[Congressional Record (Bound Edition), Volume 161 (2015), Part 10]
[House]
[Pages 13762-13765]
[From the U.S. Government Publishing Office, www.gpo.gov]




     STEM CELL THERAPEUTIC AND RESEARCH REAUTHORIZATION ACT OF 2015

  Mr. GUTHRIE. Mr. Speaker, I move to suspend the rules and pass the 
bill (H.R. 2820) to reauthorize the Stem Cell Therapeutic and Research 
Act of 2005, and for other purposes.
  The Clerk read the title of the bill.
  The text of the bill is as follows:

                               H.R. 2820

       Be it enacted by the Senate and House of Representatives of 
     the United States of America in Congress assembled,

     SECTION 1. SHORT TITLE.

        This Act may be cited as the ``Stem Cell Therapeutic and 
     Research Reauthorization Act of 2015''.

     SEC. 2. AMENDMENTS TO THE STEM CELL THERAPEUTIC AND RESEARCH 
                   ACT OF 2005.

       (a) Cord Blood Inventory.--Section 2 of the Stem Cell 
     Therapeutic and Research Act of 2005 (42 U.S.C. 274k note) is 
     amended in subsection (h)--
       (1) in paragraph (1)--
       (A) by striking ``$23,000,000 for each of fiscal years 2011 
     through 2014 and''; and
       (B) by inserting before the period at the end the 
     following: ``and $23,000,000 for each of fiscal years 2016 
     through 2020''; and
       (2) in paragraph (2), by striking ``2011 through 2015'' and 
     inserting ``2015 through 2020''.
       (b) National Program.--Section 379B of the Public Health 
     Service Act (42 U.S.C. 274m) is amended by striking ``2011 
     through 2014'' and inserting ``2016 through 2020''.

  The SPEAKER pro tempore. Pursuant to the rule, the gentleman from 
Kentucky (Mr. Guthrie) and the gentleman from Texas (Mr. Gene Green) 
each will control 20 minutes.
  The Chair recognizes the gentleman from Kentucky.


                             General Leave

  Mr. GUTHRIE. Mr. Speaker, I ask unanimous consent that all Members 
have 5 legislative days in which to revise and extend their remarks and 
insert extraneous materials into the Record on the bill.
  The SPEAKER pro tempore. Is there objection to the request of the 
gentleman from Kentucky?
  There was no objection.
  Mr. GUTHRIE. Mr. Speaker, I yield myself such time as I may consume.
  Mr. Speaker, I rise today in support of H.R. 2820, the Stem Cell 
Therapeutic and Research Reauthorization Act of 2015, introduced by my 
colleagues Chris Smith and Doris Matsui.
  Bone marrow transplantation has been used for more than 50 years to 
treat blood-related diseases, such as leukemia, different anemias, and 
lymphoma. It is a rich source of blood stem cells. In more recent 
years,

[[Page 13763]]

