Download or read book Oversight and Review of Clinical Gene Transfer Protocols written by Institute of Medicine and published by National Academies Press. This book was released on 2014-03-27 with total page 78 pages. Available in PDF, EPUB and Kindle. Book excerpt: Gene transfer research is a rapidly advancing field that involves the introduction of a genetic sequence into a human subject for research or diagnostic purposes. Clinical gene transfer trials are subject to regulation by the U.S. Food and Drug Administration (FDA) at the federal level and to oversight by institutional review boards (IRBs) and institutional biosafety committees (IBCs) at the local level before human subjects can be enrolled. In addition, at present all researchers and institutions funded by the National Institutes of Health (NIH) are required by NIH guidelines to submit human gene transfer protocols for advisory review by the NIH Recombinant DNA Advisory Committee (RAC). Some protocols are then selected for individual review and public discussion. Oversight and Review of Clinical Gene Transfer Protocols provides an assessment of the state of existing gene transfer science and the current regulatory and policy context under which research is investigated. This report assesses whether the current oversight of individual gene transfer protocols by the RAC continues to be necessary and offers recommendations concerning the criteria the NIH should employ to determine whether individual protocols should receive public review. The focus of this report is on the standards the RAC and NIH should use in exercising its oversight function. Oversight and Review of Clinical Gene Transfer Protocols will assist not only the RAC, but also research institutions and the general public with respect to utilizing and improving existing oversight processes.

Download or read book Ex Vivo Cell Therapy written by Klaus Schindhelm and published by Academic Press. This book was released on 1999 with total page 392 pages. Available in PDF, EPUB and Kindle. Book excerpt: R.E. Nordon and K. Schindhelm, Introduction. -- L. Robb, A.G. Elefanty, and C.G. Begley, Transcriptional Control of Hematopoieses. -- R. Starr and N.A. Nicola, Cell Signaling by Hemopoietic Growth Factor Receptors. -- P.J. Simmons, D.N. Haylock, and J.-P. Lévesque, Influence of Cytokines and Adhesion Molecules on Hematopoietic Stem Cell Development. -- P.A. Rowlings, Allogeneic Hematopoietic Stem Cell Transplantation. -- U. Hahn and L.B. To, Autologous Stem Cell Transplantation. -- M.R. Vowels, Cord Blood Stem Cell Transplantation. -- S.R. Riddell, E.H. Warren, D. Lewinsohn, C. Yee, and P.D. Greenberg, Reconstitution of Immunity by Adoptive Immunotherapy with T Cells. -- L.Q. Sun, M. Miller, and G. Symonds, Exogenous Gene Transfer into Lymphoid and Hematopoietic Progenitor Cells. -- C. Dowding, T. Leemhuis, A. Jakubowski, and C. Reading, Process Development for Ex Vivo Cell Therapy. -- R.E. Nordon and K. Schindhelm, Cell Separation. -- P.W. Zandstra, C.J. Eaves, and J.M. Piret, Environ ...

Download or read book Stem Cells and the Future of Regenerative Medicine written by Institute of Medicine and published by National Academies Press. This book was released on 2002-01-25 with total page 112 pages. Available in PDF, EPUB and Kindle. Book excerpt: Recent scientific breakthroughs, celebrity patient advocates, and conflicting religious beliefs have come together to bring the state of stem cell researchâ€"specifically embryonic stem cell researchâ€"into the political crosshairs. President Bush's watershed policy statement allows federal funding for embryonic stem cell research but only on a limited number of stem cell lines. Millions of Americans could be affected by the continuing political debate among policymakers and the public. Stem Cells and the Future of Regenerative Medicine provides a deeper exploration of the biological, ethical, and funding questions prompted by the therapeutic potential of undifferentiated human cells. In terms accessible to lay readers, the book summarizes what we know about adult and embryonic stem cells and discusses how to go about the transition from mouse studies to research that has therapeutic implications for people. Perhaps most important, Stem Cells and the Future of Regenerative Medicine also provides an overview of the moral and ethical problems that arise from the use of embryonic stem cells. This timely book compares the impact of public and private research funding and discusses approaches to appropriate research oversight. Based on the insights of leading scientists, ethicists, and other authorities, the book offers authoritative recommendations regarding the use of existing stem cell lines versus new lines in research, the important role of the federal government in this field of research, and other fundamental issues.

