The aim of this study was to improve the understanding of styrene emissions in sewer laterals, resulting from the installation and steam curing of a resin impregnated cured-in-place-pipe (CIPP) liner, within a sanitary sewer. The study included development and performance assessment of a controlled field test program that measures and records styrene emissions before, during, and after steam-curing a CIPP liner. Measured styrene emissions are then compared with those of published studies and regulatory exposure guidelines to assess the potential risk exposure. The field study measurements confirmed that high styrene concentrations can exist in sewer laterals during the steam-curing of the CIPP liner. They also confirm that water, in proper functioning P-traps, will prevent high styrene emissions from exiting the lateral and into buildings. Fugitive emission modeling shows that the risk of exceeding the acute exposure guideline limits is very low, even when high styrene concentrations exist in a lateral with a dry P-trap, and the styrene odor threshold is exceeded within the building, that is, when the building occupants smell styrene.

Cellulite is a common condition, and laxity in the superficial fascial system contributes significantly to its appearance in the thigh and buttock areas. Components of the superficial fascial system such as the fibrous septae and adipose tissue are targets for an effective treatment to improve the appearance of cellulite. This preliminary report demonstrates the use of radiofrequency-assisted lipolysis as a novel treatment approach to improve the appearance of cellulite by tightening the superficial fascial system. Ten female patients with grade 2 and grade 3 cellulite of the thighs or buttocks were included in this study. Minimally invasive application of bipolar radiofrequency energy to the affected areas was performed. Predetermined internal thermal endpoints at multiple tissue levels and different directions were reached in the treated tissues. Aspiration of the coagulated adipose tissue was performed using a small-diameter cannula to minimize damage to the connective tissues. Pretreatment and 6-month postoperative photographs of 70 different body areas were randomized and scored by five blinded evaluators. Using the Photonumeric Cellulite Severity Scale, scoring of preoperative and postoperative photographs revealed statistically significant differences in all body area comparisons. The magnitudes of the differences in all scored body areas were considered large, and mean differences were all positive, indicating an improvement across time. Grade 2 and grade 3 cellulite of the thighs and buttocks can be effectively treated using radiofrequency-assisted lipolysis technology to decrease the laxity of the superficial fascial system.

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Recent progress toward the application of tissue engineering methodologies for the regeneration of tubular and solid organs including the kidney is identifying shared methodologies that may underlie the development of foundational platform technologies broadly applicable toward the regeneration of multiple organ systems. Central themes emerging for both tubular and solid neo-organs include the application of a biodegradable scaffold to provide structural support for developing neo-organs and the role of committed or progenitor cell populations in establishing the regenerative micro-environment of key secreted growth factors, constitutive components of the regenerated tissue and extra-cellular matrix critical for catalyzing de novo organogenesis. However, aspects of these strategies currently under active development for tissue engineering of neo-organs may not be relevant for successful commercialization as novel TE/RM products for clinical application. For example, difficulties in large scale sourcing and quality control of biomaterials derived from decellularization of cadaveric organs imply that such biomaterials may be less suitable for incorporation into TE/RM products when compared to biomaterials of synthetic origin. Similarly, TE/RM technologies that attempt to leverage populations of stem and progenitor cells are less likely than platforms focused on committed cell populations or acellular biomaterials to facilitate rapid development of viable products. In this chapter, we present our experience in the development of RegenMedTX LLC’s Neo-Kidney Augment to identify elements of this foundational organ regeneration technology platform that may be broadly applicable toward the design and development of additional solid neo-organ products. We will focus specifically on highlighting aspects of this neo-organ regenerative platform conducive to the commercial viability of this technology.

