BILL ANALYSIS Ó
HR 37
Page 1
Date of Hearing: August 29, 2012
ASSEMBLY COMMITTEE ON HEALTH
Richard Pan, Chair
HR 37 (Hill) - As Amended: August 24, 2012
AS PROPOSED TO BE AMENDED
SUBJECT : Umbilical cord blood banking.
SUMMARY : Makes various findings and declarations related to the
uses and benefits of umbilical cord blood (UCB) as a treatment
for blood cancers and other diseases and encourages hospitals to
participate in free UCB and cord tissue collection programs.
Specifically, this resolution :
1)Makes various findings and declarations related to the uses
and benefits of umbilical cord blood (UCB) as a treatment for
blood cancers, such as leukemia, myeloma, and lymphoma, and
more than 80 inherited immunodeficiencies and other genetic
and acquired blood diseases.
2)Expresses the intent of the Assembly to assist families who
have newborns scoring three or less on the activity, pulse,
grimace, appearance, and respiration (Apgar) scale by
providing families access to the stem cells of the newborn and
states that these children have a greater likelihood of
developing neurological disabilities that may be helped by
advancements in regenerative medicine.
3)States that there are seven low-Apgar UCB stem cell collection
programs using regenerative medicine already in place in
specified hospitals in California and these hospitals contract
with an accredited umbilical cord blood bank that provides
collection kits, processing, and training to ensure quality
collection, sufficient collection volume, and sterility, as
specified.
4)Encourages acute care hospitals to participate in free
collection programs for UCB and cord tissue in general and in
free collection programs that specifically provide parents of
children born with low-Apgar scores the option of storing the
child's UCB and cord tissue, at no cost to the parent, for
therapeutic purposes as therapies become medically available.
HR 37
Page 2
EXISTING FEDERAL LAW :
1)Establishes the National Cord Blood Inventory, administered by
the federal Health Resources and Services Administration, to
provide a national UCB network and authorizes funding to
collect and maintain human cord blood stem cells for the
treatment of patients and for research.
2)Includes a process for maternal donors to be informed of all
medically appropriate options for cord blood banking and
includes additional directives for cord blood donation,
education, and advocacy.
EXISTING STATE LAW :
1)Requests the University of California (UC) to establish and
administer, until January 1, 2018, the Umbilical Cord Blood
Collection Program (UCBCP) to increase the collection and
availability of genetically diverse UCB for public use,
including transplantation and adult stem cell research, and
imposes a temporary $2 fee on specified birth certificates to
fund the program.
2)Requires the Department of Public Health (DPH), contingent
upon private funding, to conduct the Umbilical Blood Community
Awareness Campaign to provide awareness and information
regarding UCB banking options using print media, radio, the
Internet, outdoor advertising and other media, to establish an
Internet Web site, and to engage in public education
activities related to UCB donation to targeted populations, as
appropriate.
FISCAL EFFECT : None
COMMENTS :
1)PURPOSE OF THIS RESOLUTION . According to the author, cord
blood is showing potential in research to treat conditions
that have no cure today, such as brain injury, cerebral palsy,
and hearing loss, through the process of regenerative medicine
that enables scientists to evaluate the use of a child's own
cord blood stem cells in experimental treatments. The author
notes that current regenerative clinical trials and programs
HR 37
Page 3
require a child's own cord blood stem cells as a condition of
participation and this resolution is needed to raise awareness
among hospitals of the pro bono collection and storage
programs that are available to provide parents of at risk
infants, such as those born with a low Apgar score, access to
their child's own stem cells for use in these trials.
2)THE APGAR TEST . The National Institutes of Health (NIH)
states that the Apgar scale is a quick test performed on a
baby at one and five minutes after birth. The one-minute
score determines how well the baby tolerated the birthing
process and the five-minute score assesses how well the baby
is doing outside the mother's womb. The Apgar test examines
the baby's breathing effort, heart rate, muscle tone, reflex
response to stimulation, and skin color. It is based on a
total score of one to 10. The higher the score, the better
the baby is doing after birth. Any score lower than seven is
a sign that the baby needs medical attention. A low Apgar
score is most often caused by a difficult birth, a
Cesarean-section delivery, or fluid in the baby's airway.
Generally, a low score at one minute is near-normal by five
minutes. According to the NIH, the Apgar score is not
designed to predict the future health of the child and a lower
Apgar score is not an indication that a child will have
serious or long-term health problems.
3)UCB . According to the National Marrow Donor Program (NMDP)
cord blood is the blood collected from the umbilical cord and
placenta after a baby is born. It contains blood-forming stem
cells that can be used in transplants for patients who have
leukemia, lymphoma, or certain blood, immune system, and
metabolic disorders. It is one of three sources of cells used
in transplants; the other two are bone marrow and peripheral
blood stem cells. The NMDP estimates that, on any given day,
more than 6,000 patients around the world are searching the
NMDP's registry for a matching bone marrow or cord blood
donor. Since cord blood is stored and ready to use and it
does not require a perfect donor match, the NMDP states that
it is especially useful for patients who need a transplant
quickly, patients who have difficulty finding a matched bone
marrow donor, and patients from racially diverse communities
who often have uncommon tissue types.
