Tissue Engineering. Part B, Reviews最新文献

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Hydroxyapatite/Polyurethane Scaffolds for Bone Tissue Engineering. 用于骨组织工程的羟基磷灰石/聚氨酯支架。
IF 6.4 2区 医学
Tissue Engineering. Part B, Reviews Pub Date : 2024-02-01 Epub Date: 2023-08-21 DOI: 10.1089/ten.TEB.2023.0073
Tianyu Zhang, Jingxuan Li, Yahui Wang, Weimo Han, Yan Wei, Yinchun Hu, Ziwei Liang, Xiaojie Lian, Di Huang
{"title":"Hydroxyapatite/Polyurethane Scaffolds for Bone Tissue Engineering.","authors":"Tianyu Zhang, Jingxuan Li, Yahui Wang, Weimo Han, Yan Wei, Yinchun Hu, Ziwei Liang, Xiaojie Lian, Di Huang","doi":"10.1089/ten.TEB.2023.0073","DOIUrl":"10.1089/ten.TEB.2023.0073","url":null,"abstract":"<p><p>Polyurethane (PU) and PU ceramic scaffolds are the principal materials investigated for developing synthetic bone materials due to their excellent biocompatibility and biodegradability. PU has been combined with calcium phosphate (such as hydroxyapatite [HA] and tricalcium phosphate) to prepare scaffolds with enhanced mechanical properties and biocompatibility. This article reviews the latest progress in the design, synthesis, modification, and biological attributes of HA/PU scaffolds for bone tissue engineering. Diverse HA/PU scaffolds have been proposed and discussed in terms of their osteogenic, antimicrobial, biocompatibility, and bioactivities. The application progress of HA/PU scaffolds in bone tissue engineering is predominantly introduced, including bone repair, bone defect filling, drug delivery, and long-term implants.</p>","PeriodicalId":23134,"journal":{"name":"Tissue Engineering. Part B, Reviews","volume":" ","pages":"60-73"},"PeriodicalIF":6.4,"publicationDate":"2024-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10027260","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
Recent Advances in Cell Sheet-Based Tissue Engineering for Bone Regeneration. 基于细胞薄片的骨再生组织工程研究进展。
IF 6.4 2区 医学
Tissue Engineering. Part B, Reviews Pub Date : 2024-02-01 Epub Date: 2023-09-28 DOI: 10.1089/ten.TEB.2023.0119
Guoding Cao, Liling Ren, Dongyang Ma
{"title":"Recent Advances in Cell Sheet-Based Tissue Engineering for Bone Regeneration.","authors":"Guoding Cao, Liling Ren, Dongyang Ma","doi":"10.1089/ten.TEB.2023.0119","DOIUrl":"10.1089/ten.TEB.2023.0119","url":null,"abstract":"<p><p>In conventional bone tissue engineering, cells are seeded onto scaffolds to create three-dimensional (3D) tissues, but the cells on the scaffolds are unable to effectively perform their physiological functions due to their low density and viability. Cell sheet (CS) engineering is expected to be free from this limitation. CS engineering uses the principles of self-assembly and self-organization of endothelial and mesenchymal stem cells to prepare CSs as building blocks for engineering bone grafts. This process recapitulates the native tissue development, thus attracting significant attention in the field of bone regeneration. However, the method is still in the prebasic experimental stage in bone defect repair. To make the method clinically applicable and valuable in personalized and precision medicine, current research is focused on the preparation of multifunctionalized building blocks using CS technologies, such as 3D layered CSs containing microvascular structures. Considering the great potential of CS engineering in repairing bone defects, in this review, the types of cell technologies are first outlined. We then summarize the various types of CSs as building blocks for engineering bone grafts. Furthermore, the specific applications of CSs in bone repair are discussed. Finally, we present specific suggestions for accelerating the application of CS engineering in the clinical treatment of bone defects.</p>","PeriodicalId":23134,"journal":{"name":"Tissue Engineering. Part B, Reviews","volume":" ","pages":"97-127"},"PeriodicalIF":6.4,"publicationDate":"2024-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10113177","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
