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Report: Set Federal Standards for Cord Blood Banks

Stored umbilical cord blood an increasingly useful source of stem cells

THURSDAY, April 14, 2005 (HealthDay News) -- The U.S. Department of Health and Human Services (HHS) should create a National Cord Blood Policy Board that would set standards and rules for umbilical cord blood donation, collection and use, says a new report from the Institute of Medicine (IOM).

Cord blood is an increasingly useful source of hematopoietic stem cells, regenerative cells similar to those found in adult bone marrow. According to the U.S. National Academies of Sciences, transplanted cord blood stem cells are already helping save and extend the lives of roughly 20,000 Americans with leukemia, lymphoma, sickle cell anemia and other illnesses each year. At the same time, thousands of other patients in need die each year while waiting for a proper transplant match.

The new HHS report, titled Cord Blood: Establishing a National Hematopoietic Stem Cell Bank Program, also calls for the department's Health Resources and Services Administration (HRSA) to request proposals from organizations that might act as a new, national Cord Blood Coordinating Center to manage the daily operations of cord blood banking and allocation.

"The implementation of this report will provide transplanters and their patients with the assurance that we have safe units that can be used effectively," said co-author Kristine M. Gebbie, an associate professor of nursing and director of the Center for Health Policy at Columbia University School of Nursing, in New York City.

The report was mandated by Congress, which called for new strategies for overseeing federal money spent on cord blood donations and distribution.

"We were asked to do this proposal because the House and Senate version of the appropriation of $10 million for a cord blood program couldn't decide what structure should be there," Gebbie said. "So, HHS was instructed to have the IOM report on how to structure a national program that could be used to disperse these funds."

While there are 22 public banks in the United States that collect, store and distribute donated cord blood containing these cells, there is no centralized coordination, she pointed out.

"We think this proposal is based on a good understanding of what cord blood banking means," Gebbie said. "The proposal takes into account the needs of cord blood banks and physicians who do the transplants and their patients who want access to transplants in a timely manner, who want a quality product and want to know that the outcomes will be tracked, so they can see over time what works and what doesn't work and what works better."

Gebbie said there are already organizations that do some of the needed work. According to the report, the government should ask for bids from existing organizations to run the new system. "We don't think this coordinating center will be run by the government," she said. "The national coordinating center doesn't have to have everything under one roof, it just has to be able to coordinate all the pieces."

There does need to be a national oversight policy body at the level of the Secretary of HHS, Gebbie said. "This is an emerging field, and someone needs to be looking at the outcome data and providing ongoing direction."

There also needs to be a national coordinating center that makes sure that the banks meet the accreditation standards. "There needs to be a single portal to information," Gebbie said.

In addition, the inventory of cord blood has to grow. "We don't have enough blood units right now to provide matches to everybody who could benefit from them," Gebbie said. "Probably half of the units that are currently banked wouldn't meet quality standards once we get quality standards in place."

According to Gebbie, 100,000 more units are needed to insure that all current donor-recipient matches can be made.

An executive working at a private stem cell bank both agreed and disagreed with the new plan.

"The report provides an excellent and unbiased foundation for the establishment of a national cord blood program," said Kaj Rydman, president of California Cryobank Stem Cell Services Inc.

It's important that uniform quality standards are developed and enforced, whether cord blood stem cell banks are public or private, Rydman said. "No such facility should be allowed to operate without federal oversight and licensure."

However, some of the committee's recommendation may add an unnecessary layer of bureaucracy without adding any benefit, he said. "The current standards, as well as the upcoming federal regulations, provide enough tools for assuring quality and safety in cord blood stem cell collection, processing and storage," Rydman contended.

"Moreover, to avoid duplication of resources, the new National Board should consider the use of private banks to expand the regional coverage of the publicly funded Cord Blood Program by allocating funds to qualified private banks to process and store public units," he suggested.

More information

The National Marrow Donor Program can tell you more about stem cells from umbilical cord blood.

SOURCES: Kristine M. Gebbie, Dr.PH., R.N., associate professor, nursing, and director, Center for Health Policy, Columbia University School of Nursing, New York City; Kaj Rydman, president, CEO, California Cryobank Stem Cell Services Inc., Santa Monica; April 14, 2005, Institute of Medicine report, Cord Blood: Establishing a National Hematopoietic Stem Cell Bank Program
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