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Ocular gene delivery systems using ternary complexes of plasmid DNA, polyethylenimine, and anionic polymers.

By Dr. Matthew Watson

Authors: Kurosaki T, Uematsu M, Shimoda K, Suzuma K, Nakai M, Nakamura T, Kitahara T, Kitaoka T, Sasaki H
Abstract
In this experiment, we developed anionic ternary complexes for effective and safe ocular gene delivery. Ternary complexes were constructed by coating plasmid DNA (pDNA)/polyethylenimine (PEI) complex with anionic polymers such as ?-polyglutamic acid (?-PGA) and chondroitin sulfate (CS). The cationic pDNA/PEI complex showed high gene expression on the human retinal pigment epithelial cell line, ARPE-19 cells. The pDNA/PEI complexes, however, also showed high cytotoxicity on the cells and aggregated strongly in the vitreous body. On the other hand, the anionic ternary complexes showed high gene expression on ARPE-19 cells without such cytotoxicity and aggregation. Afte...

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Potent growth-inhibitory effect of a dual cancer-specific oncolytic adenovirus expressing apoptin on prostate carcinoma.

By Dr. Matthew Watson

Potent growth-inhibitory effect of a dual cancer-specific oncolytic adenovirus expressing apoptin on prostate carcinoma.
Int J Oncol. 2013 Mar;42(3):1052-60
Authors: Zhang M, Wang J, Li C, Hu N, Wang K, Ji H, He D, Quan C, Li X, Jin N, Li Y
Abstract
Apoptin is a chicken anemia virus-derived, p53-independent, bcl-2-insensitive apoptotic protein with the ability to specifically induce apoptosis in various human tumor cells, but not in normal cells. To explore the use of apoptin in tumor gene therapy, we assessed a recombinant adenovirus expressing the apoptin protein (Ad-hTERTp-E1a-Apoptin) in order to determine its lethal and growth-inhibitory effects on PC-3 and RM-1 cells in vitro and its antitumor effect on solid tumors in vivo....

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Sacramento Bee: Stem Cell Agency Falling Short on IOM Recommendations

By Dr. Matthew Watson

It's exceedingly rare when the
California stem cell agency makes the front page of any newspaper.

So it is worthy of note that The
Sacramento Bee
this morning carried a lengthy piece on its page one
about the agency and its response to the blue-ribbon Institute of
Medicine
(IOM) report.
The headline said,

 “Analyst: Stem
cell agency reforms fall short.”

The analyst is the Institute of
Medicine, more specifically Harold Shapiro, chairman of the panel that
studied California's $3 billion research effort for 17 months at
a cost of $700,000 to the agency.
Bee reporter Cynthia Craft wrote that
Shapiro said the stem cell agency is “falling short” in its
response to the IOM recommendation.
Craft wrote,

"'There certainly is a gap between
what we recommended and what they responded with,' said Shapiro,
president emeritus at Princeton
University
. ' I wish they had moved closer to our
recommendations.'"

Craft said the IOM made sweeping recommendations “emphasizing the need for new blood on a governing
board that has been plagued by the appearance of conflicts of
interest, cronyism and sluggishness in getting stem-cell products to
market.”
Craft also interviewed Jonathan
Thomas
, chairman of the stem cell agency, who said some of the IOM
recommendations would take legislative action. But Thomas said that
was “out of the question.”
Craft wrote,

“The process would take years, he
said. The first opportunity to get on the ballot, for instance, would
be in the fall of 2014.”

The agency will run out of cash for new
grants in less than four years.
Craft's story was the first major news
article in years about the agency in the Bee, the only daily
newspaper in the state's capital. She reviewed a bit of the history
of the agency and concerns about conflicts of interest. She
concluded,

“Shapiro said he stands firmly behind
his committee's report. 

"'I think our recommendations sit
together and interrelate to each other well – and should have been
moved along as quickly as possible,' Shapiro said. 

"'It might have been helpful if
they indicated to us what they were willing to do and what they
weren't,' he said."

Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/tEEJz8_Jcds/sacramento-bee-stem-cell-agency-falling.html

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Hyping the Economic Impact of the California Stem Cell Agency

By Dr. Matthew Watson

The $3 billion California stem cell agency today served up a warmed-over version of a study that would have the
public believe that the research program has had a major economic
impact on the state.

The latest study was prepared last
August by a firm that was hired under an RFP in 2010 that said it must execute "a vibrant and aggressive strategy to support the goals and initiatives of CIRM.” 
The agency paid $300,000 for the
original study but contends the report is “independent” of CIRM.
According to the CIRM press release
today, the latest version of the study by Jose Alberro of the
Berkeley Research Group claims creation of 38,000 “job years” and
$286 million in “new tax revenue” from the award of $1.5 billion. Those awards actually cost something in the neighborhood of $3 billion, given that state taxpayers must pay interest the borrowed funds that finance the agency. 
The Institute of Medicine's recent
blue-ribbon report on the stem cell agency carried remarkably different
information than the economic figures reported today. The institute's study was also financed by CIRM but at a cost of
$700,000. The report said,

“In the short term, CIRM’s
expenditures are supporting approximately 3,400 jobs and their
innovative efforts have also attracted substantial additional private
and institutional resources to this research arena in California
CIRM’s long-term impact on such critical aspects of the California
economy as state tax revenues and health care costs beyond the
shorter-term and temporary impact of its direct expenditures cannot
be reliably estimated at this point in CIRM’s history."

