Tissue Engineering. Part B, Reviews最新文献

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Efficacy of Fresh Versus Preserved Amniotic Membrane Grafts for Ocular Surface Reconstruction: Meta-analysis. 新鲜羊膜移植与保存羊膜移植用于眼表重建的疗效:META = 元分析。
IF 5.1 2区 医学
Tissue Engineering. Part B, Reviews Pub Date : 2024-10-29 DOI: 10.1089/ten.teb.2024.0217
Yu Hu, Jinhai Yu, Yuting Fu, Xinyi Guan, Fen Xiong, Hongfei Liao, Qihua Xu, Anan Wang
{"title":"Efficacy of Fresh Versus Preserved Amniotic Membrane Grafts for Ocular Surface Reconstruction: Meta-analysis.","authors":"Yu Hu, Jinhai Yu, Yuting Fu, Xinyi Guan, Fen Xiong, Hongfei Liao, Qihua Xu, Anan Wang","doi":"10.1089/ten.teb.2024.0217","DOIUrl":"10.1089/ten.teb.2024.0217","url":null,"abstract":"<p><p>Amniotic membrane transplantation is commonly employed in ophthalmology to mend corneal epithelial and stromal defects. Its effectiveness in restoring the ocular surface has been widely acknowledged in clinical practice. Nevertheless, there is ongoing debate regarding the comparative effectiveness of using fresh amniotic membranes versus preserved ones. The objective of this meta-analysis was to ascertain whether there is a disparity in the effectiveness of fresh versus preserved amniotic membrane in the restoration of the ocular surface in clinical practice. The study utilized the following keywords: \"fresh amniotic membrane,\" \"preserved amniotic membrane,\" \"amniotic membrane transplantation,\" and \"ocular surface reconstruction.\" The study conducted a comprehensive search for relevant studies published until April 18, 2024. Seven different databases, namely PubMed, Web of Science, Embase, Cochrane, China Knowledge, China Science and Technology Journal VIP database, and Wanfang database, were utilized. The search was performed using the keywords \"fresh amniotic membrane,\" \"preserved amniotic membrane,\" \"amniotic membrane transplantation,\" and \"ocular surface reconstruction.\" The process of literature review and data extraction was carried out separately by two researchers, and all statistical analyses were conducted using Review Manager 5.4.1. The final analysis comprised nine cohort studies, encompassing a total of 408 participants. The statistics included six outcome indicators: visual acuity (relative risk [RR] = 1.07, 95% confidence interval [CI] = 0.93-1.24, <i>I</i><sup>2</sup> = 0); amniotic membrane viability (RR = 1.00, 95% CI = 0.93-1.08, <i>I</i><sup>2</sup> = 0); ocular congestion resolution (RR = 1.11, 95% CI = 0.97-1.26, <i>I</i><sup>2</sup> = 0); fluorescent staining of amniotic membranes on the second day after the operation (RR = 1.31, 95% CI = 0.80-2.14, <i>I</i><sup>2</sup> = 11); postoperative recurrence rate (RR = 1.01, 95% CI = 0.50-2.03, <i>I</i><sup>2</sup> = 0); and premature lysis of amniotic membrane implants (RR = 0.96, 95% CI = 0.49-1.88, <i>I</i><sup>2</sup> = 0). The findings indicated that there was no statistically significant disparity between fresh and preserved amniotic membranes across any of the measured variables. There is no substantial disparity in the effectiveness of fresh and preserved amniotic membrane transplants in restoring the ocular surface, and both yield favorable and consistent outcomes.</p>","PeriodicalId":23134,"journal":{"name":"Tissue Engineering. Part B, Reviews","volume":" ","pages":""},"PeriodicalIF":5.1,"publicationDate":"2024-10-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142523206","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Advancing Cartilage Tissue Engineering: A Review of 3D Bioprinting Approaches and Bioink Properties. 推进软骨组织工程:三维生物打印方法和生物墨水特性综述。
IF 5.1 2区 医学
Tissue Engineering. Part B, Reviews Pub Date : 2024-10-09 DOI: 10.1089/ten.teb.2024.0168
Gabriele Boretti, Arsalan Amirfallah, Kyle J Edmunds, Helena Hamzehpour, Ólafur E Sigurjónsson
