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NCT Number: NCT05594862

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Crohn Disease Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Inflammatory Bowel Diseases Intestinal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

IRCCS S Orsola Malpighi

Bologna, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Lipogems

Device

Micro-fragmented adipose tissue infiltration

Primary outcomes

  1. Number of participants with Combined remission

    Time frame: 24 weeks

    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

Secondary outcomes

  1. Number of participants with Clinical remission

    Time frame: 2-4-8-12-24 weeks

    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)

Sponsors and collaborators

Lead sponsor

Lipogems International spa

Industry

Registry information

Official study title

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

Acronym: ATTIC

Important dates

Study start
2023
Primary completion
2025
Study completion
2026
First posted
Oct 26, 2022
Registry last updated
Mar 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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