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To provide open-label re-treatment with PROCHYMAL to participants enrolled in companion Protocol 603 to evaluate the safety in participants with active Crohn's disease who are resistant to standard Crohn's disease therapies.
Participants will receive infusions of PROCHYMAL on Day 42, Day 84, and Day 126 after initial infusion of PROCHYMAL in Protocol 603. Each infusion will contain 200 million cells. As participants will be required to be in Protocol 603 during the entire duration of their participation in Protocol 611, all concomitant medication and safety information will be monitored by Protocol 603 and the combination of data from the two protocols.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Prochymal® | Experimental | Infusions of Prochymal on days 42-45, 84-87, and 126-129 after first infusion in Protocol 603. Each infusion of PROCHYMAL (remestemcel-L) will contain 200 million cells. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Prochymal® | Drug | PROCHYMAL will be administered IV in a total volume of 300 ml (200 million cells) at a rate of 4-6 ml/minute. Treatments will be administered on Days 42-45, Days 84-87, and Days 126-129 following first infusion in Protocol 603. |
| Measure | Description | Time Frame |
|---|---|---|
| Disease remission | Crohn's Disease Activity Index (CDAI) at or below 150 and increase in IBDQ | 180 Days after first infusion in Protocol 603 |
| Measure | Description | Time Frame |
|---|---|---|
| Disease Improvement | CDAI response to treatments is defined as a CDAI of 150 or below, or a reduction in CDAI of at least 100 points. | 180 Days after first infusion in Protocol 603 |
| Improvement in Quality of Life (IBDQ) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Christopher James, PA | Mesoblast, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California, San Francisco | San Francisco | California | 94115 | United States | ||
| Clinical Research of West Florida |
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|
IBDQ response to treatment is defined as IBDQ of 170 or above, or an increase in IBDQ of at least 16 points.
| 180 Days after first infusion in Protocol 603 |
| Number of Adverse events as a measure of safety | 180 Days after first infusion in Protocol 603 |
| Infusional toxicity as a measure of safety and tolerability | Infusional toxicity will be evaluated by continuously monitoring the subject's vital signs and O2 saturation by pulse oximetry from the time of PROCHYMAL administration until two hours after infusion is complete. | 180 Days after first infusion in Protocol 603 |
| Clearwater |
| Florida |
| 33765 |
| United States |
| Shafran Gastroenterology Center | Winter Park | Florida | 32789 | United States |
| University of Chicago | Chicago | Illinois | 60611 | United States |
| Cotton-O'Neil Clinical Research Center | Topeka | Kansas | 66606 | United States |
| University of Maryland, Baltimore | Baltimore | Maryland | 21201 | United States |
| Chevy Chase Clinical Research | Chevy Chase | Maryland | 20815 | United States |
| Saint Louis Center for Clinical Research | St Louis | Missouri | 63128 | United States |
| St. Louis Center for Clinical Studies | St Louis | Missouri | 63128 | United States |
| Dartmouth Hitchcock Medical Center | Lebanon | New Hampshire | 03756 | United States |
| Weill Cornell Medical College | New York | New York | 10028 | United States |
| Mount Sinai School of Medicine | New York | New York | 10029 | United States |
| Gastroenterology Center of the Midsouth, PC | Germantown | Tennessee | 38138 | United States |
| Vanderbilt University Medical Center | Nashville | Tennessee | 37232 | United States |
| Baylor University Medical Center | Dallas | Texas | 75246 | United States |
| McGuire Research Institute | Richmond | Virginia | 23249 | United States |
| Royal Adelaide Hospital | Adelaide | South Australia | Australia |
| Royal Melbourne Hospital | Melbourne | Victoria | Australia |
| University of Otago | Christchurch | New Zealand |
| Waikato Hospital | Hamilton | New Zealand |
| ID | Term |
|---|---|
| D003424 | Crohn Disease |
| ID | Term |
|---|---|
| D015212 | Inflammatory Bowel Diseases |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D007410 | Intestinal Diseases |
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| ID | Term |
|---|---|
| C000711674 | remestemcel-l |
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