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Category Archives: Stem Cells

Stem Cell Lines and Paid-for Eggs: Stem Cell Agency Delays Action on Easing Restrictions

A key panel of the California stem cell
agency today balked at approving a plan to ease restrictions on
using stem cell lines derived from women who were paid for their
eggs.
The proposal had been scheduled to be
taken up tomorrow by the governing board of the $3 billion agency,
but the board's standards working group delayed action.
In response to a question, Kevin
McCormack, a spokesman for the agency, said in an email,

“It was felt that more discussion
was needed before moving to a vote so another meeting is going to be
scheduled.”

In 2006, the CIRM governing board
approved regulations that banned the use of CIRM funds for stem cells
lines derived using compensation. That rule would be modified under
today's plan, which would permit the CIRM governing board to approve
the use of such lines following a staff study evaluating scientific and ethical issues.
Their use would be allowed if the lines would “advance CIRM's
mission.”

The delay came after four
organizations, including the Center for Genetics and Society in
Berkeley, argued that the plan is vague and did not adequately
address safety issues.
The four-page statement by the groups
said that the plan does not appear to have met “numerous concerns”
raised in 2009 in a document co-authored by the CIRM staff. Those
concerns include long-term risk and ethical issues.
Under the proposal, the groups said
that the agency governing board

“...will decide whether to approve a
grantee’s request to use a stem cell line created with paid-for
eggs on the basis of whether doing so 'will advance CIRM’s
mission.' This criterion is much too vague, and doesn’t include
consideration of the health or welfare of the women who undergo egg
retrieval. Protecting the well-being of women providing eggs is not
even mentioned (though perhaps it could be considered as an element
of the fifth of five 'factors to be considered by the ICOC(the agency
board),' 'whether the donation…was consistent with `best practices’
at the time of donation').”

The standards group also heard from a
UCLA researcher who argued on behalf of the change. Kathrin Plath
said she and her colleagues wanted to use a paid-for stem cell line
from the Oregon experiment that cloned human stem cells.

(An earlier version of this item said the change under consideration would ease restrictions on "purchasing" stem cell lines. The word "purchasing" was changed to "using.")
Here is the text of the statement by
the four organizations.

Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/QECOGHuAvIc/stem-cell-lines-and-paid-for-eggs-stem.html

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$70 Million Alpha Stem Cell Clinic Project Garners Mainstream Media Attention

California's $70 million plan for a
chain of “Alpha” stem cell clinics today received its first major
attention from the mainstream media.
The story came in the state's largest
circulation newspaper, appearing this morning on the home page of the
website of Los Angeles Times.
The Alpha project would create five clinics
around the state and a coordination/information center under a
concept that comes before the governing board of the state's $3
billion stem cell agency at its meeting tomorrow in Burlingame, Ca. Funds could be
awarded as early as a year from now. (For more information, see here
and here.)
Reporter Eryn Brown quoted Natalie
DeWitt, special projects officer for CIRM, as the stem cell agency is known, and Maria Millan, a CIRM
medical officer. Brown wrote,

“Clinics to conduct trials of stem
cell therapies have different needs than clinics designed to deliver
conventional therapies, DeWitt and Millan said. They need special
facilities for handling the cells safely, as well as imaging
equipment to track the cells once they're delivered into a patient’s
body.  Some of this infrastructure already exists, but other
parts of it still need to be perfected.  Establishing clinics to
house multiple trials might create the critical mass needed to get
the infrastructure in place, they said....

"Additionally, they said, CIRM
hopes that such collaboration would encourage stem cell companies to
share information -- speeding their own work and also helping out
policymakers and insurers who are trying to figure out how they'll
pay for stem cell therapies in the future.”

The Times quoted the
California Stem Cell Report as saying last week,

 “The Alpha clinics
are aimed at creation of a sturdy foundation for the stem cell
industry in California, capitalizing on the burgeoning, international
lure of stem cell treatments.”

The proposal envisions Alpha stem cell
clinics at major, established institutions around the state. It is
possible that two could be located in the Los Angeles area at
institutions such as UCLA, USC, Cedars-Sinai or the City of Hope, all
of which have representatives on the stem cell agency's governing
board. Other likely locations are in the San Francisco Bay area and
San Diego, again at facilities such as Stanford, UC San Francisco and
UC San Diego that have representation on the agency board.

