Hopes are high that stem cell (SC) research will lead to treatments and cures for some of the most serious diseases affecting humankind today. SC science has been used in a treatment setting in the replacement of patients’ windpipes and in restoring sight to patients who were blind in one eye and in future it is hoped that when the body is injured it will be able to be stimulated to produce those types of SCs necessary to repair the particular damage caused. In the meantime, research into specific treatments for a wide range of serious conditions is being undertaken including Alzheimer’s disease, cancer, and diabetes.
The book considers the regulatory governance of stem cell research, setting out a readily understandable account of the science and the challenges it poses for regulators as the research is increasingly being clinically applied. It provides a critical account of those elements of a regulatory system which will be required for any jurisdiction aiming to facilitate innovative and productive SC research while maintaining appropriate ethical and legal controls. The book addresses the specific failings in the current regulatory approach to SC research in the UK and goes on to look at the regulatory approaches in the US.
The book systematically analyses the roles and responsibilities of the three key participants who collaborate in this process: regulators, scientists and tissue providers, arguing that a regulatory system which fails to recognise and facilitate the vital role which each of these three groups plays runs the risk of impairing the chances of the hopes for SC research being realised. The book places a particular emphasis on ensuring that those who contribute their bodily tissues to this endeavour are treated fairly, involving a recognition that their tissues are their property.
Stem cells are capable of generating various tissue cells which can be used for therapeutic approaches to debilitating and incurable disease. Even though many applications of stem cells are under investigation, such research has raised high hopes and promises along with warnings and ethical and religious questions in different societies. Generally, there is little concern about using non-human or adult stem cells. However, embryonic stem cell research been confronted with questions from medical professionals, the public, religious groups, and national and international organizations. The debate is partly related to “personhood” and the notion of human dignity. Sources of stem cells, the moral status of human embryo, the slippery slope toward commercialisation of human life, concerns about safety, germ line intervention and the challenge of proportionality are some ethical issues. Stem cell research is a promising but controversial issue on which many religions have taken strong positions. The point at which human life begins is a pivotal challenge. Conception, primitive streak development, implantation, ensoulment and birth are specific stages in which different groups claim dignity begins in the course of human development. In this book, we will review the history and scientific facts of stem cells in brief; then, ethical considerations will be discussed. Our other aim is to clarify the religious debate on the issue, particularly monotheistic perspectives. Some related international and national guidelines will be reviewed in brief.
Stem cell research has attracted much attention from all over the world for its immense potential in regenerative medicine and tissue replacement after injury or disease. Stem cells are those groups of cells which can generate specialized cells and organs that perform specific functions. Two main sources of stem cells include embryos during the early phase of embryonic development and adult stem cells. Stem cells from both these sources have the potential to grow and differentiate into specific cell types. The history of stem cell research can be traced back to the late 1800s at which time scientists were experimenting with mammalian egg fertilization processes, but it achieved some success only in 1959 with the production of rabbits through in vitro fertilization. This paved the way for fertilization of human eggs. The first in vitro fertilization of human eggs was successfully achieved in 1981 in the US. Numerous groundbreaking discoveries have been made through research conducted all over the world. This research has uncovered the potential these stem cells have for treating disease and improving human life. However, the research field faces economic, religious, ethical and moral dilemmas, and limitations from government policies in developing, emerging and developed nations. Moreover, regulatory and policy decisions made in developed nations have an impact on stem cell research at an international level because most research is funded by Western Nations. For a new field of study that promises treatments for diseases like diabetes and Parkinsonism, achievements in the field are, to date, modest at best. Some argue that this is due to the lack of funding for research; others argue that it is due to the constricting regulations imposed on stem cell research. I hypothesize that throughout the R&D pipeline required to move stem cells into actual products and applications, several variables affect progress from lab to market. The literature review shows that the R&D pipeline starts with a very large number of patents and publications for both adult and embryonic stem cells, indicative of substantial discovery research being conducted in the field. Data on preclinical analyses are not available, however, we do know that the first discoveries are generally followed by a dramatically reduced number of clinical trials, then even fewer products and applications for stem cells. My research shows that human embryonic stem cells research in particular is affected more than human adult stem cells research as well as other types of biotechnology research by the strict regulatory environment and religious beliefs that prevent the research from progressing through the pipeline by not allowing funding. For example, federal funds have been blocked in the US, due to a court order claiming that human embryonic stem cell research is research done on cells from an embryo once destroyed, consequently breaching the Dickey-Wicker Amendment. In addition, hardly any clinical trials related to human embryonic stem cells are carried out by private or public organizations. This book analyzes all parties involved in clinical trials related to human embryonic research and attempts to determine if an application or product did not go forward due to ethical, regulatory, or religious reasons.