Status:
COMPLETED
A Study To Investigate The Safety And Possible Clinical Benefit Of Multistem(r) In Patients With Moderate To Severe Ulcerative Colitis
Lead Sponsor:
Pfizer
Collaborating Sponsors:
Healios K.K.
Conditions:
Colitis, Ulcerative
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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 ...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
February 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2014
Estimated Enrollment :
105 Patients enrolled
Trial Details
Trial ID
NCT01240915
Start Date
February 1 2011
End Date
November 1 2014
Last Update
February 23 2016
Active Locations (58)
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1
University of California San Francisco
San Francisco, California, United States, 94115
2
USCF Endoscopy Unit at Mount Zion
San Francisco, California, United States, 94115
3
Clinical Research of the Rockies
Lafayette, Colorado, United States, 80026
4
Rocky Mountain Gastroenterology Associates, LLC
Lakewood, Colorado, United States, 80215