4)UCBCP . Pursuant to AB 52 (Portantino), Chapter 529, Statutes
of 2010, the UCBCP is administered by the UC Davis Health
HR 37
Page 4
System to serve Californians through collection of UCB units
that are representative of the state's unique and genetically
diverse population; storage of these UCB units in public cord
blood banks that are licensed by the FDA and searchable and
accessible to those in need of a transplant; and, distribution
to qualified research laboratories of UCB units that are not
suitable for transplant.
The UCBCP reports that it has just completed the contracting
process for partnering with existing FDA-licensed collection
sites and cord blood banks. According to the UCBCP, priority
contracts have also been negotiated with hospitals that have
high birth rates, serve patients of under-represented
ethnicities, and that are not currently performing cord blood
collections. The UCBCP indicates that it expects to begin
accepting collections by January 2013.
The UCBCP is funded through a $2 fee on all birth certificates
in California that will be used to support the costs
associated with collections, such as administration,
collection personnel, collection materials, and shipping of
the UCB units. The fee is set to run through 2017 and will
provide about $2 million dollars per year in funding, after
which, the UCBCP will need to be self-supporting.
5)PUBLIC AND PRIVATE CORD BLOOD BANKS . According to the
American College of Obstetricians and Gynecologists (ACOG)
Committee on Obstetric Practice, cord blood is kept in public
or private banks. Public banks operate like blood banks and
collect cord blood for later use for anyone who needs it. The
cord blood is tracked in a database so that a unit can be
found quickly when needed. Public banks do not charge
collection fees. Donors to public banks, including parents
who donate their newborn's blood, are subject to a screening
process that involves a detailed medical and lifestyle history
of the baby's mother, father, and their families. Private
banks store cord blood for directed donation, meaning the
blood is held for use by the individual donor or their family
members should the need arise. Private banks typically charge
between $1,000 and $2,000 in collection fees and between $50
and $125 annually for storage.
Although ACOG takes no position for or against cord blood
banking, it recommends that physicians disclose that there is
no reliable estimate of a child's likelihood of actually using
HR 37
Page 5
his or her own saved cord blood later. Some experts estimate
this likelihood at 1 in 2,700, while others argue the rate is
even lower. ACOG states that physicians should also disclose
to their patients that it is unknown how long cord blood can
successfully be stored.
Cord blood banks are voluntarily accredited through the American
Association of Blood Banks (AABB) and the Foundation for the
Accreditation of Cellular Therapy (FACT) using standards
governing all aspects of their operations, including
collection, processing, and transplantation. According to
their respective Web sites, 29 facilities nationwide are
currently accredited by the AABB and nine currently have FACT
accreditation.
6)CALIFORNIA BANKS . According to the NMDP, there are currently
three participating public banks in California, StemCyte
International Cord Blood Center in West Covina, which provides
both public and private banking services, Children's Hospital
of Orange County Cord Blood Bank, and the M.D. Anderson Cord
Blood Bank in Palo Alto. According to the nonprofit Parent's
Guide to Cord Blood Foundation, there are currently three
private banks operating in the state: PacifiCord, based in
Irvine; FamilyCord, based in Los Angeles; and, the largest,
Cord Blood Registry (CBR), based in San Bruno, in the author's
district.
7)PREVIOUS LEGISLATION .
a) AB 52 requests the University of California to establish
and administer the UCBCP for the purpose of collecting
units of UCB for public use, for transplantation, and for
providing nonclinical units for specified research.
b) ACR 74 (Portantino), Chapter 116, Statutes of 2010,
expresses the Legislature's desire to find ways to help
California gain a viable public UCB banking system, to
ensure that all races and ethnicities have an equal
probability of finding a match when medically necessary.
c) SB 962 (Migden), Chapter 517, Statutes of 2007, requires
DPH to provide UCB samples to the Birth Defect Monitoring
Program, for storage and research, as specified.
d) SB 1555 (Speier), Chapter 484, Statutes of 2006,
HR 37
Page 6
requires DPH to conduct the Umbilical Blood Community
Awareness Campaign to, among other things, provide
awareness, assistance, and information regarding umbilical
cord blood banking options. Authorizes a primary prenatal
care provider to provide pregnant women with information
regarding options for UCB banking during the first prenatal
visit.
8)SUPPORT . CBR writes in support that it offers the Newborn
Possibilities Program, designed to ensure that a newborn's
cord blood and cord tissue stem cells are processed and stored
at no cost for up to five years in cases of identified medical
need, as well as high-risk deliveries, to enhance treatment
options and increase access to clinical trials for conditions
where limited treatment options currently exist. CBR states
that this resolution will help raise awareness within
hospitals that newborns identified as being at-risk for
developing neurological disability, based on a low Apgar
score, may have their cord blood and cord tissue stored
without cost and will allow hospitals, by collecting cord
blood and tissue for at-risk newborns, to help give these
children access, if needed, to their own stem cells for
potential use in FDA-regulated clinical trials.
REGISTERED SUPPORT / OPPOSITION :
Support
Cord Blood Registry
Several individuals
Opposition
None on file.
Analysis Prepared by : Cassie Royce / HEALTH / (916) 319-2097