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

• Status: Completed
• Trial end date: 2011-04-28
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Mesoblast International Sàrl; Mesoblast, Inc.
• Treatments: Remestemcel-l

Criteria

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