[Congressional Record Volume 151, Number 33 (Thursday, March 17, 2005)]
[Senate]
[Pages S3060-S3061]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]

      By Mr. HATCH (for himself, Mr. Dodd, Mr. Brownback, Mr. Harkin, 
        and Mr. Specter):
  S. 681. A bill to amend the Public Health Service Act to establish a 
National Cord Blood Stem Cell Bank Network to prepare, store, and 
distribute human umbilical cord blood stem cells for the treatment of 
patients and to support peer-reviewed research using such cells; to the 
Committee on Health, Education, Labor, and Pensions.
  Mr. HATCH. Mr. President, I am pleased to introduce ``The Cord Blood 
Stem Cell Act of 2005.'' I am particularly gratified that Senators 
Dodd, Brownback, Harkin, and Specter have joined me as cosponsors of 
this bipartisan bill. Since I first introduced this bill last Congress, 
there has been strong interest in Federal support for public cord blood 
banks as a widely accepted source of hematopoietic stem cells for 
transplant and research. The purpose of the Cord Blood Stem Cell Act is 
to create an easily accessible network to prepare, store, and 
distribute human umbilical cord blood stem cells for the treatment of 
patients and to support research using such cells.
  Today, thousands of Americans receive and are saved by bone marrow 
transplants each year. But thousands more die for lack of an 
appropriate donor. The good news is that research now suggests that the 
blood and stem cells from human placenta and umbilical cords may in 
some cases provide an alternative to bone marrow transplantation. For 
some patients, particularly those for whom a bone marrow match cannot 
be found, transplantation of these cells may be a life-saving therapy. 
Cord blood stem cell transplants are readily available, and they 
require less stringent matching from donors to recipients, thus 
decreasing the difficulty of finding a fully matched donor.
  Cord blood transplantation has been used successfully to treat 
leukemia, lymphoma, immunodeficiency diseases, sickle cell anemia, and 
certain metabolic diseases. However, the number of available cord blood 
stem cell units in the United States is insufficient to meet the need. 
The Cord Blood Stem Cell Act of 2005 proposes to establish an inventory 
of 150,000 cord blood stem cell units that reflects the diversity of 
the United States. In conjunction with the 5 million registered bone 
marrow donors, this registry will enable 95 percent of Americans to 
receive an appropriately matched transplant. The inventory would 
provide a critical additional resource for those in need of transplants 
and allocate a certain proportion of units to sustain further research 
on cord blood stem cells.
  In 2004, Congress asked the Institute of Medicine to provide an 
assessment of existing cord blood programs and inventories and to make 
recommendations to enhance the structure, function, and utility of such 
programs. Following a year-long process of review and evaluation, the 
Institute of Medicine will soon issue recommendations on the best 
methods to create and implement this public cord blood bank network. I 
look forward to reviewing these recommendations and ensuring that they 
are appropriately reflected in any legislation.

[[Page S3061]]