{"title":"Advancing Cartilage Tissue Engineering: A Review of 3D Bioprinting Approaches and Bioink Properties.","authors":"Gabriele Boretti, Arsalan Amirfallah, Kyle J Edmunds, Helena Hamzehpour, Ólafur E Sigurjónsson","doi":"10.1089/ten.teb.2024.0168","DOIUrl":"https://doi.org/10.1089/ten.teb.2024.0168","url":null,"abstract":"<p><p>Articular cartilage is crucial in human physiology, and its degeneration poses a significant public health challenge. While recent advancements in 3D bioprinting and tissue engineering show promise for cartilage regeneration, there remains a gap between research findings and clinical application. This review critically examines the mechanical and biological properties of hyaline cartilage, along with current 3D manufacturing methods and analysis techniques. Moreover, we provide a quantitative synthesis of bioink properties used in cartilage tissue engineering. After screening 181 initial works, 33 studies using extrusion bioprinting were analyzed and synthesized, presenting results that indicate the main materials, cells, and methods utilized for mechanical and biological evaluation. Altogether, this review motivates the standardization of mechanical analyses and biomaterial assessments of 3D bioprinted constructs to clarify their chondrogenic potential.</p>","PeriodicalId":23134,"journal":{"name":"Tissue Engineering. Part B, Reviews","volume":" ","pages":""},"PeriodicalIF":5.1,"publicationDate":"2024-10-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142393616","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Strategies for Preventing Esophageal Stenosis After Endoscopic Submucosal Dissection and Progress in Stem Cell-Based Therapies. 预防 ESD 后食管狭窄的策略和干细胞疗法的进展。
IF 5.1 2区 医学
Tissue Engineering. Part B, Reviews Pub Date : 2024-10-01 Epub Date: 2024-02-14 DOI: 10.1089/ten.TEB.2023.0316
Shujun Ye, Jingjing Hu, Daxu Zhang, Shuo Zhao, Xiaonan Shi, Weilong Li, Jingyi Wang, Weiping Guan, Li Yan
{"title":"Strategies for Preventing Esophageal Stenosis After Endoscopic Submucosal Dissection and Progress in Stem Cell-Based Therapies.","authors":"Shujun Ye, Jingjing Hu, Daxu Zhang, Shuo Zhao, Xiaonan Shi, Weilong Li, Jingyi Wang, Weiping Guan, Li Yan","doi":"10.1089/ten.TEB.2023.0316","DOIUrl":"10.1089/ten.TEB.2023.0316","url":null,"abstract":"<p><p>Endoscopic submucosal dissection (ESD) has been widely used in the early neoplasia of the esophagus. However, postoperative esophageal stenosis is a big problem, particularly when a large circumferential proportion of esophageal mucosa is resected. Currently, there are several methods available to prevent esophageal stenosis after ESD, including steroid administration, esophageal stent implantation, and endoscopic balloon dilation (EBD). However, the therapeutic effects of these are not yet satisfactory. Stem cell-based therapies has shown promising potential in reconstructing tissue structure and restoring tissue function. In this study, we discussed the current strategies for preventing esophageal stenosis after ESD and perspectives of stem cell-based therapies for the prevention of esophageal stenosis.</p>","PeriodicalId":23134,"journal":{"name":"Tissue Engineering. Part B, Reviews","volume":" ","pages":"522-529"},"PeriodicalIF":5.1,"publicationDate":"2024-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139513439","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Optimizing Tissue Engineering for Clinical Relevance in Rotator Cuff Repair. 优化组织工程,提高肩袖修复的临床实用性。
IF 5.1 2区 医学
Tissue Engineering. Part B, Reviews Pub Date : 2024-10-01 Epub Date: 2024-04-29 DOI: 10.1089/ten.TEB.2023.0320
Maxwell S Durtschi, Sungwoo Kim, Jiannan Li, Carolyn Kim, Constance Chu, Emilie Cheung, Marc Safran, Geoff Abrams, Yunzhi Peter Yang
{"title":"Optimizing Tissue Engineering for Clinical Relevance in Rotator Cuff Repair.","authors":"Maxwell S Durtschi, Sungwoo Kim, Jiannan Li, Carolyn Kim, Constance Chu, Emilie Cheung, Marc Safran, Geoff Abrams, Yunzhi Peter Yang","doi":"10.1089/ten.TEB.2023.0320","DOIUrl":"10.1089/ten.TEB.2023.0320","url":null,"abstract":"<p><p>Rotator cuff tear (RCT) is the most common cause of disability in the upper extremity. It results in 4.5 million physician visits in the United States every year and is the most common etiology of shoulder conditions evaluated by orthopedic surgeons. Over 460,000 RCT repair surgeries are performed in the United States annually. Rotator cuff (RC) retear and failure to heal remain significant postoperative complications. Literature suggests that the retear rates can range from 29.5% to as high as 94%. Weakened and irregular