Policy on Research Using Human Stem Cells

Background

Stem Cells and Disease Treatment

Human stem cells and their applications have enormous potential to treat and even cure diseases, as well as to extend and enhance the quality of life. Chugai is deeply interested in scientific developments in human stem cell research and their related applications, both as a discovery tool and as a potential therapeutic modality. Chugai is also fully aware of important social and ethical questions raised by such research. As in all our activities, we follow all applicable laws and are open to dialogue with all stakeholders surrounding this area of research.

About stem cells

Stem cells are cells with the unique ability to renew themselves; they give rise to all other specialized cell types, such as heart or blood cells. Stem cells can be classified as follows:

  • Somatic stem cells are derived from tissues like bone marrow and cord blood. They are already being successfully used to treat patients with diseases like leukemia, and research is underway on their use against even more diseases. However, somatic stem cells can only develop into a limited number of cell types. Hence, we must also research embryonic stem cells for certain applications.
  • Embryonic stem cells (ES cells) are isolated from embryos. These cells are pluripotent, which means that can develop into any fetal or adult cell type (blood, heart, brain, or other cells).
  • Induced pluripotent stem cells (iPS cells) are derived from adult cells, such as skin cells, and are re-programmed into a pluripotent stage. Once re-programmed, they act like embryonic stem cells. If iPS cell technology develops as expected, it may eventually replace the need to derive stem cells from the embryo.

Stakeholders’ concerns and expectations

Expectations and hopes within this area of research are high. Stem cells and their applications may eventually enable researchers to find successful treatments for severe diseases (such as Alzheimer’s disease, multiple sclerosis, paraplegia, diabetes, Parkinson’s disease, and heart failure) for which we can offer few, if any, effective therapies today.

That said, ethical considerations on the use of human stem cells vary widely and depend to some extent on an individual’s cultural and religious background. The discussion is centered on the following:

  • The use of blastocysts (a blastocyst is a human embryo in a very early pre-implantation stage of development from which embryonic stem cells can be isolated).
  • Whether human embryonic stem cells should be used for research and/or as potential treatment for various diseases.
  • Whether and how society should accommodate these diverse views in regulating the use of stem cells, with due consideration to the effect such regulations would have on freedom of research and benefits for patients. How should we respond to these issues, and how should society respond?

Chugai’s position

Stem cell research is necessary.

Worldwide progress in stem cell research over the years has shown that scientific developments in pluripotent stem cell biology (i.e. the reprogramming of adult stem cells or somatic cells into pluripotent ones) provide a promising opportunity for the future of human healthcare. Chugai is also engaged in using these technologies. However, the scientific understanding of these technologies is still at an early stage. Therefore, parallel research using both adult and embryonic stem cells is necessary to increase our understanding of diseases and to develop much needed treatments.

Chugai is aware of the ethical concerns related to stem cell research. However, we believe that the vast potential and hope that stem cells might bring to patients to treat, prevent, or diagnose a disease justifies this research, provided it is done responsibly, in compliance with laws and regulations, in dialogue with stakeholders, and with the ultimate aim of developing new and more effective therapies for diseases that can currently not, or only partly, be treated.

Chugai has established an Ethics Review Committee consisting of internal and external experts to comprehensively assess the ethical and scientific validity of research activities using human pluripotent stem cells. Considering potential exposure to providers, risk reduction measures, social benefits and many other factors, we will conduct careful reviews to determine whether research activities are feasible. Chugai will also appropriately disclose any research activities involving human stem cell technology.

Principles for the use of human stem cells in research

Chugai is committed to a responsible and transparent approach to stem cell research. For this reason, we developed a clear set of principles for the use of human stem cells in research (i.e. General Principles for the Use of Human Stem Cells in Research). The following principles apply to all research projects involving human stem cells which Chugai undertakes. They include:

  • projects using stem cell research as a discovery tool.
  • projects looking into potential therapeutic modalities.

All Chugai employees involved in human stem cell research are subject to these principles, which are designed to be applicable worldwide, subject to national laws and regulations.

General Principles for the Use of Human Stem Cells in Research

  1. Chugai will conduct research using human stem cells with the ultimate aim to increase the understanding of serious diseases and to develop effective diagnostic tools and treatments.
  2. Chugai will conduct research activities with clear scientific objectives and designs.
  3. Chugai conducts research using human stem cells from human stem cell donors only after obtaining their written, voluntary, and informed consent.
  4. Chugai will not offer any inducements, financial or otherwise, to donors.
  5. Chugai will comply with all applicable national laws and regulations on stem cell research, which may differ from country to country.
  6. Chugai is committed to an open dialogue with stakeholders in this area of research.
  7. Chugai will proactively encourage all external contractors who perform stem cell research for Chugai to abide by the same principles and conduct their research with the same high standards as Chugai.
  8. Chugai does not conduct research using pluripotent human embryonic stem cells.
  9. Chugai does not use human stem cells to make germ cells.
  10. Chugai does not use stem cells to produce human embryos.
  11. Chugai’s research protocol for using pluripotent stem cells has been reviewed by an independent and fair ethics review committee.
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Ethics and Compliance

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