Treatment of Crohn's Complex Perianal Fistulas With Tissue Transplantation by Local Injection of Micro-fragmented Autologous Adipose Tissue.
NCT ID: NCT05594862
Last Updated: 2025-09-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
80 participants
INTERVENTIONAL
2023-01-09
2025-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Lipogems
surgical drainage with cone fistulectomy + infiltration of micro-fractured autologous adipose tissue at the level of the internal orifice
Lipogems
Micro-fragmented adipose tissue infiltration
Placebo
surgical drainage with cone fistulectomy + infiltration of physiological solution and suture point positioning at the internal orifice level
No interventions assigned to this group
Interventions
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Lipogems
Micro-fragmented adipose tissue infiltration
Eligibility Criteria
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Inclusion Criteria
* 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 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.
18 Years
ALL
No
Sponsors
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Lipogems International spa
INDUSTRY
Responsible Party
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Locations
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IRCCS S Orsola Malpighi
Bologna, , Italy
Countries
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Provided Documents
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Document Type: Study Protocol
Other Identifiers
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ATTIC
Identifier Type: -
Identifier Source: org_study_id
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