Cell Selection Products

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 on non-CD34+ (non-target) cells, including tumor cells, in the autograft compared with unselected PBPC products.  Clinical studies have not determined whether use of the ISOLEX 300i system will alter progression-free or overall survival.

Safety Information

• 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 cropreserved and thawed PBPC products.
• The safety of ISOLEX processing in patients with unsuccessful stem cell mobilization (a circulating CD34+ cell number of < 20/ECL) or with < 5 x 10e6 CD34+ cells/kg in the apheresis products prior to selection, has not been fully studied; thus, is not established.
• Potential risks related to additional ISOLEX processing include the risk of infusion of bacterially contaminated cells that may cause infection.
• There is the potential for infusion of foreign proteins which are residual process components, which may evoke an immune response.
• The ISOLEX Reagent Kit and disposable sets are intended for single use only.

Caution:  Federal (USA) law restricts this device to sale by or on the order of a physician.

For safe and proper use of this device please refer to the complete operating instructions in the operator's manual.

The instrument has a capacity of up to 8 x 10¹⁰ nucleated cells. 

Physical Dimensions:

Height:     82 cm / 32"

                (including weight tower)

Depth:      41 cm / 16"

Width:      63 cm / 24.5"

Weight:     32.5 kg / 71 lbs

Cell Capacity  8x10¹⁰ total nucleated cells

Sterile, non-pyrogenic fluid path disposable designed specifically for use with the ISOLEX 300i Magnetic Cell Selection System.

For use with the ISOLEX 300i Magnetic Cell Selection System.

Kit components

• One vial of IgG, anti-CD34 antibody (2.5 mL antibody at 1.0 mg/mL)
• One vial of Dynabeads^® (10 mL containing approx. 4x10⁹ microspheres)
• One vial of patented PR34⁺ stem cell release agent (20 mL peptide at 5 mg/mL)

Supplied sterile and non-pyrogenic

Dynabeads^® M-450 microspheres coated with sheep anti-mouse IgG. 

10 mL containing approx. 4 x 10⁹ microspheres, designed to bind to cells coated with murine monoclonal antibodies.

Supplied sterile and non-pyrogenic.

Store upright at 2-8º C.  Do not freeze.

Calcium and magnesium free, sterile, and non-pyrogenic.  Supplied in 3-liter bags.  For use with the ISOLEX 300i Magnetic Cell Selection System.