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Repairing Peri-Anal Fistulas with regenerative cell therapeutics (REP-PAF)
EU CTIS ID: 2022-502659-73-01
What this study is testing
This clinical study aims to evaluate the outcome of the treatment of complex crypto-glandular perianal fistulas (PAF) by the combination of minimal surgical debridement with regenerative cellular therapeutics.
- Phase I and Phase II (Integrated)- First administration to humans
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Adult patients (>= 18years) with complex PAF (high transsphincteric or suprasphincteric), with involvement of more 30% of the anal sphincter referred to the surgical department at Odense University Hospital for treatment
- and who are able to communicate with Danish language
- and who are able to communicate with Danish language
- and who are having address in the region of southern Denmark during the study
You likely can't join if
- Signs of suppuration/cavitation around the fistula
- Allergy against the antibiotics: Penicillin and streptomycin.
- Coagulopathy
- Pregnancy and lactation (positive HCG test)
- Verified syphilis, HIV, or hepatitis on screening test
- Simple or low anal fistula, which can be treated by simple surgical incision
See the full eligibility criteria
- Adult patients (>= 18years) with complex PAF (high transsphincteric or suprasphincteric), with involvement of more 30% of the anal sphincter referred to the surgical department at Odense University Hospital for treatment
- and who are able to communicate with Danish language
- and who are able to communicate with Danish language
- and who are having address in the region of southern Denmark during the study
- Signs of suppuration/cavitation around the fistula
- Allergy against the antibiotics: Penicillin and streptomycin.
- Coagulopathy
- Pregnancy and lactation (positive HCG test)
- Verified syphilis, HIV, or hepatitis on screening test
- Simple or low anal fistula, which can be treated by simple surgical incision
- Ano-vaginal and recto-vaginal fistula
- The presence of more than one fistula tract, more than two external orifices or more than one internal orifice
- Inflammatory Bowel Disease
- Immunosuppression (due to clinical condition or medical therapy)
- Malignancy within 5 years
- Previous radiotherapy of the abdomen and pelvis
- BMI under 18.5
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.