[Congressional Record Volume 161, Number 168 (Monday, November 16, 2015)]
[Senate]
[Pages S7968-S7969]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]
By Mr. HATCH (for himself, Mr. Reed, Mr. Burr, and Mr. Franken):
S. 2282. A bill to amend the Public Health Service Act to reauthorize
the C.W. Bill Young Cell Transplantation Program and the National Cord
Blood Inventory, and for other purposes; to the Committee on Health,
Education, Labor, and Pensions.
Mr. HATCH. Mr. President, I rise today to introduce the Stem Cell
Therapeutic and Research Reauthorization Act of 2015. I am glad to have
Senators Reed, Burr, and Franken joining me as sponsors of this
bipartisan bill that will reauthorize critical, innovative, and life-
saving programs.
We have been working on this legislation throughout the year and have
met with stakeholders in blood cell transplantation to receive their
input. We also included members of the Senate Health, Education, Labor
and Pension Committee who are deeply committed to passing this
legislation.
In drafting this legislation, we also collaborated with our
counterparts in the House of Representatives. I am grateful for the
leadership of Congressman Chris Smith and Congresswoman Doris Matsui,
who did so much to get this legislation through the House. I commend my
colleagues and their staffs for their hard work.
I appreciate the opportunity to provide some history and background
that will explain why this reauthorization bill is so important. This
legislation will reauthorize for another five years both the C.W. Bill
Young Cell Transplantation Program and the National Cord Blood
Inventory, which are administered by the Health Resources and Services
Administration. These vital programs provide access to life-saving
treatments for serious conditions and disease.
Bone marrow contains blood-forming stem cells that develop into the
three blood cell types that keep the body healthy. The body uses those
red blood cells, white blood cells, and platelets as building blocks
for blood, tissue, and organs. These blood cells die naturally, and the
body must continuously make new ones. Serious health problems can
develop in people whose bone marrow cannot make enough new blood cells
to replace the cells that die.
Cord blood is a newborn baby's blood that remains in the placenta or
afterbirth. This blood can be collected after delivery at no risk to
the mother and baby. Like bone marrow, cord blood is also rich with
stem cells, and doctors can use it as an alternative to bone marrow
transplant. In fact, research in the mid-1980s highlighted the promise
of cord blood, demonstrating that it is more highly enriched with
blood-forming stem cells than bone marrow.
Cord blood transplantation has been used successfully to treat
leukemia, lymphoma, immunodeficiency diseases, sickle cell anemia, and
certain metabolic diseases. In addition to treating cancer and other
blood diseases, researchers are currently testing stem cells for a host
of disorders, including autoimmune and genetic disorders.
Cord blood research is also showing potential for use in the
innovative fields of cellular therapy and regenerative medicine.
Vaccines derived from cord blood to use against viruses and certain
types of cancers are currently in early trials. Research has also
indicated that cord blood could be used to treat conditions for which
few treatments are available, such as stroke, cerebral palsy, hearing
loss, autism, and traumatic brain injury.
Dr. Joanne Kurtzberg of the Carolinas Blood Bank is one of the
world's leading stem cell researchers at Duke University in Durham,
North Carolina. At the time of that groundbreaking scientific research
in the 1980s, Dr. Kurtzberg was caring for a 5 year old boy named
Matthew who had a rare, inherited blood disorder called Fanconi
anemia--a disease that leads to bone marrow failure. In light of the
new scientific findings, doctors planned a cord blood transplant for
Matthew at a hospital in Paris, France, using fully matched cord blood
that had been collected during the birth of his newly born baby sister.
Matthew's transplant in 1988 was a success, laying the groundwork for
cord blood transplantation.
Matthew is now in his 30s. He is married, working, and living a
healthy and productive life. He is living proof that cord blood
contains stem cells that can replenish the bone marrow and immune
system throughout a patient's life.
In 1993, with the assistance of Dr. Pablo Rubenstein of the New York
Blood Center, Dr. Kurtzberg performed the world's first unrelated donor
cord blood transplant at Duke University. Over the following years,
these amazing research doctors discovered more about the use of cord
blood transplantation in patients who cannot find a fully matched
donor.
Dr. Kurtzberg is also the president of the Cord Blood Association,
CBA. I am thankful for Dr. Kurtzberg and the CBA's support in helping
us develop meaningful legislation that will help cord blood banks do
their jobs. I also owe gratitude for the input and guidance on this
reauthorization bill that my staff and I received from Mike Boo and Dr.
Jeffrey Chell with the National Marrow Donor Program, NMDP.
I am proud to have a long history of working on this issue. In early
2003, I met with Joanne Kurtzberg, Pablo Rubenstein, and Phil Coelho of
Thermogenesis Corporation to discuss umbilical cord blood therapies as
a promising alternative to bone marrow transplantation and how the
Federal Government could help to increase collection efforts.
That night, I called Health and Human Services Secretary Tommy
Thompson to talk to him about this new science, and he agreed to meet
with Joanne, Pablo, and Phil the very next day. Staff from the Health
Resources and Services Administration, the Food and Drug
Administration, and the National Institutes of Health joined us for
that discussion. Secretary Thompson stressed that cord blood banks
would need to be managed through HRSA and promised to support my
legislation.
