The definition of a "quality" umbilical cord blood unit is still being refined. Initial procedures developed in the NIH COBLT trial called for a minimum unit volume at the time of the collection of 60 mL or a total nucleated cell count of 6 x 108 or greater if the volume was between 40 and 60 mL; units with volumes of less than 40 mL were discarded. Public banks also have numerous other exclusion criteria that are meant to assure quality. Many banks now use a minimum of 1 x 109 total nucleated cell count to define an adequate unit; this results in as many as 65–70% of units being discarded after initial collection (Joanne Kurtzberg, MD, Director, Carolinas Cord Blood Bank at Duke, personal communication, July 1, 2005). The collection of units for private banking is subject to the pressure of "our only chance to collect cells." Therefore, suboptimal units are often sent to the collection facility. At the time of the processing, the private bank will usually contact the parents to have them decide whether to store or discard the unit. Many decide to proceed with storage with very little knowledge that the unit could not be realistically used at a later date.
Because umbilical cord blood banking is in its infancy, issues with long-term availability have not arisen. Studies have shown long-term survival of stem cells in cord units for up to 15 years after initial freezing. Viability of cells after this time has not been substantiated. This, therefore, calls into question the use of autologous stem cells harvested at birth for regenerative medicine many decades later. In addition, private banks must continue to recruit new donors to remain financially viable. What is to happen to privately donated units if a company becomes insolvent?
The final argument for public banking involves the use of a human resource for the greater good of mankind. Public banks collect units from patients with a wide ethnic diversity. Many actually seek out certain ethnic groups that are underrepresented in the national bone marrow registry. Private banking allows those of means to collect stem cells while the less fortunate have no access to this valuable resource. Because of the economics of maintaining a public bank based on current use, many public banks have found it necessary to curtail or even eliminate collection activity (this includes an initial effort by the Red Cross to establish a cord blood bank). The IOM report recommended federal funding for the acquisition of 100,000 new high quality units.7 Recently, the Senate Health, Education, Labor and Pensions Committee approved a bill (S.1317) to establish a national cord blood bank. The bill would authorize the use of 19 million dollars already set aside by Congress to support inventory growth in the years 2005 and 2006 and directs an additional 15 million dollars to be set aside each year between 2007 and 2010 to establish the national inventory suggested by the IOM report. The bill would also consolidate the current national bone marrow registry and the new cord blood registry under a newly created C. W. Bill Young Cell Transplantation Program. The bill is expected to pass the House without going to conference committee and will be sent to President Bush for signature.
All of these reasons have led many organizations and countries to take a stand against private banking. The American Academy of Pediatrics has suggested "...private storage of cord blood for biologic insurance is unwise." In Europe, the practice of private cord banking has been banned by law in Italy since 2002. The Royal College of Obstetricians and Gynaecologists states their position as "Routine directed commercial cord blood collection and stem cell storage cannot be recommended at the present time, because of the insufficient scientific base to support such practices...." The French National Consultative Ethics Committee's "...recommendation to decision makers is that they should encourage a considerable extension of cord public banks for essentially allogeneic purposes, rather than subscribing to the creation of private banks for strictly autologous purposes, the potential therapeutic usefulness of which is, as yet, in no way corroborated." Finally, in March of 2004, the European Group on Ethics in Science and New Technologies stated their position as follows: "The legitimacy of commercial cord blood banks for autologous use should be questioned as they sell a service which has presently no real use regarding therapeutic options. Thus, they promise more than they can deliver. The activities of such banks raise serious ethical criticisms."