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Archive for the ‘Stem Cell Therapy’ Category

Skimpy Coverage of Alpha Clinic Concept Approval

Sunday, August 4th, 2013
News coverage of approval of the
California stem cell agency's ambitious, $70 million Alpha clinic
plan has been quite light but does include one article in the Los
Angeles Times
, the state's largest circulation newspaper.
The concept proposal was ratified last
week by the agency's board with RFAs scheduled to be posted in
October. The agency is seeking to build a basis for a robust stem
cell clinic business in California that would have an international
reach and give the state dominance in the industry.
Karen Kaplan's story in the Times last
week quoted CIRM President Alan Trounson as saying in 2010 about
agency's goals.

“If we went 10 years and had no
clinical treatments, it would be a failure. We need to demonstrate
that we are starting a whole new medical revolution.”

The stem cell agency was created by
voters in 2004 and funded with $3 billion in borrowed money. It will
run out of funds for new grants in 2017.
Outsourcing-Pharma.com caught up with
the plan this week in a story that said,

“The opportunity to run trails under
the well-funded CIRM could be a boon for CROs (contract research
organizations)....But the difficulties of handling the stem cells and
gathering enough patients to enroll in a trial may prove daunting for whatever
company tries to conduct the trials.”

The article also quoted CIRM spokesman
Kevin McCormack as saying,

 “No one has reached out to us yet
because the specific details of what we are looking for in the
clinics have not yet been decided.”

That said, considerable information is
available herehereherehere and here.)
Also reporting on board approval of the
Alpha clinic plan was GenNews.

Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/g-INer3wY50/skimpy-coverage-of-alpha-clinic-concept.html

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Pay-for-Eggs Legislation Now Before California Gov. Jerry Brown

Sunday, August 4th, 2013
California's pay-for-eggs bill is now
officially on Gov. Jerry Brown's desk, awaiting his signature or
veto.
The measure, AB926 by Assemblywoman
Susan Bonilla, D-Concord, was sent to the governor at 4:45 p.m. PDT
yesterday. On July 1, it easily won legislative approval and
has been held in legislative processing since then. The governor has
12 days to act on the measure or it becomes law without his
signature.
The legislation would remove the state
ban on payment to women for their eggs for scientific purposes.
Currently women who provide their eggs for fertility purposes can be
compensated. Fees run as high as $50,000 in some cases, depending on
the characteristics of the woman providing the eggs, but generally
are in the $10,000 range or less. The bill does not affect the ban on
the use of funds from the California stem cell agency to compensate
egg providers.
Bonilla's bill is sponsored by the $5
billion-a-year fertility industry, which is backing it on motherhood
and sexual equity grounds. Supporters say women should receive
payment for their eggs just as men are paid for their sperm. They
also argue that more eggs are needed for research into fertility
problems. In the stem cell field, scientists have also said it is
nearly impossible to find women who will provide eggs unless they are
paid.
Opponents contend that the process of
stimulating production of eggs can be risky or dangerous. They say
that the longterm effects of the process have not been studied well.
They also argue that it will lead to exploitation of low income and
minority women to produce eggs that then can become a profitable
commodity for the largely unregulated fertility industry. (For more
informationon on the bill, see here, here and here.)
In one op-ed piece in The Sacramento
Bee
, opponents cited the late philosopher Ivan Illich, who was much admired by Jerry Brown, who considered him a friend. Illich was quoted as warning "against the processes of medical
industries which 'create new needs and control their satisfaction and
turn human beings and their creativity into objects.'"
The industry group says, however, that Brown is
committed to signing the bill.
The measure surfaced in the news
yesterday in an article on the Forbes magazine website by Jon Entine.
He wrote,

“Should activist groups, working
through legislators, exercise their control over women’s
reproduction? Do we really 'own' our own bodies? Or does that tenet
only hold when nanny groups say it’s okay?”

