The FDA has approved a Phase I study designed to test the safety of the procedure. It will involve injecting bone marrow stem cells at varying doses into the coronary arteries of patients suffering chronic ischemic coronary artery disease, a condition in which one or more of the primary arteries supplying blood flow to the heart are clogged. The study will include patients who are not candidates for angioplasty, stent placement or coronary artery bypass grafting (CABG).
Dale Adler, M.D., vice chair of medicine at Case and UHC, will lead this study. The Harvard Clinical Research Institute (HCRI) has been contracted to help run the trial and will establish an independent data and safety monitoring board to ensure patient safety and data integrity.
"This is a first step in a long process to determine if this method can someday be used to help patients with this heart condition," said Adler.
The trial is one of three ongoing studies in the United States to use bone marrow stem cells to treat chronic ischemia. The procedure will include harvesting stem cells from a patient's bone marrow, capturing the stem cells, and then infusing the stem cells through a coronary artery so that new blood vessels will grow (neovasculogenesis). The hope is the new blood vessels will replace or supplement those blood vessels that fail to adequately supply oxygenated blood to heart tissue. The method was developed by Mary Laughlin, M.D., a hematologist, and Vincent Pompili, M.D., a cardiologist, both of Case, UHC and the National Center for Regenerative Medicine which has the mission of bringing stem cell research from the laboratory into development for the treatment of patients.
"Traditionally, physicians have been able to prevent heart attack or alleviate its after-effects, but they have not figured out how to initiate the sort of blood vessel repair that remains a key to survival," says Dr. Laughlin. "Now there is a promise of achieving that repair by infusing highly selected marrow stem cells."
Upon acceptance in the study, patients with blocked or damaged heart vessels will be assigned to one of three groups, each made up of three to four patients who will receive a preset dose of stem cell therapy. They will have stem cells drawn from their own bone marrow. These cells will then be enriched in the laboratory and injected into the patients at the site of their ischemia.
The Phase I study is being conducted at University Hospitals of Cleveland with support from the National Institutes of Health, Case Western Reserve University, and Cleveland-based Arteriocyte.
Blocked or damaged blood vessels are a major cause of illness and death around the world. Atherosclerosis, for example, can lead to congestive heart failure and heart attacks. About 5 million people in the United States have heart failure and the number is growing. Each year, another 550,000 people are diagnosed for the first time. It contributes to or causes about 300,000 deaths each year. About 1 percent of the U.S. population over the age of 65 is diagnosed with congestive heart failure each year. Existing therapies include drugs, gene therapy, and vascular interventions for relief of arterial obstructions.
In 2003, approximately 750,000 coronary artery bypass graft (CABG) surgeries were performed worldwide and approximately 1.8 million balloon angioplasty procedures were performed. While these interventional therapies are now the standard of care, there are still a significant number of people for whom these methods do not work, or who have blockage throughout their bodies.
Arteriocyte is supporting this Phase I study through first installment of a combined Phase I/II "fast track" Small Business Technology Transfer Award grant from the National Heart, Lung, and Blood Institute (NHLBI). The grant is part of an NIH program designed to help the transfer of innovative technologies from an academic setting to the commercial sector and rapidly translate research discoveries made in the laboratory into therapy for patients. Arteriocyte was formed on the basis of the research of Drs. Laughlin and Pompili, and a colleague Dr. Steven Haynesworth from Case's College of Arts and Sciences.