The discovery of stem cells and perspectives of their utilization have become one of the most outstanding research findings, inducing promising prospects of creating essentially new and effective biomedical technologies and methods of treatment. However, this scientific progress surpasses the development of ethics and moral standards. Therefore, although stem cell research provides clinicians with extremely efficient opportunities to heal severe and even inextirpable illnesses, their application is still a hotly debated issue due to existing ethical, legal, political, scientific, and religious considerations.
“Ethics is a branch of philosophy concerned with evaluating human action”. Beneficial solutions to the issue of stem cell-based therapies and stem cell research should correspond to moral standards, principles of bioethics, religious beliefs, and official regulations. Both meta-ethical and normative solutions must be based on fundamental scientific truths.
Stem cells are one of the numerous types of human cells, and they are characterized by their unique abilities to self-renew indefinitely, regenerate, and convert to any other type of the 220 cells found in a human body (muscle cells, bone cells, blood cells, brain cells, and other types of cells and tissues). “Stem cells are unspecialized cells in the human body that are capable of becoming specialized cells, each with new specialized cell functions”. Therefore, stem cells could be used to substitute and restore cells and tissues “damaged by disease”. Oncologic diseases, diabetes, cardiovascular disorders, incomplete bladder control, hepatitis, lupus, leukemia, muscular dystrophy, sclerosis, osteoarthritis, spinal cord injuries, respiratory diseases and many other severe illnesses could be cured via the application of stem cells. Stem cells can be isolated from human embryos (preferably on the first stage of development), aborted embryos, bone marrow, umbilical cord blood of newborns, and adult tissues.
The application of embryo stem cells is the most perspective direction of research and therapy, “because of their ability to develop into different tissue types and because of their ability to be propagated for many generations in laboratory culture”. The majority of methods to retrieve stem cells are accompanied by destructive actions. Moreover, applications of embryonic stem cells are interpreted as the encouragement to abortion. The status of human embryos is the major focus of ethical debates on stem cell-based therapies. Irrespective of the stage of their development, human embryos are generally identified as human beings by Catholic and Christian religious postulates. Utilization of embryonic stem cells challenges the fundamental and basic principles of the Christian Church, according to which human personhood begins at conception, and an embryo has a soul and human dignity in compliance with the clerical document “Human dignity” (Dignitas personae). Thus, utilization of embryonic stem cells is identified as a violent intervention in human life. Moreover, it is sometimes considered to be a murder of a person. These creeds have predetermined the Vatican policy; therefore, it called the governments of the USA and European countries to abandon the application of embryonic stem cells.
Other types of stem cells are researched and implemented in therapies, as well. Stem cells extracted from tissues of an adult person possess limited properties, because they are able to differentiate into one specific type of human cells. Their main advantage is that they do not cause alienation of transplanted tissues by the immune system of a recipient.
Induced pluripotent stem cells are a third type of stem cells, which are specially generated by the conversion into a particular type cells so that their abilities can simulate those of embryonic stem cells. Although this biomedical application of stem cells has started recently and has not developed thoroughly yet, induced pluripotent stem cells “provide attractive prospects for cell replacement therapies”.
Due to the fact that stem cells were first used in humans therapies several decades ago, this medical technology appears to be novel and underresearched, thus, it requires comprehensive research investigations conducted in compliance with the legislative regulations and principles of bioethics and evidence-based medicine. Methods of retrieval, cultivation, and transplantation of stem cells, as well as their understudied possible adverse effects, comprise the complex web of ethical contradictions. The intensity of debates on stem cells is exaggerated by scientific publications containing numerous elusive terms and definitions related to stem cell research such as “pluripotent”, “neuroblasts”, “mesenchymal”, “blastocyst”, etc. Complicating public awareness of stem cell-based therapies, stem cell-oriented literature induces debates and controversy. Ethical issues emerge because of inexact definitions or incorrect interpretations of findings of stem cell-oriented research. Relevant openness and transparency in biological investigations will neutralize ethical contradictions.
