Umbilical cord blood banking: implications for perinatal care providers.

OBJECTIVE To evaluate the risks and benefits of umbilical cord blood banking for future stem cell transplantation and to provide guidelines for Canadian perinatal care providers regarding the counselling, procedural, and ethical implications of this potential therapeutic option. OPTIONS Selective or routine collection and storage of umbilical cord blood for future autologous (self) or allogenic (related or unrelated) transplantation of hematopoietic stem cells to treat malignant and nonmalignant disorders in children and adults. OUTCOMES Maternal and perinatal morbidity, indications for umbilical cord blood transplantation, short- and long-term risks and benefits of umbilical cord blood transplantation, burden of umbilical cord blood collection on perinatal care providers, parental satisfaction, and health care costs. EVIDENCE MEDLINE and PubMed searches were conducted from January 1970 to October 2003 for English-language articles related to umbilical cord blood collection, banking, and transplantation; the Cochrane library was searched; and committee opinions of the Royal College of Obstetricians and Gynaecologists, the American Academy of Pediatrics, and the American College of Obstetricians and Gynecologists were obtained. VALUES The evidence collected was reviewed and evaluated by the Maternal/Fetal Medicine Committee of the Society of Obstetricians and Gynaecologists of Canada (SOGC), and recommendations were made using the evaluation of evidence guidelines developed by the Canadian Task Force on the Periodic Health Exam. BENEFITS, HARMS, AND COSTS Umbilical cord blood is a readily available source of hematopoietic stem cells used with increasing frequency as an alternative to bone marrow or peripheral stem cells for transplantation in the treatment of malignant and nonmalignant conditions in children and adults. Umbilical cord blood transplantation provides a rich source of hematopoietic stem cells with several advantages, including prompt availability, decreased risk of transmissible viral infections and graft-versus-host disease (GVHD) in both human leukocyte antigen(HLA)-matched and HLA-mismatched stem cell transplants, and ease of collection with little risk to the mother or newborn. Potential limitations of umbilical cord blood transplantation include insufficient stem cell dose to reliably treat larger children and adult recipients, slower rate of engraftment, and the potential for transfer of genetically abnormal hematopoietic stem cells. The optimum method of umbilical cord blood transplantation is not yet clear, though available evidence would favour collection before delivery of the placenta. There are many unresolved ethical issues related to umbilical cord blood banking, particularly related to the rapid growth of private, for-profit, cord blood banks offering long-term storage for potential future autologous or related allogenic transplantation. The financial burden to the health care system for public cord blood banking and to families for private cord blood collection and storage is considerable. RECOMMENDATIONS 1. Perinatal care providers should be informed about the promising clinical potential of hematopoietic stem cells in umbilical cord blood and about current indications for its collection, storage, and use, based on sound scientific evidence (II-3B). 2. Umbilical cord blood collection should be considered for a sibling or parent in need of stem cell transplantation when an HLA-identical bone marrow cell or peripheral stem cell donation from a sibling or parent is unavailable for transplantation (II-2B). 3. Umbilical cord blood should be considered when allogeneic transplantation is the treatment of choice for a child who does not have an HLA-identical sibling or a well-matched, unrelated adult bone marrow donor (II-2B). 4. Umbilical cord blood should be considered for allogeneic transplantation in adolescents and young adults with hematologic malignancies who have no suitable bone marrow donor and who require urgent transplantation (II-3B). 5. Altruistic donation of cord blood for public banking and subsequent allogeneic transplantation should be encouraged when umbilical cord blood banking is being considered by childbearing women, prenatal care providers, and(or) obstetric facilities (II-2B). 6. Collection and long-term storage of umbilical cord blood for autologous donation is not recommended because of the limited indications and lack of scientific evidence to support the practice (III-D). 7. Birth unit staff should receive training in standardized cord blood unit volume and reduce the rejection rate owing to labelling problems, bacterial contamination, and clotting (II-3B). 8. The safe management of obstetric delivery should never be compromised to facilitate cord blood collection. Manoeuvres to optimize cord blood unit volume, such as early clamping of the umbilical cord, may be employed at the discretion of the perinatal care team, provided the safety of the mother and newborn remains the major priority (III-A). 9. Collection of cord blood should be performed after the delivery of the infant but before delivery of the placenta, using a closed collection system and procedures that minimize risk of bacterial and maternal fluid contamination (see Figures 1a-1c) (I-B). 10. Public and private cord blood banks should strictly adhere to standardized policies and procedures for transportation, safety testing, HLA typing, cryopreservation, and long-term storage of umbilical cord blood units to prevent harm to the recipient, to eliminate the risk of transmitting communicable diseases, and thus to maximize the effectiveness of umbilical cord blood stem cell transplantation (II-1A). 11. Canada should establish registration, regulation, and accreditation of cord blood collection centres and banks (III-B). 12. Recruitment of cord blood donors should be fair and noncoercive. Criteria to ensure an equitable recruitment process include the following: (a) adequate supply to meet population transplantation needs; (b) fair distribution of the burdens and benefits of cord blood collection; (c) optimal timing of recruitment; (d) appropriately trained personnel; and (e) accurate recruitment message (III-A). 13. Informed consent for umbilical cord blood collection and banking should be obtained during prenatal care, before the onset of labour, with confirmation of consent after delivery (III-B). 14. Linkage of cord blood units and donors is recommended for public safety. Policies regarding the disclosure of abnormal test results to donor parents should be developed. Donor privacy and confidentiality of test results must be respected (III-C). 15. Commercial cord blood banks should be carefully regulated to ensure that promotion and pricing practices are fair, financial relationships are transparent, banked cord blood is stored and used according to approved standards, and parents and care providers understand the differences between autologous versus allogenic donations and private versus public banks (III-B). 16. Policies and procedures need to be developed by perinatal facilities and national health authorities to respond to prenatal requests for public and private cord blood banking (III-C).