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Cell replacement therapy is under development for dry age‐related macular degeneration (AMD). A thin membrane resembling the Bruch's membrane is required to form a cell‐on‐membrane construct with retinal pigment epithelial (RPE) cells. These cells have been differentiated from human embryonic stem cells (hESCs) in vitro. A carrier membrane is required for cell implantation, which is biocompatible for cell growth and has dimensions and physical properties resembling the Bruch's membrane. Here a nanofiber electrospun poly‐L‐lactic acid (PLLA) membrane is tested for capacity to support cell growth and maturation. The requirements for laminin coating of the membrane are identified here. A porous electrospun nanofibrous PLLA membrane of ∼50 nm fiber diameter was developed as a prototype support for functional RPE cells grown as a monolayer. The need for laminin coating applied to the membrane following treatment with poly‐L‐ornithine (PLO), was identified in terms of cell growth and survival. Test membranes were compared in terms of hydrophilicity after laminin coating, mechanical properties of surface roughness and Young's modulus, porosity and ability to promote the attachment and proliferation of hESC‐RPE cells in culture for up to 8 weeks. Over this time, RPE cell proliferation, morphology, and marker and gene expression, were monitored. The functional capacity of cell monolayers was identified in terms of transepithelial electrical resistance (TEER), phagocytosis of cells, as well as expression of the cytokines, vascular endothelial growth factor (VEGF) and pigment epithelium‐derived factor (PEDF). PLLA polymer fibers are naturally hydrophobic, so their hydrophilicity was improved by pretreatment with PLO for subsequent coating with the bioactive protein laminin. They were then assessed for amount of laminin adsorbed, contact angle and uniformity of coating using scanning electron microscopy (SEM). Pretreatment with 100% PLO gave the best result over 10% PLO treatment or no treatment prior to laminin adsorption with significantly greater surface stiffness and modulus. By 6 weeks after cell plating, the coated membranes could support a mature RPE monolayer showing a dense apical microvillus structure and pigmented 3D polygonal cell morphology. After 8 weeks, PLO (100%)‐Lam coated membranes exhibited the highest cell number, cell proliferation, and RPE barrier function measured as TEER. RPE cells showed the higher levels of specific surface marker and gene expression. Microphthalmia‐associated transcription factor expression was highly upregulated indicating maturation of cells. Functionality of cells was indicated by expression of VEGF and PEDF genes as well as phagocytic capacity. In conclusion, electrospun PLLA membranes coated with PLO‐Lam have the physical and biological properties to support the distribution and migration of hESC‐RPE cells throughout the whole structure. They represent a good membrane candidate for preparation of hESC‐RPE cells as a monolayer for implantation into the subretinal space of AMD patients. [ABSTRACT FROM AUTHOR]

Background Methods Results Conclusion Poly‐L‐lactic acid (PLLA) is one of the representative polymeric materials serving as bioresorbable stents (BRS) for cardiovascular disease due to its proper biodegradation, high biocompatibility, and adequate mechanical properties among polymer candidates for BRS. However, PLLA BRS as cardiovascular stents also have limitations because their mechanical properties including low radial strength and high elastic recoil are inferior to those of metallic‐based BRS stents.In the study, we developed and manufactured distinct and novel types of stent geometries for investigating mechanical properties of thin‐walled PLLA BRS (110 μm) for cardiovascular applications. Five key mechanical tests, including radial strength, crimping profile, flexibility, elastic recoil, and foreshortening were performed through a comprehensive analysis. In addition, we applied the finite element method for further validation and insight of mechanical behaviors of the PLLA BRS.Results revealed that Model 2 had advantages in high flexibility as well as radial strengths, which would be a proper option for complex and acutely curved lesions. Model 3 would be an optimum selection for stent placement in mild target site due to its strength in minimum elastic recoil. Even though Model 4 showed the highest radial strength, finite element simulation showed that the geometry caused higher maximum stress than that of Model 2 and Model 3 during the crimping process. Model 1 showed the most vulnerable geometry among the tested models in both in vitro and finite element analysis.Such data may suggest potential guidance in regard to understanding the mechanical behaviors of PLLA BRS as not only applicable cardiovascular but also peripheral and intracranial stents. [ABSTRACT FROM AUTHOR]

Background Aims Participants/Methods Results Conclusions Injectable fillers for soft tissue augmentation stand out as one of the most favored procedures in the field of aesthetic medicine, especially in addressing the clinical signs of skin aging. Among soft tissue fillers, non‐permanent fillers have been safely used in numerous medical applications for several decades.The aim of this post‐market observational, open‐label, uncontrolled, multicentered, prospective study (PMS) was to evaluate the effects of an injectable poly‐L‐lactic acid‐based collagen stimulator (Lanluma®, the study product).This analysis is based on the clinical outcomes data (safety and effectiveness) collected from investigators and participants between the first injection (T0, September 2022) and 9 months thereafter (T3, June 2023) in the treatment of five body‐contouring areas.Overall, 70 participants had 99 treatment sessions of the neck (31%), upper arm (20%), hand (17%), thigh (16%) and décolleté (15%). Lumps (neck, upper arm, hand) and nodules (neck, hand, thigh) were the most frequent adverse events (AEs) reported by investigators. All were treatment related. None were serious, severe or fatal. No AEs were reported following treatment of the décolleté. Both investigators and participants reported high levels of satisfaction during the nine‐month follow‐up period with the treatments in five body areas.These positive clinical outcomes can be attributed to a proper implementation of best practices and recommendations, and the rheological properties of the study product. This 9‐month follow‐up analysis should be reconsidered in light of the study's objectives for the final analysis at the 25‐month follow‐up. [ABSTRACT FROM AUTHOR]

