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Category Archives: Stem Cells

Challenge to WARF hESC Patents Cites Recent U.S. Supreme Court Decision

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Patents on human embryonic stem cells
are being challenged in a new legal filing that cites the recent U.S.
Supreme Court decision that barred the patenting of human genes.
The stem cell case involves the
Wisconsin Alumni Research Foundation (WARF), which holds the patents on the
much-heralded work performed by Jamie Thomson  at the University of Wisconsin. The lawsuit was filed
by the Public Patent Foundation of New York City on behalf of
Consumer Watchdog, a nonprofit group in Santa Monica, Ca. Jeanne
Loring, director of the Center for Regenerative Medicine at the
Scripps Research Institute, is also involved along with Alan
Trounson, president of the California stem cell agency. The agency
itself is not a party.
This week's filing follows the
so-called Myriad decision last month by the nation's highest court which said,

“Myriad did not create anything. To
be sure, it found an important and useful gene, but separating that
gene from its surrounding genetic material is not an act of
invention.”

"WARF did not create or alter the
properties inherent in stem cells any more than Myriad created or
altered the genetic information encoded in the DNA it claimed.” 

The legal filing came in an appeal of
an earlier decision by the U.S. Patent Office. The Public Patent
Foundation, which was a successful party in the Myriad case, did the earlier legal work on the challenge to the WARF patents as well as this
week's appeal.
The appeal, prepared by Dan Ravicher,
said the WARF patents have "put a severe burden on taxpayer-funded
research in California.”
Trounson released a statement saying,

“We don't want to do anything that
gets in the way of finding treatments for some of the biggest killers
today, so we feel that all patients with all kinds of diseases
deserve to have access to these kinds of cells.”

Loring was quoted in a Consumer Watchdog press release as saying,

"Human embryonic stem cells hold
great promise for advancing human health, and no one has the ethical
right to own them.”

John M. Simpson of Consumer Watchdog
said,

 “The best course if WARF truly
cares about scientific advancement would be to
simply abandon these over-reaching patent claims.”

A story by Bradley Fikes in the San
Diego U-T cited intellectual property attorney Lisa Haile of DLA
Piper as saying,

“A successful use of the Myriad case
as a precedent for throwing out the foundation’s patent would open
the door to similar challenges in just about any biotech product
using material derived from life.”

WARF made no immediate comment.

Other stories on the WARF challenge
appeared in the Milwaukee Journal, Genomeweb and the LaCross Tribune. 

Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/LuLuZLLjyDo/challenge-to-warf-hesc-patents-cites.html

Bluebird and Banking: Media Pluses for California Stem Cell Agency

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The California stem cell agency scored
a couple of favorable publicity points last week as the result of a
successful stock offering by an award recipient and another piece
about creation of a stem cell bank in Northern California.
The IPO by bluebird bio (the company's
preferred spelling) of Massachusetts was a big winner for the
company, raising millions of dollars more than anticipated.
The Boston Globe wrote,

“Shares of the Cambridge life
sciences company bluebird bio Inc. soared almost 60 percent on their
first day of trading (last) Wednesday, an impressive debut for a
business that endured years of stagnation and another encouraging
sign for the biotechnology industry.

“The local gene therapy company
raised $101 million in an initial public offering priced at $17 per
share, higher than the $14 to $16 estimated by investment bankers.
Bluebird shares closed at $26.91 per share on Wednesday.”

The stock continues to trade around $25
a share at the time of this writing, which is good news generally for
the biotech industry.
The company received a $9.4 million
award last fall from the $3 billion stem cell agency. The company has yet to receive any actual cash from the agency as both parties work
out final details of an agreement, a spokesman for the agency said
last week.
The stem cell agency touted the
successful IPO in a blog item by  that said,

“Bluebird Bio, one of the oldest
companies in the struggling gene therapy field, is having an
outstanding first day in the stock market today, and largely by
marrying its gene therapy technology with stem cell science. The
company’s financial milestone brings hope and excitement to both
fields.”

However, the news stories about the IPO
failed to mention the stem cell agency's involvement, which would
have been nice for the agency but was to be expected given the way
news is covered.
The story about the stem cell bank
appeared on Xconomy, an Internet news service dealing with
technology. Written by Bernadette Tansey, a former San Francisco
Chronicle reporter, the piece dealt with the both business and science of stem cell banking. She wrote,

“One of the main goals of
California’s $3 billion stem cell research agency is to draw
companies into the state so they can vie for a share of the funding.

