Stem Cell Therapy – StemCell Therapy

Patient Advocate Says IOM Recommendations Would ‘Destroy’ California Stem Cell Agency

♫ Sunday, January 20th, 2013

California's “beloved,” $3 billion
stem cell research program should not be altered despite
recommendations from the most prestigious scientific organization of
its kind. So says longtime patient advocate Don Reed of Fremont, Ca.

Reed says the recommendations by the
Institute of Medicine (IOM) are a “threat” that would “destroy” an
agency that “is like nothing else on earth.” Reed is urging other
patient advocates to turn out at next week's critical meeting of the stem cell agency's board and lobby against alterations in how it does
business.

Reed and CIRM's Amy Adams
World Stem Cell Summit photo

Reed is a fixture in stem cell circles
nationally and in California and has been a regular at the stem cell
agency's public meetings since 2004. He is also vice president of
Americans for Cures, a private stem cell lobbying group created by
Robert Klein when he was chairman of the stem cell agency, formally known as the California Institute for Regenerative
Medicine(CIRM).

Reed has written twice about the IOM
report on his blog with duplicate publication on the Huffington Post.
Yesterday, he said IOM “defies” the voters' will when they
created the stem cell agency in 2004. On Dec. 19, he said the
$700,000, 17-month study was “staggeringly misguided.” He wrote,

“If its recommendations were enacted,
they would silence stem cell patient advocate involvement, eliminate
public debate on funding proposals, and delegate the real decisions
to secret proceedings by an out-of-state-controlled board.”

Reed described the stem cell agency as
“fantastic” and wrote,

“So why mess with it, in such a
brutal and insulting manner?”

This writer has known Reed since the
early days of the stem cell agency and respects him. But in this
case he has many of his facts wrong. To mention just a few key
points: Patient advocates would not be silenced; their role would be
changed. Public comment would not be eliminated. Scientists could
still appeal negative decisions by reviewers to the full board if
they so choose, although the “extraordinary petition” process
would be eliminated. The voters' will would not be defied; they provided for a mechanism for making changes in the stem cell program.

While Bob Klein has not been heard from
publicly on the IOM report, some of Reed's comments reflect Klein's
past positions against altering the agency. Klein, an attorney and
real estate investment banker, might well be considered the father of
the agency. He directed the writing of the 10,000-word measure, Prop. 71, that created the program and wrote much of ballot initiative himself. The initiative contained a detailed description of the
qualifications for the chairman, which fit only one person in
California. It was no surprise when he won the post.

In years past, Klein has been extraordinarily protective of the ballot measure, at one point boxing
in the board on earlier proposals for changes that he disliked and that the IOM report now echoes.

In 2010, he was the prime
advocate for commissioning the IOM report which he expected
to serve as the basis for continued funding of the agency. It will
run out of cash for new grants in 2017.

To keep the money rolling in, Klein
said the IOM report would constitute a “gold standard” that would
generate increased enthusiasm for the research.

According to the transcript of the Aug.18, 2010, governing board meeting, Klein declared,

“(We will) never convince the people
that are adamant against us. But for the public and for the
constituent groups that are reasoned and prepared to look at
evidence, this is a very important validation that they can look to
to separate out what is a false claim from real performance.”

Also writing yesterday about the IOM
study was Bradley Fikes of the San Diego U-T, the dominant daily
newspaper in that area.

He summarized Reed's latest item as well as this on the California Stem Cell Report yesterday. Fikes
plans to file his own story within the next few days.

Feel free to file your own comments by
clicking on the word “comment” below or with the stem cell agency
at info@cirm.ca.gov. Anonymous
comments are permitted on this blog.

Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/wX7BEi46lc8/patient-advocate-says-iom.html

♫ Posted in Stem Cell Therapy | | Comments Off»

UC Davis Stem Cell Researcher: ‘Ivory Tower’ IOM Recommendations Harmful to California Stem Cell Agency

♫ Sunday, January 20th, 2013

The $3 billion California stem cell
agency has funded in the neighborhood of 500 to 600 scientists and
institutions, reviving and starting careers and stimulating
construction of $1 billion in new research labs around the state.

None of those recipients, as far as we
know, has come forward to comment publicly on the sweeping recommendations by Institute of Medicine for changes at the agency.
Until today, that is.

UC Davis researcher Paul Knoepfler, who
may be the only stem cell scientist in the United States with a stem
cell blog, weighed in with his thoughts today, which do not align
with those of the blue-ribbon IOM panel.

