@article{EbnerOstheimerSautermeister2020,
  author    = {Ebner, Katharina and Ostheimer, Jochen and Sautermeister, Jochen},
  title     = {The role of religious beliefs for the acceptance of xenotransplantation. Exploring dimensions of xenotransplantation in the field of hospital chaplaincy},
  series = {Xenotransplantation},
  volume    = {27},
  journal   = {Xenotransplantation},
  number    = {4},
  doi       = {10.1111/xen.12579},
  url       = {http://nbn-resolving.de/urn:nbn:de:bvb:20-opus-214114},
  year      = {2020},
  abstract  = {Background The Changsha Communiqu{\´e} (2008) calls for a greater account to be taken of the ethical aspects of xenotransplantation as well as of public perception. This also applies to the field of hospital chaplaincy. So far, there has been no empirical exploration of the assessment and acceptance of xenotransplantation by pastoral workers in German-speaking countries. In view of the prospect of clinical trials, in-depth research is both sensible and necessary, since both xeno- and allotransplantation can have far-reaching consequences for patients, their relatives, and the social environment. In addition to the tasks of health monitoring, questions of the individual handling with and integration of a xenotransplant must also be considered. They can affect one's own identity and self-image and thus also affect religious dimensions. Hence, they make a comprehensive range of accompaniment necessary. Methods This paper presents the first explorative results of a Dialogue Board with Christian, Jewish, and Muslim hospital chaplains. It explores pastoral challenges of xenotransplantation for the German-speaking countries, in particular (a) self-image and tasks of hospital pastoral care, (b) religious aspects of transplantation, and (c) religious aspects of xenotransplantation as anticipated by the hospital pastors. Results Depending on their religious background, hospital chaplains see different pastoral challenges when xenotransplantation reaches clinical stage. In particular, the effects on the identity and religious self-image of those affected must be taken into account. Three desiderata or recommendations for action emerged from the Dialogue Board: (a) initial, advanced and further training for hospital pastoral workers, (b) contact points for patients, and (c) interreligious cooperation and a joint statement. All participants of the Dialogue Board emphasized the chances of xenotransplantation and expressed their hope that xenogenic transplants could save patients or improve the quality of their life substantially. Conclusions Xenotransplantation can affect the identity work of patients and relatives also in religious terms. In order to provide better pastoral and psychosocial support for these persons within the framework of the hospital, it is important to reflect on such challenges at an early stage and to develop concepts for pastoral further training and pastoral care in xenotransplantation.},
  language  = {en}
}
@article{BittorfBergmannMerlinetal.2020,
  author    = {Bittorf, Patrick and Bergmann, Thorsten and Merlin, Simone and Olgasi, Chistina and Pullig, Oliver and Sanzenbacher, Ralf and Zierau, Martin and Walles, Heike and Follenzi, Antonia and Braspenning, Joris},
  title     = {Regulatory-Compliant Validation of a Highly Sensitive qPCR for Biodistribution Assessment of Hemophilia A Patient Cells},
  series = {Molecular Therapy - Methods \& Clinical Development},
  volume    = {18},
  journal   = {Molecular Therapy - Methods \& Clinical Development},
  doi       = {10.1016/j.omtm.2020.05.029},
  url       = {http://nbn-resolving.de/urn:nbn:de:bvb:20-opus-230284},
  pages     = {176-188},
  year      = {2020},
  abstract  = {The investigation of the biodistribution profile of a cell-based medicinal product is a pivotal prerequisite to allow a factual benefit-risk assessment within the non-clinical to clinical translation in product development. Here, a qPCR-based method to determine the amount of human DNA in mouse DNA was validated according to the guidelines of the European Medicines Agency and the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use. Furthermore, a preclinical worst-case scenario study was performed in which this method was applied to investigate the biodistribution of 2 x 10\(^6\) intravenously administered, genetically modified, blood outgrowth endothelial cells from hemophilia A patients after 24 h and 7 days. The validation of the qPCR method demonstrated high accuracy, precision, and linearity for the concentration interval of 1:1 x 10\(^3\) to 1:1 x 10\(^6\) human to mouse DNA. The application of this method in the biodistribution study resulted in the detection of human genomes in four out of the eight investigated organs after 24 h. After 7 days, no human DNA was detected in the eight organs analyzed. This biodistribution study provides mandatory data on the toxicokinetic safety profile of an actual candidate cell-based medicinal product. The extensive evaluation of the required validation parameters confirms the applicability of the qPCR method for non-clinical biodistribution studies.},
  language  = {en}
}