Press Releases

University of Miami announces successful completion of safety phase of autologous stem cells in Transendocardial Autologous Cells in Heart Failure Trial (TAC-HFT); sixty patient randomized portion of trial has been initiated

Miami, FL - August 14, 2009

Physicians at the Miller School’s Interdisciplinary Stem Cell Institute have successfully completed the first safety phase of a novel trial using stem cell injections into the heart muscle for patients who have had a prior heart attack. With this milestone, the study’s independent Data Safety Monitoring Board has given approval for the UM team to begin the next phase of their study.

The trial involves the first use in the United States of a unique injection catheter to deliver stem cells. Joshua M. Hare, M.D., FACC, a heart failure specialist and director of the Interdisciplinary Stem Cell Institute which coordinates the study, and Alan W. Heldman, M.D., FSCA, an interventional cardiologist and professor of medicine who specializes in advanced catheter techniques, are leading this study which is the world’s first stem cell trial comparing two types of cells, bone marrow cells and mesenchymal cells, against placebo. The study is being conducted at University of Miami Hospital, and involves an interdisciplinary team from the Cardiovascular Division, Hematology Division, and Department of Radiology of University of Miami Health System (UHealth).

Hare, who is the Louis Lemberg Professor of Medicine, says he is “very excited” about the prospect of opening this trial to a randomized study. The Transendocardial Autologous Cells in Ischemic Heart Failure Trial (TAC-HFT) uses the Helical Infusion catheter system developed by BioCardia, a biotechnology company based in California. This is the only catheter with a spiral-shaped needle to deliver stem cells directly into the heart muscle, with the goal of providing better retention of stem cells within the damaged tissue. Because the catheter is minimally invasive, “the procedure will open up the possibilities of treatment to many more patients. This safety milestone will speed up the next phase of the program,” says Hare.

When approval for this unique trial was granted in May 2008, the Food and Drug Administration required a “run-in open label phase” to establish the safety of the trial. In October 2008, the first of four patients was given ten injections each of .25 ml of cells using the BioCardia catheter. In March 2009, the second portion of the safety phase began, with four more patients receiving .50 ml in each of their ten injections. The Data Safety Monitoring Board has now reviewed the safety of the trial based upon those eight patients, and given Hare and his team approval to begin the double-blind comparison study. “We have been able to treat these eight patients seamlessly,” says Hare. “We’re thrilled with how it went.

Heldman, the interventional cardiologist performing the stem cell injections at University of Miami Hospital, gained experience using the BioCardia Helical Injection Catheter for years in preclinical studies and in clinical studies outside the United States. He says “the possibility of using stem cells to regenerate new heart muscle in place of the damage from a heart attack holds a lot of potential to improve lives, and also to reduce health care costs.”

During the randomized phase of the study, patients will receive either bone marrow cells, mesenchymal cells or a placebo. The goal is to assure safety of the approach, while comparing the ability of the cells to grow new cardiomyocytes, the cells which make up the muscle tissue of the heart, and to reduce the size of the scar caused by a heart attack and improve the function of the heart. The UM team recently published findings in the Proceedings of the National Academy of Sciences showing that mesenchymal stem cells have enormous ability to repair hearts damaged by a heart attack, and have the ability to become both new heart muscle cells and new blood vessels. Right now, physicians have no available treatments to restore the function of scarred heart tissue.

Hare and Heldman are shepherding another randomized trial with mesenchymal stem cells, where patients receive injections during open heart surgery. Using a minimally invasive device is especially thrilling to cardiologists. “We will continue these and other studies looking for ways to get the greatest possible healing benefit from stem cell therapy,” says Heldman.

Peter Altman, Ph.D., president and CEO of BioCardia, Inc., says passing the safety criteria is a “significant milestone in an important endeavor.” Because doctors currently have no way of reversing heart failure, he believes the efforts of the UM stem cell team in this trial will benefit society as a whole. This therapy has “the potential to help heart failure patients today, and because of its scientific rigor in comparing cell types, help in the treatment of patients in the future.”

Hare is just as enthusiastic about the possibilities. “All indications so far have us very excited about the avenue we’re pursuing based on our experience with the first eight patients.”