By Martine Geraerts, Catherine M. Verfaillie (auth.), Ulrich Martin (eds.)
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Nontarget) cells. 96% of CD34-negative cells are removed. P is usually very small for high performance cell separation systems. Therefore, the logarithmic scale is used: # neg pos - log P = - log10 . 5 log depletion of CD34negative cells. When stem cell isolation is used clinically for graft engineering of hematopoietic stem cell grafts for allogeneic transplantation, the removal of T cells is of utmost importance for patient safety. T cells in the graft may cause life-threatening immune reactions versus patient tissue (graft vs host disease, GVHD).
M. Verfaillie 5. Beltrami AP, Barlucchi L, Torella D, Baker M, Limana F, Chimenti S, Kasahara H, Rota M, Musso E, Urbanek K, Leri A, Kajstura J, Nadal-Ginard B, Anversa P (2003) Cell 114:763 6. Oliver JA, Maarouf O, Cheema FH, Martens TP, Al-Awqati Q (2004) J Clin Invest 114:795 7. Ballester G, Tirona MT, Ballester O (2007) Oncology (Williston Park) 21:1576 8. Denker HW (2006) J Med Ethics 32:665 9. Till JE, Mc CE (1961) Radiat Res 14:213 10. Becker AJ, Mc CE, Till JE (1963) Nature 197:452 11. Siminovitch L, McCulloch EA, Till JE (1963) J Cell Physiol 62:327 12.
The CliniMACS® System components (Reagents, Tubing Sets, Instruments and PBS/EDTA Buffer) are manufactured and controlled under an ISO 13485 certified quality system. In Europe, the CliniMACS System components are available as CE-marked medical devices. In the USA, the CliniMACS System components including the CliniMACS Reagents are available for use only under an approved Investigational New Drug (IND) application or Investigational Device Exemption (IDE). CliniMACS® MicroBeads are for research use only and not for use in humans Isolex® 300i Baxter Healthcare Corporation has adapted Dynabead-based stem cell isolation to an automated process in a clinical scale.