The IRCCS Istituto Clinico Humanitas joins the ATTIC project, the Italian multicentre clinical study for the treatment of Crohn’s disease with complex perianal fistulas (MPC).
The research was announced back in March 2023 by IRCCS Policlinico Sant’Orsola-Malpighi of Bologna – coordinator of the study – and currently involves Luigi Sacco Hospital of Milan, Careggi University Hospital of Florence, IRCCS Fondazione Policlinico Universitario Agostino Gemelli of Rome, Federico II University Hospital of Naples.
To date, thanks to the work of the hospitals and IRCCS already involved in the study, the clinical trial has enrolled 51 patients, suffering from Crohn’s disease, who have developed a complex perianal fistula as a consequence of the inflammatory process of the disease.
The aim of the study is to treat half of them with tissue transplantation, through infiltration of micro-fractured autologous adipose tissue around the fistula, to evaluate its effectiveness after 24 weeks. The research is designed on a final cohort of 80 patients: therefore, the invitation to join the project is still open in order to complete patient enrollment in the shortest possible time. The call is to men and women who are multi-resistant to the standard therapies, such as systemic or local biological drugs and surgery.
The entire procedure of harvesting, micro fragmentation and infiltration of adipose tissue is carried out using the Lipogems device and takes place in a single surgical stage, therefore facilitating the pre-operative organization and the subsequent course of the patient.
“Complex perianal fistulas represent one of the most challenging manifestations of Crohn’s disease, causing considerable physical and psychological suffering for the patient. Combined surgical and medical therapy with biological drugs currently represents the main therapeutic option, but the overall success rate does not exceed 60%. Finding a valid therapeutic alternative is, therefore, of fundamental importance. The ATTIC study, opening up to an innovative approach such as that of the sampling of adipose tissue, micro fragmented and intended for autologous grafting, can be considered a promising prospect for patients refractory to standard therapies, to whom we feel we can offer new hope”, declared Professor Antonino Spinelli, Head of the Colon and Rectal Surgery Unit, co-director of the IBD Center for chronic intestinal inflammatory diseases of the IRCCS Istituto Clinico Humanitas.