An interventional study of Lipogems in Crohn Disease, sponsored by Lipogems International spa. Active, not recruiting at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-03-27.
Sponsored by Lipogems International spa · Not applicable, Interventional, and Treatment
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.
1,880 studies on the registry are indexed under Crohn Disease; 462 are open to participants now.
This study's planned enrollment of 80 is above the median of 66 across 1,188 interventional studies indexed under Crohn Disease.
Browse Crohn Disease studies →Lipogems International spa is the lead sponsor of 4 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
surgical drainage with cone fistulectomy + infiltration of micro-fractured autologous adipose tissue at the level of the internal orifice
Device: Lipogems
surgical drainage with cone fistulectomy + infiltration of physiological solution and suture point positioning at the internal orifice level
Micro-fragmented adipose tissue infiltration
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
Time frame: 24 weeks
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)
Time frame: 2-4-8-12-24 weeks
Documents are hosted by the registry — open the source record to download them.
Plan to share: No
This study is active, not recruiting, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.
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Lipogems International spa