breakthroughs have been made using blood stem cells from umbilical cord 
blood in the treatment of those various blood-related diseases and 
conditions.
  It can be very difficult to find a bone marrow transplant match, and 
in some cases, cord blood can be used instead. Bone marrow and cord 
blood donation are critical to ensure those in need of transplant can 
find a match. The need for this lifesaving transplantation has risen 25 
percent since 2005.
  H.R. 2820 reauthorizes the National Marrow Donor Program and creates 
a national network of public cord blood banks. The legislation also 
provides healthcare professionals the ability to search for bone marrow 
and umbilical cord blood units for transplantation.
  H.R. 2820 also bolsters patient and advocacy services; provides for 
public and professional education; and collects, analyzes, and reports 
data on transplant outcomes.
  Mr. Speaker, I urge my colleagues to support this important 
legislation.
  I reserve the balance of my time.
  Mr. GENE GREEN of Texas. Mr. Speaker, I yield myself such time as I 
may consume.
  Mr. Speaker, I rise in support of H.R. 2820, the Stem Cell 
Therapeutic Research Reauthorization Act. This important legislation is 
championed by Representatives Doris Matsui and Chris Smith.
  According to the Health Resources and Services Administration, nearly 
20,000 patients in the United States need a bone marrow or cord blood 
transplant each year. Stem cells from both cord blood and bone marrow 
are used to treat nearly 80 lifesaving diseases, including cancers, 
blood diseases, and immune disorders.
  H.R. 2820 provides Federal support for cord blood donation, the 
continuation of the national bone marrow registry, and critical medical 
research. This legislation reauthorizes the C. W. Bill Young Cell 
Transplantation Program, which includes the National Marrow Donor 
Program.
  The program helps patients in need of lifesaving transplants find 
matching bone marrow donors or cord blood units. It also includes a 
stem cell therapeutic outcomes database, which facilitates research to 
better understand the matching process. This legislation will give hope 
of access to patients and their families in need of a curative 
transplant.
  I want to thank Representatives Matsui and Smith for their leadership 
on this issue. I also want to thank Chairman Upton, Ranking Member 
Pallone, Chairman Pitts, and my colleagues on the Committee on Energy 
and Commerce for advancing this important legislation. I urge my 
colleagues to support H.R. 2820.
  Mr. Speaker, I reserve the balance of my time.
  Mr. GUTHRIE. Mr. Speaker, I yield 6 minutes to the gentleman from New 
Jersey (Mr. Smith), my good friend.
  Mr. SMITH of New Jersey. I thank my good friend Mr. Guthrie for 
yielding and for his support on this important legislation.
  Mr. Speaker, Maalik was diagnosed with Hurler syndrome at 15 months 
old, a rare and life-threatening metabolic disorder. He had a curved 
spine, and he could not walk.
  After receiving an umbilical cord blood transplant facilitated 
through the Carolinas Cord Blood Bank, Maalik is running around and is 
expected to have a normal lifespan. His mother, Krystal, said: ``My son 
is extremely happy now. He is energetic and more independent. The 
transplant saved his life.''
  In like manner, bone marrow donations provide lifesaving transplants 
for a myriad of diseases. Clara was only 4 months old when she was 
diagnosed with acute myeloid leukemia. John had registered with the 
National Marrow Donor Program Be The Match as a bone marrow donor when 
Clara was only 17 days old. It turned out it was a perfect match for 
Clara. John's donation saved Clara's life. She is now thriving at 2 
years of age.
  Mr. Speaker, not only has God in His wisdom and goodness created a 
placenta and an umbilical cord to nurture and protect the precious life 
of an unborn child, but now, we find He has left a great gift behind. 
Immediately after birth, something very special is left behind, cord 
blood that is teeming with lifesaving stem cells.
  Breathtaking scientific breakthroughs have turned medical waste--
postbirth placentas and umbilical cord blood--into medical miracles, 
treating more than 80 diseases, including leukemia, lymphoma, and 
sickle cell anemia.
  As a matter of fact, Dr. Joanne Kurtzberg of Duke University and 
president of the Cord Blood Association told Chairman Pitts' 
subcommittee on June 25 that sickle cell anemia can be cured with cord 
blood transplantation and that it has become one of the most optimal 
donor sources for patients with sickle cell disease.
  H.R. 2820, under consideration by the House today, reauthorizes 
through 2020 the Stem Cell Therapeutic and Research Act of 2005, a law 
I sponsored a decade ago, joined by Artur Davis of Alabama, legislation 
that cleared the Senate with the incomparable help of Senator Orrin 
Hatch.
  That law built upon the excellent work of our distinguished late 
colleague Bill Young of Florida to facilitate bone marrow transplants 
and created a brand-new national umbilical cord blood donation and 
transplantation program.
  Special thanks, Mr. Speaker, to both Chairmen Upton and Pitts for 
their outstanding leadership and help on this bill, as well as the 
strong support by Ranking Members Pallone and my good friend and 
colleague Mr. Green.
  I am deeply grateful to our original sponsors, Ms. Matsui, Mr. Jolly, 
and Mr. Fattah, for their contributions and special thanks to Adrianna 
Simonelli, Katie Novaria, and Megan McCrum.
  Today, Mr. Speaker, under the National Cord Blood Inventory program, 
contracts are awarded to cord blood banks to collect cord blood units 
donated after their mothers give birth. These units are then made 
available through the C. W. Bill Young Cell Transplantation Program, 
also called the Be The Match Registry.
  The program provides a single point of access, enabling those in need 
of lifesaving transplants to search for a match via an integrated 
nationwide network of bone marrow and cord blood stem cells.
  Americans willing to volunteer are at the heart of the success of 
this program. In reauthorizing it, we are grateful for the adult donors 
willing to donate bone marrow or peripheral blood stem cells, as well 
as mothers who donate their baby's cord blood to public cord blood 
banks.
  There are 13 public banks contracted through the NCBI, including the 
New Jersey Cord Blood Bank in my home State, which collects cord blood 
from five participating hospitals.

