Tissue Therapy of Transsphincteric Anal Fistula

Recruiting now · Phase 1/Phase 2

Conditions studied: Anal Fistula

In brief

This clinical study aims to evaluate the outcome of the treatment of complex perianal fistulas (PAF) by the combination of minimal surgical debridement with regenerative cellular therapeutics.

Key facts

Study ID

NCT06303752

Run by

University of Southern Denmark

People needed

75

Starts

2024-10-09

Expected to finish

2028-10-08

Last updated by the study team

2024-11-05

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

• Signs of suppuration/cavitation around the fistula
• 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
• Allergy against the antibiotics: Penicillin and streptomycin.
• Coagulopathy
• Pregnancy and lactation (positive HCG (human chorionic gonadotropin) test)
• Verified syphilis, HIV, or hepatitis on screening test

Where it is running

• Odense University Hospital — Odense, Denmark (enrolling)

Full record on ClinicalTrials.gov

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