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Background  Intraoperative blood salvage (IBS) is regarded as an alternative to allogeneic blood transfusion excluding the risks associated with allogeneic blood. Currently, IBS is generally avoided in tumor surgeries due to concern for potential metastasis caused by residual tumor cells in the erythrocyte concentrate.    Methods  The feasibility, efficacy and safety aspects of the new developed  Catuvab  procedure using the bispecific trifunctional antibody Catumaxomab was investigated in an ex-vivo pilot study in order to remove residual EpCAM positive tumor cells from the autologous erythrocyte concentrates (EC) from various cancer patients, generated by a IBS device.    Results  Tumor cells in intraoperative blood were detected in 10 of 16 patient samples in the range of 69–2.6 × 10 5  but no residual malignant cells in the final erythrocyte concentrates after  Catuvab  procedure. IL-6 and IL-8 as pro-inflammatory cytokines released during surgery, were lowered in mean 28-fold and 52-fold during the  Catuvab  procedure, respectively, whereas Catumaxomab antibody was detected in 8 of 16 of the final EC products at a considerable decreased and uncritical residual amount (37 ng in mean).    Conclusion  The preliminary study results indicate efficacy and feasibility of the new medical device  Catuvab  allowing potentially the reinfusion of autologous erythrocyte concentrates (EC) produced by IBS device during oncological high blood loss surgery. An open-label, multicenter clinical study on the removal of EpCAM-positive tumor cells from blood collected during tumor surgery using the  Catuvab  device is initiated to validate these encouraging results.

Removal of EpCAM-positive tumor cells from blood collected during major oncological surgery using the Catuvab device- a pilot study