BILL NUMBER: HR 37 AMENDED
BILL TEXT
AMENDED IN ASSEMBLY AUGUST 24, 2012
INTRODUCED BY Assembly Member Hill
AUGUST 7, 2012
Relative to umbilical cord blood banking.
LEGISLATIVE COUNSEL'S DIGEST
HOUSE OR SENATE RESOLUTIONS DO NOT CONTAIN A DIGEST
WHEREAS, Umbilical cord blood is rich in hematopoietic, or
blood-forming, stem cells, similar to those found in bone marrow.
Therefore, cord blood can be used as an alternative to bone marrow in
transplants; and
WHEREAS, Since the first umbilical cord blood transplant in 1988,
the systems for collecting umbilical cord blood for both public and
private use have grown rapidly, both as a treatment for over 80
medical conditions and as an investigational therapy in numerous
United States Food and Drug Administration (FDA) approved clinical
trials; and
WHEREAS, Umbilical cord blood is rich in hematopoietic, or
blood-forming, stem cells, similar to those found in bone marrow.
Therefore, cord blood can be used as an alternative to bone marrow
transplants; and
WHEREAS, Scientists are currently researching the possibility that
umbilical cord blood may be able to assist the body in the repair of
nerve and tissue damage, such as nerve and heart cells; and
WHEREAS, The demand for stem cells from umbilical cord blood is
greater than the supply, and both personal and public banking are
needed in order to increase the storage of umbilical cord blood; and
WHEREAS, The umbilical cord blood industry has grown rapidly and
umbilical cord blood is currently used to treat blood cancers, such
as leukemia, myeloma, and lymphoma, and more than 80 inherited
immunodeficiencies and other genetic and acquired blood diseases,
including sickle cell anemia, thalassemias, hemoglobinopathies,
aplastic anemias, and marrow failure disorders, and inherited
disorders or errors of metabolism; and
WHEREAS, The benefits of banking umbilical cord blood are life
saving, and storing cord blood is less expensive compared to the
medical costs associated with life-threatening illnesses; and
WHEREAS, It is 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 the families
access to the stem cells of the newborn. These children have a
greater likelihood of developing neurological disabilities that may
be helped by advancements in regenerative medicine and stem cell
research to treat diseases like brain injury, cerebral palsy (CP),
and hearing loss; and
WHEREAS, CP is a heterogeneous group of neurological disorder
conditions that appear in infancy or early childhood and permanently
affect body movement and muscle coordination. CP is caused by
abnormal brain development or damage to the developing brain, and
might not be detected until months or years later; and
WHEREAS, According to a 2010 study published in the British
Medical Journal, a low Apgar score was strongly associated with a
later diagnosis of CP. The prevalence of CP in children scoring less
than three on the Apgar scale was more than 130-fold higher than in
children with a score of 10; and
WHEREAS, The average prevalence of CP in the United States is 3.3
per 1,000. Currently, there are an estimated 800,000 children and
adults living with CP in the United States; and
WHEREAS, Births in California account for approximately 13 percent
of all babies born in the United States. There were approximately
1,772 babies born with CP in California in 2009; and
WHEREAS, Based on federal Centers for Disease Control and
Prevention data, the lifetime cost of CP in 2003 was $921,000 per
person. When multiplied by the number of babies described above, this
equates to an approximate cost of $1.632 billion; and
WHEREAS, Clinical trials looking at umbilical cord blood stem
cells and CP are ongoing. Dr. James Carroll, pediatric neurologist at
Georgia Health Sciences University, received the first FDA clearance
to run a clinical trial using a child's own umbilical cord blood
stem cells as a potential therapy for children with CP. Other
clinical trials also have been approved by the FDA to evaluate the
use of a child's own umbilical cord blood in regenerative therapies
for diseases and conditions that could not previously be treated,
such as hearing loss, traumatic brain injury, and juvenile diabetes;
and
WHEREAS, There is growing evidence of the restorative potential of
umbilical cord blood stem cells, and indications that many future
therapies may come from autologous cells using the patient's own
immune system; and
WHEREAS, There are seven low-Apgar umbilical cord blood stem cell
collection programs already in place in California, located at
Providence Health Systems in southern California, Southwest
Healthcare System at Inland Valley Medical Center, Southwest
Healthcare System at Rancho Springs Medical Center, Hoag Memorial
Hospital in Newport Beach, Washington Hospital in Fremont, John Muir
Medical Center in Walnut Creek, and Sequoia Hospital in Redwood City;
and
