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Category Archives: Stem Cell Therapy

Nearly $6 Million Sought: Four Scientists Seek to Overturn Rejection by CIRM Reviewers


Four researchers are appealing
rejection of their proposals to win millions of dollars from the
California stem cell agency just as the agency is moving to curb such
reconsideration efforts by scientists.

The latest appeals come in what the
agency calls its basic biology round. The agency's governing board
meets next Wednesday and Thursday to hand out as much as $35 million
to as many as 25 scientists competing for the research dollars.
The four appeals follow a record outpouring last month of attempts at reconsideration in another
round. One upshot has been a proposal that would tighten the review process. That plan also comes before directors next week.
In three of the latest appeals, the
applications were given scientific scores that exceeded those of some
proposals that were approved by reviewers. The lower scoring
proposals were given the go-ahead on the basis of “programmatic
review,” which one CIRM document says is designed to allow
“consideration of issues beyond scientific merit, such as disease
representation and societal impact.” 
The latest appeals – formally known
as extraordinary petitions – were filed by Michael Teitell of UCLA,
Deborah Lieu of UC Davis, Tony Hunter of Salk and Hanna Mikkola, also
of UCLA. In all, their applications seek nearly $6 million from CIRM.
Hunter's $1.8 million application had the highest scientific score, 70,  of the four appeals. It ranked above three grants approved by reviewers. 
In his appeal, Hunter said “no major scientific issues were found” by reviewers concerning his application. He also reported new data involving a “major concern” of reviewers. Hunter said the information was developed after the application was submitted April 25.

In the case of Lieu, reviewers
said she was “relatively inexperienced.” Lieu's appeal said she
has “24 publications with over 6 years of experience in the
differentiation of cardiac muscle cells from human pluripotent stem
cells, 12 publications (3 co-corresponding author) on human
pluripotent stem cells and their cardiac derivatives, and 3
publications on the engineering of pacemaker cells” in addition to
other related professional experience.
She is seeking $1.3 million. Her
application received a score of 68, ranking it above two other grants
approved by reviewers and equal to a third also approved by
reviewers.
Mikkola said her application built on work previously funded by CIRM. She also cited new data that the
reviewers did not have access to. Mikkola's application for $1.4 million
received a score of 65, which ranks it above one grant approved by
reviewers.
Teitell's letter to the board also cited new data that is scheduled to published in November that deals with one of the concerns of reviewers. Teitell additionally disputed some of the critical information in the summary of reviewer comments.

He is seeking $1.4 million. CIRM did not release a score on his application, although it appears to be below 63, the lowest score disclosed publicly by the agency.

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USC Researchers Appeal Rejection of $20 Million Proposal


Researchers from the University of
Southern California
are making a pitch to overturn rejection of their
$20 million grant application by reviewers in one of the signature
commercialization rounds of the California stem cell agency.

The appeal by Roberta Diaz Brinton and
Lon Schneider will be taken up one week from tomorrow by the
governing board of the $3 billion state enterprise.
The USC application deals with Alzheimer's. It came in the $243
million disease team round that was considered last month during a
record-breaking outpouring of appeals and a day of emotion-filled
appearances by patients. CIRM directors adjourned their meeting
without completing action on a number of items, leaving open the possibility of additional appeals such as the one from USC.
The Brinton-Schneider application
received a score of 63 from reviewers. They said in a letter to
the board,

“We are submitting the petition at
this time as we are new to the CIRM ICOC(governing board) process and after listening
to the July 26 ICOC meeting deliberations now understand that the
petition process allows the ICOC to further consider our proposal.
We noted that the proposal scored one point above ours and another
two points below ours, each utilized the extraordinary petition
strategy to gain ICOC review which resulted in funding approval in
the former, and reconsideration in the latter instance.”

Their statement reinforced a concern
expressed by CIRM Director Oswald Steward, director of the Reeve Center at UC Irvine,  at last month's board
meeting about fairness in the grant process. He said,

“I'm not really quire sure that all
of the applicants clearly understood that they could come back to us
to address the criticisms(of reviewers).”

Concerns about whether all applicants fully understand the appeal process have surfaced on a number of occasions over the last several years. The CIRM board, however, is generally reluctant to overturn negative recommendations by reviewers. It also almost never reverses positive recommendations.

Next week the board is scheduled to
make unspecified changes in the appeal process. No further details on
those changes have yet been released by the agency although the
meeting is just four business days away.
In the Brinton-Schneider letter to the
CIRM board, the scientists defended their scientific approach and
responded to criticism by reviewers, especially those related to
sedation. Reviewers expressed reservations about over-sedation, which
the researchers said were erroneous.
It is not clear whether other scientists will
be making appeals during next week's board meeting.

