Tissue Therapy of Transsphincteric Anal Fistula (REP-PAF)

University of Southern Denmark (SDU)

Status and phase: Enrolling; Phase 2; Phase 1

Conditions: Anal Fistula

Treatments: Drug: ADRC001 injection; Drug: ADRC injection

Study type: Interventional

Funder types: Other

Identifiers

NCT06303752

260-2021-NQ

2022-502659-73 (EudraCT Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 75 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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75 participants in 2 patient groups

Autologous ADRC

Experimental group

Description:

Allocated patients will be treated for the fistula by combined surgical debridement of the fistula tract, closure of the internal orifice and injection of 30 ml lipoaspirate around the entire length of the fistula tract. Lipoaspirate will be harvested from the anterior abdominal wall under the same operation. Two hours later, the patient 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.

Treatment:

Drug: ADRC injection

allogenic ADRC001

Experimental group

Description:

Allocated patients will be treated for the fistula by combined surgical debridement of the fistula tract, closure of the internal orifice and injection of 30 ml lipoaspirate around the entire length of the fistula tract. Lipoaspirate will be harvested from the anterior abdominal wall under the same operation. Two hours later, the patient will receive injection of 5 ml suspension including 30 million cultured allogenic adipose-derived regenerative cells ADRC001 and injected at the same site of the lipoaspirate injection.

Treatment:

Drug: ADRC001 injection