[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.
                                 ______