In addition to our other programs, we are developing MultiStem^®, a proprietary stem cell product for the treatment of multiple distinct disease indications including myocardial infarction and bone marrow transplant support.  MultiStem is a biologic product that consists of undifferentiated human stem cells obtained from adult bone marrow or other nonembryonic tissue sources.  The cells may be produced on a large scale for future clinical use and stored in frozen form until needed.  Material from a single qualified donor may be used to produce hundreds of thousands or even millions of clinical doses of MultiStem, which are extensively characterized to ensure product consistency and safety. 

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 safety profile.  Though the cells have the potential to differentiate into a variety of cell types, in certain indications the primary mechanism of MultiStem appears to be the production of a physiologically relevant and complex set of therapeutic molecules in response to the local environment. In the initial indications Athersys is pursuing, the cells appear to minimize the inflammatory reaction that occurs in response to ischemic events (such as myocardial infarction or stroke) or the anti-host immune reaction seen in graft vs. host disease (GvHD), and promote recovery.

MultiStem^'s ability to be delivered “off the shelf” like a traditional pharmaceutical is based on:

• Scalability - The product can be produced efficiently and consistently in large quantities and stored (frozen) for subsequent use
• Minimal immunogenicity - In contrast to conventional bone marrow or hematopoietic stem cell transplants, preclinical studies have shown that MultiStem may be used without tissue matching (i.e., not immunogenic) or immunosuppression, making it analogous to type “O” blood
• Multiple approaches to delivery -  MultiStem may be delivered systemically (e.g. I.V.) or local administration   (e.g. using a catheter based delivery system), depending on the disease indication and the specific needs of the patient

MultiStem allows us to efficiently pursue multiple, high-value commercial and therapeutic opportunities from a single product platform.