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Report on Stem Cell Research Centers STEM CELL RESEARCH CENTERS A Report of the Legislative Committee on Health Care as Required by Senate Bill 363 of the 2019 Legislative Session August 2020 This report was prepared by the Research Division of the Legislative Counsel Bureau. For additional copies of this report, please contact the Research Library at (775) 684-6827 or [email protected]. The Research Division provides objective policy analysis, research, and assistance to the Nevada Legislature—its members, committees, and constituents. TABLE OF CONTENTS Page Legislative Charge ii Executive Summary ................................................................................................................... 1 What Are Stem Cells? ................................................................................................................ 2 International Stem Cell Research ............................................................................................... 2 Stem Cell Research in the United States .................................................................................... 3 Regulation of Stem Cell Products ........................................................................................... 3 Funding for Stem Cell Research ............................................................................................. 3 Stem Cell Research Centers ....................................................................................................... 4 Establishment .......................................................................................................................... 4 Services Provided .................................................................................................................... 4 Governing/Oversight ............................................................................................................... 5 Funding.................................................................................................................................... 5 Value ....................................................................................................................................... 5 State Laws Related to Stem Cell Research ................................................................................ 7 Laws Establishing Stem CellResearch Centers ....................................................................... 7 Laws Providing Funding for Stem Cell Research 8 Laws Encouraging Stem Cell Research and Access to Treatment 13 Placement of a Stem Cell Research Center in Nevada ............................................................... 13 Existing Resources ................................................................................................................ 13 Benefits and Costs ................................................................................................................. 14 Desire for a Stem Cell Research Center in Nevada .............................................................. 15 Conclusion ............................................................................................................................... 15 Appendix A: Stem Cell Research at UNR School of Medicine 16 i LEGISLATIVE CHARGE Senate Bill 363 of the 2019 Legislative Session requires the Legislative Committee on Health Care (LCHC), during the 2019–2020 Interim, to study: Stem cell centers in different states and countries; The services provided by stem cell centers and the value such centers bring to the community; and The best placement for a stem cell center in Nevada—whether within a state agency, the Nevada System of Higher Education (NSHE), or as a public or private nonprofit entity. The Committee must submit its findings and any recommendations for legislation on or before September 1, 2020, to the governor and the director of the Legislative Counsel Bureau (LCB) for submission to the 81st Session of the Legislature. At its meeting on November 20, 2019, the LCHC directed LCB staff to review required areas of study and report back to the Committee. DISCLAIMER The LCB is a nonpartisan agency; as such, LCB staff neither advocate for nor against any issue, position, or ideology. The purpose of this report is to present information in an unbiased manner to better assist legislators in making informed decisions regarding the subjects addressed herein. ii EXECUTIVE SUMMARY Often described as “the future of medicine,” stem cells are a unique type of regenerating cells that hold great promise for treating, and potentially curing, a variety of diseases. Across the nation, stem cell research is ongoing at numerous institutions, including stem cell research centers. Though no standardized definition exists, stem cell research centers are typically large, well-established centers or institutes of academic research that conduct activities in accordance with federal and state regulations within a university, school of medicine, or major healthcare system. They differ from smaller stem cell clinics, which often sell unproven, unapproved stem cell therapies. Centers generally engage in basic, translational, and clinical research and bring researchers together from across disciplines to collaborate on innovative research and help accelerate stem cell research and regenerative medicine by providing financial, human, and physical resources—such as grants for high risk projects, business development, and commercialization assistance—and navigating regulatory systems. Funding typically comes from private donations, research grants, and federal and state funds. In the United States, the vast majority of stem cell research centers were established without state intervention, although Indiana and Kansas passed legislation authorizing and requiring the establishment of a stem cell research center, respectively. At least eight other states have laws related to funding stem cell research, although the funding approach varies by state. Still other states declare their public policy to be to encourage stem cell research and facilitate access to stem cell treatments. Stem cell research centers offer numerous benefits to the nation, state, and communities in which they are located. These range from public health benefits such as treating currently incurable diseases and improving health outcomes, to societal benefits such as improving the state’s competitiveness in the fields of stem cell research and regenerative medicine, and economic benefits such as creating jobs, attracting researchers and funding, and diversifying and growing the economy. In contemplating whether and how best to establish a stem cell research center in Nevada, it is important to consider existing resources in the state, the possible benefits and costs of establishing a center, and an appetite within the state for such a center—especially given the current fiscal situation caused by the Coronavirus Disease of 2019 (COVID-19) pandemic. 1 WHAT ARE STEM CELLS? Stem cells are a unique type of cells that serve as the foundation for every tissue and organ in the body. They have two key properties: (1) the potential to self-renew; and (2) the ability to differentiate, becoming different types of cells. Stem cells fall into two general categories: those that can differentiate into any type of cell in the adult body and those that are tissue- or organ-specific, which can differentiate only into the types of cell of the tissue or organ. Stem cells are found in amniotic fluid, bone marrow, human embryos, the placenta, specific tissues and organs in the body, and umbilical cord blood. Stem cells hold significant promise for science and medicine to better understand how diseases occur, replace cell tissues damaged or destroyed by illness (often called regenerative medicine), and develop treatments and cures for a variety of diseases. Stem cell therapies have been approved to help treat certain types of cancer and blood-related diseases, such as leukemia, lymphoma, multiple myeloma, and neuroblastoma; for use in procedures such as bone marrow transplants; and to treat certain immune diseases. Research continues exploring the potential of stem cells for a wide range of diseases and injuries—from cardiovascular disease and neurological disorders to orthopedic issues, respiratory diseases, and certain birth defects. While stem cells open a world of possibilities, they also are associated with certain challenges. According to the U.S. Food and Drug Administration (FDA), certain health care providers and stem cell clinics promote and administer unproven and unapproved stem cell treatments. These are not only illegal, they are also potentially dangerous as they have a high risk of adverse side effects. Additional research is required in order to expand safe, approved stem cell therapies and treatments. In addition, the use of embryonic stem cells—which come from early stage embryos that are destroyed in the extraction process—can be controversial. These concerns have influenced the availability of federal funding for certain types of stem cell research and led to a variety of state laws regarding stem cell research and funding opportunities. INTERNATIONAL STEM CELL RESEARCH Researchers and scientists across the globe are examining the promise of stem cells. Internationally, stem cell research centers take a variety of forms, and are largely influenced by each country’s legal and regulatory framework, ethical standards, and cultural and political perspectives. While no international or national organization for stem cell research
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