enthesis regeneration is a crucial factor in postsurgical failure. Although commercially available RC repair grafts have been introduced to augment RC enthesis repair, they have been associated with mixed clinical outcomes. These grafts lack appropriate biological cues such as stem cells and signaling molecules at the bone-tendon interface. In addition, they do little to prevent fibrovascular scar tissue formation, which causes the RC to be susceptible to retear. Advances in tissue engineering have demonstrated that mesenchymal stem cells (MSCs) and growth factors (GFs) enhance RC enthesis regeneration in animal models. These models show that delivering MSCs and GFs to the site of RCT enhances native enthesis repair and leads to greater mechanical strength. In addition, these models demonstrate that MSCs and GFs may be delivered through a variety of methods including direct injection, saturation of repair materials, and loaded microspheres. Grafts that incorporate MSCs and GFs enhance anti-inflammation, osteogenesis, angiogenesis, and chondrogenesis in the RC repair process. It is crucial that the techniques that have shown success in animal models are incorporated into the clinical setting. A gap currently exists between the promising biological factors that have been investigated in animal models and the RC repair grafts that can be used in the clinical setting. Future RC repair grafts must allow for stable implantation and fixation, be compatible with current arthroscopic techniques, and have the capability to deliver MSCs and/or GFs.</p>","PeriodicalId":23134,"journal":{"name":"Tissue Engineering. Part B, Reviews","volume":" ","pages":"559-569"},"PeriodicalIF":5.1,"publicationDate":"2024-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139973566","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
The Application of Three-Dimensional-Printed Hydrogels in Bone Tissue Engineering. 三维打印水凝胶在骨组织工程中的应用。
IF 5.1 2区 医学
Tissue Engineering. Part B, Reviews Pub Date : 2024-10-01 Epub Date: 2024-01-17 DOI: 10.1089/ten.TEB.2023.0218
Chengcheng Zhang, Tengbin Shi, Dingwei Wu, Dingxiang Hu, Wenwen Li, Jie Fei, Wenge Liu
{"title":"The Application of Three-Dimensional-Printed Hydrogels in Bone Tissue Engineering.","authors":"Chengcheng Zhang, Tengbin Shi, Dingwei Wu, Dingxiang Hu, Wenwen Li, Jie Fei, Wenge Liu","doi":"10.1089/ten.TEB.2023.0218","DOIUrl":"10.1089/ten.TEB.2023.0218","url":null,"abstract":"<p><p>Bone defects are a prevalent clinical issue that presents a serious medical challenge. Bone tissue engineering (BTE) has emerged as an effective approach for treating large bone defects. Hydrogels, as hydrophilic three-dimensional polymers, are recognized as suitable material for BTE due to their excellent biocompatibility and degradability. However, the submicron and nanoporous structure of hydrogels limits the survival of osteoblasts, hindering bone tissue regeneration. In recent years, 3D printing technology has attracted appreciable attention. The use of hydrogels as 3D-printed ink facilitates the printing of hydrogels in any desired shape, enabling personalized or more complex requirements. This article provides a systematic review of the latest applications of 3D-printed hydrogels in BTE. These hydrogels serve as a multifunctional platform for the next generation technology in treating bone defects. The advantages and limitations of 3D-printed hydrogels in BTE are discussed, and future research directions are explored. This review can form the basis for future hydrogel design.</p>","PeriodicalId":23134,"journal":{"name":"Tissue Engineering. Part B, Reviews","volume":" ","pages":"492-506"},"PeriodicalIF":5.1,"publicationDate":"2024-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"138831633","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Rosalind Franklin Society Proudly Announces the 2023 Award Recipient for Tissue Engineering Part B. 罗莎琳德-富兰克林学会自豪地宣布 2023 年组织工程 B 部分获奖者。
IF 5.1 2区 医学
Tissue Engineering. Part B, Reviews Pub Date : 2024-10-01 DOI: 10.1089/ten.teb.2024.17785.rfs2023
Johnna S Temenoff