Here is what the California Stem Cell Report wrote in 2011 when the first study was released:

“No doubt exists that the stem cell
spending has had a beneficial economic impact. But whether it has had
a 'significant' impact on the California economy is in the eye of the
beholder. The state's economy runs to something like $1.7 trillion a
year. If California were a nation, it would rank among one of the
larger economies in the world. The workforce totals around 18
million, making 25,000 jobs statistically less than a hiccup. Keep in
mind as well that CIRM, until 2009,  paid the interest on its
borrowing with more borrowed funds, all of which adds to the total
cost of the borrowing, which is about $3 billion on top of the $3
billion CIRM is handing out.”

By ballyhooing economic impact reports
the stem cell agency would seem to be inviting assessment of its
efforts as an industrial development enterprise, which involve
criteria significantly different than that of a research enterprise.
A few years ago, we asked the agency's then Chairman Robert Klein
whether he wanted to have CIRM assessed as industrial development
effort. His quick response was a very emphatic no. Klein nonetheless
frequently touted the figures produced under the contract with the
agency.
The latest figures are undoubtedly
likely to be cited as the agency begins a road trip around the state
to meet with newspaper editorial boards to trumpet CIRM's reponse to
the Institute of Medicine study.
See below for a full copy of the
report. We have asked CIRM for a copy of the contract with the group
that prepared it. We will carry it when we receive it.
   

Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/l9y8li36Cn8/hyping-economic-impact-of-california.html

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Los Angeles Times Columnist: Stem Cell Agency Still Saddled with Conflict of Interest Problems

By Dr. Matthew Watson

The governing board of the $3 billion
California stem cell agency will remain dominated by “special
interests” even with the adoption of a plan last week responding to
the far-reaching recommendations of a blue-ribbon Institute of
Medicine (IOM)
study, a columnist for the Los Angeles Times said today.

Michael Hiltzik, Pulitzer Prize winning
writer and author, wrote that IOM study showed the agency “the path
to cleansing itself of its aura of connivance and influence trading.
That the board can't even bring itself to place the proposals before
the voters or their elected representatives only shows how much money
it's willing to waste to keep living in its own little world.”
Hiltzik's column in California'slargest circulation newspaper included fresh comments from both
Harold Shapiro, who chaired 17-month IOM study, which was
commissioned by CIRM, and Jonathan Thomas, the chairman of CIRM and
who drew up the response.
Hiltzik wrote that the study “concluded
that the CIRM board members were saddled with 'almost unavoidable
conflicts of interest, whether actual or perceived.'” He continued,

“That's because by law, 23 of the 29
members must be representatives of California institutions eligible
for CIRM grants or of disease advocacy groups with their own interest
in steering money toward their particular concerns. 

“As a remedy, the panel proposed
eliminating some board slots reserved for grant-receiving
institutions by Proposition
71,
 the 2004 initiative that created the agency. The idea
was to fill those slots with truly independent members free of any
stake in CIRM funding, even indirectly.”

 Hiltzik wrote,

 "Thomas told me his proposal dealt
with even perceived conflicts of interest on the board in such
"definitive fashion" that it won't be necessary to bother
the Legislature, much less the voters, with such big changes as
remaking the board with a majority of independent members. He pointed
out, not without some pride, that one board member called his
proposed changes 'draconian.'"

Hiltzik had some praise for Thomas.

“Let's stipulate that Thomas has, in
CIRM terms, moved a mountain by jostling the board even this far.
Since its inception, the board has set records for arrogance. That's
a direct legacy from Proposition 71, which exempted the stem cell
program, uniquely among California government bodies, from any
practical oversight by the Legislature or elected officials.”

The Times columnist continued,

“Shapiro told me from his Princeton
office that Thomas' proposals were 'a significant step in the right
direction, which at least indicates that they haven't ignored the
report.' But he doesn't share Thomas' view that voluntary recusals
solve the conflict of interest problem. That can be done, Shapiro
said, only by replacing stake-holding board members with
independents.

"'The more you can reduce the
inherent conflicts, the better off everyone is going to be,' he said.
The board will 'have to go further over time, in my view.'"

Hiltzik wrote,

“The Shapiro panel said it didn't
find any instances of inappropriate behavior by board members or
specific conflicts, but there are two reasons for that: It didn't
search for any, and Proposition 71 defined certain conflicts out of
existence. The measure states that it's no conflict for a board
member to also be an officer of an academic institution or private
corporation that might be applying for grants.

“One of the CIRM board's enduring
self-delusions is that its conflicts of interest are purely a matter
of 'perception.' But there have been documented instances
of favoritism shown to well-connected grant or loan applicants, and
at least one overt attempt by a board member to overturn a rejection
of his institution's project. So much of the board's discussion takes
place behind closed doors or informally that the opportunities for
mutual back scratching are incalculable.

“Thomas' 'draconian' proposals won't
change this state of affairs. Special interests will still dominate
the board. Will barring 13 members from voting on grants while giving
them full rein to participate in discussions really eradicate even
the perception of conflicts? You'd have to be terminally naive to
think so.”

Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/I_jSJSpM3nU/los-angeles-times-columnist-stem-cell.html

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Stem Cell Agency Plan Falls Far Short of Solving IOM Concerns

By Dr. Matthew Watson

The governing board of the $3 billion
California stem cell agency last week fell far short of complying
with the recommendations of a blue-ribbon Institute of Medicine (IOM) study
that the agency itself commissioned to improve its performance.

Many of the proposals by the IOM dealt
with conflicts of interest at the eight-year-old agency, which board members
reluctantly recognized on Wednesday as a perception problem. Under the plan approved last week, 13 of the 29 members of the board would not be allowed to vote on any awards. They are members tied to institutions that benefit from funding. Three other board members linked to those beneficiary
institutions, however, would still be allowed to vote on grants other than
those to their institutions. .
The board did nothing to deal with the
structural issues involving conflicts of interest that are built into
the board as the result of Prop. 71, the ballot measure that created the research
effort in 2004. The 29-member board was constituted in such a way as
to give nearly all institutions that could benefit a seat at the
table where the money is handed out. It is as if the state's Public
Utility Commission
, which sets utility rates, were dominated by
executives of the utility companies.
Under longstanding rules, individual members of the stem
cell board are barred from voting on grants to their institutions. However, the board still determines the game and the rules. The board approves the
specific areas of research for funding, approves plans for individual
RFAS, sets the rules for the grants and loans and enforces compliance
through CIRM staff.
The board last week limited itself to
changes that it could enact on its own. Many of the IOM
recommendations, including a new majority of independent members,
would require legislative action, which opens the agency to a wider
range of changes than even the IOM recommended. That is not a prospect the agency relishes. Nonetheless,
how well the board complies with the IOM recommendations is likely to
be critical to its plans to raise funds to continue its operations
beyond 2017, when the taxpayer cash runs out for new grants.
Here is a look at the key IOM recommendations and the response so far from the stem cell agency(see here and here).
More details may emerge between now the next CIRM board meeting in
the San Francisco Bay Area March 19, when the board is schedule to finalize its IOM plan. 
IOM Recommendation
“Change the Composition and Structure
of the Board and Working Groups.
“CIRM should put systems in place to
restructure the board to have a majority of independent members,
without increasing the size of the board. It should include
representatives of the diverse constituencies with interests in stem
cell research, but no institution or organization should be
guaranteed a seat on the board. Consideration should be given to
adding members from the business community....The chair and other
ICOC members should be prohibited from serving on the working groups.
During the reconstitution of the working groups, the current level of
representation of disease advocates should be maintained, such board
members being replaced with other disease advocates who are not board
members.”
CIRM Response
The Thomas plan basically is a total
rejection of this recommendation. The CIRM board does not support
creation of a new majority of independent members, which would mean
some current members would lose their seats if the board were not
increased beyond 29 members. No members will be added from industry.
Board members will continue to serve on the grant review panel and
other groups, contrary to IOM recommendations. In the case of grant
reviews, however, they would no longer vote in the closed door
sessions. The board has no plans to add patient advocates who are not
board members to working groups, including the grant review panel.
The University of California will continue to have five guaranteed
seats on the board. No independent members currently sit on the
board.
IOM Recommendation
“Revise Conflict of Interest
Definitions and Policies.
“CIRM should revise its definitions
of conflict of interest to recognize conflicts arising from
nonfinancial interests, such as the potential for conflict arising
from an individual’s interest in a specific disease, and should
reassess its policies for managing conflict of interest in light of
this broader definition.”
CIRM Response
CIRM has no plans to move to prevent
nonfinancial conflicts of interest. Several board members expressed
strong opposition to such an effort. Sixteen persons who sit on the
board have ties to institutions that receive CIRM funds. Currently
individual board members cannot vote on applications from their
institutions. To avoid the appearance of conflicts of interest, the
Thomas plan would have the 13 members directly appointed from
beneficiary institutions voluntarily abstain from voting on any grant
applications. Apparently not affected under the Thomas plan would be
three other board members who are appointed as patient advocates. Two
of them are employed by beneficiary institutions. The third is
chairwoman of the UC Board of Regents. All of the board members would
continue to vote on plans for all rounds of grants, including
determination of some of the specifics of the ensuing RFAs.
IOM Recommendation
“Restructure the Grant Review and
Funding Process.
“CIRM should restructure the grant
review and funding process to separate oversight and strategic
planning from day-to-day operations. The ICOC (the agency's governing
board) should remain responsible for oversight and articulation of an
overall strategic plan. However, grant management, funding
recommendations, and grant administration should be the
responsibility of the CIRM scientific staff, reporting to the
president. This restructuring would help mitigate concerns related to
conflicts of interest and would also put the review and funding
process in the hands of those best equipped to make those decisions.”
CIRM Response
CIRM patient advocate board members who
serve on the grant review group would not vote on applications during
the grant review sessions. They would be limited to voting at public
board meetings. They would lead discussion of non-scientific
considerations for approval of applications during the public
sessions. Currently that occurs during the closed door review.
IOM Recommendation
Abolish the “extraordinary petition”
mechanism for public appeals of negative grant reviews.
CIRM Response
Move all appeals to staff level and
behind closed doors. Currently extraordinary petitions are handled in
public board meetings, sometimes leading to lengthy, emotional
sessions with presentations by patient advocates. The public in
general, including grant applicants, continues to have the right
under state law to address the board on grant applications or any
other matter they wish.
IOM Recommendation
“Separate Operations from Oversight.
“The board should focus on strategic
planning, oversee financial performance and legal compliance, assess
the performance of the president and the board, and develop a plan
for transitioning CIRM to sustainability. The board should oversee
senior management but should not be involved in day-to-day
management. The chair and the board
should delegate day-to-day management responsibilities to the
president. Each of the three working groups should report to
management rather than to the ICOC.”
CIRM Response
The Thomas plan does not appear to
differ significantly from current operations, which reflect the
troubling dual executive arrangement involving the chairman and
president that was created by Prop. 71, the ballot measure that
created CIRM. The existing arrangement is also a hangover from the
days of the agency's first chairman, Robert Klein, and has been an
obstacle in previous recruitment efforts for a president of the
agency. The Thomas plan does eliminate a dual reporting arrangement
for the chief financial officer, a position that has been vacant
since last summer. Thomas indicated last fall that the position would
not be filled. Both the chairman of the IOM study panel and the
California state controller's office both say more needs to be done
to separate operations from oversight.
IOM Recommendation
“Enhance Industry Representation in
Key Aspects of CIRM Organization.
“Industry representation on the ICOC,
the Scientific Advisory Board, the Standards Working Group, and the
Grants Working Group should be enhanced to leverage industry’s
expertise and resources in product development, manufacturing, and
regulatory approval in support of the ultimate goal of bringing
therapies to patients.”
CIRM Response
The Thomas plan would increase industry
involvement “where appropriate.” However, industry has complained
for years about this problem, and some board members as well. But
little has been done to deal with the problem. Recently, the agency
has taken some steps to engage industry, but the IOM was aware of
those when it made its recommendation for closer cooperation.
IOM Recommendation
“Establish a Scientific Advisory
Board.
“CIRM should establish a single
Scientific Advisory Board comprising individuals with expertise in
the scientific, clinical, ethical, industry, and regulatory aspects
of stem cell biology and cell-based therapies.” Members of this
board would be from out of state and replace existing advisory
boards. They would be appointed by and report to president.
CIRM Response
CIRM says the structure and membership
of the a new board is under discussion, but generally indicated it
would go along this proposal. Not specifically addressed was
abolition of other advisory groups.
Develop a “sustainability” platform
in consultation with current and future partners, including sources
of funding.
IOM Recommendation
Develop a “sustainability” platform
in consultation with current and future partners, including sources
of funding.

