The Experts below are selected from a list of 3612 Experts worldwide ranked by ideXlab platform
Anil V Parwani - One of the best experts on this subject based on the ideXlab platform.
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the development and deployment of common data elements for Tissue Banks for translational research in cancer an emerging standard based approach for the mesothelioma virtual Tissue bank
BMC Cancer, 2008Co-Authors: Sambit K Mohanty, Anil V Parwani, Amita T Mistry, Waqas Amin, Andrew K Pople, Linda Schmandt, Sharon Winters, Erin Milliken, Nancy B Whelan, Ghada N FarhatAbstract:Background Recent advances in genomics, proteomics, and the increasing demands for biomarker validation studies have catalyzed changes in the landscape of cancer research, fueling the development of Tissue Banks for translational research. A result of this transformation is the need for sufficient quantities of clinically annotated and well-characterized biospecimens to support the growing needs of the cancer research community. Clinical annotation allows samples to be better matched to the research question at hand and ensures that experimental results are better understood and can be verified. To facilitate and standardize such annotation in bio-repositories, we have combined three accepted and complementary sets of data standards: the College of American Pathologists (CAP) Cancer Checklists, the protocols recommended by the Association of Directors of Anatomic and Surgical Pathology (ADASP) for pathology data, and the North American Association of Central Cancer Registry (NAACCR) elements for epidemiology, therapy and follow-up data. Combining these approaches creates a set of International Standards Organization (ISO) – compliant Common Data Elements (CDEs) for the mesothelioma Tissue banking initiative supported by the National Institute for Occupational Safety and Health (NIOSH) of the Center for Disease Control and Prevention (CDC).
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the development and deployment of common data elements for Tissue Banks for translational research in cancer an emerging standard based approach for the mesothelioma virtual Tissue bank
BMC Cancer, 2008Co-Authors: Sambit K Mohanty, Anil V Parwani, Amita T Mistry, Waqas Amin, Andrew K Pople, Linda Schmandt, Sharon Winters, Erin Milliken, Paula Kim, Nancy B WhelanAbstract:Recent advances in genomics, proteomics, and the increasing demands for biomarker validation studies have catalyzed changes in the landscape of cancer research, fueling the development of Tissue Banks for translational research. A result of this transformation is the need for sufficient quantities of clinically annotated and well-characterized biospecimens to support the growing needs of the cancer research community. Clinical annotation allows samples to be better matched to the research question at hand and ensures that experimental results are better understood and can be verified. To facilitate and standardize such annotation in bio-repositories, we have combined three accepted and complementary sets of data standards: the College of American Pathologists (CAP) Cancer Checklists, the protocols recommended by the Association of Directors of Anatomic and Surgical Pathology (ADASP) for pathology data, and the North American Association of Central Cancer Registry (NAACCR) elements for epidemiology, therapy and follow-up data. Combining these approaches creates a set of International Standards Organization (ISO) – compliant Common Data Elements (CDEs) for the mesothelioma Tissue banking initiative supported by the National Institute for Occupational Safety and Health (NIOSH) of the Center for Disease Control and Prevention (CDC). The purpose of the project is to develop a core set of data elements for annotating mesothelioma specimens, following standards established by the CAP checklist, ADASP cancer protocols, and the NAACCR elements. We have associated these elements with modeling architecture to enhance both syntactic and semantic interoperability. The system has a Java-based multi-tiered architecture based on Unified Modeling Language (UML). Common Data Elements were developed using controlled vocabulary, ontology and semantic modeling methodology. The CDEs for each case are of different types: demographic, epidemiologic data, clinical history, pathology data including block level annotation, and follow-up data including treatment, recurrence and vital status. The end result of such an effort would eventually provide an increased sample set to the researchers, and makes the system interoperable between institutions. The CAP, ADASP and the NAACCR elements represent widely established data elements that are utilized in many cancer centers. Herein, we have shown these representations can be combined and formalized to create a core set of annotations for banked mesothelioma specimens. Because these data elements are collected as part of the normal workflow of a medical center, data sets developed on the basis of these elements can be easily implemented and maintained.
