Hemocompatibility evaluation of poly(glycerol-sebacate) in vitro for vascular tissue engineering.

Poly(glycerol-sebacate) (PGS) is an elastomeric biodegradable polyester that could potentially be used to engineer blood vessels in vivo. However, its blood-material interactions are unknown. The objectives of this study were to: (a) fabricate PGS-based biphasic tubular scaffolds and (b) assess the blood compatibility of PGS in vitro in order to get some insight into its potential use in vivo. PGS was incorporated into biphasic scaffolds by dip-coating glass rods with PGS pre-polymer. The thrombogenicity (platelet adhesion and aggregation) and inflammatory potential (IL-1beta and TNFalpha expression) of PGS were evaluated using fresh human blood and a human monocyte cell line (THP-1). The activation of the clotting system was assessed via measurement of tissue factor expression on THP-1 cells, plasma recalcification times, and whole blood clotting times. Glass, tissue culture plastic (TCP), poly(l-lactide-co-glycolide) (PLGA), and expanded polytetrafluorethylene (ePTFE) were used as reference materials. Biphasic scaffolds with PGS as the blood-contacting surface were successfully fabricated. Relative to glass (100%), platelet attachment on ePTFE, PLGA and PGS was 61%, 100%, and 28%, respectively. PGS elicited a significantly lower release of IL-1beta and TNFalpha from THP-1 cells than ePTFE and PLGA. Similarly, relative to all reference materials, tissue factor expression by THP-1 cells was decreased when exposed to PGS. Plasma recalcification and whole blood clotting profiles of PGS were comparable to or better than those of the reference polymers tested.

[1]  A. Wasiluk Markers of platelets activation, CD 62P and soluble P-selectin in healthy term neonates , 2004, Journal of perinatal medicine.

[2]  T. Glant,et al.  Human monocyte/macrophage response to cobalt‐chromium corrosion products and titanium particles in patients with total joint replacements , 1997, Journal of orthopaedic research : official publication of the Orthopaedic Research Society.

[3]  N. Huang,et al.  Hemocompatibility of titanium oxide films. , 2003, Biomaterials.

[4]  J J Sixma,et al.  Activated platelets release two types of membrane vesicles: microvesicles by surface shedding and exosomes derived from exocytosis of multivesicular bodies and alpha-granules. , 1999, Blood.

[5]  K. Mann,et al.  Blood clotting in minimally altered whole blood. , 1996, Blood.

[6]  Paula Finn,et al.  American Heart Association--scientific sessions 2005. 13-16 November 2005, Dallas, TX, USA. , 2006, IDrugs : the investigational drugs journal.

[7]  G. Lip,et al.  Hypothesis: is soluble P-selectin a new marker of platelet activation? , 1997, Atherosclerosis.

[8]  R. Fijnheer,et al.  Soluble P-selectin as Parameter for Platelet Activation during Storage , 1996, Thrombosis and Haemostasis.

[9]  Y. Ikada,et al.  Simple method for platelet counting. , 1995, Biomaterials.

[10]  W. Tsai,et al.  Human plasma fibrinogen adsorption and platelet adhesion to polystyrene. , 1999, Journal of biomedical materials research.

[11]  Robert Langer,et al.  Microfabrication of poly (glycerol-sebacate) for contact guidance applications. , 2006, Biomaterials.

[12]  Michael V Sefton,et al.  Biomaterial-associated thrombosis: roles of coagulation factors, complement, platelets and leukocytes. , 2004, Biomaterials.

[13]  T. Bauer,et al.  The effect of particle wear debris on NFkappaB activation and pro-inflammatory cytokine release in differentiated THP-1 cells. , 2002, Journal of biomedical materials research.

[14]  J. Wataha,et al.  Human peripheral blood monocytes versus THP-1 monocytes for in vitro biocompatibility testing of dental material components. , 2002, Journal of oral rehabilitation.

[15]  J. Wataha,et al.  Ability of Ni-containing biomedical alloys to activate monocytes and endothelial cells in vitro. , 1999, Journal of biomedical materials research.

[16]  M. Basson,et al.  Differential regulation of monocyte/macrophage cytokine production by pressure. , 2005, American journal of surgery.

