tissue-engineered products

  • 文章类型: Journal Article
    膀胱癌是一种非常普遍的恶性肿瘤,在手术后的伤口处理中存在很大的困难。本研究通过将常规方法与先进方法进行对比,以促进康复和减轻并发症,调查了优化膀胱癌手术患者伤口愈合技术的关键必要性。该研究评估了常规和高级伤口愈合方法对这些患者的疗效,考虑到患者特异性因素和手术复杂性的复杂相互作用。方法对温州医科大学附属第一医院行膀胱癌手术的120例患者进行横断面分析。除了医疗记录评估和直接伤口评估,患者访谈用于收集有关人口统计的信息,手术细节,伤口愈合方法和术后结果。生存分析和逻辑回归分析用于统计分析,与潜在的混杂变量,如年龄,合并症和手术类型。先进的伤口愈合技术,如负压伤口治疗,组织工程产品,生物活性敷料和富含血小板的血浆(PRP),与传统缝合相比,表现出明显的优势。上述技术,尤其是PRP,导致伤口加速愈合,并发症发生率降低(p<0.05),次要结局增强,包括缩短住院时间和降低再入院率。PRP治疗,特别是,显示出显着改善,平均伤口愈合时间为9±2天,并发症发生率为2(6.7%)(p<0.05),表明其优越的疗效。一项亚组分析显示,年轻患者,男性和接受腹腔镜手术的患者表现出更好的结局(p<0.05).结果得到了逻辑回归和Cox比例风险模型的进一步支持,这进一步表明,复杂的技术,特别是PRP治疗的风险比为3.00(2.00-4.50),调整后的比值比为0.20(0.09-0.43),能有效改善术后恢复。该研究阐明了先进的伤口愈合技术在诊断为膀胱癌的患者的术后护理中提供的显着优势。通过定制这些方法,以适应个别患者的独特要求和外科手术的具体情况,它们可以显着增强手术后的康复过程,并为患者护理树立新的标准。
    Bladder cancer is a highly prevalent malignancy that presents significant difficulties in the management of wounds following surgery. The present study investigated the critical necessity to optimize wound healing techniques in patients undergoing bladder cancer surgery by contrasting conventional approaches with advanced modalities in order to promote recovery and mitigate complications. The study assessed the efficacy of conventional and advanced wound healing methods in these patients, taking into account the complex interaction of patient-specific factors and surgical complexities. A cross-sectional analysis was performed on 120 patients who underwent bladder cancer surgery at the first affiliated hospital of Wenzhou Medical University. In addition to medical record evaluations and direct wound assessments, patient interviews were utilized to gather information regarding demographics, surgical specifics, wound healing methodologies and postoperative results. Survival analysis and logistic regression were utilized in statistical analysis, with potential confounding variables such as age, comorbidities and type of surgery being accounted for. Advanced wound healing techniques, such as negative pressure wound therapy, tissue-engineered products, bioactive dressings and platelet-rich plasma (PRP), exhibited distinct advantage in comparison with conventional suturing. The aforementioned techniques, especially PRP, resulted in expedited wound healing, decreased rates of complications (p < 0.05) and enhanced secondary outcomes, including curtailed hospital stays and decreased rates of readmissions. PRP therapy, in particular, demonstrated significant improvements with the faster mean time to wound healing of 9 ± 2 days and lower complication incidence of 2 (6.7%) (p < 0.05), indicating its superior efficacy. A subgroup analysis revealed that younger patients, males and those undergoing laparoscopic surgery exhibited superior outcomes (p < 0.05). The results were further supported by logistic regression and Cox proportional hazards models, which further indicated that sophisticated techniques, notably PRP therapy with a hazard ratio of 3.00 (2.00-4.50) and adjusted odds ratio of 0.20 (0.09-0.43), were effective in improving postoperative recovery. The research clarified the significant advantages that advanced wound healing techniques offered in postoperative care of patients diagnosed with bladder cancer. By customizing these methods to suit the unique requirements of individual patients and specific circumstances of surgical procedures, they can significantly enhance the recuperation process after surgery and set a new standard for patient care.
