Stem cell injection for complex anal fistula in Crohn's disease: A single-center experience.

Early human evidence such as case series or small samples is exploring possible benefits.

• Level A · Stronger Clinical Evidence
• Level B · Emerging clinical evidence with positive signals
• Level C · Early human research exploring benefits
• Level D · Scientific groundwork from lab and animal studies
• Emerging · Emerging topic under active research

Abstract (original English)

Background Despite tremendous progress in medical therapy and optimization of surgical strategies, considerable failure rates after surgery for complex anal fistula in Crohn's disease have been reported. Therefore, stem cell therapy for the treatment of complex perianal fistula can be an innovative option with potential long-term healing. Aim To evaluate the results of local administration of allogenic, adipose-derived mesenchymal stem cells (darvadstrocel) for complex anal Crohn's fistula. Methods All patients with complex anal fistulas associated with Crohn's disease who were amenable for definite fistula closure within a defined observation period were potential candidates for stem cell injection (darvadstrocel) if at least one conventional or surgical attempt to close the fistula had failed. Darvadstrocel was only indicated in patients without active Crohn's disease and without presence of anorectal abscess. Local injection of darvadstrocel was performed as a standardized procedure under general anesthesia including single-shot antibiotic prophylaxis, removal of seton drainage, fistula curettage, closure of the internal openings and local stem cell injection. Data collection focusing on healing rates, occurrence of abscess and follow-up was performed on a regular basis of quality control and patient care. Data were retrospectively analyzed. Results Between July 2018 and Jan

Evidence level

Early human evidence such as case series or small samples is exploring possible benefits.

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