CIRM Response
Chairman Jonathan Thomas said he is
working on details of a plan.
IOM Recommendations
“Incorporate Future Enforcement of
Intellectual Property Policies in the Sustainability Platform.
“As part of the plan maximizing the
continued impact of CIRM’s many achievements..., CIRM should
propose regulations that specify who will have the power and
authority to assert and enforce in the future rights retained by the
state in CIRM-funded intellectual property.”
“Consider Harmonizing Intellectual
Property Policies with Policies of Bayh-Dole Act.
“As other sources of funding for stem
cell research become available and as the field of regenerative
medicine advances from the laboratory to the clinic, the ICOC should
reconsider whether its goal of developing cures would be better
served by harmonizing CIRM’s IP policies wherever possible with the
more familiar policies of the Bayh-Dole Act.”
CIRM Response
The governing board's IP Subcommittee
will review the policies and make recommendations.

Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/0VfeUpeWrOw/stem-cell-agency-plan-falls-far-short.html

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CIRM’s Thomas: Conflicts ‘Put to Bed’ at Stem Cell Agency

By Dr. Matthew Watson

The chairman of the $3 billion
California stem cell agency, Jonathan Thomas, today hailed board
action last week as putting “to bed once and for all” questions
about financial conflicts of interest by members of the agency's
governing board.

Writing on the agency's blog, Thomas
pointed to board approval of a new policy that would bar 13 of the 29
members of the governing board from voting on any grants whatsoever.
The 13 are the members who are “appointed from an institution that
is eligible to receive money.” Three other board members have ties
to institutions that receive money. Two are employees of the institutions and one is the
chair of the University of California board of regents, Sherry
Lansing
. All three are appointed as patient advocate members of the
board. Currently all 16 are barred individually from voting on grants
to their institutions, but they can vote for awards to other
institutions.
Thomas proposed the plan last week to
the governing board, which approved it on a 23-0 vote with one
abstention. Thomas advanced the proposal in response to the
recommendations of a 17-month study by the Institute of Medicine(IOM).
CIRM paid $700,000 for the blue-ribbon report, hoping that it would
serve as the basis for continued financing of the agency beyond 2017,
when funds for new grants run out.
The IOM's far-reaching recommendations
included creation of a majority of independent members on the board,
which would mean some current members of the board would lose their
seats. No institutions would be guaranteed seats on the board.
Currently five members are appointed from the University of
California.
The Thomas plan does not deal with those recommendations.
The IOM said “far too many” members
of the board have ties to institutions that receive funds from CIRM.
Compilations by the California Stem Cell Report show that about 90
percent of the $1.7 billion that the board has awarded has gone to
institutions linked to directors.
Thomas said that the board last week
“endorsed a framework of proposals that would dramatically change
the way the board works, and directly addresses the concerns and
recommendations of the IOM, in particular their feeling that the way
our Board works could create a perception of conflict of interest.”
Concerning the change in voting for the
13 board members, Thomas wrote,

“It was not an easy change to propose
and certainly not an easy one for our board members to approve. They
all care deeply about our mission and devote a great deal of thought,
time and energy to helping us do our work. So for 13 of them to agree
to abstain from a key aspect of their work was difficult to say the
least. And yet they did it because they felt it was important for the
overall goal of the agency.”

