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Archive for the ‘Stem Cell Therapy’ Category

Grant Reviewer Conflict in $40 Million Round at California Stem Cell Agency

Sunday, May 26th, 2013

Internationally renown scientist Lee
Hood
, winner of a National Medal of Science, violated the conflict of
interest policies of the California stem cell agency earlier this
year when he was involved in reviewing applications in a $40 million round to create genomics centers in California.

Lee Hood
Institute of Systems Biology photo
The agency quietly disclosed the
February violation in letters dated April 2 to the leadership of the
California Legislature. The letter (full text below)
said that Hood “agreed that there was a conflict of interest that
he had overlooked.”
The conflict of interest involved a $24
million application that included participation by another eminent
scientist, Irv Weissman of Stanford University, and funding for facilities at
Stanford.
Hood owns property jointly with
Weissman in Montana. In 2008, San Francisco Magazine, in a well-reported piece on the ballot measure that created the stem cell
agency, described the property as a ranch and Hood as Weissman's
“good buddy.” Hood has co-authored research papers with
Weissman. Both are on the scientific advisory board of Cellerant
Therapeutics, Inc.
, of San Carlos, Ca., a firm co-founded by
Weissman. Hood's nonprofit firm, Institute for Systems Biology in
Seattle, lists Stanford as a partner in the genetics of aging in humans. At Stanford, Weissman is director of the Institute
for Stem Cell Biology and Regenerative Medicine
, whose research
involves aging. Weissman also serves on the Hood's institute's scientific advisory board.
Hood has not responded to an inquiry
yesterday by the California Stem Cell Report for his perspective on
the conflict of interest matter.
The conflict was not discovered by the
agency during the review. It was raised by another reviewer at the
end of the review, which, for the first time in CIRM history, failed
to conclude with a decision supporting any of the proposals.
Reviewers' comments have been sent back to applicants with another
review scheduled for November. The agency said Hood will not take
part in that session.
CIRM spokesman Kevin McCormack said
today that Hood's conflict was “clearly a case of a new reviewer
making an innocent error.” McCormack said it was not a violation of
the state's conflict of interest law. The agency's conflict policies
go beyond economic issues and deal with personal and professional
conflicts. 
The agency's letter to the state legislative leadership said,

“Dr. Hood had not previously
participated in a meeting of the GWG(grant review group), and as a
result, he was not familiar with CIRM’s conflict of interest
policy, particularly the policy’s inclusion of 'personal' conflicts of interest.  Thus, when he completed the conflict of
interest form for the Genomics Awards review, he inadvertently
neglected to indicate that he had a personal relationship with an
investigator who was involved in one component of a joint application
submitted by two institutions. Dr. Hood and the investigator are
close personal friends and their families own vacation property
together. Because of his personal relationship with the
investigator, Dr. Hood had a conflict of interest with respect to the
joint application under CIRM’s conflict of interest policies.”

The agency's letter said that Weissman would have received $11,000 over five years under the terms of the application, but that it also involved  "creation of a data center at one institution and three research projects that would be undertaken at (Weissman's) institution (Stanford). 
The California Stem Cell Report asked the agency about the involvement of CIRM President Alan Trounson, who has
been a guest at the Montana ranch, and whether he recruited Hood as a
reviewer. Last year, Trounson excused himself from participating in
public discussion of another application involving Weissman.
McCormack said,

“Alan helps recruit many reviewers,
including in this case Dr. Hood, but he is not involved in assigning
reviewers to individual applications.”

The conflict of interest involving Hood
was easily detectable in routine searches on the Internet, including
a Google search on the search term “lee hood irv weissman.” The first
two entries in that search yesterday turned up serious red flags.
Asked whether the agency performed “any
sort of serious examination” of the confidential statements of
interests filed by reviewers prior to review sessions, McCormack said,

“Yes, we do a serious examination of
statements of interest from all our reviewers. However, this conflict
was not identified by the reviewer either in the financial disclosure
statement or identified in the conflict of interest list. Normally we
do not check Google for all possible combinations of 15 GWG reviewers
times about 200 individuals listed in these applications. That would
be about 3000 independent Google searches to identify a possible
conflict.”

The agency's legislative letter said
that it plans to “amend its regulations to add greater clarity in
an effort to prevent future conflicts from arising and to augment its
efforts to educate reviewers, particularly new reviewers.”
Our take?
This is the latest in a series of
questionable activities involving the stem cell agency, which is
trying to come up with a plan to sustain itself after its state
funding runs out in 2017(see here, here and here). The agency is
giving more-than-serious consideration to an effort to raise funds
from the private sector, which can lead to new and more difficult
ethical considerations than a state-funded agency would normally face.
What these questionable activities
demonstrate is that the $3 billion agency needs to give much more
thought, to put it mildly, to its policies ranging from conflicts of
interest to incompatible employee/director activities to the conduct
of top management in providing special treatment for donors.
It also is clear that the statements of
interests of reviewers are not examined closely for their accuracy by
CIRM staff and attorneys. McCormack's remarks clearly indicate that
the agency does not think it has time to be sure that no conflicts
exist among its plethora of reviewers. That is precisely the reason
reviewers' statements of interests – economic, professional and
personal – should be made public rather than kept under wraps
by CIRM. Then, interested parties, presumably mainly applicants, can
check a panel of reviewers, if they wish, for conflicts in a
particular round. Obviously, the agency can and should withhold the
names of reviewers examining a specific application – the release
of the names on the panel in a given review session is sufficient.
Tomorrow the CIRM governing board's
evaluation subcommittee meets privately to discuss Alan Trounson's
performance. It appears to be the second part of an evaluation
process that began last October. Trounson's involvement with Weissman
and Hood -- and his actions in connection with a $21,630 gift from a member of the public, albeit a not-so-ordinary member of the public
-- should also be on the evaluation subcommittee agenda.

Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/mIVQtkph_JQ/grant-reviewer-conflict-in-40-million.html

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Nature Reports on Lee Hood Conflict Case

Sunday, May 26th, 2013

The journal Nature and genomeweb.com
today picked up the story from the California Stem Cell Report about
the conflict of interest case at the California stem cell agency involving renown scientist Lee Hood of
Seattle, Wash.

Science news aggregators on the
Internet also relayed various versions of the story. The facts were
first reported on this blog yesterday. The matter involved a $24
million application for a genome project involving Irv Weissman of
Stanford. Hood was one of the reviewers in the round. Hood and
Weissman are longtime friends and own property together in Montana.
They have also have a number of professional relationships.
In piece by Ewen Callaway, Nature
additionally referred to ongoing conflict of interest issues at the agency,
including the findings of an Institute of Medicine study. Harold Shapiro, head of the study, said the agency directors make "proposals to themselves, essentially, regarding what should be funded. They cannot exert independent oversight." 
The genomeweb item was also brief and
did not mention the IOM study.

Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/xBpF71FS1Ys/nature-reports-on-lee-hood-conflict-case.html

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Text of CIRM Comments on Lee Hood Questions

Sunday, May 26th, 2013

Here is the full text of the statement
today by Kevin McCormack, senior director for public communications
at the California stem cell agency, in connection with the conflict
of interest issue involving Lee Hood, president of Institute for
Systems Biology
of Seattle, Wash. See here for a story on the matter.

McCormack's comments came in response
to the following questions from the California Stem Cell Report.

“Did (CIRM President Alan) Trounson
recruit Hood to serve on the grants working group?

“Does CIRM perform any sort of
serious examination of the statements of interests of its scientific
reviewers prior to specific review sessions. The conflict involving
Weissman and Hood was easily detected by a Google search. The first
two entries on the search term "lee hood irv weissman"
raise serious red flags. Additionally, I imagine it is more than
common knowledge among many in the scientific community that
these two scientists are longtime friends.”

Here is McCormack's reply,

“Alan helps recruit many reviewers,
including in this case Dr. Hood, but he is not involved in assigning
reviewers to individual applications. Furthermore he expects all
reviewers to declare whatever conflicts they have.  

“Yes, we do a serious examination of
statements of interest from all our reviewers. However, this conflict
was not identified by the reviewer either in the financial disclosure
statement or identified in the conflict of interest list. Normally we
do not check Google for all possible combinations of 15 GWG reviewers
times about 200 individuals listed in these applications. That would
be about 3000 independent Google searches to identify a possible
conflict. While this relationship may be known to some it certainly
was not known to the CIRM staff who checked the conflicts. If it had
been they would have raised it before the meeting.

“It's also important to point out
that Dr. Hood was a new member of this review panel and was not
familiar with our conflict of interest rules. This was clearly a case
of a new reviewer making an innocent error.

“Finally, CIRM’s rules are stricter
than state law, and this would not have been a conflict under
California conflict of interest law.”

Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/1ndmVIt2OlQ/text-of-cirm-comments-on-lee-hood.html

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Stem Cell Therapy Worldwide – Video

Thursday, May 23rd, 2013


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LaViv stem cell therapy for acne scars – Video

Thursday, May 23rd, 2013


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Replicating Oregon Cloning in California: Views on the Legality

Sunday, May 19th, 2013

Oregon's stem cell cloning achievement
has triggered some discussion about whether it could be replicated
legally in California, which bans paying for eggs as was done in
Oregon.

Stanford researcher Irv Weissman said
it is “not true” that Oregon's stem cell research would be
illegal in California. Leftovers from IVF clinics could be used, he said.
But in response Oregon researcher
Shoukhrat Mitalipov said that “SCNT (the process he used) did not
work with discarded human eggs.”
He added,

 “SCNT worked with eggs from
healthy young volunteers (paid of course). IVF patients (whether paid
or not) have reproductive health problems and may not provide
acceptable quality eggs for SCNT.” 

Their comments came in emails to the
California Stem Cell Report in connection with yesterday's item that said because the Oregon researchers used paid donors for eggs, the research would be illegal in the Golden State.
Weissman said,

 "Not true. They did
it with nearly 40 percent efficiency, which does not require paying
for eggs, just use leftovers from IVF clinics."

There is no question that it is illegal
to pay donors for their eggs in California. The question is whether
the research could be done properly without using paid donors. In recent
years, researchers at Harvard and elsewhere have said they needed paid donors for stem cell research to properly perform their research
and could not find them without providing compensation.

Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/IimgOYxndkg/replicating-oregon-cloning-in.html

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Oregon-style Stem Cell Cloning Research Illegal in California: No Pay for Eggs in Golden State

Sunday, May 19th, 2013

The good news out of Oregon is that
some diligent scientists in the Beaver State have accomplished a
major advance in stem cell research --- the cloning of human stem
cells.

