NCT01155362

A Multi-Center Study to Evaluate the Safety and Efficacy of Intravenous Infusion of Human Placenta-Derived Cells (PDA001) for the Treatment of Adults With Moderate-to-Severe Crohn's Disease

A Phase 2a, Randomized, Double Blind, Placebo Controlled, Multi-Center Study to Evaluate the Safety and Efficacy of Intravenous Infusion of Human Placenta-Derived Cells (PDA001) for the Treatment of Adults With Moderate-to-Severe Crohn's Disease

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: Celularity Incorporated · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of the study is to estimate the treatment effect of PDA001 (evaluating 3 different PDA001 dosings) versus placebo in subjects with moderate-to-severe Crohn's Disease. The secondary objective of the study is to assess the safety and tolerability of PDA001 versus placebo in the above-mentioned patient population.

Conditions

• Crohn's Disease

Interventions

Type	Name	Description
BIOLOGICAL	Human Placenta-Derived Cells PDA001 Intravenous Infusion
DRUG	Vehice Control

Timeline

• Start date: 2010-08-01
• Primary completion: 2012-02-01
• Completion: 2014-04-01
• First posted: 2010-07-01
• Last updated: 2020-07-22

Locations

13 sites across 1 country: United States