orsola – Malpighi Policlinico of Bologna, the Luigi Sacco Hospital of Milan, the Careggi University Hospital of Florence, the IRCCS Foundation Agostino Gemelli University Hospital of Rome, the Federico II University of Naples together, have launched an important multicentric, randomized double-blind study, enrolling the first patients with Crohn’s disease who developed a complex perianal fistula as a consequence of the inflammatory process of the disease.
The clinical study involves the recruitment of 80 patients, men and women with an average age of 35, multi-resistant to the available standard therapies, such as systemic or local biological drugs and surgery.
The aim of the study is to treat a part of these patients with tissue transplantation, by infiltration of micro-fractured autologous adipose tissue around the fistula and to evaluate its efficacy after 24 weeks.
The entire procedure for the collection, micro-fragmentation and administration of adipose tissue is carried out using the Lipogems device and takes place in a single surgical step, thus facilitating the pre-operative organization and the subsequent clinical course of the patient.
“It is essential to underline the clinical, social and economic impact of Crohn’s disease, a pathology that is affecting more and more young people and which, unfortunately, can also appear in children. It is a chronic pathology that causes suffering, both physical and psychological, and the limitations in daily, social and work activities, combined with the high costs of existing treatments, have a very significant impact on the quality of life. Literature data tell us that only 55/60% of patients affected by Crohn’s perianal disease respond to currently known standard treatments. With this study we intend to test a new therapeutic alternative, to give hope to patients refractory to standard therapies and destined to suffer a constant deterioration of the quality of life” declared the Principal Investigator and coordinator of the study, Professor Silvio Laureti, Associate Professor of General Surgery of the University of Bologna, and Departement of Surgery of the Alimentary Tract and Emergencies of the IRCCS Policlinico Sant’Orsola – Malpighi, directed by Professor Gilberto Poggioli.