RecruitingPhase 1Phase 2NCT06303752

Tissue Therapy of Transsphincteric Anal Fistula

Repairing Peri-Anal Fistulas With Regenerative Cell Therapeutics

Sponsor

University of Southern Denmark

Enrollment

75 participants

Start Date

Oct 9, 2024

Study Type

INTERVENTIONAL

Conditions

Anal Fistula

Summary

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.

Eligibility

Min Age: 18 Years

Inclusion Criteria5

Inclusion criterion:
Adult patients (>= 18years) with complex anal fistula (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
able to provide informed consent
having address in the region of southern Denmark during the study

Exclusion Criteria13

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

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Interventions

DRUGADRC injection

Allocated patients will receive injection of 5 ml suspension including 30 million autologous adipose-derived regenerative cells ADRC and injected at the same site of the lipoaspirate injection.

DRUGADRC001 injection

Allocated patients will receive injection of 5 ml suspension including 30 million allogenic adipose-derived regenerative cells ADRC001 and injected at the same site of the lipoaspirate injection.