Download or read book Mitochondrial Replacement Techniques written by National Academies of Sciences, Engineering, and Medicine and published by National Academies Press. This book was released on 2016-04-17 with total page 201 pages. Available in PDF, EPUB and Kindle. Book excerpt: Mitochondrial replacement techniques (MRTs) are designed to prevent the transmission of mitochondrial DNA (mtDNA) diseases from mother to child. While MRTs, if effective, could satisfy a desire of women seeking to have a genetically related child without the risk of passing on mtDNA disease, the technique raises significant ethical and social issues. It would create offspring who have genetic material from two women, something never sanctioned in humans, and would create mitochondrial changes that could be heritable (in female offspring), and therefore passed on in perpetuity. The manipulation would be performed on eggs or embryos, would affect every cell of the resulting individual, and once carried out this genetic manipulation is not reversible. Mitochondrial Replacement Techniques considers the implications of manipulating mitochondrial content both in children born to women as a result of participating in these studies and in descendants of any female offspring. This study examines the ethical and social issues related to MRTs, outlines principles that would provide a framework and foundation for oversight of MRTs, and develops recommendations to inform the Food and Drug Administration's consideration of investigational new drug applications.

Download or read book Genetic Engineering of Plants written by National Research Council and published by National Academies Press. This book was released on 1984-02-01 with total page 97 pages. Available in PDF, EPUB and Kindle. Book excerpt: "The book...is, in fact, a short text on the many practical problems...associated with translating the explosion in basic biotechnological research into the next Green Revolution," explains Economic Botany. The book is "a concise and accurate narrative, that also manages to be interesting and personal...a splendid little book." Biotechnology states, "Because of the clarity with which it is written, this thin volume makes a major contribution to improving public understanding of genetic engineering's potential for enlarging the world's food supply...and can be profitably read by practically anyone interested in application of molecular biology to improvement of productivity in agriculture."

Download or read book Human Embryonic Stem Cells written by Jon Odorico and published by Garland Science. This book was released on 2004-02-01 with total page 391 pages. Available in PDF, EPUB and Kindle. Book excerpt: Since the first successful isolation and cultivation of human embryonic stem cells at the University of Wisconsin, Madison in 1998, there has been high levels of both interest and controversy in this area of research. This book provides a concise overview of an exciting field, covering the characteristics of both human embryonic stem cells and pluripotent stem cells from other human cell lineages. The following chapters describe state-of-the-art differentiation and characterization of specific ectoderm, mesoderm and endoderm-derived lineages from human embryonic stem cells, emphasizing how these can be used to study human developmental mechanisms. A further chapter discusses genetic manipulation of human ES cells. The concluding section covers therapeutic applications of human ES cells, as well as addressing the ethical and legal issues that this research have raised.

Download or read book Scientific and Medical Aspects of Human Reproductive Cloning written by National Research Council and published by National Academies Press. This book was released on 2002-06-17 with total page 295 pages. Available in PDF, EPUB and Kindle. Book excerpt: Human reproductive cloning is an assisted reproductive technology that would be carried out with the goal of creating a newborn genetically identical to another human being. It is currently the subject of much debate around the world, involving a variety of ethical, religious, societal, scientific, and medical issues. Scientific and Medical Aspects of Human Reproductive Cloning considers the scientific and medical sides of this issue, plus ethical issues that pertain to human-subjects research. Based on experience with reproductive cloning in animals, the report concludes that human reproductive cloning would be dangerous for the woman, fetus, and newborn, and is likely to fail. The study panel did not address the issue of whether human reproductive cloning, even if it were found to be medically safe, would beâ€"or would not beâ€"acceptable to individuals or society.

Download or read book Molecular Biology of the Cell written by and published by . This book was released on 2002 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Download or read book Synthetic DNA Delivery Systems written by Dan Luo and published by Springer Science & Business Media. This book was released on 2003-09-30 with total page 160 pages. Available in PDF, EPUB and Kindle. Book excerpt: DNA delivery into cells is a rapidly developing area in gene therapy and biotechnology. Moreover, it is a powerful research tool to determine gene structure, regulation, and function. Viral methods of DNA delivery are well-characterized and efficient, but little is known about the toxicity and immunogenecity of viral vectors. As a result, non-viral, transfection methods of DNA delivery are of increasing interest. Synthetic DNA Delivery Systems is a comprehensive and current resource on DNA transfection. The use of histidine-rich peptides and polypeptides as DNA delivery systems and self-assembled delivery systems based on cationic lipids and polymers are discussed. Targeted delivery to organelles, tumor cells and dendritic cells comprise an important topic.

