Efficacy and Safety of Allogeneic Mesenchymal Precursor Cells (Rexlemestrocel-L) for the Treatment of Heart Failure.



Status:Active, not recruiting
Conditions:Cardiology, Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:18 - 80
Updated:4/6/2019
Start Date:January 2014
End Date:December 2019

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Double-blind, Randomized, Sham-procedure-controlled, Parallel-Group Efficacy and Safety Study of Allogeneic Mesenchymal Precursor Cells (Rexlemestrocel-L) in Chronic Heart Failure Due to LV Systolic Dysfunction (Ischemic or Nonischemic) Dream HF-1

The primary objective of this study is to determine whether transendocardial delivery of
allogeneic human bone marrow-derived MPCs (rexlemestrocel-L) is effective in the treatment of
chronic heart failure due to LV systolic dysfunction.

The purpose of this study is to evaluate the efficacy and safety of a single transendocardial
delivery in the cardiac catheterization laboratory of human bone marrow-derived allogeneic
MPCs (rexlemestrocel-L) for improvement in clinical outcomes (HF-MACE), preventing further
adverse cardiac remodeling (LVESV and LVEDV), and increasing exercise capacity (6MWT) in
patients with chronic HF due to LV systolic dysfunction of either ischemic or nonischemic
etiology who have received optimal medical/revascularization therapy.

Inclusion Criteria:

- The patient is 18 to 80 years of age, inclusive; both men and women will be enrolled.

- The patient has a diagnosis of chronic HF of ischemic or nonischemic etiology for at
least 6 months

- The patient is on stable, optimally tolerated dosages of HF therapies including
beta-blockers (approved for country-specific usage), angiotensin-converting enzyme
(ACE) inhibitors or angiotensin-receptor blockers (ARBs), and/or aldosterone
antagonists, without change in dose for at least 1 month before study intervention

- The patient is on a stable, outpatient, oral diuretic dosing regimen in which the
patient remains clinically stable during screening.

- Other Criteria apply, please contact the investigator

Exclusion Criteria:

- The patient has NYHA Functional Class I or Functional Class IV symptoms.

- Other Criteria apply, please contact the investigator
We found this trial at
57
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Allentown, Pennsylvania 18103
Principal Investigator: Ronald Freudenberger, MD
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Atlanta, Georgia 30322
Principal Investigator: David Markham, MD
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Augusta, Georgia 30912
Principal Investigator: Neal Weintraub, MD
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Austin, Texas 78756
Principal Investigator: Roger Gammon, MD
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Birmingham, Alabama 35211
Principal Investigator: Alain Bouchard, MD
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Birmingham, Alabama 35233
Principal Investigator: Sumanth Prabhu, MD
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Boston, Massachusetts
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Boynton Beach, Florida 33435
Principal Investigator: Christina Michael, MD
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Charlotte, North Carolina 28203
Principal Investigator: Joseph Mishkin, MD
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Charlotte, NC
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Chicago, Illinois 60612
Principal Investigator: Dinesh Kalra, MD
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Chicago, IL
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Cincinnati, Ohio 45219
Principal Investigator: Eugene Chung, MD
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Cincinnati, Ohio 45267
Principal Investigator: Vlad Cotarlan, DO
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Clearwater, Florida 33756
Principal Investigator: Leslie Miller, MD
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Cleveland, OH
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Columbus, Ohio 43214
Principal Investigator: Anupam Basuray, MD
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Dallas, TX
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Durham, North Carolina 27710
Principal Investigator: Thomas Povsic, MD
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Edmonton,
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Gainesville, Florida 32610
Principal Investigator: Carl Pepine, MD
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Germantown, Tennessee 38125
Principal Investigator: Frank McGrew, MD
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Gilbert, Arizona 85297
Principal Investigator: Anantharam Kalya, MD
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Houston, Texas 77030
Principal Investigator: Emerson Perin, MD, PhD
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Houston, Texas 77030
Principal Investigator: Barry Trachtenberg, MD
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Iowa City, Iowa 52242
Principal Investigator: Linda Cadaret, MD
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Jacksonville, Florida 32209
Principal Investigator: Francesco Franchi, MD
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La Jolla, California 92037
Principal Investigator: Eric Adler, MD
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La Jolla, California 92037
Principal Investigator: James Heywood, MD
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Las Vegas, NV
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Lexington, Kentucky 40536
Principal Investigator: Ahmed Abdel-Latif, MD
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Los Angeles, California 90045
Principal Investigator: Ali Nsair, MD
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Los Angeles, California 90211
Principal Investigator: David Chang, MD
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Louisville, Kentucky 40202
Principal Investigator: Emma Birks, MD
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Madison, Wisconsin 53792
Principal Investigator: David Murray, MD, FACC
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Mesa, Arizona 85206
Principal Investigator: Andrew Kaplan, MD
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Miami, Florida 33215
Principal Investigator: Sandra Chaparro, MD
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Milwaukee, Wisconsin 53215
Principal Investigator: Nasir Sulemanjee, MD
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Minneapolis, Minnesota 55407
Principal Investigator: Mosi Bennett, MD
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New Orleans, Louisiana
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New York, New York 10032
Principal Investigator: Maryjane Farr, MD
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Newark, New Jersey 07112
Principal Investigator: Saurabh Kapoor, MD
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Orange, California 92868
Principal Investigator: Kelly Tucker, MD
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Oxnard, California 93030
Principal Investigator: Richard Rothschild, MD
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Philadelphia, Pennsylvania 19104
Principal Investigator: Brian Drachman, MD
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Philadelphia, Pennsylvania 19140
Principal Investigator: Rene Alvarez, Jr., MD
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Philadelphia, Pennsylvania
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Phoenix, Arizona 85054
Principal Investigator: Robert Scott, MD
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Pittsburgh, Pennsylvania 15213
Principal Investigator: Marc Simon, MD, MS, FACC
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Rochester, Minnesota 55905
Principal Investigator: Barry Borlaug, MD
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Saginaw, Michigan 48602
Principal Investigator: Peter Fattal, MD, FACC
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Salt Lake City, Utah 84132
Principal Investigator: Craig Selzman, MD
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Seattle, Washington 98122
Principal Investigator: John Petersen II, MD
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Stanford, California 94305
Principal Investigator: Phillip Yang, MD
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Tampa, Florida 33613
Principal Investigator: Mohammadreza Tabesh, MD
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Tucson, Arizona 85724
Principal Investigator: Ranjith Shetty, MD
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Wausau, Wisconsin 54401
Principal Investigator: German Larrain, MD
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