Tissue Therapy of Transsphincteric Anal Fistula
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: ADRC injection, ADRC001 injection.
- Who it may be relevant to
- Registry conditions: Anal Fistula. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Denmark
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Repairing Peri-Anal Fistulas With Regenerative Cell Therapeutics
Overview
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.
Interventions
- Drug 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. - Drug 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.
Primary outcome measures
- Healing rate (percentage) [Time frame: at 6 and 12 months follow-up]
Secondary outcome measures (7)
- QoL [Time frame: at12 months follow-up.]
- Fecal Incontinence [Time frame: at12 months follow-up.]
- Risk factors for recurrence of fistula. [Time frame: at12 months follow-up.]
- Radiological healing. [Time frame: at12 months follow-up.]
- Treatment efficacy. [Time frame: at12 months follow-up.]
- Cellular composition [Time frame: at 3 months follow-up.]
- Transplantation-related alloantibodies [Time frame: at12 months follow-up.]
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
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
Denmark · 1 center
- Odense University Hospital — Odense
Identifiers
NCT: NCT06303752 · 260-2021-NQ · 2022-502659-73