"With a recently funded $32 million
initiative, the California
Institute for Regenerative Medicine(CIRM) has attracted two of
the biggest US players in stem cell banking to Novato, CA, to form
one of the largest biobanks of induced pluripotent stem cells (iPS
cells) in the world.”

The stem cell bank effort has become a
minor staple in recent news coverage of CIRM, surfacing in a number
of articles since the awards were approved. One of the reasons for that is that the project has a relatively straight-forward story line compared to many research efforts and the concept of "banking" is familiar to editors, writers and readers. 

Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/6WeU6kIIs6E/bluebird-and-banking-media-pluses-for.html

Cost of a Stem Cell Therapy? An Estimated $512,000

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The likely costs of potential stem cell therapies
and cures receive almost no attention in the media as well as
publicly from scientists and the biotech firms.
Usually any public discussion is
obliquely framed in the context of “reimbursement,” as if
industry is owed something instead of making a business decision
about what will make a profit. Euphemisms and jargon cloak unpleasant realities such as astronomical patient costs. But what reimbursement really involves are, in fact, pricing decisions and profit margins along with
lobbying campaigns for inclusion of
therapies in normal coverage of health insurance and Medicare. 
And today a singular figure – $512,000
for one stem cell treatment – appeared in the Wall Street
Journal . The story by Kosaku Narioka and Phred Dvorak dealt
with what would be the first-ever human study of a treatment that
uses reprogrammed adult stem cells.
They reported that the study received
preliminary approval on Wednesday from a key panel of the Japan
Health Ministry. The treatment involves a form of age-related macular
degeneration, which has also been targeted by the California stem
cell agency with different approaches.
Buried deep in the Wall Street Journal
article, with little other discussion, was this sentence:

“One eventual obstacle, even if tests
go well, could be cost: (Masayuki) Yamato (of Tokyo Women's Medical
University) says initial estimates for the treatment run around ¥50
million ($512,000) per person."

The subject of costs for potential stem
cell treatments has rattled around in the background for years
without much deep public discussion. One reason is that high costs of
treatments are controversial and can trigger emotional debate.
Another reason is that it is very early in the therapy development
process and estimates are not likely to be entirely reliable.
A few years ago, however, the California stem
cell agency commissioned a study involving costs of stem cell therapies. The UC Berkeley report said,

“The cost impact of the therapy is
likely to be high, because of a therapy’s high cost per patient,
and the potentially large number of individuals who might benefit
from the therapy. This expense would put additional stress on
the Medicare and Medicaid budgets, cause private
insurance health premiums to increase, and create an incentive for
private plans to avoid covering individuals eligible for a therapy.”

The findings did not seem to be exactly
welcomed. The agency sat on the 2009 study for seven months until it
was uncovered by the California Stem Cell Report in April 2010. Then
the agency was careful to say that the study did not reflect the view
of CIRM management or board leadership.
Their wariness of being out in front on the issue could be well-advised. The pharmaceutical industry received some unpleasant attention this spring when more than 100 influential cancer specialists from more than 15 countries publicly denounced the cost of cancer drugs that exceed more than $100,000 a year.
Nonetheless pricing is critical
to both patient accessibility and therapy development. If companies
cannot make a profit on a possible therapy, it is virtually certain
not to appear in the marketplace.
While the subject remains in the
background, it does not mean there is a lack of interest. The copy of
the Berkeley stem cell cost study that was posted online by the California
Stem Cell Report has been read 11,701 times since it was made
available in April 2010 on scribd.com.
A copy of the study can be found below.

Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/IObtHBtAe_E/cost-of-stem-cell-therapy-estimated.html

Merksamer Makes Only Bid For Stem Cell Agency Lobbying Contract

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Only one of California's lobbying firms
is interested in working for the California stem cell agency – at
least interested enough to put in a bid.
However, that is likely more of a
function of the small size of the contract – $65,000 – and the
entrenched nature of CIRM's existing lobbyist – Nielsen, Merksamer,
Parrinello, Gross & Leoni LLP – one of the state Capitol's
larger lobbying firms with $5 million in billings last year.
The firm touted its longstanding
connection to the $3 billion agency in its 21-page proposal in
response to a CIRM RFA this spring. The firm has been with CIRM since
2005.
Nielsen Merksamer's proposal also noted
a couple of other interesting aspects of the continuing arrangement.
CIRM will run out of money for new grants in 2017, and Nielsen
Merkasamer said,

“Furthermore, as a premier
legislative advocacy and (Nielsen's italics) ballot measure
law ?rm, Nielsen Merksamer can actively and effectively assist CIRM
as it contemplates returning to the voters for additional funding.”

