Presentation Information
[INTS4-1]Efficacy and safety of microfragmented autologous adipose tissue transplantation for perianal fistulas in Crohn’s disease (ATTIC): a phase 3 multicenter randomized controlled trial
*Silvio Laureti1, Luigi Sofo2, Francesco Colombo3,4, Gaetano Luglio5, Stefano Scaringi6, Alberta Cappelli7, Piergiorgio Danelli3,4, Claudio Isopi1, Franco Sacchetti2, Giorgia Gualtieri8, Michele Cricrì9, Federico Perna6, Alessandra Menon10, Nikolas Konstantine Dussias11, Paolo Gionchetti11, Antonino Spinelli8,12 (1. Experimental Proctology, Department of Medical and Surgical Sciences, University of Bologna, IRCCS Azienda Ospedaliero-Universitaria di Bologna, Bologna, Italy, 2. Dipartimento di Scienze Gastroenterologiche, Endocrino-Metaboliche e Nefro-Urologiche, Fondazione Policlinico Universitario Gemelli IRCCS, Rome, Italy , 3. General Surgery Department, Luigi Sacco University Hospital, Milan, Italy, 4. Department of Biomedical and Clinical Sciences, University of Milan, Milan, Italy, 5. Department of Public Health, University of Naples Federico II, Naples, Italy, 6. IBD Unit, Azienda Ospedaliero Universitaria Careggi, Florence, Italy, 7. Radiologia e Diagnostica per Immagini, ASST Mantova, Mantua, Italy, 8. Division of Colon and Rectal Surgery, IRCCS Humanitas Research Hospital, Rozzano, Milan, Italy, 9. Department of Clinical Medicine and Surgery, Department of Information Technology and Electrical Engineering, University of Naples Federico II, Naples, Italy, 10. Lipogems International Spa, Milan, Italy, 11. IBD Unit, Department of Medical and Surgical Sciences, University of Bologna, IRCCS Azienda Ospedaliero-Universitaria di Bologna, Bologna, Italy, 12. Department of Biomedical Sciences, Humanitas University, Pieve Emanuele, Milan, Italy)
Background: Complex perianal fistulas in Crohn’s disease are often refractory to the recommended combination of surgery and biological drug therapy. We investigated the efficacy and safety of local injections of minimally manipulated, microfragmented, autologous adipose tissue (“MFat”) in promoting fistula healing.
Materials and methods: This double-blind randomized controlled trial enrolled 80 adults who all underwent cone-like partial fistulectomy of a complex fistula (one inner orifice and up to three external openings) followed by either MFat injection or suture of the inner orifice and saline injection. MFat was prepared from lipoaspirates using Lipogems medical devices immediately before fistulectomy and transplanted around the inner orifice and along the residual tracts immediately after fistulectomy. The primary efficacy outcome was combined (clinicoradiological) remission at 24 weeks in the per-protocol populations. Safety was assessed in the all-patients-treated populations. ATTIC was registered on ClinicalTrials.gov, NCT05594862, and has ended.
Results: Between 9 January 2023 and 16 April 2024, 92 patients were screened and 80 were enrolled. After randomization, 37 patients in each group were treated and 33 patients each were assessed. Combined remission occurred in 19 patients of the intervention group and 6 control patients (risk ratio 3∙17 [95% CI 1.45–6.91]; p=0.004). Clinical remission was found in 26 and 18 patients (p=0.037), respectively, while clinical indices improved in both groups. Seven adverse events were reported, including three classified as serious (ischemic stroke and two cases of abdominal disease flare-up), without significant differences between groups in safety endpoints.
Conclusions: Partial fistulectomy alone led to substantial clinical improvement, but the addition of MFat significantly increased the likelihood of achieving MRI-confirmed healing.
Materials and methods: This double-blind randomized controlled trial enrolled 80 adults who all underwent cone-like partial fistulectomy of a complex fistula (one inner orifice and up to three external openings) followed by either MFat injection or suture of the inner orifice and saline injection. MFat was prepared from lipoaspirates using Lipogems medical devices immediately before fistulectomy and transplanted around the inner orifice and along the residual tracts immediately after fistulectomy. The primary efficacy outcome was combined (clinicoradiological) remission at 24 weeks in the per-protocol populations. Safety was assessed in the all-patients-treated populations. ATTIC was registered on ClinicalTrials.gov, NCT05594862, and has ended.
Results: Between 9 January 2023 and 16 April 2024, 92 patients were screened and 80 were enrolled. After randomization, 37 patients in each group were treated and 33 patients each were assessed. Combined remission occurred in 19 patients of the intervention group and 6 control patients (risk ratio 3∙17 [95% CI 1.45–6.91]; p=0.004). Clinical remission was found in 26 and 18 patients (p=0.037), respectively, while clinical indices improved in both groups. Seven adverse events were reported, including three classified as serious (ischemic stroke and two cases of abdominal disease flare-up), without significant differences between groups in safety endpoints.
Conclusions: Partial fistulectomy alone led to substantial clinical improvement, but the addition of MFat significantly increased the likelihood of achieving MRI-confirmed healing.