drugset / Trial / NCT01510431

Safety and Treatment Outcome Study of PROCHYMAL® (Remestemcel-L) Intravenous Infusion in Subjects With Treatment-resistant Crohn's Disease

NCT01510431

Expanded access No longer available Mesoblast, Inc.

Summary

Protocol 620 provides PROCHYMAL(R) adult human mesenchymal cells to specifically chosen Crohn's disease patients at participating centers who typically have already demonstrated good response in another PROCHYMAL study, are not eligible for other PROCHYMAL studies, and in the view of the investigator, would not benefit significantly from other Crohn's therapies but would benefit from use of PROCHYMAL. The study is not placebo-controlled or randomized.

Timeline

Start
Primary completion
Completion

Drugs

EvaluationDrugModalityDoseRoute
Subject Prochymal® Cell therapy 2e+08 cells Intravenous

Indications