Thomas continued,

“So why did we take this approach?
It's simple. We want people to focus on the great work we do, on the
groundbreaking research we fund, and the impact we are having on the
field of regenerative medicine not just in California but throughout
the U.S. and around the world. As long as there are perceptions of
conflict of interest hanging over the Board, this will continue to be
difficult.”

Thomas said,

“This puts the economic conflicts
issue to bed once and for all.”

Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/GHXrGjkYixw/cirms-thomas-conflicts-put-to-bed-at.html

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Loring on Patient Advocates and Their Role at the California Stem Cell Agency

By Dr. Matthew Watson

The following statement by stem cell researcher Jeanne
Loring
was read at the January 23, 2013, meeting of the governing board of the California stem cell agency. Loring is director
of the Center for Regenerative Medicine at the Scripps Research
Institute
in La Jolla, CA.

“I am sorry that I
cannot attend this important meeting of the ICOC. I'm in Toronto
reviewing stem cell grants for Japan and Canada. I've asked (patient advocate) Don Reed
to read my statement.
“I am a California
stem cell scientist whose research is funded by the NIH, private
foundations, and CIRM. I am the director of one of CIRM's shared
laboratories, which has provided formal training in research and
ethics to hundreds of young stem cell scientists. My CIRM funding
supports the stem cell genomics research that is the main focus of
the lab. We have also been funded by CIRM to investigate stem cell
therapies for Alzheimer disease and multiple sclerosis. I have
leveraged CIRM grant support to obtain funding for studies of autism
through the NIH, and for Parkinson's disease from a private
foundation.
“The IOM report
recommended a number of changes in CIRM's policies. One of these
recommendations is of especially great concern to me: the suggestion
that patient advocates should have much less influence in CIRM's
decisions about what research should be funded.
“Patient advocates
are extremely valuable to us researchers. Most of us stem cell
researchers had never met a patient advocate- and perhaps not even a
patient- before CIRM was founded. In my 20 years of being funded by
the NIH, the funding agency never once suggested that I should talk
to people who have the disease, or have relatives with a disease that
I was receiving funding to study.
“With my first CIRM
grant, I started meeting patient advocates, and now I can't imagine
pursuing a disease-related research project without them. I've
learned a great deal from the advocates on the ICOC, and I greatly
enjoy talking with them. They are wonderful sources of knowledge:
Jeff Sheehy taught me about HIV/AIDS and patient activism, I learned
about Parkinson's disease from Joan Samuelson, autism from John
Shestack, and David Serrano-Sewell, Diane Winoker have educated me
about MS and ALS.
“Professional
research scientists are competitive by nature- a conversation between
scientists is often constrained by our secrecy- we need to publish,
or perish. But advocates have no such constraints, which makes ICOC
meetings more enjoyable and informative than many scientific
meetings.
“Patient advocacy has
made me a better scientist. Advocacy makes CIRM-funded research
breathtakingly relevant and uniquely powerful to change the course of
medicine.”

Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/l-jQiD3JTec/loring-on-patient-advocates-and-their.html

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Patient Advocate Reed Defends Patient Advocates on Stem Cell Board

By Dr. Matthew Watson

Patient advocate Don Reed, declaring that the Institute of Medicine's (IOM) 17-month study of the $3 billion California stem cell agency is "grossly misguided," this weekend nonetheless said the agency took "the high road" in its response to the study's recommendation.

Reed, of Fremont, Ca., was particularly incensed about the IOM's recommendations concerning patient advocates on the board. The IOM said that none of the board members, including patient advocates, should vote on grant applications secretly in grant review groups. The IOM said their votes should be recorded in public at full board meetings. Other patient advocates would still have seats on the grant review group, under the IOM recommendations. But they would not also be members of the governing board.

The IOM also said that CIRM should also revise its conflict of interest standards to regulate personal conflicts of interest, such as those involving particular diseases and patient advocates. Some members of the CIRM governing board bristled at the recommendation, and the board did not act on it last week.

Last Wednesday, the CIRM board acted to permit board members who are patient advocates to continue to participate in the closed door grant review sessions, but not vote on the grants at that stage. Previously patient advocates had two cuts at applications, one in the grant review group and one at the public board meeting.

Writing on the Daily Kos blog, Reed also said that no real conflicts of interest currently exist on the board, although 90 percent of the $1.7 billion that has awarded has gone to institutions tied to board members.

Source:
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IOM’s Shapiro Wants to See More Changes from California Stem Cell Agency

By Dr. Matthew Watson

Additional mainstream media news
coverage surfaced last Friday involving the California stem cell
agency's response to the blue-ribbon report from the Institute of
Medicine(IOM)
, whose concerns about the agency ranged from conflicts of interest to grant
appeals by rejected researchers.

