Recent Developments in Stem Cell Research: Social, Ethical, and Legal Issues for the Future

On February 12, 2009, Professor Skene delivered the George P. Smith II Lecture at the Indiana University Maurer School of Law.

“While Americans might decide to limit ‘halfway’ or exotic, sciencefiction inspired technologies, such as artificial hearts or brain transfers into robot bodies, it would appear unlikely they would ever approve limitations on medical research whose focus is to discover technologies, drugs and scientific techniques which not only maintain qualitative existence but extend life.” Professor George P. Smith II.¹

Introduction

In March 2009, President Obama signed an Executive Order reversing President Bush’s Order limiting the types of human embryonic stem cells that can receive federal funding for research. Many people believe this Order signals a new era in this research. However, it is only the first step towards allowing federal funding for American scientists to do the types of embryo research that are allowed in some other countries. Also, science moves at varying speeds and the focus moves quickly from one type of stem cell research to another. At the time of writing, embryonic stem cell research is moving more slowly, due partly to reports of an unregulated stem cell procedure in Moscow causing a young Israeli boy to develop tumors, and partly to new developments in research deriving stem cells without forming embryos. However, embryonic stem cell research may again advance, especially with the increased funds that are expected to become available for it. This paper suggests that if embryonic stem cell research—or any other aspect of stem cell research—ultimately produces effective treatments for human health care, it will receive broad community support, even if there have been earlier reservations about the research has have led to the new treatments.

The paper describes the aims of human stem cell research and the progress that scientists have made over the last few years. It explains how the potential of stem cell treatments has been established in animal experiments and in recent research in which stem cells have been formed from embryos and from body cells; and pluripotent stem cells have been differentiated into other kinds of cells. Some significant experiments have illustrated the effectiveness of stem cell treatment in treating medical conditions, both in animals and humans. In humans, research has been proceeding more slowly but there have been many developments in basic biology and we are on the brink of clinical applications. The U.S. Food and Drug Administration (FDA) has been asked to approve the first drug for human health care produced in the milk of an animal, which was created by inserting a human gene into the animal at an embryonic stage, and the first U.S. clinical trial of a stem cell treatment in humans, which was about to start when the news of the Moscow procedure was announced, has been placed on hold. The paper considers some of the regulatory issues that have arisen in relation to stem cell research, especially research involving human embryos and human bodily material. It outlines regulatory responses to date, mainly in the U.S., Canada, the U.K., and Australia. It examines and evaluates those responses in light of the actual and anticipated progress of the various aspects of stem cells described in the paper and suggests that if research produces safe and effective treatments, that research will guide future regulation.

I. Human Embryonic and Stem Cell Research: Aims, Achievements, and Future Prospects

A. Aims of Research

One aim of human stem cell research is to treat patients by transplanting healthy cells derived from their own bodies to stimulate the repair of diseased tissue. The concept of treating patients in this way has been established for more than forty years in treatment for leukemia. Bone marrow (a type of body tissue containing stem cells) is obtained from donors and transplanted into patients. If the transplanted cells come from the patient, rather than a donor, the cells will not be rejected as foreign material by the patient’s immune system and the patient will avoid a lifetime of immuno-suppressive drugs, which may...