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Inflamm Bowel Dis. 2019 Oct 12. pii: izz215. doi: 10.1093/ibd/izz215. [Epub ahead of print]

Matrix-Delivered Autologous Mesenchymal Stem Cell Therapy for Refractory Rectovaginal Crohn's Fistulas.

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Department of Colorectal Surgery, Cleveland Clinic, Cleveland, Ohio, USA.
Division of Colon and Rectal Surgery, Rochester, Minnesota, USA.
IMPACT Lab, Division of Transfusion Medicine, Department of Laboratory Medicine and Pathology, Rochester, Minnesota, USA.
Department of Radiology, Rochester, Minnesota, USA.
Department of Gastroenterology, Mayo Clinic, Rochester, Minnesota, USA.



Crohn's rectovaginal fistulizing disease remains notoriously difficult to treat. A phase I clinical trial to evaluate the safety and feasibility of a novel protocol using a mesenchymal stem cell (MSC)-coated Gore Bio-A fistula plug for the treatment of medically and surgically refractory Crohn's rectovaginal fistulas was conducted.


Five patients underwent an autologous subcutaneous adipose tissue harvest via a 2-cm abdominal wall incision at time of exam under anesthesia (EUA) with seton placement. MSCs were isolated, expanded, and impregnated on the plug. After 6 weeks, patients returned to the operating room for placement of the MSC-coated plug. The primary end points were safety and feasibility; the secondary end point was clinical and radiographic healing at 6 months.


Five female patients (median age [range], 49 [38-53] years) with a median disease duration (range) of 23 (7-34) years who were on biologic (n = 5) or combination therapy (n = 3) had successful harvest and expansion of MSCs and delivery of the Gore Bio-A plug. There were no serious adverse events or adverse events related to the MSCs or plug during the 6-month follow-up. At 6 months, 3 patients had complete cessation of drainage, and 2 had >50% reduction in drainage; all had a persistent fistula tract identified on magnetic resonance imaging and EUA at 6 months.


Surgical placement of an autologous adipose-derived MSC-coated fistula plug in diverted patients with Crohn's rectovaginal fistulas was safe and feasible. All patients had a reduction in the size of their fistula tract, and 3 of 5 had cessation of drainage, but none achieved complete healing.This was a phase I clinical trial of autologous mesenchymal stem cells on a plug for rectovaginal Crohn's fistulas.


Crohn’s disease; matrix; mesenchymal stem cell; rectovaginal fistula


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