Study of Mesenchymal Stem Cells for the Treatment of Ileal Pouch Fistula's in Participants With Crohn's Disease
Status:
Recruiting
Trial end date:
2022-10-01
Target enrollment:
Participant gender:
Summary
Restorative proctocolectomy with ileal pouch anal anastomosis (IPAA) is the procedure of
choice for patients with ulcerative colitis, familial adenomatous polyposis, and select
patients with Crohn's disease due to overall low patient morbidity and good quality of life.
However, some patients can develop Crohn's disease of the pouch, a clinical diagnosis of
Crohn's disease following IPAA. One of the manifestations of Crohn's disease of the pouch
includes a fistula from the pouch that travels to the vagina or perianal area. These fistulas
can be quite difficult to manage with medications and local surgical intervention, and, on
occasion result in a reconstruction pouch but more often require a pouch excision with
permanent end ileostomy. The purpose of this study is to evaluate the safety and efficacy of
using allogeneic bone marrow derived mesenchymal stem cells to treat people who have a
peri-pouch fistula related to a clinical diagnosis of Crohn's disease of the pouch.