Cellular Senescence in Craniofacial Tissue Regeneration: Inducers, Biomarkers, and Interventions. 颅面组织再生中的细胞衰老:诱导因素、生物标志物和干预措施。
IF 6.4 2区 医学
Tissue Engineering. Part B, Reviews Pub Date : 2024-02-01 Epub Date: 2023-09-11 DOI: 10.1089/ten.TEB.2023.0136
Weibing Tang, Fangjun Huo, Jie Long, Siyuan Zhang, Weidong Tian
{"title":"Cellular Senescence in Craniofacial Tissue Regeneration: Inducers, Biomarkers, and Interventions.","authors":"Weibing Tang, Fangjun Huo, Jie Long, Siyuan Zhang, Weidong Tian","doi":"10.1089/ten.TEB.2023.0136","DOIUrl":"10.1089/ten.TEB.2023.0136","url":null,"abstract":"<p><p>Craniofacial defects and dental tissue loss have significant negative impacts on the structure and function of jaws and face, often resulting in psychological issues in patients, emphasizing the urgent need for effective craniofacial tissue reconstruction. Unfortunately, natural regeneration of these tissues is limited. Dental-derived mesenchymal stem cells (MSCs) have emerged as a promising resource for tissue engineering-based therapeutic approaches. However, the clinical outcomes of MSC-based transplantation have not met expectations due to various complex reasons, and cellular senescence is recognized as one of the potential mechanisms contributing to the suboptimal results. The quality of MSC decreases during large-scale <i>in vitro</i> expansion, and it is also influenced by the age and the health status of donors. To address these challenges, extensive efforts have been made to developing strategies to combat senescence in tissue engineering, leveraging on current knowledge of underlying mechanisms. This review aims to elucidate the impact of cell senescence in craniofacial and dental regeneration and provides an overview of state-of-the-art antisenescence strategies. We first discuss the potential factors that trigger cell senescence in craniofacial tissue engineering. Then we describe senescence biomarkers, monitoring methods for senescent MSCs, and their underlying molecular mechanisms. The primary focus of this review is on current strategies to inhibit and alleviate cell senescence in tissue engineering. We summarize the strategies concerning the prevention of cell senescence, senolysis, modulation of the senescent associated secretory phenotype, and reversal of senescent MSCs, offering promising opportunities to overcome the challenges associated with cell senescence in craniofacial tissue engineering.</p>","PeriodicalId":23134,"journal":{"name":"Tissue Engineering. Part B, Reviews","volume":" ","pages":"128-141"},"PeriodicalIF":6.4,"publicationDate":"2024-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10211777","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 Host Response to Autogenous, Allogeneic, and Xenogeneic Treated Dentin Matrix/Demineralized Dentin Matrix-Oriented Tissue Regeneration. 自体、异体和异种牙本质基质/脱矿牙本质基质导向组织再生的宿主反应。
IF 6.4 2区 医学
Tissue Engineering. Part B, Reviews Pub Date : 2024-02-01 Epub Date: 2023-08-16 DOI: 10.1089/ten.TEB.2023.0065
Tianyi Wang, Yongwen Guo
{"title":"The Host Response to Autogenous, Allogeneic, and Xenogeneic Treated Dentin Matrix/Demineralized Dentin Matrix-Oriented Tissue Regeneration.","authors":"Tianyi Wang, Yongwen Guo","doi":"10.1089/ten.TEB.2023.0065","DOIUrl":"10.1089/ten.TEB.2023.0065","url":null,"abstract":"<p><p>Dentin is a bone-like matrix that forms the bulk of the tooth. By fabricating dentin with protocols involving demineralization, sterilization, and preservation, treated dentin matrix (TDM)/demineralized dentin matrix (DDM) could be obtained, which is considered as a useful tool for bone and tooth-tissue regeneration. Non-negligible inflammatory and immune responses are reviewed in this article of autogenous, allogeneic, and xenogeneic TDM/DDM for the first time. Both autogenous and allogeneic TDM/DDM showed good biocompatibility in original and clinical studies, while a few cases reported the observation of inflammatory cells around tissue samples. As for xenogeneic TDM/DDM, multiple immune responses were revealed. Immune cells, including eosinocytes, macrophages, lymphocytes, mutinucleated giant cell, M1/M2 macrophages, and Th1-type CTL responses were involved. To avoid these adverse inflammatory responses caused by TDM/DDM implantation, some of the effective fabricating methods are discussed to reduce host immune responses to TDM/DDM.