Evaluation of PROCHYMAL® Adult Human Stem Cells for Treatment-resistant Moderate-to-severe Crohn's Disease
Public ClinicalTrials.gov record NCT00482092. 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 III, Multicenter, Placebo-controlled, Randomized, Double-blind Study to Evaluate the Safety and Efficacy of PROCHYMAL® (ex Vivo Cultured Adult Human Mesenchymal Stem Cells) Intravenous Infusion for the Induction of Remission in Subjects Experiencing Treatment-refractory Moderate-to-severe Crohn's Disease
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
Protocol 603 is enrolling subjects with moderate-to-severe Crohn's disease who are intolerant to, or have previously failed therapy with, at least one steroid and at least one immunosuppressant and a biologic monoclonal anti-body to tumor necrosis factor alpha. The protocol investigates the safety and efficacy of using PROCHYMAL® adult human stem cells to induce remission. PROCHYMAL is delivered through a vein in the arm four times over two weeks, for approximately an hour each time.
Study identification
- NCT ID
- NCT00482092
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 330 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 70 Years
- 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
- Sep 17, 2007 (Actual)
- Primary completion
- Sep 15, 2014 (Actual)
- Completion
- Sep 15, 2014 (Actual)
- Last update posted
- Mar 11, 2026
2007 – 2014
United States locations
- U.S. sites
- 47
- U.S. states
- 24
- U.S. cities
- 41
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of Southern California University Hospital | Los Angeles | California | 90033 | — |
| University of California, San Francisco | San Francisco | California | 94115 | — |
| Western States Clinical Research | Wheat Ridge | Colorado | 80033 | — |
| Clinical Research of West Florida | Clearwater | Florida | 33765 | — |
| Borland-Groover Clinic | Jacksonville | Florida | 32256 | — |
| Shafran Gastroenterology Center | Winter Park | Florida | 32789 | — |
| Atlanta Gastroenterology Associates | Atlanta | Georgia | 30342 | — |
| University of Chicago Medical Center | Chicago | Illinois | 60637 | — |
| Carle Clinic Association | Urbana | Illinois | 61801 | — |
| Indiana University Medical Center | Indianapolis | Indiana | 46202 | — |
| Cotton-O'Neil Clinical Research Center | Topeka | Kansas | 66606 | — |
| University of Kentucky Hospital | Lexington | Kentucky | 40536 | — |
| University of Louisville Hospital | Louisville | Kentucky | 40202 | — |
| Gulf Coast Research | Baton Rouge | Louisiana | 70808 | — |
| University of Maryland, Baltimore | Baltimore | Maryland | 21201 | — |
| National Institutes of Health | Bethesda | Maryland | 20892 | — |
| Chevy Chase Clinical Research | Chevy Chase | Maryland | 20815 | — |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | — |
| Brigham and Womens Hospital | Boston | Massachusetts | 02115 | — |
| Clinical Pharmacology Study Group | Worcester | Massachusetts | 01610 | — |
| Center for Clinical Studies | Dearborn | Michigan | 48124 | — |
| Center for Digestive Health | Troy | Michigan | 48098 | — |
| University of Minnesota Hospital | Minneapolis | Minnesota | 55455 | — |
| St Louis Center for Clinical Studies | St Louis | Missouri | 63128 | — |
| Dartmouth Hitchcock Medical Center | Lebanon | New Hampshire | 03756 | — |
| Weill Cornell Medical College | New York | New York | 10028 | — |
| Mount Sinai School of Medicine | New York | New York | 10029 | — |
| Rochester Institute for Digestive Diseases | Rochester | New York | 14607 | — |
| Rochester General Hospital | Rochester | New York | 14621 | — |
| University Hospital and Medical Center | Stony Brook | New York | 11794 | — |
| Charlotte Gastroenterology and Hepatology | Charlotte | North Carolina | 28207 | — |
| Pinehurst Medical Clinic | Pinehurst | North Carolina | 28734 | — |
| Wake Forest University | Winston-Salem | North Carolina | 27157 | — |
| Gastroenterology United of Tulsa | Tulsa | Oklahoma | 74135 | — |
| Options Health Research | Tulsa | Oklahoma | 74137 | — |
| Allegheney Center for Digestive Health | Pittsburgh | Pennsylvania | 15212 | — |
| University of Pittsburgh | Pittsburgh | Pennsylvania | 15213 | — |
| Gastroenterology Center of the Midsouth | Germantown | Tennessee | 37138 | — |
| Nashville GI Specialists | Nashville | Tennessee | 37205 | — |
| Vanderbilt University Medical Center | Nashville | Tennessee | 37232 | — |
| Baylor University Medical Center | Dallas | Texas | 75246 | — |
| University of Texas Medical Branch | Galveston | Texas | 77555 | — |
| University of Texas Health Science Center | Houston | Texas | 77030 | — |
| University of Vermont | Burlington | Vermont | 05401 | — |
| Digestive and Liver Disease Specialists | Norfolk | Virginia | 23502 | — |
| McGuire Research Institute | Richmond | Virginia | 23249 | — |
| Seattle Gastroenterology Associates | Seattle | Washington | 98133 | — |
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 9 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00482092, 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 Mar 11, 2026 · Synced Oct 19, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT00482092 live on ClinicalTrials.gov.