Since the discovery of human embryonic stem cells in 1998, many promises have been made by individuals and groups about the potential of stem cell research to revolutionize the practice of regenerative medicine. Yet to date, very little has been seen in terms of novel therapies in the clinic. Because of the substantive economic investments made in stem cell research in order to realize the promise they can offer, greater efforts to translate stem cell research into medicines has ensued. However, many factors might impede the clinical translation of stem cell research. In this blog, we briefly highlight the ethical and scientific issues surrounding the successful translation and commercialization of stem cell research.
The process of clinical translation begins with preclinical research using in vitro systems and animal models to show proof-of-principle and demonstrate safety and efficacy of a potential therapeutic. For example, if a stem cell is to be transplanted into a patient to treat a degenerative disease, then the type of stem cell that is being used must show that it can successfully treat a similar disease in animals prior to testing the product in humans. There are many reasons for using appropriate animal models that mimic human diseases: low cost, reproductive cycle, number of offspring, genetic similarity, similarity in the manifestation of the disease in humans, and ease of handling. However, there are many limitations to animal models that do not result in direct translation in humans, meaning what may work in animals may not at the end of the day be effective in people. While we choose animals as models to mimic human disease, the biology of animals is still significantly different than humans and thus may simply not translate 100%. This issue is difficult to get around.
The Alden March Bioethics Institute offers a Master of Science in Bioethics, a Doctorate of Professional Studies in Bioethics, and Graduate Certificates in Clinical Ethics and Clinical Ethics Consultation. For more information on AMBI's online graduate programs, please visit our website.