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an informatics model for Tissue Banks lessons learned from the cooperative prostate cancer Tissue resource
BMC Cancer, 2006Co-Authors: Ashokkumar A Patel, Andre Kajdacsyballa, Jules J Berman, Milton W Datta, Rajiv Dhir, John R Gilbertson, Jonathan Melamed, Anil V Parwani, Rajnish Gupta, Jan M OrensteinAbstract:Background Advances in molecular biology and growing requirements from biomarker validation studies have generated a need for Tissue Banks to provide quality-controlled Tissue samples with standardized clinical annotation. The NCI Cooperative Prostate Cancer Tissue Resource (CPCTR) is a distributed Tissue bank that comprises four academic centers and provides thousands of clinically annotated prostate cancer specimens to researchers. Here we describe the CPCTR information management system architecture, common data element (CDE) development, query interfaces, data curation, and quality control.
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an informatics model for Tissue Banks lessons learned from the cooperative prostate cancer Tissue resource
BMC Cancer, 2006Co-Authors: Ashokkumar A Patel, Andre Kajdacsyballa, Jules J Berman, Milton W Datta, Rajiv Dhir, John R Gilbertson, Jonathan Melamed, Anil V Parwani, Rajnish Gupta, Jan M OrensteinAbstract:Advances in molecular biology and growing requirements from biomarker validation studies have generated a need for Tissue Banks to provide quality-controlled Tissue samples with standardized clinical annotation. The NCI Cooperative Prostate Cancer Tissue Resource (CPCTR) is a distributed Tissue bank that comprises four academic centers and provides thousands of clinically annotated prostate cancer specimens to researchers. Here we describe the CPCTR information management system architecture, common data element (CDE) development, query interfaces, data curation, and quality control. Data managers review the medical records to collect and continuously update information for the 145 clinical, pathological and inventorial CDEs that the Resource maintains for each case. An Access-based data entry tool provides de-identification and a standard communication mechanism between each group and a central CPCTR database. Standardized automated quality control audits have been implemented. Centrally, an Oracle database has web interfaces allowing multiple user-types, including the general public, to mine de-identified information from all of the sites with three levels of specificity and granularity as well as to request Tissues through a formal letter of intent. Since July 2003, CPCTR has offered over 6,000 cases (38,000 blocks) of highly characterized prostate cancer biospecimens, including several Tissue microarrays (TMA). The Resource developed a website with interfaces for the general public as well as researchers and internal members. These user groups have utilized the web-tools for public query of summary data on the cases that were available, to prepare requests, and to receive Tissues. As of December 2005, the Resource received over 130 Tissue requests, of which 45 have been reviewed, approved and filled. Additionally, the Resource implemented the TMA Data Exchange Specification in its TMA program and created a computer program for calculating PSA recurrence. Building a biorepository infrastructure that meets today's research needs involves time and input of many individuals from diverse disciplines. The CPCTR can provide large volumes of carefully annotated prostate Tissue for research initiatives such as Specialized Programs of Research Excellence (SPOREs) and for biomarker validation studies and its experience can help development of collaborative, large scale, virtual Tissue Banks in other organ systems.
Jan M Orenstein - One of the best experts on this subject based on the ideXlab platform.
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an informatics model for Tissue Banks lessons learned from the cooperative prostate cancer Tissue resource
BMC Cancer, 2006Co-Authors: Ashokkumar A Patel, Andre Kajdacsyballa, Jules J Berman, Milton W Datta, Rajiv Dhir, John R Gilbertson, Jonathan Melamed, Anil V Parwani, Rajnish Gupta, Jan M OrensteinAbstract:Background Advances in molecular biology and growing requirements from biomarker validation studies have generated a need for Tissue Banks to provide quality-controlled Tissue samples with standardized clinical annotation. The NCI Cooperative Prostate Cancer Tissue Resource (CPCTR) is a distributed Tissue bank that comprises four academic centers and provides thousands of clinically annotated prostate cancer specimens to researchers. Here we describe the CPCTR information management system architecture, common data element (CDE) development, query interfaces, data curation, and quality control.
