1 Division of Colon and Rectal Surgery, Mayo Clinic, Rochester, Minnesota2 Department of Radiology, Mayo Clinic, Rochester, Minnesota3 Division of Transfusion Medicine, Mayo Clinic, Rochester, Minnesota4 Division of Gastroenterology and Hepatology, Mayo Clinic, Rochester, Minnesota
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BACKGROUND:Management of transsphincteric cryptoglandular fistulas remains a challenging problem and the optimal surgical approach remains elusive. Mesenchymal stem cells, increasingly being utilized for perianal Crohn’s disease, offer a novel therapy to treat cryptoglandular fistulas.OBJECTIVES:This study aimed to determine safety and feasibility of using an autologous mesenchymal stem cell-coated fistula plug in patients with transsphincteric cryptoglandular fistulas.DESIGN:This study is a phase I clinical trial.SETTING:This study was conducted at a tertiary academic medical center.PATIENTS:Adult (>18 years) male and female patients with transsphincteric cryptoglandular fistulas were selected.MAIN OUTCOMES MEASURES:The primary outcomes measured were the safety, feasibility, and efficacy of a mesenchymal stem cell-coated fistula plug in patients with transsphincteric fistulas.RESULTS:Fifteen patients (8 women, mean age 39.8 years) with a single-tract transsphincteric fistula received a mesenchymal stem cell-loaded fistula plug and were followed for 6 months. Duration of disease at the time of study enrollment was a median of 3.0 years (range, 1–13 years) with a median of 3.5 (range, 1–20) prior surgical interventions. Adverse events included 1 plug extrusion, 1 abdominal wall seroma, 3 perianal abscesses requiring drainage, and 1 patient with perianal cellulitis. There were no serious adverse events. At 6 months, 3 patients had complete clinical healing, 8 had partial healing, and 4 patients showed no clinical improvement. Radiographic improvement was seen in 11 of 15 patients.LIMITATIONS:This study was limited by the small cohort and short follow-up.CONCLUSIONS:Autologous mesenchymal stem cell-coated fistula plug treatment of transsphincteric cryptoglandular fistulas was safe and feasible and resulted in complete or partial healing in a majority of patients. See Video Abstract at http://links.lww.com/DCR/A897.