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Mesenchymal Stem Cell Therapy

Stem Cell Therapy for Ulcerative Colitis

Phase 1

Recruiting

Led By William Faubion, MD

Research Sponsored by Mayo Clinic

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Males and Females 18-65 years of age

All patients must have failed at least 2 standard FDA approved medications for the treatment of UC

Must not have

C. Difficile infection within 30 days of study injection

Neoplasia of the colon and preoperative biopsy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 24 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing whether using a person's own stem cells can help treat Ulcerative Colitis.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects may include reactions related to the infusion of stem cells such as pain or swelling at injection site, fever, allergic reactions or immune system responses. Since this is a test for safety and feasibility, other unexpected side effects might also occur.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 18 and 65 years old.

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

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I am capable of understanding and signing the consent form.

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My ulcerative colitis is severe and not responding to standard treatments.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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I have a colon tumor and had a biopsy before surgery.

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I have a history of hepatitis B, C, or HIV.

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I have had part of my colon removed.

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I might have Crohn's disease or an unclear type of colitis.

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I haven't had major heart issues or other serious health problems in the last 6 months.

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I have a condition that increases my risk of blood clots.

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I have severe colon issues, including an ostomy or ileoanal pouch.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~24 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Number of participants with treatment-related adverse events

Secondary study objectives

Number of participants with clinical symptom response

Number of participants with improved healing on pathology

Number of participants with mucosal healing

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

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.

0 / 12Eligibility criteria met