                              {time}  1645

  Mr. Speaker, it ought to be noted as well that, in addition to 
treating more than 80 diseases, cord blood units from the NCBI banks 
are also available for research on future therapies.
  Indeed, Dr. Kurtzberg pointed out that, ``in addition to use in 
patients with malignant and genetic diseases, cord blood is showing 
enormous potential for use in cellular therapies and other regenerative 
medicine. Cord blood derived vaccines against viruses and certain types 
of cancers are currently under development and in early phase clinical 
trials. Cells, manufactured from cord blood units are being developed 
to boost recovery of the immune system. Cells regulating autoimmunity 
are also in clinical trials. These approaches, which often utilize cord 
blood banked in family banks, may help patients with type 1 diabetes, 
as well as other diseases,'' she testified just a few months ago.
  She also pointed out that ``over the past 6 years, we have initiated 
trials of the patient's own cord blood in babies with birth asphyxia, 
cerebral palsy, hearing loss''; and she is doing some incredible work 
on an issue that I have worked on for over 20 years, and that is the 
issue and the disability known as autism.
  Dr. Kurtzberg finally said, ``We've learned that when a donor cells 
are infused into one's body, they go to the brain and help heal the 
brain. When a child has a brain injury around birth, we can use their 
own cord blood cells

[[Page 13764]]

to correct the damage that's occurred.''
  Dr. Jeffrey Chell, of Be the Match--he is the CEO for it--noted that 
for many diseases, including blood cancers and sickle cell disease, 
cellular therapy is the best hope for a cure.
  Last year, Mr. Speaker, I visited Celgene Corporation of Summit, New 
Jersey, to learn of their extraordinary efforts to use cord blood to 
heal diabetic foot ulcers, and they now have turned amniotic membrane, 
an old placenta, into wound management that has now advanced--it is on 
the market--past stage 3 clinical trials.
  The SPEAKER pro tempore. The time of the gentleman has expired.
  Mr. GUTHRIE. I yield the gentleman another 30 seconds.
  Mr. SMITH of New Jersey. H.R. 2820 authorizes $265 million over 5 
years and will ensure that thousands of present-day and future patients 
benefit from this exciting field of regenerative medicine.
  We have only just begun. This legislation furthers that work. And 
again, I thank my colleagues for this bipartisan support.
  Mr. Speaker, Maalik was diagnosed with Hurler Syndrome at 15 months 
old--a rare and life-threatening metabolic disorder. He had a curved 
spine and could not walk. After receiving an umbilical cord blood 
transplant facilitated through the Carolina Blood Bank, Maalik is 
running around and expected to have a normal lifespan. His mother 
Krystal told the Herald Sun newspaper in North Carolina, ``My son is 
extremely happy now . . . He's energetic, and more independent. The 
transplant saved his life.''
  In like manner, bone marrow donations provide lifesaving transplants 
to treat diseases like blood cancer or inherited metabolic or immune 
system disorders. Clara was only 4 months old when she was diagnosed 
with acute myeloid leukemia. John had registered with the National 
Marrow Donor Program (NMDP) Be the Match as a bone marrow donor when 
Clara was only 17 days old. It turned out he was a perfect match for 
Clara. John's donation saved Clara's life, she is now a thriving 2-
year-old.
  Valentina was 10 months old and only 13 pounds--and diagnosed with 
severe combined immunodeficiency (SCID). Her doctor treated her with 
chemotherapy followed by a cord blood transplant. 5 months after the 
transplant Valentina weighed 21 pounds and doctors credited her 
strengthened immune system from the stem cells in cord blood.
  Jennifer, 45, was suffering from acute myeloid leukemia but unable to 
find a matched bone-marrow transplant. Because of the high rate of 
tissue type diversity among racial and ethnic minorities it can be 
difficult to find a matched bone marrow transplant, but umbilical cord 
blood can be successfully used for treatment with a less perfect match 
of tissue type. After undergoing chemotherapy and radiation she 
received a cord blood transplant, and is now living cancer free.
  Not only has God in His wisdom and goodness created a placenta and 
umbilical cord to nurture and protect the precious life of an unborn 
child, but now we know that another gift awaits us immediately after 
birth. Something very special is left behind--cord blood that is 
teeming with lifesaving stem cells.
  Breathtaking scientific breakthroughs have turned medical waste--post 
birth placentas and umbilical cord blood--into medical miracles 
treating more than 80 diseases including leukemia, lymphoma and sickle 
cell anemia.
  As a matter of fact, Dr. Joanne Kurtzberg of Duke University and 
President of the Cord Blood Association told Chairman Pitts' Health 
Subcommittee on June 25 that sickle cell anemia can be ``cured'' with 
cord blood transplantation and that ``it has become one of the optimal 
donor sources for patients with sickle cell disease'' because it 
doesn't have to be perfectly matched.
  H.R. 2820 under consideration by the House today reauthorizes through 
2020 the Stem Cell Therapeutic and Research Act of 2005 a law that I 
sponsored a decade ago joined by Artur Davis of Alabama; legislation 
that cleared the Senate with the incomparable help of Senator Orrin 
Hatch. That law built upon the excellent work of our distinguished late 
colleague Bill Young of Florida to facilitate bone marrow transplants 
and created a brand new national umbilical cord blood donation and 
transplantation program.
  Special thanks to both Chairmen Upton and Pitts for their outstanding 
leadership and help on this bill, as well as the strong support by 
Ranking Members Pallone and Green. I am deeply grateful to original 
cosponsors Ms. Matsui, Mr. Jolly and Mr. Fattah for their important 
contributions. And special thanks to Katie Novaria, Adrianna Simonelli, 
and Megan McCrum.
  Today, Mr. Speaker, under the National Cord Blood Inventory Program 
