7/24/2009

World’s first FDA-approved cardiac adult stem cell patient receives infusion

Trial taking place in Louisville, KY

LOUISVILLE, Ky. – Michael (Mike) Jones has become the world’s first recipient of first phase-one FDA-approved clinical trial using “c-kit-positive” adult cardiac stem cells to treat congestive heart failure. Jones’ infusion on July 17 marks the world’s first phase-one FDA-approved clinical trial using adult cardiac stem cells to treat heart disease The clinical trial is being conducted by a team of University of Louisville physicians at Jewish Hospital.

During the infusion procedure, Jones was directly injected with his own cardiac stem cells into heart scar tissue using a minimally-invasive cardiac catheterization procedure, which reaches the heart through an artery in the patient’s leg. The 66-year-old, self-employed man continues to recover following the outpatient procedure.

Mark Slaughter, M.D., Chief of the Division of Cardiothoracic Surgery at UofL and Director of the Heart Transplant and Mechanical Assist Device Program at Jewish Hospital, performed coronary artery bypass surgery on Jones on March 23. Jones suffered from congestive heart failure due to multiple blocked arteries that had resulted in permanent scarring of his heart muscle. During the procedure, Jones’ cardiac stem cells were retrieved from a portion of his own atrium, the upper chamber of the heart. The tissue was then sent to Piero Anversa, of Harvard University and Brigham & Women’s Hospital in Boston, for processing and to grow cardiac stem cells from Jones’ tissue.

Jones’ infusion procedure was performed at Jewish Hospital by Sohail Ikram, M.D., UofL Professor of Medicine and Director and Chief of Invasive and Interventional Cardiology at Jewish Hospital. 
 
Study leader Roberto Bolli, Jewish Hospital Heart and Lung Institute Distinguished Chair in Cardiology and Director of UofL’s Institute for Molecular Cardiology said, “Another clinical trial is being conducted at another facility.  The difference between what we have done and what another institute nationally has done is that, we have injected a pure population of stem cells, the c-kit-positive cells.  The other institution injected cardiosphere-derived cells, which are a mixture of primitive and partially differentiated cells, complicating the recognition of the actual therapeutic cell. Our study involves a specific, well-characterized population of undifferentiated cells: the c-kit-positive cardiac stem cells are self-renewing, clonogenic and multipotent, which are the fundamental properties of stem cells.”

Bolli addied, “We continue to enroll patients in this first-of-its-kind clinical trial. We hope to help the heart regenerate its own tissue and improve heart function.” Bolli is collaborating with a number of leaders in the field of cardiovascular and stem cell medicine for this clinical trial.

The team will continue to evaluate Jones, as well as other patients who have enrolled in the clinical trial, for heart function and blood flow. In addition, the heart’s overall size and the size of the scar tissue will be measured.

Since this is a phase-one clinical trial designed to test the treatment’s safety and feasibility, all patients enrolled in the trial will receive the cardiac stem cell therapy.

Individuals wishing to learn more about this study should call 502-852-1387 or email cardiactrial@louisville.edu.

Video of a news briefing along with b-roll with the physicians and the patient will be uplinked today, July 24, via satellite from 12-1 p.m. (EDT) at the following coordinates:

C-band AMC 6 Transponder 21
Uplink Frequency  6345 Horizontal
Downlink Frequency  4120 Vertical

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Roberto Bolli, M.D.	Mark Slaughter, M.D.	Michael Jones