Continuous CD34+ cell collection by a new device is safe and more efficient than by a standard collection procedure: results of a two-center, crossover, randomized trial.

BACKGROUND: Peripheral blood stem cells (PBSCs) collected from granulocyte-colony-stimulating factor (G-CSF)-mobilized donors are routinely used for hematopoietic stem cell transplantation. Most PBSC collections worldwide have used the COBE Spectra (COBE) platform that is being replaced by the Spectra Optia (OPTIA). This study compared the PBSC collection performance and safety of the OPTIA using a single-step, continuous mononuclear cell (CMNC) collection procedure and the standard COBE MNC procedure.

STUDY DESIGN AND METHODS: A prospective, noninferiority, randomized, open-label, crossover, multicenter study was conducted in G-CSF-mobilized donors randomized to undergo MNC collection on Days 5 and 6. The primary endpoint was CD34+ cell collection efficiency (CE1%) with a noninferiority margin of 10%. The secondary endpoint was CD34+ cell CE2%. Product purity and safety were also assessed.

RESULTS: Twenty-three healthy donors (87% male) participated in the study. Mean (±SD) CD34+ CE1% was 84.4% (±16.4%) and 66.2% (±15.3%) for the OPTIA and COBE, respectively (p < 0.001 for noninferiority and superiority). Mean (±SD) CD34+ CE2% was 62.4 (±11.6) and 48.4 (±11.2) for the OPTIA and COBE, respectively (p < 0.001 for superiority). Granulocyte and platelet (PLT) contamination were lower in OPTIA-collected products. There were no unexpected adverse events (AEs) and no significant differences in the incidence of AEs between study arms. PLT loss was less with the OPTIA than with the COBE.

CONCLUSION: The OPTIA CMNC collection procedure is safe and effective for the collection of CD34+ cells in G-CSF-mobilized donors and was superior to the COBE for CE1% and CE2%, collecting approximately 19 and 16% higher, respectively.