The proposal also suggested that it can
conceal information that normally would be public record. The firm
said,

“Another unique advantage offered by
Nielsen Merksamer is that, unlike the vast majority of lobbying ?rms,
since we are a full-service law ?rm, our relationships with our
clients are subject to the attorney-client privilege.”

CIRM used such a technique in 2012 and 2008 in matters involving its budget and PR advice.
Nielsen Merksamer also said,

“(N)o one understands CIRM’s 'total
picture' better than Nielsen Merksamer. Not only has Nielsen
Merksamer been representing CIRM before the Legislature for the past
decade, but Nielsen Merksamer was also one of the principal drafters
of the aforementioned Proposition 71—which brought CIRM to life.
The depth of Nielsen Merksamer’s familiarity with, and
understanding of, CIRM’s mission and structure, the challenges it
faces, and the promise it holds simply cannot be matched by any other
legislative advocate.”

The firm said it would not need the
$65,000 offered by CIRM but would charge only $49,200 annually, about the same as
it has been paid for several years. Steve Merksamer and Gene Erbin,
who drafted portions of Proposition 71, would handle most of CIRM's
affairs. John Moffatt and Missy Johnson would also be available.
The firm's proposal outlined several
instances where it successfully killed legislation opposed by CIRM.
You can read about them in their proposal below.

Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/kTRN6kUuSDk/merksamer-makes-only-bid-for-stem-cell.html

Compensation for Human Eggs Approved by Key California Senate Committee, But Not For CIRM Researchers

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Legislation that would permit women in
California to be paid for their eggs for scientific research
yesterday cleared a key state Senate committee and is likely headed
for the governor's desk.
The measure by Assemblywoman Susan
Bonilla, D-Concord, was approved on a 6-1 vote by the Senate Health
Committee and now goes to the Senate floor. Earlier, it passed the
Assembly on a 54-20 vote.
Some stem cell researchers and other
scientists have chafed under state restrictions that bar compensation
for eggs while that the same time fertility clinics are paying an average of $9,000 a session for eggs, with some prices going as high as $50,000.
However, the legislation will not
affect researchers using grants from the $3 billion California stem
cell agency. The agency's regulations bar compensation for eggs in
the research that it funds. That means that at least a two-tiered
research system would exist in California not to mention another tier
created by federal regulations that differ from both those of the
stem cell agency and those set by the legislation.
CIRM's restrictions are required by
Proposition 71, which created the agency in 2004, and cannot be
changed without a 70 percent vote of the legislature. Bonilla's bill
requires only a majority vote.
Bonilla's legislation is sponsored by
American Society for Reproductive Medicine, the chief industry
group for the largely unregulated fertility industry.
The analysis prepared for yesterday's
committee session summarized Bonilla's arguments for the measure in
this fashion:

“This bill seeks to create equity in
the field of medical research compensation by removing the
prohibition on compensation for women participating in oocyte (egg)
donation for medical research. All other research subjects are
compensated for their time, trouble, and inconvenience involved in
participating in research. AB 926 ensures that women are treated
equally to all other research subjects - allowing them to actively
evaluate their participation in research studies. Unfortunately, the
ban on compensation has had serious unintended consequences. It has
led to a de facto prohibition on women’s reproductive research in
California, adversely impacting the same women that the ban intended
to protect. With few oocytes donated, fertility research and
fertility preservation research has been at a standstill. This
greatly affects women suffering from fertility issues and women
facing cancer who would like to preserve their oocytes.”

A number of organizations are opposed
to the bill including the Center for Genetics and Society in Berkeley
and the Catholic Church. The bill analysis summarized some of the
opposition arguments in this fashion:

“Egg harvesting exposes healthy young
women to multiple synthetic hormones in order to produce many times
the normal number of eggs per cycle. One of the potential harms is
OHSS, which has resulted in hospitalizations and at least a few
documented deaths. These groups state that many experts remain
concerned about the long-term risks of these drugs, especially
their potential impact on infertility and various cancers.
Follow-up research on egg providers, which could establish the
frequency and severity of these adverse outcomes, is widely
recognized to be grossly inadequate.”

