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UHealth Cardiologists Are First in the U.S. to Use a Novel Catheter to Inject Stem Cells

10/30/2008

To look at Max S. Eaton, you wouldn’t know that he has survived one heart attack, that he has heart failure -- or that he has made history.  Last Thursday, the 66-year-old Broward County man became the first person in the United States to have stem cells injected into his heart using a novel, corkscrew-shaped catheter.  Cardiologists at the University of Miami Health System (UHealth) performed the procedure, using bone marrow cell therapy in an effort to treat heart failure.

This trial, the Transendocardial Autologous Cells in Ischemic Heart Failure Trial (TAC-HFT) study, is being led by Joshua M. Hare, M.D., chief of the Cardiovascular Division and director of the Interdisciplinary Stem Cell Institute.  It is the world’s first stem cell trial comparing two cell populations, bone marrow cells and mesenchymal cells, against placebo.  “This is truly a breakthrough procedure,” says Hare.

BioCardia, a biotechnology company based in California, developed the Helical Infusion catheter system, which is the first catheter with a spiral-shaped needle to deliver the stem cells.  This unique design contains several infusion points along the helix, with the goal of providing better retention of stem cells within the damaged tissue.  Like other catheters, this minimally invasive method is able to inject stem cells into the heart without the complications of surgery.  “We’ve already injected cells in surgery,” explains Hare, “but this will be a non-surgical procedure, which opens up the possibilities of treatment to many more patients.”

Eaton is a self-described “news junkie” who began digging around for more information when he began feeling ill.  On the internet he learned about the novel techniques being used in the Cardiovascular Division of the Miller School of Medicine.

Alan W. Heldman, M.D., clinical chief of the Cardiovascular Division, has been using the BioCardia Helical Injection Catheter and the Morph guiding catheter system to inject stem cells into the heart in preclinical studies for four years.  Clinical studies have been performed successfully with the device in Canada and Argentina.  Heldman performed this novel procedure and describes it as “the beginning of a real revolution in medicine.”  As an interventional cardiologist, he says it is “incredibly exciting to treat patients with heart failure using a non-surgical treatment that repairs the heart muscle itself.”

The Food and Drug Administration has designated this first procedure as a run-in open label phase, which is an early phase to establish the safety of the trial.  The first eight patients will receive bone marrow stem cells and not a placebo.  Of those eight patients, the first four will be injected ten times with .25 ml of bone marrow cells during their procedure.  The next four will receive .50 ml in each of their ten injections.  Once those cases are completed and safety is confirmed, the double-blind Phase I study will begin.

One group of patients in the randomized trial will get bone marrow cells, another group will get mesenchymal cells, and a third group will get a placebo.  Ian K. McNiece, Ph.D., director of the experimental and clinical cell-based therapies program, say this study will test the ability of mesenchymal stem cells to enable the generation of new cardiomyocytes, cells that make up the tissue of the heart, to repair damaged heart tissue.  “The goal is to improve the function of the heart,” says Dr. McNiece.  Currently, there are no treatments available that restore the function of scarred heart tissue.

“We are very excited to be on the vanguard of stem cell therapy for patients with damaged heart tissue,” says William O’Neill, M.D., F.A.C.C., executive dean for clinical affairs and a renowned interventional cardiologist. “If this catheter approach is successful, tens of thousands of patients could benefit and have improved quality of life.”