drugset / Trial / NCT00543374
Extended Evaluation of PROCHYMAL® Adult Human Stem Cells for Treatment-Resistant Moderate-to-Severe Crohn's Disease
RandomizedParallel-groupQuadruple-blindTreatment
Summary
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.
Timeline
- Start
- 2007-09-17
- Primary completion
- 2009-07
- Completion
- 2011-04-28
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Prochymal® | Cell therapy | 1200 cells | Intravenous |
| Comparator | Prochymal® | Cell therapy | 6e+08 cells | Intravenous |