(NCBI), contracts are awarded to cord blood banks to collect cord blood 
units donated after mothers give birth. These units are then made 
available through the C.W. Bill Young Cell Transplantation Program also 
called the Be the Match Registry. The Program provides a single point 
of access, enabling those in need of lifesaving transplants to search 
for a match via an integrated nationwide network of bone marrow donors 
and cord blood stem cells. The Program's Bone Marrow and Cord Blood 
Coordinating Centers makes information about bone marrow and cord blood 
transplant available to donors and patients, and the Office of Patient 
Advocacy helps support patients and families dealing with a life-
threatening diagnosis. And the Stem Cell Therapeutic Outcomes Database 
tracks results.
  Americans willing to volunteer are the heart of the success of this 
program. In reauthorizing it we are grateful for the adult donors 
willing to donate bone marrow or peripheral blood stem cells, as well 
as mothers who donate their babies' cord blood through public cord 
blood banks.
  There are 13 public banks contracted through NCBI, including the New 
Jersey Cord Blood Bank in my home state, which collects cord blood from 
5 participating hospitals.
  According to the Health Resources and Services Administration (HRSA), 
every year 18,000 people in the U.S. are diagnosed with illnesses for 
which blood stem cell transplantation from a matched donor is their 
best treatment option. Of this number, only about 30% have a sibling 
who can be the ideal matched donor, so about 12,600 people annually 
depend on the programs made available by this law to find an unrelated 
adult marrow donor or cord blood unit for treatment.
  Cord blood transplants have accounted for about one half of the 
growth in stem cell transplants since NCBI was established in 2005. 
More NCBI units have been released for transplantation with each 
successive year since the program's inception.
  In addition to currently treating more than 80 diseases, cord blood 
units from NCBI banks are also made available for research on future 
therapies. In groundbreaking research, Dr. Kurtzberg of Duke University 
also testified last June that ``in addition to use in patients with 
malignant and genetic diseases, cord blood is showing enormous 
potential for use in cellular therapies and regenerative medicine. Cord 
blood derived vaccines against viruses and certain types of cancers are 
currently under development and in early phase clinical trials. Cells 
manufactured from cord blood units are being developed to boost 
recovery of the immune system. Cells regulating autoimmunity 
(Regulatory T cells) are also in clinical trials. These approaches, 
which often utilize cord blood banked in family banks, may help 
patients with Type 1 Diabetes, as well as other diseases.''
  Dr. Kurtzberg further testified that she and others are developing 
uses for cord blood to treat acquired brain disorders. ``Over the past 
six years'' she said ``we have initiated trials of autologous (the 
patient's own) cord blood in babies with birth asphyxia, cerebral 
palsy, hearing loss and autism . . .''
  Dr. Kurtzberg has also said ``We've learned that when donor cells are 
infused into one's body, they go to the brain and help heal the brain. 
When a child has a brain injury around birth, we can use their own cord 
blood cells to correct the damage that's occurred.''
  Dr. Jeffrey W. Chell, CEO of NMDP/Be the Match noted that for many 
diseases including blood cancers and sickle cell disease, cellular 
therapy is the best hope for a cure. He told Chairman Pitts' 
subcommittee that the patient population ``rising the most quickly is 
the elderly population . . . growing by double digits every year, and 
the reason for that is the medical conditions for which transplant is 
often the only cure tend to occur in older populations for diseases 
like acute myeloid leukemia, myelodysplastic syndrome, myelofibrosis 
and others.''
  Last year, Mr. Speaker, I visited Celgene Corporation of Summit, New 
Jersey to learn of their extraordinary efforts to use cord blood to 
heal diabetic foot ulcers and how they've turned amniotic membrane--an 
old placenta--into wound management that has now advanced past stage 3 
clinical trials to the approval and regulatory filings stage.
  H.R. 2820 authorizes $265 million over five years and will ensure 
that thousands of present-day and future patients benefit from the 
exciting field of regenerative medicine.
  Mr. GENE GREEN of Texas. Mr. Speaker, I have no other speakers.
  I yield back the balance of my time.
  Mr. GUTHRIE. Mr. Speaker, I yield myself the balance of my time to 
close with a quick story.

