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Assessing the Medical Risks of Human Oocyte Donation for Stem Cell Research

Assessing the Medical Risks of Human Oocyte Donation for Stem Cell Research
Author: National Research Council
Publisher: National Academies Press
Total Pages: 112
Release: 2007-03-22
Genre: Medical
ISBN: 0309179602

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It is widely understood that stem cell treatments have the potential to revolutionize medicine. Because of this potential, in 2004 California voters approved Proposition 71 to set up a 10-year, $3 billion program to fund research on stem cells. Under the direction of the California Institute for Regenerative Medicine, this program will pay to build facilities for stem cell research and will fund doctors and scientists to carry out research with the ultimate goal of helping to develop therapies based on stem cells. For this research to move forward, however, will require a steady supply of stem cells, particularly human embryonic stem cells. Those stem cells are collected from developing human embryos created from eggs-or oocytes-harvested from the ovaries of female donors. Thus much of the promise of stem cells depends on women choosing to donate oocytes to the research effort. The oocyte donation process is not without risk, however. Donors are given doses of hormones to trigger the production of more eggs than would normally be produced, and this hormone treatment can have various side effects. Once the eggs have matured in the ovary, they must be retrieved via a surgical procedure that is typically performed under anesthesia, and both the surgery and the anesthesia carry their own risks. Furthermore, given the very personal nature of egg donation, the experience may carry psychological risks for some women as well. With this in mind, in 2006 the California Institute for Regenerative Medicine contracted with the National Academies to organize a workshop that would bring together experts from various areas to speak about the potential risks of oocyte donation and to summarize what is known and what needs to be known about this topic. The Committee on Assessing the Medical Risks of Human Oocyte Donation for Stem Cell Research was formed to plan the workshop, which was held in San Francisco on September 28, 2006. This report is a summary and synthesis of that workshop.


Guidelines for Human Embryonic Stem Cell Research

Guidelines for Human Embryonic Stem Cell Research
Author: National Research Council
Publisher: National Academies Press
Total Pages: 224
Release: 2005-09-15
Genre: Medical
ISBN: 0309096537

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Since 1998, the volume of research being conducted using human embryonic stem (hES) cells has expanded primarily using private funds because of restrictions on the use of federal funds for such research. Given limited federal involvement, privately funded hES cell research has thus far been carried out under a patchwork of existing regulations, many of which were not designed with this research specifically in mind. In addition, hES cell research touches on many ethical, legal, scientific, and policy issues that are of concern to the public. This report provides guidelines for the conduct of hES cell research to address both ethical and scientific concerns. The guidelines are intended to enhance the integrity of privately funded hES cell research by encouraging responsible practices in the conduct of that research.


Mitochondrial Replacement Techniques

Mitochondrial Replacement Techniques
Author: National Academies of Sciences, Engineering, and Medicine
Publisher: National Academies Press
Total Pages: 201
Release: 2016-04-17
Genre: Medical
ISBN: 0309388708

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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.


Final Report of the National Academies' Human Embryonic Stem Cell Research Advisory Committee and 2010 Amendments to the National Academies' Guidelines for Human Embryonic Stem Cell Research

Final Report of the National Academies' Human Embryonic Stem Cell Research Advisory Committee and 2010 Amendments to the National Academies' Guidelines for Human Embryonic Stem Cell Research
Author: National Research Council
Publisher: National Academies Press
Total Pages: 59
Release: 2010-07-13
Genre: Medical
ISBN: 0309158354

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In 2005, the National Academies released the book, Guidelines for Human Embryonic Stem Cell Research, which offered a common set of ethical standards for a field that, due to the absence of comprehensive federal funding, was lacking national standards for research. In order to keep the Guidelines up to date, given the rapid pace of scientific and policy developments in the field of stem cell research, the Human Embryonic Stem Cell Research Advisory Committee was established in 2006 with support from The Ellison Medical Foundation, The Greenwall Foundation, and the Howard Hughes Medical Institute. As it did in 2007 and 2008, the Committee identified issues that warranted revision, and this book addresses those issues in a third and final set of amendments. Specifically, this book sets out an updated version of the National Academies' Guidelines, one that takes into account the new, expanded role of the NIH in overseeing hES cell research. It also identifies those avenues of continuing National Academies' involvement deemed most valuable by the research community and other significant stakeholders.


Stem Cell Research

Stem Cell Research
Author: Great Britain. Parliament. House of Lords. Select Committee on Stem Cell Research
Publisher:
Total Pages: 68
Release: 2002
Genre: Medical
ISBN:

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The Committee was appointed in March 2001 to examine the issues arising from the Human Fertilisation and Embryology (Research Purposes) Regulations 2001. These regulations extended the legal grounds for research on human embryos to include the increase of knowledge about the development of embryos or serious disease, or to enable such knowledge to help in the development of treatments for serious diseases. The Committee's report analyses the potential of stem cell research to generate new therapies, and assesses the relative scientific advantages and disadvantages of research on embryonic and adult stem cells. It considers the ethical concerns about the use of early human embryos for research purposes and the implications of developments in cell nuclear replacement and reproductive cloning. The report discusses the current regulatory regime and the scope for future legislation, including the issue of informed consent and the creation of stem cell banks. Overall, the Committee finds that there is a strong scientific and medical case for continued research on human embryonic stem cells in order to realise the full therapeutic potential of stem cell research. Adult stems cell research holds the promise of future therapies which might make further research on embryonic cells unnecessary, although this is unlikely in the foreseeable future. In the meantime, to ensure maximum medical benefit, it is necessary to keep both routes to therapy open since neither alone is likely to meet all therapeutic needs. The role of the Human Fertilisation and Embryology Authority is crucial to the effective regulation of research and maintenance of public confidence.


