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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

2014-08-27 03:12:29 | BioPortfolio

Summary

The primary objective of the study is to estimate the treatment effect of 3 different doses of PDA001 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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Conditions

Crohn's Disease

Intervention

Human Placenta-Derived Cells PDA001 Intravenous Infusion

Location

Mt Sinai Hospital
New York
New York
United States
10029

Status

Not yet recruiting

Source

Celgene Corporation

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:12:29-0400

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