Ethics for human ES cells

Stem cell research is one of the most promising areas of biotechnology and it is expected to be equally important for basic science to understand cell differentiation and growth as well as for other specific medical applications such as for understanding of disease development and for the development of safer and more efficient drugs.

One of the possible sources for stem cells is human pre-implantation embryos. However, when this research involves the use of human embryos it raises questions of ethical values at stake and of the limits and conditions for such research. Opinions on the legitimacy of experiments using human embryos are divided according to the different ethical, philosophical, and religious traditions in which they are rooted. The ethical debate concerning human embryonic stem cell research is focused primarily on the process of donation of supernumerary embryos. Supernumerary embryos are embryos created by means of in vitro fertilization (IVF) for the purpose of assisted reproduction but subsequently not used for it. The donation of supernumerary human embryos is only possible after the donating couple or woman has given their free and informed consent. It is important to emphasize that the decision that the embryo is to be destructed has already been taken before the donation of the embryo is even considered (i.e., under all circumstances the embryo would have been destroyed even if no donation would take place). Using the technology of today, stem cells are isolated from the inner cell mass of the embryo and are subsequently cultured in advanced cell cultures. These isolated cells cannot give rise to a pregnancy. It should also be noted that neither this handling nor this material has anything to do with somatic cell nuclear transfer (usually referred to as therapeutic cloning).

Cellartis has identified the following principal requirements regarding human embryonic stem cell research and the procurement of embryonic stem cells from supernumerary embryos:

• Free and informed consent from the donating couple or woman.
• Approval of the research by an authority.
• No financial gain for donation.
• Anonymity of the donors and protection of the confidentiality of personal information of the donors.
• Transparency regarding donation and all general handling of the donated material.

Cellartis warrants that:

• All research and handling of hES cells, as well as adult stem cells are based on careful ethical considerations.
• The company is guided by and follows all existing laws and regulations in the major markets (including Europe, USA and Japan).
• The company is not involved in neither therapeutic, nor reproductive cloning.