As my colleagues at Aastrom participate in important medical meetings on regenerative medicine and cellular therapy, we can see why 2013 has been named the “Year of the Stem Cell” by The Atlantic magazine.  The medical community is excited about the therapeutic potential of regenerative medicine and our unique multicellular product candidate ixmyelocel-T is attracting great interest as a promising new treatment modality for serious cardiovascular diseases such as advanced heart failure due to ischemic dilated cardiomyopathy.

It is well understood that there are multiple cell populations and multiple signaling pathways involved in the disease progression involving tissue injury, chronic inflammation, and the resulting tissue damage that leads to loss of organ function, as well as the processes involved in the repair and regeneration of damaged tissue.  Therapeutic approaches targeting single signaling pathways in these complex disease and repair processes have not proven effective, and most cell therapy approaches expand a single cell type to attempt to arrest manifestations of the disease.  Aastrom is taking what we believe is a highly differentiated and superior therapeutic approach by developing multicellular therapies that utilize an expanded population of the key cell types that the body naturally uses to repair and regenerate damaged tissue.

Ongoing discovery research by Aastrom scientists and our outside collaborators continues to define the mechanism of action of ixmyelocel-T and differentiate our product from other cell therapies based on the activity of the two key cell populations in ixmyelocel-T:  mesenchymal stromal cells (MSCs) and M2-like anti-inflammatory macrophages.  These key cells have multiple direct activities and beneficial effects on nearby cells that have been shown to promote tissue repair and regeneration by reducing inflammation and promoting angiogenesis and remodeling of damaged tissue.  Based on the activities of these cells and the resulting therapeutic effects, Aastrom’s unique multicellular therapy platform offers the potential for multiple therapeutic applications in treating cardiovascular and other fibrovascular disorders of the lungs, liver, kidney and other organs.

There is enormous therapeutic potential for ixmyelocel-T based on its multicellular composition and the promising results in the treatment of ischemic or damaged tissue demonstrated in preclinical and clinical studies conducted to date.  We look forward to generating results in our current ixCELL-DCM phase 2b study of ixmyelocel-T for the treatment of advanced heart failure due to ischemic dilated cardiomyopathy, and continuing to explore the potential therapeutic effects of ixmyelocel-T to repair and regenerate damaged tissue in other severe diseases.

Regards,

Nick Colangelo