</p>","PeriodicalId":23134,"journal":{"name":"Tissue Engineering. Part B, Reviews","volume":" ","pages":"74-81"},"PeriodicalIF":6.4,"publicationDate":"2024-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10011360","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
Three-Dimensional Bioprinting of Biocompatible Photosensitive Polymers for Tissue Engineering Application. 用于组织工程应用的生物相容性光敏聚合物三维生物打印。
IF 6.4 2区 医学
Tissue Engineering. Part B, Reviews Pub Date : 2023-12-01 Epub Date: 2023-07-06 DOI: 10.1089/ten.TEB.2023.0072
Joshua Lim, Sasinan Bupphathong, Wei Huang, Chih-Hsin Lin
{"title":"Three-Dimensional Bioprinting of Biocompatible Photosensitive Polymers for Tissue Engineering Application.","authors":"Joshua Lim, Sasinan Bupphathong, Wei Huang, Chih-Hsin Lin","doi":"10.1089/ten.TEB.2023.0072","DOIUrl":"10.1089/ten.TEB.2023.0072","url":null,"abstract":"<p><p>Three-dimensional (3D) bioprinting, or additive manufacturing, is a rapid fabrication technique with the foremost objective of creating biomimetic tissue and organ replacements in hopes of restoring normal tissue function and structure. Generating the engineered organs with an infrastructure that is similar to that of the real organs can be beneficial to simulate the functional organs that work inside our bodies. Photopolymerization-based 3D bioprinting, or photocuring, has emerged as a promising method in engineering biomimetic tissues due to its simplicity, and noninvasive and spatially controllable approach. In this review, we investigated types of 3D printers, mainstream materials, photoinitiators, phototoxicity, and selected tissue engineering applications of 3D photopolymerization bioprinting.</p>","PeriodicalId":23134,"journal":{"name":"Tissue Engineering. Part B, Reviews","volume":" ","pages":"710-722"},"PeriodicalIF":6.4,"publicationDate":"2023-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9758971","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
Mesenchymal Stem Cells: Their Role in the Tumor Microenvironment. 间充质干细胞:间充质干细胞:它们在肿瘤微环境中的作用
IF 6.4 2区 医学
Tissue Engineering. Part B, Reviews Pub Date : 2023-12-01 Epub Date: 2023-07-10 DOI: 10.1089/ten.TEB.2023.0048
Jhon Alexander Ramírez Idarraga, Luz Marina Restrepo Múnera
{"title":"Mesenchymal Stem Cells: Their Role in the Tumor Microenvironment.","authors":"Jhon Alexander Ramírez Idarraga, Luz Marina Restrepo Múnera","doi":"10.1089/ten.TEB.2023.0048","DOIUrl":"10.1089/ten.TEB.2023.0048","url":null,"abstract":"<p><p>Mesenchymal stem cells (MSCs) have been seen for years as great candidates for treating different diseases and an alternative to embryonic stem cells due to their differentiation capacity <i>in vitro</i>. More recent research has focused on their ability to modulate the immune response and regeneration at sites associated with inflammation, activities attributable to the release of trophic factors into the extracellular medium, a set of components known as the secretome. It has been possible to demonstrate the presence of these cells within the tumor microenvironment, which is associated with their tropism for sites of inflammation; however, their role here needs to be clarified. In different investigations, the feasibility of using MSCs or their secretome to treat cancer has been sought, with these results being ambiguous. It has been described that MSCs can be activated and present various phenotypes, which could explain the divergence in their action; however, these activation mechanisms and the different phenotypes still need to be well known. This review explores MSCs and their use in regenerative medicine with a targeted approach to cancer. Impact Statement This text addresses the diverging findings on the role of mesenchymal stem cells in the tumor microenvironment and discrepancies on the use of these cells as cancer treatment, separating the direct use of the cells from the use of the secretome. Multiple authors refer equally to the cells and their secretome to conclude on the positive or negative outcome, without taking into consideration how the cells are affected by their surroundings.