Clinical trial NCT06303752: Tissue Therapy of Transsphincteric Anal Fistula
Official title: Repairing Peri-Anal Fistulas With Regenerative Cell Therapeutics
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
PHASE2
Conditions: Anal Fistula
Keywords: anal fistula
stem cells
ADRC
Lead sponsor: University of Southern Denmark
Sponsor class: OTHER
First posted: 2024-03-12
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: After being informed about the study and potential risks, all patients giving written informed consent will undergo screening serology and preoperative work-up to determine eligibility for study entery. Patients who meet the eligibility requirements will be treated for their fistulas by combined minor surgical debridement of the fistula tract and closure of the internal orifice as well as liposuction from the abdominal wall. Regenerative cells- enriched lipoaspirate will be injected around the entire length of the fistula tract. The first five patients will receive their own regenerative cells and act as donors for the next included patients, but they will not be included in the final analysis. The rest of the included patients (70) will be randomized in double-blinded manner (participant and investigator) in a 1:1 ratio to either recieve own regenerative cells (ADRC Adipose-Derived Regeneative Cells) or donated cultured regenerative cells (ADRC001). All included patients will be scheduled for follow-up at 3, 6 and 12 months after treatment.

Eligibility criteria: 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 outcomes:
measure: Healing rate (percentage)
timeFrame: at 6 and 12 months follow-up
Secondary outcomes:
measure: QoL
timeFrame: at12 months follow-up.
measure: Fecal Incontinence
timeFrame: at12 months follow-up.
measure: Risk factors for recurrence of fistula.
timeFrame: at12 months follow-up.
measure: Radiological healing.
timeFrame: at12 months follow-up.
measure: Treatment efficacy.
timeFrame: at12 months follow-up.
measure: Cellular composition
timeFrame: at 3 months follow-up.
measure: Transplantation-related alloantibodies
timeFrame: at12 months follow-up.
Other outcomes:
Locations:
city: Odense
country: Denmark
facility: Odense University Hospital
Study officials:
affiliation: OUH
name: Karam M Sørensen
role: PRINCIPAL_INVESTIGATOR
References: