BioCardia and the University of Miami Receive FDA Clearance to Initiate Co-Sponsored Heart Failure Stem Cell Clinical Trial Comparing Two Cell Populations
South San Francisco, CA., April 30, 2008
BioCardia, Inc., a regenerative medicine company, and the University of Miami today announced that the United States Food and Drug Administration approved a clinical investigation of two adult stem cell populations in the setting of heart failure. This groundbreaking study will take place at the University of Miami Miller School of Medicine.
This is the first stem cell trial comparing two cell populations. The two investigational cell populations to be studied include autologous adult bone marrow derived mononuclear cells and adult autologous mesenchymal cells. These cell populations have excellent safety profiles in clinical studies performed to date. As cells are taken from the patient's own bone marrow, there will be no issues of rejection of the cells as foreign by the patient’s immune system.
Each cell population will be compared to placebo and delivered percutaneously with BioCardia's Investigational Helical Infusion System which is advanced through Biocardia's FDA approved Morph catheter. The catheters are inserted much like a standard angioplasty catheter through a blood vessel in the groin, but instead of advancing to the coronary artery, the catheter is advanced into the ventricle of the heart so that it can deliver directly into the heart muscle using a small helical needle. Twenty patients have been treated to date with this system delivering bone marrow derived cells with excellent safety results and an average total procedure time from insertion to removal of catheters of only 43 minutes.
"This work builds on the extensive experience at the University of Miami under the leadership of Dr. Joshua Hare, as well as our experience here at BioCardia" said Peter Altman, CEO of BioCardia. "Our respective teams have been working together for some time on this project and feel this elegant trial has great potential to help patients and inform the scientific community which is to the benefit of all future patients."
"This research has great potential to help patients with heart failure in need of new therapeutic options," said Joshua M. Hare, M.D., director of the University of Miami's Interdisciplinary Stem Cell Institute and chief of the Cardiovascular Division. "This cosponsored investigation will provide insights into some of the key questions in the field of cardiovascular cell therapy and also position the collaboration team to explore larger pivotal work together in the future."
"We may be at the beginning of a real revolution in medicine," said Alan W. Heldman, M.D., clinical chief of the Cardiovascular Division at the University of Miami, and a practicing interventional cardiologist who has used the Biocardia Helical Injection Catheter and the Morph guiding catheter system to inject stem cells into the heart in preclinical studies for four years. "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.
Heart failure is a significant disease with 550,000 new patients each year and a total population of 5,200,000 patients suffering from this disease in the United States. With five percent of total U.S. health care costs attributable to these patients, it is a significant economic burden and therapies today for these patients are limited. Stem cell therapy in this population has shown enormous promise.
Headquartered in South San Francisco, BioCardia, Inc. is a leader in the development of catheter systems which enable local delivery of therapeutics to the heart and other organs. BioCardia currently is marketing the Morph? Catheter used through the vascular system for complex cases. Biotherapeutic clinical trials are ongoing using BioCardia's Helical Infusion System to deliver cell and gene therapies directly to the heart muscle.
About The Interdisciplinary Stem Cell Institute at the University of Miami
The Interdisciplinary Stem Cell Institute at the University of Miami was established to capitalize on pioneering work in the use of adult stem cells for the repair of malfunctioning human organs. The goal of the Institute is to find new treatments for heart disease, neurological disease, bone disease, diabetes, cancer, eye diseases and other chronic, debilitating, or incurable diseases. University of Miami scientists have led in the development of procedures to extract adult stem cells from bone marrow, and have conducted ground breaking research in cell-based therapy for the diseased human heart. This type of procedure can be adapted for other diseased tissues, such as liver, lung, spinal cord disease, bone disease, and diabetes. The end result of stem cell therapy is a cure for diseases that have as yet defied conventional therapies. More information available at: www.med.miami.edu/isci/