Overview

Despite recent advances in cardiovascular care, myocardial infarction remains one of the leading causes of death and disability in the United States. Myocardial infarction is caused by the blockage of one or more arteries that supply blood to the heart, resulting in significant injury to the heart muscle that severely affects the patient's quality of life, or causes death. Such blockages can be caused, for example, by the rupture of an atherosclerotic plaque. According to the American Heart Association 2007 Statistical Update, there were approximately 865,000 cases of myocardial infarction that occurred in the United States in 2004 and approximately 7.9 million individuals living in the United States that had previously suffered a heart attack. In addition, there were more than 452,000 deaths that occurred from various forms of ischemic heart disease, and 156,000 deaths due directly to myocardial infarction in 2004. A variety of risk factors are associated with an elevated risk of myocardial infarction or atherosclerosis, including age, high blood pressure, smoking, sedentary lifestyle, and genetics. While advances in the diagnosis, prevention, and treatment of heart disease have had a positive impact, there is clearly room for improvement – myocardial infarction remains a leading cause of death and disability in the United States and the rest of the world.

Our Approach

MultiStem is a patented and proprietary biologic therapy that consists of a special class of human stem cells obtained from adult bone marrow or other non-embryonic tissue sources.  In contrast to other stem cell types, which typically cannot be expanded to a substantial degree, material from a single qualified donor may be used to produce hundreds of thousand or even millions of clinical doses of MultiStem, which are extensively characterized to ensure product consistency and safety. MultiStem may be produced on a large scale for future clinical use and stored in frozen form until needed. 

MultiStem has great potential as a “best-in-class” cell therapy based on its ability to deliver therapeutic benefit through multiple mechanisms of action, its ability to be delivered “off-the-shelf” like a pharmaceutical product and its consistent safety profile.

MultiStem has been studied in validated animal models of acute myocardial infarction at both the Cleveland Clinic and the University of Minnesota. Investigators demonstrated that the administration of allogeneic MultiStem into the hearts of animals damaged by experimentally induced heart attacks resulted in significant functional improvement in cardiac output and other functional parameters compared with animals that received placebo or no treatment. Further, the administration of immunosuppressive drug was not required and provided no additional benefit, and supports the concept of potentially using MultiStem as an allogeneic product.

Development Progress to Date

On Februrary 16th, 2010 we announced successful enrollment of a company-sponsored multicenter Phase I clinical trial to evaluate the safety of MultiStem administered via catheter to patients who have suffered an acute myocardial infarction, commonly referred to as a heart attack. We are working with leading cardiovascular treatment centers and experts in the area of cardiovascular disease to complete this clinical trial.  

The phase I clinical trial is an open label, multi-center dose escalation trial evaluating the safety and maximum tolerated dose of a single administration of allogeneic MultiStem cells following an AMI. Enrolled patients received MultiStem delivered via a catheter into the damaged region of the heart two to five days following percutaneous coronary intervention (PCI), a standard treatment for heart attack. The study includes patients in three treatment cohorts or dose groups and a registry group where patients received only standard of care. The trial is being conducted at cardiovascular treatment centers in the United States, including the Cleveland Clinic, Columbia University Medical Center and Henry Ford Health System.