{"title":"Rosalind Franklin Society Proudly Announces the 2023 Award Recipient for <i>Tissue Engineering Part B</i>.","authors":"Johnna S Temenoff","doi":"10.1089/ten.teb.2024.17785.rfs2023","DOIUrl":"https://doi.org/10.1089/ten.teb.2024.17785.rfs2023","url":null,"abstract":"","PeriodicalId":23134,"journal":{"name":"Tissue Engineering. Part B, Reviews","volume":"30 5","pages":"491"},"PeriodicalIF":5.1,"publicationDate":"2024-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142475500","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
The Structure, Biology, and Mechanical Function of Tendon/Ligament-Bone Interfaces. 肌腱/韧带-骨界面的结构、生物学和机械功能。
IF 5.1 2区 医学
Tissue Engineering. Part B, Reviews Pub Date : 2024-10-01 Epub Date: 2024-03-05 DOI: 10.1089/ten.TEB.2023.0295
Huizhi Wang, Kaixin He, Cheng-Kung Cheng
{"title":"The Structure, Biology, and Mechanical Function of Tendon/Ligament-Bone Interfaces.","authors":"Huizhi Wang, Kaixin He, Cheng-Kung Cheng","doi":"10.1089/ten.TEB.2023.0295","DOIUrl":"10.1089/ten.TEB.2023.0295","url":null,"abstract":"<p><p>After tendon or ligament reconstruction, the interface between the hard bone and soft connective tissue is considerably weakened and is difficult to restore through healing. The tendon/ligament-bone interface is mechanically the weakest point under tensile loading and is often the source of various postoperative complications, such as bone resorption and graft laxity. A comprehensive understanding of the macro- and microfeatures of the native tendon/ligament-bone interface would be beneficial for developing strategies for regenerating the tissue. This article discusses the structural, biological, and mechanical features of the tendon/ligament-bone interfaces and how these can be affected by aging and loading conditions.</p>","PeriodicalId":23134,"journal":{"name":"Tissue Engineering. Part B, Reviews","volume":" ","pages":"545-558"},"PeriodicalIF":5.1,"publicationDate":"2024-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139698395","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
The Pathological Factors Involved in Current In Vitro Atherosclerotic Models. 当前体外动脉粥样硬化模型中的病理因素
IF 5.1 2区 医学
Tissue Engineering. Part B, Reviews Pub Date : 2024-10-01 Epub Date: 2024-03-01 DOI: 10.1089/ten.TEB.2023.0272
Yuxin Bao, Hangyu Zhang, Danbo Wang, Peishi Yan, Shuai Shao, Zhengyao Zhang, Bo Liu, Na Li
{"title":"The Pathological Factors Involved in Current <i>In Vitro</i> Atherosclerotic Models.","authors":"Yuxin Bao, Hangyu Zhang, Danbo Wang, Peishi Yan, Shuai Shao, Zhengyao Zhang, Bo Liu, Na Li","doi":"10.1089/ten.TEB.2023.0272","DOIUrl":"10.1089/ten.TEB.2023.0272","url":null,"abstract":"<p><p>Cardiovascular disease stemmed from atherosclerosis (AS) is well recognized to be the predominant cause of global death. To comprehensively clarify the pathogenesis of AS, exploit effective drugs, as well as develop therapeutic solutions, various atherosclerotic models were constructed <i>in vitro</i> and widely utilized by the scientific community. Compared with animal models, the <i>in vitro</i> atherosclerotic models play a prominent role not only in the targeted research of single pathological factor related to AS in the human derived system, but also in the combined study on multipathological factors leading to AS, thereby contributing tremendously to the in-depth elucidation of atherosclerotic pathological process. In the current review, a variety of pathological factors incorporated into the existing atherosclerotic models <i>in vitro</i> are broadly elaborated, including the pathological mechanism, <i>in vitro</i> simulation approaches, and the desired improvement perspectives for reproducing each pathological factor. In addition, this review also summarizes the advantages and disadvantages of current atherosclerotic models as well as their potential functionality. Finally, the promising aspects for future atherosclerotic models <i>in vitro</i> with potential advances are also discussed.</p>","PeriodicalId":23134,"journal":{"name":"Tissue Engineering. Part B, Reviews","volume":" ","pages":"530-544"},"PeriodicalIF":5.1,"publicationDate":"2024-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139521956","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Emerging diabetes therapies: Regenerating pancreatic β cells. 新兴糖尿病疗法:再生胰腺β细胞。
IF 6.4 2区 医学