One of the more interesting pieces was
done by Stephanie O'Neill of Los Angeles radio station KPCC. To her
credit, she contacted the chairman of the IOM panel, Harold Shapiro,
for his fresh take on what the stem cell agency's board did on
Wednesday.
His comments were somewhat different
than those read Wednesday at the CIRM board meeting. On Friday, Shapiro was quoted as
saying the board action was “an important first step forward,”
but he added a caveat. O'Neill wrote,

“'I’m encouraged by this,' Shapiro
told KPCC. 'Presumably in the future they’ll take other steps. But
these are steps they could take without any legislative approval and
…I think it does respond in a pretty significant way to the spirit
of the report.'
“But Shapiro expressed concern that
the agency is making only 'small moves' to address a recommendation
that CIRM separate operations from oversight. Currently, the ICOC
functions 'both as an executor and as an overseer—competing duties
that compromise the ICOC’s critical role of providing independent
oversight and strategic direction,' according to the December IOM
report.
“'But  I do understand… that
would be a move that they would have to take over time so we’ll
have to wait and see,' Shapiro said.
“Thomas agreed and said that while
CIRMs recommendations more clearly define the roles of chairman and
president, more refinements will be likely over time.”

From the Los Angeles Times, came a
piece from Eryn Brown. Her article was brief and she referred her
readers to the California Stem Cell Report for details. Her first
paragraph said,

“Changes may be on the way at
California’s stem cell funding agency.”

In coverage outside the mainstream media,
the Burrill Report carried an article by Daniel Levine. The Burrill
Report is produced by Burrill & Co., a San Francisco life
sciences financial firm. Levine's straight-forward account was
largely based on the CIRM press release and the IOM report.
Two bloggers surfaced with some
coverage. UC Davis stem cell researcher Paul Knoepfler, who is a CIRM
grantee, called the Thomas plan a “bold one-year experiment” and
“biggest development for CIRM in many years.” Knoepfler said,

“I’m still not sure I’m a fan of
all of the proposed changes, but I would say the plan is bold and
creative.”

On livingbiology.com, an unidentified
CIRM grantee carried a few brief items live from the meeting.

Source:
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Norman Receives Stemlogix Stem Cell Therapy – Continued – Video

By Dr. Matthew Watson


Norman Receives Stemlogix Stem Cell Therapy - Continued
This video shows a more in-depth look at Norman, a chocolate lab, who has received stemlogix stem cell therapy at the County Animal Clinic. VIDEO COURTESY OF WLIO TV LIMA OHIO

By: StemLogixLLC

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MSI Pre-Stem Cell Therapy – Video

By Dr. Matthew Watson


MSI Pre-Stem Cell Therapy
Buyer came to VOSM in 2009 with medial shoulder instability. This is what the damaged tissues inside his shoulder looked like at that point, prior to stem cell injections and radiofrequency treatments.

By: VetSportsMedicine

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MSI Pre-Stem Cell Therapy - Video

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MSI 2nd Look – Post Stem Cell Therapy – Video

By JoanneRUSSELL25


MSI 2nd Look - Post Stem Cell Therapy
Buyer came to VOSM in 2009 with medial shoulder instability. He had stem cell injections in the spring and came back in the summer for a second look scope. The shoulder tissue had repaired and regenerated.

By: VetSportsMedicine

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MSI 2nd Look - Post Stem Cell Therapy - Video

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Norman’s Stemlogix Stem Cell Therapy Treatment at County Animal Clinic – Video

By JoanneRUSSELL25


Norman #39;s Stemlogix Stem Cell Therapy Treatment at County Animal Clinic
This is a video of live news coverage courtesy of WHIO TV of Dayton, Ohio. NORMAN A 5 YEAR OLD BLACK LAB SUFFERED A STROKE, AND WAS BROUGHT TO THE COUNTY ANIMAL CLINIC FOR A STEMLOGIX STEM CELL TREATMENT. THIS CREATED QUITE A BIT OF INTEREST FROM THE NEWS MEDIA. NOW AFTER 2 INFUSIONS NORMAN IS ALREADY SHOWING SIGNS OF RECOVERY.

By: StemLogixLLC

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Norman's Stemlogix Stem Cell Therapy Treatment at County Animal Clinic - Video

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Dr.Omar Gonzalez Stem Cell Therapy Method – Video

By NEVAGiles23


Dr.Omar Gonzalez Stem Cell Therapy Method
New Project 75

By: OmarGonzalezMD

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Dr.Omar Gonzalez Stem Cell Therapy Method - Video

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Angie the Chimp Receives Stemlogix Stem Cell Therapy – Video

By JoanneRUSSELL25


Angie the Chimp Receives Stemlogix Stem Cell Therapy
Angie the chimp received Stemlogix stem cell therapy to treat her torn ACL. Video is courtesy of WPTV - read the full article: Chimp with torn ACL receives stem cell treatment at http://www.wptv.com

By: StemLogixLLC

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Angie the Chimp Receives Stemlogix Stem Cell Therapy - Video

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Lady Receives Stemlogix Stem Cell Therapy – Video

By NEVAGiles23


Lady Receives Stemlogix Stem Cell Therapy
Lady received Stemlogix stem cell therapy to help with her severe arthritis in her hips! Watch Dr. Whalen, of LePar Animal Hospital in Evergreen Park, perform surgery and Stem Cell Therapy on Lady Bender, a 5 year old Mastiff with severe arthritis in the hips. Dr. Whalen has been treating her for severe arthritis since June of 2011. Lady #39;s condition was acute as she was not able to get up on her own. Lady was also overweight and gradually lost 20 lbs under Dr. Whalen #39;s care. The video also shows the process for Stem Cell Therapy, the collection and re-injection phase. Stem cells are harvested using the dog #39;s own fat tissue, then processed in-hospital and then re-injected into the joints that need it most. Concurrently to the Stem Cell treatment, Lady also undergoes cruciate ligament repair. Dr. Whalen is the first veterinarian in Illinois to perform stem cell therapy in-house. Video is courtesy of LePar Animal Hospital.

