Photos courtesy of Coriell Institute of Medical Research
This spring Korea's Seoul National University announced plans to open a human embryonic stem cell bank. In the United States, the federal government is poised to fund a stem cell bank of different kind.
With $79 million (US) in funding over the next five years, bills under consideration by the US Senate and House would organize public cord blood banking, set new standards, and offer money to make it happen. The Stem Cell Therapeutic and Research Act of 2005 would set aside a significant proportion (10%) of donated units for research. "Part of what we think an improved national system will do is facilitate making units available for research, so we can go a lot farther in understanding how to use this resource," says Kristine M. Gebbie, the lead author of an April report from the Institute of Medicine (IOM), which was...
HOW IT STANDS
At the moment, the process of getting donors and patients together is at best inefficient. The median time for locating an HLA match is now more than four months, according to the IOM report. In reality, finding a match may happen almost instantaneously or may never happen, says NMDP spokesman Patrick Thompson. "The new legislation will help by increasing the supply of cord blood and by having more banks in the registry. The more banks in the registry the smoother the program is run, and the more units are available the greater their chances of finding a match," he says.
Without a single organization overseeing all the banks, "it was hard to know what the state of the banks was," says Gebbie, who is also director of the Center for Health Policy at the Columbia University School of Nursing in New York. They found that only a few cord blood banks had gone through an accreditation process. "There isn't a standard accreditation and there are no commonly accepted standards," she says. "We concluded that a sizable proportion of the units currently in storage probably would never be usable, because they wouldn't meet standards if we had them."
There are currently only 50,000 usable units of cord blood in public banks, largely due to poor collection procedures and incomplete paperwork. At least 100,000 more high-quality units are necessary, according to the IOM.
Cord blood banks need to collect units with a high enough concentration of stem cells to establish a new immune system in an immunocompromised patient. And more high-quality units mean the greater likelihood of a match. Often, a mismatch of one or two degrees is the best that can be found in public banks. The problem is particularly acute when it comes to minority populations, where it is often impossible to find a match. In the current stock of cord blood, 62% of units are from whites, 15% from Hispanics, 7% from African Americans, 5% from Asians, 5% from mixed-race donors, and 1% from Native Americans.
How the approximately 15 private banks will fit into this new system isn't clear; the purpose of private banks is different than public banks. They market heavily to expectant parents, and charge up to $1,500 to store cord blood, plus a $100 yearly maintenance fee. There are also additional fees for the cord blood collection kit, courier service to the cord blood bank, and initial processing.
By storing their baby's cord blood, parents are assured that stem cells will be a perfect match to treat diseases their children might never get. Some of these banks even hold out the promise that the banked stem cells might one day cure diseases in which stem cells are theoretically useful, but no evidence or treatment currently exists.
"There are some people who would say the private banking is very much on the seedy side," Gebbie says. "It is holding out in what some of the advertising is called biological insurance, as if it's a sure thing that at some point you and your family might make use of this unit of stored cord blood."
The American Academy of Pediatrics (AAP) has taken a strong stand against private cord blood banking. The likelihood that a currently healthy child would need his or her own stored cells ranges from 1 in 1,000 to 1 in 200,000. It's typically a sensible move only if there is a family member with a current or potential need to undergo a stem cell transplantation, although the AAP does recommend that people donate cord blood to public banks.
One private bank CEO believes that establishing national standards will be a step forward for private banks. "It legitimizes the industry as a whole," says Kaj Rydman, the president of California Cryobank Stem Cell Services in Santa Monica.
John McCamant, from the Medical Technology Stock Letter in Berkeley, Calif., doesn't think the legislation will have any effect on private banks, because they are not directly competing with public banks. However, "if private banks were to explode and we really thought there were a lot of uses for cord blood, that would make it harder for public banks to get cord blood," McCamant says. "If they could prove there was a value to keeping this stuff, that would grow the market tremendously."
Another expert sees many new uses for cord blood stem cells developing over the next two decades. "In the future we will be using these cells for the treatment of neurodegenerative disease and other forms of tissue repair and regeneration," says Joanne Kurtzberg, the chief of the division of bone and marrow transplantation at Duke University.
"There is a lot more work that needs to be done," she adds. "I have treated children with genetic diseases that involve the heart and the brain, and these cells can correct those diseases. We have evidence that these cells differentiate into cells of those organs. But whether we will be able to use these cells to treat more common diseases is unknown," she says.
Kurtzberg thinks the bill falls short when it comes to money earmarked for research. "I don't think that's really enough to support the biologic research necessary for cord blood stem cells. There has to be more federal funding for all stem cell research," she says.
On May 24, the act passed the House by a vote of 430 to 1. It is awaiting action in the Senate, where it is expected to pass by a wide margin. President Bush has said he will sign the bill, while vetoing a bill to provide funding for embryonic stem cell research.