Institutions competing for the grants,
including businesses, will be subject to closed-door. peer review
prior to final action by the full governing board.  

Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/s_-mm4nTU_0/70-million-alpha-stem-cell-clinic.html

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UCLA Researcher Calls for Easing of Restrictions on Stem Cell Lines Derived from Eggs From Paid Providers

A UCLA researcher has spoken out in
support of a proposal to allow use of California stem cell agency
funds to purchase stem cell lines derived from eggs provided by women
who have been paid for the service.
Kathrin Plath, an associate professor, said in a letter to the agency that she and her colleagues would like to use a line from the Oregon SCNT
experiment by Shoukhrat Mitalipov in which human stem cells were cloned. Currently agency funds cannot be used for that purpose as
a result of regulations that are the extension of a state law that
bars use of agency funds for payment for eggs.
The agency's standards group meets later today to consider changing those regulations. The proposal will
then go before the full board tomorrow.
Plath, who has received $5 million from CIRM, said,

“In my lab, we are ... interested in
understanding what happens to the somatically silenced X chromosome
when differentiated cells are reprogrammed by SCNT. The key question
is: are these SCNT-ESCs more similar to iPSCs or
fertilization-derived ESCs with respect to the epigenetic state of
the X chromosome. Furthermore, it has been shown in mouse
reprogramming that the active X chromosome becomes deregulated during
SCNT-based reprogramming, and we would like to address this problem
in the human system as well.

“We believe that the comparison of
the epigenetic states between fertilization-derived ESCs, SCNT-ESCs
and human iPSCs is important for a better characterization of these
cells and understanding of their epigenetic nature.”

Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/2YTtgbJCtRw/ucla-researcher-calls-for-easing-of.html

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Paying for Human Eggs, Ivan Illich and Jerry Brown

California's pay-for-eggs bill is
stalled in a technical parliamentary process as opponents continue to
wage their campaign urging Gov. Jerry Brown to veto the proposal,
which swept easily through the legislature.
The latest volley against the
industry-sponsored measure appeared this week as an op-ed in The Sacramento Bee. The legislation would allow women to be paid for eggs for scientific research. The op-ed piece invoked the philosopher Ivan Illich, a
longtime friend of Jerry Brown and much respected by him.
Written by Diane Tober and Nancy
Scheper-Hughes of the Center for Genetics and Society of Berkeley,
the July 16 article said,

“The late historian of science and
technology, Ivan Illich, warned against the processes of medical
industries which 'create new needs and control their satisfaction and
turn human beings and their creativity into objects.'"

The op-ed said,

“Women's research eggs (have) become
the hot new bio-product, increasing the profits of the
multibillion-dollar-per-year infertility industry at the expense of
women's health, safety and possibly, their future fertility. Is this
the 'equity' we want for ourselves, our sisters and our daughters?”

In 2003, Brown wrote a remembrance of
Illich, whom he first met in 1976. Brown said that Illich

“...bore witness to the destructive
power of modern institutions that 'create needs faster than they can
create satisfaction, and in the process of trying to meet the needs
they generate, they consume the earth.'”

The egg compensation bill (AB926 by
Assemblywoman Susan Bonilla, D-Concord) would remove a ban in
California on paying women who provide their eggs for scientific
research. Currently women who provide eggs for fertility purposes can
be paid, sometimes as much as $50,000, depending on the
characteristics of the woman providing the eggs. The bill would not
alter the ban on using research funds from the California stem cell
agency to pay for eggs. However, the agency next week will consider a proposal to allow use of agency funds to purchase stem cell lines
derived from eggs through compensation. (For
more information on
the bill,
see here, here and here.)
The egg bill received final legislative
approval on July 1. The governor has 12 days to act on the measure
once it actually reaches his desk. However, as of this morning, the
legislation remained in what is known as the “engrossing and
enrolling” process. It could be a routine delay but the process can
also be used to manage the flow of legislation to the governor. Brown
is currently on a two-week trip to Germany and Ireland and is not
expected to return until near the first of August.

Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/emjwUNr50p4/paying-for-human-eggs-ivan-illich-and.html

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California Stem Cell Agency to Commit 20 Percent of Remaining Cash

The California stem cell agency next
Thursday is expected to move forward with plans to give away $128
million, roughly 20 percent of its remaining funds.
The programs include the $70 million Alpha clinic plan, an ambitious five-year project that would be one
of the $3 billion agency's hallmark efforts. The other “concept”
rounds up next week include a $35 million “tools and technology”RFA and $23 million to recruit four more star, stem cell scientists to California.
The agency has committed about $1.8
billion of its $3 billion so far with about $700 million available
for future spending. The remainder is going for the agency's
administrative expenses. Cash for new grants is expected to run out
sometime in 2017. Total cost of the agency's efforts run to about $6
billion because it operates with money borrowed by the state and must
pay interest.
The agency is currently engaged in
developing a plan to develop new sources of funding with an eye on
some sort of public-private model. It solicited proposals in May for
help with the effort, with the goal of completing a plan by this
fall. At last report, however, the contract with the consultant had
not been let.
The “strategic roadmap,” as it is
called, is likely to come up at next week's governing board meeting
along with a review of agency goals for the 2013-14 fiscal year.
On the agenda is a proposal to modify the agency's ban on use of its funds to purchase stem cell lines derived from human eggs supplied by women who have been paid. That proposal will
also be heard by the agency's standards group next Wednesday.
The agency has additionally been busy
implementing recommendations from a performance audit in May 2012.
The audit said the agency was laboring under a range of problems that
include protection of its intellectual property and management of its
nearly 500 grants plus an inadequate ability to track its own
performance. A staff Power Point presentation seems to indicate that it is making substantial progress in solving the problems identified by the audit.
Next week's meeting will be in
Burlingame near the San Francisco Airport. Two remote locations where
the public can participate are also available in Los Angeles.
Addresses can be found on the agenda.

The California Stem Cell Report will
provide live coverage of the meeting based on the Internet audiocast
with stories filed as warranted.  

Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/8Zu2WtPeFrI/california-stem-cell-agency-to-commit.html

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California’s $70 Million ‘Alpha’ Stem Cell Clinic Plan Headed for Approval Next Week

Alpha clinic organizational diagram
Graphic by CIRM
California's stem cell agency next week
is likely to approve a $70 million plan to build a taxpayer-financed
chain of  “Alpha” stem cell clinics in what could be a major step
towards making California the stem cell capital of the world,
The proposal would create five centers
at existing institutions or businesses to be funded at up to $11
million each over five years. Also proposed is a coordination and
information center that would receive $15 million over five years.
A story in Nature Medicine said that
the Alpha clinics would be the first-ever “clinical trials network focused around a broad therapeutic platform.”
The clinics are expected to draw stem
cell projects from the around the world as well as those
funded by the $3 billion California stem cell agency. The proposal
would be one of the largest single research efforts funded by the
agency, formally known as the California Institute for Regenerative
Medicine (CIRM) and use about 10 percent of its remaining cash.
The Alpha clinics are aimed at creation
of a sturdy foundation for the stem cell industry in California,
capitalizing on the burgeoning, international lure of stem cell
treatments. Indeed, one of the objectives of the information center
is to divert people from dubious treatments elsewhere.
The plan would fill a “profound gap”
in quality information about stem cell treatments, according to a CIRM document, which said,

“By providing this resource, the public and potential patients
would be better educated and informed, whether or not they should opt
to enroll in clinical trials or approved treatments at any of the
Alpha clinics.”

The Alpha concept was first broached two years ago publicly by
CIRM President Alan Trounson, a pioneer in IVF research and the IVF
business. His proposal has received early and heavy
attention on the CIRM website with a video, blog items and a white paper.
The plan has received little critical
attention although a researcher from an institution that could be a
candidate for an Alpha clinic commented harshly in May on the California
Stem Cell Report, calling the proposal “an irresponsible waste”and a “boondoggle for some medical schools.” The researcher, who
asked that he/she not be identified, said,

“CIRM will pay for an unneeded
infrastructure that will be empty space and staff sitting on their
hands 99 percent of the time.  Or worse yet, CIRM will pay but
the space will be used for other things, other clinic procedures paid
for by insurance.”  

