Stem Cell Therapy for Ulcerative Colitis

Recruiting in Palo Alto (17 mi)

Overseen byWilliam Faubion, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: Mayo Clinic

No Placebo Group

Trial Summary

What is the purpose of this trial?Researchers are trying to determine the safety and feasibility of using an adipose derived mesenchymal stem cell (MSC) to treat people with Ulcerative Colitis.

Eligibility Criteria

This trial is for men and women aged 18-65 with moderate to severe ulcerative colitis that hasn't improved after trying at least two FDA-approved treatments. Participants must have a stable hemoglobin level, normal blood clotting, and agree to use contraception. Excluded are those with certain medical conditions like vasculitis, cancer history (except localized skin cancers), recent investigational drug use, partial colectomy, or significant allergies.

Inclusion Criteria

Ability to comply with protocol

I am between 18 and 65 years old.

I have tried at least 2 standard treatments for UC without success.

+7 more

Exclusion Criteria

Pregnant patients or trying to become pregnant or breastfeeding

Inability to give informed consent

I have had a C. Diff infection in the last 30 days.

+13 more

Participant Groups

The study is testing the safety and effectiveness of using adipose-derived mesenchymal stem cells (cells from one's own body fat) in treating ulcerative colitis. Researchers will deliver these cells through an angiographic procedure to see if they can help heal ulcers in the colon.

1Treatment groups

Experimental Treatment

Group I: Autologous mesenchymal stem cellsExperimental Treatment1 Intervention

Adipose derived, autologous mesenchymal stem cells (AD-MSCs) at a dose of 15 million or 30 million cells will be administered via intra-arterial delivery with interventional radiology to the inferior mesenteric artery in subjects with medically refractory ulcerative colitis.