Treatment of Crohn's Complex Perianal Fistulas With Tissue Transplantation by Local Injection of Micro-fragmented Autologous Adipose Tissue. (ATTIC)

Treatment of Crohn's Complex Perianal Fistulas With Tissue Transplantation by Local Injection of Micro-fragmented Autologous Adipose Tissue. Multicenter Randomized Controlled Prospective Study

multicentre randomized controlled prospective study aimed at evaluating the efficacy of the infiltration of microfractured adipose tissue in the healing of perianal fistulas not-responding to treatment with biologics, in order to improve the quality of life and significantly reduce the risk of definitive ostomy.

Study Overview

• Status: Active, not recruiting
• Conditions: Crohn Disease
• Intervention / Treatment: Device: Lipogems

• Study Type: Interventional
• Enrollment (Estimated): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Bologna
    • Bologna, Bologna, Italy
      • IRCCS S Orsola Malpighi

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• The patient's age is over 18 at the time of surgery.
• The patient suffers from Crohn's disease confirmed by instrumental and histological methods.
• The patient presents with complex perianal fistulising disease refractory to standard treatment (combination of surgical drainage of sepsis and local / systemic administration of anti-TNF-α for at least 1 year)
• The patient received, understood and signed informed consent for active participation in the study.
• The patient is able to understand the conditions of the study and to participate throughout the duration.

Exclusion Criteria:

• Patients with more than 1 internal and 3 external openings.
• Patients with ileus / colo ostomy.
• Patients with anus / rectum-vaginal fistulas.
• Patients with active HIV infections, hepatitis C (HCV), hepatitis B (HBV), tuberculosis.
• Patients with abdominal localization of Crohn's disease who may require general surgery during the study.
• Patients with active oncological or lymphoproliferative diseases from which it was not possible to safely withdraw an adequate quantity of lipoaspirate (at least 60 cc).
• Patients with clinical conditions that may compromise the success of the surgery or the follow-up.
• Pregnant or breastfeeding women.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Lipogems; surgical drainage with cone fistulectomy + infiltration of micro-fractured autologous adipose tissue at the level of the internal orifice	Device: Lipogems; Micro-fragmented adipose tissue infiltration
No Intervention: Placebo; surgical drainage with cone fistulectomy + infiltration of physiological solution and suture point positioning at the internal orifice level

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants with Combined remission	The primary outcome of the study will be the evaluation of the difference between the two experimental groups in terms of "combined remission" which will be defined at 24 weeks from surgery to clinical evaluation as "absence of drainage at a slight digital compression". of all treated external orifices that were draining at baseline and pelvic MRI as the absence of abscesses> 3 mm in correspondence of the treated perianal fistulas	24 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants with Clinical remission	Comparison between the two experimental groups in terms of clinical remission at 2 weeks (± 2 days), 4 weeks (± 2 days), 8 weeks (± 2 days), 12 weeks (± 3 days) and 24 weeks ± (5 days) from surgery (ie the closure of all external orifices treated that were draining at baseline despite a slight digital compression)	2-4-8-12-24 weeks

Collaborators and Investigators

• Sponsor: Lipogems International spa

Study record dates

Study Major Dates

• Study Start (Actual): January 9, 2023
• Primary Completion (Actual): April 9, 2025
• Study Completion (Estimated): June 9, 2026

Study Registration Dates

• First Submitted: October 13, 2022
• First Submitted That Met QC Criteria: October 21, 2022
• First Posted (Actual): October 26, 2022

Study Record Updates

• Last Update Posted (Actual): March 27, 2026
• Last Update Submitted That Met QC Criteria: March 24, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Intestinal Diseases; Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Inflammatory Bowel Diseases; Crohn Disease
• Other Study ID Numbers: ATTIC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No