A comparative analysis of the opinions from European national and international ethics committees regarding the collection, storage and use of umbilical cord blood.

Abstract

Since the first cord blood transplant was performed in a patient with Fanconi’s anaemia in 19881, umbilical cord blood has successfully been used as a source of stem cells, mostly in children, for haematopoietic reconstitution in allogeneic haematopoietic stem cell transplantation as an alternative to bone marrow or peripheral blood progenitor cells2. Related and unrelated umbilical cord blood transplants have been used for children with malignant3,4 and non-malignant5 diseases. Fewer data are available on adult cord blood transplants6, with most reported cases involving patients with haemoglobinopathies7. Cord blood as a source of stem cells has important advantages when compared with human leucocyte antigen (HLA)-matched unrelated bone marrow transplants. These advantages include: a lower incidence of Graft-versus-Host disease, absence of risks and pain for donors, immediate availability for access and use, minimal cell manipulation and better long-term immune recovery resulting in a similar long-term survival8. In 1991 the first public cord blood bank was established at the New York Blood Center9. Two main cord blood banking options are available: public and private10–14. Public non-profit accredited cord blood banks receive umbilical cord blood following informed parental consent. Cell count and volume are key parameters for the eligibility of cord blood units for storage. If the unit of blood meets the requisites for therapeutic use it will be screened using a series of tests, registered in international registries and made available to national and foreign transplant centres15. In this case the cord blood becomes the property of the public bank for subsequent clinical use. Approximately 20% of all collected cord blood units meet the established criteria for storage16. Samples that are not suitable, or that cease to be suitable, for storage for therapeutic purposes may be used for research purposes17. In this way society also benefits from discarded blood units18. Most banks co-operate through international registries that list publicly banked cord blood units in searchable databases such as Bone Marrow Donors Worldwide (BMDW), the NetCord Foundation, the National Marrow Donor Program (NMDP) and other national registries, in order to provide access to all patients in need. International accreditation bodies, such as the NetCord Foundation for the Accreditation of Cellular Therapy (FACT) and governmental regulatory requirements are in place to ensure that publicly available cord blood units meet strict quality criteria. On 21st November 2011 the Bone Marrow Donor Worldwide website reported that a total of 497,501 cord blood units were stored by 43 banking networks in 26 countries19. These free and anonymous donations resulted in over 20,000 unrelated cord blood transplantations worldwide20. Private cord blood banks obtain blood samples and store them for individual use by families. In this case the blood remains the property of the child under the guardianship of the parents. Cord blood samples stored in private banks for either autologous or allogeneic transplants (for the infant donor or for a related family member) are not searchable by the public. Indeed, the major criticism of private banks is precisely the non-availability to the public of this blood21. Moreover, both scientific and clinical data show that the estimated chance that an individual will develop a disease treatable with his or her own stored cord blood is between 0.04% and 0.005%22. More than 780,000 cord blood units are stored in over 130 private cord blood banks worldwide23. Other models of banking (family directed24, mixed public-private25, and others) also exist. For instance, in the United Kingdom, Richard Branson launched Virgin Health Bank, an innovative experiment in dual banking (mixed public-private storage): 20% of the cord blood sample is stored for private use, for the child or a family member, and 80% is donated to the public part of the bank, which is accessible to anyone in the world who needs it, at no cost. Virgin Health Bank’s challenge is to combine the known potential of public-sector allogeneic storage with the possible, albeit at present remote, applications of autologous storage in specific fields of regenerative medicine26. Numerous research teams continue to investigate the usefulness of cord blood for purposes other than haematological disorders, including in particular: repairing damage caused by heart disease and infarcts, diabetes mellitus, traumatic brain and spinal injuries and stroke27. Although the therapeutic usefulness of cord blood for these diseases and pathological conditions has not yet been demonstrated and there are currently very few validated indications for autologous storage, significant advances are being made28. In this regard, according to many authors “the possibility for future discovery or additional indications for autologous cord blood transplant” motivates “us to re-examine our attitudes towards private cord blood banking”29. In particular, “directed-family cord blood banking activities should be encouraged”30.