Biomechanical Comparison of Four Soft Tissue Replacement Materials: An In Vitro Evaluation of Single and Multilaminate Porcine Small Intestinal Submucosa, Canine Fascia Lata, and Polypropylene Mesh

Arnold, Gregory A.; Mathews, Kyle G.; Roe, Simon C.; Mente, Peter L.; Seaboch, Tim

doi:10.1111/j.1532-950x.2009.00577.x

Cited by 23 publications

(25 citation statements)

References 44 publications

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“…An investigation addressed to evaluate if such relevant residual DNA remnants could comprise endogenous retrovirus sequences, as previously found in acellular porcine heart valve scaffolds [50], is still in progress. Further studies are performing in order to assess how these nucleic residues can be correlated to the failure of the SIS-derived material in high-strain environments [51].…”

Section: Cormatrix™ Ecmmentioning

confidence: 99%

Biocompatibility Evaluation Criteria for Novel Xenograft Materials: Distribution and Quantification of Remnant Nucleic Acid and Alpha-Gal Epitope

Naso¹,

Andrea²,

Iop³

2013

J Stem Cell Res Ther

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Objective: Commercially decellularized xenogeneic scaffolds are currently employed as for the healing of diseased tissues. Strangely enough their use is permitted even in absence of any assessment of the elimination of xenogeneic cell material, as the alpha-Gal epitopes. In addition, the decellularization procedures are not monitored to prove the elimination of the calcific potential associated to the nucleic acids remnants. The currently treatment with glutaraldehyde is unable to grant a complete immuno-tolerance of implanted xenogeneic tissues, reducing but not eliminating the immunogenicity particularly for the alpha-Gal epitope (the major hindrance for the success of xenotransplantation). Recently, our group has extensively reported studies focused on the evaluation of biocompatibility properties of xenogeneic tissues. In this report we are performing this investigation and nucleic acid detection to novel xenogeneic tissues that have shown very promising preclinical/clinical results in different areas of application. Methods:The alpha-Gal quantification was conducted by an ELISA test previously developed and patented by our research team which involves the use of the monoclonal anti apha-Gal antibody M86. Immunofluorescence analysis was performed for the visual distribution of both xenogeneic epitopes and nucleic acids residues. Finally for the total DNA quantification a commercially available kit was adopted.Results: While the amount and distribution of the alpha-Gal epitopes was found different between the investigated biomaterials, the presence of nucleic acid remnants has been revealed as common feature, even in those tissues delivered as acellular by the manufacturer. Conclusion:Insufficient quantitative evaluations performed at preclinical level about the residual content of xenogeneic epitopes, detergents and nucleic acid materials in scaffolds have led to disappointing and disastrous results. The risk of these dramatic accidents reoccurring remains very high unless safety parameters, among which the complete removal of major xenogeneic determinants (alpha-Gal) and calcification-prone nucleic acid residues, are identified and introduced in manufacturing practices.

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Section: Cormatrix™ Ecmmentioning

confidence: 99%

Biocompatibility Evaluation Criteria for Novel Xenograft Materials: Distribution and Quantification of Remnant Nucleic Acid and Alpha-Gal Epitope

Naso¹,

Andrea²,

Iop³

2013

J Stem Cell Res Ther

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“…When compared with multilayered small intestinal submucosa, the synthetic polymer scaffold showed similar load at yield but a lower stiffness (slope of curve). 16 It is noted that there were small drops along the curve that could be indications of PU-PLGA layer breakage (Figure 7). Moreover, the PU-PLGA polymer graft showed maximum force similar to that of four-layer small intestinal submucosa material in the ball burst and suture pullout tests (Figures 8 and 9).…”

Section: Graft Mechanical Strengthmentioning

confidence: 99%

“…Moreover, the PU-PLGA polymer graft showed maximum force similar to that of four-layer small intestinal submucosa material in the ball burst and suture pullout tests (Figures 8 and 9). 16 Again, the polymer graft showed much larger displacement and, thus, lower stiffness. In summary, the mechanical tests provided evidence of mechanical properties (tensile, ball burst, and suture pullout) similar to those of natural bladder tissue and small intestinal submucosa (Table 2).…”