Prepubertal boys with cancer may suffer from reduced fertility and maturity following gonadotoxic chemoradiotherapy. Thus, a viable method of immature testicular tissue (ITT) preservation is required in this cohort. In this study, we used poly-L-lactic acid electrospun scaffolds with two levels of fineness to support the development of ITT transplanted from transgenic donors to wild-type recipient mice. The purpose of this study was to evaluate the potential of ITT transplantation and spermatogenesis after using the two scaffolds, employing bioluminescence imaging for evaluation. The results suggest that ITT from 4-week-old mice possessed the most potential in spermatogenesis on the 70th day, together with the fine electrospun scaffolds. Moreover, bioluminescent imaging intensity was observed in recipient mice for up to 107 days, approximately six times more than the coarse electrospun scaffold and the control group. This occurs since the fine scaffold is more akin to the microenvironment of native testicular tissue as it reduces stiffness resulting from micronization and body fluid infiltration. The thermal analysis also exhibited recrystallization during the biodegradation process, which can lead to a more stable microenvironment. Overall, these findings present the prospect of fertility preservation in prepubertal males and could serve as a framework for future applications. [ABSTRACT FROM AUTHOR]

As one of the main functions of vascular endothelial cells, Vascular permeability is determined by four tight junction proteins (TJPs): Zonula Occludens-1 (ZO-1), Claudin-5, Occludin and Tricellulin. The barrier function of blood vessels will be reconstructed after they are damaged by endothelial mechanical injuries caused by vascular interventions. In this study, the effects of balloon expansion (transient mechanical injury) on four TJPs and vascular permeability were compared with those of poly-l-lactic acid bioresorbable scaffolds (BRSs) implantation (continuous mechanical stimulation). We found that BRSs do not affect vascular permeability, while the recovery of vascular barrier function was found to be only related to the mechanical injuries and repair of endothelium. Mechanical stimulation affects and accelerates the recovery process of vascular permeability with the heterogeneous expression levels of TJPs induced after BRSs implantation. Different TJPs have different sensitivity to different loyal mechanical stimuli. ZO-1 is more sensitive to shear stress and tension than to static pressure. Occludin is sensitive to static pressure and shear stress. Tricellulin is more sensitive to tension stretching. Compared with the other three TJPs, Claudin-5 can respond to mechanical stimulation, with relatively low sensitivity, though. This difference in sensitivity determines the heterogeneous expression of TJPs. Mechanical stimulation of different kinds and strengths can also cause different cell morphological changes and inflammatory reactions. As an important element affecting endothelial function, the mechanical factors emerging after BRSs implantation are worthy of more attention.

Background. Synthetic vascular graft calcification is a serious complication of graft placement. Here, we analysed migration and osteogenic genes of human umbilical vein endothelial cells (HUVEC) cultured with a poly-L-lactic acid (PLLA) electrospun mat. The role of epigallo-catechin-3-gallate (EGCG) in pathogenic processes involving HUVEC and peripheral blood mononuclear cells (PBMCs) was also tested. Methods. HUVEC were cultured in indirect contact with PLLA for 48 h, with or without EGCG, and processed for mRNA expression. HUVEC proliferation, migration and osteogenic differentiation were evaluated after EGCG treatment. EGCG was also administrated to human PBMCs, to analyse proliferation and migration toward HUVEC cultured with PLLA. Results. HUVEC cultured with PLLA exhibited increased expression of SLUG, VIMENTIN, MMP-9 (migration, vascular remodelling) and RUNX-2 (osteogenic transcription factor). EGCG at 25 μM significantly reduced HUVEC migration, osteogenic differentiation, without affecting cell viability, and mitigated PLLA influence on SLUG, MMP-9, VIMENTIN and RUNX-2 expression. EGCG affected PBMC proliferation and migration toward PLLA in a transwell co-culture system with HUVEC. Conclusion. Our study suggests the pro-calcific effect of PLLA, proposing EGCG as an anti-inflammatory modulatory approach. Research efforts need to deepen PLLA-vascular wall interactions for preventing vascular graft failure. [ABSTRACT FROM AUTHOR]

Background. Synthetic vascular graft calcification is a serious complication of graft placement. Here, we analysed migration and osteogenic genes of human umbilical vein endothelial cells (HUVEC) cultured with a poly-L-lactic acid (PLLA) electrospun mat. The role of epigallo-catechin-3-gallate (EGCG) in pathogenic processes involving HUVEC and peripheral blood mononuclear cells (PBMCs) was also tested. Methods. HUVEC were cultured in indirect contact with PLLA for 48 h, with or without EGCG, and processed for mRNA expression. HUVEC proliferation, migration and osteogenic differentiation were evaluated after EGCG treatment. EGCG was also administrated to human PBMCs, to analyse proliferation and migration toward HUVEC cultured with PLLA. Results. HUVEC cultured with PLLA exhibited increased expression of SLUG, VIMENTIN, MMP-9 (migration, vascular remodelling) and RUNX-2 (osteogenic transcription factor). EGCG at 25 μM significantly reduced HUVEC migration, osteogenic differentiation, without affecting cell viability, and mitigated PLLA influence on SLUG, MMP-9, VIMENTIN and RUNX-2 expression. EGCG affected PBMC proliferation and migration toward PLLA in a transwell co-culture system with HUVEC. Conclusion. Our study suggests the pro-calcific effect of PLLA, proposing EGCG as an anti-inflammatory modulatory approach. Research efforts need to deepen PLLA-vascular wall interactions for preventing vascular graft failure.

Biodegradable polymers such as poly‐l‐lactic acid (PLLA) are essential tools for a wide range of medical applications because of their mechanical robustness and bio‐affinity. Laser processing is commonly used to construct various structures from biodegradable polymers. However, in general, polymers deteriorate rapidly owing to laser‐induced heating effects. In this study, we investigate the optimum irradiation conditions for PLLA processing, using an ultrafast laser and finely controlling the pulse duration over the femtosecond‐to‐picosecond range. We report on the morphological characteristics of the craters generated by single‐shot and multiple‐shot laser irradiation under pulse duration control. Our results show that crater morphology and damage threshold in the single‐shot regime depend on pulse duration and that the degree of crater unevenness is insensitive to pulse duration in the multishot regime. [ABSTRACT FROM AUTHOR]

