PDA001, Placenta-derived cells for Crohn's disease

PDA001 is an agent comprised of placenta-derived cells, which are adherent mesenchyme-like human cells isolated from postpartum human placenta. Following expansion, the the effect, safety and tolerability of PDA001 versus placebo was assessed in subjects with moderate to severe Crohn's disease. PDA001 infusions appear safe and well-tolerated in subjects with treatment-resistant Crohn's disease. A response was seen in all subjects in the low-dose group. Only two responders were identified in the high-dose group, with a higher baseline disease activity, suggesting a more treatment-resistant population.