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1

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Long-term ingrowth and apposition of porous hydroxylapatite implants (1997)

Nunes, C. R. ; Simske, S. J. ; Sachdeva, R. ; [et al.]

Hoboken, NJ : Wiley-Blackwell

Journal of Biomedical Materials Research 36 (1997), S. 560-563

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ISSN: 0021-9304

Keywords: bone ; implant ; hydroxylapatite ; biocompatibility ; histomorphometric implant saturation ; Chemistry ; Polymer and Materials Science

Source: Wiley InterScience Backfile Collection 1832-2000

Topics: Medicine , Technology

Notes: Bone implant materials are often used to fill in bone gaps that frequently result from orthognathic and craniofacial reconstruction. The substrate hydroxylapatite (HA) is commonly implanted into the bone voids, resulting from these conditions due to its established biocompatibility and osteoconductive properties. The porous structure of HA provides a three-dimensional guideline for fibrovascular ingrowth, facilitating the process that ultimately results in the deposition of new bone. Porous HA (Interpore, 200) implants were implanted in the mandible or maxilla of nine humans and removed after 14-30 months (19.1-month mean). There was no evidence of an inflammatory response. The sample composition and apposition against the implant were determined using point counting and a digitizing tablet and software. Percent ingrowth in available space (%IAS) was defined as %Bone/(%Bone + %Void). A new measure of implant saturation (%IAS - %Apposition of bone) was established to help determine the fundamental manner in which long-term HA implants incorporate bone. In the mean, the samples were composed of 27% bone, 21% void, and 53% implant. The apposition percentages averaged 60% bone, 16% void, and 24% soft tissue. The %IAS averaged 58%, and implant saturation averaged -3%, indicating that a near-balance between the implant and surrounding bone has been established. © 1997 John Wiley & Sons, Inc. J Biomed Mater Res, 36, 560-563, 1997.

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2

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Osteogenic cell cytotoxicity and biomechanical strength of the new ceramic Diopside (1997)

Kobayashi, T. ; Okada, K. ; Kuroda, T. ; [et al.]

Hoboken, NJ : Wiley-Blackwell

Journal of Biomedical Materials Research 37 (1997), S. 100-107

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ISSN: 0021-9304

Keywords: Diopside ; biocompatibility ; osteogenic cell (MC3T3-E1) ; biomechanical strength ; apatite wollastonite-containing glass-ceramic (AWGC) ; Chemistry ; Polymer and Materials Science

Source: Wiley InterScience Backfile Collection 1832-2000

Topics: Medicine , Technology

Notes: Diopside was prepared by sintering a powder compact composed of CaMgSi2O6 at 1573K for 2 h. In order to clarify the biocompatibility of Diopside, the cytotoxicity of Diopside against the osteogenic cell line MC3T3-E1 and the bone-Diopside interface strength were examined. On both the 14th and 21st days of incubation of MC3T3-E1 cells with Diopside, ALP activities were not significantly lower than those of the CTRL. TEM photographs of MC3T3-E1 on Diopside after 14 days of incubation showed active secretion of crystals from osteoblast-like cells. Scanning electron microscopic analysis showed that the cells on Diopside formed multiple cell layers similar to those on the CTRL both 14 and 21 days after incubation. These results showed that Diopside had no cytotoxic effect on MC3T3-E1. The pulling test showed that failure loads of Diopside were significantly lower than those of AWGC. Histologically, there was no fibrous tissue or foreign body reaction at the bone interface. SEM-EPMA showed that Diopside had attached to the bone via a calcium-phosphorus layer. SEM back-scattered electron imaging showed that the Diopside plate had degraded to a porous state 12 weeks after implantation. These findings indicate that Diopside is a biodegradable ceramic. © 1997 John Wiley & Sons, Inc. J Biomed Mater Res, 37, 100-107, 1997.

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3

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Assessment of wrought ASTM F1058 cobalt alloy properties for permanent surgical implants (1997)

Clerc, Claude O. ; Jedwab, Michael R. ; Mayer, David W. ; [et al.]