That bad news is that their research
would have been illegal in California, and probably will be banned
for decades, if not longer – thanks to Proposition 71 of 2004.
The proposition was the ballot
initiative that created the $3 billion California stem cell agency,
which is hailed internationally as being one of the world leaders in
financing stem cell science. Unfortunately, the 10,000-word
initiative also contains language that was aimed at winning voter
approval of the measure -- not promoting good science.
The team writing the initiative, led by
Robert Klein, the former and first chairman of the stem cell agency,
put in a provision that made it illegal to pay women for their eggs.
The Oregon researchers paid women $3,000 to $7,000 each for their eggs, reflecting the current market rate based on prices paid in
connection with IVF. In some cases for IVF, the compensation is
dramatically higher. (See here and here.) Stem cell researchers in
recent years in the United States have found that they cannot secure
an adequate number of donors without matching IVF donor compensation.
While compensation for eggs is a matter
of some controversy, strong cases have been made that women
should make their own decisions about selling their eggs – not the what some call the nanny state. Of course, that should occur under well-regulated
situations. But Proposition 71 backers wanted to remove any possible
campaign objections by opponents of stem cell research, and so they
inserted the ban along with management minutia and other dubious
material.
Can't that be changed, one might ask?
Not without a herculean effort. That means another ballot measure or
a super, super majority vote in the California legislature plus the
signature of the governor. Imagine a measure on the ballot to
allow women to sell their eggs. The uproar would be heard
internationally. In 2004, when Proposition 71 was approved, it would
have been better to leave the compensation issue unaddressed. Then it
could have been dealt with through regulation or normal legislation,
both of which are far more flexible than ballot measures that alter
the state Constitution and state law.
Our quick and limited survey of the
news coverage indicated that many of the mainstream media stories
omitted the price of the eggs, which may suggest that the issue of
compensation is becoming moot.
In related news about the Oregon
accomplishment, UC Davis stem cell researcher Paul Knoepfler has
posted a good look at the some of the misinformation that is
surfacing on the Internet about the research, including its
implications.
He said,

“Keep in mind that on day one of the
iPS cell era in the stem cell field we had a huge number of
misconceptions because we simply had so much to learn. Same is true
here.”

Jessica Cussins over at the
Berkeley-based Biopolitical Times also has a solid roundup of the
coverage of the Oregon research and the analysis of its significance.
Here are links to two blog items from
the California stem cell agency on the Oregon research, including one
dealing with “cloning hysteria” and a more general look.

Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/A4AXZfPs3dc/oregon-style-stem-cell-cloning-research.html

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Weissman Says Oregon-style Stem Cell Research Could be Done in California

Sunday, May 19th, 2013

Stanford researcher Irv Weissman says it
is “not true” that Oregon's stem cell research could not be done
legally in California.

In a brief email to the California Stem
Cell Report
, he commented in connection with yesterday's item that said because the Oregon researchers used paid donors for eggs,the research would be illegal in the Golden State.
Weissman said, 

"Not true. They did
it with nearly 40 percent efficiency, which does not require paying
for eggs, just use leftovers from IVF clinics."

There is no question that it is illegal
to pay donors for their eggs in California. The question is whether
the research could be done without using paid donors. In recent
years, researchers at Harvard and elsewhere have said they needed paid donors to properly perform their research
and could not find them without providing compensation.
We have queried Shoukhrat Mitalipov in
Oregon concerning his views on Weissman's comments. We welcome other
comments as well. Comments can be filed directly by clicking on the word "comment" at the end of this item or you can email them to djensen@californiastemcellreport.com
We should also note the comment from
researcher Paul Knoepfler of UC Davis who notes that SCNT cloning is
permissible in California, which is what was done in Oregon. The
state does ban reproductive cloning, however.

Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/vlJ5XeK4AOU/weissman-says-oregon-style-stem-cell.html

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Klein, StemCells, Inc., and $31,000 in Consulting Fees for Torres

Sunday, May 19th, 2013

The Robert Klein-StemCells, Inc.,
affair has taken another turn with the disclosure that a vice
chairman of the California stem cell agency was paid at least $31,000
over a two-year period by Klein and also voted on behalf of Klein's
effort to win approval of a $20 million award for StemCells, Inc.

Art Torres received what he reported were
consulting fees during 2011 and 2012 from firms controlled by Klein, former chairman of
the agency. In 2012, Torres backed Klein's
efforts to override grant reviewers' rejection of the $20 million
application from the Newark, Ca., publicly traded firm.
Art Torres, center, with Bob Klein, left, at Klein's last meeting in
2011 as chairman of the California stem cell agency.
 Incoming chairman Jonathan Thomas is at right. 

The 29-member board of the California
Institute for Regenerative Medicine (CIRM)
, as the agency is formally
known, narrowly voted 7-5 last September for the award. It was the
first time that the board has approved an application rejected twice
by its scientific reviewers. It was also the first time that Klein
has lobbied the board on behalf of a specific application since
stepping down in June 2011. He was elected chairman in 2005 as the
agency was just beginning its work and is an iconic figure to many in
the California stem cell community.

Asked for comment last week by the
California Stem Cell Report, Torres said,

"My decision to support an award
to StemCells, Inc. to explore the use of neural stem cell
transplantation to treat Alzheimer's disease was based on the merits
of the application and the hope it offers to patients who suffer from
Alzheimer's, a disease that affects millions, including Bob Klein's
late mother. I have no financial interest in StemCells, Inc. nor does
Bob Klein, and my decision to support the award has no connection
whatsoever to the work I do with Bob Klein."

