Title |
The Aastrom experience
|
---|---|
Published in |
Stem Cell Research & Therapy, July 2012
|
DOI | 10.1186/scrt117 |
Pubmed ID | |
Authors |
Ronnda L Bartel, Caryn Cramer, Kelly Ledford, Amy Longcore, Christopher Parrish, Theresa Stern, Sharon Watling, Frank Zeigler |
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. |
X Demographics
Geographical breakdown
Country | Count | As % |
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Unknown | 2 | 100% |
Demographic breakdown
Type | Count | As % |
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Members of the public | 2 | 100% |
Mendeley readers
Geographical breakdown
Country | Count | As % |
---|---|---|
United States | 1 | 2% |
Unknown | 48 | 98% |
Demographic breakdown
Readers by professional status | Count | As % |
---|---|---|
Student > Ph. D. Student | 12 | 24% |
Researcher | 6 | 12% |
Student > Bachelor | 4 | 8% |
Student > Doctoral Student | 3 | 6% |
Professor | 3 | 6% |
Other | 7 | 14% |
Unknown | 14 | 29% |
Readers by discipline | Count | As % |
---|---|---|
Medicine and Dentistry | 16 | 33% |
Biochemistry, Genetics and Molecular Biology | 8 | 16% |
Engineering | 3 | 6% |
Agricultural and Biological Sciences | 3 | 6% |
Pharmacology, Toxicology and Pharmaceutical Science | 2 | 4% |
Other | 2 | 4% |
Unknown | 15 | 31% |