UM Researchers Receive Approval to Begin Stem Cell Trial Using BioCardia Catheter to Treat Heart Failure

5/1/2008

Stem cell researchers at the University of Miami Miller School of Medicine continue to blaze scientific trails with another first.  They have received approval from the Food and Drug Administration for a study using a Helical Infusion catheter system to inject stem cells into the heart.  BioCardia, a California-based biotechnology company, developed the minimally invasive percutaneous catheter system for the safe delivery of cells to the heart through a helical, or spiral-shaped needle.   Joshua M. Hare, M.D., F.A.C.C., chief of the Cardiovascular Division and director of the Interdisciplinary Stem Cell Institute, will lead the research that is the world’s first stem cell trial that will compare two cell populations, bone marrow cells and mesenchymal cells, against placebo.

Stem Cell treatment of a damaged heart.
The process of treating a damaged heart are as follows: 1. Stem cells are filtered from bone marrow removed from a patient's hip; 2. The cells are injected into the heart's damaged area; and 3. The cells embed themselves and produce proteins that may signal the growth of new blood vessels and heart muscle. Courtesy: BioCardia, Inc.

Mesenchymal cells are rare cells in bone marrow that can be grown in large numbers in a laboratory.  For this study, they’ll be grown into stem cells and then injected back into the patient’s heart, using the BioCardia catheter.  “We inject cells now in surgery,” explains Dr. Hare, “but this will be a non-surgical procedure using a catheter.”

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.  Miller School scientists, including 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.

In April, Dr. Hare’s team performed a stem cell injection on the first patient enrolled in a clinical trial using stem cells to treat heart failure.  That study is a double-blind, placebo-controlled trial that is funded by the NIH Specialized Center for Cell-based Therapy Initiative.  In that trial, which is also being performed at Johns Hopkins University, the patients will either receive a low-dose of mesenchymal stem cells, a high-dose of mesenchymal stem cells, or a placebo during open heart surgery.

Using a catheter, such as the Helical Infusion device approved for this study, opens this type of therapy up to many more patients.  It has been successfully used most recently in clinical studies in Argentina and is a less invasive way of introducing stem cell therapy.

“We may be at the beginning of a real revolution in medicine,” said Alan W. Heldman, M.D.  As clinical chief of the Cardiovascular Division at the Miller School and an interventional cardiologist, Dr. Heldman 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, and participated in clinical studies in Argentina.  “The Biocardia system is a very nicely engineered tool for delivering cells to the heart through a cardiac catheter, without requiring surgery.”  Dr. Heldman said it was “incredibly exciting” to imagine treating patients with heart failure using a non-surgical treatment that repairs the heart muscle itself.

Dr. Hare’s team hopes to begin enrolling patients in the trial in the summer of 2008, but clinicians are now ready to examine patients who may be candidates.

“We are enormously excited to be on the vanguard of stem cell therapy for patients with damaged heart tissue,” said William W. O’Neill, M.D., F.A.C.C., executive dean for clinical affairs at the Miller School.  “If this catheter approach proves successful, tens of thousands of patients could benefit and have improved quality of life.”

Interested patients should call (305) 243-1998 or (305) 243-5138.

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