Untargeted nuclear magnetic resonance (NMR) metabolomics was employed, for the first time to our knowledge, to characterize the metabolome of human osteoblast (HOb) cells and extracts in the presence of non‐poled or negatively poled poly‐L‐lactic acid (PLLA). The metabolic response of these cells to this polymer, extensively used in bone regeneration strategies, may potentially translate into useful markers indicative of in vivo biomaterial performance. We present preliminary results of multivariate and univariate analysis of NMR spectra, which have shown the complementarity of lysed cells and extracts in terms of information on cell metabolome, and unveil that, irrespective of poling state, PLLA‐grown cells seem to experience enhanced oxidative stress and activated energy metabolism, at the cost of storage lipids and glucose. Possible changes in protein and nucleic acid metabolisms were also suggested, as well as enhanced membrane biosynthesis. Therefore, the presence of PLLA seems to trigger cell catabolism and anti‐oxidative protective mechanisms in HOb cells, while directing them towards cellular growth. This was not sufficient, however, to lead to a visible cell proliferation enhancement in the presence of PLLA, although a qualitative tendency for negatively poled PLLA to be more effective in sustaining cell growth than non‐poled PLLA was suggested. These preliminary results indicate the potential of NMR metabolomics in enlightening cell metabolism in response to biomaterials and their properties, justifying further studies of the fine effects of poled PLLA on these and other cells of significance in tissue regeneration strategies. [ABSTRACT FROM AUTHOR]

The in vitro and in vivo degradation behaviour and biocompatibility of a Mg-Mn-Zn alloy with MAO coating and MAO/PLLA composite coating were studied. The in vitro degradation behaviour was studied by investigating electrochemical behaviour and observing surface morphology for up to 12 weeks and the in vivo degradation behaviour and osteogenic effect were studied by implanting the samples in the mandibles for up to 16 weeks. Both in vitro and in vivo degradation results demonstrated the MAO/PLLA composite coating effectively reduced the degradation rate Mg-Mn-Zn alloy in comparison with MAO coated alloy, while localized degradation was the main degradation form for the coated Mg alloys. In vivo implantation analysis results clearly showed that the MAO/PLLA coated sample exhibited less local osteogenic defects, less bone cavities and less local inflammatory reaction than MAO coated sample. However, more attentions should be paid on the osteogenic defects around the localized corrosion region of the MAO/PLLA coated sample. It was suggested that MAO/PLLA might be an effective coating for the bone implant application of magnesium alloy. • PLLA polymer blocks MAO oxidation hole, hinders charge transfer and slows down corrosion process. • Samples with lower corrosion rate had stronger bone growth promoting ability. • Localized corrosion is the main corrosion form of the MAO/PLLA composite coating samples. • The rapid accumulation of local corrosion products and alkalization led to surrounding cavity bone non-union. • Tightly wrapped bone tissue surrounding the implant protected the erosion of body fluid and delayed the subsequent degradation process. [ABSTRACT FROM AUTHOR]

Scaffolds providing a 3D environment which can effectively promote the adhesion, proliferation and differentiation of cells are crucial to tissue regeneration. In this study, the poly-l-lactic acid (PLLA) scaffold with hierarchical pore structural was fabricated via two-step thermally induced phase separation (TIPS). To mimic both physical architecture and chemical composite of natural bone extracellular matrix (ECM), gelatin fibers were introduced into the pores of PLLA scaffolds and formed 3D network structure via TIPS. Human adipose tissue-derived stem cells (ADSCs) were harvested and seeded into PLLA/gel hybrid scaffolds and cultured in vitro for biocompatibility assay. The surface morphology, porosity and compressive modulus of scaffolds were characterized by scanning electron microscopy (SEM), density analysis and compression test respectively. The results showed that hybrid scaffolds had high porosity (91.62%), a good compressive modulus (2.79 ± 0.20 MPa), nanometer fibers (diameter around 186.39~354.30 nm) and different grades of pore size from 7.41 ± 2.64 nm to 387.94 ± 102.48 nm. The scaffolds with mild hydrolysis by NaOH were modified by 1-ethyl-3-(3-dimethyl ami-nopropyl) carbodiimide/N-hydroxysuccinimide (EDC/NHS). Gelatin was performed onto PLLA scaffold via TIPS aiming at enhancement cell-material interaction. In comparison with PLLA scaffold, the PLLA/gel scaffold had better biological performance and the mechanical properties because the gelatin fibers homogeneously distributed in each pore of PLLA scaffold and formed 3D network structure.

Context: Due to their renewal and potency, umbilical cord blood (UCB) stem cells have the ability to proliferate and serve as an attractive alternative source for bone marrow transplantation. However, insufficient number of haematopoietic stem cells (HSCs) in UCB is still a major constraint in clinical applications. Objective: In vitro expansion of stem cells on fibronectin (Fn)-coated poly-L-lactic acid (PLLA) scaffold can be a proper way to overcome this limitation. Materials and method: UCB CD133 + cells were isolated by magnetic cell sorting (MACS), and then the flowcytometry method was used for analysing CD133 + cells. Confirmed cells were seeded on the Fn-coated PLLA scaffold; also, collagen-coated PLLA scaffold, PLLA scaffold and two-dimensional (2D) culture system were expanded for 7 days. During this time, we used the flowcytometric method for analysing CD133 + cells and real-time PCR for the expression level of CXCR4 gene. The number of total cells and CD133 + cells, as well as MTT assay and colony-forming unit (CFU) assay were evaluated. Results: Flowcytometry data indicated that the purity of CD133 + before expansion was 93%. After 7 days, there was higher number of CD133 + cells on the Fn-coated PLLA scaffold compared to other groups. Moreover, results of MTT and colony assays showed higher viability and proliferation of CD133 + on the Fn-coated PLLA scaffold. Also, the quantity of CXCR4 gene expression increased compared to other groups. Discussion: The Fn-coated scaffold was the most effective scaffold for proliferation and improved the adhesiveness to the scaffold. Conclusion: The Fn-coated PLLA scaffold could be a suitable in vitro mimicry niche over a 2D system. [ABSTRACT FROM AUTHOR]