(One of the authors of The Sacramento Bee op-ed piece criticized in the Forbes article later filed a comment concerning their position.)

The egg legislation may have implications for
regulation of stem cell research by the state Department of Public
Health
(again not involving the California stem cell agency). Last
month the California Stem Cell Report asked Hank Greely, a Stanford
law professor and chair of the state department's Human Stem Cell Research Advisory Committee, about the measure. He replied,

“Well, if (when?) AB 926 is signed, I
think our committee should meet to consider what recommendations we
would make to the (the department) as a result of the bill.  Those
recommendations could lead, if the committee and the department
agree, to a revision of the state guidelines.  As a matter of
law, a statute, particularly a subsequent statute, trumps a guideline
where they are in conflict, but basically I expect we'll see what the
committee thinks and what the department decides.  I don't wish
to guess at the results of either process.”

Another question that was not discussed
publicly during the debate on the legislation deals with whether human eggs provided with compensation would be subject to state sales tax at any stage in the process. A check of the tax code, however, makes it
clear that eggs are tax free. The code states that “any human body
parts held in a bank for medical purposes, shall be exempt from
taxation for any purpose." The definition of “bank”
includes research facilities, and "medical purposes" includes research.

Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/sZ_beYvQCX8/pay-for-eggs-legislation-now-before.html

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Comment re Pay-for-Eggs Item and Forbes Article

Sunday, August 4th, 2013
One of the authors of an op-ed piece in The
Sacramento Bee
has filed a comment in connection with an item today on the California Stem Cell Report. The item dealt with the California pay-for-eggs bill, which was also the subject of an op-ed piece in The Sacramento Bee as well as an article yesterday on the Forbes
magazine website that discussed the op-ed piece critically.
A quotation from the article was contained in this item earlier
today.
Here is the text of the comment from
Nancy Scheper-Hughes, a professor of anthropology at UC Berkeley and
director of Organs Watch.  Diane Tober, associate executive director of the Center for
Genetics and Society
of Berkeley, was the other author.

“Dr. Diane Tober and Prof. Nancy
Scheper-Hughes  are 'pro choice'  social scientists who are
concerned about the absence of any evidence-based medicine on the
long term effects of hyper-stimulation for oocyte (egg) production in
young women research subjects. We are not concerned about abortion,
right to life, or obstructing  needed and valuable research on
stem cells. We are concerned about the safety for potential research
subjects who are being actively recruited to participate in
 invasive medical procedures without any medical research
studies on the possible risks and consequences of egg multiplication
and extraction. We are on record that we  fully support stem
cell research but not at the expense of unprotected egg donors.”  

Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/CdOjDrBctTE/comment-re-pay-for-eggs-item-and-forbes.html

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Pay-for-Eggs Legislation: A Comment on Risk

Sunday, August 4th, 2013
The author of the Forbes piece cited in
the eggs legislation item today has responded to a comment filed
by two persons opposed to the measure that would remove the ban in
California on paying women for their eggs for scientific research.
Here is the text filed by Jon Entine,
executive director of the Genetic Literacy Project.

“Diane and Nancy, I'm shocked that
you are either unaware or do not acknowledge that there are studies
of oocyte retrieval surgeries that show very persuasively that the
potential harm from this procedure is manageable. While you refer to 'stories' of women being harmed--that's called anecdotal
evidence and is the antithesis of science--you ignore the established
research in this area, which makes it clear that you are reacting
hysterically rather than responding to empirical evidence. I would
suggest that you read the National Academies Press workshop report:
Assessing the Medical Risks of Human Oocyte Donation for Stem Cell
Research (http://www.nap.edu/catalog.php?record_id=11832).
It cites numerous studies, including a German study that examined the
outcome of approximately 380,000 oocyte retrieval surgeries during
2000-2004. For the procedures for which there was information, the
rate of complications was very low: only 0.002 percent—2 in every
100,000—had complications that required surgery to correct.

