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

Crohn Disease Clinical Trial

— ATTIC  

Official 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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05594862
• Other study ID #: ATTIC
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 9, 2023
• Est. completion date: December 31, 2024

Study information

• Verified date: March 2024
• Source: Lipogems International spa
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 80
• Est. completion date: December 31, 2024
• Est. primary completion date: June 9, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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-a 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.

Related Conditions & MeSH terms

• Crohn Disease
• Fistula

Intervention

Device:
• Lipogems
Micro-fragmented adipose tissue infiltration

Locations

Country	Name	City	State
Italy	IRCCS S Orsola Malpighi	Bologna

Sponsors (1)

Lead Sponsor	Collaborator
Lipogems International spa

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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) with the presence of abscess collections> 3 mm on MRI.	2-4-8-12-24 weeks