Bacterial infection of implanted biomaterials is a serious problem that increases health care costs and negatively affects a considerable fraction of orthopedic procedures. In this field, magnesium oxide nanoparticles (MgO NPs) have emerged as a promising material to combat bacterial infection while maintaining or improving bone cell functions. Here, MgO NPs were electrophoretically deposited onto poly-L-lactic acid (PLLA) sheets to achieve a coating of highly exposed MgO NPs that directly influenced cell-substrate interactions at short time scales. Samples were characterized for their surface chemistry, crystal structure, roughness, wettability, degradation characteristics, and their ability to support the growth of human fibroblasts and osteoblasts, as well as their resistance to colonization by Staphylococcus aureus, Staphylococcus epidermidis, and Pseudomonas aeruginosa. In general, increasing the applied voltage during deposition increased the surface coverage of the coating and significantly decreased the colonization of all three bacterial strains (up to a 90% reduction). Furthermore, S. aureus cells that did attach onto substrates prepared at high voltages exhibited trademark signs of membrane damage and cell death. Importantly, MTS cell viability assays indicated that osteoblast adhesion increased with increasing deposition voltage, while fibroblast adhesion exhibited the opposite trend. Thus, although requiring more studies, this research provides the first evidence that MgO NP coatings prepared at relatively high voltages (120-150 V) may have the ability to resist bacterial colonization, promote bone cell attachment, and curb fibrous capsule formation. Therefore, it is recommended that this technology be further investigated and developed for numerous orthopedic applications. © 2017 Wiley Periodicals, Inc. J Biomed Mater Res Part A: 105A: 3136-3147, 2017. [ABSTRACT FROM AUTHOR]

Regardless the low production rate, electrospinning remains the attractive technique for the nanofibers production in various fields. Thus, the development of a multi-jet technologies for electrospinning gives an opportunity to scale up and increase throughput of the fibers production. However, the multi-jet electrospinning technologies exhibit one major drawback- electrostatic mutual jet repulsion issue. In present research, we propose air blow-assisted multi-jet electrospinning system allowing production of nanofibers with yield, at least, tenfold higher than single jet electrospinning. The system produces nanofibers in two modes: multi-jet electrospinning and blow-assisted multi-jet electrospinning. In case of the latter, the application of sheath air stream allows the system to overcome the electrostatic mutual repulsion issue. These lead to the reduction of deviation of the polymer solution jets, the reduction of instabilities of the jets and the improvement of the control of the nanofibers deposition. Nanofibers morphology and size were investigated based on the scanning electron microscope micrographs. The comparison of the two modes shows changes in nanofibers morphology from beaded structure to fine nanofibers, and the slight increase in fiber mean size when the blowing assistance was applied to the process. [ABSTRACT FROM AUTHOR]

Scaffolds providing a 3D environment which can effectively promote the adhesion, proliferation and differentiation of cells are crucial to tissue regeneration. In this study, the poly-L-lactic acid (PLLA) scaffold with hierarchical pore structural was fabricated via two-step thermally induced phase separation (TIPS). To mimic both physical architecture and chemical composite of natural bone extracellular matrix (ECM), gelatin fibers were introduced into the pores of PLLA scaffolds and formed 3D network structure via TIPS. Human adipose tissue-derived stem cells (ADSCs) were harvested and seeded into PLLA/gel hybrid scaffolds and cultured in vitro for biocompatibility assay. The surface morphology, porosity and compressive modulus of scaffolds were characterized by scanning electron microscopy (SEM), density analysis and compression test respectively. The results showed that hybrid scaffolds had high porosity (91.62%), a good compressive modulus (2.79 ± 0.20 MPa), nanometer fibers (diameter around 186.39~354.30 nm) and different grades of pore size from 7.41 ± 2.64 nm to 387.94 ± 102.48 nm. The scaffolds with mild hydrolysis by NaOH were modified by 1-ethyl-3-(3-dimethyl ami-nopropyl) carbodiimide/N-hydroxysuccinimide (EDC/NHS). Gelatin was performed onto PLLA scaffold via TIPS aiming at enhancement cell-material interaction. In comparison with PLLA scaffold, the PLLA/gel scaffold had better biological performance and the mechanical properties because the gelatin fibers homogeneously distributed in each pore of PLLA scaffold and formed 3D network structure. [ABSTRACT FROM AUTHOR]

Objectives: This study sought to evaluate the safety and performance of the Igaki-Tamai (Igaki Medical Planning Company, Kyoto, Japan) biodegradable stent in patients with occlusive superficial femoral artery (SFA) disease. Background: Poly-L-lactic acid (PLLA) biodegradable stents have been shown to be effective in the coronaries, but no data are available regarding their efficacy in the femoral artery. Methods: A prospective, multicenter, nonrandomized study enrolled 30 patients with symptomatic de novo SFA disease undergoing implantation of Igaki-Tamai bioresorbable stents. Clinical examinations and duplex ultrasound were prospectively performed after 1, 6, 9, and 12 months. The main study endpoints were technical success, restenosis rate, rate of target lesion revascularization (TLR), changes in ankle-brachial index (ABI), and quality of life by evaluating the walking impairment questionnaire (WIQ). Safety was assessed by monitoring the occurrence of major adverse clinical events and serious adverse events. Results: The mean age of the patients was 67.7 years, and 77% were male. The mean lesion length was 5.9 cm. Mean diameter stenosis was reduced from 89.9% to 6.2%, after stent implantation. Technical success was 96.7%. Binary restenosis rate for the 6 and 12 months follow-up was 39.3% and 67.9%, respectively. The TLR rate was 25.0% after 6 months and 57.1% after 12 months. All TLR were successful; the secondary patency rate after 1 year was 89.3%. Between baseline and 12 months, ABI increased in 53.6% of patients. Functional endpoints (WIQ), even if affected by a relatively high reintervention rate, showed improvement in most of the patients. Conclusions: The GAIA (Evaluation of the Biodegradable Peripheral Igaki-Tamai Stent in the Treatment of De Novo Lesions in the Superficial Femoral Artery) study shows that when using biodegradable PLLA stents (Igaki-Tamai), the immediate angiographic results are comparable to the results of metal stents, achieving a high secondary patency rate after 1 year. Modifications of stent characteristics and technical modifications are needed with the goal to reduce the restenosis rate during the reabsorption period. [Copyright &y& Elsevier]