  Let me be clear--I am open to all options. It is my goal to create 
the best system to provide patients, clinicians, and families with 
access to these life-saving treatments by ensuring that the number of 
cord blood units available for transplant and research increases in the 
coming years.
  The system will include a network of qualified donor banks which will 
collect, test, and preserve cord blood stem cells. In addition, the 
system should educate and recruit donors, facilitate the rapid matching 
of donors and recipients, and quickly make such cells available to 
transplant centers for stem cell transplantation.
  I also strongly endorse the excellent work done by the National 
Marrow Donor Program (NMDP), which Congress created in 1986 and 
continues to fund. This registry already lists more than 42,000 units 
of umbilical cord blood and provides important patient advocacy and 
support services. It also provides an online service which allows 
physicians to compare potential cord blood matches with potential adult 
volunteer donor matches so that they can select the source of cells 
that best meets their patients' needs. Cord blood should be used to 
expand patient choices, not to restrict them. Patients, in consultation 
with their physicians, should have the ability to decide which is best 
for them.
  The establishment of a national infrastructure for cord blood will 
help save the lives of thousands of critically ill Americans. And while 
this legislation is not perfect, it is my hope that its introduction 
will encourage discussions on cord blood and the federal government's 
role in helping to increase the inventory of cord blood units in the 
United States.
  In my opinion, we must be sure that our nation can meet the needs of 
patients and physicians by ensuring a strong future for cord blood in 
this country. My primary goal is to ensure that the number of cord 
blood units available for transplant and research increases in the 
coming years. The only way that goal may be accomplished is through 
strong federal support. I look forward to working with my colleagues on 
doing everything possible to provide transplant patients with the best 
possible options by ensuring a strong future for cord blood 
transplantation in this country.
  Mr. DODD. Mr. President, I am pleased to join Senator Hatch and 
Senator Brownback in introducing legislation to advance the use of 
umbilical cord blood for clinical applications and research. I first 
became aware of the potential therapeutic benefits of cord blood when 
my first daughter was born three and a half years ago. At that time, 
our doctor informed me and my wife that preserving a small amount of 
blood from the umbilical cord could prove enormously beneficial later 
in her life. Should she become ill with a disease requiring bone marrow 
reconstitution, such as leukemia, her own cord blood stem cells could 
be used. This would eliminate the need to find a suitable bone marrow 
donor.
  The bill that we are introducing today will begin a new national 
commitment to the development of this technology--which has the 
potential to reduce pain and suffering and save the lives of so many 
Americans afflicted with some of the most debilitating illnesses. Cord 
blood has already been used successfully in treating a number of 
diseases, including sickle cell anemia and certain childhood cancers. 
However, the use of cord blood is still fledgling. Recent developments 
have suggested that the stem cells derived from cord blood may be 
useful in treating a much wider range of diseases, such as Parkinson's 
disease, diabetes, and heart disease.
  Like many Americans, I had never heard of cord blood before the birth 
of my daughter. It is not widely used--at least in this country. 
Approximately 95 percent of all bone marrow reconstitutions were done 
using a bone marrow transplant. Only five percent used cord blood. This 
figure is surprising when we consider the potential benefits of cord 
blood relative to bone marrow.
  First, it can be very difficult to find a suitable bone marrow donor. 
According to a General Accounting Office (GAO) report, of the 15,231 
individuals needing bone marrow transplants between 1997 and 2000 who 
conducted a preliminary search of the National Bone Marrow Donor 
Registry (NBMDR), only 4,056 received a transplant--a 27 percent 
success rate. This number is even lower for minorities. Cord blood 
would not only produce an additional source of donation; it also does 
not require as exact a match as bone marrow.
  In addition, cord blood is readily available. While it can take 
months between finding a bone marrow match and actually receiving a 
transplant, a unit of cord blood can be utilized in a matter of days or 
weeks. Cord blood also lowers the risk of complications for both the 
donor and the recipient. The need to extract bone marrow from the donor 
is eliminated, and the risk of infection or rejection by the recipient 
is significantly reduced. Finally, research has suggested that cord 
blood might produce better outcomes than bone marrow in children.
  Why then, given all of these benefits, has the use of cord blood not 
become much more prevalent in the United States? In Japan, where the 
use of cord blood in clinical setting is more advanced, nearly half of 
all transplants now use cord blood rather than bone marrow.
  The relatively infrequent use of cord blood in our country is at 
least partly attributable to the lack of a national infrastructure for 
the matching and distribution of cord blood units. There are a handful 
of cord blood banks around the country doing excellent work, but there 
is a much more developed infrastructure for bone marrow. This is thanks 
to legislation passed by Congress in 1986 that established a National 
Registry for bone marrow. By the way, that legislation is due to be 
reauthorized--and I would like to voice my strong support for that 
reauthorization.
  Our bill would create a similar infrastructure for cord blood. 
Specifically, it would direct the Secretary of Health and Human 
Services (HHS), acting through the Administrator of the Health 
Resources and Services Administration (HRSA), to establish a National 
Cord Blood Stem Cell Bank Network, as well as a registry of available 
cord blood units. The network and registry would be required to collect 
a minimum of 150,000 units, which should be sufficient to provide a 
suitable match for 90 percent of the U.S. population.
  Donor banks would also be required to educate the general public 
about the potential benefits of cord blood, and encourage an ethnically 
diverse population of cord blood donors. Given the untapped potential 
of cord blood, at least ten percent of the available units must also be 
made available for research. Finally, the legislation authorizes an 
appropriation of $15 million for fiscal year 2006, and such sums as may 
be necessary for fiscal years 2007 through 2010.
  Before finishing today I would like to make it clear that I strongly 
support the continuation of the excellent work done by the National 
Marrow Donor Program (NMDP). Cord blood should act as a complement to--
not a replacement for--bone marrow. In many cases, a bone marrow 
transplant is still the preferred therapy. Physicians should have the 
ability to decide on a case by case basis which is best for their 
patient.
  In the coming weeks, the Institute of Medicine (IOM) will release a 
report with recommendations about the appropriate structure for a cord 
blood registry. I look forward to reviewing those recommendations and, 
if necessary, making the appropriate changes to our legislation.
  I firmly believe that the creation of a national infrastructure for 
cord blood will, in time, save the lives of thousands of gravely ill 
Americans. We have a responsibility to encourage use of cord blood 
where appropriate today, and invest in research to fully tap the 
potential of this technology. I urge my colleagues to support this 
legislation.
                                 ______