TY - JOUR A1 - Söhling, Nicolas A1 - Leiblein, Maximilian A1 - Schaible, Alexander A1 - Janko, Maren Carina A1 - Schwäble, Joachim A1 - Seidl, Christian A1 - Brune, Jan C. A1 - Nau, Christoph A1 - Marzi, Ingo A1 - Henrich, Dirk A1 - Verboket, René T1 - First human leucocyte antigen (HLA) response and safety evaluation of fibrous demineralized bone matrix in a critical size femoral defect model of the Sprague Dawley rat T2 - Materials N2 - Treatment of large bone defects is one of the great challenges in contemporary orthopedic and traumatic surgery. Grafts are necessary to support bone healing. A well-established allograft is demineralized bone matrix (DBM) prepared from donated human bone tissue. In this study, a fibrous demineralized bone matrix (f-DBM) with a high surface-to-volume ratio has been analyzed for toxicity and immunogenicity. f-DBM was transplanted to a 5-mm, plate-stabilized, femoral critical-size-bone-defect in Sprague-Dawley (SD)-rats. Healthy animals were used as controls. After two months histology, hematological analyses, immunogenicity as well as serum biochemistry were performed. Evaluation of free radical release and hematological and biochemical analyses showed no significant differences between the control group and recipients of f-DBM. Histologically, there was no evidence of damage to liver and kidney and good bone healing was observed in the f-DBM group. Reactivity against human HLA class I and class II antigens was detected with mostly low fluorescence values both in the serum of untreated and treated animals, reflecting rather a background reaction. Taken together, these results provide evidence for no systemic toxicity and the first proof of no basic immunogenic reaction to bone allograft and no sensitization of the recipient. KW - demineralized bone matrix KW - rat femur critical size defect Y1 - 2020 UR - http://publikationen.ub.uni-frankfurt.de/frontdoor/index/index/docId/55434 UR - https://nbn-resolving.org/urn:nbn:de:hebis:30:3-554341 SN - 1996-1944 N1 - © 2020 by the authors. Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license (http://creativecommons.org/licenses/by/4.0/). VL - 13 IS - 14, art. 3120 SP - 1 EP - 17 PB - MDPI CY - Basel ER -