</p>","PeriodicalId":23134,"journal":{"name":"Tissue Engineering. Part B, Reviews","volume":" ","pages":"681-691"},"PeriodicalIF":6.4,"publicationDate":"2023-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9819624","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
Attenuating Chronic Fibrosis: Decreasing Foreign Body Response with Acellular Dermal Matrix. 减轻慢性纤维化:用细胞真皮基质减少异物反应
IF 6.4 2区 医学
Tissue Engineering. Part B, Reviews Pub Date : 2023-12-01 Epub Date: 2023-06-07 DOI: 10.1089/ten.TEB.2023.0060
Norah E Liang, Michelle F Griffin, Charlotte E Berry, Jennifer B Parker, Mauricio A Downer, Derrick C Wan, Michael T Longaker
{"title":"Attenuating Chronic Fibrosis: Decreasing Foreign Body Response with Acellular Dermal Matrix.","authors":"Norah E Liang, Michelle F Griffin, Charlotte E Berry, Jennifer B Parker, Mauricio A Downer, Derrick C Wan, Michael T Longaker","doi":"10.1089/ten.TEB.2023.0060","DOIUrl":"10.1089/ten.TEB.2023.0060","url":null,"abstract":"<p><p>Surgical implants are increasingly used across multiple medical disciplines, with applications ranging from tissue reconstruction to improving compromised organ and limb function. Despite their significant potential for improving health and quality of life, biomaterial implant function is severely limited by the body's immune response to its presence: this is known as the foreign body response (FBR) and is characterized by chronic inflammation and fibrotic capsule formation. This response can result in life-threatening sequelae such as implant malfunction, superimposed infection, and associated vessel thrombosis, in addition to soft tissue disfigurement. Patients may require frequent medical visits, as well as repeated invasive procedures, increasing the burden on an already strained health care system. Currently, the FBR and the cells and molecular mechanisms that mediate it are poorly understood. With applications across a wide array of surgical specialties, acellular dermal matrix (ADM) has emerged as a potential solution to the fibrotic reaction seen with FBR. Although the mechanisms by which ADM decreases chronic fibrosis remain to be clearly characterized, animal studies across diverse surgical models point to its biomimetic properties that facilitate decreased periprosthetic inflammation and improved host cell incorporation. Impact Statement Foreign body response (FBR) is a significant limitation to the use of implantable biomaterials. Acellular dermal matrix (ADM) has been observed to decrease the fibrotic reaction seen with FBR, although its mechanistic details are poorly understood. This review is dedicated to summarizing the primary literature on the biology of FBR in the context of ADM use, using surgical models in breast reconstruction, abdominal and chest wall repair, and pelvic reconstruction. This article will provide readers with an overarching review of shared mechanisms for ADM across multiple surgical models and diverse anatomical applications.</p>","PeriodicalId":23134,"journal":{"name":"Tissue Engineering. Part B, Reviews","volume":" ","pages":"671-680"},"PeriodicalIF":6.4,"publicationDate":"2023-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9962373","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
Fatter Is Better: Boosting the Vascularization of Adipose Tissue Grafts. 越胖越好促进脂肪组织移植物的血管化。
IF 6.4 2区 医学
Tissue Engineering. Part B, Reviews Pub Date : 2023-12-01 Epub Date: 2023-06-07 DOI: 10.1089/ten.TEB.2023.0069
Ettore Limido, Andrea Weinzierl, Yves Harder, Michael D Menger, Matthias W Laschke
