Florida Hospital Pepin Heart Institute and Dr. Kiran C. Patel Research Institute announced the first patient, a 59 year old Clearwater man, has been treated as part of the ATHENA clinical trial. The trial, sponsored by San Diego-based Cytori Therapeutics, derives stem cells from the patient’s own fat tissue and injects extracted cells into damaged parts of the heart. The ATHENA trial is a treatment for chronic heart failure due to coronary heart disease. Dr. Charles Lambert, Medical Director of Florida Hospital Pepin Heart Institute, is leading the way for the first U.S. FDA approved clinical trial using adipose-derived regenerative cells, known as ADRCs, in chronic heart failure patients. Florida Hospital Pepin Heart Institute is the is first in west and central Florida to perform the trial.
“I am pleased to report that all procedures went well. The patient is doing well, he was released and is recovering at home. We look forward to following his progress over the coming months,” said Dr. Lambert.
Heart failure (HF) can occur when the muscles of the heart become weakened and cannot pump blood sufficiently throughout the body. The injury is most often caused by inadequate blood flow to the heart resulting from chronic or acute cardiovascular disease, including heart attacks. The ATHENA clinical trial procedure is a three-step process. First, the trial involves the collection of fat from the patient’s body by liposuction. Then the fat sample is filtered through a machine that extracts out the stem cells. Finally, the stem cells are injected into the damaged part of the patient’s heart.
During this first case at Florida Hospital Pepin Heart Institute, Dr. Paul Smith performed the liposuction to obtain the fat sample, a team at the Dr. Kiran C. Patel Research Institute isolated stem cells from the fat sample and then Dr. Charles Lambert performed the cell therapy by direct injection into the patient’s heart.
“Pepin Heart and Dr. Kiran C. Patel Research Institute is exploring and conducting leading-edge research to develop breakthrough treatments long before they are even available in other facilities. Stem cells have the unique ability to develop into many different cell types, and in many tissues serve as an internal repair system, dividing essentially without limit to replenish other cells,” said Dr. Lambert.
The Pepin Heart Institute has a history of cardiovascular stem cell research as part of the NIH sponsored Cardiac Cell Therapy Research Network (CCTRN) as well as other active cell therapy trials. The trial is a double blind, randomized, placebo controlled study designed to study the use of a patient’s own Adipose-Derived Regenerative Cells (ADRCs) to treat chronic heart failure from coronary heart disease in patients who are on maximal therapy and still have heart failure symptoms. All trial participants undergo a minor liposuction procedure to remove fat (adipose) tissue. Following the liposuction, trial participants may have their tissue processed with Cytori’s proprietary Celution® System to separate and concentrate cells, and prepare them for therapeutic use. Trial participants will then have either their own cells or a placebo injected back into their damaged heart tissue.
To test whether ADRCs will improve heart function, several measurements will be made, including peak oxygen consumption (VO2max), which measures how much physical exercise (gentle walking on a treadmill) a patient can perform, blood flow to the heart (perfusion), the amount of blood in the left ventricle at the end of contraction and relaxation (end-systolic and end-diastolic volumes), and the fraction of blood that is pumped during each contraction (ejection fraction). After the injection procedure, patients are seen in the clinic for follow-up visits over the first 12 months; they are then contacted by phone once a year for up to five years after the procedure.
There are approximately 5.1 million Americans currently living with heart failure, according to the American Heart Association. Chronic heart failure due to coronary heart disease is a severe, debilitating condition caused by restriction of blood flow to the heart muscle, reducing the heart’s oxygen supply and limiting its pumping function.
Individuals interested in participating in the ATHENA clinical research trial or learning more can visit the ATHENA website or call Brian Nordgren, Florida Hospital Pepin Heart Institute Physician Assistant & Stem Cell Program Lead at (813) 615-7527.
To learn more about clinical trials at Florida Hospital Pepin Heart Institute, visit the Dr. Kiran C. Patel Research Institute's web page.