TY  - JOUR
A1  - Winter, Andreas
A1  - Zacharowski, Kai
A1  - Meybohm, Patrick
A1  - Schnitzbauer, Andreas
A1  - Ruf, Peter
A1  - Kellermann, Claudia
A1  - Lindhofer, Horst
T1  - Removal of EpCAM-positive tumor cells from blood collected during major oncological surgery using the Catuvab device - a pilot study
T2  - BMC anesthesiology
N2  - 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 × 105 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.
KW  - Intraoperative blood salvage
KW  - Leukocyte depletion filter
KW  - Tumor cell
KW  - EpCAM positive tumor
KW  - Catumaxomab
Y1  - 2021
UR  - http://publikationen.ub.uni-frankfurt.de/frontdoor/index/index/docId/69787
UR  - https://nbn-resolving.org/urn:nbn:de:hebis:30:3-697878
SN  - 1471-2253
N1  - The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated in a credit line to the data.
N1  - The study was funded by LINDIS Blood Care GmbH, Neuendorfstr. 20b, Henningsdorf, Germany. Open Access funding enabled and organized by Projekt DEAL.
N1  - Availability of data and materials
The datasets analysed are available from the corresponding author upon reasonable request.
For data request please contact Andreas Winter, University Hospital Frankfurt, Germany (andreas.winter@kgu.de)
VL  - 21.2021
IS  - art. 261
SP  - 1
EP  - 11
PB  - BioMed Central
CY  - [Erscheinungsort nicht ermittelbar]
ER  -