A Randomized, Double-Blind, Placebo-Controlled Dose-Escalation Study to Determine the Safety and Efficacy of Intravenous Infusion of Human Placenta-Derived Cells (PDA001) for the Treatment of Crohn's Disease

Phase 1 Completed 14 enrolled Celularity Incorporated

RandomizedParallel-groupQuadruple-blindTreatment

Summary

To assess the safety and efficacy of intravenous (IV) PDA001 infused every two weeks for up to 5 total infusions in subjects with Crohn's disease who are refractory to one or more standard Crohn's disease therapies.

Timeline

Start: 2013-03
Primary completion: 2014-11
Completion: 2014-11

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	PDA001	Cell therapy	0.25 unknown	Intravenous
Subject	PDA001	Cell therapy	0.5 unknown	Intravenous
Subject	PDA001	Cell therapy	1 unknown	Intravenous

A Randomized, Double-Blind, Placebo-Controlled Dose-Escalation Study to Determine the Safety and Efficacy of Intravenous Infusion of Human Placenta-Derived Cells (PDA001) for the Treatment of Crohn's Disease

Summary

Timeline

Drugs

Indications