<p>Fiber-reinforced polymers (FRPs) are widely recognized as versatile materials for the retrofit and repair of structural members for a variety of existing deficiencies. As a supplement to the FRP, mechanical or composite anchorage is sometimes utilized to increase the performance of various FRP-reinforced structural members. With proper design and detailing, the use of composite anchors has proven to prevent premature debonding failure of externally bonded FRP. The performance of FRP-retrofitted concrete members continues to be cited as a high-priority topic for research and an assortment of tests have been completed to validate the use of composite anchors in different types of applications. This paper will review the performance of different tested assemblies using FRP with and without the use of composite anchorage, including state of the art testing on a beam-column assembly. In addition, there will be discussions on the variety of structural applications and specific detailing required on composite anchors to ensure a safe and durable strengthening system.</p>

Identification of mechanistic pathways for selected renal cell (SRC) therapeutic bioactivity in rodent models of chronic kidney disease. In vivo and in vitro functional bioassays applied to investigate regenerative outcomes associated with delivery of SRC to diseased rodent kidney. In vivo, SRC reduces chronic infiltration by monocytes/macrophages. SRC attenuates NF-κB and PAI-1 responses while simultaneously promoting host tubular cell expansion through trophic cues. In vitro, SRC-derived conditioned media attenuates TNF-α-induced NF-κB response, TGF-β-mediated PAI-1 response and increases expression of transcripts associated with cell cycle regulation. Observed bioactive responses were from vesicle and nonvesicle-associated factors, including specific miRNAs. We identify a paracrine mechanism for SRC immunomodulatory and trophic cues on host renal tissues, catalyzing long-term functional benefits in vivo.

Trenchless technologies similar to Cured in Place Pipe (CIPP) continue to be embraced for pipeline repair and rehabilitation since the first installation in the early 1970’s. The varying levels of repair from corrosion mitigation, leak protection, to semi-structural and fully structural repair systems require alternating levels of strength, stiffness and durability properties under loading conditions. ASTM F1216 is widely used in water and wastewater pipelines to determine the required thickness of composite liners for semi structural (class II and III) and fully structural (class IV) repair/rehabilitation systems as defined in AWWA M28 Appendix A. It is important to understand the initial assumptions and limitations of these design guidelines. The ASTM F1216 was developed for felt-epoxy CIPP systems that demonstrate quasi-isometric properties. Likely because of this, longitudinal loading is not considered in this design process. As CIPP products continuously develop to resist increasing external and internal loading conditions, stronger materials are used in specific orientations to meet those increasing demands. When unidirectional glass and carbon reinforced polymers (GFRP and CFRP’s) are used to meet the demands of high internal and external loading conditions, additional design criteria are required to cover both hoop direction and longitudinal loading. These additional design criteria extend beyond ASTM F1216. Thus, theoretical calculations from existing and developing pipeline standards, and experimental validation is required to demonstrate the capabilities of new technology utilizing high strength and high stiffness materials like CFRP. This paper will address the additional design considerations appropriate for CFRP pull-in-place rehabilitations and the validation of a fully structural CFRP in situ pressure barrier for small diameter (six to fourteen inch) pressure pipe.

The incidence of cardiovascular disease represents a significant and growing health-care challenge to the developed and developing world. The ability of native heart muscle to regenerate in response to myocardial infarct is minimal. Tissue engineering and regenerative medicine approaches represent one promising response to this difficulty. Here, we present methods for the construction of a cell-seeded cardiac patch with the potential to promote regenerative outcomes in heart muscle with damage secondary to myocardial infarct. This method leverages iPS cells and a fibrin-based scaffold to create a simple and commercially viable tissue-engineered cardiac patch. Human-induced pluripotent stem cells (hiPSCs) can, in principle, be differentiated into cells of any lineage. However, most of the protocols used to generate hiPSC-derived endothelial cells (ECs) and cardiomyocytes (CMs) are unsatisfactory because the yield and phenotypic stability of the hiPSC-ECs are low, and the hiPSC-CMs are often purified via selection for expression of a promoter-reporter construct. In this chapter, we describe an hiPSC-EC differentiation protocol that generates large numbers of stable ECs and an hiPSC-CM differentiation protocol that does not require genetic manipulation, single-cell selection, or sorting with fluorescent dyes or other reagents. We also provide a simple but effective method that can be used to combine hiPSC-ECs and hiPSC-CMs with hiPSC-derived smooth muscle cells to engineer a contracting patch of cardiac cells.

Regenerative medicine is providing the next wave of innovative therapies for the pharmaceutical industry, with the potential to cure intractable diseases. These novel products present unique challenges to standard pharma manufacturing and regulatory approaches. In this chapter, we present general methods used to produce tissue engineered and regenerative medicine products for clinical and commercial applications. Insights are provided regarding technical, regulatory, and financial considerations.