Kevin McCormack, senior director for
public communications at CIRM, said that Torres' statement would be
the only comment on the matter from the agency.
Klein did not respond to questions,
declaring that personal issues were occupying his time.
The California Stem Cell Report's
questions to all three dealt with the propriety of Torres' employment
by both CIRM and Klein while Klein was asking the board to award a
business $20 million. The governing board has a code of conduct that
declares members should “maintain the highest standards of
integrity and professionalism.” However, it does not speak to
questions of appropriate employment by CIRM directors outside of the
agency.
In January 2012, Torres authored a document discussing CIRM's conflict of interest rules. He said they
are intended “to eliminate even the appearance of impropriety.”
He also referred to CIRM's policy on “incompatible activities”
for employees. It deals with activities that could “discredit”
the agency or that are “inimical” to it. However, it does not
specifically deal with the type of situation involving Torres and
Klein, who is a real estate investment banker and attorney. The policy additionally does not address cases where a
governing board member is also an employee of the agency.
Torres' economic disclosure statements,
which are required by state law, contain only broad ranges for compensation, and the amount could be significantly higher than
$31,000. Torres reported that in 2011 he was paid between $10,001 and
$100,000 by both Klein Financial Corp. and K CP Cal, which share the
same address as Klein's offices in Palo Alto. In 2012, Torres reported receiving between $10,001 and $100,000 from K CP Cal and
between $1,001 and $10,000 from Klein Ventures LLC, which also has
the same address.
Torres reported that the payments were
consulting fees and that the firms dealt with real estate. He did not
respond to requests for more details.
Torres earns $225,000 a year in his part-time role as one of two vice chairmen for the agency. Under the
arrangement, he works four days a week.
Torres was chairman of the state
Democratic Party and a longtime state legislator. He was nominated
for vice chairman in 2009 by state Treasurer Bill Lockyer, among
others.
Last week, another financial
arrangement involving Klein surfaced in connection with the
StemCells, Inc., application. Klein gave the agency $21,000 last May,two months before he pitched the board on the StemCells, Inc.,application. The donation was not reported to the board prior to
Klein's appearances before the panel. The agency's regulations
require such gifts to be reported to the board but do not specify a
time frame. Following inquiries from the California Stem Cell Report,
the agency said it would report the donation at the agency board
meeting next week.
Klein's donation financed a trip by six
CIRM science officers to Japan for an international stem cell
conference. The agency directed the officers to give special access
to Klein. Two of the officers were heavily involved in the grant
round that included the StemCells, Inc., application, which scientific reviewers scored at 61 on a scale of 100.

Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/7zwWISe_LMA/klein-stemcells-inc-and-31000-in.html

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A Patent War on iPS: One Researcher’s View

Sunday, May 19th, 2013

As the California stem cell agency
pushes ever more aggressively to turn research into cures, the second
largest share of its awards, in terms of numbers of grants, has gone
to efforts involving induced pluripotent cells, also known as
reprogrammed adult cells.

But questions do exist whether those
efforts can surmount barriers that have to do with patents and
ownership of the intellectual property.
UC Davis stem researcher and blogger
Paul Knoepfler discussed some of the problems in a post yesterday. He wrote,

“All the talk and the slew of
publications about potentially using iPS cells to develop therapies
to help patients is exciting in theory, but unfortunately the reality
is that it is not entirely clear if most researchers are, from a
legal standpoint, even allowed to develop and commercialize iPS
cell-based therapies at all.

“The patent landscape for iPS cells
is complicated to put it mildly. A
Google patent search for “induced pluripotent stem cells”
produced almost 200,000 results
.

“A search for “cellular
reprogramming produced more than 1,000
results
.
I’m not sure all of these results are
really separate patents, but still….that’s a big complicated
mess.…..

“It is no exaggeration to say
there are likely dozens of institutions around the world wanting to
commercialize iPS cell-based products.

“Will they all have to pay expensive
licensing fees or end up in court?
…or will the patent holders
voluntarily and freely allow others to commercialize iPS cell-based
medical treatments?

“I don’t think so.

“This could get really messy.”

Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/ZX0PoUag-pE/a-patent-war-on-ips-one-researchers-view.html

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Patient Advocate Reed Defends Klein Donation to Stem Cell Agency

Sunday, May 19th, 2013
The California Stem Cell Report today
received the following email from Don Reed, a patient advocate, who
has long been involved in California stem cell agency affairs. Reed
is vice president of public policy for Americans for Cures
Foundation,
 a position he has held for some years. Americans for
Cures is the personal lobbying organization created by Robert Klein,
former chairman of the California stem cell agency. Reed said his
opinions below are his own and may or may not reflect those of the
foundation.

“I must take issue with your entry,
'Robert Klein Gives $21,630 to the California Stem Cell Agency,' May
05, 2013.

“When
Bob Klein donated $21,630 to the California stem cell program (to
allow scientists to attend a research conference in Japan) he was
doing exactly what he always does: advancing research to ease
suffering and save lives.  The scientists needed a way to attend
a top-level conference. Believing in the benefits of researchers
sharing thoughts, Bob paid for their trip.

“Unfortunately,
your article appears to imply corrupt motivations.

“'A
seemingly innocuous…gift…generated a wave of special favors for
(Klein) that stretched out to include a gold mining multimillionaire
from Canada.'.
A 'wave of special favors?'  The article
states that 'Klein wanted to meet with the six science officers…'
 and to get their impressions on the conference.

“Is
that not natural? First, would it not be helpful to hear from the
scientists if the trip was worth the time and expense? Second, Bob
Klein works in real estate, a full-time job. He does not have the
scientist’s automatic involvement to keep him up to speed on
everything new in regenerative research. But he wants to know the
latest: what is working, what is not. He is always eager for a chance
to speak one-on-one with an expert.

“He met with a Canadian
millionaire? Why is this shocking? The millionaire supports stem cell
research; so does Bob. California is working closely with Canada on
several projects; they pay their scientists, we pay ours; more bang
for the buck. If there is a person with the resources and will to
advance Canadian research, it is natural that Bob would want to
develop a deeper interest in the shared research.

“And why
should Klein be criticized for supporting a research project
attempting to alleviate Alzheimer’s? He saw his own mother die of
the disease, after losing the ability  to recognize her own son.
 I am familiar with that particular Alzheimer’s project, and
it had some amazing results, restoring memory to laboratory rats.
This was a water maze test, and the rats recovered the memory of a
pathway out of the water, which they had forgotten. To the best of my
knowledge, no one else in the world had achieved memory return, and
the project deserved the most serious consideration.  Yes, the
board of directors voted against the Grants Working Group; it is not
only their right but their responsibility to exercise judgment, and
not merely be a rubber stamp for the GWG.