Heritable Human Genome Editing

Heritable Human Genome Editing
Author: The Royal Society
Publisher: National Academies Press
Total Pages: 239
Release: 2021-01-16
Genre: Medical
ISBN: 0309671132

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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.


The European Blood and Marrow Transplantation Textbook for Nurses

The European Blood and Marrow Transplantation Textbook for Nurses
Author: Michelle Kenyon
Publisher: Springer
Total Pages: 311
Release: 2018-03-14
Genre: Medical
ISBN: 3319500260

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This book is open access under a CC BY 4.0 license. This textbook, endorsed by the European Society for Blood and Marrow Transplantation (EBMT), provides adult and paediatric nurses with a full and informative guide covering all aspects of transplant nursing, from basic principles to advanced concepts. It takes the reader on a journey through the history of transplant nursing, including essential and progressive elements to help nurses improve their knowledge and benefit the patient experience, as well as a comprehensive introduction to research and auditing methods. This new volume specifically intended for nurses, complements the ESH-EBMT reference title, a popular educational resource originally developed in 2003 for physicians to accompany an annual training course also serving as an educational tool in its own right. This title is designed to develop the knowledge of nurses in transplantation. It is the first book of its kind specifically targeted at nurses in this specialist field and acknowledges the valuable contribution that nursing makes in this area. This volume presents information that is essential for the education of nurses new to transplantation, while also offering a valuable resource for more experienced nurses who wish to update their knowledge.


Principles and Practice of Fertility Preservation

Principles and Practice of Fertility Preservation
Author: Jacques Donnez
Publisher: Cambridge University Press
Total Pages: 569
Release: 2011-02-03
Genre: Medical
ISBN: 1139496123

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The specialty of fertility preservation offers patients with cancer, who are rendered infertile by chemo- and radiotherapy, the opportunity to realize their reproductive potential. This gold-standard publication defines the specialty. The full range of techniques and scientific concepts is covered in detail, and the author team includes many of the world's leading experts in the field. The book opens with introductions to fertility preservation in both cancer and non-cancer patients, followed by cancer biology, epidemiology and treatment, and reproductive biology and cryobiology. Subsequent sections cover fertility preservation strategies in males and females, including medical/surgical procedures, ART, cryopreservation and transplantation of both ovarian tissue and the whole ovary, and in-vitro follicle growth and maturation. Concluding chapters address future technologies, as well as ethical, legal and religious issues. Richly illustrated throughout, this is a key resource for all clinicians specializing in reproductive medicine, gynecology, oncology, hematology, endocrinology and infertility.


Clinical Labor

Clinical Labor
Author: Melinda Cooper
Publisher: Duke University Press
Total Pages: 290
Release: 2014-01-22
Genre: Social Science
ISBN: 0822377004

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Forms of embodied labor, such as surrogacy and participation in clinical trials, are central to biomedical innovation, but they are rarely considered as labor. Melinda Cooper and Catherine Waldby take on that project, analyzing what they call "clinical labor," and asking what such an analysis might indicate about the organization of the bioeconomy and the broader organization of labor and value today. At the same time, they reflect on the challenges that clinical labor might pose to some of the founding assumptions of classical, Marxist, and post-Fordist theories of labor. Cooper and Waldby examine the rapidly expanding transnational labor markets surrounding assisted reproduction and experimental drug trials. As they discuss, the pharmaceutical industry demands ever greater numbers of trial subjects to meet its innovation imperatives. The assisted reproductive market grows as more and more households look to third-party providers for fertility services and sectors of the biomedical industry seek reproductive tissues rich in stem cells. Cooper and Waldby trace the historical conditions, political economy, and contemporary trajectory of clinical labor. Ultimately, they reveal clinical labor to be emblematic of labor in twenty-first-century neoliberal economies.


Fertility Cryopreservation

Fertility Cryopreservation
Author: Ri-Cheng Chian
Publisher: Cambridge University Press
Total Pages: 287
Release: 2010-05-13
Genre: Medical
ISBN: 0521517788

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Protecting the reproductive potential of young patients undergoing cancer therapy is increasingly important. With modern treatment protocols, 80% of patients can be expected to survive. It has been estimated that up to one in 250 young adults will be a survivor of childhood cancer in the future; infertility, however, may be a consequence. As a wide range of fertility preservation methods are increasingly offered by clinicians, this systematic and comprehensive textbook dealing with the cryobiology, technology and clinical approach to this therapy will be essential reading to infertility specialists, embryologists, oncologists, cryobiologists, ObGyns, andrologists, and urologists with an interest in fertility preservation. Fertility Cryopreservation reviews all the techniques of this increasingly important field within reproductive medicine. It covers the basic principles of pertinent cryobiology, and contains major sections on the different therapies available, written by international specialists combining experience from both academic centers and commercial industries.