Download or read book Heritable Human Genome Editing written by The Royal Society and published by National Academies Press. This book was released on 2021-01-16 with total page 239 pages. Available in PDF, EPUB and Kindle. Book excerpt: Heritable human genome editing - making changes to the genetic material of eggs, sperm, or any cells that lead to their development, including the cells of early embryos, and establishing a pregnancy - raises not only scientific and medical considerations but also a host of ethical, moral, and societal issues. Human embryos whose genomes have been edited should not be used to create a pregnancy until it is established that precise genomic changes can be made reliably and without introducing undesired changes - criteria that have not yet been met, says Heritable Human Genome Editing. From an international commission of the U.S. National Academy of Medicine, U.S. National Academy of Sciences, and the U.K.'s Royal Society, the report considers potential benefits, harms, and uncertainties associated with genome editing technologies and defines a translational pathway from rigorous preclinical research to initial clinical uses, should a country decide to permit such uses. The report specifies stringent preclinical and clinical requirements for establishing safety and efficacy, and for undertaking long-term monitoring of outcomes. Extensive national and international dialogue is needed before any country decides whether to permit clinical use of this technology, according to the report, which identifies essential elements of national and international scientific governance and oversight.

Download or read book Principles of Tissue Engineering written by Robert Lanza and published by Elsevier. This book was released on 2000-05-16 with total page 1039 pages. Available in PDF, EPUB and Kindle. Book excerpt: The opportunity that tissue engineering provides for medicine is extraordinary. In the United States alone, over half-a-trillion dollars are spent each year to care for patients who suffer from tissue loss or dysfunction. Although numerous books and reviews have been written on tissue engineering, none has been as comprehensive in its defining of the field. Principles of Tissue Engineering combines in one volume the prerequisites for a general understanding of tissue growth and development, the tools and theoretical information needed to design tissues and organs, as well as a presentation of applications of tissue engineering to diseases affecting specific organ systems. The first edition of the book, published in 1997, is the definite reference in the field. Since that time, however, the discipline has grown tremendously, and few experts would have been able to predict the explosion in our knowledge of gene expression, cell growth and differentiation, the variety of stem cells, new polymers and materials that are now available, or even the successful introduction of the first tissue-engineered products into the marketplace. There was a need for a new edition, and this need has been met with a product that defines and captures the sense of excitement, understanding and anticipation that has followed from the evolution of this fascinating and important field.Key Features* Provides vast, detailed analysis of research on all of the major systems of the human body, e.g., skin, muscle, cardiovascular, hematopoietic, and nerves* Essential to anyone working in the field* Educates and directs both the novice and advanced researcher* Provides vast, detailed analysis of research with all of the major systems of the human body, e.g. skin, muscle, cardiovascular, hematopoietic, and nerves* Has new chapters written by leaders in the latest areas of research, such as fetal tissue engineering and the universal cell* Considered the definitive reference in the field* List of contributors reads like a "who's who" of tissue engineering, and includes Robert Langer, Joseph Vacanti, Charles Vacanti, Robert Nerem, A. Hari Reddi, Gail Naughton, George Whitesides, Doug Lauffenburger, and Eugene Bell, among others

Download or read book Human Embryonic Stem Cells written by Arlene Chiu and published by Springer Science & Business Media. This book was released on 2003-08 with total page 488 pages. Available in PDF, EPUB and Kindle. Book excerpt: A discussion of all the key issues in the use of human pluripotent stem cells for treating degenerative diseases or for replacing tissues lost from trauma. On the practical side, the topics range from the problems of deriving human embryonic stem cells and driving their differentiation along specific lineages, regulating their development into mature cells, and bringing stem cell therapy to clinical trials. Regulatory issues are addressed in discussions of the ethical debate surrounding the derivation of human embryonic stem cells and the current policies governing their use in the United States and abroad, including the rules and conditions regulating federal funding and questions of intellectual property.

