A Need for Renewed and Cohesive US Policy on Cord Blood Banking
Stem cells obtained from umbilical cord blood (CB) are used to treat more than 80 different diseases and are a standard treatment for many types of leukemias, lymphomas, myelodysplasias, and inherited immune system disorders. CB transplants have been carried out in humans for over 25 years, and hundreds of clinical trials are currently underway investigating CB’s therapeutic potential for a wide range of disorders, including autism, diabetes, cerebral palsy, and spinal cord injury. Extensive storage facilities have been established in the United States and around the world to collect, test, and freeze CB for later use in medical procedures. However, a divide between two different banking models—public versus private—has emerged, presenting several policy challenges. While the Food and Drug Administration currently regulates CB storage and use in the United States, other state and federal guidelines on CB education, awareness, and ethical considerations remain variable, and no mandatory international guidelines exist. In addition, federal funding for an important CB collection initiative that specifically targets minority populations is set to expire by the end of FY2015. To help organize and coordinate efforts across the United States and other nations, policymakers should implement regulations for: high quality standards for both private and public CB banks, a commitment to ethical practices, and an investment in educational campaigns and training programs for all steps of the CB banking process.
KeywordsCord blood Stem cell Policy United States Education FDA Legislation
Conflict of Interest
The authors have no conflicts of interest to report.
- 1.Stem Cell Transplant (Peripheral Blood, Bone Marrow, and Cord Blood Transplants). (2013). American Cancer Society. http://www.cancer.org/treatment/treatmentsandsideeffects/treatmenttypes/bonemarrowandperipheralbloodstemcelltransplant/bone-marrow-and-peripheral-blood-stem-cell-transplant-toc. Accessed 20 June 2015.
- 2.Interim Report to Congress on How Federal Funds Are Distributed to Cord Blood Banks Participating in the National Cord Blood Inventory. (2011). http://bloodcell.transplant.hrsa.gov/about/legislation_and_contracts/cbcc/072011interimreport.pdf. Accessed 20 June 2015.
- 6.North America Public Cord Blood Banks. (2015). Parent’s Guid to Cord Blood Found. http://parentsguidecordblood.org/public_NA.php. Accessed 20 June 2015.
- 7.USA Family Banks. (2015). Parent’s Guid to Cord Blood Found. http://parentsguidecordblood.org/findabankUS.php. Accessed 20 June 2015.
- 8.National Cord Blood Inventory: Practices for Increasing Availability for Transplants and Related Challenges. (2011). Washington, D.C., http://gao.gov/products/GAO-12-23. Accessed 11 June 2015.
- 9.Cord blood registries. (2015). Bone Marrow Donors Worldwide. http://www.bmdw.org/index.php?id=statistics_cordblood. Accessed 20 June 2015.
- 10.Cord blood donation programs for siblings. (2015). National Marrow Donor Progress. https://bethematch.org/Support-the-Cause/Donate-cord-blood/Cord-blood-options/Sibling-directed-donation/. Accessed 20 June 2015.
- 11.Newsletter - July 2013. (2013). Parent’s Guid to cord blood found. http://parentsguidecordblood.org/newsletter_archive/newsletters_2013-07.php. Accessed 20 June 2015.
- 13.O’Connor, M. A. C., Samuel, G., Jordens, C. F. C., & Kerridge, I. H. (2012). Umbilical cord blood banking: beyond the public-private divide. Journal of Law and Medicine, 9(3):512–516.Google Scholar
- 15.Donor Registry Transplant Data. (2015). http://bloodcell.transplant.hrsa.gov/research/transplant_data/registry_tx_data/index.html. Accessed 20 June 2015.
- 16.AMENDENT #2 - Request for Information--National Cord Blood Inventory. (2013). Federal Business Opportunities. https://www.fbo.gov/index?id=e4d2136a201a3cab1c559ca5918391d6. Accessed 20 June 2015.
- 17.Guidance for Industry: Biologics License Applications for Minimally Manipulated, Unrelated Allogeneic Placental/Umbilical Cord Blood Intended for Hematopoietic and Immunologic Reconstitution in Patients With Disorders Affecting the Hematopoietic System. (2014). FDA - Central Biology Evaluation Research, 1–48. http://www.fda.gov/downloads/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/CellularandGeneTherapy/UCM357135.pdf. Accessed 20 June 2015.
- 18.Human Cell and Tissue Establishment Registration - Public Query. (2014). FDA - Central Biology Evaluation Research. https://www.accessdata.fda.gov/scripts/cber/CFAppsPub/tiss/index.cfm. Accessed 20 June 2015.
- 19.Marketed Products. (2015). US Food Drug Adm. http://www.fda.gov/BiologicsBloodVaccines/CellularGeneTherapyProducts/ApprovedProducts/. Accessed 11 June 2015.
- 20.McCright B. (2013). Summary Basis for Regulatory Action, May 30, 2013 - ALLOCORD. http://www.fda.gov/biologicsbloodvaccines/cellulargenetherapyproducts/approvedproducts/ucm357569.htm. Accessed 20 June 2015.
- 21.Laughlin MJ. (2015). Cleveland cord blood center biologics license application. http://bloodcell.transplant.hrsa.gov/about/advisory_council/meetings/laughlinccbcblaapplicationmjl28aug2014.pdf. Accessed 20 June 2015.
- 22.Cassata R. (2013). The Second Anniversary of HPC, Cord Blood BLA Requirements – A Regulatory Review. http://www.raps.org/regulatoryDetail.aspx?id=9677. Accessed 20 June 2015.
- 23.Membership - Benefits. (2015). Int NetCord Found. http://www.netcord.org/?page=Benefits. Accessed 20 June 2015.
- 24.Cord Blood Bank Standards. (2015). http://www.factwebsite.org/cbstandards/. Accessed 20 June 2015.
- 25.AABB Accredited Cord Blood (CB) Facilities. (2015). AABB. http://www.aabb.org/sa/facilities/celltherapy/Pages/CordBloodAccrFac.aspx. Accessed 20 June 2015.
- 26.Member Cord Blood Bank Participation Criteria. (2015). National Marrow Donor Progress, 1–5. https://network.bethematchclinical.org/WorkArea/DownloadAsset.aspx?id=5112. Accessed 20 June 2015.
- 27.Cord Blood Association. (2015). http://www.cb-association.org/. Accessed 18 June 2015.
- 28.About Parent’s Guide to Cord Blood Foundation. (2015). Parent’s Guid to cord blood found. http://parentsguidecordblood.org/about.php. Accessed 20 June 2015.
- 29.Fernandez, C. V., Gordon, K., Van den Hof, M., Taweel, S., & Baylis, F. (2003). Knowledge and attitudes of pregnant women with regard to collection, testing and banking of cord blood stem cells. Canadian Medical Association Journal, 168(6):695–698.Google Scholar
- 30.Karagiorgou, L. Z., Pantazopoulou, M. N. P., Mainas, N. C., Beloukas, A. I., & Kriebardis, A. G. (2014). Knowledge about umbilical cord blood banking among Greek citizens. Blood Transfusion, 12(SUPPL.1). doi: 10.2450/2013.0297-12.