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Repairing Peri-Anal Fistulas with regenerative cell therapeutics: study protocol for a double-blinded randomized
Karam Matlub Sørensen1, Charlotte Harken Jensen2, Sören Möller3
1Research Unit of Surgery, Surgical Department A, Odense University Hospital (OUH), J. B. Winsløws Vej 4, Odense C, 5000, Denmark. Karam.Faiq.Sorensen@rsyd.dk.
Trials
|March 4, 2026
Summary
This clinical trial investigates adipose-derived regenerative cells (ADRCs) for treating complex perianal fistulas (PAFs). It compares autologous and allogeneic ADRCs to assess healing rates and functional outcomes, aiming for a minimally invasive treatment option.
Area of Science:
- Regenerative medicine and surgical innovation in proctology.
- Investigating the efficacy of stem cell therapy for complex anorectal conditions.
Background:
- Surgical treatment for high anal fistulas presents challenges with high complication and failure rates.
- Stem cell therapy shows promise for Crohn's disease fistulas but is less studied in cryptoglandular fistulas.
- Complex perianal fistulas (PAFs) require advanced treatment strategies beyond conventional surgery.
Purpose of the Study:
- To evaluate the clinical healing rate of complex cryptoglandular PAFs treated with minimal debridement and adipose-derived regenerative cells (ADRCs).
- To compare the efficacy of autologous versus allogeneic ADRCs in treating PAFs.
- To assess functional outcomes, including quality of life and anal continence, and radiological healing.
Main Methods:
- A double-blinded, randomized, phase I-II clinical trial involving 75 adult patients with complex PAFs.
- Patients receive minimal surgical debridement combined with either autologous or allogeneic ADRCs and microfat.
- Outcomes are assessed at 3, 6, and 12 months post-surgery, including clinical healing, SF-36, Wexner score, and MRI.
Main Results:
- Primary outcome is the clinical healing rate at 12 months post-treatment.
- Secondary outcomes include functional results (quality of life, continence), recurrence risk factors, and radiological healing.
- Comparison of autologous vs. allogeneic ADRCs regarding cell characteristics, immune response, and treatment efficacy.
Conclusions:
- The minimally invasive approach aims to reduce recovery time, facilitate return to daily activities, and preserve sphincter function.
- The trial is expected to determine if allogeneic ADRCs with microfat are a viable alternative to autologous ADRCs for PAF treatment.
- Evidence generated will inform future therapeutic strategies for complex perianal fistulas.