“Studies have also examined the
potential risks of retrieval for a woman's future fertility.
“According to one large study, the
rate of infection after oocyte retrieval was about 1 in every 200 IVF
cycles, and surgery is needed to treat pelvic abscesses in less than
1 in 1,000 IVF cycles. 

“About five hundred egg donations
take place in Canada each year, according to the Canadian Fertility
and Andrology Society.The CFAS told me that, between 2001 and 2010,
only two donors in Canada, out of a total of 4,177 donations,
suffered from “severe” OHSS, which usually involves
hospitalization. Fourteen others had “moderate” OHSS. These
numbers are collected in a database called the Canadian Assisted
Reproductive Technologies Registry.

“So sure, you can find your 'stories' but they do not represent a scientific review of the available
data--you are trying to legislate based on fear. That's not science;
that's the dark ages, and it's exactly the tactics used by
anti-abortionists (and indeed by organizations like the Center for
Genetics and Society which opposes such beneficial advances as
mitochondrial replacement surgery).

“Furthermore, because women have a
set of two ovaries and two fallopian tubes, they can remain fertile
even if one set is damaged, and there is no evidence that both might
be threatened simultaneously by the side effects of retrieval
surgery. 

“Today doctors have had two decades
of experience with the use of hormone treatments to maximize the
number of eggs that can be harvested from a woman, and they have
become quite proficient in the production of oocytes. During that
time they have also worked to improve the safety of the procedure and
decrease the potential risks. Despite these improvements some risk
will remain, because hormones have a powerful effect on the body—they
could not increase egg production so dramatically if this were not
true—and anything with a powerful effect on the body has the
potential for harmful side effects as well. 

“Egg donations are done for a reason.
There are risks and benefits. For you to exaggerate the risks based
on 'stories' and ignore the evidence is unconscionable.
It's exactly what anti-abortion groups do and what opponents of
genetically modified foods do--you promote fear around manageable (or
in the case of GMOs, negligible) risk. 

“Your call for 'further studies' is the age old technique of reactionaries trying to control other
people and impose their values on other people. You know darned well,
because of your fundamental ideological opposition to this procedure,
no study results could ever meet your standard of acceptability. 

“You are trying to control other
women's bodies, claiming you have superior knowledge and
wisdom--those are pro-life talking points. Your views, and that of
the organizations that you represent, are illiberal.”

Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/ib44Z4ZI-j0/pay-for-eggs-legislation-comment-on-risk.html

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California Stem Cell Agency Looking for New Home in Two Years

Sunday, August 4th, 2013
The California stem cell agency is located south of Market Street in San
 Francisco, close to the San Francisco Giants ballpark(upper right).  Since
 the agency has been there, the area has grown from seedy to gentrified. 
Some not-so-good news surfaced today in
San Francisco involving the $3 billion California stem cell agency.
The news has little to do with its
science efforts but everything to do with where it is located and its
overhead expenses. The agency will be forced out of its free office
space – 20,000 square feet – in two years. The free space was
provided under an $18 million recruitment package and is worth at
least $1 million a year, according to the agency's auditors.
The bad news is that the San Francisco
office-space market is sizzling hot. Google, Yahoo, Microsoft and
other technology firms are scrambling for space in
Baghdad-by-the-Bay, as the city is sometimes known. According to a story this morning by James Temple in the San Francisco Chronicle,
the firms are looking for a total of about 800,000 square feet and
are prepared to pay well for it.
One nearly completed deal involving
Yahoo would cost about $48 per square foot for a 10-year lease. If
CIRM paid at that rate, it would have nearly $1 million in additional
costs annually. However, leasing rates are expected to rise substantially in the next year or so. Also involved in a move would
be the cost of parking, which could run about $360,000 a year.
The stem cell agency is already
examining its options for new offices, including some sort of special
deal with the City of San Francisco.
Former State Sen. Art Torres, onetime
chairman of the state Democratic Party and co-vice chairman of CIRM,
briefed agency directors on the matter at its meeting in May. He
said,

“I met with the mayor of San
Francisco(Ed Lee), who's a dear friend, and he encouraged us to be
aware that he's very committed to helping us find some space in San
Francisco. Whether it means tax credits or incentives to a potential
landlord, we still have to work that out. Obviously we still have to
work out what the space will be. But the fact that the mayor has
indicated very explicitly that he wants to keep us in San Francisco,
I think it will bode well for us down the road.

