[Congressional Record Volume 149, Number 139 (Friday, October 3, 2003)]
[Senate]
[Pages S12469-S12470]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]

      By Mr. HATCH (for himself, Mr. Brownback, Mr. Specter, and Mr. 
        Dodd):
  S. 1717. 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, today, I am pleased to introduce the ``Cord 
Blood Stem Cell Act'' of 2003. I am particularly gratified that 
Senators Brownback, Specter, and Dodd have joined me as cosponsors of 
this bipartisan bill. The purpose of the Cord Blood Stem Cell Act is to 
create a network of qualified cord blood banking centers to prepare, 
store, and distribute human umbilical cord blood stem cells for the 
treatment of patients and to support research using such cells.
  As my colleagues are aware, 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 for several years, 
experts from a few centers have collected and preserved the blood and 
stem cells from human placenta and umbilical cords. These cells can 
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 can be a life-saving therapy.
  In some cases cord blood stem cell transplants provide an advantage 
relative to bone marrow transplants because they reduce risk to the 
donor, they are readily available, and they lower the risk of 
transplant complications. Cord blood stem cells also increase the 
success of transplantation from donors to recipients who are not fully 
matched, 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 
several metabolic diseases. However, despite initial successes, not 
enough cord blood exists currently to meet the need. Currently, the 
number of cord blood stem cell units in the United States is 
insufficient to meet the need.
  The bipartisan Cord Blood Stem Cell Act of 2003 proposes to establish 
an inventory of 150,000 cord blood stem cell units that reflects the 
diversity of the United States and will enable at least 90 percent of 
Americans to receive an appropriately matched cord blood stem cell 
transplant. The inventory would provide a critical resource for those 
in need of transplants and allocate a certain proportion of units to 
sustain further research on cord blood stem cells.
  The National Cord Blood Stem Cell Network, administered by the 
Secretary of Health and Human services and a Board of Directors 
appointed by the Secretary, would be a system of qualified donor banks 
which will acquire, test, and preserve cord blood stem cells, educate 
and recruit donors, and make such cells available to transplant centers 
for stem cell transplantation. The Network would establish a National 
Cord Blood Stem Cell Registry, which would acquire and distribute 
donated units of cord blood, provide health care professionals with the 
ability to search the entire registry for a suitable donor match for 
patients and maintain a database to document the activities of the 
Network.
  I ask unanimous consent that a brief section-by-section analysis of 
the National Cord Blood Stem Cell Act be printed in the Record.
  There being no objection, the analysis was ordered to be printed in 
the Record, as follows:

                    Cord Blood Stem Cell Act of 2003

       Section 1--Short Title: Cord Blood Stem Cell Act of 2003
       Section 2--National Cord Blood Stem Cell Bank Network:
       Subsection (a): Sets fourth the definitions to be used for 
     the purposes of this document.
       Subsection (b): (1) In general--A national cord blood stem 
     cell bank containing of 150,000 units will be established and 
     provided for by qualified cord blood stem cell banks. (2) 
     Purpose of donor banks--The banks will acquire tissue type, 
     test, cryopreserve, and store donated cord blood stem cell 
     units and make cord blood units available. Ten percent of 
     this cord blood inventory will be allocated for research. (3) 
     Eligibility of donor banks--In order to create an effective 
     donor bank it must obtain all licenses, certifications, and 
     registrations needed to operate. It must preform adequate 
     screenings of the cord blood in order to eliminate 
     transmission of disease and other harmful infections. Donor 
     banks must uphold the utmost confidentiality to protect the 
     patients and the donors under HIPAA. A donor bank must 
     encourage an ethnically diverse population of cord blood stem 
     cells. A donor bank must also develop an adequate system of 
     communication for nationwide usage of cord blood stem cells, 
     and educate the public on the advantages of donating and 
     utilizing cord blood stem cells.
       Subsection (c): Administration of the Network--Cord blood 
     stem cell banks shall be run by a board of directors, 
     including a chairman. Each member of the board of directors 
     shall serve a 3-year term, and the board will be represented 
     by various experienced people. Each year \1/3\ of the board 
     of directors' terms will expire.
       There shall also be a National Cord Blood Stem Cell 
     registry. The registry shall find appropriate cord blood for 
     matched candidates; allow searches in the registry for a 
     suitable donor for patients; and maintain a healthy, updated 
     database.
       The Database shall be confidential under HIPAA, and will be 
     carefully monitored by the Secretary.
       Subsection (d): Authorization of Appropriation--Authorizes 
     $15 million for FY2004.
       This is a therapy that can be life-saving for many 
     Americans with diseases that can be treated by stem cell 
     transplantation; particularly for many minorities and other 
     Americans who are unable to find a matching bone marrow 
     donor. I am pleased to introduce this bill that will save 
     lives by providing Americans with the opportunity to receive 
     a promising therapy.

  Mr. DODD. Mr. President, I am pleased to join Senator Hatch, Senator 
Brownback, and Senator Specter 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 daughter was born 2 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, he told us, 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. In the 
first 8 months of this year, 95 percent of all bone marrow 
reconstitutions were done using a bone marrow transplant. Only 5 
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 of 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

[[Page S12470]]

much more prevalent in the United States? In Japan, where the use of 
cord blood in clinical settings 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 next year--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 10 percent of the available units must also be 
made available for research. Finally, the legislation authorizes an 
appropriation of $15 million for fiscal year 2004, and such sums as may 
be necessary for fiscal years 2005 through 2008.
  Mr. President, 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 patients. That is why I am hopeful that the NMDP will have a 
very active role in designing and supporting the National Cord Blood 
Stem Cell Network and Registry. Ideally, the two will work together to 
provide a single resource where doctors can search both cord blood 
stockpiles and a list of marrow donors for a suitable match for their 
patients.
  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.

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