Repairing Peri-Anal Fistulas With Regenerative Cell Therapeutics

What this Trial Is About

Researchers are evaluating the treatment of complex perianal fistulas using a combination of minor surgical cleaning and regenerative cell therapy. This clinical study is focused on patients with high transsphincteric or suprasphincteric anal fistulas involving more than 30% of the anal sphincter. The goal is to assess healing outcomes and other effects of these treatments in adults who meet specific eligibility criteria. Patients eligible for the study will undergo minor surgical debridement of the fistula tract, closure of the internal orifice, and liposuction from the abdominal wall to collect fat tissue. Following this, regenerative cells enriched from the fat tissue will be injected around the fistula tract. The study includes two groups: one receiving their own regenerative cells (autologous ADRC) and the other receiving donated cultured regenerative cells (allogenic ADRC001). The first five patients act as donors but are not included in the final analysis. Participants will be randomly assigned to one of these two treatment groups in a double-blinded manner. Participants will be monitored through follow-up visits scheduled at 3, 6, and 12 months after treatment. Researchers will assess healing rates, quality of life, fecal incontinence, recurrence risk factors, radiological healing, treatment efficacy, and cellular composition. Safety measures include monitoring for transplantation-related antibodies. The study aims to provide detailed information about the effectiveness and safety of these regenerative cell therapies over a one-year period.

Tissue Therapy of Transsphincteric Anal Fistula