A Study To Investigate The Safety And Possible Clinical Benefit Of Multistem(r) In Patients With Moderate To Severe Ulcerative Colitis
Public ClinicalTrials.gov record NCT01240915. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT01240915
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 105 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Feb 2011 (Type not available)
- Primary completion
- Nov 2014 (Actual)
- Completion
- Nov 2014 (Actual)
- Last update posted
- Feb 23, 2016
2011 – 2014
United States locations
- U.S. sites
- 37
- U.S. states
- 15
- U.S. cities
- 27
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of California San Francisco | San Francisco | California | 94115 | — |
| USCF Endoscopy Unit at Mount Zion | San Francisco | California | 94115 | — |
| Clinical Research of the Rockies | Lafayette | Colorado | 80026 | — |
| Rocky Mountain Gastroenterology Associates, LLC | Lakewood | Colorado | 80215 | — |
| Arapahoe Gastroenterology, PC | Littleton | Colorado | 80120 | — |
| Metropolitan Gastroenterology Group, PC | Washington D.C. | District of Columbia | 20006 | — |
| Gastroenterology Consultants of Clearwater | Clearwater | Florida | 33756 | — |
| West Coast Endoscopy Center | Clearwater | Florida | 33756 | — |
| Clinical Research of West Florida, Inc. | Clearwater | Florida | 33765 | — |
| Borland-Groover Clinic | Jacksonville | Florida | 32256 | — |
| Jacksonville Center for Endoscopy | Jacksonville | Florida | 32256 | — |
| Miami Research Associates | South Miami | Florida | 33143 | — |
| University of Chicago Medical Center | Chicago | Illinois | 60637 | — |
| Cotton-O'Neil Clinical Research Center, Digestive Health | Topeka | Kansas | 66606 | — |
| University of Louisville Healthcare Outpatient Center | Louisville | Kentucky | 40202 | — |
| University of Louisville Hospital | Louisville | Kentucky | 40202 | — |
| Metropolitan Gastroenterology Group, PC - Chevy Chase Clinical Research | Chevy Chase | Maryland | 20815 | — |
| Endoscopic Microsurgery Associates, PA | Towson | Maryland | 21204 | — |
| Clinical Research Institute of Michigan, LLC | Chesterfield | Michigan | 48047 | — |
| Center for Digestive Health | Troy | Michigan | 48098 | — |
| Utica Surgery Center | Utica | Michigan | 48317 | — |
| Surgery Center of Columbia | Columbia | Missouri | 65201 | — |
| Center for Digestive and Liver Diseases, Inc. | Mexico | Missouri | 65265 | — |
| Present, Chapman, Steinlauf and Marion | New York | New York | 10028 | — |
| Mount Sinai School of Medicine | New York | New York | 10029 | — |
| Asher Kornbluth, MD PC | New York | New York | 10128 | — |
| Charlotte Gastroenterology and Hepatology, PLLC | Charlotte | North Carolina | 28207 | — |
| Wake Internal Medicine Consultants, Inc. | Raleigh | North Carolina | 27612 | — |
| Wake Research Associates | Raleigh | North Carolina | 27612 | — |
| Wake Forest University University Baptist Medical Center - Internal Medicine | Winston-Salem | North Carolina | 27157 | — |
| Gastro One | Germantown | Tennessee | 38138 | — |
| Vanderbilt University Medical Center | Nashville | Tennessee | 37232-1375 | — |
| Digestive and Liver Disease Specialists | Norfolk | Virginia | 23502 | — |
| Sentara Leigh Hospital | Norfolk | Virginia | 23502 | — |
| Sentara Norfolk General Hospital | Norfolk | Virginia | 23507 | — |
| McGuire DVAMC | Richmond | Virginia | 23249 | — |
| University of Washington Medical Center | Seattle | Washington | 98195 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 21 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01240915, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Feb 23, 2016 · Synced Oct 19, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT01240915 live on ClinicalTrials.gov.