Elie Dolgin's July 8 piece in Nature
Medicine quoted Mahendra Rao, director of the Center for Regenerative
Medicine at the US National Institutes of Health (NIH), as applauding the concept. However, Rao said he doesn't
anticipate the approach being tried nationally soon.
Dolgin wrote,

“Rao regularly asks researchers
hoping to advance promising stem cell therapies whether they require
additional clinical infrastructure. 'So far, what they've told us is
they'll let us know if they need anything more than (the) programs
that we have already established,' he says.”

The question of the size of the demand
for Alpha clinics is not addressed in the CIRM concept plan. Also
absent is much discussion of the business aspects of the proposal. It
does mention “corporate sponsors” in passing. In a CIRM blog item
yesterday, Natalie DeWitt, special project director at the agency,
touched on business elements, declaring,

“(The proprosal) will yield better
clinical trial design, accelerated approval of high quality
treatments, and data and know-how to inform regulatory and
reimbursement decisions.”

Reimbursement is the industry euphemism
for creating ways to generate profits for stem cell firms.
The proposal said applicants would have
to bring substantial support from their own institutions and
“demonstrate the potential to bring in a pipeline of additional
stem cell-based therapeutic trials as well as future funding streams
to sustain the clinic.” Applicants would also be “evaluated in
their ability to create a positive 'brand' that would attract
clinical trials.”
Also up in the air was whether grant
reviewers, all of whom come from out-of-state, would have special
expertise to evaluate the business aspects of each applicant's
proposal along with their business track record.
What is before the CIRM directors July
25 at their meeting in Burlingame, Ca., is a request for approval of the concept, which
would be fleshed out for the RFA. The governing board almost always
approves staff concepts, although they may modify them slightly. A
number of directors come from institutions that are likely to be
applicants in the program. They can participate in voting on the
concept plan but would be barred from voting on any applications that
come in later. The two RFAs could go out as early as October with
approval of funding of applications one year from now.
In addition to the Burlingame meeting
site, members of the public can participate from two teleconference
locations in the Los Angeles area. The specific locations can be
found on the meeting agenda.
The California Stem Cell Report will
provide live coverage of the entire meeting, filing reports as
warranted based on the Internet audiocast.
Here are excerpts from CIRM's staff
document on the plan.

“To accelerate therapeutic
development and delivery of stem cell therapies, CIRM proposes
establishing the CIRM Alpha Stem Cell Clinics Network (CASC Network).
The network will be designed to support projects emanating from
CIRM’s funding pipeline, as well as scientifically outstanding stem
cell products being developed worldwide and brought to California.
Conceptually, the CASC Network is intended to be a sustainable
infrastructure designed to support academic- and industry-initiated
clinical trials, and delivery of therapies proven safe and
effective.”

“The major thrusts (of the overall
plan) will be:

• Development of clinical capacity
and associated resources designed to support the effective
implementation and execution of clinical trials and delivery of
registered stem cell therapies

• Compilation of data and
information concerning clinical trial experience and therapy outcomes
to further inform the research, regulatory, and general community
about the status of investigational stem cell interventions and
long-term outcomes

• Dissemination of information to
the public and counseling of patients and potential trial subjects
about therapeutic options and clinical trials involving stem cells in
the network and elsewhere.”

“The long-term vision is for the
Alpha Clinics to expand and accommodate a broad array of stem
cell-based clinical trials, where the trial meets the scientific,
clinical trial design and ethical standards set forth by the Alpha
Clinics Network, as well as FDA approved treatments.”

The coordinating and information center
would be expected to :
“Build relationships with
Accountable Care Organizations, and participate in initiatives for
informing coverage and payment decisions

“Design strategies to attract
investors and philanthropists to CASC network

“Create business plans, and marketing
and branding strategies for financial sustainability of the Alpha
Clinics Sites and (the coordination/information center)”.

Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/VhnrrutbBC0/californias-70-million-alpha-stem-cell.html

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