OBJECTIVES: To evaluate whether hematopoietic stem cells collected using Terumo BCT’s Spectra Optia Apheresis System were able to reconstitute the hematopoietic systems of patients treated with myeloablative therapy, and that the cells were functionally equivalent to hematopoietic cells harvested on the FDA-cleared COBE Spectra Apheresis System.

METHODS: 26 multiple myeloma (MM) patients undergoing their first myeloablative therapy and autologous peripheral blood hematopoietic stem-cell transplant were chosen for the study from four investigational sites. Patients were followed for 21 days to determine the number of days required for absolute neutrophil count (ANC) to exceed 500/uL (ANC500) following stem cell transplant. Peripheral blood collected during the mononuclear cells (MNC) protocol were assessed for CD34+ cell, red blood cell, and platelet content, sterility, and viability of white blood cells in post-thaw products.

RESULTS: The median time to ANC500 was 12 days (Range: 10-14 days). There was no significant difference in the time to ANC500 for subjects treated with Spectra Optia compared to historical COBE Spectra data. No device-related serious or unanticipated adverse events occurred during the study.

CONCLUSIONS: The study met its primary end point and demonstrated that there was no significant difference in the time to ANC500 in MM patients treated with Spectra Optia compared to historical COBE Spectra data. Using the Spectra Optia System’s MNC Collection Protocol, the overall median day to ANC500 recovery was 12 days with little variation across subjects (Range: 10-14 days). Every subject transplanted with Spectra Optia-collected cells achieved the expected clinical outcome (neutrophil recovery). The Spectra Optia MNC Collection Protocol is safe and effective for its intended use and is substantially equivalent to the previously cleared COBE Spectra Apheresis System.