U.S. Cord Blood Supply Lacking, GAO Says

Private industry competition and a sluggish market affect public supply.

October 12, 2011, 2:38 PM

Oct. 12, 2011— -- WASHINGTON -- The national supply of umbilical cord blood is not growing as fast as it could, in part because of competition from private blood banks and a slowdown in growth in the cord blood market, according to a new report from the Government Accountability Office (GAO).

In the year after the government created a National Cord Blood Inventory (NCBI) in 2005, sales of cord blood rose by nearly 14 percent, then went up more than 38 percent the following year.

But sales grew just 0.4 percent between 2009 and 2010.

In addition, public cord blood banks are facing competition from the growing number of private banks, the GAO report said. Some parents choose to bank their infants' cord blood with a private blood bank so it can be used by a family member if needed, an option not available if they donate to a public cord blood bank.

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Although the overall number of umbilical cord blood units available for transplants has grown, more progress is needed, the report writers concluded.

There are nearly 135,000 units of cord blood available in the NCBI, and in 2010 about 1,200 patients received cord blood transplants from units identified in the registry.

Still, the government and cord blood advocates would like to see 30 percent more cord blood units and say there aren't enough units from certain racial and ethnic groups, who may have difficulty finding a match if they need a stem cell transplant.

A 2005 stem cell law provided funding to bank 150,000 new units of cord blood. At the time, there were an estimated 44,000 units, which was considered inadequate to offer a wide range of units for those who might benefit from a stem cell transplant.

As mandated by the law, the federal government contracted with 13 public cord blood banks to provide blood. Because the donor in a cord blood transplant doesn't need to be an exact match, cord blood is particularly valuable for people for whom an exact donor match can't be found, including African Americans and people of mixed ethnic heritage with blood and genetic disorders who often have a difficult time finding a transplant donor.

When the stem cell law was reauthorized in 2010, it included new money to increase the genetic diversity of the supply. More than 70 percent of the units of cord blood in the NCBI are from white and Hispanic donors. Just 14 percent of all units in the registry are from blacks, and just 4 percent are from Asians.

Thousands of people who need a transplant every year can't find a match, said Machi Scaradavou, MD, pediatric oncologist at Memorial Sloan-Kettering Cancer Center in New York City and medical director of the New York Blood Center's National Blood Cord Program.

The federal government pays the 13 cord blood banks -- most of which are nonprofits -- a little more than $1,000 for each unit banked, but the banks' biggest source of income is from selling the unit to be used in a transplant. The GAO report said banks receive payments of between $22,800 and $30,000 per cord blood unit.

But demand for cord blood seems to be slowing, and along with it, money from the blood banks' biggest revenue stream.

HHS added that the waning demand is likely due to the costs associated with cord blood transplants and issues with banking and not that fewer people need transplants.

The GAO claims that part of the demand slowdown may center around the medical community's questions about which diseases can most benefit from stem cell transplants. HHS has convened an expert panel to develop a consensus for which diagnoses stem cell transplants would be an accepted standard of care.

Another option to improve blood cord collection identified in the report is establishment of a remote collection program that would allow mothers who deliver a child at a site that is not equipped to collect the cord blood to send the umbilical cord to a bank that can process it.

To examine that idea, the Health Resources and Services Administration is trying out remote collection to determine whether using a "cord blood donation kit" can increase donations.

Of the 758 units collected through the remote collection pilot program as of March 2011, just 68 were banked. Most units were considered unusable because they arrived too late, not enough cord blood was collected, or required labels or documents were missing.

Officials who were interviewed for the GAO report said they weren't sure samples sent via a kit would meet the FDA's requirement for licensure, which goes into effect Oct. 20.

The FDA regulates cord blood used in transplants when the donor is not related to the patient. Starting in less than 10 days, centers that collect cord blood units must be licensed by the FDA and the units will be treated like any other FDA-regulated biologic.

Units from nonlicensed centers may still be used in FDA-approved clinical trials.

A number of banks expressed concern over the new FDA regulations, including the cost of complying.