“There is also the
matter of free speech. Anybody else in California can come to the
meetings of the program and voice their opinion—why should Klein be
denied the right to voice his opinion?

“Bob Klein owns no
stem cell stock, no biomedical enterprises. Financially, supporting
stem cell research has cost him a great deal. This is the man who led
the fight to build the California stem cell program, donating roughly
six million dollars, taking out loans on his house to help finance
Proposition 71. And, for six years (without salary) he worked
full-time as Chair of the Board of the oversight committee.
Physically and emotionally, it has been an exhausting decade for him.
He has not profited in any way, except to see the advancement of
research for cure.

“Passing a $3 billion stem cell program
in the midst of a recession was like relocating Mount
Everest—seemingly impossible, but he did it anyway. He moved the
mountain. Thousands of people helped, but one man made it possible.
Without Bob Klein, California would not have the greatest stem cell
program in the world: challenging diseases considered incurable since
the dawn of time. That he should continue to support it, with his
dollars, time, energy and creativity, is commendable.

“Sometimes
a good deed is just that: no sinister motivations, no secret
agendas-- just a positive action which benefits all.”  

Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/hW_Zc6qeDYY/patient-advocate-reed-defends-klein.html

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WARF hESC Patent Update: Seven Years and Challenge Still Underway

Sunday, May 19th, 2013

Last week UC Davis stem cell researcher
Paul Knoepfler and Scripps researcher Jeanne Loring engaged in an
online Q&A that touched on patents and how they can stifle
research and discourage development of therapies.

Loring did not mention it in the Q&A
but she is the key figure in the ongoing challenge to the WARF
(Wisconsin Alumni Research Foundation)
patents on human embryonic
stem cells. Her effort began in 2006 but has dropped out of the news.
We asked her for an update on the case.
Here is the text of what she replied,

Dan Ravicher is the lawyer behind
several big patent cases, including the recent Supreme Court case
challenging human gene patenting (Myriad), and a challenge to
Monsanto's restrictive enforcement of its patents on genetically
modified seeds. 

“I'm lucky that he is also the lawyer
working with John M. Simpson (of Consumer Watchdog) and me to
challenge the WARF patents.  Currently, we are getting ready for
another year of appeals and counter-appeals on the third of WARF's
three patents that give them control over all human embryonic stem
cells.

“This is Dan's summary of the current
situation:

"'We filed challenges at the
Patent Office to all three of WARF's hESC patents. During those
challenges, WARF agreed to narrow all three of the patents, and
they also loosened their licensing requirements. But, even
though the patents were narrowed, we still think they're invalid, and
thus disagree with the Patent Office's decision to re-issue them in
the narrowed forms. Unfortunately, due to the age of the patents and
changes in the law, we were only allowed to appeal one of the three
decisions, and that appeal is now pending at the Court of Appeals in
Washington. But, we expect the decision in our appeal will affect
the validity of the other two patents, since they're all basically
on the same technology." 

“The 'narrowing' of the patents has
had an unexpected consequence.  Before the narrowing, WARF's
patents would have covered iPSCs as well as hESCs. After the
narrowing, they can only claim hESCs.”

In the Q&A on Knoepfler's blog,
which also involved an interesting discussion of IPS research,
Loring said,

Patents
on fundamental things
--
genes, human embryonic stem cells, iPS cells
--
allow the patent holder to have a monopoly, preventing anyone else
from using whatever they’ve patented.

Patents
are supposed to stimulate investment in development.  Why, as
Justice Scalia said last week, would anyone have the incentive to
study a gene and, for example, develop diagnostic tests, if they
couldn’t prevent everyone else from working on that gene?

But
patents also stifle competition and the advances that come from
having many different groups studying the genes or cells.  One
of the main reasons I returned to academia was so I could have
freedom to study human ES cells without worrying about getting
threatening letters from a patent holder, demanding that I either
stop working on the cells or pay a steep licensing fee.

There
will inevitably be problems commercializing iPSC-based therapies and
assays, because at least three institutions own patents on aspects of
iPSCs.  I’m paying attention to the patent
'landscape,'
but have decided to deal with those problems when they arise, and
hope that the iPSC patent holders realize that the potential of these
cells is too great to keep to themselves.  It would be better
for all of us if the issue of stem cell patents never has to be
decided in the Supreme Court.”

Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/fXlAaqQbBAs/warf-hesc-patent-update-seven-years-and.html

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Replicating Oregon Cloning in California: Views on the Legality

Sunday, May 19th, 2013

Oregon's stem cell cloning achievement
has triggered some discussion about whether it could be replicated
legally in California, which bans paying for eggs as was done in
Oregon.

Stanford researcher Irv Weissman said
it is “not true” that Oregon's stem cell research would be
illegal in California. Leftovers from IVF clinics could be used, he said.
But in response Oregon researcher
Shoukhrat Mitalipov said that “SCNT (the process he used) did not
work with discarded human eggs.”
He added,

 “SCNT worked with eggs from
healthy young volunteers (paid of course). IVF patients (whether paid
or not) have reproductive health problems and may not provide
acceptable quality eggs for SCNT.” 

Their comments came in emails to the
California Stem Cell Report in connection with yesterday's item that said because the Oregon researchers used paid donors for eggs, the research would be illegal in the Golden State.
Weissman said,

 "Not true. They did
it with nearly 40 percent efficiency, which does not require paying
for eggs, just use leftovers from IVF clinics."

There is no question that it is illegal
to pay donors for their eggs in California. The question is whether
the research could be done properly without using paid donors. In recent
years, researchers at Harvard and elsewhere have said they needed paid donors for stem cell research to properly perform their research
and could not find them without providing compensation.

Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/IimgOYxndkg/replicating-oregon-cloning-in.html

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Weissman Says Oregon-style Stem Cell Research Could be Done in California

Sunday, May 19th, 2013

Stanford researcher Irv Weissman says it
is “not true” that Oregon's stem cell research could not be done
legally in California.

