Legal and Policy Frameworks for Clinical-Grade Stem Cell Banking
Ulmer, Elizabeth, von Tigerstrom, Barbara, Health Law Review
The potential applications of stem cell therapy and regenerative medicine make this area of research a dynamic, fast evolving field. To accommodate the considerable growth of stem cell research, banks have been created to provide researchers with access to current, high quality stem cell lines.' Banks accept and distribute stem cell lines to and from researchers, providing documentation on their use and provenance. Banks fulfill important functions to ensure the cell lines are ethically sourced and the quality of cell lines is reliable,2 helping to realize the full potential of stem cells.
While many clinical applications of stem cell research remain distant possibilities, some novel stem cell-based therapies are beginning to be developed and tested. As these efforts continue, stem cell banks will increasingly take on an important role in the distribution of clinical-grade stem cell lines that can be used to develop therapies administered to humans. In December 2011, the first clinical-grade stem cells were deposited with the United Kingdom Stem Cell Bank (UKSCB),3 marking a shift to a new era in stem cell banking. More recently, plans were announced to establish a bank of clinical-grade induced pluripotent stem cells (iPSCs) in Japan.4
As the banking of clinical-grade stem cells gains momentum, this will bring new regulatory and policy issues into play. The aim of this article is to describe the legal and policy framework relevant to stem cell banking, with a focus on clinical-grade stem cell lines, and to identify some of the issues and challenges that arise in the context of clinical-grade stem cell banking.
Stem Cell Banks
The phrase "stem cell bank" is sometimes used to refer to both stem cell registries and repositories. Registries are databases that collect and provide information on derived stem cell lines. The European Human Embryonic Stem Cell Registry and the UMass International Stem Cell Registry are examples of stem cell registries.' Repositories are facilities that process, store, and maintain the actual stem cell lines such as the UK Stem Cell Bank (UKSCB), the Spanish National Cell Bank, and the US Wisconsin International Stem Cell Bank (WISC)."Registries and repositories are not mutually exclusive and have complementary functions.' They provide researchers with information about matters such as stem cell provenance and culture methods, enabling more accurate and reliable research. Coordination among these functions is critical for the advancement of stem cell research, providing researchers with the materials and information to produce the highest quality work. This article is primarily concerned with repositories and unless otherwise indicated, the term "stem cell bank" in this article refers to banks that are acting as repositories and are actually handling human cells. Stem cell banks play a significant role in the advancement of stem cell research. Given the rapid expansion of the science, centralized stem cell banks are needed to provide researchers with access to cell lines!' By providing access to existing lines, banking reduces the need for derivation of new cell lines; in the case of human embryonic stem cells, in particular, this has ethical value because it reduces the number of human embryos that must be destroyed.' Banks also reduce unnecessary duplication in research by screening applications for use of cell lines,'" and minimize waste and errors by promoting standardization."By ensuring the maintenance of only ethically sourced cells using accepted quality conditions, stem cell banks promote consistency, safety, and ethical conduct in cell line derivation and subsequent use in research.
The benefits of using stem cell banks will also extend to clinical applications. There is general agreement that the use of centralized banks will serve the development of stem cell research, especially as it moves into clinical translation. …