PG11: Regenerative Medicine: Promise, Pitfalls And Realities

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Supporters

Developed in Cooperation with the Regenerative Medicine and Stem Cell Biology Special Interest Group

ACGME COMPETENCY
Medical knowledge 

NEEDS ASSESSMENT AND COURSE DESCRIPTION
Patients throughout the United States and worldwide are seeking innovative treatments involving stem cells from various sources, including reproductive tissues. Physicians and other caregivers are frequently confronted with patients requesting treatments for a diverse set of disorders and diseases. Frequently these patients or their loved ones, with benevolent motives, are encouraged to participate in medical tourism for these alleged “stem cell therapies.” The U.S. Food and Drug Administration (FDA) and several professional associations are trying to discourage these unapproved and unwarranted therapies, while still maintaining enthusiasm for the development of reliable stem cell research. Against this background, there are emerging changes in the federal and state regulations governing stem cells that directly influence assisted reproductive technology (ART) clinics and their practices. Furthermore, the ability to generate gametes from pre-gametes offers the theoretical promise of restoring fertility in survivors of childhood cancer. Finally, significant progress has been made in making gametes of varying quality from stem cells in vitro in model systems. These strategies hold promise for understanding the mechanisms that result in germ cells versus somatic cells, and they also might help in designing novel contraceptives and treating infertility as its root causes.

The goal of this course is to help inform physicians, genetic counselors, lawyers, social workers, and laboratory scientists and technicians, about the scientific status of stem cells and regenerative medicine, and also to alert them to the progress being made in the process of safely translating them to use in ART for routine clinical practice. This course will provide up-to-date information regarding the regulatory and ethical considerations of stem cell therapies by arming participants with the knowledge they need to accurately inform and counsel patients seeking these novel treatments. 

LEARNING OBJECTIVES
At the conclusion of this course, participants should be able to:

1. Evaluate the multicenter efforts to generate de novo gametes from induced pluripotent stem cells (iPS), including current achievements and limitations.
2. Describe the current treatment options for severe forms of nonobstructive azoospermia and critique the current research focused on replicating the male genome.
3. Evaluate the potential treatment of premature menopause and female sterility.
4. Identify the ethical issues surrounding the use of human embryos for stem cell research and explain the informed consent, provenance and regulatory bodies overseeing human embryonic stem cell research.
5. Discuss some of the ethical issues in both research and clinical practice regarding production of gametes from pluripotent cells.