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Researcher Alert: Troubling CIRM Grant Appeal Process Up for Revision


Directors of the California stem cell
agency next week are expected to make unspecified changes in how
scientists can appeal denials of their applications for millions of
dollars in research grants.

The move follows a jam-packed and
emotional meeting last month in which the CIRM governing board faced a record outpouring of appeals of negative decisions by grant
reviewers. The board is the ultimate arbiter on applications. While it almost never overturns positive decisions by reviewers, it sometimes
approves applications that they have rejected. 
No details of the proposed changes in
the appeal process are yet available for the meeting Sept. 5-6 in
Burlingame, Ca. All that is known at this point is the following item
from the board agenda: “consideration of modifications to the
extraordinary petition policy and adoption of additional
information policy.” Extraordinary petitions are the key vehicle
for appeals.
The appeals process has long troubled the CIRM board. It has made changes in the procedures, but last
month's high stakes, $243 million round posed new challenges and
consumed so much time that the board was unable to complete action on
several items.
As a result of the July appeals, the
board sent five applications back for re-review. (See here, here and
here.) Some of those are expected to come up next week and others at
the end of October. The board agenda, however, did not specify which
applications would be considered next week. Nor did it specify how many additional appeals have been filed in the round that was up for
approval in July.

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PART 1: Lorna Tolentino admits undergoing stem cell treatment to keep vital organs rejuvenated

PART 1: Lorna Tolentino admits undergoing stem cell treatment to keep vital organs rejuvenated

Isang bihirang pagkakataon na nakausap uli ng PEP.ph (Philippine Entertainment Portal) sa isang mahabang interview ang multi-awarded actress na si Lorna Tolentino.

Naganap ang panayam noong nakaraang Huwebes, August 23, sa faculty office ng Central Colleges of the Philippines (CCP), kung saan ginanap ang taping ng weekly supernatural mystery drama series naThird Eye ng TV5.

During dinner break, nabanggit ni Lorna ang tungkol sa pinsang si Zsa Zsa Padilla, who was diagnosed with Stage 1 cancer of the kidney.

"Ka-text ko si Zsa Zsa. Four weeks daw siya doon, tapos saka babalik dito.

Four weeks after the operation, hindi pa siya puwedeng mag-work.

August 27 ang naiulat noon na schedule ng operasyon ni Zsa Zsa sa Cedars-Sinai Medical Center sa Los Angeles, California.

Sixteen hours and delay ng oras ng U.S. sa Pilipinas, kayat malamang na ngayong araw na ang operasyon ni Zsa Zsa.

Tatanggalin ang mala-golf ball sa laking namuong laman sa kanyang kidney.

Read more:
PART 1: Lorna Tolentino admits undergoing stem cell treatment to keep vital organs rejuvenated

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An Unseemly Performance: Former Chair of Stem Cell Agency Promotes $20 Million Research Proposal


Bob Klein is nearly an icon in the
history of the $3 billion California stem cell. And when he appeared
before its governing board last month and aggressively touted a $20
million grant proposal already rejected by agency reviewers, his
actions raised eyebrows.

Robert Klein
Elie Dolgin/Nature photo
Klein's comments carried unusual
weight, given that they were supported by his unique and influential
relationship with the California Institute for Regenerative
Medicine(CIRM)
. He and his associates wrote the 10,000-word ballot
initiative that created the stem cell agency in 2004. He ran the $35
million electoral campaign that convinced voters to buy into the
idea. Klein raised millions on behalf of the effort. He personally
provided the campaign $3 million. And he was the first chairman of
the agency, leaving that office only 13 months ago, when he was
designated chairman emeritus.
The meeting last month marked Klein's
first public appearance before the board on behalf of a specific
application.. He heralded the applicant, StemCells, Inc., as unique
and the “best” in United States with a “huge body of
experience.”

(The full text of his testimony can be found here.)
Irv Weissman
Stanford Photo
StemCells Inc. is a publicly traded company based in Newark, Ca., that was founded by renown Stanford
scientist Irv Weissman, who sits on its board. Weissman also played
an important role in the Prop. 71 ballot campaign that created the
stem cell agency. StemCells, Inc.'s application was turned down by
CIRM reviewers who gave it a score of 61, but the company appealed the action to the agency's governing board. Following the appearance by Klein, Weissman and others, the CIRM board sent the application back for more review.
The board will reconsider it next month or in October.
One California stem cell researcher,
who requested anonymity, said it is “highly inappropriate for Bob
Klein to be advocating for any grant application from a public
company.”
The scientist said,

 “He has
considerable influence with the ICOC(the CIRM governing board), and
is closely associated with biotech in the Bay Area. Even if he
doesn't make a lot of money himself from this, then he certainly has
friends who will.  Irv Weissman would be one of those friends."