[17]  Robert Langer,et al.  Endothelialized microvasculature based on a biodegradable elastomer. , 2005, Tissue engineering.

[18]  M. Herring,et al.  Endothelial cell seeding in the management of vascular thrombosis. , 1989, Seminars in thrombosis and hemostasis.

[19]  David Gurney,et al.  A reliable plasma marker of platelet activation: Does it exist? , 2002, American journal of hematology.

[20]  W. Tsai,et al.  Hemocompatibility of treated polystyrene substrates: contact activation, platelet adhesion, and procoagulant activity of adherent platelets. , 1998, Journal of biomedical materials research.

[21]  A. Schmaier,et al.  Contact Activation: A Revision , 1997, Thrombosis and Haemostasis.

[22]  B D Ratner,et al.  In vivo evaluation of artificial surfaces with a nonhuman primate model of arterial thrombosis. , 1980, The Journal of laboratory and clinical medicine.

[23]  W. Godwin Article in Press , 2000 .

[24]  H. Greisler,et al.  Biomaterials in the development and future of vascular grafts. , 2003, Journal of vascular surgery.

[25]  K. Leong,et al.  The design of scaffolds for use in tissue engineering. Part I. Traditional factors. , 2001, Tissue engineering.

[26]  J. Feijen,et al.  Endothelialization of Small-Diameter Vascular Prostheses , 2003, Archives of physiology and biochemistry.

[27]  J. Fletcher,et al.  Fluoropolymer coated Dacron or polytetrafluoroethylene for femoropopliteal bypass grafting: a multicentre trial , 2003, ANZ journal of surgery.

[28]  Jian Yang,et al.  Synthesis and evaluation of poly(diol citrate) biodegradable elastomers. , 2006, Biomaterials.

[29]  C. Gemmell Activation of platelets by in vitro whole blood contact with materials: Increases in microparticle, procoagulant activity, and soluble P-selectin blood levels , 2001, Journal of biomaterials science. Polymer edition.

[30]  R. Simmons,et al.  TNF and IL-1 generation by human monocytes in response to biomaterials. , 1992, Journal of biomedical materials research.

[31]  Joseph P Vacanti,et al.  Biocompatibility analysis of poly(glycerol sebacate) as a nerve guide material. , 2005, Biomaterials.

[32]  L. Harker Platelets and vascular thrombosis. , 1994, The New England journal of medicine.

[33]  Robert Langer,et al.  In vivo degradation characteristics of poly(glycerol sebacate). , 2003, Journal of biomedical materials research. Part A.

[34]  R. Langer,et al.  A tough biodegradable elastomer , 2002, Nature Biotechnology.

[35]  Anthony Atala,et al.  Principals of neovascularization for tissue engineering. , 2002, Molecular aspects of medicine.

[36]  M. Shuman,et al.  A platelet alpha-granule membrane protein (GMP-140) is expressed on the plasma membrane after activation , 1985, The Journal of cell biology.

[37]  Jian Yang,et al.  Novel biphasic elastomeric scaffold for small-diameter blood vessel tissue engineering. , 2005, Tissue engineering.

[38]  J. Gamble,et al.  Characterization of GMP-140 (P-selectin) as a circulating plasma protein , 1992, The Journal of experimental medicine.

[39]  J. Anderson,et al.  In vitro stimulation of fibroblast activity by factors generated from human monocytes activated by biomedical polymers. , 1989, Journal of biomedical materials research.

[40]  L. Yahia,et al.  Metalloproteinase and cytokine production by THP-1 macrophages following exposure to chitosan-DNA nanoparticles. , 2004, Biomaterials.

[41]  W. J. Bos,et al.  An in vitro test model to study the performance and thrombogenicity of cardiovascular devices. , 1989, ASAIO transactions.

[42]  C. Dinarello Cytokines and biocompatibility. , 1990, Blood purification.

[43]  R. Misra,et al.  Biomaterials , 2008 .

[44]  R Langer,et al.  Functional arteries grown in vitro. , 1999, Science.

[45]  J. Anderson,et al.  Biomaterial biocompatibility and the macrophage. , 1984, Biomaterials.

[46]  Y. Nosé,et al.  A new method for evalution of antithrombogenicity of materials. , 1972, Journal of biomedical materials research.