TAMPA, FL (November 9, 2012) – Florida Hospital Pepin Heart Institute has participated in two landmark studies that provide answers, giving researchers new information to move forward in heart stem cell therapy research. The clinical trial, called Transplantation In Myocardial Infarction Evaluation (TIME), was designed to see if heart function would improve by administering stem cells derived from the patient’s own bone marrow either three or seven days after a heart attack. The results show therapy with bone marrow-derived stem cells does not improve short-term recovery after a heart attack.
The results mirror a previous, related study called LateTIME. The LateTIME study found that cells which come from the patients (called autologous stem cells) given two to three weeks after a heart attack did not improve heart function. Both TIME and LateTIME were conducted by the Cardiovascular Cell Therapy Research Network (CCTRN). Florida Hospital Pepin Heart Institute and the Dr. Kiran C. Patel Research Institute are members of the CCTRN.
The findings from the TIME clinical trial will be presented this month at the American Heart Association 2012 Scientific Sessions in Los Angeles and published in the Journal of the American Medical Association (JAMA). Dr. Charles Lambert, Medical Director of Florida Hospital Pepin Heart Institute, is the site’s principal investigator for the trial and co-author of the JAMA article.
“The TIME study was extremely important because it answered the question: will the bone marrow-derived stem cells improve short-term recovery?…and the answer is no. Now, with both TIME and LateTIME, we have baseline results. The clinical trial conclusions play a critical role in helping us take the next step in stem cell therapy research,” said Dr. Lambert.
The TIME study researchers enrolled about 120 volunteers between July 2008 and February 2011. The participants suffered from moderate to severe impairment in their left ventricles and had undergone stenting procedures following heart attacks. Heart improvements were assessed six months after stem cell therapy by measuring the percentage of blood that was pumped out of the left ventricle during each contraction.
Now with the baseline set, researchers can adjust some of the components to grow and administer stem cell to find cases where the procedure may improve function. For example, researchers believe this therapy may work better in different population groups, or during new methods of delivery. Another advantage of the TIME study is that CCTRN will store samples of the stem cells taken from the participants. Investigators can examine the relationship between people who showed significant improvement during the study.
Heart attack patients from the TIME study will continue to be followed at Florida Hospital Pepin Heart Institute for at least a year to monitor any late changes in cardiac function. Although no significant improvement was recorded with heart attack patients in the LateTIME trial, Dr. Lambert says the work that went into collecting patient data over the past years is very useful for the National Institutes of Health stem cell researchers.
“Well-controlled trials such as this are very important in determining whether therapies are actually effective and we will continue to design and test new cell treatment strategies with scientists in the CCTRN,” says Dr. Lambert. Other members of the study’s Cardiac Cell Therapy Research Network include the University of Florida, Vanderbilt University, the Texas Heart Institute, the Cleveland Clinic and the Mayo Clinic.