In addition to risk and religious
objections, opponents also argue that poor and minority women are
likely to be exploited by enterprises seeking their eggs to resell at
a profit.
No major stem cell research
organizations, including the California stem cell agency, have taken
a position on the bill. The legislation has received little public
attention, although The Sacramento Bee carried an article last March.
Ruha Benjamin, author of "People's Science" and assistant professor at Boston
University, also wrote about the measure in April on the Huffington
Post. Benjamin said,
“UC Berkeley professor Charis
Thompson compares egg
donation to 'other kinds of physically demanding service work,'
arguing for a 'salary negotiation between the state agency (or
relevant employer) and the donor.' This, she contends, is a 'sensible
and dignified recognition of [the donor's] work, time, and effort.'
And instead of refusing compensation to women, Thompson suggests that
we 'direct our efforts to understanding and minimizing' the risks.
“Indeed. Now more than ever, we must
redouble our efforts, because the market in eggs appears to be
expanding from private reproduction to public research, and
increasingly overseas, if the surrogacy
industry is any indication of how 'cheaper' women become a
reserve army of bio-labor in less regulated regions.” 

Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/SVuriAz87l0/compensation-for-human-eggs-approved-by.html

International team submits IND application

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On 18 June 2013, there was an announcement at the Princess Margaret Cancer Centre, Toronto. There was also a post on the California stem cell agency blog entitled: Clinical trial to thwart cancer stem cells may begin soon. An excerpt from the post:

The Prince Margaret Center announced the FDA filing, called an Investigational New Drug application (IND), at an event in Toronto recognizing the private donors. A press release about the announcement was picked up at this biotech news site.

The Principal Investigators present for the announcement were Dr. Tak Mak of the Princess Margaret Cancer Centre and Dr. Dennis Slamon of the University of California, Los Angeles (UCLA). What they have done is summarized in another excerpt from the blog post:

By working first to understand the various proteins that drive cells to divide, particularly in cancer, they were able to pinpoint an enzyme, that if blocked, could be the key to keeping cancer in check. They then discovered that this enzyme, called PLK4, can be derailed by a new drug they developed. In the lab, it has been shown to inhibit the growth of breast, ovarian, colorectal, lung, pancreatic and prostate cancer, as well as melanoma.

Information about the human PLK4 protein is available here.

Some background: In June 2008, it was announced that a partnership had been formed between Canada’s Cancer Stem Cell Consortium (CSCC) and the California Institute for Regenerative Medicine (CIRM) for international collaboration to advance cancer stem cell research. An excerpt from the CSCC's announcement:

It is proposed that one of the first initiatives to be launched by the CSCC will be a collaboration between Canadian and Californian scientists through CIRM's upcoming Disease Team Research Awards Competition, which will support multi-disciplinary teams of scientists in pursuit of therapies for specific diseases.The goal is to fund teams that will develop therapy or diagnostics for a particular disease or serious injury.Successful proposals will likely include a description of a path to an Investigational New Drug filing at the end of the four-to-five year grant.

Note the intent to file an IND by the end of the term of the grant.

The results of the Disease Team Research Awards Competition were announced on October 28, 2009. The award to Drs. Slamon and Mak is Grant number DR1-01477. See: Therapeutic Opportunities to Target Tumor Initiating Cells in Solid Tumors. As was stated in a page about Cancer Stem Cells on the website of the Canadian Institutes for Health Research (CIHR), this award was to one of two multi-disciplinary research teams co-led by Canadian and Californian scientists. The other team is co-led by Dr. John Dick of the University Health Network and Dr. Dennis Carson of the University of California, San Diego. My blog post (October 29, 2009) about the awards is entitled: Disease Team awards announced. The post ends with this Disclosure:

I'm a member of the Board of the CSCC, but also a staff member (emeritus) at the University Health Network. So, I was in conflict of interest, and was absent during all of the discussions, by the CSCC Board, about which Canadian applications should be considered for the Disease Team awards.

