Mobilized allogeneic peripheral stem/progenitor cell apheresis with Spectra Optia v.5.0, a novel, automatic interface-controlled apheresis system: results from the first feasibility trial.

摘要

BACKGROUND AND OBJECTIVES: G-CSF mobilized peripheral blood stem/progenitor cells are frequently used for allogeneic transplantation. Available manual apheresis systems generate stem cell products of consistently high quality. Short-comings include need for continuous interface monitoring/adjustment, interface instability in donors with inconsistent blood flow, high collection variability, high platelet loss, and failure to electronically document apheresis parameters. MATERIAL AND METHODS: A fundamentally different, novel apheresis system, Spectra Optia v.5.0, featuring optical sensors, which provide real-time automatic interface and product collect line control, and newly developed tubing sets, was designed to address these short-comings. In a prospective validation study, 30 healthy volunteer stem cell donors were subjected to apheresis with Spectra Optia to test feasibility and effectiveness. Results were compared to 608 historic first-day allogeneic aphereses with COBE Spectra MNC. RESULTS: Usability and function of automatic interface control of Spectra Optia were good. Most collection parameters, including collection efficiency and product size, were similar. Cells were viable and provided timely engraftment. Platelet loss with Spectra Optia was 25% less than with COBE Spectra MNC. Products contained fewer erythrocytes, but more granulocytes. CONCLUSION: The automatic apheresis system Spectra Optia is functional and user-friendly. Thus Spectra Optia aphereses are associated with similar, and equally variable, collection efficiencies as COBE Spectra MNC.