[[Page 13765]]

  There is a good friend of mine. His name is Philip Schardein, and I 
am great friends with his family. He went off to play golf in college--
great athlete. All of a sudden, he came down with leukemia, and I 
remember that there were some issues at first about his sister being 
able to donate bone marrow.
  So my town, Bowling Green, Kentucky, organized a bone marrow drive to 
see if anybody could match Philip Schardein. I have probably never been 
more proud to call myself a resident of the hometown of Bowling Green 
than that day. I remember going three times, and it was so overwhelmed 
with volunteers trying to have their bone marrow, the blood type, to 
see if they matched, that it just overwhelmed the system.
  I remember finally getting through late in the afternoon, and people 
waited all day to see if they could match and help Philip Schardein. 
And God bless, for whatever reason his sister couldn't donate, it 
turned out that she could donate, and he is a healthy person now with 
family and children, and everything is going well.
  But just about a year after that, I was in Holiday World with my 
family. I was having a day with them. My cell phone rang, and it turned 
out I had matched, because of going to get my bone marrow tested, or my 
blood tested, that I matched someone. The lady got on the phone, and 
she told me what it takes to be a donor and, Will you be willing to 
move forward? I said, Of course.
  I remember the reason I said I was at Holiday World was because I 
remember standing there going, here I am with my family having fun, 
laughing and having a great afternoon, and there is some family 
somewhere that is anonymous, not having the same experience, probably 
trying to figure out if their loved one is going to live or survive or 
what is going to be the prognosis.
  So I went through the process, and I remember going through, having 
my blood taken and several of the steps. Just getting close to the 
actual time to do the bone marrow transplant, for whatever reason, we 
got notified that it wasn't going forward. It could do that for many 
reasons. One, hopefully, is the anonymous person was cured or the 
prognosis was better, or maybe a sibling or something matched like it 
did for Philip Schardein.
  But I've often wondered about the life on the other end, because they 
don't tell you for reason of anonymity, and it is just something that 
has always weighed on my mind. Even sitting here and getting ready to 
close, I was thinking about who was on the other end, and I hope that 
they have a good story, as well as Philip Schardein.
  But what I want to stress is how important it is that families in 
need and worry and wondering what is going to happen with their loved 
ones, and the loved ones themselves, and this is something we can do. 
It was a little thing that I was able to do, that we all were able to 
do in my community, and people across this country can do to try to 
help people live long and fruitful lives.
  Our prayers were answered with Philip Schardein, and this is an 
opportunity for us to come together, in a bipartisan way, as all the 
bills were.
  I want to close with this. We have been through four bills in the 
last hour, and they are dealing with touching families, and every one 
of them has been bipartisan. We have been able to come together and 
find where we agree and work together, that we can work for infants, 
for families suffering with leukemia and other blood disorders, for 
infants with opioid addiction, for parents who have children with early 
hearing detection, and that is where we have been able to come together 
and work together.
  I appreciate the effort of Ranking Member Green in bringing us all 
together, and our subcommittee chairman, Mr. Pitts.
  I look forward to voting for this bill, and I urge my colleagues to 
vote for H.R. 2820. I appreciate my friend, Mr. Smith, for bringing it 
forward.
  I yield back the balance of my time.
  Mr. PALLONE. Mr. Speaker, H.R. 820, the ``Stem Cell Therapeutic and 
Research Reauthorization Act,'' would continue critical federal support 
for the C.W. Bill Young Cell Transplantation Program. This program 
includes the Be the Match registry for bone marrow and umbilical cord 
blood transplantation which continues to provide hope to people in need 
of a lifesaving transplants.
  Each year thousands of patients in need of life saving transplants 
are unable to find a match within their family and therefore require a 
nonrelative donor. That is why the Be the Match registry and its nearly 
12.5 million registered bone marrow donors and collection of more than 
209,000 cord blood units is so important. The Program also supports the 
collection and use of transplantation data to advance medical research.
  I'd like to thank Representative Doris Matsui for her leadership in 
this area and I urge my colleagues to support H.R. 2820 to ensure that 
the lifesaving Be the Match registry continues.
  The SPEAKER pro tempore. The question is on the motion offered by the 
gentleman from Kentucky (Mr. Guthrie) that the House suspend the rules 
and pass the bill, H.R. 2820.
  The question was taken; and (two-thirds being in the affirmative) the 
rules were suspended and the bill was passed.
  A motion to reconsider was laid on the table.

                          ____________________