title: The Aastrom experience.
abstract: Aastrom Biosciences has developed a proprietary cell-processing technology that enables the manufacture of ixmyelocel-T, a patient-specific multicellular therapy expanded from a small sample of a patient's own bone marrow. Ixmyelocel-T is produced under current good manufacturing practices (cGMP) in a fully closed, automated system that expands mesenchymal stem cells (MSCs) and macrophages. While the cell types in ixmyelocel-T are the same as those found in the bone marrow, the numbers of MSCs and alternative macrophages are greater in ixmyelocel-T. We propose that the mixture of expanded MSCs and alternatively activated macrophages promote long-term tissue repair of ischemic tissue. The multiple cell types in ixmyelocel-T have a range of biological activities that are likely to contribute to a complex mechanism of action. Clinical trial data collected to date support the potential for ixmyelocel-T as an efficacious and safe treatment for ischemic cardiovascular indications, including critical limb ischemia (CLI) and a severe form of heart failure, dilated cardiomyopathy (DCM). The CLI clinical program has completed phase 2 and has reached concurrence with the Food and Drug Administration (FDA) on a phase 3 study (REVIVE) through the Special Protocol Assessment (SPA) process. The phase 3 study began screening patients in February 2012. The DCM clinical program will initiate phase 2b in 2012.
authors: Ronnda L
authors: RL
authors: Bartel
authors: Caryn
authors: C
authors: Cramer
authors: Kelly
authors: K
authors: Ledford
authors: Amy
authors: A
authors: Longcore
authors: Christopher
authors: C
authors: Parrish
authors: Theresa
authors: T
authors: Stern
authors: Sharon
authors: S
authors: Watling
authors: Frank
authors: F
authors: Zeigler
mesh_terms: D015703:Antigens, CD / Q000378:metabolism; D002318:Cardiovascular Diseases / Q000401:mortality / Q000628:therapy; D002986:Clinical Trials as Topic; D004345:Drug Industry; D006801:Humans; D053208:Kaplan-Meier Estimate; D008264:Macrophages / Q000166:cytology; D045164:Mesenchymal Stem Cell Transplantation; D059630:Mesenchymal Stem Cells / Q000166:cytology / Q000378:metabolism; D010641:Phenotype
chemical_list: D015703:Antigens, CD