In a brief email to the California Stem
Cell Report
, he commented in connection with yesterday's item that said because the Oregon researchers used paid donors for eggs,the research would be illegal in the Golden State.
Weissman said, 

"Not true. They did
it with nearly 40 percent efficiency, which does not require paying
for eggs, just use leftovers from IVF clinics."

There is no question that it is illegal
to pay donors for their eggs in California. The question is whether
the research could be done without using paid donors. In recent
years, researchers at Harvard and elsewhere have said they needed paid donors to properly perform their research
and could not find them without providing compensation.
We have queried Shoukhrat Mitalipov in
Oregon concerning his views on Weissman's comments. We welcome other
comments as well. Comments can be filed directly by clicking on the word "comment" at the end of this item or you can email them to djensen@californiastemcellreport.com
We should also note the comment from
researcher Paul Knoepfler of UC Davis who notes that SCNT cloning is
permissible in California, which is what was done in Oregon. The
state does ban reproductive cloning, however.

Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/vlJ5XeK4AOU/weissman-says-oregon-style-stem-cell.html

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Oregon-style Stem Cell Cloning Research Illegal in California: No Pay for Eggs in Golden State

Sunday, May 19th, 2013

The good news out of Oregon is that
some diligent scientists in the Beaver State have accomplished a
major advance in stem cell research --- the cloning of human stem
cells.

That bad news is that their research
would have been illegal in California, and probably will be banned
for decades, if not longer – thanks to Proposition 71 of 2004.
The proposition was the ballot
initiative that created the $3 billion California stem cell agency,
which is hailed internationally as being one of the world leaders in
financing stem cell science. Unfortunately, the 10,000-word
initiative also contains language that was aimed at winning voter
approval of the measure -- not promoting good science.
The team writing the initiative, led by
Robert Klein, the former and first chairman of the stem cell agency,
put in a provision that made it illegal to pay women for their eggs.
The Oregon researchers paid women $3,000 to $7,000 each for their eggs, reflecting the current market rate based on prices paid in
connection with IVF. In some cases for IVF, the compensation is
dramatically higher. (See here and here.) Stem cell researchers in
recent years in the United States have found that they cannot secure
an adequate number of donors without matching IVF donor compensation.
While compensation for eggs is a matter
of some controversy, strong cases have been made that women
should make their own decisions about selling their eggs – not the what some call the nanny state. Of course, that should occur under well-regulated
situations. But Proposition 71 backers wanted to remove any possible
campaign objections by opponents of stem cell research, and so they
inserted the ban along with management minutia and other dubious
material.
Can't that be changed, one might ask?
Not without a herculean effort. That means another ballot measure or
a super, super majority vote in the California legislature plus the
signature of the governor. Imagine a measure on the ballot to
allow women to sell their eggs. The uproar would be heard
internationally. In 2004, when Proposition 71 was approved, it would
have been better to leave the compensation issue unaddressed. Then it
could have been dealt with through regulation or normal legislation,
both of which are far more flexible than ballot measures that alter
the state Constitution and state law.
Our quick and limited survey of the
news coverage indicated that many of the mainstream media stories
omitted the price of the eggs, which may suggest that the issue of
compensation is becoming moot.
In related news about the Oregon
accomplishment, UC Davis stem cell researcher Paul Knoepfler has
posted a good look at the some of the misinformation that is
surfacing on the Internet about the research, including its
implications.
He said,

“Keep in mind that on day one of the
iPS cell era in the stem cell field we had a huge number of
misconceptions because we simply had so much to learn. Same is true
here.”

Jessica Cussins over at the
Berkeley-based Biopolitical Times also has a solid roundup of the
coverage of the Oregon research and the analysis of its significance.
Here are links to two blog items from
the California stem cell agency on the Oregon research, including one
dealing with “cloning hysteria” and a more general look.

Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/A4AXZfPs3dc/oregon-style-stem-cell-cloning-research.html

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A Patent War on iPS: One Researcher’s View

Sunday, May 19th, 2013

As the California stem cell agency
pushes ever more aggressively to turn research into cures, the second
largest share of its awards, in terms of numbers of grants, has gone
to efforts involving induced pluripotent cells, also known as
reprogrammed adult cells.

But questions do exist whether those
efforts can surmount barriers that have to do with patents and
ownership of the intellectual property.
UC Davis stem researcher and blogger
Paul Knoepfler discussed some of the problems in a post yesterday. He wrote,

“All the talk and the slew of
publications about potentially using iPS cells to develop therapies
to help patients is exciting in theory, but unfortunately the reality
is that it is not entirely clear if most researchers are, from a
legal standpoint, even allowed to develop and commercialize iPS
cell-based therapies at all.

“The patent landscape for iPS cells
is complicated to put it mildly. A
Google patent search for “induced pluripotent stem cells”
produced almost 200,000 results
.

“A search for “cellular
reprogramming produced more than 1,000
results
.
I’m not sure all of these results are
really separate patents, but still….that’s a big complicated
mess.…..

“It is no exaggeration to say
there are likely dozens of institutions around the world wanting to
commercialize iPS cell-based products.

“Will they all have to pay expensive
licensing fees or end up in court?
…or will the patent holders
voluntarily and freely allow others to commercialize iPS cell-based
medical treatments?

“I don’t think so.

“This could get really messy.”

Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/ZX0PoUag-pE/a-patent-war-on-ips-one-researchers-view.html

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Klein, StemCells, Inc., and $31,000 in Consulting Fees for Torres

Sunday, May 19th, 2013

The Robert Klein-StemCells, Inc.,
affair has taken another turn with the disclosure that a vice
chairman of the California stem cell agency was paid at least $31,000
over a two-year period by Klein and also voted on behalf of Klein's
effort to win approval of a $20 million award for StemCells, Inc.

