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

Study Overview
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Brief Summary
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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.

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

Conditions
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Crohn Disease

Intervention / Treatment
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* Device: Lipogems


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

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

What is the study measuring?
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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) with the presence of abscess collections> 3 mm on MRI. | 2-4-8-12-24 weeks |