Biocompatibility

Research Focus

The development, validation and standardization of relevant methods for the preclinical evaluation of tissue-engineered medicinal products is a challenge owing to the complexity of these products, their individual risks and effects, and the multiple interactions between cells, (bio)materials and host tissues. BioMedimplant is specialized in test development in the field of biocompatibility assessment and regulatory issues: as a certified test laboratory for medical devices, we provide manufacturers and research groups with preclinical biological tests (www.biomedimplant.de ).The laboratory is accredited by the relevant German accreditation body (DAkkS, www.dakks.de) for the testing of medical devices in accordance with the 90/385/EWG, 93/42/EWG and DIN EN ISO 17025 directives. This certification means the biocompatibility tests conducted at BioMedimplant are relevant for CE marking and market approval of medical devices within the European Union. Our aim is the development of standard procedures and methods for preclinical testing of medicinal products based on tissue engineering. To promote translation of research findings into international standards, Dr. Loos supports – as a member and German delegate, respectively – the corresponding DIN mirror committees and ISO working groups.

Collaborations

  • J. D. Schmitto, HTTG, Hannover Medical School/L. Sajti, REBIRTH Unit, Nanoparticles: Untersuchung der Antibakteriellen Wirksamkeit von mit Nanopartikel dotierten und Antibiotika beschichteten Kunststoffen
  • HIK Hannover (www.HIK-hannover.de)
  • Institut für Biotechnologie und Pathologie Hannover (BioPior), Histopathology of implant-tissue interfaces (www.biopior.com)
  • MDSS, Medical Device Safety Service GmbH Hannover (www.mdss.com)
  • ITEM, Fraunhofer Gesellschaft zur Förderung der angewandten Forschung e.V., Hannover (www.item.fraunhofer.de)

Further Projects

  • Biofabrication 4 Nife, Modul Klinische Translation
  • Contract testing of Medical Devices according to DIN EN ISO 10993
  • DFG-Forschergruppe FOR 2180 “Gradierte Implantate für Sehnen-Knochen-Verbindungen” (Consulting)

    Publications

    2013 - ongoing

    2017

    Willbold E, Weizbauer A, Loos A, Seitz J-M, Angrisani N, Windhagen H, Reifenrath J. Magnesium alloys: A stony pathway from intensive research to clinical reality. Different test methods and approval-related considerations. Journal of Biomedical Materials Research Part A. 2017;105(1):329-47.

    2016

    Duda F, Lipokatic-Takacs E, Loos A, Lüdtke N, Wilhelmi M, Kampmann A, Voigt H, Schubert C, Elff M, Lenarz T, Haverich A. Institutional and sociopolitical factors in supporting clinical translation: the case of biomedical implant research in Hannover, Germany. BioNanoMaterials2016. p. 89.

    2015

    Loos A. 11 - Biocompatibility Testing and Marketing Authorisation Of degradable Magnesium Implants. In: Narayanan TSNS, Lee I-SP-H, editors. Surface Modification of Magnesium and Its Alloys for Biomedical Applications. Oxford: Woodhead Publishing; 2015. p. 331-53.

    Loos A, Bischoff P.Standardisierung im Bereich Tissue Engineering - Ein Blick auf die aktuelle Situation”. Bioforum. 2015, 38 (1), 17-19

    2013

    Sowa-Söhle Eveline N, Schwenke A, Wagener P, Weiss A, Wiegel H, Sajti Csaba L, Haverich A, Barcikowski S, Loos A. Antimicrobial Efficacy, Cytotoxicity, and Ion Release of Mixed Metal (Ag, Cu, Zn, Mg) Nanoparticle Polymer Composite Implant Material. BioNanoMaterials2013. p. 217.

    2006 - 2012

    2012

    Glasmacher B, Krolitzki B, Müller M, Loos A, Löbler M. „Blutverträglichkeit von Kunststoffen“, Kunststoffe in der Medizintechnik, VDI Verlag GmbH, 2012, 273-290, ISBN 978-3-18-234319-6.

    Hahn A, Fuhlrott J, Loos A, Barcikowski S. Cytotoxicity and Ion Release of Alloy Nanoparticles. J Nanopart Res. 2012;14(1):1-10.

    2009

    Ghodsizad A, Niehaus M, Kogler G, Martin U, Wernet P, Bara C, Khaladj N, Loos A, Makoui M, Thiele J, Mengel M, Karck M, Klein HM, Haverich A, Ruhparwar A. Transplanted Human Cord Blood-Derived Unrestricted Somatic Stem Cells Improve Left-Ventricular Function and Prevent Left-Ventricular Dilation and Scar Formation after Acute Myocardial Infarction. Heart. 2009;95(1):27-35.

    Fuhlrott J.; Loos A.; Glasmacher B.; Löbler M.: Endozytose und Zytotoxizität von Nanopartikeln. BIOmaterialien, 2009;10 (3/4):109.

    2007

    Loos A, Rohde R, Haverich A, Barlach S. In Vitro and in Vivo Biocompatibility Testing of Absorbable Metal Stents. Macromolecular Symposia. 2007;253(1):103-8.

    2006

    Waksman R, Pakala R, Kuchulakanti PK, Baffour R, Hellinga D, Seabron R, Tio FO, Wittchow E, Hartwig S, Harder C, Rohde R, Heublein B, Andreae A, Waldmann KH, Haverich A. Safety and Efficacy of Bioabsorbable Magnesium Alloy Stents in Porcine Coronary Arteries. Catheter Cardiovasc Interv. 2006;68(4):607-17; discussion 18-9.

    2003

    Heublein B, Rohde R, Kaese V, Niemeyer M, Hartung W, Haverich A. Biocorrosion of Magnesium Alloys: A New Principle in Cardiovascular Implant Technology? Heart. 2003;89(6):651-6.

    2002

    Heublein B, Evagorou EG, Rohde R, Ohse S, Meliss RR, Barlach S, Haverich A. Polymerized Degradable Hyaluronan--a Platform for Stent Coating with Inherent Inhibitory Effects on Neointimal Formation in a Porcine Coronary Model. Int J Artif Organs. 2002;25(12):1166-73.

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