Last updated on March 2015

A Phase IIa Single-blind Placebo-controlled Crossover Multi-center Randomized Study to Assess the Safety Tolerability and Preliminary Efficacy of a Single Intravenous Dose of Ischemia-tolerant Allogeneic Mesenchymal Bone Marrow Cells to Subjects With Heart Failure of Non-ischemic Etiology


Brief description of study

TITLE: A phase IIa, single-blind, placebo-controlled, crossover, multi-center, randomized study to assess the safety, tolerability, and preliminary efficacy of a single intravenous dose of ischemia-tolerant allogeneic mesenchymal bone marrow cells to subjects with heart failure of non-ischemic etiology PROTOCOL NUMBER: STEM-104-M-CHF INVESTIGATIONAL PRODUCTS: Ischemia-Tolerant Allogeneic Mesenchymal Bone Marrow Cells (aMBMC), (adult human) PHASE: IIa INDICATION: Heart failure of non-ischemic etiology

Detailed Study Description

The study will enroll 20 subjects and will consist of 2 cohorts. Enrolled subjects will be randomized at 1:1 into an experimental group (n=10) or a placebo group (n=10), respectively. Subjects in the experimental group will receive 1.5 million cells per kg and subjects in the placebo group will receive 1 mL/kg Lactated Ringer's Solution. At 90 days the two groups will change arms and the placebo group will receive 1.5 million cells per kg and the initially treated group will receive a Lactated Ringer's Solution (LRS) at a volume of 1 mL/kg.

Clinical Study Identifier: NCT02123706

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Robert Cole, MD

Emory University Centers for Heart Failure Therapy & Transplantation
Atlanta, GA United States
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Allen S Anderson, MD

Northwestern University Bluhm Cardiovascular Institute
Chicago, IL United States
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Hal A Skopicki, MD

Stony Brook Medicine Heart Institute
Stony Brook, NY United States
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Kenneth B Margulies, MD

University of Pennsylvania Heart Failure and Transplant Program
Philadelphia, PA United States
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