Section: Graft Mechanical Strengthmentioning

confidence: 99%

“…In summary, the mechanical tests provided evidence of mechanical properties (tensile, ball burst, and suture pullout) similar to those of natural bladder tissue and small intestinal submucosa (Table 2). 16 …”

Section: Graft Mechanical Strengthmentioning

confidence: 99%

“…The reference material, ie, small intestinal submucosa, had a water contact angle about 60 degrees. 16 Lastly, x-ray photoelectron spectroscopy was used to confirm covalent bonding of the two peptides of interest in the present study, IKVAV and YIGSR, onto the polymer surfaces (Table 1). With the presence of only EDC and NHS, there was no significant increase in nitrogen content after an hour of soaking with polymer graft and rinsing afterwards (Table 1, 0.2% for PLGA and 0.3% for PLGA soaked with EDC/NHS).…”

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confidence: 99%

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Nanostructured polyurethane-poly-lactic- co-glycolic acid scaffolds increase bladder tissue regeneration: an in vivo study

Yao¹,

Hedrick²,

Pareek³

et al. 2013

IJN

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Abstract:Although showing much promise for numerous tissue engineering applications, polyurethane and poly-lactic-co-glycolic acid (PLGA) have suffered from a lack of cytocompatibility, sometimes leading to poor tissue integration. Nanotechnology (or the use of materials with surface features or constituent dimensions less than 100 nm in at least one direction) has started to transform currently implanted materials (such as polyurethane and PLGA) to promote tissue regeneration. This is because nanostructured surface features can be used to change medical device surface energy to alter initial protein adsorption events important for promoting tissue-forming cell functions. Thus, due to their altered surface energetics, the objective of the present in vivo study was to create nanoscale surface features on a new polyurethane and PLGA composite scaffold (by soaking the polyurethane side and PLGA side in HNO 3 and NaOH, respectively) and determine bladder tissue regeneration using a minipig model. The novel nanostructured scaffolds were further functionalized with IKVAV and YIGSR peptides to improve cellular responses. Results provided the first evidence of increased in vivo bladder tissue regeneration when using a composite of nanostructured polyurethane and PLGA compared with control ileal segments. Due to additional surgery, extended potentially problematic healing times, metabolic complications, donor site morbidity, and sometimes limited availability, ileal segment repair of a bladder defect is not optimal and, thus, a synthetic analog is highly desirable. In summary, this study indicates significant promise for the use of nanostructured polyurethane and PLGA composites to increase bladder tissue repair for a wide range of regenerative medicine applications, such as regenerating bladder tissue after removal of cancerous tissue, disease, or other trauma.

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In vivo biomechanical properties of heavy versus light weight monofilament polypropylene meshes. Does the knitting pattern matter?

Bigozzi

Provenzano

Maeda

et al. 2015

Neurourology and Urodynamics

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The final mechanical behavior of PP mesh can be changed by its weight and knitting pattern. These properties may be useful in making more biocompatible prostheses for pelvic organ prolapse (POP) with less foreign material to maintain longitudinal vaginal elasticity and minimize sexual symptoms while maintaining transverse resistance (i.e., between vaginal fornixes) to prevent POP recurrence. Neurourol. Urodynam. 36:73-79, 2017. © 2015 Wiley Periodicals, Inc.

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Biomechanical Comparison of Four Soft Tissue Replacement Materials: An In Vitro Evaluation of Single and Multilaminate Porcine Small Intestinal Submucosa, Canine Fascia Lata, and Polypropylene Mesh

Abstract: PM's orientation may need to be considered when used clinically. FL is a biomechanically suitable soft tissue replacement material but its use may be limited by currently available sizes. SIS cannot be recommended in high-strain environments.

Cited by 23 publications

References 44 publications

Biocompatibility Evaluation Criteria for Novel Xenograft Materials: Distribution and Quantification of Remnant Nucleic Acid and Alpha-Gal Epitope

Biocompatibility Evaluation Criteria for Novel Xenograft Materials: Distribution and Quantification of Remnant Nucleic Acid and Alpha-Gal Epitope

Nanostructured polyurethane-poly-lactic- co-glycolic acid scaffolds increase bladder tissue regeneration: an in vivo study

In vivo biomechanical properties of heavy versus light weight monofilament polypropylene meshes. Does the knitting pattern matter?

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