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

NCT05594862 | Active Not Recruiting

• 1 other identifier: ATTIC
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Crohn Disease

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Number of participants with Clinical remission

  2-4-8-12-24 weeks

Study Arms (2)

Lipogems

ACTIVE COMPARATOR

surgical drainage with cone fistulectomy + infiltration of micro-fractured autologous adipose tissue at the level of the internal orifice

Device: Lipogems

Placebo

NO INTERVENTION

surgical drainage with cone fistulectomy + infiltration of physiological solution and suture point positioning at the internal orifice level

Interventions

Lipogems DEVICE

Micro-fragmented adipose tissue infiltration

Lipogems

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Lipogems International spa: lead

Study Sites (1)

IRCCS S Orsola Malpighi

Bologna, Bologna, Italy

Location

MeSH Terms

Conditions

Crohn Disease

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 13, 2022
• First Posted: October 26, 2022
• Study Start: January 9, 2023
• Primary Completion: April 9, 2025
• Study Completion (Estimated): June 9, 2026
• Last Updated: March 27, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)