Hoboken, NJ : Wiley-Blackwell

Journal of Biomedical Materials Research 38 (1997), S. 229-234

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ISSN: 0021-9304

Keywords: cobalt alloy ; implant ; biocompatibility ; Chemistry ; Polymer and Materials Science

Source: Wiley InterScience Backfile Collection 1832-2000

Topics: Medicine , Technology

Notes: The behavior of the ASTM F1058 wrought cobalt-chromium-nickel-molybdenum-iron alloy (commonly referred to as Elgiloy® or Phynox) is evaluated in terms of mechanical properties, magnetic resonance imaging, corrosion resistance, and biocompatibility. The data found in the literature, the experimental corrosion and biocompatibility results presented in this article, and its long track record as an implant material demonstrate that the cobalt superalloy is an appropriate material for permanent surgical implants that require high yield strength and fatigue resistance combined with high elastic modulus, and that it can be safely imaged with magnetic resonance. © 1997 John Wiley & Sons, Inc. J Biomed Mater Res (Appl Biomater) 38: 229-234, 1997

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4

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Culture materials affect ex vivo expansion of hematopoietic progenitor cells (1997)

LaIuppa, Jennifer A. ; McAdams, Todd A. ; Papoutsakis, E. Terry ; [et al.]

Hoboken, NJ : Wiley-Blackwell

Journal of Biomedical Materials Research 36 (1997), S. 347-359

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ISSN: 0021-9304

Keywords: hematopoietic cultures ; biocompatibility ; culture materials ; serum-free medium ; CD34+ cells ; Chemistry ; Polymer and Materials Science

Source: Wiley InterScience Backfile Collection 1832-2000

Topics: Medicine , Technology

Notes: Ex vivo expansion of hematopoietic cells is important for applications such as cancer treatment, gene therapy, and transfusion medicine. While cell culture systems are widely used to evaluate the biocompatibility of materials for implantation, the ability of materials to support proliferation of primary human cells in cultures for reinfusion into patients has not been addressed. We screened a variety of commercially available polymer (15 types), metal (four types), and glass substrates for their ability to support expansion of hematopoietic cells when cultured under conditions that would be encountered in a clinical setting. Cultures of peripheral blood (PB) CD34+ cells and mononuclear cells (MNC) were evaluated for expansion of total cells and colony-forming unit-granulocyte monocyte (CFU-GM; progenitors committed to the granulocyte and/or monocyte lineage). Human hematopoietic cultures in serum-free medium were found to be extremely sensitive to the substrate material. The only materials tested that supported expansion at or near the levels of polystyrene were tissue culture polystyrene, Teflon perfluoroalkoxy, Teflon fluorinated ethylene propylene, cellulose acetate, titanium, new polycarbonate, and new polymethylpentene. MNC were less sensitive to the substrate materials than the primitive CD34+ progenitors, although similar trends were seen for expansion of the two cell populations on the substrates tested. CFU-GM expansion was more sensitive to substrate materials than was total cell expansion. The detrimental effects of a number of the materials on hematopoietic cultures appear to be caused by protein adsorption and/or leaching of toxins. Factors such as cleaning, sterilization, and reuse significantly affected the performance of some materials as culture substrates. We also used PB CD34+ cell cultures to examine the biocompatibility of gas-permeable cell culture and blood storage bags and several types of tubing commonly used with biomedical equipment. While many of the culture bag materials gave satisfactory results, all of the tubing materials severely inhibited total cell and CFU-GM expansion. Taken together, our results show that many materials approved for blood contact or considered biocompatible are not suitable for use with hematopoietic cells cultured in serum-free medium. As hematopoietic cultures are scaled up for a variety of clinical applications, it will be essential to carefully examine the biocompatibility of all materials involved. © 1997 John Wiley & Sons, Inc. J Biomed Mater Res, 36, 347-359, 1997.

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5

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Crosslinking density and resorption of dimethyl suberimidate-treated collagen (1997)

Charulatha, V. ; Rajaram, A.