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  • 文章类型: Journal Article
    The United States Food and Drug Administration\'s (FDA) regulatory approach for xenotransplantation products and xenografts encompasses regulatory considerations for biological products, medical devices, drugs, combination products, and genetically altered animals, depending on the product. This communication aims to clarify the regulatory approaches and considerations for animal-derived products, specifically xenotransplantation and xenograft products.
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  • 文章类型: Journal Article
    Background: Cell and gene therapy products belong to a diverse class of biopharmaceuticals known as advanced therapy medicinal products. Cell and gene therapy products are used for the treatment and prevention of diseases that until recently were only managed chronically. The objective of this study was to examine the characteristics of market authorizations, discontinuations, and prices of cellular and gene therapy products worldwide. Data and Methods: We conducted an electronic search of authorized cell, tissue-engineered, and gene therapy products from the databases of the main drug regulatory agencies. The analysis excluded hematopoietic progenitor cell cord blood products authorized by the U.S. Food and Drug Administration. Price information was derived from the Red Book (Truven Health Analytics) for the United States, health technology assessment agencies for Europe, and other public sector sources and company news for other countries. We also searched the scientific literature for authorizations, discontinuations, and price information using MEDLINE/PubMed, Cochrane Library, Google Scholar, and EMBASE databases. All cost data were converted to U.S. dollars. Descriptive analysis was conducted in this study. Results: There were 52 different cell, tissue engineering and gene therapy products with 69 market authorizations in the world as of December 31, 2018. The products included 18 (34%) cell therapies, 23 (43.4%) tissue engineered products, and 12 (22.6%) gene therapies. There were 21 (30.4% of all authorizations) cell therapy, 26 (37.7%) tissue-engineered, and 22 (31.9%) gene therapy market authorizations. The EMA withdrew the authorization for two tissue engineering products, one cell therapy and one gene therapy, and New Zealand lapsed approval of one cell therapy. Most products were first authorized after 2010, including 10 (83.3%) gene therapies, 13 (72.2%) cell therapies, and 13 (56.5%) tissue-engineered products. The treatment price for four allogenic cell therapies varied from $2,150 in India to $200,000 in Canada. The treatment price for three autologous cell therapies ranged from $61,500 in the United Kingdom to a listed price of $169,206 in the United States. Tissue-engineered treatment prices varied from $400 in South Korea to $123,154 in Japan. Gene therapy treatment prices ranged from $5,501 for tonogenchoncel-L in South Korea to $1,398,321 for alipogene tiparvovec in Germany. Conclusions: A significant number of new cell, tissue, and gene therapies have been approved in the past decade. Most products were conditionally authorized and targeted rare cancers, genetic diseases, and other debilitating diseases. However, there are also products approved for cosmetic reasons. Cell, tissue, and gene therapies are among the most expensive therapies available. Healthcare systems are not prepared to assume the cost of future therapies for a myriad of rare diseases and common diseases of epidemic proportions.
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    文章类型: Journal Article
    Urethral strictures are a pressing issue in modern medicine. Substitution urethroplasty is considered one of the most effective treatment methods. However, despite the surgery showing good results, many problems remain unresolved, one being substitute material deficiency in extensive or recurrent strictures, as well as in cases requiring multistage surgeries, including those used to treat hypospadias. Graft removal also leaves the donor area prone to diseases and increases the length of surgery leading to a higher risk of intra- and postoperative complications. Tissue engineering (namely tissue-engineered products comprised of scaffolds and cells) may be a useful tool in dealing with these issues. The authors assessed the characteristics of a novel hybrid scaffold created from \"reconstructed\" collagen and a poly(lactic-co-glycolic acid) mesh. The resulting composite product showed good mechanical properties and functional performance. The hybrid scaffold was non-cytotoxic and provided an adequate base for cell adhesion and proliferation. Biodegradation resulted in the scaffold being replaced by urothelium and urethral mucosa. The newly formed tissues possessed adequate structural and functional properties. Only one rabbit out of 12 developed urethral stricture at the site of scaffold implantation. The above-mentioned facts suggest that the novel hybrid scaffold is a promising tissue-engineered product with potential implication in substitution urethroplasty.
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