Mesenchymal Stem Cells for the Treatment of Pouch Fistulas in Crohn's
(IPAAF Trial)

Recruiting in Palo Alto (17 mi)

Overseen byAmy Lightner, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: The Cleveland Clinic

No Placebo Group

Trial Summary

What is the purpose of this trial?

The purpose of this study is to determine the safety and feasibility of using allogeneic bone marrow derived mesenchymal stem cells (MSCs) to treat people with an ileal pouch anal anastomosis (IPAA) who develop a fistula in the setting of Crohn's disease of the pouch.

Research Team

Amy Lightner, MD

Principal Investigator

The Cleveland Clinic

Eligibility Criteria

Inclusion Criteria

Men and women 18-75 years of age who have undergone an ileal pouch anal anastomosis at least 6 months prior who have developed a clinical diagnosis of Crohn's disease of the pouch as determined by a combination of clinical symptoms, pouchoscopy with biopsy, enterography.

Single and multi-tract (up to 2 internal and 3 external openings) fistula tract arising from the ileal pouch, ileal anal anastomosis, or anal canal distal to anastomosis that travels to the perianal skin, perineal body, or vagina. Patients with fistulas that arise from the pouch, anastomosis, or anal canal distal to the anastomosis will both be included in enrollment.

Acceptable internal openings and tract locations for the fistula to arise from include the ileal pouch body, the pouch anal anastomosis, and the anal canal distal to the anastomosis.

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Treatment Details

Interventions

mesenchymal stem cells (MSCs) (Stem Cell Therapy)

Participant Groups

1Treatment groups

Experimental Treatment

Group I: mesenchymal stem cells (MSCs)Experimental Treatment1 Intervention

Direct injection of 75 million allogeneic bone marrow derived mesenchymal stem cells (MSC) into ileal pouch fistula at baseline and possibly again after 3 months if not completely healed.