Treatment of Crohn's Complex Perianal Fistulas With Tissue Transplantation by Local Injection of … (NCT05594862) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Treatment of Crohn's Complex Perianal Fistulas With Tissue Transplantation by Local Injection of Micro-fragmented Autologous Adipose Tissue.
Italy80 participantsStarted 2023-01-09
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.