Objectives: This study sought to perform clinical and imaging assessments of the DESolve Bioresorbable Coronary Scaffold (BCS). Background: BCS, which is drug eluting, may have potential advantages compared with conventional metallic drug-eluting stents. The DESolve system, designed to provide vessel support and neointimal suppression, combines a poly-l-lactic acid–based scaffold with the antiproliferative myolimus. Methods: The DESolve First-in-Man (A NON-RANDOMIZED, CONSECUTIVE ENROLLMENT EVALUATION OF THE DESolve MYOLIMUS ELUTING BIORESORBABLE CORONARY STENT IN THE TREATMENT OF PATIENTS WITH DE NOVO NATIVE CORONARY ARTERY LESIONS) trial was a prospective multicenter study enrolling 16 patients eligible for treatment. The principal safety endpoint was a composite of cardiac death, myocardial infarction, and clinically indicated target lesion revascularization. The principal imaging endpoint was in-scaffold late lumen loss (LLL) assessed by quantitative coronary angiography (QCA) at 6 months. Intravascular ultrasound (IVUS) and optical coherence tomography (OCT) imaging was performed at baseline and 6 months; multislice computed tomography (MSCT) was performed at 12 months. Results: Acute procedural success was achieved in 15 of 15 patients receiving a study scaffold. At 12 months, there was no scaffold thrombosis and no major adverse cardiac events directly attributable to the scaffold. At 6 months, in-scaffold LLL (by QCA) was 0.19 ± 0.19 mm; neointimal volume (by IVUS) was 7.19 ± 3.56%, with no evidence of scaffold recoil or late malapposition. Findings were confirmed with OCT and showed uniform, thin neointimal coverage (0.12 ± 0.04 mm). At 12 months, MSCT demonstrated excellent vessel patency. Conclusions: This study demonstrated the feasibility and efficacy of the DESolve BCS. Results showing low in-scaffold LLL, low % neointimal volume at 6 months, no chronic recoil, and maintenance of lumen patency at 12 months prompt further study. (DESolve First-in-Man; EudraCT number 2011-000027-32) [Copyright &y& Elsevier]

An article titled “Current issues in dermatologic office-based surgery” was published in the JAAD in October 1999 (volume 41, issue 4, pp. 624-634). The article was developed by the Joint American Academy of Dermatology/American Society for Dermatologic Surgery Liaison Committee. A number of subjects were addressed in the article including surgical training program requirements for dermatology residents and selected advances in dermatologic surgery that had been pioneered by dermatologists. The article concluded with sections on credentialing, privileging, and accreditation of office-based surgical facilities. Much has changed since 1999, including more stringent requirements for surgical training during dermatology residency, and the establishment of 57 accredited Procedural Dermatology Fellowship Training Programs. All of these changes have been overseen and approved by the Residency Review Committee for Dermatology and the Accreditation Committee for Graduate Medical Education. The fertile academic environment of academic training programs with interaction between established dermatologic surgeons and fellows, as well as the inquisitive nature of many of our colleagues, has led to the numerous major advances in dermatologic surgery, which are described herein. Learning objectives: Dermatologists have been responsible for multiple advances and refinements in dermatologic office-based surgery over many decades. Dermatologists receive extensive training in office-based surgical procedures during residency, fellowships, and continuing medical education courses. The last update on this subject appeared in the Journal in 1999. This article will document the multitude of advances that have occurred since 1999. [Copyright &y& Elsevier]

Abstract: This review intends to highlight the potential of the membrane science in developed clothing and protective textiles. In particular, the purpose is to provide an overview of the membrane use in wearable fabrics as well as indoor and outdoor protection. Membrane basics and related applications in the field of textiles are discussed by covering papers and patents focused on membrane materials and sustainable strategies for the creation of a large variety of innovative textile solutions. Breathing membranes along with barrier films are examined, discussing related advantages and limitations. A special section is dedicated to the development of ultra-smart textiles, which use adaptable membranes and actuators based on electro-active materials, smart gels, and shape memory polymers along with sensing compounds for self-cleaning, release and capture processes. Future directions of membrane science in sustainable marketplaces, including societal challenges, industrial competitiveness and excellence in science, are also examined. [Copyright &y& Elsevier]

Abstract: The aim of this retrospective study was to evaluate the risk factors associated with breakage of biodegradable plate systems after bilateral sagittal split mandibular setback. We studied 169 Japanese adults (62 men, 107 women; age range 16–53 years) with deformities of the jaw diagnosed as mandibular prognathism. All patients were treated by bilateral sagittal split osteotomy (BSSO) with 2 biodegradable fixation plates and screws at the anterior mandibular ramus. We collected the following data from the medical records and radiological findings: sex; age; degree of setback; presence of asymmetry; presence of open bite; operation; design of the plate; operating time; and blood loss. Multiple logistic regression analysis was used to find the factors that were independently associated with the dependent variable: breakage of the biodegradable plate system. In 10 of the 169 patients (6%) the biodegradable plate system for the BSSO broke. Factors that influenced whether or not the biodegradable plate system fractured were if they were asymmetrical (odds ratio (OR) 5.35; P =0.02) and had an open bite (OR 5.20; P =0.02). Asymmetry or open bite was significantly associated with breaks in the biodegradable plate system. Biodegradable plates should be used only when loading is minimal. [Copyright &y& Elsevier]

As one of the main functions of vascular endothelial cells, Vascular permeability is determined by four tight junction proteins (TJPs): Zonula Occludens-1 (ZO-1), Claudin-5, Occludin and Tricellulin. The barrier function of blood vessels will be reconstructed after they are damaged by endothelial mechanical injuries caused by vascular interventions. In this study, the effects of balloon expansion (transient mechanical injury) on four TJPs and vascular permeability were compared with those of poly- l -lactic acid bioresorbable scaffolds (BRSs) implantation (continuous mechanical stimulation). We found that BRSs do not affect vascular permeability, while the recovery of vascular barrier function was found to be only related to the mechanical injuries and repair of endothelium. Mechanical stimulation affects and accelerates the recovery process of vascular permeability with the heterogeneous expression levels of TJPs induced after BRSs implantation. Different TJPs have different sensitivity to different loyal mechanical stimuli. ZO-1 is more sensitive to shear stress and tension than to static pressure. Occludin is sensitive to static pressure and shear stress. Tricellulin is more sensitive to tension stretching. Compared with the other three TJPs, Claudin-5 can respond to mechanical stimulation, with relatively low sensitivity, though. This difference in sensitivity determines the heterogeneous expression of TJPs. Mechanical stimulation of different kinds and strengths can also cause different cell morphological changes and inflammatory reactions. As an important element affecting endothelial function, the mechanical factors emerging after BRSs implantation are worthy of more attention., Competing Interests: The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (© 2022 The Authors.)

