drugset / Trial / NCT00543374

Extended Evaluation of PROCHYMAL® Adult Human Stem Cells for Treatment-Resistant Moderate-to-Severe Crohn's Disease

NCT00543374

Phase 3 Completed 98 enrolled Mesoblast, Inc.
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

EvaluationDrugModalityDoseRoute
Comparator Prochymal® Cell therapy 1200 cells Intravenous
Comparator Prochymal® Cell therapy 6e+08 cells Intravenous

Indications