Art Torres received what he reported were
consulting fees during 2011 and 2012 from firms controlled by Klein, former chairman of
the agency. In 2012, Torres backed Klein's
efforts to override grant reviewers' rejection of the $20 million
application from the Newark, Ca., publicly traded firm.
Art Torres, center, with Bob Klein, left, at Klein's last meeting in
2011 as chairman of the California stem cell agency.
 Incoming chairman Jonathan Thomas is at right. 

The 29-member board of the California
Institute for Regenerative Medicine (CIRM)
, as the agency is formally
known, narrowly voted 7-5 last September for the award. It was the
first time that the board has approved an application rejected twice
by its scientific reviewers. It was also the first time that Klein
has lobbied the board on behalf of a specific application since
stepping down in June 2011. He was elected chairman in 2005 as the
agency was just beginning its work and is an iconic figure to many in
the California stem cell community.

Asked for comment last week by the
California Stem Cell Report, Torres said,

"My decision to support an award
to StemCells, Inc. to explore the use of neural stem cell
transplantation to treat Alzheimer's disease was based on the merits
of the application and the hope it offers to patients who suffer from
Alzheimer's, a disease that affects millions, including Bob Klein's
late mother. I have no financial interest in StemCells, Inc. nor does
Bob Klein, and my decision to support the award has no connection
whatsoever to the work I do with Bob Klein."

Kevin McCormack, senior director for
public communications at CIRM, said that Torres' statement would be
the only comment on the matter from the agency.
Klein did not respond to questions,
declaring that personal issues were occupying his time.
The California Stem Cell Report's
questions to all three dealt with the propriety of Torres' employment
by both CIRM and Klein while Klein was asking the board to award a
business $20 million. The governing board has a code of conduct that
declares members should “maintain the highest standards of
integrity and professionalism.” However, it does not speak to
questions of appropriate employment by CIRM directors outside of the
agency.
In January 2012, Torres authored a document discussing CIRM's conflict of interest rules. He said they
are intended “to eliminate even the appearance of impropriety.”
He also referred to CIRM's policy on “incompatible activities”
for employees. It deals with activities that could “discredit”
the agency or that are “inimical” to it. However, it does not
specifically deal with the type of situation involving Torres and
Klein, who is a real estate investment banker and attorney. The policy additionally does not address cases where a
governing board member is also an employee of the agency.
Torres' economic disclosure statements,
which are required by state law, contain only broad ranges for compensation, and the amount could be significantly higher than
$31,000. Torres reported that in 2011 he was paid between $10,001 and
$100,000 by both Klein Financial Corp. and K CP Cal, which share the
same address as Klein's offices in Palo Alto. In 2012, Torres reported receiving between $10,001 and $100,000 from K CP Cal and
between $1,001 and $10,000 from Klein Ventures LLC, which also has
the same address.
Torres reported that the payments were
consulting fees and that the firms dealt with real estate. He did not
respond to requests for more details.
Torres earns $225,000 a year in his part-time role as one of two vice chairmen for the agency. Under the
arrangement, he works four days a week.
Torres was chairman of the state
Democratic Party and a longtime state legislator. He was nominated
for vice chairman in 2009 by state Treasurer Bill Lockyer, among
others.
Last week, another financial
arrangement involving Klein surfaced in connection with the
StemCells, Inc., application. Klein gave the agency $21,000 last May,two months before he pitched the board on the StemCells, Inc.,application. The donation was not reported to the board prior to
Klein's appearances before the panel. The agency's regulations
require such gifts to be reported to the board but do not specify a
time frame. Following inquiries from the California Stem Cell Report,
the agency said it would report the donation at the agency board
meeting next week.
Klein's donation financed a trip by six
CIRM science officers to Japan for an international stem cell
conference. The agency directed the officers to give special access
to Klein. Two of the officers were heavily involved in the grant
round that included the StemCells, Inc., application, which scientific reviewers scored at 61 on a scale of 100.

Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/7zwWISe_LMA/klein-stemcells-inc-and-31000-in.html

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Patient Advocate Reed Defends Klein Donation to Stem Cell Agency

Sunday, May 19th, 2013
The California Stem Cell Report today
received the following email from Don Reed, a patient advocate, who
has long been involved in California stem cell agency affairs. Reed
is vice president of public policy for Americans for Cures
Foundation,
 a position he has held for some years. Americans for
Cures is the personal lobbying organization created by Robert Klein,
former chairman of the California stem cell agency. Reed said his
opinions below are his own and may or may not reflect those of the
foundation.

“I must take issue with your entry,
'Robert Klein Gives $21,630 to the California Stem Cell Agency,' May
05, 2013.

“When
Bob Klein donated $21,630 to the California stem cell program (to
allow scientists to attend a research conference in Japan) he was
doing exactly what he always does: advancing research to ease
suffering and save lives.  The scientists needed a way to attend
a top-level conference. Believing in the benefits of researchers
sharing thoughts, Bob paid for their trip.

“Unfortunately,
your article appears to imply corrupt motivations.

“'A
seemingly innocuous…gift…generated a wave of special favors for
(Klein) that stretched out to include a gold mining multimillionaire
from Canada.'.
A 'wave of special favors?'  The article
states that 'Klein wanted to meet with the six science officers…'
 and to get their impressions on the conference.

“Is
that not natural? First, would it not be helpful to hear from the
scientists if the trip was worth the time and expense? Second, Bob
Klein works in real estate, a full-time job. He does not have the
scientist’s automatic involvement to keep him up to speed on
everything new in regenerative research. But he wants to know the
latest: what is working, what is not. He is always eager for a chance
to speak one-on-one with an expert.

