Extended Evaluation of PROCHYMAL® Adult Human Stem Cells for Treatment-Resistant Moderate-to-Severe Crohn's Disease
Public ClinicalTrials.gov record NCT00543374. 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 Durability and Retreatment Study to Evaluate the Safety and Efficacy of PROCHYMAL® (ex Vivo Cultured Adult Human Mesenchymal Stem Cells) Intravenous Infusion for the Maintenance and Re-induction of Clinical Benefit and 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 610 is enrolling subjects who successfully achieved clinical benefit (reduction in Crohn's Disease Activity Index (CDAI) of at least 100 points) in Protocol 603. Protocol 610 is evaluating the length of initial effect of PROCHYMAL® adult human mesenchymal stem cells and the ability of these cells to successfully re-induce clinical benefit.
Study identification
- NCT ID
- NCT00543374
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 98 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
- Jul 2009 (Actual)
- Completion
- Apr 28, 2011 (Actual)
- Last update posted
- Mar 11, 2026
2007 – 2011
United States locations
- U.S. sites
- 53
- U.S. states
- 27
- U.S. cities
- 47
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Advanced Clinical Research Institute | Anaheim | California | 92801 | — |
| Veteran's Administration Medical Center (does not require vet status) | Long Beach | California | 90822 | — |
| 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 | — |
| Gastroenterology Center of Connecticut | Hamden | Connecticut | 06518 | — |
| Clinical Research of West Florida | Clearwater | Florida | 33765 | — |
| Borland-Groover Clinic | Jacksonville | Florida | 32256 | — |
| Venture Research Institute | Miami | Florida | 33162 | — |
| 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 | — |
| National Institutes of Health | Bethesda | Maryland | 20892 | — |
| Metropolitan Gastroenterology Group | 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 | — |
| Gastroenterology Research Associates | Cedar Knolls | New Jersey | 07927 | — |
| Holy Name Hospital | Teaneck | New Jersey | 07666 | — |
| 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 | — |
| Dayton Science Institute | Dayton | Ohio | 45415 | — |
| 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 | — |
| Memorial Hermann Hospital | 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 5 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00543374, 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 28, 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 NCT00543374 live on ClinicalTrials.gov.