Hoboken, NJ : Wiley-Blackwell

Journal of Biomedical Materials Research 36 (1997), S. 478-486

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ISSN: 0021-9304

Keywords: collagen ; crosslinking density ; glutaraldehyde ; dimethyl suberimidate ; biocompatibility ; Chemistry ; Polymer and Materials Science

Source: Wiley InterScience Backfile Collection 1832-2000

Topics: Medicine , Technology

Notes: Collagen was purified from bovine Achilles tendon and crosslinked with dimethyl suberimidate (DMS) and glutaraldehyde (GTA). Under optimal conditions, the shrinkage temperature (TS) was raised to 74°C for collagen crosslinked with DMS and to 80°C for those crosslinked with GTA. Crosslinking density measurements were done on the hydrothermally denatured collagen by the method based on the Flory-Rehner equation. GTA treatment was found to introduce more number of crosslinks than DMS. The maximum tension attained during heating (after shrinkage has occurred) was greater for GTA-treated collagen than for DMS and control. The control collagen membranes broke during heating (at 73°C), while for the crosslinked membranes the tension kept on increasing up to 100°C. The crosslinking density correlated well with the data determined from the in vitro and in vivo degradation studies. Uncrosslinked and DMS crosslinked collagen membranes were more susceptible to degradation by enzymes in vitro, while GTA-treated collagen was highly resistant to degradation. The biocompatibility of the collagen membranes was studied by subcutaneous implantation in rats. Uncrosslinked collagen membranes degraded within 14 days with the formation of granulation tissue. DMS crosslinked membranes degraded within 21 days and the area was replaced by numerous fibroblasts and newly formed collagen. No calcification was observed. For GTA-treated membranes, necrosis was observed after 7 days implantation and by 14 days the membrane had started to calcify. © 1997 John Wiley & Sons, Inc. J Biomed Mater Res, 36, 478-486, 1997.

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6

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Tissue response to fast-setting calcium phosphate cement in bone (1997)

Miyamoto, Youji ; Ishikawa, Kunio ; Takechi, Masaaki ; [et al.]

Hoboken, NJ : Wiley-Blackwell

Journal of Biomedical Materials Research 37 (1997), S. 457-464

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ISSN: 0021-9304

Keywords: biocompatibility ; bone ; calcium phosphate cement ; fast-setting ; hydroxyapatite ; Chemistry ; Polymer and Materials Science

Source: Wiley InterScience Backfile Collection 1832-2000

Topics: Medicine , Technology

Notes: Fast-setting calcium phosphate cement (FSCPC) is a promising new bioactive cement with a significantly short setting time (approximately 5-6 min) compared to conventional calcium phosphate cement (c-CPC) (30-60 min) at physiologic temperatures. As a result of its ability to set quickly, it is applicable in surgical procedures where fast setting is required. In this study, FSCPC was implanted in rat tibiae to evaluate tissue response and biocompatibility. FSCPC was converted to hydroxyapatite (HAP) in bone faster than c-CPC in the first 6 h. By 24 h, significant amounts of both FSCPC and c-CPC had been converted to HAP. The conversion of FSCPC into HAP further proceeded gradually, reaching 100% within 8 weeks. Infrared spectroscopic analysis disclosed the deposition of B-type carbonate apatite, which is a biological apatite contained in human dentin or bone, on the surface of the FSCPC. Histologically, FSCPC showed a tissue response similar to that of c-CPC. A slight inflammatory reaction was observed in the soft tissue apposed to both cements in the early period, and new bone was formed along the surface of the FSCPC at the adjacent bone. However, no resorption of either cement by osteoclasts or macrophages was observed within 8 weeks. We conclude that FSCPC is superior to c-CPC in clinical applications in oral and maxillofacial, orthopedic, plastic, and reconstructive surgery, since it shows a faster setting time and higher mechanical strength in the early period that are required in these surgical procedures, as well as osteoconductivity and excellent biocompatibility similar to that of c-CPC. © 1997 John Wiley & Sons, Inc. J Biomed Mater Res, 37, 457-464, 1997.

