Cardiovascular Regenerative Medicine

Heart Failure

Heart failure affects 5 million Americans, with more than 550,000 new cases each year.  Heart failure is a condition in which the heart's ability to pump blood is weaker than normal, resulting in inadequate circulation of blood throughout the body.  Eventually, heart failure leads to the failure of other vital organs due to inadequate blood flow.

Douglas W. Losordo, MD is the Director of the Program in Cardiovascular Regenerative Medicine.  It is through Dr. Losordo’s years of experience in basic and clinical research that the following clinical research trial is being offered to heart failure patients who are not, in the opinion of their physicians, candidates for standard treatments (i.e., opening the coronary blood vessels with a balloon catheter a procedure known as angioplasty, or bypassing the blocked vessels with surgery) to improve blood flow to the heart muscle:

Injection of Autologous CD34-Positive Cells for Neovascularization and Symptom Relief in Patients with Myocardial Ischemia and LVEF <40%:  An Open Label Pilot Study

The goal of this clinical research trial is to determine the safety of various doses and possible activity of an experimental cell therapy for patients with poor blood flow to areas in the heart and less efficient pumping of the heart. The clinical goal of the therapy is to improve heart function and therefore reduce symptoms such as shortness of breath. Appropriate patients are invited to participate in this clinical research trial to look at the safety and activity of autologous (one’s own) stem cells, delivered with a needle into the regions of the heart with poor blood flow.  Stem cells are cells produced by bone marrow that can develop into blood cells or become another type of cell with a more specialized function, such as a cardiac muscle cell.

This phase I clinical research trial has been set up to evaluate the safety and possible effectiveness of injecting a patient’s own stem cells in the regions of the heart with poor blood flow. The goal of this trial is to determine if the investigational therapy will improve heart function and reduce symptoms of congestive heart failure. A phase I study is the first use of a new drug (in this case, cell therapy) in humans.  In a phase I study the new cell therapy is tested in escalating doses in a series of small groups of patients.

This clinical research trial is being conducted at Northwestern Memorial Hospital.  Dr. Losordo is responsible for this trial at Northwestern Memorial Hospital (local principal investigator).  Additional co-investigators on this study include Nirat Beohar, MD, Charles J. Davidson, MD, Patrick M. McCarthy, MD, and John B. O'Connell, MD.

More information about this clinical trial can be found at ClinicalTrials.gov.

Contact

If you wish to obtain more information about this clinical research trial and for more information regarding Cardiovascular Regenerative Medicine, please contact the Program in Cardiovascular Regenerative Medicine at (312) 695-0072.

Last published on:May 16, 2008 7:43 AM

Feinberg Cardiovascular Research Institute
Northwestern University
Feinberg School of Medicine
303 East Chicago Avenue, Tarry 12-703
Chicago, IL 60611
(312)-695-0072
www.fcvri.northwestern.edu

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