By: StemLogixLLC

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Diabetes distresses bone marrow stem cells by damaging their microenvironment

By Dr. Matthew Watson

Jan. 31, 2013 New research has shown the presence of a disease affecting small blood vessels, known as microangiopathy, in the bone marrow of diabetic patients. While it is well known that microangiopathy is the cause of renal damage, blindness and heart attacks in patients with diabetes, this is the first time that a reduction of the smallest blood vessels has been shown in bone marrow, the tissue contained inside the bones and the main source of stem cells.

These precious cells not only replace old blood cells but also exert an important reparative function after acute injuries and heart attacks. The starvation of bone marrow as a consequence of microangiopathy can lead to a less efficient healing in diabetic patients. Also, stem cells from a patient's bone marrow are the most used in regenerative medicine trials to mend hearts damaged by heart attacks. Results from this study highlight an important deficit in stem cells and supporting microenvironment that can reduce stem cells' therapeutic potential in diabetic patients.

The research team, led by Professor Paolo Madeddu, Chair of Experimental Cardiovascular Medicine in the School of Clinical Sciences and Bristol Heart Institute at the University of Bristol, investigated the effect of diabetes on bone marrow stem cells and the nurturing of small blood vessels in humans.

The new study, published in the American Heart Association journal Circulation Research, was funded by the British Heart Foundation (BHF).

The researchers have shown a profound remodelling of the marrow, which shows shortage of stem cells and surrounding vessels mainly replaced by fat, especially in patients with a critical lack of blood supply to a tissue (ischaemia). This means that, as peripheral vascular complications progress, more damage occurs in the marrow. In a vicious cycle, depletion of bone marrow stem cells worsens the consequences of peripheral ischaemia.

Investigation of underpinning mechanisms revealed that exposure of bone marrow stem cells to the high glucose level typical of diabetes mellitus impacts on "microRNAs," which are tiny RNA molecules controlling gene expression and hence biological functions. In particular, microRNA-155, that normally controls the production of stem cells, becomes dramatically reduced in bone marrow cells exposed to high glucose. Diabetes-induced deficits are corrected by reintroducing microRNA-155 in human stem cells. The authors foresee that microRNAs could be used to regain proper stem cells number in diabetes and fix stem cells before reintroduction into a patient's body.

Professor Paolo Madeddu said: "Our study draws attention to the bone marrow as a primary target of diabetes-induced damage. The research suggests that the severity of systemic vascular disease has an impact on bone marrow causing a precocious senescence of stem cells. More severe bone marrow pathologies can cause, or contribute to, cardiovascular disease and lead to worse outcomes after a heart attack, through the shortage of vascular regenerative cells. Clinical evidence indicates that achieving a good control of glucose levels is fundamental to prevent vascular complications, but is less effective in correcting microangiopathy. We need to work hard to find new therapies for mending damaged microvessels."

Professor Costanza Emanueli, Chair of Vascular Pathology and Regeneration at the University of Bristol and co-author of the paper, added: "MicroRNAs represent an attractive means to repair the marrow damage and generate "better" stem cells for regenerative medicine applications. We are working at protocols using microRNA targeting for enhancing the therapeutic potential of stem cells before their transplantation to cure heart and limb ischaemia, which are often associated with diabetes mellitus. More work is, however, necessary before using this strategy in patients."

The findings advance the current understanding of pathological mechanisms leading to collapse of the vascular niche and reduced availability of regenerative cells. The data provides a key for interpretation of diabetes-associated defect in stem cell mobilisation following a heart attack. In addition, the research reveals a new molecular mechanism that could in the future become the target of specific treatments to alleviate vascular complications in patients with diabetes.

Professor Jeremy Pearson, Associate Medical Director at the BHF said: "Professor Madeddu and his team have shown for the first time that the bone marrow in patients with diabetes can't release stem cells which are important for the repair of blood vessel damage commonly found in people with the disease.

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Beauty Innovation: Young-looking skin with stem cell therapy

By Sykes24Tracey

Admit it or not, as you age your skin starts showing signs that you would rather hide. Spots, wrinkles, and even crow's feet are just some of those signs that you would camouflage with makeup and skin creams to make them disappear-temporarily. But fear not, for beauty experts have discovered that stem cell treatment can also help in maintaining youthful skin.

According to Ma Fe Doria, a skin care expert, stem cell therapy is an intervention strategy that introduces new adult stem cells into damaged tissue in order to treat disease or injury. As many may be aware, the most popular stem cell treatment is in Germany, where lots of celebrities and personalities (i.e. politicians) have flown to have stem cell injections for their ailments, using cells mostly harvested from the sheep. According to those who have undergone the procedure, the treatments have improved their body and the pains they've experienced have disappeared.

