PDA001 for the Treatment of Adults With Moderate-to-Severe Crohn's Disease

Summary

This Phase 2a study evaluated the efficacy, safety, and tolerability of intravenous human placenta-derived cells (PDA001) compared with placebo in adults with moderate-to-severe Crohn's disease. Three PDA001 dose levels were evaluated.

Timeline

Start

2010-08

Primary completion

2012-02

Completion

2014-04

Outcome

Met primary endpoint

paper The primary endpoint was achieved in 10/28 (36%) of PDA-001 subjects compared with placebo (0%, P = 0.026). PMID 25985246 ↗

Publications

• Results Melmed GY, Pandak WM, Casey K, Abraham B, Valentine J, Schwartz D, Awais D, Bassan I, Lichtiger S, Sands B, Hanauer S, Richards R, Oikonomou I, Parekh N, Targan S, Johnson K, Hariri R, Fischkoff S. Human Placenta-derived Cells (PDA-001) for the Treatment of Moderate-to-severe Crohn's Disease: A Phase 1b/2a Study. Inflamm Bowel Dis. 2015 Aug;21(8):1809-16. doi: 10.1097/MIB.0000000000000441.

Drugs

Indications