In October 2003, I introduced 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 stems
cells for the treatment of patients and to support peer-reviewed
research using those cells. That bill, the Cord Blood Stem Cell Act of
2003, S. 1717, gained strong bipartisan support over the last few
months of the 108th Congress.
Although it did not pass the Senate, my 2003 bill helped to generate
more interest in and support for blood stem cell transplantation. I
kept working on legislation to help increase access to these life-
saving transplants in the following Congress. In April 2005, the
Institute of Medicine, IOM, issued recommendations to create a national
cord blood network. Those of us in Congress who had been working on
cord blood and bone marrow realized that combining our bipartisan,
bicameral efforts would benefit patients by increasing treatment
options and encouraging future research. We reviewed the IOM report and
incorporated those important recommendations into one comprehensive
bill.
That legislation, the Stem Cell Therapeutic and Research Act of 2005,
P.L. 109-129, that was signed into law on December 20, 2005, created
the National Cord Blood Inventory and established an inventory goal of
at least 150,000 new and diverse cord blood stem cell units.
[[Page S7969]]
The 2005 law also combined the NCBI with the bone marrow donor
program that had been created in 1986 by the late Congressman Bill
Young to create a single point of access for blood stem cell
transplants and research. This single point of access allows physicians
the ability to search for any potential adult volunteer bone marrow
donor or umbilical cord blood unit anywhere across the globe.
Finally, our 2005 law also named the program the C.W. Bill Young Cell
Transplantation Program, in honor of Bill's tireless efforts to promote
bone marrow donation and transplantation.
Five years later, I was the lead sponsor of the Stem Cell Therapeutic
and Research Reauthorization Act of 2010, P.L. 111-264, which was
signed into law on October 8, 2010, and reauthorized the Program and
the NCBI for another 5 years. The 2010 law also placed new emphasis on
exploring innovations in cord blood collection and increasing the
number of collection sites across the nation.
Great progress has been made toward achieving the NCBI's goal of at
least 150,000 diverse cord blood units; however, data suggest that the
number of available cord blood units in the United States is still
insufficient to meet the estimated need for unrelated transplant, which
has increased by 25 percent since 2005. The number of transplants for
patients in minority populations has increased from 253 in 2000 to 990
in 2014. Much of this increase can be attributed to the increased
potential for bone marrow or cord blood transplant. This is exciting,
promising science.
There are still challenges to the success of bone marrow and cord
blood transplantation. Not all cord blood units contain enough cells to
transplant into all patients. In many cases, more than one unit is
preferred or necessary for larger children or adults. New science
indicates the possibility that using larger, higher quality cord blood
units will reduce the incidence of graft-versus-host disease, GVHD, a
serious complication of blood cell transplantation in which the donor
cells attack the recipient. GVHD is the biggest barrier to successful
transplantation.
I am glad to know that the Advisory Council and HRSA have been
working with public cord blood banks to discuss ways to increase CBU
quality and diversity. As the inventory continues to grow, the diverse
units within the NCBI will serve an increasing number of patients that
have difficulty obtaining cells from well-matched adult donors.
Cell dose and degree of match between patient and CBU are both
strongly associated with transplant outcomes. A larger inventory of
publicly available CBUs also will contribute to improved patient
survival after transplant because a growing inventory of high cell
count CBUs will allow better tissue matches.
Cord blood banks have told us that they cannot do this on their own.
Without continued support from HRSA, this life-saving science would be
financially unsustainable. We must reauthorize this important program.
Today, I am introducing the Stem Cell Therapeutic and Research
Reauthorization Act of 2015 to further advance the important work of
the bone marrow and cord blood programs.
Passage of this legislation will preserve the commitment that the
Congress made three decades ago to help patients with blood cancers and
other life-threatening diseases by helping to increase access to life-
saving transplants. It will also open the doors to new discoveries
within the fields of cellular therapy and regenerative medicine. I am
proud to introduce the Stem Cell Therapeutic and Research
Reauthorization Act of 2015, and I urge my colleagues to support it.
Mr. REED. Mr. President, today I am pleased to introduce the Stem
Cell Therapeutic and Research Reauthorization Act of 2015 with Senators
Hatch, Franken, and Burr. This bill offers promise to the tens of
thousands of individuals diagnosed with leukemia and lymphomas, sickle
cell anemia, and rare genetic blood disorders.
It will reauthorize the C.W. Bill Young National Marrow Donor
Program, which has been helping to connect individuals in need of a
bone marrow transplant with donors since 1986, and the National Cord
Blood Inventory, which has been helping to connect individuals in need
of an umbilical cord blood transplant with donors since 1999.
The public registries, made up of donors from all over the country,
have been a true lifeline for the Americans who have found an unrelated
match. By strengthening and enhancing the important programs operating
these registries, many more Americans will be afforded the opportunity
to find a match if they are ever in need.
I look forward to swift consideration of this legislation in the
Health, Education, Labor, and Pensions Committee and working toward
passage in the full Senate.
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