Format

Send to

Choose Destination

See 1 citation found by title matching your search:

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.

Author information

1
Department of Colorectal Surgery, Cleveland Clinic, Cleveland, Ohio, USA.
2
Division of Colon and Rectal Surgery, Rochester, Minnesota, USA.
3
IMPACT Lab, Division of Transfusion Medicine, Department of Laboratory Medicine and Pathology, Rochester, Minnesota, USA.
4
Department of Radiology, Rochester, Minnesota, USA.
5
Department of Gastroenterology, Mayo Clinic, Rochester, Minnesota, USA.

Abstract

BACKGROUND:

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.

METHODS:

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.

RESULTS:

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.

CONCLUSIONS:

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.

KEYWORDS:

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

PMID:
31605115
DOI:
10.1093/ibd/izz215

Supplemental Content

Full text links

Icon for Silverchair Information Systems
Loading ...
Support Center