“The current owner of the property
(Stockbridge Capital Partners) has not been happy that for ten years
they've had to supply free rent to us. And what they didn't
anticipate was having to provide for over $755,000 in operating
costs, which they thought some donors would take are of. Those donors
-- some of whom passed away and others who chose to give money to
other institutions, UC San Francisco, in particular, to the stem cell
lab, which was very much appreciated, I know, by UCSF – but at
the end of the day, there's no room for negotiations with this
current owner.”

CIRM Director Joan Samuelson asked
Torres whether future rent would also be free. Torres, who is also
president of San Francisco's Public Utilities Commission, replied,

“I would not work on that assumption.
I would work on the assumption somewhere between a dollar and more,
again, dependent upon what kind of tax incentives the City of San
Francisco would provide. We're very fortunate that my son(Joaquin
Torres
) is the deputy mayor for economic development, so we also have
him working on this as well.”

Samuelson replied,

“I'll ask more questions offline.”

Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/v8usDDMWucE/california-stem-cell-agency-looking-for.html

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Part 2 Stem Cell Therapy – Video

Tuesday, July 30th, 2013


Part 2 Stem Cell Therapy

By: Tiffany Vinson

Follow this link:
Part 2 Stem Cell Therapy - Video

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Mac Stem Cell Therapy 2012 – Video

Monday, July 29th, 2013


Mac Stem Cell Therapy 2012
Before and After Mac #39;s Stem Cell Therapy. Surgery done by Dr. Mark McCloskey, DVM, Columbus, OH.

By: Mary Hammond

Read the rest here:
Mac Stem Cell Therapy 2012 - Video

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California Stem Cell Official Duane Roth in Improving Condition

Sunday, July 28th, 2013
Duane Roth, the co-vice chairman of the
California stem cell agency, is improving after he was hospitalized
for treatment of a serious brain injury sustained in a bicycle accident Sunday in
the mountains east of San Diego.
According to a report on Xconomy.com,
Roth's brother, Ted, said yesterday, 

“Were certainly moving in the
right direction. We're now looking at the recovery phase.”

The article by Bruce Bigelow said Roth
has passed through the most critical period following surgery at the
UC San Diego hospital.
Roth, the 63-year-old CEO of the San
Diego technology organization, Connect, is in serious condition in a
medically induced coma.
The governing board of the California
stem cell agency yesterday took special note of Roth at its meeting and sent its best wishes to him and his family.  

Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/nmnYkisG6MU/california-stem-cell-official-duane.html

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Another $23 Million to Recruit Star Stem Cell Scientists to California

Sunday, July 28th, 2013
California's $46 million effort to lure
stem cell research stars to the Golden State was expanded today by
another $23 million.
Directors of the stem cell agency
approved the funds on a 14-4-1 vote. CIRM directors Jeff Sheehy and
Francisco Prieto were among those opposing the move. Prieto declared,

“We are coming up against finite resources. We have better ways to spend
our money."

 Sheehy said that CIRM is contributing to inflation in stem cell science with its lucrative recruitment grants. 

Those supporting the expansion said that the grants have had a great impact on the field, not only bringing in individual scientists, but accompanying researchers in their labs along with grants from other sources.
The additional funds will go to
institutions that have not already benefited from one of the earlier
grants in the program. Up to four awards are expected to be made.
The CIRM staff proposal on the plan
said,

“A number of California institutions
have not yet been able to secure a confirmed Research Leadership
award but would benefit greatly from the recruitment of emerging or
established leaders in stem cell biology. Participation in the CIRM
program could bring additional, exceptional researchers to
California, strengthen and synergize with other efforts to build up
local sustained research communities in stem cell biology and
medicine and provide ongoing leadership at the cutting edge of
California regenerative medicine.”