Source:
http://cancerstemcellnews.blogspot.com/2013/06/international-team-submits-ind.html

Bluebird bio of Massachusetts Still Waiting for California Stem Cell Money

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Seven months after the California stem
cell agency awarded $9.4 million to bluebird bio of Cambridge, Mass.,
the company has yet to receive any of the cash from the Golden State.
Kevin McCormack, a spokesman for the $3
billion agency, this week said negotiations are still underway with
the bluebird, which is planning to go public,  but did not elaborate. Post-award negotiations are
common at the agency, but generally take much less time.
The cash from CIRM is scheduled to
assist in clinical trials for a stem cell-gene therapy to correct a genetic disease in young patients with B-thalassemia, a
rare blood disorder that can cause widespread organ damage
and premature death.
Earlier this month, bluebird bio, which
prefers the lower case lettering for its name, announced that it
intends to take the company public in an $86 million offering. In
March, it announced a collaboration with Celgene that provided for an upfront payment of $75 million and promised up to $225 million per
product in potential option fees and clinical and regulatory
milestones. The CIRM grant is conditioned on a matching commitment
from bluebird.
Cash from the stem cell agency can only
be spent on operations within California. According to the CIRM summary of the review of the bluebird application, which was scored
at 73, the company said,

“We will have at least two clinical
sites in California, and more likely up to 4 sites, 2) our viral
vector manufacturing will occur in California, 3) our cell processing
will occur in California, 4) we will hire several consultants and
full-time employees within California to support the program.
Overall, several million dollars will be spent employing the services
of people, academic institutions, and other companies within the
state of California.”

The company has said that it is working
with Donald Kohn at UCLA and Elliot Vichinsky at Oakland's Children's
Hospital.
The bluebird web site lists a
California location for bluebird at 1001 Bayhill Dr, Suite 200, in
San Bruno, which is south of San Francisco. An Internet search
indicates that is a generic address for a number of business
including a realty firm, a roof repair business and a family law
attorney. The California Stem Cell Report has asked bluebird to
clarify the nature of the address.
In an interview last October with Ron Leuty of the
San Francisco Business Times, David Davidson, the lead scientist on
the project, said,

“We began the process (with CIRM)
early in (2012) but discussions have been going on for over a year
about potentially pursuing this.

“The interaction with CIRM has been
extraordinarily collaborative. We had contact with the coordinators
at CIRM that helped us manage the process. It took a lot of effort on
our part to put together a dossier providing support for our program.
It was really like a mini-regulatory filing — on the science, the
preclinical toxicology work that we’ve done, a detailed plan for
the trial, a detailed plan for the budgets, a detailed plan on how we
intended to spend the CIRM money in California. That was an important
part of it. They wanted a clear plan on how this investment would be
spent."

Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/zR-Ht90u_7o/bluebird-bio-of-massachusetts-still.html

Pomeroy on Doing the Right Thing and Foster Care

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Claire Pomeroy
CIRM photo
On Claire Pomeroy's last day as a
member of the governing board of the $3 billion California stem cell
agency, she also published an essay on the Huffington Post in which
she discussed fleeing from an abusive home at age 14.
Pomeroy, former vice chancellor and
dean of the medical school at UC Davis and now president of the Lasker Foundation in New York,  wrote last month,

“For some children, the uncertainty
of life on the street is better than certainty of violence at home.
It was for me. At age 14, I escaped from an abusive home with no
money, nowhere to go and only the clothes I was wearing. I remember
staring into the night, standing somewhere between fear and freedom.
I became one of the millions of homeless teens, yet I was lucky
because foster care ultimately saved me.”

“However, after an emergency
placement and three foster homes, the challenges were not over. At 17
I aged out of the foster care system early when my foster parents
moved out of state. On my own again, I had to find a job, a place to
live and finish high school. Then I climbed the next mountain to
graduate from college and medical school.”

Pomeroy said she only recently began
publicly talking about her foster care experience. She said she is
doing so because “many  people lack an understanding of
the harsh statistics and their impact on the country's future. The
nation faces a crisis that demands a call to action to start truly
caring about foster youth before it is too late.”
She said that she was “lucky” in the
foster care system but said that many children, particularly minorities among others such as the disabled, were not as fortunate and “were failed by the system and society.” Pomeroy called them
“throwaway children” who were “robbed of their ideals, gave up
hope and struggled to find a reason to live.”
Less than half of the foster children
who “age out” of the system graduate from high school, she wrote. Only 3
percent to 11 percent earn a bachelor's degree. More than
400,000 children were in foster care in 2011 and have a one in 11 chance
of being homeless.
Pomeroy called for expansion and
improvement of foster care across the country. “It is time to stop
forcing children to be the heroes of their own survival,” she
wrote. “Now is the time to do the right the right thing.”
------
On a personal note, we have four
grandchildren, one of whom was adopted out of foster care as a
toddler. The other was adopted at birth. Some of the siblings of
those two African-American children remain in foster care today.

Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/zancriHTUC4/pomeroy-on-doing-right-thing-and-foster.html

Monterey Newspaper Chides California Stem Cell Agency

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The California stem cell agency and its
former chairman, Robert Klein, came under sharp criticism this week
in an editorial in the Monterey County Herald newspaper.
The editorial cited articles on the
California Stem Cell Report dealing with a $21,630 gift by Klein to
the agency, his employment of the vice chairman of the agency and the
violation of the agency's conflict of interest policies by a grant reviewer.
The editorial was headlined "State Stem Cell Agency Still Up to Old Tricks." The piece said,

“Robert Klein is no longer chairman
of California's stem cell bureaucracy, but it is still doing things
his way. Which is too bad for all concerned.

“Klein is the former developer and
financier who wrote and sponsored the ballot measure that created the
California Institute for Regenerative Medicine. The ballot language
practically guaranteed he would be the chairman, and he ran the
agency the way he ran his businesses, using undisclosed side deals
and other machinations to create webs that outsiders could never
penetrate.

“Now, Klein has been replaced as
chairman, but he is still up to his old tricks.”

The editorial concluded,

“Much has been said about the agency
setting a new more straightforward direction now that Klein is gone,
but so far it seems to be following a twisting and expensive path
toward irrelevance and litigation.”

Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/SGmn7k9T1Vw/monterey-newspaper-chides-california.html

Vatican Funding for California Stem Cell Agency?

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So what's with the Vatican sending cash
to the California stem cell agency? One would imagine that is an
improbable event since the agency is involved in human embryonic stem
cell research, which is an anathema to the Roman Catholic church.
However, CIRM President Alan Trounson
earlier this week disclosed the payment in an interview with Patt
Morrison of the Los Angeles Times. He said,

“Last
year I was invited to the Vatican to
present a paper, but when I sent in a summary of what I was going to
say, they decided not to have it. They sent a check to the treasurer
of California and the treasurer rang us up and said, "What the
heck is this check from the Vatican for?" It was for the
inconvenience!”

We wanted to know a little more about
this so we queried the agency about the matter. Kevin McCormack, a
CIRM spokesman, said,

“The money was actually a wire
transfer from the Vatican to us for $453.23 and it went to CIRM's
account. It was to reimburse us for money spent on plane tickets,
etc., for Dr. Trounson to attend the Vatican conference on stem
cells.”   

Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/bOQKBXJGmJ8/vatican-funding-for-california-stem.html

Trounson Proposes $70 Million, Fast-Track Stem Cell Clinic Plan for California

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Alan Trounson, president of the
California stem cell agency, this summer plans to seek $70 million
for creation of what he calls Alpha Clinics, high-powered
organizations that will fast-track stem cell therapies to patients.
The proposal is scheduled to come
before CIRM board at its meeting in late July and would consume a
significant slice of the $700 million to $800 million that the $3
billion agency has left to hand out.
Trounson broached the need for the
clinics as far back as two years ago, but did not put a price tag on
the concept until an interview published online late today in the Los
Angeles Times. The interview will be carried in the print edition of
the paper tomorrow.
In the Q&A session between Times
columnist Patt Morrison and Trounson, he said, 

"I'm intending to set up a network of
stem cell clinics in California in the next couple of years, to make
treatments available as clinical trials or as registered treatments
for patients. I'm going to ask the [CIRM] board for about $70 million
to get that set up. It will make California a go-to place for stem
cell therapies. I want to make sure it's part of our medical fabric."

In other media reports in previous
years, Trounson has said the Alpha Clinics would speed delivery of
stem cell-based therapies and reduce costs of clinical trials by
building on the success of specialist cancer, transplant and in-vitro
fertilization clinics.
Leigh Dayton wrote about Trounson's
plan in The Australian last July 14. Dayton said,

“Initially the clinics would use the
capacities and infrastructure in the most advanced university medical
clinics to deliver bone-marrow stem cell therapies. As research
evolves, so will the treatments and services offered.”

Trounson also discussed the Alpha
Clinics during an appearance at USC in 2011. A university publication wrote,

"These clinics will initially serve
to get patients into clinical trials or to offer sound advice to
individuals who might otherwise go overseas to receive harmful stem
cell therapies from disreputable clinics.

"'I’m willing to invest money to
get these [clinics] up,' Trounson said. 'I think if nothing happens
beyond 2017 and we don’t get any refunding, we can leave a
footprint of stem cell clinics in California that will go on
forever.'"

