We could be free of an infinitude of maladies both of body and mind, and even possible the infirmities of age, if we had sufficient knowledge of their causes, and of all the remedies with which nature has provided us.

Rene Descartes

stemcellsnowmen

As the world becomes increasingly aware of the benefits of stem cell technologies, countries in Asia and Oceania are embracing the technology; along with the United States which has loosened some of the restrictions in recent years. Here in California, ten years has passed since voters approved Proposition 71, which created the $3 billion state taxpayer-funded California Institute for Regenerative Medicine. In Europe, under general directives of the European Community (EC), individual member countries have the right to choose to use stem cells on the grounds of medical and health benefits.

The thawing environment for stem cell products partly reflects a realization that medical technology is ultimately limited in its ability to treat and care for patients but that, according to the United Nations General Assembly, human cloning must be prohibited in as much as they are incompatible with human dignity and the protection of human life. [1]. As a result, multinational organizations like The International Society for Stem Cell Research (ISSCR) have developed a list of guidelines to assist the clinical application of stem cells. (http://www.isscr.org/home/publications/guide-clintrans).

In the USA, the National Academies and NIH also have specific guidelines for research involving stem cells and to address patients concerns (http://www.nap.edu/catalog.php?record_idZ11278; http://stemcells.nih.gov/info/ethics.asp) [2].

The end of ethics?

Despite controversy about efficacy and safety, the adoption of a limited variety of embryonic stem cells has been remarkably widespread. Since research began over four decades ago, stem cells are being used and researched under flexible or permissive policies in thirty-five countries, according to the University of Minnesota (Fig. 1) [3]. Since the majority of research and cell production comes out of academic institutions in the developed world, this work is giving birth to new discoveries and product development with a wide stream of applications. Although stem cell technology has yet to reach commercialization to date, this process is beginning to develop a picture of how the applications of cell therapy will appear.

Fig. 1 Worldwide map of stem cell research

world map of stem cell research

Figure courtesy of University of Minnesota

Map Explanation

  • "Permissive" = various embryonic stem cell derivative techniques including somatic cell nuclear transfer (SCNT), also called research or therapeutic cloning. Countries in this category include Australia, Belgium, China, India, Israel, Japan, Singapore, South Korea, Sweden, the United Kingdom and others. These countries represent a global population of more than 2.7 billion people.
  • "Flexible" = fertility clinic donations only, excluding SCNT, and often under certain restrictions. "Research is permitted only on remaining embryos no longer needed for reproduction." Countries in this category include Brazil, Canada, France, Iran, South Africa, Spain, The Netherlands, Taiwan, the United States of America, and others. These countries represent a global population of more than 1 billion people.
  • Restrictive = limited policy or no established policy. Restrictive policies range from outright prohibition of human embryo research to permitting research on imported embryonic stem cell lines and only to permit research on a limited number of previously established stem cell lines. Countries with a restrictive policy include: Austria, Germany, Ireland, Italy, Norway, and Poland.

Hello, society!

Yes, there are the social, even existential, consequences of regenerative medicine. If the hype about embryonic and adult stem cells contains even a smattering of truth, these techniques could shake up our most modest assumptions about our place in the universe, turning us from its residents to the architects of its most rudimentary elements.

But because the laws of our society are modeled from ancient ethics such as, Thou shall not it leaves no room under any circumstance for the unique situation. By analyzing human disease as a function of either age or genetics would reveal a generally unrecognized principle of morality, that, according to Joseph Fletcher, the morality of an act is a function of the state of the system at the time it is performed. [4]. But the idea that morality is flexible may seem counterintuitive in our society. To make matters worse, the frontier conditions of stem cell biology are unbearably immoral because there is no public consensus that can register what the future implications of stem cell technology are on treating disease.

Nevertheless, as stem cell research and technology burgeons, and as federal agencies wrangle over the many issues involved, it's all the more crucial to take stock of the field, where we stand, what we know, how we know it, and to do it as soon as possible. Likewise, the ability for this research to be deposited in life-saving vaccines, spinal cord repair, diabetes cures, heart disease, cancer, etc., demands a certain responsibility on the part of scientists and researchers, echoed by President Barack Obama in March of 2009, when he told the American people, We have the humanity and conscience to do this responsibly.

Old problems, new solutions

Medical breakthroughs do not happen by themselves. To stave off the effects of aging and/or disease (inherited or otherwise), stem cells provide medical practitioners with the tools and applications that become a key part of a patient's recovery. Federal law should allow and provide for that. Albeit, legislating for stem cells is easy (though perhaps not as much to enforce). The results and products of stem cell technologies will be governed by the principles of cGMP and mediated within administrative law.

The principles of cGMP, set forth in 21 CFR 210 and 211, do also apply to stem cell products, as well as, the manufacturing facility and to the specific product prepared within the facility. Implementation of cGMP requires licensure, but earlier phases within a product's lifecycle could be staged in a way consistent with usual product development.

Stem cells are also some of the most complex biologics being produced to date. In advising licensed organizations, the FDA recognizes the need for flexibility in the recommendations established in the CFR guidelines. The FDA also takes into consideration multiple factors, including the intended target population, the seriousness of the disease being studied, and all potential benefits and side effects from the investigational product. The agency is continually updating their recommendations on producing stem cells and methods for testing based upon a growing body of knowledge and feedback from a variety of sources.

The quickening pace and the widening variety of innovations and applications of stem cells by academic institutions is being motivated not so much to compete with each other, but to outpace the emerging innovations that are produced as a result of increased research.

Thus begins the stem cell revolution.

SOURCES

[1] Fifty-Ninth General Assembly. United Nations Declaration on Human Cloning, United Nations. 2005. (http://www.un.org/News/Press/docs/2005/ga10333.doc.htm)

[2] Defining stem cell types: understanding the therapeutic potential of ESCs, ASCs, and iPS cells. Journal of Molecular Endocrinology R89-111. 2012. (http://jme.endocrinology-journals.org/content/49/2/R89.full.pdf).

[3] Hoffman, William. Stem Cell Policy Map, University of Minnesota Medical School.http://www.mbbnet.umn.edu/scmap.html

[4] Fletcher, Joseph. Situation Ethics. Westminster, Philadelphia, 1966.