WHEREAS, These hospitals contract with an accredited umbilical
cord blood bank that provides collection kits and processing in order
to provide this service, under a memorandum of understanding. As
part of the contract, training is provided to ensure quality
collection, sufficient collection volume, and sterility to ensure
eligibility for acceptance in FDA-regulated clinical trials for CP;
and
WHEREAS, Transplanting physicians have performed 25,000 stem cell
transplants to date; and
WHEREAS, Not all umbilical cord blood samples collected
specifically for public banks and allogeneic
bone marrow or cord blood transplants are available for
transplantation; and
WHEREAS, The remaining public banking units should be provided to
research institutions to explore the potential of umbilical cord
blood stem cells to treat many debilitating and lethal medical
conditions; and
WHEREAS, The federal government enacted the Stem Cell Therapeutic
and Research Act of 2005 to collect and maintain umbilical cord blood
for public use in transplantation and research; and
WHEREAS, The Legislature enacted Senate Bill 1555 (Chapter 484 of
the Statutes of 2006), requiring the State Department of Public
Health to conduct the Umbilical Blood Community Awareness Campaign,
which requires the department to, among other things, provide
awareness, assistance, and information regarding umbilical cord blood
banking options. Senate Bill 1555 also authorized a primary prenatal
care provider to provide to a woman who is known to be pregnant,
during the first prenatal visit, with information developed by the
department pursuant to Senate Bill 1555 regarding her options with
respect to umbilical cord blood banking; and
WHEREAS, The Legislature enacted Assembly Bill 34 (Chapter 516 of
the Statutes of 2007) to create a public banking infrastructure in
California that adds genetically diverse umbilical cord blood units
to the national public inventory to ensure that Californians, who are
ethnically and genetically diverse, have that ethnic and genetic
diversity reflected in the inventory. The more the inventory mirrors
the genetic makeup of California's population, the greater the chance
residents of California will find a match when they are in need; and
WHEREAS, The Legislature passed Assembly Concurrent Resolution 74
(Resolution Chapter 116 of the Statutes of 2010) expressing the
Legislature's desire to find ways to help California gain a viable
public umbilical cord blood banking system, to ensure that all races
and ethnicities have an equal probability of finding a match when
medically necessary, and also to specify that the Legislature
supports related research being done with collected units that are
not suitable for transplantation; and
WHEREAS, The Legislature enacted Assembly Bill 52 (Chapter 529 of
the Statutes of 2010), to request the University of California to
establish and administer the Umbilical Cord Blood Collection Program
for the purpose of collecting units of umbilical cord blood for
public use, for transplantation, and for providing nonclinical units
for specified research; and
WHEREAS, The National Marrow Donor Program, in a recent plea to
states to help increase the national umbilical cord blood public
inventory, declared that states can help expand the number of
publicly available umbilical cord blood units by appropriating
additional resources for the collection and storage of units; now,
therefore, be it
Resolved by the Assembly of the State of California, That the
Assembly continues to desire to seek ways to help California gain a
viable public umbilical cord blood banking system, to ensure all that
races and ethnicities have an equal probability of finding a match
when medically necessary; and be it further
Resolved, That the Assembly continues to support related research
being done with collected units that are not suitable for
transplantation; and be it further
Resolved, by the Assembly of the State of California,
That the Assembly encourages acute care hospitals to participate in
free collection programs for umbilical cord blood and cord tissue in
order to maximize the potential medical benefits that umbilical cord
blood therapies can provide; and be it further
Resolved, That the Assembly encourages acute care hospitals to
participate in free collection programs that provide parents of
children born in those hospitals who have an activity, pulse,
grimace, appearance, and respiration (Apgar) score of three or less
at five minutes, with the option of storing the child's umbilical
cord blood and cord tissue, at no cost to the parent, in order that
the umbilical cord blood and cord tissue may be used for therapeutic
purposes as therapies become medically available; and be it further
Resolved, That the Chief Clerk of the Assembly transmit copies of
this resolution to the State Department of Public Health and the
California Institute for Regenerative Medicine.