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Six major Italian hospitals involved in the study to address the most complex and devastating complication of Crohn’s disease: perianal fistulas

Bologna, 16th May 2024 – The enrollment phase of the ATTIC clinical trial has been completed. This multicentric study, entirely  Italian, was coordinated by the IRCCS Policlinico Sant’Orsola-Malpighi in Bologna, in collaboration with the IRCCS Humanitas Clinical Institute, the IRCCS Agostino Gemelli University Polyclinic Foundation in Rome, the Luigi Sacco Hospital in Milan, the Federico II University Hospital in Naples and the Careggi University Hospital in Florence.

Started one year ago, the double-blind, randomized clinical trial has enrolled 80 patients, all suffering from Crohn’s disease – who have developed a complex perianal fistula because of the inflammatory process of the disease – and all resistant to the standard therapies used so far, such as systemic or local biological drugs and surgery.

All 80 enrolled patients underwent a fistulectomy procedure, while only half – the socalled treatment group – received tissue transplantation, through the infiltration of micro- fragmented autologous adipose tissue around the fistula, with efficacy evaluation after 24 weeks. The control group, consisting of the other half of the patients, received a simple saline solution as a placebo. Participants were randomly assigned to these groups, following the logic of any randomized controlled trial.

The entire procedure of tissue harvesting, micro fragmentation and administration of adipose tissue takes place in a single surgical session, facilitating the pre-operative organization and the subsequent patient recovery.

«Enrolling 80 patients, suffering from Crohn’s disease, who have developed a complex perianal fistula, has been an extraordinary achievement, possible only through the incredible commitment of all the Centers involved in the ATTIC Study. Thanks to them, in six months, we may see the first results that could lead to a true revolution in the treatment of Crohn’s disease and what is certainly the most complex and devastating complication from the patient’s quality of life perspective. In this way, we will provide concrete hope to patients refractory to standard therapies (literature data tells us that only 55/60% of patients with perianal Crohn’s disease respond to currently known standard treatments) » said the principal investigator and study coordinator, Professor Silvio Laureti, Associate Professor of General Surgery at the University of Bologna, and Head of the Digestive Tract Surgery and Emergencies Unit at the IRCCS Policlinico Sant’Orsola – Malpighi, directed by Professor Gilberto Poggioli.

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