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an informatics model for Tissue Banks lessons learned from the cooperative prostate cancer Tissue resource
BMC Cancer, 2006Co-Authors: Ashokkumar A Patel, Andre Kajdacsyballa, Jules J Berman, Milton W Datta, Rajiv Dhir, John R Gilbertson, Jonathan Melamed, Anil V Parwani, Rajnish Gupta, Jan M OrensteinAbstract:Advances in molecular biology and growing requirements from biomarker validation studies have generated a need for Tissue Banks to provide quality-controlled Tissue samples with standardized clinical annotation. The NCI Cooperative Prostate Cancer Tissue Resource (CPCTR) is a distributed Tissue bank that comprises four academic centers and provides thousands of clinically annotated prostate cancer specimens to researchers. Here we describe the CPCTR information management system architecture, common data element (CDE) development, query interfaces, data curation, and quality control. Data managers review the medical records to collect and continuously update information for the 145 clinical, pathological and inventorial CDEs that the Resource maintains for each case. An Access-based data entry tool provides de-identification and a standard communication mechanism between each group and a central CPCTR database. Standardized automated quality control audits have been implemented. Centrally, an Oracle database has web interfaces allowing multiple user-types, including the general public, to mine de-identified information from all of the sites with three levels of specificity and granularity as well as to request Tissues through a formal letter of intent. Since July 2003, CPCTR has offered over 6,000 cases (38,000 blocks) of highly characterized prostate cancer biospecimens, including several Tissue microarrays (TMA). The Resource developed a website with interfaces for the general public as well as researchers and internal members. These user groups have utilized the web-tools for public query of summary data on the cases that were available, to prepare requests, and to receive Tissues. As of December 2005, the Resource received over 130 Tissue requests, of which 45 have been reviewed, approved and filled. Additionally, the Resource implemented the TMA Data Exchange Specification in its TMA program and created a computer program for calculating PSA recurrence. Building a biorepository infrastructure that meets today's research needs involves time and input of many individuals from diverse disciplines. The CPCTR can provide large volumes of carefully annotated prostate Tissue for research initiatives such as Specialized Programs of Research Excellence (SPOREs) and for biomarker validation studies and its experience can help development of collaborative, large scale, virtual Tissue Banks in other organ systems.
Thomas C Vangsness - One of the best experts on this subject based on the ideXlab platform.
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allograft update the current status of Tissue regulation procurement processing and sterilization
American Journal of Sports Medicine, 2007Co-Authors: David R Mcallister, Michael J Joyce, Barton J Mann, Thomas C VangsnessAbstract:Allografts are commonly used during sports medicine surgical procedures in the United States, and their frequency of use is increasing. Based on surgeon reports, it is estimated that more than 60 000 allografts were used in knee surgeries by members of the American Orthopaedic Society for Sports Medicine in 2005. In the United States, there are governmental agencies and other regulatory bodies involved in the oversight of Tissue Banks. In 2005, the Food and Drug Administration finalized its requirements for current good Tissue practice and has mandated new rules regarding the “manufacture” of allogenic Tissue. In response to well-publicized infections associated with the implantation of allograft Tissue, some Tissue Banks have developed methods to sterilize allograft Tissue. Although many surgeons have significant concerns about the safety of allografts, the majority believe that sterilized allografts are safe but that the sterilization process negatively affects Tissue biology and biomechanics. However, ...