Trounson was not at last week's CIRM
board meeting, but Ellen Feigal, senior vice president for research
and development, said a white paper is being prepared on Alpha
Clinics. She said a concept proposal would be brought to the board
July 25 at a meeting in the San Francisco Bay Area. Once the board
approves the concept, the staff will then prepare and post the RFA.

Interested parties can address
suggestions or questions to Feigal at info@cirm.ca.gov.

Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/lND8J7NKqzc/trounson-proposes-70-million-fast-track.html

$70 Million Alpha Stem Cell Clinic Proposal Draws Reader Comment

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In addition to the comments filed online in connection with the $70 million proposal to create Alpha Clinics in California for stem cell treatments,  two other readers commented privately in emails. 
One came from a close observer of the
stem cell agency who said, “If done right -- and I'm sure you and I
agree that is a big 'if' – it could be an outstanding legacy.”
The other comment came from a
physician-researcher at a major California institution and was longer
and more critical. Here is the text.

“Another boondoggle for some medical
schools but made to order for private operators like for profit
cancer, dialysis, and laser eye specialty clinics that do one
procedure.  I can see each of the medical schools gifted with
one as they each were gifted with about 25 million dollars for stem
cell institute buildings; and CIRM and (Irv) Weissman's companies
like Stem Cells, Inc., getting a piece of the action as well.  Of
course the deans and chancellors on the CIRM steering committee will
vote for it. How can they not? It's money in their pockets.

“This has the fit and feel of, say,
old Latin American Laetrile clinics or offshore clinics offering
suspect surgeries or injections for cancers, Parkinson's disease, and
the like.  It makes no difference that they are set up in
California.  CIRM will pay for an unneeded infrastructure that
will be empty space and staff sitting on their hands 99% of the
time.  Or worse yet, CIRM will pay but the space will be used
for other things, other clinic procedures paid for by insurance.  

“Now (CIRM President Alan) Trounson and
CIRM want to get into the medical tourism business making California
a 'go-to place' for stem cell treatments.  They want to start
with bone marrow injections and transplants, procedures that cancer
centers do regularly.  All CIRM needs is a drug or treatment. 
It's not like there are tons of drugs out there and the only barrier
is the lack of clinical space and capacity.  The start up time
for any one drug is very long.

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

“The CIRM clinics are going to be
generic stem cell clinics advancing California tourism.  Come to
California, we will inject stem cells for any illness, in any part of
your body, never mind that cancer is different from heart disease is
different from bone disease is different from brain disease, no
matter.  Next step is for CIRM to form a travel agency with
discounted air and Ritz Carlton packages for patients and extended
family non-stop from China.  There is likely considerable
revenue to be generated here and Trounson, Weissman, and (Robert)
Klein (former CIRM chairman) should find a way to benefit. It sounds
so wonderful!!  The public will love it.  Now all they need
are some treatments.  Love the name: Alpha Clinics, they
wouldn't want to start with Beta test clinics when they can go big
from the get-go.  What an irresponsible waste.”    

The other comments can be found at the end of the original item or in the column to the right of this item, headed "recent comments."

Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/nKbicxl9mzA/70-million-alpha-stem-cell-clinic.html

California's Alpha Stem Cell Clinics: Open in 2014, Six to Eight Locations

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The San Francisco Business Times
yesterday said that the first Alpha Clinic sponsored by the $3
billion California stem cell agency could open as early as 2014.
The timing was disclosed by CIRM
President Alan Trounson in an article by Ron Leuty, who also reported
that that Trounson's $70 million proposal (see here and here) would involve as many as
six to eight clinics. The locations of the clinics was not disclosed
and would be subject to a competitive RFA. However, Leuty's piece
mentioned UC San Francisco and Stanford.
The article also said initial
treatments might focus on eye disease, “brain therapies” and
spinal cord injuries.
The Alpha Clinic plan is scheduled to
come before the CIRM board in late July. The proposal is aimed at
speeding stem cell treatments and creating something of a one-stop
shopping experience for patients.

Once the CIRM board approves the
concept, an RFA will be issued and interested institutions will have
to submit bids and compete for funding.  

Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/So_NOlmLU2E/californias-alpha-stem-cell-clinics.html

Multimillion Dollar Carrots for Stem Cell Research in California

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Directors of the California stem cell
agency approved an $80 million business-friendly plan that will
dangle multimillion dollar carrots before biotech firms in an effort
to push therapies into the marketplace.

