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Efficacy and Safety Study of Allogeneic Mesenchymal Precursor Cells (rexlemestrocel-L) in Patients with Chronic Heart Failure Due to Left Ventricular Systolic Dysfunction of Either Ischemic or Nonischemic Etiology (DREAM HF-1)

Research area:
Heart Failure
Principal investigator:
Cara East, MD
Type of study:
Interventional

Study synopsis:
This study evaluates 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 heart failure due to left ventricle systolic dysfunction of either ischemic or nonischemic etiology who have received optimal medical/revascularization therapy.

“Medicines are the backbone of treatment for a failing heart, but there are times that medicines stop working. If the heart becomes severely ill, the treatment options are heart transplant or mechanical heart implant. Stem cells provide an option when the medicines are not working and the advanced therapies are not an option. We have been implanting stem cells as part of research studies for eight years and think this can be the future of heart failure care.” Cara East, MD, principal investigator

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

Main/critical inclusion and exclusion criteria:
A complete list of inclusion and exclusion criteria can be found at https://www.clinicaltrials.gov/ct2/show/NCT02032004?term=rexlemestrocel-L&cond=Heart+Failure&rank=1

Study contact:
Merielle Boatman, MBA, BAAs, Merielle.Boatman@bswhealth.org, 214-820-2273

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