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allograft update the current status of Tissue regulation procurement processing and sterilization
American Journal of Sports Medicine, 2007Co-Authors: David R Mcallister, Michael J Joyce, Barton J Mann, Thomas C VangsnessAbstract:Allografts are commonly used during sports medicine surgical procedures in the United States, and their frequency of use is increasing. Based on surgeon reports, it is estimated that more than 60 000 allografts were used in knee surgeries by members of the American Orthopaedic Society for Sports Medicine in 2005. In the United States, there are governmental agencies and other regulatory bodies involved in the oversight of Tissue Banks. In 2005, the Food and Drug Administration finalized its requirements for current good Tissue practice and has mandated new rules regarding the "manufacture" of allogenic Tissue. In response to well-publicized infections associated with the implantation of allograft Tissue, some Tissue Banks have developed methods to sterilize allograft Tissue. Although many surgeons have significant concerns about the safety of allografts, the majority believe that sterilized allografts are safe but that the sterilization process negatively affects Tissue biology and biomechanics. However, most know very little about the principles of sterilization and the proprietary processes currently used in Tissue banking. This article will review the current status of allograft Tissue regulation, procurement, processing, and sterilization in the United States.
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soft Tissue for allograft reconstruction of the human knee a survey of the american association of Tissue Banks
American Journal of Sports Medicine, 1996Co-Authors: Thomas C Vangsness, Michael J Joyce, Mark J Triffon, Tillman M. MooreAbstract:With increasing use and availability of musculoskeletal soft Tissue allografts, orthopaedic surgeons need current knowledge about allograft processing, costs, and availability. In conjunction with the American Association of Tissue Banks, a comprehensive survey consisting of specific questions on several topics in Tissue banking was sent to 42 member Banks or Banks undergoing accreditation review that distribute musculoskeletal Tissues. Donors came from organ procurement organizations, coroners' offices, hospital morgues, and donations; the average age of the donors was 35. Most of the 36 Tissue Banks responding to the questionnaire harvest patellar and Achilles tendons. Patellar tendon demand exceeded supply. Tissue processing was done by outside organizations approximately 50% of the time. Of the four types of Tissue sterilization processes performed, gamma irradiation was the most common. Doses of sterilizing gamma irradiation varied from 1 to 3.5 mrad. The average approximate costs of fresh-frozen Tissue were $800 for patellar tendon allograft, $615 for Achilles tendon, and $640 for menisci. There was no consensus of opinion of how to size or sterilize meniscal allografts. As demand increases for soft Tissue allografts, it is essential that the orthopaedic surgeon is knowledgeable about the clinical impact of Tissue banking.
Tillman M. Moore - One of the best experts on this subject based on the ideXlab platform.
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Allograft transplantation in the knee: Tissue regulation, procurement, processing, and sterilization
American Journal of Sports Medicine, 2003Co-Authors: C. Thomas Vangsness, Ivan A. Garcia, C. Randal Mills, Marion A. Kainer, Michael R Roberts, Tillman M. MooreAbstract:Use of musculoskeletal allografts has become increasingly popular, with widespread use among knee surgeons. The advantages and disadvantages of their use have been documented. In the knee, allografts are used for ligament reconstruction, meniscal transplantation, and articular surface reconstruction. The purpose of this review is to present issues surrounding the allograft industry, including regulation of Tissues and Tissue Banks and procurement, processing, sterilization, and storage of allograft Tissue. Tissue bank regulation is ultimately under the jurisdiction and authority of the Food and Drug Administration; some individual states regulate Tissue Banks. The American Association of Tissue Banks is a scientific organization that encourages education, research, and voluntary accreditation of Tissue Banks. It promotes safety and standards for retrieval, processing, storage, and distribution of transplantable human Tissue. Allograft Tissues are generally harvested and processed aseptically, which may not prevent contamination. Tissue sterilization is difficult and controversial. Tissue Banks historically have used one of two methods of sterilization, ethylene oxide or gamma radiation. Both methods have risks and benefits. Newer methods of sterilization are being developed. Allograft Tissue that is not transplanted fresh can be freeze-dried or deep frozen for storage. Ultimately, allograft transplantation in the knee facilitates knee form and function and enhances the patient's quality of life. Orthopaedic surgeons who use allograft Tissue must understand the Tissue banking process to provide safe and effective Tissues to their patients.