The upfront payment effort will allow
CIRM to take part in early stage clinical trials at no risk and could
generate a list of achievements that will be useful in creating
support for fresh funding after CIRM's money runs out in 2017.
The proposal is the first-ever from
CIRM that involves no upfront payments. Instead, recipients will have
to meet agreed-upon criteria to receive either grants or loans.
A CIRM staff document said,

“The major development milestone and
success criteria will be mutually agreed upon between CIRM and the
applicant at the beginning of the project(s) and at a minimum will
require completion of a clinical trial that shows some level of
biological activity/clinical efficacy and safety. The advantage to
CIRM of this...is that CIRM funds will only be applied to projects
that are successful.”

The proposal was wrapped into what the
agency calls its strategic partnership plan, which also has a more
conventional aspect, providing loans and grants in advance.
As part of the program, the CIRM board
also today approved a $6.4 million award to Sangamo BioSciences of
Richmond, Ca., to help develop a therapy for
beta-thalassemia. The firm will have to match the amount of the
award.

Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/uJidDBHhPdI/multimillion-dollar-carrots-for-stem.html

Sacramento Bee: Ongoing Conflict Problems No Help for Future Funding of Stem Cell Agency

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The Sacramento Bee says conflict of
interest problems continue to trouble the California stem cell agency
despite its assertions that it has “turned a page” on the issues.
In an editorial Saturday, The Bee said
that CIRM Chairman Jonathan Thomas “has vowed to be aggressive in
avoiding conflicts in dispersing millions of public dollars for stem
cell research. Yet serious conflicts continue to be
revealed involving CIRM.”
The Bee cited articles on the
California Stem Cell Report earlier this month about a $21,630 gift
by its former chairman, Robert Klein, and the employment by Klein of
Vice Chairman Art Torres. The Bee said the situation “throws
into question a $20 million grant awarded last year to StemCells
Inc., a company that wants to transplant neural stem
cells to treat Alzheimer's
disease.” (See here, here and here)
The Bee also cited the case of Lee
Hood, an internationally renown scientist who violated the agency's conflict of interest policy. Hood failed to disclose to CIRM a
conflict involving an application that he was reviewing on behalf of
the agency. The Bee said the agency's failure to detect the conflict
was “serious oversight."
Eight readers commented on the
editorial and agency, generally unfavorably about CIRM.
But reader “bchild” said,

“It took a couple years for them to start funding projects and it may take years to see results. Wall
Street got 1.5 trillion and the promise of 10x that if they get
into trouble again, the scientists (and their business buds) just
want a couple billion...In the end who do you trust more with
public money? At least there is the appearance of public benefit
here..."

The Bee concluded,

“None of this helps CIRM's reputation
in being fair and impartial in spending $3 billion in public funds.
It surely won't help the institute's standing with the Legislature
and the public, should it need help staying in operation when its
funding is exhausted in a few years.”

The editorial was also carried by at least one other paper in the McClatchy chain.

Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/BZeSccFCbBU/sacramento-bee-ongoing-conflict.html

Replicating Oregon Cloning in California: Views on the Legality

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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.” 

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

California Stem Cell Agency: 5 Percent Budget Increase for Coming Fiscal Year

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Directors of the California stem cell
agency today approved a $17.4 million operating budget for the fiscal
year beginning July 1, an increase of 5.1 percent over spending for
the current year.

As usual, the agency tries to portray
its budget as a decrease in spending. Directors were told that it
represented a 3 percent decline from the current year. However, the
comparison is not made to actual spending for this year. Instead, the
staff compares the 2013-14 budget to budget figures proposed last
May, which are now no more than time-worn ephemera.
Most of the budget goes for salaries
and benefits ($12.2 million ) with outside contracting running next
($2 million). (See here for details.) The budget projects 59 employees for next year
compared to 57 currently. CIRM staff said the number of employees is expected to remain about
the same until 2017 or so when its workload is projected to diminish.
The agency is expected to run out of
money for new grants in 2017, but it is working on a plan to develop
a combination of private and public funding to continue its work.
The spending plan reflects the cost of
overseeing about $1.8 billion in nearly 600 grants and loans plus
developing new research proposals that are likely to be funded in the
next few years. The operational budget is capped by law at 6 percent
of the amount of funds the agency distributes over its lifetime.  

Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/GJSQ_B3ck_8/california-stem-cell-agency-5-percent.html

A Patent War on iPS: One Researcher's View

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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

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

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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

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

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

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


  1. Stem Cells