All of the California institutions
involved with the winning researchers have representatives on the
governing board of the stem cell agency. They are not allowed, however, to vote
on grants to their institutions or researchers -- only on proposals such as today's $23 expansion.
Applications are due in January with
final approval scheduled for next May. The program is not open to
businesses.

Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/iJ66PTxTsX8/another-23-million-to-recruit-star-stem.html

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California Stem Cell Agency Launches $70 Million Alpha Stem Cell Clinic Project

Sunday, July 28th, 2013

The California stem cell agency today approved
a $70 million plan to create a network of “Alpha” stem cell
clinics that is aimed at making the Golden State one of the leading
purveyors and developers of stem cell therapies in the world.

The 29-member governing board of the California
Institute for Regenerative Medicine (CIRM)
adopted the plan on a 19-1 vote. The negative vote came from Joan Samuelson, who questioned
whether the plan was premature and whether existing scientific research justified development of the clinics. 
Sherry Lansing, a patient advocate board member and
former head of a Hollywood studio, said the proposal is “one of the
most exciting proposals that we have ever had in front of us.” She
said it was the “beginning of this dream coming true.”
Under the far-reaching proposal, which
CIRM President Alan Trounson has been promoting for two years, the
agency will finance five stem cell clinics at established
institutions in California with grants of up to $11 million. Another
$15 million will be allotted for a stem cell information and
coordination center. Major matching contributions will be expected
from award winners over the five-year terms of the grants.
The effort is aimed at drawing in
clinical trials and patients from the around the world and creating a
central bank of knowledge, know-how and regulatory expertise. It
will also guide efforts to build profits into stem cell therapies
and to develop strategies to attract investors and philanthropists.
(For more information on the plan, see here, here, here, here and
here.)
Trounson said in a statement,

“These clinics have the potential to
revolutionize how we deliver stem cell therapies to patients. Stem
cell therapies are a completely new way of treating diseases and
disorders so we need a completely new way of delivering those in a
safe and effective manner. These clinics will help us do just that
and the clinical trials carried out in this network will fulfill the
agency’s promise of bringing new therapies to patients who need
them.” 

The journal Nature Medicine has
reported that the Alpha clinics would be the first-ever “clinical
trials network focused around a broad therapeutic platform.”
The CIRM board heard no negative
comment on the plan other than the remarks by Samuelson. . However,
not everyone sees a need for it. Mahendra Rao, director of the Center
for Regenerative Medicine
 at the National Institutes of
Health(NIH)
, says its surveys of researchers have not shown a demand
for such centers. In May, a researcher at institution that likely
would be an applicant filed a blistering, anonymous comment on the
California Stem Cell Report, describing it as a "boondoggle" and "irresponsible." The scientist said,

“Another boondoggle for some medical
schools but made to order for private operators like for-profit
cancer, dialysis, and laser eye specialty clinics that do one
procedure.  I can see each of the medical schools gifted with
one as they each were gifted with about 25 million dollars for stem
cell institute buildings.”

The researcher continued,

“The NIH at various times has tried
to organize clinical trials groups with infrastructure, like quick
reaction forces, ready to gear up for a new trial at the drop of a
hat. They mainly did nothing but suck money, kept staff employed,
because there are generally few drugs ready for early human trials
and each treatment that is brought along requires a unique contract,
ethics reviews, and different facilities, equipment and staff than
planned for.  The latest incarnation are CTSAs or CTSIs,
clinical and translational science centers funded by the federal NIH
that most if not all California medical schools already have.”

The RFA for the proposal is expected to
go out in October and approval of funding coming one year from now. Here is the link to today's CIRM press release on the plan. 

Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/EBbBzLL9dQQ/california-stem-cell-launches-70.html

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

Sunday, July 28th, 2013
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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Coming Up: Live Coverage of Today’s California Stem Cell Meeting

Sunday, July 28th, 2013
The California Stem Cell Report will
provide live, wall-to-wall coverage of today's meeting of the
governing board of the $3 billion California stem cell agency.
At the top of the agenda is a $70
million proposal aimed at creating a string of Alpha stem cell clinics in
California that would serve as a foundation for the state's stem cell
business. Also on tap are other proposed grant programs, including a
$23 million expansion of a researcher recruitment effort and a $35 million round aimed at removing roadblocks to turning research into
cures.
Stories will be filed as warranted
throughout the day based on the Internet audiocast of the proceedings. 

Interested parties can also listen in
on the meeting via the Internet. Instructions can be found on the agenda.  

Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/Vi8IGlL2TzY/coming-up-live-coverage-of-todays.html

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

Sunday, July 28th, 2013
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

Sunday, July 28th, 2013
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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California Stem Cell Official Duane Roth in Improving Condition

Sunday, July 28th, 2013
Duane Roth, the co-vice chairman of the
California stem cell agency, is improving after he was hospitalized
for treatment of a serious brain injury sustained in a bicycle accident Sunday in
the mountains east of San Diego.
According to a report on Xconomy.com,
Roth's brother, Ted, said yesterday, 

“Were certainly moving in the
right direction. We're now looking at the recovery phase.”

The article by Bruce Bigelow said Roth
has passed through the most critical period following surgery at the
UC San Diego hospital.
Roth, the 63-year-old CEO of the San
Diego technology organization, Connect, is in serious condition in a
medically induced coma.
The governing board of the California
stem cell agency yesterday took special note of Roth at its meeting and sent its best wishes to him and his family.  

Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/nmnYkisG6MU/california-stem-cell-official-duane.html

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California Stem Cell Agency Launches $70 Million Alpha Stem Cell Clinic Project

Sunday, July 28th, 2013

The California stem cell agency today approved
a $70 million plan to create a network of “Alpha” stem cell
clinics that is aimed at making the Golden State one of the leading
purveyors and developers of stem cell therapies in the world.

The 29-member governing board of the California
Institute for Regenerative Medicine (CIRM)
adopted the plan on a 19-1 vote. The negative vote came from Joan Samuelson, who questioned
whether the plan was premature and whether existing scientific research justified development of the clinics. 
Sherry Lansing, a patient advocate board member and
former head of a Hollywood studio, said the proposal is “one of the
most exciting proposals that we have ever had in front of us.” She
said it was the “beginning of this dream coming true.”
Under the far-reaching proposal, which
CIRM President Alan Trounson has been promoting for two years, the
agency will finance five stem cell clinics at established
institutions in California with grants of up to $11 million. Another
$15 million will be allotted for a stem cell information and
coordination center. Major matching contributions will be expected
from award winners over the five-year terms of the grants.
The effort is aimed at drawing in
clinical trials and patients from the around the world and creating a
central bank of knowledge, know-how and regulatory expertise. It
will also guide efforts to build profits into stem cell therapies
and to develop strategies to attract investors and philanthropists.
(For more information on the plan, see here, here, here, here and
here.)
Trounson said in a statement,

“These clinics have the potential to
revolutionize how we deliver stem cell therapies to patients. Stem
cell therapies are a completely new way of treating diseases and
disorders so we need a completely new way of delivering those in a
safe and effective manner. These clinics will help us do just that
and the clinical trials carried out in this network will fulfill the
agency’s promise of bringing new therapies to patients who need
them.” 