{"title":"Fatter Is Better: Boosting the Vascularization of Adipose Tissue Grafts.","authors":"Ettore Limido, Andrea Weinzierl, Yves Harder, Michael D Menger, Matthias W Laschke","doi":"10.1089/ten.TEB.2023.0069","DOIUrl":"10.1089/ten.TEB.2023.0069","url":null,"abstract":"<p><p>Adipose tissue resorption after fat grafting is a major drawback in plastic and reconstructive surgery, which is primarily caused by the insufficient blood perfusion of the grafts in the initial phase after transplantation. To overcome this problem, several promising strategies to boost the vascularization and, thus, increase survival rates of fat grafts have been developed in preclinical studies in recent years. These include the angiogenic stimulation of the grafts by growth factors and botulinum neurotoxin A, biologically active gels, and cellular enrichment, as well as the physical and pharmacological stimulation of the transplantation site. To transfer these approaches into future clinical practice, it will be necessary to establish standardized procedures for their safe application in humans. If this succeeds, the surgical outcomes of fat grafting may be markedly improved, resulting in a significant reduction of the physical and psychological stress for the patients.</p>","PeriodicalId":23134,"journal":{"name":"Tissue Engineering. Part B, Reviews","volume":" ","pages":"605-622"},"PeriodicalIF":6.4,"publicationDate":"2023-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9643544","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
Preclinical Studies and Clinical Trials on Cell-Based Treatments for Meniscus Regeneration. 基于细胞的半月板再生疗法的临床前研究和临床试验。
IF 6.4 2区 医学
Tissue Engineering. Part B, Reviews Pub Date : 2023-12-01 Epub Date: 2023-06-14 DOI: 10.1089/ten.TEB.2023.0050
Xiaoke Li, Dijun Li, Jiarong Li, Guishan Wang, Lei Yan, Haifeng Liu, Jingwei Jiu, Jiao Jiao Li, Bin Wang
{"title":"Preclinical Studies and Clinical Trials on Cell-Based Treatments for Meniscus Regeneration.","authors":"Xiaoke Li, Dijun Li, Jiarong Li, Guishan Wang, Lei Yan, Haifeng Liu, Jingwei Jiu, Jiao Jiao Li, Bin Wang","doi":"10.1089/ten.TEB.2023.0050","DOIUrl":"10.1089/ten.TEB.2023.0050","url":null,"abstract":"<p><p>This study aims at performing a thorough review of cell-based treatment strategies for meniscus regeneration in preclinical and clinical studies. The PubMed, Embase, and Web of Science databases were searched for relevant studies (both preclinical and clinical) published from the time of database construction to December 2022. Data related to cell-based therapies for <i>in situ</i> regeneration of the meniscus were extracted independently by two researchers. Assessment of risk of bias was performed according to the Cochrane Handbook for Systematic Reviews of Interventions. Statistical analyses based on the classification of different treatment strategies were performed. A total of 5730 articles were retrieved, of which 72 preclinical studies and 6 clinical studies were included in this review. Mesenchymal stem cells (MSCs), especially bone marrow MSCs (BMSCs), were the most commonly used cell type. Among preclinical studies, rabbit was the most commonly used animal species, partial meniscectomy was the most commonly adopted injury pattern, and 12 weeks was the most frequently chosen final time point for assessing repair outcomes. A range of natural and synthetic materials were used to aid cell delivery as scaffolds, hydrogels, or other morphologies. In clinical trials, there was large variation in the dose of cells, ranging from 16 × 10<sup>6</sup> to 150 × 10<sup>6</sup> cells with an average of 41.52 × 10<sup>6</sup> cells. The selection of treatment strategy for meniscus repair should be based on the nature of the injury. Cell-based therapies incorporating various \"combination\" strategies such as co-culture, composite materials, and extra stimulation may offer greater promise than single strategies for effective meniscal tissue regeneration, restoring natural meniscal anisotropy, and eventually achieving clinical translation. Impact