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7

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Biocompatibility of nickel-titanium shape memory metal and its corrosion behavior in human cell cultures (1997)

Ryhänen, J. ; Niemi, E. ; Serlo, W. ; [et al.]

Hoboken, NJ : Wiley-Blackwell

Journal of Biomedical Materials Research 35 (1997), S. 451-457

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ISSN: 0021-9304

Keywords: biocompatibility ; nitinol ; shape memory alloy ; corrosion ; human cell cultures ; Chemistry ; Polymer and Materials Science

Source: Wiley InterScience Backfile Collection 1832-2000

Topics: Medicine , Technology

Notes: Nickel-titanium alloy (Nitinol) is a metallic biomaterial that has a unique thermal shape memory, superelasticity, and high damping properties. Nitinol is potentially very useful in orthopedic surgery, for example. At present, there are not enough confirmative biocompatibility data available on Nitinol. The aim of our study was to clarify the primary cytotoxicity and corrosion rate of Nitinol in human cell cultures. Comparisons were made with stainless steel (Stst), titanium (Ti), composite material (C), and control cultures with no test discs. Human osteoblasts (OB) and fibroblasts (FB) were incubated for 10 days with test discs of equal size, 6 × 7 mm. The cultures were photographed and the cells counted. Samples from culture media were collected on days 2, 4, 6, and 8, and the analysis of metals in the media was done using flameless atomic absorption spectrophotometry. The proliferation of FB was 108% (Nitinol), 134% (Ti) (p 〈 0.02), 107% (Stst), and 48% (C)(p 〈 0.0001) compared to the control cultures. The proliferation of OB was 101% (Nitinol), 100% (Ti), 105% (Stst), and 54% (C) (p 〈 0.025) compared to the controls. Initially, Nitinol released more nickel (129-87 μg/L) into the cell culture media than Stst (7 μg/L), but after 2 days the concentrations were about equal (23-5 μg/L versus 11-1 μg/L). The titanium concentrations from both Nitinol and Ti samples were all 〈20 μg/L. We conclude that Nitinol has good in vitro biocompatibility with human osteoblasts and fibroblasts. Despite the higher initial nickel dissolution, Nitinol induced no toxic effects, decrease in cell proliferation, or inhibition on the growth of cells in contact with the metal surface. © 1997 John Wiley & Sons, Inc. J Biomed Mater Res, 35, 451-457, 1997.

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8

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Glass peek composite promotes proliferation and osteocalcin production of human osteoblastic cells (1997)

Lin, T. W. ; Corvelli, A. A. ; Frondoza, C. G. ; [et al.]

Hoboken, NJ : Wiley-Blackwell

Journal of Biomedical Materials Research 36 (1997), S. 137-144

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ISSN: 0021-9304

Keywords: PEEK ; composite ; biocompatibility ; cell culture ; osteoblasts ; Chemistry ; Polymer and Materials Science

Source: Wiley InterScience Backfile Collection 1832-2000

Topics: Medicine , Technology

Notes: An isoelastic intramedullary implant has been developed using a composite of polyetheretherketone and 10% random, chopped E-glass fibers (GPEEK). The effect of this novel material on human bone cells has not been defined. The objective of this study was to test whether GPEEK supported the proliferation of the human bone cell line MG63, which exhibits osteoblastlike characteristics. Cells (1 × 105/mL) were propagated on GPEEK discs with three different surface roughnesses (3, 6, and 9 μm) and on polystyrene plates, for comparison. The reaction of MG63 osteoblastlike cells to the GPEEK polymer composite was analyzed by determination of cell yield, osteocalcin production, and levels of alkaline phosphatase. The viable cells that were retrieved from the GPEEK discs of all three surface roughness had an approximate sixfold increase in number. Osteoblastic function of the cells, indicated by osteocalcin production, was unimpaired after a 5-day culture on the three surfaces of GPEEK. The highest level of osteocalcin was produced by osteoblastic cells propagated on GPEEK with a 9-μm surface roughness. The levels of alkaline phosphatase of these cells were similarly greater for the different degrees of surface roughness. Overall, this study demonstrates that GPEEK supported proliferation of osteoblastlike cells and provided a favorable environment for the continued production of osteocalcin in vitro. © 1997 John Wiley & Sons, Inc. J Biomed Mater Res, 36, 137-144, 1997.

