Survival guide to stem cell research and therapies: Part II

21. september 2015 at 8:00 | Veronika Valdova |  Medicine & Pharmacy
Article 11 of the Universal Declaration on the human genome and human rights (1997) states, that "Practices which are contrary to human dignity, such as reproductive cloning of human beings, shall not be permitted. States and competent international organizations are invited to co-operate in identifying such practices and in taking, at national or international level, the measures necessary to ensure that the principles set out in this Declaration are respected." [10] This wording does not prohibit cloning for non-reproductive purposes, though.

According to the International Bioethics Committees report "The Use of Embryonic Stem Cells in Therapeutic Research" (2001), "research involving human embryonic stem cells is an ethical question and it is not only the right but also the obligation of each individual society to discuss this question in its own right." The Committee promotes free and informed public debates in all countries and suggests state rather than internationally binding regulation. It requires donors' consent for the use of "surplus" embryos, review of research projects by Ethics Committees, and careful assessment of advantages and risks of alternative stem cell derivation. [11]

Development of EU policy on stem cell research
Source: Drug Development Primer: Stem cells, Arete-Zoe (2015)
The situation in Europe is much more complex and ambiguous. The Biopatent Directive (98/44/EC) excludes human embryos and cells derived from them from patentability for industrial or commercial purposes. Patentability of pre-existing cell lines is permissible, however. Moreover, the directive only affects signatories of the European Patent Convention. Research on adult stem cells, mesenchymal stem cells (MSCs) or induced pluripotent stem cells (iPSCs) is less restricted. [12] Heterogenous implementation of this legislation across the EU further complicates the issue: the stance of European countries ranges from very permissive to very restrictive.

Stem cell therapies in Europe are regulated as "Advanced-therapy medicinal products (ATMPs)": that means medicines for human use that are based on gene therapy, somatic-cell therapy or tissue engineering. [13] In December 2014, the EMA approved the first ATMP in the EU: ex-vivo expanded autologous human corneal epithelial cells containing stem cells Holoclar.[14]

National positions on human embryonic stem cell research policy
European Science Foundation: 1. National positions on human embryonic stem cell research policy and regulatory framework in Europe range from very permissive to very restrictive. The policies in the UK, Sweden and Belgium (green) are very permissive, allowing the use of embryos from different sources including those created solely for the purpose of research. In most other countries (yellow) embryonic stem cell research is permitted with restrictions (only on surplus IVF embryos). Countries marked in purple and red show various degrees of restrictive policies. The issue is not legislated at all in Austria, Poland and Ireland. Balkan countries are not included in the assessment. [15]

ClinicalTrials.Gov database: All stem cell trials registered globally (August 2015) Of 5,101 stem cell studies in total, vast majority was and is conducted in the U.S. (2,866) and Europe (1,157). The leading countries in Europe are Poland (328), Germany (287), Italy (239), United Kingdom (203) and Spain (198).

Most of the studies in the Clinical register are in early stage of research (phase I to II). Almost all (4,968) these trials involve adult stem cells. The range of conditions tested is enormous. The true success of these studies is difficult to assess, however, because only 366 of these more than 5,000 trials have posted results available for public scrutiny.
WHO register ICTRP contains 5,401 records for 4,804 trials from all over the world, main source being U.S. and European databases.

Overall, stem cell therapy remains hope for the future rather than immediate reality, with very few exceptions. Caution is highly advisable for anyone who is seeking novel and emerging treatments for currently incurable diseases. Available resources such as clinical trial databases and WHO ICTRP and the FDA register of Human Cell and Tissue Establishment offer a lot of useful information for those who need to make the right decision for themselves.


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