You have completed a distance learning course that has addressed the biology, bioethics, legal, regulatory, political and religious issues, as well as clinical applications of stem cell science. Given what has been presented in this course,
we, the authors of this course, hope that you will find it exciting to imagine the future of stem cell research.

While predicting the future is always open-ended, three areas seem to hold particular promise:
  • Emerging biotechnologies developing in the context of stem cell research
  • Globalization of bioethics and clinical trials
  • Non-clinical applications of stem cell technology

Lessons we have learned about contemporary stem cell bioethics, science, medicine, and legal issues will continue to be relevant as new scientific discoveries and ethical dilemmas inevitably emerge.As these complex issues emerge and are grappled with, the highest standards for responsible conduct of research must always be maintained.

Emerging biotechnologies developing in the context of stem cell research


Epigenetics: One of the most important mechanistic aspects of stem cell biology is epigenetics. The differentiation pathway of stem cells, as well as how stem cells are generated (i.e., iPS vs. SCNT), depend upon gene activation and gene silencing which are in large measure regulated by epigenetic modulation of DNA base pairs or the surrounding chromatin proteins. As our understanding of epigenetics evolves - as revealed by experimentation with stem cells - scientists will be able to apply their discoveries to create and design new epigenetic-based therapies for the major diseases that plague humanity such as heart disease, cancer, and neurodegenerative diseases.

As an example of this bright future, consider Dr. Feinberg’s new theory of cancer. Currently, scientists understand that cancerous tumors are a family of heterogeneous diseases. The theory that cancer is hetereogeneous presents a major barrier to effective cancer diagnosis and treatment (i.e., heterogeneity of types of cells within the tumor, which may respond differently to a specific therapy). In the fall of 2011, Dr. Feinberg and his colleagues identified cancer-specific regions of a colon cancer genome that were methylated in a different fashion than normal colon cells. The methylation patterns of a genome are also DNA fingerprints which distinguishes normal cell types in different organs. In other words, Dr. Feinberg speculates that all cancers are in reality diseases in which there is a serious defect in epigenetic regulation of cellular proliferation as presented in the methylation patterns of their genomes (see: Hansen et al., 2001). These findings, if validated, will revolutionize how we treat and hopefully cure this devastating disease by focusing on methods to reformulate the epigenetics of each specific cancer. These types of advances will certainly be accelerated as we understand how epigenetics regulates stem cell differentiation into the various cell types of the body.

Synthetic biology and nanotechnology


The capacity to employ methods of synthetic biology in gene design or to incorporate nanomaterials such as microfiber systems will enhance our capacity to manipulate stem cell biology for the purpose of tissue or organ regeneration. In December of 2011, scientists used these technologies to engineer a 3D extra-cellular matrix-like environment in which the stem cells were embedded into this extra-cellular scaffold.
Scientists now are able to use this technology to coax stem cells to develop and differentiate to their appropriate target state within these matrices, thus setting the stage for tissue and organ regeneration.

We are beginning to see the fruits of these discoveries as scientists report the first synthetic trachea transplant using a patient’s own stem cells. Christopher Lyles, 30 years old, underwent an experimental procedure, involving adult derived stem cells to treat his tracheal cancer. Mr. Lyles represents the first U.S. stem cell tracheal transplant, using his own (i.e. adult) stem cells. (See the State Column:
Cancer Patient Pioneers first Stem Cell Trachea Transplant)

Genomics at $50 per genome: In the very near future, synthetic biology, DNA analysis, and stem cell epigenetics will dramatically reduce the cost of individual genomic analysis. Personalized genomics will identify the various genotypes of each person’s genes as well as the specific regulatory units found in the non-encoding regions of their genome. In the year 2000, it cost almost 1 billion dollars to decipher most of the base pairs in one human genome. Now, only twelve years later, the cost to decipher an individual’s genome is estimated to run several thousands of dollars per person. Eventually, obtaining your genome, as well as that of your entire family, will be as inexpensive as doing a simple blood test (Wetterstrand, 2012).

Currently there are at least ten commercial companies that will decipher a person’s genome. Understanding the genomic profiles of a patient may be an important criterion in pharmacogenomics- selecting the appropriate drug for treatment, as well as better assessing the disease risk (i.e., likelihood of mortality or severity of disease). Thus, genomics will have a significant impact on the emerging domain of personalized medicine.