Today, many medical researchers continue to do experiments to determine if stem cell can help in curing various types of ailments from cancer to diabetes, which doctors have said may not be far behind. Aside from its healing benefits, stem cell is now being used by the beauty industry. Many cosmetic and beauty centers have started offering stem cell injections for the face, which is said to regenerate the skin where the cells are injected. While some continue to use sheep cells, plant and fat stem cells are now becoming the popular alternatives, with the fat stem cells being used to heal wounds, improve scars, and rejuvenate the skin.

But stem cell treatment is not cheap. Those who can afford it need to fly out of the country to avail of the treatment. Realizing the need in the market, Flawless Facial Center partnered with a local industry leader to produce Flawless' Stem Cell line, which uses the potent power of plant stem cells. Dubbed as the "superfood for the skin," Flawless' Stem Cell line is the epitome of skin nutrition.

"This new range of products allowed us to mark several milestones not just for Flawless but for the local beauty industry. Once again, we have taken something that, for the longest time, has remained exclusive to celebrities and other influential people, and made it affordable for the regular Juan and Juana," says Flawless ceo Ruby Sy.

For P2,500, the line includes a cleanser, day cream, and night serum. Flawless' Stem Cell line utilizes the plant stem cell technology to achieve the skin's youthful appearance by protecting it against oxidative stress and boosting the skin's repair and rejuvenation systems. "Times have really changed. No thanks to free radicals that are present in almost everything around us-from the food we eat to the air we breathe-people today age so much faster. This is especially true for people who like to spend late nights partying or spend too much time in front of the [TV/computer] monitor. Various studies have proven time and again the harmful effects such activities have on our skin," Sy said.

But with Flawless' latest baby, you can say goodbye to those ugly marks on your face. The Stem Cell line promises to solve all these, and more, by providing your skin with the right amount of nutrition and protection. Indeed, youthful glow is not only safe and available in a bottle, it's also now within reach of your pocket.

Go to http://www.flawless.com.ph for

store locations

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Beauty Innovation: Young-looking skin with stem cell therapy

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ViaCyte's Role as a Leading Cell Therapy Company Bolstered with the Issuance of 20 Patents in 2012

By daniellenierenberg

SAN DIEGO, Jan. 31, 2013 /PRNewswire/ -- ViaCyte, Inc., a leading regenerative medicine company focused on developing new approaches to treat major diseases through the application of a stem cell-derived cell therapy, announced today that the Company was granted 20 patents worldwide in 2012, eight U.S. and twelve foreign. These patents bolster the Company's already strong proprietary position for its ground-breaking diabetes product, VC-01, as well as other applications of its broad technology platform.

(Logo: http://photos.prnewswire.com/prnh/20121026/LA00871LOGO-a)

VC-01 is a very promising, development-stage product that consists of pancreatic precursor cells (called PEC-01) derived from a proprietary human embryonic stem cell line and encapsulated in a proprietary, immune isolating medical device (the ENCAPTRA device). When implanted under the skin in suitable animal models, the cells further differentiate into insulin producing and other endocrine cells that regulate blood glucose in a manner similar or identical to a normal pancreas. If VC-01 performs in humans as it has in animal studies, it could effectively cure type 1 diabetics and be an important new therapy for insulin dependent type 2 diabetics.

ViaCyte's significant intellectual property portfolio now includes over 300 issued patents and pending applications related to the growth, directed differentiation and use of human pluripotent stem cells such as human embryonic stem cells and induced pluripotent stem cells. This portfolio includes 51 issued U.S. and foreign patents specifically directed to the Company's VC-01 product. In addition to the protection afforded by patents, the Company also relies on significant proprietary know-how to develop its product offerings.

Dr. Paul Laikind, ViaCyte's president and chief executive officer said, "Our comprehensive and growing intellectual property portfolio helps to establish us as a leading company in the cell therapy and regenerative medicine field. Although the Company's resources are currently fully committed to the rapid development of VC-01 as a potentially transformative treatment for patients with insulin-dependent diabetes, our platform technology has many other important applications."

In July and August of 2012, the Board of Patent Appeals and Interferences of the U.S. Patent and Trademark Office (the "Board") also issued two decisions favoring ViaCyte on motions filed in the patent interference proceedings between ViaCyte and Geron Corporation (Menlo Park, California). The interferences involved ViaCyte's U.S. Patent No. 7,510,876 ("876 Patent"), which is directed to human definitive endoderm cell cultures in vitro. The Board upheld the claims of ViaCyte's '876 Patent in its entirety over Geron's applications. In September 2012, Geron appealed this decision in the United States District Court for the Northern District of California.

About ViaCyteViaCyte, a private company that has emerged as a leader in the field of regenerative medicine, is currently focused on developing a novel cell therapy for the treatment of diabetes. The Company's lead product is based on the production of pancreatic progenitors derived from human pluripotent stem cells. These cells are implanted in a durable and retrievable encapsulation device. Once implanted and matured, these cells secrete insulin and other regulatory factors in response to blood glucose levels. ViaCyte's goal for this potentially transformative diabetes product is long term insulin independence without immune suppression, and without risk of hypoglycemia and other diabetes-related complications.

ViaCyte is headquartered in San Diego, California with additional operations in Athens, Georgia. The Company is funded in part by the California Institute for Regenerative Medicine (CIRM) and JDRF.

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ViaCyte's Role as a Leading Cell Therapy Company Bolstered with the Issuance of 20 Patents in 2012

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