Statement This review provides an up-to-date and comprehensive overview of preclinical and clinical studies that tested cell-based treatments for meniscus regeneration. It presents novel perspectives on studies published in the past 30 years, giving consideration to the cell sources and dose selection, delivery methods, extra stimulation, animal models and injury patterns, timing of outcome assessment, and histological and biomechanical outcomes, as well as a summary of findings for individual studies. These unique insights will help to shape future research on the repair of meniscus lesions and inform the clinical translation of new cell-based tissue engineering strategies.</p>","PeriodicalId":23134,"journal":{"name":"Tissue Engineering. Part B, Reviews","volume":" ","pages":"634-670"},"PeriodicalIF":6.4,"publicationDate":"2023-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9630964","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
Poor Result Reporting Rate in Cell Therapy Trials Registered at ClinicalTrials.gov. 在 ClinicalTrials.gov 上注册的细胞疗法试验的不良结果报告率。
IF 6.4 2区 医学
Tissue Engineering. Part B, Reviews Pub Date : 2023-12-01 Epub Date: 2023-06-07 DOI: 10.1089/ten.TEB.2023.0053
Takaharu Negoro, Hanayuki Okura, Shigekazu Hayashi, Tsutomu Arai, Akifumi Matsuyama
{"title":"Poor Result Reporting Rate in Cell Therapy Trials Registered at ClinicalTrials.gov.","authors":"Takaharu Negoro, Hanayuki Okura, Shigekazu Hayashi, Tsutomu Arai, Akifumi Matsuyama","doi":"10.1089/ten.TEB.2023.0053","DOIUrl":"10.1089/ten.TEB.2023.0053","url":null,"abstract":"<p><p>As research associates in clinical experiments, we have an obligation to disclose clinical methodologies and findings in full transparency in ethics. However, inadequate disclosure in results reporting clinical trials registered on ClinicalTrials.gov has been revealed, with approximately half the trial results not being reported in an applicable manner. Our recent study in clinical trials of regenerative medicine for four kinds of neurological diseases revealed that the rate of result reporting to ClinicalTrials.gov is inadequate for gene and cell therapy (CT) trials. In this path, further curiosity emerged to see what the findings would be if the analysis was conducted for trials in all disease areas, and outcomes if gene therapy (GT) and CT were distinguished in terms. In this study, the scope of analysis was further expanded to include all disease areas, and the drug classification from the AdisInsight database was used for modality classification, with biologic drug trials classified as controls, CT, <i>ex vivo</i> GT, and <i>in vivo</i> GT. To begin, among all interventional clinical trials with registration in the ClinicalTrials.gov registry and with a primary completion between 2010 and 2019, we created a total of 5539 datasets corresponding to trials classified as GT and CT, while biologics (BLG) as controls in the AdisInsight drug classification. The status of reported results of these trials was identified by surveying posting status of ClinicalTrials.gov and publication in journals (PubMed), respectively. Based on the obtained dataset, multivariate analysis was performed on the data on the reporting rate of clinical trial results, aggregated by sponsor, phase, status, and modality (CT, <i>ex vivo</i> GT, <i>in vivo</i> GT, and BLG), respectively. The result shows that CT was identified as an independent factor restraining result reporting ratio in both ClinicalTrials.gov and total disclosures, whereas <i>ex vivo</i> GT as boosting result reporting ratio. Since the result reporting rate of CT results was notably poor, we discussed the causes and solutions in this regard.</p>","PeriodicalId":23134,"journal":{"name":"Tissue Engineering. Part B, Reviews","volume":" ","pages":"623-633"},"PeriodicalIF":6.4,"publicationDate":"2023-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9643548","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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