The three examples described above are just a few of the biotechnologies that are being developed in concert with or as a result of stem cell research.
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Globalization of bioethics and clinical trials


The Universal Declaration on Bioethics and Human Rights adopted by UNESCO in 2005 advocates for the establishment of independent, multidisciplinary, and pluralist ethics committees at national, regional, local, or institutional levels. The purpose of these committees is to:
  1. evaluate the relevant ethical, legal, scientific, and social issues related to research involving human beings;
  2. provide advice on ethical problems in clinical settings;
  3. assess scientific and technological development, formulate recommendations, and contribute to the preparation of guidelines; and
  4. foster debate, education, and public awareness and engagement in bioethics (Article 19).

Moral responsibility for the ethical conduct of research has always been extremely important. Now it is assuming an ever more central role, as society and institutions ongoingly evaluate what are the wisest, most productive and most ethical uses of biomedical research resources, and how best to protect the welfare of both human participants and animals used in research, as well as the wider community. We see in the continuing legal battle over whether federal funds should be used to sponsor human embryonic stem cell research a microcosm of many of the varied – and often charged - viewpoints in American society. We observe in many other areas of science the emergence of complex debate concerning the ethical practice of specific types of research.

Stem cell tourism


Globalized bioethics also is increasingly important as health-related travel, also referred to as "medical tourism," increases. People desperate to access questionable, unavailable, or less costly therapies are increasingly resorting to obtaining “therapies” - even if often unproven - when not available in the US. By 2012, several “medical tourism” hospitals in developing countries such as Thailand and India received international medical accreditation after establishing corporate links with major health insurance companies in the US. By positioning themselves as low-cost (often at one quarter of the US price), high-tech, fast-access and high-quality healthcare destinations, developing countries can offer healthcare to medical travelers who are frustrated with waiting lists, cost, regulations and the limited availability of some procedures in their home country in the developed world.

Even before any FDA approval of stem cells to treat diseases in the US, given minimal hESC human research to date, stem cell therapies are currently available in several Asian countries, and elsewhere. Ads for these therapies appear to offer fail-safe cures that are effective mostly in luring vulnerable individuals. Reports of successes and miracle cures are difficult to evaluate but spread the hype and attract more patients. Stem cell therapy has already emerged as an important and highly lucrative component of the medical tourism industry.

Globalization of clinical trials: As rapidly as the development of a globalized bioethics, clinical trials conducted by pharmaceutical companies concomitantly are becoming more global. Financial incentives prompt major pharmaceutical companies to conduct clinical trials in developing countries where costs of such trials are a fraction of those conducted in western countries. In order for the US and all participating countries’ scientific and medical establishments to both regulate and benefit from these trials, there is the need to establish international clinical and ethical standards that are universal. All clinical trial participants, no matter where they are, must be protected according to universal ethical standards. In this way, the FDA and other major drug-approving agencies will have a standard of clinical research and ethics that will foster more rapid and less expensive approval of new therapies, for Americans and hopefully eventually for all the world’s people.

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Non-clinical applications of stem cell technology


Even today many research institutions, both academic and commercial, are developing stem cell applications for an increasing number of non-medical conditions. A method to treat male or female baldness, removal of age-related wrinkles, enhanced vision, and behavior enhancement (such as improving memory or intelligence) are just a few examples.

The first profitable application of stem cell biology is likely to be in the area of baldness or vision. Already in 2011, for example, a company called Ortho K is developing a contact lens coated with a patient’s own stem cells to treat myopia. Predictions are this method will be a more effective cure for childhood near-sightedness than glasses or standard contact lenses. (See igolenses.com: Using Ortho K lenses as a cure for myopia)

Summary


We began this online learning experience with the word “imagine.” Our imaginations, voyaging into the future of stem cell science, are increasingly awed and stirred by the vistas that lie ahead. The intellectual fire ignited by stem cell science has the potential to create amazing new regenerative therapies for millions of people affect by a wide variety of diseases. At the same time, this intellectual fire can rage out of control, creating through hype and premature commercialization a myriad of opportunities to be unethically exploited. As a global society, we truly must always be vigilant and careful to ensure we heed the many historical lessons of deliberate or unknowing ethical breaches that have harmed so many in the past. In moving toward our future, we must progress rapidly, yet ethically - without compromising in our pursuit of science and medicine to benefit humankind.

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References


  • Hansen KD, Timp W, Bravo HC, Sabunciyan S, Langmead B, McDonald OG, Wen B, Wu H, Liu Y, Diep D, Briem E, Zhang K, Irizarry RA, Feinberg AP (2011). Increased methylation variation in epigenetic domains across cancer types. Nat Genet. 2011 Jun 26;43(8):768-75.
  • Wetterstrand, K. (2012). "DNA Sequencing Costs: Data from the NHGRI Large-Scale Genome Sequencing Program". Large-Scale Genome Sequencing Program. National Human Genome Research Institute. http://www.genome.gov/sequencingcosts.



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