Saving the leftovers: models for banking cord blood stem cells.

• Author: Cogdell, Kimberly J.

ABSTRACT: Each year there are over four million live births in the United States. Each birth produces umbilical cord blood stem cells, which are usually discarded. The author argues that rather than discarding the umbilical cord, this valuable resource of cord blood should be banked and used for research and therapeutic purposes. Umbilical cord blood could provide a solution to the critical need to find matching donors for hematopoietic transplants in patients who have no matching bone marrow donors. Creating a system of universal donation to a public bank will greatly increase the number of donors and therefore, the number of matches for patients. Such a system will facilitate the development and use of new technologies and transplant procedures, while providing an opportunity for treatment to individuals who would otherwise not be able to find suitable donors.

1. Introduction: The Benefits and Challenges of Banking Cord Blood Stem Cells

   The use of embryonic stem cells is a highly publicized, politically charged topic, which implicates many ethical, legal, and moral issues. (1) Cord blood stem cells, however, have not received the same level of media attention. Cord blood stem cells are extracted from the umbilical cord and exhibit many of the same therapeutic qualities as embryonic stem cells but present fewer ethical problems. The purposes of this Article are: (1) to distinguish between cord blood stem cells and embryonic stem cells for non-scientists; (2) to highlight the opportunities that exist to collect more cord blood stem cells; (3) to propose consent models for their collection; and (4) to provide guidance for future legislation.

   Often, cord blood stem cell publicity relates to private cord blood banking, which is a very individualistic approach to banking and focuses mainly on using banked cells for a family member. (2) Public banking, on the other hand, is based on a population approach and focuses on the use of banked cells to treat any patient whose tissue might match. (3) This Article emphasizes the utility of cord blood stem cells as a therapeutic and research resource, suggests a framework for obtaining consent to collect the cells, and drafts suggested guidelines for legislation. Thus, this Article lays the groundwork for creating a comprehensive program that will benefit many Americans--namely the establishment of a national, public biobank for both research and transplantation purposes.

   Each year there are over four million live births in the United States. (4) Each birth produces umbilical cord blood stem cells, which hospitals usually throw away. This Article argues that rather than discarding the umbilical cord, the valuable resource of the cord blood should be banked and used for research and therapeutic purposes. Throughout the world, models for biobanking biological and genetic materials already exist that take into consideration many of the ethical, legal, and social concerns. (5) Clear, established processes for collecting cells are used by the numerous existing biobanks; therefore, by incorporating existing banking and collection strategies, researchers and medical professionals could use cord blood stem cells for transplantation in ways that benefit populations often underrepresented in traditional donor registries. Establishing a framework that banks can follow to obtain many more patients' consent to cord blood donation could facilitate the collection of larger numbers of usable samples. This may not be as difficult as it might initially seem, as avenues are already in place to collect cord blood stem cells.

   One program currently collecting and banking cord blood cells is the New York Blood Center's National Cord Blood Donor Program. (6) This is a public bank of umbilical cord blood established in 1992. (7) The purpose of this program is to investigate the uses of cord blood as a possible substitute for bone marrow, one of the currently available sources of stem cells for medical therapies. (8) Umbilical cord blood could provide a solution to the critical need to find matching donors for hematopoietic (9) transplants in patients who have no matching bone marrow donors. Creating a system of universal donation to a public bank will greatly increase the number of donors and therefore, the number of matches for patients. Such a system will facilitate the development and use of new technologies and transplant procedures, while providing an opportunity for treatment to individuals who would otherwise not be able to find suitable donors. (10)

   The technology for collecting cord blood cells already exists; however, most people do not know about the possibility of saving cord blood stem cells after the birth of a baby. This scenario is directly comparable to other situations such as genetic manipulation and artificial reproductive technology. For example, genetic manipulation has become increasingly popular, but the by-products of these types of research activities, therapies, and medical treatments are often discarded. In addition, the popularity of the use of artificial reproductive technology is increasing. (11) After the process of in vitro fertilization is complete and the couple has achieved the goal of childbirth, typically there are unused embryos. The couple often has the choice of whether to donate the unused embryos to other infertile couples, as an "embryo adoption," (12) or to have them destroyed. (13) However, advocates of embryonic stem cell research would prefer to see some of the frozen embryos used for research purposes. (14) A similar situation occurs with unused umbilical cord blood. Often families are unaware that the umbilical cord blood contains stem cells. There is the option of storing the cord blood privately, donating it for research, donating it for use by others, or simply discarding it. Generally, the umbilical cord blood is discarded rather than stored. (15)

   The question of what to do with unused biological materials creates many challenging legal, ethical, and moral issues. This Article proposes that umbilical cord blood should be stored in a national, public biobank for research and transplantation purposes; this article also suggests solutions to inevitable legal questions concerning ownership and control over the cells. In Part II, this Article provides background on biobanking. Part III provides information on the various genetic materials stored in biobanks. In Part IV, this article draws parallels between discarded biological materials and other generally discarded materials, as an aid in classifying the donated material. Likewise, this Part makes recommendations about the type of consent necessary for legally placing cord blood stem cells in a public bank.

   Specifically, Part IV proposes two models for the consent process in collecting and storing these materials: first, presumed consent and second, informed consent during prenatal treatment on delivery intake. (16) The informed consent process includes giving the potential donor sufficient information to determine whether or not to donate. This consent process will occur during visits to the doctor prior to birth or as the woman checks in to the hospital for delivery. Classifying the material as either "trash" (17) or as genetic material donated for research, (18) forms the basis for establishing the proper consent process for biobanking. In addition to the proper classification of the genetic material, there are two other considerations that affect the consent necessary for obtaining cord blood stem cell donations: the donors' expectations of privacy and the donors' beliefs about retaining ownership rights in the donated material. If the donor retains no expectation of privacy in discarded materials-analogous to the trash classification--this supports the presumed consent model. Similarly, when a donor consents to donate material for research purposes, this supports the model for obtaining consent during prenatal screening. Establishing a uniform system for consent to deposit cord blood stem cells in public biobanks will facilitate the use of these samples within ethical and acceptable legal standards. Part V of this article proposes guidelines for legislation governing cord blood stem cell banking.

2. Biobanking: A General Overview

   Biobanking is not a new concept. Many countries around the world have some form of a biobank, including the United States, the United Kingdom, Iceland, Canada, and Estonia. (19) In fact, biobanking is gaining more popularity, and the term is used in many different ways to mean different things. There are banks for storing different kinds of body tissue, such as brain and breast tissue, as well as banks for storing tissues used to study diseases such as AIDS, Alzheimer's, and other mental illnesses. (20) This article uses the term "biobank" to describe a collection of biological or genetic material, stored in a common facility, organized by sample, and accessible to some entity. When referring to cord blood stem cell biobanks, the term "biobank" narrowly includes only the storage of cord blood stem cells.

   There are several different kinds of biobanks, including government sponsored banks, private industry sponsored banks, and academic and non-profit banks. (21) Many biobanks store biological materials for research purposes in response to the growing demand for clinical samples. (22) Some biobanks allow researchers to access the stored material, while others do not. (23) In fact, commentators suggest that the reluctance of some biobank owners to allow researchers to access samples is financially motivated because owners of the genetic material want to discover genes for patenting. (24) Gene patents generate large amounts of money, thus creating an incentive to limit access. (25) One concern with these types of patents is that the owner of the gene patent can charge large sums of money for the tests to detect mutations in the gene. (26)

   Currently there is a...