In response to questions asked on Aug. 7 by the
California Stem Cell Report, Klein today defended his actions.  He was asked if he had “any sort of
financial ties” to firms or individuals that would benefit from
approval of the award. Klein, who is a real estate investment banker and also an attorney, said he has
“no financial interest” in the firm or individuals that might
benefit.
Klein also indicated his appearance was
entirely appropriate. He defined his role as a patient advocate –
not as a lobbyist who is paid for advocating on behalf of a company.
Klein said he had “a particular responsibility to contribute my
background knowledge and experience.”
Klein said he hoped other former board
members would follow his example. He said,

“(I)t would be a tragedy if the
expertise of board members built up over six or more years is lost.”

(The full text of his response can be found here.)
Klein's appearance came at a propitious
time for financially strapped StemCells, Inc. The company's
financial information shows that it is losing $5.4 million a quarter
as of the end of June and had only $9 million in cash on hand. It
also had liabilities of $11.6 million, up substantially from $8.5
million in September of last year.
The researcher who criticized Klein's efforts as inappropriate also said,

"StemCells Inc has been on the
stock market for 20 years, without producing anything of value for
the investors.  The stock price has been sinking fast:  it
was 60 cents this June; last year at this time, it was around $5 a
share.   

“On July 17, when the CIRM Disease
Team Award review results became available, the stock rose from 87
cents to $1.80 – a person who could anticipate the outcome of the
CIRM applications could have made considerable money in that 24 hour
period.”

Weissman's role
with the StemCells, Inc., is more than scientific. According to the
company's financial statements, he holds 88,612 shares. His wife,
Ann Tsukamoto
, is executive vice president of the firm. She holds
185,209 shares in the firm.
Weissman played a significant role in
the Prop. 71 campaign. He did the “billionaire circuit,” raising
money for the initiative, according to an article by Diana Kapp in
San Francisco magazine. Among other things, Weissman worked the
exclusive Bohemian Grove in Northern California and “pitched”
Bill Bowes, a co-founder of Amgen, who, along with his wife, gave
$1.3 million to the campaign. Weissman was the key to securing a
$400,000 contribution from Microsoft's Bill Gates. Weissman also plumped for Prop. 71 in a TV campaign ad.
In addition to StemCells, Inc., Klein
and Weissman supported a successful attempt last month to overturn
reviewers' rejection of another $20 million application by Judith Shizuru
of Stanford. The application received a score of 53 from reviewers.
One of the application's problems cited
by reviewers was the availability of antibodies for the study. The
antibodies were developed by Systemix, a company founded by Weissman.
Systemix was acquired by Novartis in 1997 for about $70 million.
Weissman said he has “negotiated back” rights to key antibodies,
which he said are now held by Stanford.
Klein said that reviewers believed the
research was “a showstopper” but did not think the documentation
was adequate. He told the CIRM directors that they now have a letter
with proprietary information that supports the grant application.
Our take: The stem cell agency has long
labored under the perception that it is something of an insiders'
club. Even the prestigious journal Nature warned in 2008 about what
it called “cronyism” at CIRM. If anything, the situation is worse today,  four years later. Enterprises associated with persons on the CIRM board of directors have received more than 90 percent of the funds handed out by the agency. Klein's efforts last month
reinforce the not-so-pleasant image of the stem cell agency as an
old boy's club and create an impression – at the very least – of
unseemly insider influence.

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CIRM Board Member Prieto Defends Klein’s Right to Appear Before Board


A member of the governing board of the
California stem cell agency, Francisco Prieto, has commented
in an email about the “unseemly performance” item concerning the
agency's former chairman, Robert Klein. Prieto is a
Sacramento physician who serves as a patient advocate member of the
board. He has been on the board since its inception. Here are his
remarks.

“I wanted to comment on this piece
from the perspective of another patient advocate.  While I think
you know that I did not always agree with Bob Klein during his tenure
on the ICOC(the agency's governing board), I would strongly defend
his right to appear and give his opinions to the Board.  He is a
private citizen now, albeit one with considerable experience and
expertise, and I think his greatest vested interest in this case
stems (you should pardon the expression) from being the child of a
parent with Alzheimers.  As you point out, some eyebrows may be
raised, and I can imagine that some board members might be swayed in
either direction by his testimony, but  he is a passionate and
committed advocate, and he has the right to advocate before us.”

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