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9

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Biocompatibility of alumina ceramic and polyethylene as materials for pivot bearings of a centrifugal blood pump (1997)

Takami, Yoshiyuki ; Nakazawa, Tadashi ; Makinouchi, Kenzo ; [et al.]

Hoboken, NJ : Wiley-Blackwell

Journal of Biomedical Materials Research 36 (1997), S. 381-386

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ISSN: 0021-9304

Keywords: alumina ceramic ; polyethylene ; biocompatibility ; centrifugal blood pump ; pivot bearing ; Chemistry ; Polymer and Materials Science

Source: Wiley InterScience Backfile Collection 1832-2000

Topics: Medicine , Technology

Notes: The double pivot bearings in the Gyro C1E3 centrifugal blood pump incorporate a high-purity alumina (Al2O3) ceramic and an ultra-high-molecular-weight polyethylene (UHMWPE). This centrifugal pump has been developed as a completely sealless pump for long-term usage. The combination of Al2O3 and UHMWPE are the materials of choice for the acetabular bearing in artificial joints, which have proven to be clinically reliable for over 10 years. Previous studies have examined the biocompatibility of Al2O3 and UHMWPE as bulky implant materials. The present study investigated this material as a blood-contacting material using a standard assessment in vitro and in vivo analysis. The examined items were systemic toxicity, sensitization (guinea pig maximization test), cytotoxicity (elution test), mutagenicity (Ames test), direct contact hemolysis, and thrombogenicity. The studies were performed according to the United States Pharmacopoeia and published previous studies. The samples of both Al2O3 and UHMWPE demonstrated no differences from the negative controls in all tests. These findings indicate that both Al2O3 and UHMWPE are biocompatible materials for double-pivot bearings in the centrifugal blood pump. © 1997 John Wiley & Sons, Inc. J Biomed Mater Res, 36, 381-386, 1997.

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10

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The effects of calcium phosphate particles on the growth of osteoblasts (1997)

Sun, Jui-Sheng ; Tsuang, Yang-Hwei ; Liao, Chun-Jen ; [et al.]

Hoboken, NJ : Wiley-Blackwell

Journal of Biomedical Materials Research 37 (1997), S. 324-334

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ISSN: 0021-9304

Keywords: biocompatibility ; calcium phosphate ; particle ; osteoblast ; Chemistry ; Polymer and Materials Science

Source: Wiley InterScience Backfile Collection 1832-2000

Topics: Medicine , Technology

Notes: With advances in ceramics technology, calcium phosphate bioceramics have been applied as bone substitutes for several decades. The focus of this work is to elucidate the biocompatibility of the particulates of various calcium phosphate cytotoxicities. Four different kinds of calcium phosphate powders, including β-tricalcium phosphate (β-TCP), hydroxyapatite (HA), β-dicalcium pyrophosphate (β-DCP), and sintered β-dicalcium pyrophosphate (SDCP), were tested by osteoblast cell culture. The results were analyzed by cell count, concentration of transforming growth factor-β1 (TGF-β1), alkaline phosphatase (ALP), and prostaglandin E2 (PGE2) in culture media. The changes were most significant when osteoblasts were cultured with β-TCP and HA bioceramics. The changes in cell population of the β-TCP and HA were quite low in the first 3 days, then increased gradually toward the seventh day. The changes in TGF-β1 concentration in culture medium inversely related to the changes in cell population. The ALP titer in the culture media of the β-TCP and HA were quite high in the first 3 days, then decreased rapidly between the third and seventh days. The concentrations of PGE2 in the culture media tested were quite high on the first day, decreased rapidly to the third day, and then gradually until the seventh day. The changes in the β-DCP and SDCP were quite similar to those of HA and β-TCP but much less significant. We conclude that HA and β-TCP have an inhibitory effect on the growth of osteoblasts. The inhibitins effects of the HA and β-TCP powders on the osteoblast cell cultures possibly are mediated by the increased synthesis of PGE2. © 1997 John Wiley & Sons, Inc. J Biomed Mater Res, 37, 324-334, 1997.

