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Banking Umbilical Cord Blood for Transplantation Raises Ethical Issues, Duke Doctors Say

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DURHAM, N.C. -- The reconstitution of bone marrow in severely ill patients using umbilical cord blood collected at birth is so promising that collection and banking of it already have begun. But doctors from Duke University Medical Center say that before that system goes too far, a host of ethical issues must be addressed. These issues include who "owns" the now-valuable tissue that was once discarded and who should have access to private medical information such as genetic tests on the tissue.

The Duke physicians make their arguments for the development of such policies in an article in the Dec. 13 issue of the Journal of the American Medical Association (JAMA).

The rebuilding of a patient's bone marrow using umbilical cord blood from an unrelated donor -- which has been done less than 100 times nationally -- has shown great promise as a potential substitute for traditional bone marrow transplants, said Dr. Joanne Kurtzberg, director of the Duke Pediatric Bone Marrow Transplant Program and the first doctor to perform the procedure just over two years ago. Bone marrow transplants replace a person's entire blood-forming system, which is destroyed by high doses of chemotherapy and radiation therapy used for cancer treatment.

Kurtzberg and Duke medical ethicist Dr. Jeremy Sugarman warn that banking umbilical cord blood is fraught with ethical issues that ought to be addressed in advance to prevent the types of problems that have occurred in blood banks and fertility clinics. Such problems include who should "own" the blood, who should have access to private medical information, how the system can ensure equitable treatment for all ethnic groups.

Unlike the National Marrow Donor Program, which is basically a list of prospective donors, umbilical cord blood is collected at birth, tested for infectious agents such as HIV and other diseases, typed and frozen until needed. Such a system will face the types of ethical issues associated with blood banking, said Sugarman, but with the added problem that while blood is drawn only from healthy adults, umbilical cord blood comes from infants whose future health is unknown. For example, Sugarman poses: Who should have access to the results of tests for AIDS and genetic disorders, which are necessary to safe use of umbilical blood? Should the bank follow the health status of children whose blood has been banked to assure they remain healthy? If infants get life-threatening inherited disease, should their blood be discarded? If a genetic test for a life-threatening disease becomes available, should previously banked blood be tested? If so, who should be told if the test is positive? Hospitals currently assume ownership over placental tissue, including umbilical cord blood, which traditionally has been treated as discarded material. But with a newly assumed value for such tissue, this approach could be challenged by parents, the child and even society at large.

At least one private company has already sprung up to store a newborn's umbilical cord blood in the unlikely event the child may need it for bone marrow reconstitution, Sugarman said. "But this raises questions about who assumes ownership should the family no longer be able to or desire to pay for storage," he said. "This all seems a little strange. In the United States we tend to consider most human tissues as a public commodity. The sensitivity of medical information and questions about ownership suggest that meaningful informed consent of parents must be a part of any banking operation." But such a consent process has not yet been developed. Any process that is developed should ensure that parents of newborns understand how the umbilical cord blood might be used, Sugarman said. It also should include information about how the privacy of medical facts that would be learned from tissue typing and testing will be ensured. Kurtzberg, who recently completed Duke's 30th bone marrow reconstitution using cord blood from an unrelated donor, says banking of cord blood should begin as soon as possible because the technique has shown such promise. Moreover, researchers and physicians have only scratched the surface of what could be many uses of cord blood, she said. The cord blood procedure could also be used to treat hereditary metabolic disorders, bone marrow failure and possibly sickle cell anemia.

Currently, the New York Blood Center is the only public bank of umbilical cord blood, but that may soon change. The National Heart, Lung, and Blood Institute has requested proposals to start a national cord blood banking system. Duke is among those proposing creation of a cord blood bank that would serve North Carolina and South Carolina.

While cord blood compatibility matching for unrelated donors does not have to be as close a match as traditional bone marrow transplants, matching across ethnic groups is rare, Kurtzberg said. To ensure the bone marrow reconstitution procedure is available to anyone who might need it, the Duke doctors propose a banking system that would include soliciting donations from a variety of ethnic and racial groups.

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