Tissue Engineering. Part B, Reviews Pub Date : 2024-09-14 DOI: 10.1089/ten.teb.2024.0041
Haojie Zhang,Yaxin Wei,Yubo Wang,Jialin Liang,Yifan Hou,Xiaobo Nie,Junqing Hou
{"title":"Emerging diabetes therapies: Regenerating pancreatic β cells.","authors":"Haojie Zhang,Yaxin Wei,Yubo Wang,Jialin Liang,Yifan Hou,Xiaobo Nie,Junqing Hou","doi":"10.1089/ten.teb.2024.0041","DOIUrl":"https://doi.org/10.1089/ten.teb.2024.0041","url":null,"abstract":"The incidence of diabetes mellitus (DM) is steadily increasing annually, with 537 million diabetic patients as of 2021. Restoring diminished β cell mass or impaired islet function is crucial in treating DM, particularly type 1 diabetes mellitus (T1DM). However, the regenerative capacity of islet β cells, which primarily produce insulin, is severely limited, and natural regeneration is only observed in young rodents or children. Hence, there is an urgent need to develop advanced therapeutic approaches that can regenerate endogenous β cells or replace them with stem cell (SC)-derived or engineered β-like cells. Current strategies for treating insulin-dependent DM mainly include promoting the self-replication of endogenous β cells, inducing SC differentiation, reprogramming non-β cells into β-like cells, and generating pancreatic-like organoids through cell-based intervention. In this Review, we discuss the current state of the art in these approaches, describe associated challenges, propose potential solutions, and highlight ongoing efforts to optimize β cell or islet transplantation and related clinical trials. These effective cell-based therapies will generate a sustainable source of functional β cells for transplantation and lay strong foundations for future curative treatments for DM.","PeriodicalId":23134,"journal":{"name":"Tissue Engineering. Part B, Reviews","volume":"17 1","pages":""},"PeriodicalIF":6.4,"publicationDate":"2024-09-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142268753","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Induced Pluripotent Stem Cell-Derived Cardiomyocytes: From Regulatory Status to Clinical Translation. 诱导多能干细胞衍生的心肌细胞:从监管状态到临床转化。
IF 5.1 2区 医学
Tissue Engineering. Part B, Reviews Pub Date : 2024-08-01 Epub Date: 2024-02-19 DOI: 10.1089/ten.TEB.2023.0080
Catarina S P Soares, Maria H L Ribeiro
{"title":"Induced Pluripotent Stem Cell-Derived Cardiomyocytes: From Regulatory Status to Clinical Translation.","authors":"Catarina S P Soares, Maria H L Ribeiro","doi":"10.1089/ten.TEB.2023.0080","DOIUrl":"10.1089/ten.TEB.2023.0080","url":null,"abstract":"<p><p>Cardiovascular diseases, considered the deadliest worldwide by the World Health Organization (WHO), lack effective therapies for regenerating cardiomyocytes. With their self-renewal and pluripotency capabilities, stem cell therapies are increasingly used in precision medicine. Induced pluripotent stem cells (iPSCs) are a promising alternative to embryonic stem cells. Good Manufacturing Practice (GMP) principles are not yet adapted for large-scale production of iPSCs. Additionally, the quality risk for iPSC products may not always be possible to eliminate, potentially jeopardizing the health of patients. This review aims to identify critical quality attributes (CQAs) for iPSC-derived cardiomyocytes (iPSC-CMs) for the development of cardiovascular therapy to ensure compliance with regulations and safety for patients. To attain these goals, the literature review was conducted with articles related to iPSCs and iPSC-CM therapies, legislation, and regulatory guidelines of the European Medicines Agency (EMA), Food and Drug Administration (FDA), and Pharmaceuticals and Medical Devices Agency (PMDA). In conclusion, additional regulations and guidelines are needed to monitor differentiation, maturation, and tumorigenicity. GMP-compliant cell banks and fast-track approval systems may increase accessibility for patients.</p>","PeriodicalId":23134,"journal":{"name":"Tissue Engineering. Part B, Reviews","volume":" ","pages":"436-447"},"PeriodicalIF":5.1,"publicationDate":"2024-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139040534","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
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