“He met with a Canadian
millionaire? Why is this shocking? The millionaire supports stem cell
research; so does Bob. California is working closely with Canada on
several projects; they pay their scientists, we pay ours; more bang
for the buck. If there is a person with the resources and will to
advance Canadian research, it is natural that Bob would want to
develop a deeper interest in the shared research.

“And why
should Klein be criticized for supporting a research project
attempting to alleviate Alzheimer’s? He saw his own mother die of
the disease, after losing the ability  to recognize her own son.
 I am familiar with that particular Alzheimer’s project, and
it had some amazing results, restoring memory to laboratory rats.
This was a water maze test, and the rats recovered the memory of a
pathway out of the water, which they had forgotten. To the best of my
knowledge, no one else in the world had achieved memory return, and
the project deserved the most serious consideration.  Yes, the
board of directors voted against the Grants Working Group; it is not
only their right but their responsibility to exercise judgment, and
not merely be a rubber stamp for the GWG.

“There is also the
matter of free speech. Anybody else in California can come to the
meetings of the program and voice their opinion—why should Klein be
denied the right to voice his opinion?

“Bob Klein owns no
stem cell stock, no biomedical enterprises. Financially, supporting
stem cell research has cost him a great deal. This is the man who led
the fight to build the California stem cell program, donating roughly
six million dollars, taking out loans on his house to help finance
Proposition 71. And, for six years (without salary) he worked
full-time as Chair of the Board of the oversight committee.
Physically and emotionally, it has been an exhausting decade for him.
He has not profited in any way, except to see the advancement of
research for cure.

“Passing a $3 billion stem cell program
in the midst of a recession was like relocating Mount
Everest—seemingly impossible, but he did it anyway. He moved the
mountain. Thousands of people helped, but one man made it possible.
Without Bob Klein, California would not have the greatest stem cell
program in the world: challenging diseases considered incurable since
the dawn of time. That he should continue to support it, with his
dollars, time, energy and creativity, is commendable.

“Sometimes
a good deed is just that: no sinister motivations, no secret
agendas-- just a positive action which benefits all.”  

Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/hW_Zc6qeDYY/patient-advocate-reed-defends-klein.html

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WARF hESC Patent Update: Seven Years and Challenge Still Underway

Sunday, May 19th, 2013

Last week UC Davis stem cell researcher
Paul Knoepfler and Scripps researcher Jeanne Loring engaged in an
online Q&A that touched on patents and how they can stifle
research and discourage development of therapies.

Loring did not mention it in the Q&A
but she is the key figure in the ongoing challenge to the WARF
(Wisconsin Alumni Research Foundation)
patents on human embryonic
stem cells. Her effort began in 2006 but has dropped out of the news.
We asked her for an update on the case.
Here is the text of what she replied,

Dan Ravicher is the lawyer behind
several big patent cases, including the recent Supreme Court case
challenging human gene patenting (Myriad), and a challenge to
Monsanto's restrictive enforcement of its patents on genetically
modified seeds. 

“I'm lucky that he is also the lawyer
working with John M. Simpson (of Consumer Watchdog) and me to
challenge the WARF patents.  Currently, we are getting ready for
another year of appeals and counter-appeals on the third of WARF's
three patents that give them control over all human embryonic stem
cells.

“This is Dan's summary of the current
situation:

"'We filed challenges at the
Patent Office to all three of WARF's hESC patents. During those
challenges, WARF agreed to narrow all three of the patents, and
they also loosened their licensing requirements. But, even
though the patents were narrowed, we still think they're invalid, and
thus disagree with the Patent Office's decision to re-issue them in
the narrowed forms. Unfortunately, due to the age of the patents and
changes in the law, we were only allowed to appeal one of the three
decisions, and that appeal is now pending at the Court of Appeals in
Washington. But, we expect the decision in our appeal will affect
the validity of the other two patents, since they're all basically
on the same technology." 

“The 'narrowing' of the patents has
had an unexpected consequence.  Before the narrowing, WARF's
patents would have covered iPSCs as well as hESCs. After the
narrowing, they can only claim hESCs.”

In the Q&A on Knoepfler's blog,
which also involved an interesting discussion of IPS research,
Loring said,

Patents
on fundamental things
--
genes, human embryonic stem cells, iPS cells
--
allow the patent holder to have a monopoly, preventing anyone else
from using whatever they’ve patented.

Patents
are supposed to stimulate investment in development.  Why, as
Justice Scalia said last week, would anyone have the incentive to
study a gene and, for example, develop diagnostic tests, if they
couldn’t prevent everyone else from working on that gene?

But
patents also stifle competition and the advances that come from
having many different groups studying the genes or cells.  One
of the main reasons I returned to academia was so I could have
freedom to study human ES cells without worrying about getting
threatening letters from a patent holder, demanding that I either
stop working on the cells or pay a steep licensing fee.

There
will inevitably be problems commercializing iPSC-based therapies and
assays, because at least three institutions own patents on aspects of
iPSCs.  I’m paying attention to the patent
'landscape,'
but have decided to deal with those problems when they arise, and
hope that the iPSC patent holders realize that the potential of these
cells is too great to keep to themselves.  It would be better
for all of us if the issue of stem cell patents never has to be
decided in the Supreme Court.”

Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/fXlAaqQbBAs/warf-hesc-patent-update-seven-years-and.html

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Treatment of a patient with Parkinson’s Disease using stem cell therapy – Video

Sunday, May 19th, 2013


Treatment of a patient with Parkinson #39;s Disease using stem cell therapy
Here we demonstrate how a patient who suffers from Parkinson #39;s Disease has benefited from stem cell therapy with us in Panama.

By: SCRMPanama

See the original post here:
Treatment of a patient with Parkinson's Disease using stem cell therapy - Video

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