A Study To Investigate The Safety And Possible Clinical Benefit Of Multistem(r) In Patients With Moderate To Severe Ulcerative Colitis
Status: | Completed |
---|---|
Conditions: | Colitis, Gastrointestinal |
Therapuetic Areas: | Gastroenterology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 4/21/2016 |
Start Date: | February 2011 |
End Date: | November 2014 |
A Phase 2 Randomized, Double-blind, Placebo-controlled, Parallel Group, Multi-center Study To Investigate The Safety And Efficacy Of Multistem (Pf-05285401) In Subjects With Moderate To Severe Ulcerative Colitis
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.
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.
Inclusion Criteria:
- 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 Criteria:
- 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.
We found this trial at
38
sites
Sentara Norfolk General Hospital Sentara Norfolk General Hospital is recognized as the number one ranked...
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1211 Medical Center Dr
Nashville, Tennessee 37232
Nashville, Tennessee 37232
(615) 322-5000
Vanderbilt Univ Med Ctr Vanderbilt University Medical Center (VUMC) is a comprehensive healthcare facility dedicated...
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Miami Research Associates Miami Research Associates (MRA) is the largest privately-owned multi-specialty clinical research center...
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University of Chicago Medical Center The University of Chicago Medicine has been at the forefront...
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University of Louisville Hospital As the academic hospital at the heart of the Louisville Metro...
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Wake Research Associates, LLC Wake Research is an Organization of Unified Investigational Sites working closely...
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University of Washington Medical Center University of Washington Medical Center is one of the nation's...
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Winston Salem, North Carolina 27157
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