NCT05594862Active, not recruiting
Treatment of Crohn's Complex Perianal Fistulas With Tissue Transplantation by Local Injection of Micro-fragmented Autologous Adipose Tissue.
Treatment of Crohn's Complex Perianal Fistulas With Tissue Transplantation by Local Injection of Micro-fragmented Autologous Adipose Tissue. Multicenter Randomized Controlled Prospective Study
Source: ClinicalTrials.gov · Last updated 27 Mar 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 80 (estimated)
- First submitted
- 13 Oct 2022
- Start date
- 9 Jan 2023
- Primary completion date
- 9 Apr 2025
- Lead sponsor
- Lipogems International spa
- Diseases
- Crohn's disease
- NCT number
- NCT05594862
What you commit to
- Study type: Interventional
- Planned participants: 80
- From 9 Jan 2023 to the primary completion date, 9 Apr 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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.
Other
- Patients with more than 1 internal and 3 external openings.
- Patients with ileus / colo ostomy.
- Patients with anus / rectum-vaginal fistulas.
- Pregnant or breastfeeding women.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| IRCCS S Orsola Malpighi Coordinator of this site? Confirm its status | Bologna | Italy | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.