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

Lipogems

Status

Active, not recruiting

Conditions

Crohn Disease

Treatments

Device: Lipogems

Study type

Interventional

Funder types

Industry

Identifiers

NCT05594862

ATTIC

Details and patient eligibility

About

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.

Enrollment

80 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.