Introduction: Bioabsorbable screws are, at the expense of metal screws, increasingly used as fixation device in ACL-reconstructions. The possible advantages with bioabsorbable screws are better postoperative MRI evaluations and easier revision surgery. Purpose: The aim of this study was to compare the clinical outcome after ACL-reconstructions with BPTB-grafts fixed with metal interference screws or bioabsorbable screws 7 years postoperatively. The resorption of the bioabsorbable screws was also analyzed. Methods: Between 2000 and 2001, 41 patients with ACL deficient knees were randomized for the use of BPTB-graft fixed with either metal interference screws or bioabsorbable poly- l-lactic acid screws. This is a 7-year follow-up with clinical examinations of both groups and, MRI of the patients with bioabsorbable screws. Results: The clinical and functional results were satisfactory in both groups. There were no significant differences between the groups in any parameter measured, except for better Pivot shift results in the bioscrew group ( P = 0.04). The MRI evaluation showed degradation of the bioscrews. A residual screw tract which appeared threaded was seen in the tibia in 11 of the 16 patients. There was no sign of bony ingrowth in the previous screw site in the tibia in any of the patients. Conclusion: The potential advantages of using PLLA-screws compared to metal screws are not sufficient to warrant the routine use of PLLA-screws in ACL-reconstructions. Level of evidence: I. [ABSTRACT FROM AUTHOR]

Background: l-lactide is the monomer for the polymer poly- l-lactic acid (PLLA). PLLA can be made from renewable resources, and is used in an increasing amount of applications. The biopolymer PLLA is one type of polymer of the family of polylactic acids (PLAs). Purac produces l-lactide and d-lactide, and supports partners with know-how to produce their own PLA from lactide. This life cycle assessment (LCA) study supporting market development presents the eco-profile of lactides and PLA biopolymers. Method: An LCA was carried out for l-lactide, d-lactide, PLLA, and two PLLA/PDLA blends made from cane sugar in Thailand, and were compared with that of fossil-based polymers. The LCA complies with ISO standards, and is a cradle-to-gate analysis including sugarcane cultivation, sugarcane milling, auxiliary chemicals production, transport, and production of lactide and PLAs. In the analysis, process data were taken from the designs of full-scale plants for the production of lactic acid, lactides, and PLA. The data were combined with ecoprofiles of chemicals and utilities and recalculated to the following environmental impacts: primary renewable and non-renewable energy, non-renewable abiotic resource usage, farm land use, global warming, acidification, photochemical ozone creation, human toxicity, and eutrophication. Results and discussion: On a weight-by-weight basis, PLLA results in significantly lower emissions of greenhouse gasses, and less use of material resources and non-renewable energy, compared to fossil-based polymers. With the present calculations, the Global Warming Potential (GWP) in l-lactide production is 300-600 kg CO eq./tonne and for PLLA 500-800 kg CO eq./tonne. The range indicates the sensitivity of the GWP to the energy credit for electricity production from bagasse in the sugar mill. The GWP of PLLA/PDLA blends with increased heat resistance is also lower compared to fossil based polymers with similar durable character. Being based on an agricultural system the biobased PLA gives rise to higher contributions to acidification, photochemical ozone creation, eutrophication, and farm land use compared to the fossil polymers. Conclusions: The application spectrum of PLAs is expanding, and there are opportunities to replace various fossil-based polymers. This facilitates climate change mitigation and reduces dependence on fossil and scarce resources while promoting the use of local and renewable resources. It is evident that in emerging green economies agricultural technology will form an integral part in the changeover towards a more sustainable industry and society. [ABSTRACT FROM AUTHOR]

The intention of this study was to surface modify the poly-L-lactic acid (PLLA) film and evaluate the effects of the surfaces on the growth of vascular smooth muscle cells (VSMCs) in vitro. Collagen and hyaluronic acid (HA) were utilized as polycation and polyanion in this study. Layer-by-layer (LBL) self-assembly technique was used to lead to the formation of multilayer moleculer on the poly-L-lactic acid (PLLA) film surfaces. Collagen/HA layers was overcasted coating on the PLLA surface after the activation layers by poly-(ethyleneimine) (PEI). The structure and morphology of the multilayer molecular were examined by attenuated total reflectance Fourier transform infrared (ATR-FTIR) spectrophotometer and atomic force microscope (AFM), respectively. The ATR-FTIR analysis illuminated the presence of collagen on the PLLA surface. The AFM results showed the multilayer appeared on PLLA surface. The VSMCs were adopted to evaluate the cyto-compatibility of the modified PLLA films. It was found that the viability of VSMCs on the modified PLLA films were greater than that on original PLLA films and tissue culture plastic after ten days culture ( p < 0.05). Scanning electron microscopy (SEM) and laser scanning confocal microscopy (LSCM) data also confirmed the homogeneous results. These data suggest that collagen/HA coat can be successfully adopted in the surface modification of PLLA film through LBL technique, and also can enhance its cell compatibility. [ABSTRACT FROM AUTHOR]

Background: During the past decade, bioabsorbable interference screws have become increasingly popular in endoscopic reconstructions of the anterior cruciate ligament. With these screws, there is no need for a second operation for removal and no complicating factor if later revision surgery is necessary. Several pullout studies have found similar results between metal and bioabsorbable interference screws; however, few studies have investigated the clinical outcome. Hypothesis: There is no difference in the clinical outcome of bioabsorbable interference screws compared with metal screws. Study Design: Randomized controlled clinical trial; Level of evidence, 1. Methods: Forty-one patients were randomized for the use of either metal interference screws (20 patients) or bioabsorbable poly-L-lactic acid screws (21 patients). The patients were followed with clinical examinations at 6, 12, and 24 weeks and at 1 and 2 years postoperatively. Results: Subjective knee function was better in the patients in the metal screw group; they had less pain at rest, a higher Tegner score, a higher Lysholm score, and better subjective knee function at 2 years compared to the bioabsorbable screw group. However, there was no difference in stability between the groups. Conclusion and Clinical Relevance: Because of the inferior results in the bioabsorbable screw group in our study, and until larger studies show otherwise, we do not find the advantages of using bioabsorbable screws sufficient to warrant the routine use of poly-L-lactic acid screws in anterior cruciate ligament reconstructions. [ABSTRACT FROM AUTHOR]

