Evaluation of the new continuous mononuclear cell collection protocol versus an older version on two different apheresis machines.

BACKGROUND: Cell separators are routinely used to collect CD34+ blood stem cells in the context of customized stem cell transplantation procedures. The Spectra Optia (Terumo BCT) is a novel development of the precursor instrument, the Cobe Spectra (Terumo BCT). STUDY DESIGN AND METHODS: In this report, 146 autologous and 42 allogeneic donors undergoing apheresis on the Cobe Spectra using the mononuclear cell (MNC) program 4.7 or on the Spectra Optia using the new continuous mononuclear cell (cMNC) program 11.2 are compared. RESULTS: Viability of cells and collection efficacy within the apheresis products was comparable for autologous and allogeneic products collected with the MNC or cMNC method. However, we found a reduced duration of the apheresis procedure and lower hematocrit within the apheresis products when using the cMNC in autologous and allogeneic donors. Moreover, allogeneic donors collected substantially more CD34+ cells per kilogram of body weight when using the cMNC method. Differences in platelets before and after apheresis were substantially smaller in this cohort when compared to the cohort collected with the MNC method. Neutrophil and platelet engraftment after autologous or allogeneic transplantation with a product collected with the MNC procedure was comparable to a transplantation with a product processed according to the cMNC method. CONCLUSION: Comparison of the MNC (Cobe Spectra) and the cMNC (Spectra Optia) methods demonstrated an equal performance and outcome. However, advantages were present using the cMNC method with respect to apheresis duration and hematocrit within the apheresis product (autologous/allogeneic donors) and numbers of CD34+ cells collected, especially in allogeneic donors.

Patients' outcome after rescue plerixafor administration for autologous stem cell mobilization: a single-center retrospective analysis.

BACKGROUND: Plerixafor is predominantly used for patients mobilizing inadequate stem cell numbers for autologous transplantation after stimulation with granulocyte-colony-stimulating factor (G-CSF). STUDY DESIGN AND METHODS: We here report on 300 patients undergoing stem cell mobilization with G-CSF, among them 36 poor mobilizers (CD34+ cell counts < 50 × 106 /L blood) receiving G-CSF alone and 49 receiving G-CSF in combination with plerixafor for rescue intervention. Mobilization efficacy and short-time outcome after autologous stem cell transplantation were analyzed and compared in the respective subgroups. RESULTS: Out of 49 patients treated with plerixafor and G-CSF, 46 (94%) collected sufficient hematopoietic stem cell numbers although the number was clearly inferior in poor mobilizers. Compared to good mobilizers, viability of CD34+ cells analyzed after collection was slightly reduced in poor mobilizers independent of the application of plerixafor. A total of 232 patients underwent autologous stem cell transplantation, among them 26 poor mobilizers who received only G-CSF and 31 patients who received G-CSF in combination with plerixafor. Time until neutrophil engraftment was in median 1 day later in poor mobilizers irrespective of the application of plerixafor. Platelet engraftment was in median 2 days delayed in patients mobilized with G-CSF and plerixafor compared to 1 day in poor mobilizers treated with G-CSF only. Frequency of detected CD38+ CD138+ CD45- CD56+ plasma cells in the apheresis products of myeloma patients was comparable for all groups. CONCLUSION: Our data demonstrate that plerixafor is highly effective as rescue measurement after mobilization failure with G-CSF alone and short-term clinical outcome after stem cell transplantation is comparable.

Long-term experiences in cryopreservation of mobilized peripheral blood stem cells using a closed-bag system: a technology with potential for broader application.

BACKGROUND: In several European countries, preparation of cellular products with open manufacturing systems as used for cryopreservation of peripheral blood stem cells (PBSCs) needs to be performed in a clean-room facility. However, this form of manufacturing is highly expensive and laborious. Thus, safe techniques providing improved efficacy regarding time and material, which are in accordance with legal requirements are highly desirable. STUDY DESIGN AND METHODS: We have developed, validated, and applied a simple method for cryopreservation of PBSCs within a functionally closed-bag system using the closed cryo freeze prep set. This process fulfills good manufacturing practice requirements and allows for the cryopreservation of PBSCs without a clean-room facility. In addition to cryopreservation of PBSCs, we have recently successfully modified our system for processing, portioning, and cryopreservation of allogeneic donor lymphocytes. RESULTS: Since 2010, cryopreservation of PBSCs using a closed-bag system has been performed in our facility on a routine basis and 210 patients and healthy donors have been included in this analysis. No significant reduction in viability of CD34+ cells and no process-related contamination were observed. Outcome of hematopoietic stem cell transplantation regarding time of engraftment and infectious complications is comparable to products manufactured in conventional clean-room facilities. CONCLUSION: Our data confirm that cryopreservation of PBSCs within a functionally closed-bag system is safe, effective, and economical. Furthermore, the system has the potential to be extended to other manufacturing processes of cellular products.