Stem cell research is conducted in different countries according to their religious beliefs and official regulations. Therefore, the utilization of stem cells and its perspectives differentiate worldwide. Accurately defined legislative regulations should be developed in order to promote stem cells research and overcome existing obstacles to the implementation of this innovative healthcare technology.
Although national and federal funding for stem cell research has been provided in the USA since 2001, it has been limited to the 15 stem cell lines. Today, stem cell research in the USA is performed in accordance with the Guidelines designed by the National Institutes of Health (NIH) in 2009 and in compliance with Executive Order 13505 issued by President Barack H. Obama. Recommendations provided by members of the USA Congress, proposals developed by scientific and academic institutions, religious and healthcare organisations, as well as suggestions from the general public, were considered. In addition, the US Court of Appeals overruled the ban on funding stem cell research on embryos in 2011. Thus, today, stem cell research in the USA is promoted by the congenial regulatory environment.
Research studies on stem cells in general and human embryonic stem cells in particular have been conducted in Australia since the early 1980s. The Gene Technology Ministerial Council governs the legislative environment for studies on stem cells. The studies are regulated by the Gene Technology Act 2000, which was designed and passed in 2000, and the Gene Technology Regulations. However, the sufficient financial support has been provided for approximately 9 years since the time when the Australian Stem Cell Centre (ASCC) was founded. This organization is closed now. Today, the National Stem Cell Foundation of Australia and the consortium Stem Cells Australia are carrying out studies on induced pluripotent stem cells (iPS).
Regulatory regimes of stem cell research in the UK are determined in conformity with national legislative acts and the EU regulations (the European Medicine Agency (EMA). The background to the study, prospects, objectives, and significance of the study identify crucial aspects of this issue. The UK Medicines and Healthcare Products Regulatory Agency (MHRA), the Human Fertilization and Embryology Authority (HFEA), the Human Tissue Authority (HTA), the Health Protection Agency (HPA), and the Gene Therapy Advisory Committee (GTAC) define the regulatory framework for stem cell research and medical applications in the UK. “The stem cell clinical trial can begin when all the approvals have been granted”. In order to promote further stem cell studies, comprehensively explore this novel method, and expand the utilization of stem cell therapies, the UK Parliament adopted a bill that allows creating hybrid embryos of humans and animals in 2011. However, the development of this innovative technology in the UK can be significantly decelerated by numerous regulatory institutions.
Clinical trials of stem cell therapies are conducted in such countries as Spain, Greece, China, Italy, Finland, Sweden, France, Mexico, and some others while legislative acts do not coincide everywhere due to specific national policies, religious creeds, moral standards, and ethical considerations. However, irrespective of its location, stem cell research should be conducted in conformity with the principles of evidence-based medicine and bioethics. Evidence-based medicine is “the conscientious, explicit, and judicious use of current best evidence in making decisions about the care of individual patients”.
Affecting every area of health care, bioethics determines and specifies general moral and ethical principles of new methods utilization. Health care procedures in general and utilization of stem cells in particular should be implemented in conformity with ethical norms and based on the principles of autonomy, nonmaleficence, justice, beneficence, fidelity, and veracity. Everybody involved in stem cell research or provided with stem cell therapies should be aware of possible adverse effects, complications, moral and ethical aspects of this issue. It is obligatory to obtain patients’ informed consent. This is essential to ensure that those who participate in stem cell studies understand exactly what the research involves for them. “The legal basis for informed consent arises largely from fundamental principles of medical ethics and human rights”.
To sum up, despite the high efficiency and obvious potential of stem cells application for therapeutic purposes, this method triggers numerous debates of ethical and religious nature, generated by the protection of humans’ rights and dignity. In order to correspond to universal ethical norms and moral standards, scientific investigations of stem cells and stem cell therapies should be “based on four different criteria: biological humanity, personhood, possession of interests, and having a future- like-ours (FLO)”. Taking into consideration possible unpredictable clinical results, applications of stem cell therapies must be under the strict control of official institutions. Humans’ safety is an obligatory prerequisite for stem cell-based therapies and research studies.