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Clinical Trials in Denmark / NCT06303752
Recruiting Phase 1/2

Tissue Therapy of Transsphincteric Anal Fistula

NCT06303752 · tracked via the Priya Life Science Denmark tracker
Sponsor
University of Southern Denmark
Phase
Phase 1/2
Started
2024-10-09
Last updated
2024-11-05

Condition(s) studied

Anal Fistula

Investigational drug(s) / intervention(s)

ADRC injectionADRC001 injection

ADRC 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.

ADRC001 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.

Study 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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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 criteria: 1. Signs of suppuration/cavitation around the fistula 2. Simple or low anal fistula, which can be treated by simple surgical incision 3. Ano-vaginal and recto-vaginal fistula 4. The presence of more than one fistula tract, more than two external orifices or more than one internal orifice 5. Inflammatory Bowel Disease 6. Immunosuppression (due to clinical condition or medical therapy) 7. Malignancy within 5 years 8. Previous radiotherapy of the abdomen and pelvis 9. BMI under 18.5 10. Allergy against the antibiotics: Penicillin and streptomycin. 11. Coagulopathy 12. Pregnancy and lactation (positive HCG (human chorionic gonadotropin) test) 13. Verified syphilis, HIV, or hepatitis on screening test

Primary outcome measure(s)

  • Healing rate (percentage) — at 6 and 12 months follow-up
    Clinical healing is defined as closure of the external opening(s), absence/cessation of discharge and swelling by palpation.

Trial sites (1)

FacilityCityRegionStatus
Odense University Hospital Odense Denmark Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06303752 on ClinicalTrials.gov ↗ ← All trials in Denmark