Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00543374 | Extended Evaluation of PROCHYMAL® Adult Human Stem Cells for Treatment-Resistant Moderate-to-Severe Crohn's Disease | PHASE3 | COMPLETED | 98 | — | — | Sep 17, 2007 | Apr 28, 2011 | Mar 11, 2026 | 58 | United States, Canada |
| NCT00294112 | Prochymal™ Adult Human Mesenchymal Stem Cells for Treatment of Moderate-to-severe Crohn's Disease | PHASE2 | COMPLETED | 10 | — | — | Mar 13, 2006 | Jul 21, 2006 | Apr 2, 2020 | 4 | United States |
The CDAI is a composite index of 8 disease variables (stool frequency, severity of abdominal pain, degree of general well-being, presence or absence of extra-intestinal manifestations or fistula, use or non-use of antidiarrheal agents, presence or absence of an abdominal mass, hematocrit, and body weight). Scores range from approximately 0 to 600, with a higher score indicating more disease activity.
| Arm | Type | Description |
|---|---|---|
| Placebo | PLACEBO_COMPARATOR | Placebo |
| PROCHYMAL Low dose | ACTIVE_COMPARATOR | Low dose (total of 600 million cells). |
| PROCHYMAL High dose | ACTIVE_COMPARATOR | High dose (total of 1200 cells). |
| High dose | EXPERIMENTAL | High dose (8 million cells per kg of body weight) |
| Low dose | EXPERIMENTAL | Low dose: 2 million cells per kg body weight |
| Name | Type | Description |
|---|---|---|
| Placebo | DRUG | - |
| PROCHYMAL adult human mesenchymal stem cells | DRUG | intravenous infusion four times over two weeks; possibly repeated once |
| Prochymal™ adult human mesenchymal stem cells | DRUG | Cells in plasmalyte and containing dimethylsulfoxide |
| adult human mesenchymal stem cells | DRUG | two infusions, one week apart, each comprising adult human mesenchymal stem cells |
Inclusion Criteria: * Participation in Osiris Protocol 603, with drop of at least 100 points in CDAI at Day 28 Exclusion Criteria: * Substance abuse * Failure to receive full dose of all interventions in Protocol 603