Cord Blood Registry Sees FDA Regulation as Good for Consumers and Industry
SAN BRUNO, Calif., Nov. 24 /PRNewswire/ -- Beginning in May 2005, cord
blood banks must meet new federal safety standards mandated by the Food and
Drug Administration (FDA). Since 1997, Cord Blood Registry (CBR), the
nation's leading newborn stem cell bank, has been preparing for these new
regulations, which will set the baseline standards for all cord blood banks.
The blood remaining in the umbilical cord after it has been clamped and
cut, "cord blood," has proven to be a rich source of stem cells, and a growing
number of expectant parents are taking advantage of this once-in-a-lifetime
chance by arranging to collect and bank their newborns' stem cells as a type
of "biological insurance" to help protect their families' future health.
"Unlike other companies, we have been anxious for the FDA to issue these
regulations," said Stephen Grant, Vice President of Communications for CBR.
"CBR has spent a great deal of time and effort working with the FDA. Although
CBR has always maintained the highest level of quality standards, these
regulations provide an important legal foundation and add validation to the
importance of family banking."
First proposed in 1997, the FDA rules require cord blood banks to take
specific steps to prevent contamination throughout the collection, processing,
labeling, and distribution aspects of the service. The only current industry
oversight is offered by the AABB (formerly the American Association of Blood
Banks), which established voluntary accreditation guidelines for cord blood
banks. Leading the industry, CBR also worked with the AABB and became the
first family cord blood bank to achieve accreditation in 1998.
Achieving and maintaining regulatory compliance is a significant financial
investment that many banks will not be able to undertake. According to Johnnie
Domingue, VP, COO, and CFO, "CBR has no outstanding debt and had approximately
$25 million in cash and investments as of September 30, 2004. CBR has been
profitable from operating activities since 1999, and being financially strong
is critical to maintaining systems that are in compliance with federal
regulations. It offers our clients the peace of mind and confidence that we
will be here for them in the future and that their cord blood was processed
and stored properly."
CBR focuses its business and research solely on the processing and
preservation of newborn stem cells, unlike some other cord blood banks that
have elected a more risky business model by branching out into biotech and
drug development. In 2004, CBR committed $10 million to its new laboratory and
will invest $75 million more in this facility over the next 7 years. The new
80,000-square-foot facility can handle the exponential growth the company has
seen in the last year and expects to see in the future. CBR announced
increased sales, with client contracts up 107% over the same period in 2003.
"Recent, early success and promise using stem cells for heart disease,
stroke, vascular disease, and brain and spinal cord injury has fueled an
increased level of awareness about the power and value of saving newborn stem
cells," Grant said. "Banking newborn stem cells is literally a one-time
opportunity to collect and preserve a lifesaving biological resource for
families."
About Cord Blood Registry
Cord Blood Registry is the leader in newborn stem cell processing and
cryopreservation for familial use in transplantation and regenerative
medicine. The stem cells preserved by CBR are collected immediately after the
birth of a newborn and are then available to be used in treatments for the
newborn, siblings, and any compatible genetic family member. Once
transplanted, the cells have the ability to repair damaged or diseased tissues
with little risk of rejection and increased long-term survival. The company's
research and development is focused on the collection, processing, and storage
improvement to optimize cell yield. Additionally, CBR facilitates collection
of donated research samples, available for the nearly 200 research programs
worldwide that are focused on stem cell expansion and cell-based therapies.
For more information visit http://www.cordblood.com, or call 1-888-CORD BLOOD.
Cord Blood Registry is a registered trademark of Cbr Systems, Inc.
Contact:
Rita Kennen
Cord Blood Registry
San Bruno, CA 94066
1-800-588-6377, Ext. 239
rkennen@cordblood.com
http://www.cordblood.com
SOURCE Cord Blood Registry
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Related links:
http://www.cordblood.com
CONTACT:
Rita Kennen of Cord Blood Registry,
800-588-6377, ext. 239, or rkennen@cordblood.com
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