Safety and performance of the Spectra Optia apheresis system for white blood cell depletion in patients with elevated white blood cell counts.

Background: For the past 30 years, white blood cell depletion (WBCD) or leukocytapheresis has been conducted to rapidly reduce excessive circulating white blood cell (WBC) concentrations in patients at risk for or with symptoms of leukostasis due to hyperleukocytosis. The goal of leukocytapheresis is to prevent or treat acute complications from leukostasis, thereby enabling patients to receive potentially curative chemotherapy.

Methods: This report details the results from a retrospective and a prospective clinical study conducted in the European Union and the People's Republic of China, which assessed the use of the Spectra Optia Apheresis System for leukocytapheresis in patients with hyperleukocytosis.

The safety and performance of the Spectra Optia apheresis system platelet depletion protocol in patients with elevated platelet counts.

Background: Thrombocytosis is a presenting and progressive clinical feature found in multiple disease states. It is characterized by high platelet (PLT) counts (>450 × 10 /L) and can lead to thrombohemorrhagic events. Thrombocytapheresis or platelet depletion (PLTD) can be performed in acutely symptomatic patients suffering from thrombocytosis and may reduce or prevent acute serious complications associated with thrombocythemia thereby enabling patients to receive potentially curative high-dose chemotherapy.

Spectra Optia granulocyte apheresis collections result in higher collection efficiency of viable, functional neutrophils in a randomized, crossover, multicenter trial.

Background: Granulocyte transfusion from healthy donors is used in the treatment of patients with granulocyte function defects, or transient neutropenia and severe bacterial or fungal infections resistant to maximal antimicrobial treatment.

Study Design And Methods: This study evaluated the performance and safety of the newly developed granulocyte collection protocol of the Spectra Optia in a prospective, multicenter, open-label, randomized, paired crossover trial compared with the COBE Spectra apheresis system in a population of 32 evaluable healthy subjects. All subjects received granulocyte-colony-stimulating factor and dexamethasone before collection.

The evaluation of a new apheresis device for automated red blood cell exchange procedures in patients with sickle cell disease.

Background: The Spectra Optia apheresis system (SO), a blood component separator, can be used to perform red blood cell exchange (RBCX) procedures for the transfusion management of sickle cell disease (SCD) in adults and children. This study was designed to evaluate the performance of the SO RBCX protocols (exchange and depletion/exchange) in patients with SCD.

Study Design And Methods: Patients with SCD and a need for an RBCX procedure as part of a chronic program or as a single procedure were enrolled in this multicenter, single-arm, open-label study.

Evaluation of the spectra Optia® mononuclear cell collection procedure in multiple myeloma patients.

Background: Peripheral blood stem cell (PBSC) rescue following myeloablative therapy is a mainstay of cancer therapy. To evaluate the ability of the Spectra Optia Apheresis System (SO), a newly developed apheresis device, the device was studied in multiple myeloma patients undergoing a first autologous PBSC transplant.

Aim: To demonstrate that neutrophil recovery was not inferior to historical controls when SO harvested PBSCs were reinfused following myeloablative therapy.

Improved plasma removal efficiency for therapeutic plasma exchange using a new apheresis platform.

Background: The Spectra Optia (SPO; CaridianBCT) is a new apheresis device based on the COBE Spectra (CSP; CaridianBCT) platform. This study was designed to evaluate the safety and efficiency of the SPO in comparison to the predicate CSP device.

Study Design And Methods: Twenty patients were recruited for a randomized, nonblinded, paired (crossover) clinical trial comparing the SPO to the CSP (pivotal trial).

Antigen-specific T cells in rheumatoid arthritis.

There is considerable evidence of a key role for CD4+ T cells in the pathogenesis of rheumatoid arthritis. Several attractive candidate antigens, mostly joint-specific, have been studied, but information regarding T cell responses to these antigens in patients is limited and occasionally contradictory. Novel reagents (such as major histocompatibility complex and peptide tetramers) and sensitive techniques (such as intracellular cytokine staining) will aid in future studies to identify antigen-specific T cells.