A Study To Investigate The Safety And Possible Clinical Benefit Of Multistem(r) In Patients With Moderate To Severe Ulcerative Colitis

Completed · Phase 2 · Has a placebo group

Conditions studied: Colitis, Ulcerative

In brief

MultiStem(r) is a new biological product, manufactured from human stem cells obtained from adult bone marrow or other nonembryonic tissue sources. Factors expressed by MultiStem cells are believed to reduce inflammation and regulate immune system function, protect damaged or injured cells and tissue, promote formation of new blood vessels, and augment tissue repair and healing. MultiStem cell treatment resulted in significant efficacy in a mouse model of Graft versus Host Disease with almost complete reversal of gastrointestinal pathology (similar to pathology that would be expected in Ulcerative Colitis). These data, together with safety data generated in 2 other clinical trials, suggest that MultiStem has the potential to be a new treatment option for patients with ulcerative colitis. This is the first study of MultiStem in this patient population and will cautiously explore the safety/toleration and potential benefit of this new treatment in patients with moderate to severe disease.

Key facts

Study ID

NCT01240915

Run by

Pfizer

People needed

105

Starts

2011-02-01

Expected to finish

2014-11-01

Last updated by the study team

2016-02-23

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Subjects must have a documented diagnosis of ulcerative colitis at least 6 months prior to screening.
• Subjects must have active moderate-to-severe ulcerative colitis based on Mayo score.
• Subjects must have Modified Baron endoscopic score of at least 2 determined within 7 days of first dosing.
• Subjects must have failed or be intolerant (as determined by the investigator) of at least one of the following treatments for UC: Oral corticosteroids, azathioprine or 6-mercaptopurine (6-MP), or anti-tumor necrosis factor (TNF) therapy, eg, infliximab or adalimumab.
• Subjects must be on stable steroid doses.

You may not qualify if…

• Subjects who have abnormal organ and marrow function.
• Subjects with a diagnosis of indeterminate colitis, or clinical findings suggestive of Crohn's disease.
• Subjects who meet Truelove-Witts criteria for severe ulcerative colitis.
• Subjects receiving or who are expected to receive Infliximab or other biologic treatment within 8 weeks of the Day 1 study visit.
• Subjects receiving or who are expected to receive Cyclosporine, mycophenolate, or tacrolimus within 4 weeks of the Day 1 study visit.

Where it is running

• USCF Endoscopy Unit at Mount Zion — San Francisco, California, United States
• Clinical Research of the Rockies — Lafayette, Colorado, United States
• Rocky Mountain Gastroenterology Associates, LLC — Lakewood, Colorado, United States
• Arapahoe Gastroenterology, PC — Littleton, Colorado, United States
• Metropolitan Gastroenterology Group, PC — Washington D.C., District of Columbia, United States
• Gastroenterology Consultants of Clearwater — Clearwater, Florida, United States
• West Coast Endoscopy Center — Clearwater, Florida, United States
• Clinical Research of West Florida, Inc. — Clearwater, Florida, United States
• Borland-Groover Clinic — Jacksonville, Florida, United States
• Jacksonville Center for Endoscopy — Jacksonville, Florida, United States
• Miami Research Associates — South Miami, Florida, United States
• University of Chicago Medical Center — Chicago, Illinois, United States
• Cotton-O'Neil Clinical Research Center, Digestive Health — Topeka, Kansas, United States
• University of Louisville Healthcare Outpatient Center — Louisville, Kentucky, United States
• University of Louisville Hospital — Louisville, Kentucky, United States
• Metropolitan Gastroenterology Group, PC - Chevy Chase Clinical Research — Chevy Chase, Maryland, United States
• Endoscopic Microsurgery Associates, PA — Towson, Maryland, United States
• Clinical Research Institute of Michigan, LLC — Chesterfield, Michigan, United States
• Center for Digestive Health — Troy, Michigan, United States
• Utica Surgery Center — Utica, Michigan, United States
• Surgery Center of Columbia — Columbia, Missouri, United States
• Center for Digestive and Liver Diseases, Inc. — Mexico, Missouri, United States
• Present, Chapman, Steinlauf and Marion — New York, New York, United States
• Mount Sinai School of Medicine — New York, New York, United States
• University of California San Francisco — San Francisco, California, United States

Full record on ClinicalTrials.gov

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