Treatment of Crohn's Complex Perianal Fistulas With Tissue Transplantation by Local Injection of Micro-fragmented Autologous Adipose Tissue.
Condition(s) studied
Investigational drug(s) / intervention(s)
Lipogems: Micro-fragmented adipose tissue infiltration
Study 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.
Eligibility
Primary outcome measure(s)
- Number of participants with Combined remission — 24 weeks
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
Trial sites (1)
| Facility | City | Region | Status |
|---|---|---|---|
| IRCCS S Orsola Malpighi | Bologna | Bologna |
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT05594862 on ClinicalTrials.gov ↗ ← All trials in Italy