Cell therapy in surgical treatment of fistulas. Preliminary results

Risk of recurrence after surgical treatment of a recurrent fistula is up to 50%. It has be known that more aggressive surgical treatment is associated with a high risk of anal sphincter damage and leads to incontinence. Several studies have been designed to elaborate minimally invasive treatment of rectovaginal and anal fistulas. The properties of Adipose-derived Stem Cells (ASC) significantly enhance a natural healing potency. Here, we present our experience with combined surgical and cell therapy in the treatment of fistulas.

Four patients were enrolled in our study after unsuccessful treatments in the past - patients 1-3 with rectovaginal fistulas including two women after graciloplasty, and patient 4 - a male with complex perianal fistula. Adipose tissue was obtained from subcutaneous tissue. ASCs were isolated, cultured up to 10+/-2 mln cells and injected into the walls of fistulas. Follow-up physical examination and anoscopy were performed at 1, 4, 8, and 12 weeks, 6 and 12 months after implantation.

Up to 8 weeks after ASC implantation, symptoms of fistulas' tracts disappeared. At 8 weeks, in patients 1-3, communication between vaginal and rectal openings was closed and at 12-16 w. intestinal continuity was restored in patient 3 and 4. After a 6-month follow-up, the fistula tract of patient 4 was closed. Up to 12 m. after ASC implantation no recurrences or adverse events were observed.

ASCs combined with surgical pre-treated fistula tracts were used in four patients. All of them were healed. This encouraging result needs further trials to evaluate the clinical efficiency and the cost-effectiveness ratio.