Hydrophilic groups, i.e. hydroxyl (–OH), carboxyl (–COOH) or amide (–CONH2) were introduced onto the poly-l-lactic acid (PLLA) membrane surfaces via the photo-induced grafting copolymerization of the corresponding monomers, i.e. hydroxyethyl methacrylate, methacrylic acid or acrylamide, respectively. Chondrocyte culture was used to study the correlation between the cell behaviors and the hydrophilic functional groups. The results showed that the cytocompatibility of the PLLA membranes with hydroxyl or amide groups on the surface was greatly improved compared to that of the original PLLA membrane. However, the PLLA membrane with carboxyl groups on the surface had even worse cytocompatibility though possessed a similar hydrophilicity. [Copyright &y& Elsevier]

In the Sauvé–Kapandji (S–K) procedure for rheumatoid wrist reconstruction, the distal end of the ulna is fixed to the radius with screws. Recently, absorbable screws have increasingly been used instead of metal ones. However, the clinical usefulness of absorbable screws in S–K procedures for rheumatoid patients is still unknown. The purpose of this article is to evaluate the effect of absorbable screws in this procedure by comparing their clinical results with those of metal screws. Poly- l-lactic acid (PLLA) absorbable screws were used in 23 wrists, and metal screws were used in 20 wrists. We evaluated the presence of general or local reactions to PLLA, the stability of the ulnar head, the time to bone union, changes in the shape of the distal ulna, and the presence of bone resorption around the screws. There were no complications with the use of PLLA screws, and their fixation stability was adequate to form sufficient bone union. In five cases in the metal screw group, bone resorption around the screws occurred between 1 and 2 years after surgery. Bone resorption around the PLLA screws was not observed. We conclude that absorbable screws may be more useful than metal screws in the S–K procedure for rheumatoid wrist reconstruction. [ABSTRACT FROM AUTHOR]

Synthetic biopolymers are effective cues to replace damaged tissue in the tissue engineering (TE) field, both for in vitro and in vivo application. Among them, poly-l-lactic acid (PLLA) has been highlighted as a biomaterial with tunable mechanical properties and biodegradability that allows for the fabrication of porous scaffolds with different micro/nanostructures via various approaches. In this review, we discuss the structure of PLLA, its main properties, and the most recent advances in overcoming its hydrophobic, synthetic nature, which limits biological signaling and protein absorption. With this aim, PLLA-based scaffolds can be exposed to surface modification or combined with other biomaterials, such as natural or synthetic polymers and bioceramics. Further, various fabrication technologies, such as phase separation, electrospinning, and 3D printing, of PLLA-based scaffolds are scrutinized along with the in vitro and in vivo applications employed in various tissue repair strategies. Overall, this review focuses on the properties and applications of PLLA in the TE field, finally affording an insight into future directions and challenges to address an effective improvement of scaffold properties.

Male pediatric survivors of cancers and bone marrow transplantation often require adjuvant chemoradiation therapy that may be gonadotoxic. The optimal methods to preserve fertility in these prepubertal males are still under investigation. This manuscript presents an in vivo experiment which involved transplantation of immature testicular tissues (ITT) from transgenic donor, to wild-type recipient mice. Donors and recipients were age-mismatched (from 20-week-old donors to 3-week-old recipients, and vice versa) and the transplantation sites involved the abdomen, skin of the head, back muscle, and scrotum. The application of poly-l-lactic acid (PLLA) scaffold was also evaluated in age-matched donors and recipients (both 3-weeks-old). To quantitively evaluate the process of spermatogenesis after ITT transplantation and scaffold application, bioluminescence imaging (BLI) was employed. Our result showed that ITT from 3-week-old mice had the best potential for spermatogenesis, and the optimal transplantation site was in the scrotum. Spermatogenesis was observed in recipient mice up to 51 days after transplantation, and up to the 85th day if scaffold was used. The peak of spermatogenesis occurred between the 42nd and 55th days in the scaffold group. This animal model may serve as a framework for further studies in prepubertal male fertility preservation.

The objective of this study is to characterize the micromechanical properties of poly-l-lactic acid (PLLA) composites reinforced by grade 420 stainless steel (SS) particles with a specific focus on the interphase properties. The specimens were manufactured using 3D printing techniques due to its many benefits, including high accuracy, cost effectiveness and customized geometry. The adopted fused filament fabrication resulted in a thin interphase layer with an average thickness of 3 µm. The mechanical properties of each phase, as well as the interphase, were characterized by nanoindentation tests. The effect of matrix degradation, i.e., imperfect bonding, on the elastic modulus of the composite was further examined by a representative volume element (RVE) model. The results showed that the interphase layer provided a smooth transition of elastic modulus from steel particles to the polymeric matrix. A 10% volume fraction of steel particles could enhance the elastic modulus of PLLA polymer by 31%. In addition, steel particles took 37% to 59% of the applied load with respect to the particle volume fraction. We found that degradation of the interphase reduced the elastic modulus of the composite by 70% and 7% under tensile and compressive loads, respectively. The shear modulus of the composite with 10% particles decreased by 36%, i.e., lower than pure PLLA, when debonding occurred.

Microsphere and particle technology with selective transport of radiation represents a new generation of therapeutics. Poly-L-lactic acid (PLLA) microspheres loaded with holmium-166 acetylacetonate ((166)Ho-PLLA-MS) are novel microdevices. In this research, (165)HoAcAc-PLLA microparticles were prepared by the solvent evaporation technique. Microspheres were irradiated at Tehran Research Reactor. The diameter and surface morphologies were characterized by particle sizer and scanning electron microscopy before and after irradiation. The complex stability, radiochemical purity, and in vivo biodistribiotion were checked in the final solution up to 3 days. In this study, (166)Ho-PLLA spherical particles with a smooth surface and diameter of 20-40 µm were obtained, which were stable in vitro and in vivo studies. Neutron irradiation did not damage the particles. The ease with which the PLLA spheres could be made in the optimal size range for later irradiation and their ability to retain the (166)Ho provided good evidence for their potential use in radioembolization., (Copyright © 2015 John Wiley & Sons, Ltd.)