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11

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New anionic polyelectrolyte hydrogel for corneal surgery (1997)

Honiger, J. ; Couturier, C. ; Goldschmidt, P. ; [et al.]

Hoboken, NJ : Wiley-Blackwell

Journal of Biomedical Materials Research 37 (1997), S. 548-553

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ISSN: 0021-9304

Keywords: hydrogel ; biocompatibility ; permeability ; complement activation ; AN-69 dialysis membrane ; synthetic biopolymers ; Chemistry ; Polymer and Materials Science

Source: Wiley InterScience Backfile Collection 1832-2000

Topics: Medicine , Technology

Notes: A new high-water-content (78%) anionic polyelectrolyte hydrogel was obtained by phase inversion (demixion) of a polymer solution containing 9.0% poly(acrylonitrile sodium methallylsulphonate), 85.0% dimethylformamide, and 6.0% saline solution (0.9% NaCl). The hydrogel is permeable to water, saline, urea, creatinine, glucose, human albumin, and saline-dissolved oxygen. Investigation of the interactions between human serum and surfaces prepared with the new yielded hydrogel, compared to serum interaction with silica-free silicone (RTV), regenerated cellulose (Cuprophan), MMA/PVP copolymer (Lidofilcon), PMMA (Perspex), PTFE (Gore-Tex), and poly(acrylonitrile sodium methallylsulphonate) hemodialysis membrane (AN-69), showed the hydrogel and hemodialysis membrane (both prepared with AN-69 copolymer) to be the only materials devoid of complement (C′)-activating ability. © 1997 John Wiley & Sons, Inc. J. Biomed Mater Res, 37, 548-553, 1997.

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12

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Human osteoblast-like cells (MG63) proliferate on a bioactive glass surface (1997)

Price, Neil ; Bendall, Stephen P. ; Frondoza, Carmelita ; [et al.]

Hoboken, NJ : Wiley-Blackwell

Journal of Biomedical Materials Research 37 (1997), S. 394-400

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ISSN: 0021-9304

Keywords: Bioglass® ; tissue culture ; biocompatibility ; bone ; Chemistry ; Polymer and Materials Science

Source: Wiley InterScience Backfile Collection 1832-2000

Topics: Medicine , Technology

Notes: Bioglass®, a resorbable glass, previously has been evaluated as a bone graft substitute using cells of animal origin. Limited information is available on its effect on human cells. The objective of this study was to test the hypothesis that Bioglass® supports viability and proliferation of human bone cells. As a prototype of human bone cells, the osteoblast cell line MG63 was used and propagated on Bioglass® disks. MG63 cells also were seeded onto disks made of titanium (Ti-6Al-4V) and of cobalt chrome (Co-Cr-Mo) alloys. The number of viable cells recovered was similar for Bioglass®, titanium, and polystyrene control surfaces. Significantly fewer cells were recovered from CoCr (P 〈 0.05) compared to Bioglass®, Ti-6 Al-4v, and polystyrene surfaces. The proportion of cells undergoing DNA synthesis, estimated by thymidine uptake, was significantly greater on Bioglass® and titanium surfaces (P 〈 0.05) than on the CoCr surface. There were detectable differences in cell morphology on these biomaterials. Functional capacity was tested by assay of osteocalcin production and no differences were detectable among the different biomaterials. This study supports the hypothesis that 45S5 Bioglass® provides a favorable environment for human osteoblast proliferation and function. Bioglass® may have clinical potential as a bone graft substitute, a bioactive grout, or an implant coating for promoting bony ingrowth in uncemented prostheses. © 1997 John Wiley & Sons, Inc. J Biomed Mater Res, 37, 394-400, 1997

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