FDA approved technology for the clinical selection of CD34+ cells, allowing the passive depletion of tumor cells from autologous apheresis products. A functionally closed system, automated technology giving high purity and yield of CD34+ cells.
The ISOLEX 300i Magnetic Cell Selection System is indicated for processing autologous peripheral blood progenitor cell (PBPC) products to obtain a CD34+ cell enriched population intended for hematopoietic reconstitution after myeloablative therapy in patients with CD34 negative tumors. ISOLEX processing reduces the number of non-CD34+ (non-target) cells, including tumor cells, in the autograft compared with unselected PBPC. Clinical studies have not determined whether use of the ISOLEX 300i system will alter progression-free or overall survival.
The use of the ISOLEX system is contraindicated in patients whose tumors express the CD34 antigen. ISOLEX processing is not indicated for use with previously cryopreserved and thawed PBPC products.
Caution: Federal (USA) law restricts this device to sale by or on the order of a physician.
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