Scaffolds providing a 3D environment which can effectively promote the adhesion, proliferation and differentiation of cells are crucial to tissue regeneration. In this study, the poly-l-lactic acid (PLLA) scaffold with hierarchical pore structural was fabricated via two-step thermally induced phase separation (TIPS). To mimic both physical architecture and chemical composite of natural bone extracellular matrix (ECM), gelatin fibers were introduced into the pores of PLLA scaffolds and formed 3D network structure via TIPS. Human adipose tissue-derived stem cells (ADSCs) were harvested and seeded into PLLA/gel hybrid scaffolds and cultured in vitro for biocompatibility assay. The surface morphology, porosity and compressive modulus of scaffolds were characterized by scanning electron microscopy (SEM), density analysis and compression test respectively. The results showed that hybrid scaffolds had high porosity (91.62%), a good compressive modulus (2.79 ± 0.20 MPa), nanometer fibers (diameter around 186.39~354.30 nm) and different grades of pore size from 7.41 ± 2.64 nm to 387.94 ± 102.48 nm. The scaffolds with mild hydrolysis by NaOH were modified by 1-ethyl-3-(3-dimethyl ami-nopropyl) carbodiimide/N-hydroxysuccinimide (EDC/NHS). Gelatin was performed onto PLLA scaffold via TIPS aiming at enhancement cell-material interaction. In comparison with PLLA scaffold, the PLLA/gel scaffold had better biological performance and the mechanical properties because the gelatin fibers homogeneously distributed in each pore of PLLA scaffold and formed 3D network structure.

Background: Ceramic and polymer composite scaffolds are widely used in tissue engineering for bone tissue regeneration. Composite of β-tricalcium phosphate (β-TCP) and poly L-lactic acid (PLLA), due to its biocompatibility and biodegradability, is widely used in bioengineering. However, optimal ratio, porosity and pore size of this kind of scaffolds were not very clear yet., Materials and Methods: We cultured osteoblastic induced rMSCs on β-TCP/PLLA scaffolds to investigate the optimum construction, which owned better properties for supporting cells growth, proliferation and differentiation. A total of 24 mice were divided into three groups: rMSCs + β-TCP/PLLA, osteoblastic rMSCs + β-TCP/PLLA and β-TCP/PLLA without cells. 8 rude mice were implanted with rMSCs + β-TCP/PLLA in the left thighs and β-TCP/PLLA without cells in the right thighs. 8 rude mice were implanted with osteoblastic rMSCs + β-TCP/PLLA in the left thighs and the same treatments in the right thighs as the above. After 8 and 12 weeks, the mice were sacrificed and implants with the surrounding tissues were harvested together. Paraffin sections were got and HE stain and Masson-Goldner stain were employed to observe the ectopic bone formation., Results: The scaffolds of β-TCP/PLLA = 2:1 significantly increased osteocalcin production of the cells. In addition, scaffolds with NaCl = 70 wt%, pore size 200~450 μm showed better compatibility to these seeding cells. A significantly larger area of bone formation in the osteoblastic rMSCs and β-TCP/PLLA composite than that in rMSCs/scaffold and in the scaffold without cells in vivo., Conclusion: compounds of osteoblastic induced rMSCs and the scaffold with β-TCP/PLLA = 2:1, NaCl = 70 wt%, pore size = 200-450 μm had good properties as a kind of bone substitute.

Objectives: This study evaluates the feasibility of delivery and deployment of low and medium molecular weight (LMW and MMW, respectively) double-opposing helical (DH) poly-l-lactic acid biodegradable stent (BDS) in rabbit descending aorta (DAO). Secondary objectives were to assess patency and inflammation of stented vessels at 9 months and to investigate safety following intentional embolization of stent fragments in DAO., Background: A BDS that will relieve aortic obstruction and disappears as the child grows older allowing for preservation of aortic wall elasticity and natural growth of aorta will be ideal to treat Coarctation (CoA). BDS have never been evaluated in the DAO., Methods: Seven New Zealand white rabbits underwent implantation of DH-LMW (n = 7), DH-MMW (n = 3), and metal stents (n = 7) in DAO. BDS fragments were intentionally embolized into DAO in two rabbits., Results: All stents were deployed via a 6-French sheath. Five BDS covered the origin of major DAO side branches. Angiography and intravascular ultrasound showed good stent apposition to the wall of DAO with minimal luminal loss at 9 months follow-up. All stents had minimal neointimal hyperplasia on histopathology. Adverse events included 1 death, 1 aortic aneurysm, and lower extremity ulceration due to self-mutilation in an embolization rabbit., Conclusions: Pilot study confirms the feasibility of delivery and deployment of up to 6-millimeter diameter DH BDS in rabbit DAO. Stent integrity with DH design was maintained at 9 months with minimal vessel inflammation. Potential morbidity due to embolized BD fragments cannot be ruled out and needs further evaluation., (© 2014 Wiley Periodicals, Inc.)

Stents have been an effective tool to restore and maintain the patency of narrowed blood vessels, but they must have sufficient radial strength. Biodegradable stent materials have substantially lower mechanical properties than permanent stents. The stent geometry and material properties must be considered simultaneously when assessing stent performance. Material tests were performed to determine the mechanical characteristics of high-molecular-weight poly-l-lactic acid (PLLA). The results were used to calibrate an anisotropic elastic-plastic material model. Three distinct geometries were analysed with a range of material stiffness values in a finite element analysis to investigate their comparative effect on the radial strength, recoil, and radial stiffness. The performance of the different geometries varies substantially, with one particular geometry, with the highest material stiffness of 9 GPa, exceeding the desired radial strength of 300 mmHg., (Copyright © 2014 IPEM. Published by Elsevier Ltd. All rights reserved.)