Download or read book Holland Frei Cancer Medicine written by Robert C. Bast, Jr. and published by John Wiley & Sons. This book was released on 2017-03-10 with total page 2004 pages. Available in PDF, EPUB and Kindle. Book excerpt: Holland-Frei Cancer Medicine, Ninth Edition, offers a balanced view of the most current knowledge of cancer science and clinical oncology practice. This all-new edition is the consummate reference source for medical oncologists, radiation oncologists, internists, surgical oncologists, and others who treat cancer patients. A translational perspective throughout, integrating cancer biology with cancer management providing an in depth understanding of the disease An emphasis on multidisciplinary, research-driven patient care to improve outcomes and optimal use of all appropriate therapies Cutting-edge coverage of personalized cancer care, including molecular diagnostics and therapeutics Concise, readable, clinically relevant text with algorithms, guidelines and insight into the use of both conventional and novel drugs Includes free access to the Wiley Digital Edition providing search across the book, the full reference list with web links, illustrations and photographs, and post-publication updates

Download or read book Electroporation and Electrofusion in Cell Biology written by C.A. Jordan and published by Springer Science & Business Media. This book was released on 2013-11-11 with total page 435 pages. Available in PDF, EPUB and Kindle. Book excerpt: Cells can be funny. Try to grow them with a slightly wrong recipe, and they turn over and die. But hit them with an electric field strong enough to knock over a horse, and they do enough things to justify international meetings, to fill a sizable book, and to lead one to speak of an entirely new technology for cell manipulation. The very improbability of these events not only raises questions about why things happen but also leads to a long list of practical systems in which the application of strong electric fields might enable the merger of cell contents or the introduction of alien but vital material. Inevitably, the basic questions and the practical applications will not keep in step. The questions are intrinsically tough. It is hard enough to analyze the action of the relatively weak fields that rotate or align cells, but it is nearly impossible to predict responses to the cell-shredding bursts of electricity that cause them to fuse or to open up to very large molecular assemblies. Even so, theoretical studies and systematic examination of model systems have produced some creditable results, ideas which should ultimately provide hints of what to try next.

Download or read book Pharmaceutical Biotechnology written by Daan J. A. Crommelin and published by CRC Press. This book was released on 2002-11-14 with total page 456 pages. Available in PDF, EPUB and Kindle. Book excerpt: The field of pharmaceutical biotechnology is evolving rapidly. A whole new arsenal of protein pharmaceuticals is being produced by recombinant techniques for cancer, viral infections, cardiovascular and hereditary disorders, and other diseases. In addition, scientists are confronted with new technologies such as polymerase chain reactions, combinatorial chemistry and gene therapy. This introductory textbook provides extensive coverage of both the basic science and the applications of biotechnology-produced pharmaceuticals, with special emphasis on their clinical use. Pharmaceutical Biotechnology serves as a complete one-stop source for undergraduate pharmacists, and it is valuable for researchers and professionals in the pharmaceutical industry as well.

Download or read book Gene Transfer written by R. Kucherlapati and published by Springer Science & Business Media. This book was released on 2012-12-06 with total page 447 pages. Available in PDF, EPUB and Kindle. Book excerpt: Genetic analysis of microbial systems provided us with the foundation for un derstanding gene structure, expression, and regulation. It was long felt that the ability to generate mutants and conduct genetic studies in mammalian systems would prove to be equally useful. However, genetic analysis based on sexual systems is difficult in mammals because of the long generation times and the inability to perform controlled matings. As a result, genetic analysis of mam malian systems had to await the development of parasexual systems. This book is an attempt to bring together descriptions of a number of these parasexual systems. A common theme of all the parasexual systems is the transfer of genetic information from a defined source into a specific cell type. This volume deals with a number of methods of gene transfer into mammalian cells. The early methods of gene transfer involved transfer of relatively large amounts of genetic information. These include somatic cell hybridization, microcell fusion, and chromosome transfer, which constitute the first part of this book. Each of these methods has already proven to be of enormous value in arriving at a genetic understanding of the mammalian genome. Development of recombinant DNA methods, and the ability to introduce purified DNA into mammalian cells, has had a significant impact on our ability to dissect important aspects of mammalian gene expression and regulation. The second part of this book deals with gene transfer systems involving defined nucleic acid sequences.

Download or read book Primary and Stem Cells written by Uma Lakshmipathy and published by John Wiley & Sons. This book was released on 2011-10-31 with total page 314 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book describes basic cell engineering methods, emphasizing stem cell applications, and use of the genetically modified stem cells in cell therapy and drug discovery. Together, the chapters introduce and offer insights on new techniques for engineering of stem cells and the delivery of transgenes into stem cells via various viral and non-viral systems. The book offers a guide to the types of manipulations currently available to create genetically engineered stem cells that suit any investigator's purpose, whether it's basic science investigation, creation of disease models and screens, or cells for therapeutic applications.