Short summary

The trial will be conducted as double blinded randomized clinical trial and aims to evaluate the outcome of the treatment of complex crypto-glandular perianal fistulas (PAF) by the combination of minimal surgical debridement of the fistula as welle as injection of autologous lipoaspirate and injection of either autologous or allogenic ADRC (Adipose Derived Regenerative Cells). treated patients will be scheduelled for 3 follow-up visits at 3, 6 and 12 months postoperatively.

Rationale

Treatment of high anal fistula is demanding and is associated with relatively high rate of complications and failure. The use of stem cells in the treatment of complicated anal fistula has been shown to be safe with promising short and long term results. This clinical study aims to evaluate the outcome of the treatment of complex crypto-glandular perianal fistulas (PAF) by the combination of minimal surgical debridement with regenerative cellular therapeutics.

Description of the cohort

The study will include adult patients (>= 18years) with complex perianal 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

Data and biological material

Data collection includes clinical and radiological findings, blod sample results and questionnaire data.

Collaborating researchers and departments

Department of Plastic Surgery, OUH

Department of Clinincal biochemistry and Pharmacology, OUH