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soft Tissue for allograft reconstruction of the human knee a survey of the american association of Tissue Banks
American Journal of Sports Medicine, 1996Co-Authors: Thomas C Vangsness, Michael J Joyce, Mark J Triffon, Tillman M. MooreAbstract:With increasing use and availability of musculoskeletal soft Tissue allografts, orthopaedic surgeons need current knowledge about allograft processing, costs, and availability. In conjunction with the American Association of Tissue Banks, a comprehensive survey consisting of specific questions on several topics in Tissue banking was sent to 42 member Banks or Banks undergoing accreditation review that distribute musculoskeletal Tissues. Donors came from organ procurement organizations, coroners' offices, hospital morgues, and donations; the average age of the donors was 35. Most of the 36 Tissue Banks responding to the questionnaire harvest patellar and Achilles tendons. Patellar tendon demand exceeded supply. Tissue processing was done by outside organizations approximately 50% of the time. Of the four types of Tissue sterilization processes performed, gamma irradiation was the most common. Doses of sterilizing gamma irradiation varied from 1 to 3.5 mrad. The average approximate costs of fresh-frozen Tissue were $800 for patellar tendon allograft, $615 for Achilles tendon, and $640 for menisci. There was no consensus of opinion of how to size or sterilize meniscal allografts. As demand increases for soft Tissue allografts, it is essential that the orthopaedic surgeon is knowledgeable about the clinical impact of Tissue banking.
Jorge Morales Pedraza - One of the best experts on this subject based on the ideXlab platform.
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lessons learned from implementation and management of skin allograft banking programs in low and middle income countries a systematic review
Journal of Burn Care & Research, 2020Co-Authors: Jeffrey L Roberson, Jorge Morales Pedraza, Julie Pham, Jolie Shen, Kelly Stewart, Paa Ekow Hoytewilliams, Kajal Mehta, Shankar Man Rai, Nikki AllortoAbstract:Wound excision and temporary coverage with a biologic dressing can improve survival for patients with large burns. Healthcare systems in low- and middle-income countries (LMICs) rarely have access to allografts, which may contribute to the limited survival of patients with large burns in these settings. Therefore, we aimed to describe the lessons learned from the implementation and maintenance of Tissue Banks in LMICs to guide system planning and organization. PubMed, MEDLINE, CINAHL, and World Health Organization Catalog were systematically searched with database-specific language to represent a priori terms (eg, skin, allograft, and Tissue bank) and all LMICs as defined by the World Bank. Data regarding Tissue banking programs were extracted and described in a narrative synthesis. The search returned 3346 records, and 33 reports from 17 countries were analyzed. Commonly reported barriers to ideal or planned implementation included high capital costs and operational costs per graft, insufficient training opportunities, opt-in donation schemes, and sociocultural stigma around donation and transplantation. Many lessons were learned from the implementation and management of Tissue Banks around the world. The availability of skin allografts can be improved through strategic investments in governance and regulatory structures, international cooperation initiatives, training programs, standardized protocols, and inclusive public awareness campaigns. Furthermore, capacity-building efforts that involve key stakeholders may increase rates of pledges, donations, and transplantations. Some issues were ubiquitously reported and could be addressed by current and future Tissue banking programs to ensure allograft availability for patients living in countries of all income levels.
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The importance of establishing an international network of Tissue Banks and regional Tissue processing centers
Cell and Tissue Banking, 2013Co-Authors: Jorge Morales PedrazaAbstract:During the past four decades, many Tissue Banks have been established across the world with the aim of supplying sterilized Tissues for clinical use and research purposes. Between 1972 and 2005, the International Atomic Energy Agency supported the establishment of more than sixty of these Tissue Banks in Latin America and the Caribbean, Asia and the Pacific, Africa and Eastern Europe; promoted the use of the ionizing radiation technique for the sterilization of the processed Tissues; and encouraged cooperation between the established Tissue Banks during the implementation of its program on radiation and Tissue banking at national, regional and international levels. Taking into account that several of the established Tissue Banks have gained a rich experience in the procurement, processing, sterilization, storage, and medical use of sterilized Tissues, it is time now to strengthen further international and regional cooperation among interested Tissue Banks located in different countries. The purpose of this cooperation is to share the experience gained by these Banks in the procurement, processing, sterilization, storage, and used of different types of Tissues in certain medical treatments and research activities. This could be done through the establishment of a network of Tissue Banks and a limited number of regional Tissue processing centers in different regions of the world.