The journal Nature Medicine has
reported that the Alpha clinics would be the first-ever “clinical
trials network focused around a broad therapeutic platform.”
The CIRM board heard no negative
comment on the plan other than the remarks by Samuelson. . However,
not everyone sees a need for it. Mahendra Rao, director of the Center
for Regenerative Medicine
 at the National Institutes of
Health(NIH)
, says its surveys of researchers have not shown a demand
for such centers. In May, a researcher at institution that likely
would be an applicant filed a blistering, anonymous comment on the
California Stem Cell Report, describing it as a "boondoggle" and "irresponsible." The scientist said,

“Another boondoggle for some medical
schools but made to order for private operators like for-profit
cancer, dialysis, and laser eye specialty clinics that do one
procedure.  I can see each of the medical schools gifted with
one as they each were gifted with about 25 million dollars for stem
cell institute buildings.”

The researcher continued,

“The NIH at various times has tried
to organize clinical trials groups with infrastructure, like quick
reaction forces, ready to gear up for a new trial at the drop of a
hat. They mainly did nothing but suck money, kept staff employed,
because there are generally few drugs ready for early human trials
and each treatment that is brought along requires a unique contract,
ethics reviews, and different facilities, equipment and staff than
planned for.  The latest incarnation are CTSAs or CTSIs,
clinical and translational science centers funded by the federal NIH
that most if not all California medical schools already have.”

The RFA for the proposal is expected to
go out in October and approval of funding coming one year from now. Here is the link to today's CIRM press release on the plan. 

Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/EBbBzLL9dQQ/california-stem-cell-launches-70.html

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Another $23 Million to Recruit Star Stem Cell Scientists to California

Sunday, July 28th, 2013
California's $46 million effort to lure
stem cell research stars to the Golden State was expanded today by
another $23 million.
Directors of the stem cell agency
approved the funds on a 14-4-1 vote. CIRM directors Jeff Sheehy and
Francisco Prieto were among those opposing the move. Prieto declared,

“We are coming up against finite resources. We have better ways to spend
our money."

 Sheehy said that CIRM is contributing to inflation in stem cell science with its lucrative recruitment grants. 

Those supporting the expansion said that the grants have had a great impact on the field, not only bringing in individual scientists, but accompanying researchers in their labs along with grants from other sources.
The additional funds will go to
institutions that have not already benefited from one of the earlier
grants in the program. Up to four awards are expected to be made.
The CIRM staff proposal on the plan
said,

“A number of California institutions
have not yet been able to secure a confirmed Research Leadership
award but would benefit greatly from the recruitment of emerging or
established leaders in stem cell biology. Participation in the CIRM
program could bring additional, exceptional researchers to
California, strengthen and synergize with other efforts to build up
local sustained research communities in stem cell biology and
medicine and provide ongoing leadership at the cutting edge of
California regenerative medicine.”

All of the California institutions
involved with the winning researchers have representatives on the
governing board of the stem cell agency. They are not allowed, however, to vote
on grants to their institutions or researchers -- only on proposals such as today's $23 expansion.
Applications are due in January with
final approval scheduled for next May. The program is not open to
businesses.

Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/iJ66PTxTsX8/another-23-million-to-recruit-star-stem.html

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

Sunday, July 28th, 2013
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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Coming Up: Live Coverage of Today’s California Stem Cell Meeting

Sunday, July 28th, 2013
The California Stem Cell Report will
provide live, wall-to-wall coverage of today's meeting of the
governing board of the $3 billion California stem cell agency.
At the top of the agenda is a $70
million proposal aimed at creating a string of Alpha stem cell clinics in
California that would serve as a foundation for the state's stem cell
business. Also on tap are other proposed grant programs, including a
$23 million expansion of a researcher recruitment effort and a $35 million round aimed at removing roadblocks to turning research into
cures.
Stories will be filed as warranted
throughout the day based on the Internet audiocast of the proceedings. 

Interested parties can also listen in
on the meeting via the Internet. Instructions can be found on the agenda.  

Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/Vi8IGlL2TzY/coming-up-live-coverage-of-todays.html

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

Sunday, July 28th, 2013
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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