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A model of a code of ethics for Tissue Banks operating in developing countries.
Cell and Tissue Banking, 2011Co-Authors: Jorge Morales PedrazaAbstract:Ethical practice in the field of Tissue banking requires the setting of principles, the identification of possible deviations and the establishment of mechanisms that will detect and hinder abuses that may occur during the procurement, processing and distribution of Tissues for transplantation. This model of a Code of Ethics has been prepared with the purpose of being used for the elaboration of a Code of Ethics for Tissue Banks operating in the Latin American and the Caribbean, Asia and the Pacific and the African regions in order to guide the day-to-day operation of these Banks. The purpose of this model of Code of Ethics is to assist interested Tissue Banks in the preparation of their own Code of Ethics towards ensuring that the Tissue bank staff support with their actions the mission and values associated with Tissue banking.
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the future role of the professional associations in the promotion of Tissue banking activities in asia and the pacific and in the latin america regions
Cell and Tissue Banking, 2011Co-Authors: Jorge Morales Pedraza, Yongyudh Vajaradul, Ines AlvarezAbstract:There are several important roles that the established professional associations [Asia-Pacific Association of Surgical Tissue Banking (APASTB) and Latin American Association of Tissue Banks (ALABAT)] could play for the promotion of Tissue banking activities in Asia and the Pacific and in the Latin American regions in the future. The International Atomic Energy Agency (IAEA) and the World Health Organisation (WHO) could also play an important role in supporting the activities of both professional associations in the field of training, exchange of scientific information, the standardisation of national norms and regulations, the use of the IAEA documents, particularly the “Radiation Sterilisation of Tissue Allografts: Requirements for Validation and Routine Control. A Code of Practice”, with the purpose to improve the quality of the activities carried out by the established Tissue Banks and the nuclear facilities in charge of the sterilisation of the processed Tissues, and to increase Tissue donations. The role of APASTB and ALABAT could be relevant and important for the improvement of the work of the established Tissue Banks in Asia and the Pacific and in the Latin American regions, and could increase the effectiveness and efficiency of their works, the improvement of management good practices and for increasing the awareness of the community on the importance of the activities carried out by the Tissue Banks, among others.
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the evolution and impact of the international atomic energy agency iaea program on radiation and Tissue banking in the latin american region
Cell and Tissue Banking, 2009Co-Authors: Jorge Morales Pedraza, Glyn O. PhillipsAbstract:Since 1993, the IAEA supported the establishment or the consolidation of seven Tissue Banks in the region. As a direct or indirect consequence of the implementation of the IAEA program, more than 53 Tissue Banks are now operating in the participating countries. The fast development of Tissue Banks in the Latin America region under the ARCAL Agreement and with the financial and technical support of the IAEA program made it necessary to train new Tissue bank operators and medical personnel. In general, 90 Tissue bank operators and medical personnel were trained in the training centre of Buenos Aires. Another six Tissue bank operators and medical personnel were trained in the International Training Centre of Singapore. The main impact of the IAEA program in the region was the following: the establishment or consolidation of fifty-three Tissue Banks in nine countries in the region; the implementation of five national projects, allocating $1,006,737 dollars for this purpose and of one regional project allocating $284,741 dollars for this purpose; the use of the IAEA Standards, the IAEA Code of Practice and the IAEA Public Awareness Strategies in several Tissue Banks in the region; the application of quality control and quality assurances manuals in all of the participating countries.