“Harmful” is one word that Knoepfler, who is a stem cell agency grant recipient, used to describe the recommendations. He predicted “extremely negative repercussions” that “would
actually make CIRM less effective and less responsive to patients and
California citizens.”

He wrote that the IOM report, which
will come before stem cell agency governing board next week “...seems more like an ivory tower
intellectual exercise than an operative, realistic guide to a dynamic
agency that must operate in the real world.”

He defended the CIRM governing board,
which came under fire from the IOM for conflicts of interest.
Institutions linked to board members have received about 90 percent
of the $1.7 billion that the board has awarded, according to compilations by the California Stem Cell Report. The IOM said,

“Far too many board members
represent organizations that receive CIRM funding or benefit from
that funding. These competing personal and professional
interests compromise the perceived independence of the ICOC,
introduce potential bias into the board’s decision making, and
threaten to undermine confidence in the board."

Knoepfler said,

“(The) IOM itself admits there is no
evidence that any conflicts of interest have ever guided (the agency's governing board) decisions. Not one example.”

Knoepfler also wrote,

“Interestingly, highlighting the
extremely sensitive nature of this issue, while I’ve been talking
with many bigwigs about this, at this point no one is wiling to go on
the record with an opinion about it except one courageous soul, Don
Reed (see
his piece here).”

There is a reason for that. The IOM is the most prestigious organization of its sort. Its studies are
described as the gold standard. And it has a rareified membership
that many scientists seek to join. So few are ready to give the
organization a smack on the nose. Likewise, California researchers
are loath to publicly criticize the stem cell agency because it
holds the strings to the purse that finances their careers.

California scientists, however, should
be asking themselves a bottom-line question. Do they want to see the
stem cell agency continue for another 10 to 20 years? Under the best
of circumstances, that may be unlikely given the other pressing needs
that the state faces. But if CIRM directors do not forthrightly
address the recommendations of the IOM panel, the fate of the stem
cell agency is exceedingly uncertain.

Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/pW_1A2nkyrM/uc-davis-stem-cell-researcher-ivory.html

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Live Audiocast Available for Next Week’s CIRM-IOM Meetings

♫ Sunday, January 20th, 2013

The California stem cell agency will
provide a live audiocast of next week's critical discussions of
action on the sweeping recommendations proposed for the agency by the
Institute of Medicine.

Instructions for hooking into the
telephonic arrangement can be found on the agendas for Wednesday and
Thursday. Also expected to be posted soon on the Wednesday agenda are
recommendations by CIRM Chairman J.T. Thomas.

The audiocast will only provide the
opportunity to listen and no opportunity to provide testimony. If you
are interesting in making suggestions or comments ahead of the
meeting, email them to info@cirm.ca.gov. The public can also testify at the board meeting.

The meeting is scheduled for the
Claremont Hotel in the Berkeley hills across the bay from CIRM's San
Francisco headquarters.

Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/XiZzHp3Zp_s/live-audiocast-available-for-next-weeks.html

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California Stem Cell Face-Off: CIRM Directors Wrestle with Tough IOM Recommendations

♫ Sunday, January 20th, 2013

Two days next week at the posh
Claremont Hotel in the Berkeley hills could settle the fate of
California's $3 billion stem cell agency.

At 9 a.m. next Wednesday, the governing
board of the state research effort will begin a critical, two-day
public session. On the table will be the $700,000, blue-ribbon
report from the prestigious Institute of Medicine (IOM). The study
recommends sweeping changes in the structure and operations of the
California Institute of Regenerative Medicine (CIRM), as the stem
cell agency is formally known.

The IOM report alone poses major
challenges for the agency. But the recommendations are freighted with
even more significance. Below the surface lies the hard fact of
CIRM's dwindling resources and possible demise. In less than four
years – without either renewed public support or private
contributions – the research effort will begin a shriveling,
downward spiral.

Claremont Hotel

The IOM report places a special burden
on the agency governing board. The board paid the IOM to evaluate its
performance. In 2010, then CIRM Chairman Robert Klein trumpeted the
value of an IOM study, saying it would serve as a springboard for a
new, multibillion-dollar state bond measure for the agency(see here and here). Given the
state's difficult financial condition – not to mention the position
of potential private sector investors – winning approval of that
kind of investment will be more than difficult.

California's major newspapers already have editorially backed the IOM proposals. Indeed, if the
directors choose to ignore the major IOM recommendations, they will
hand opponents a devastating weapon, one that could be used to convince voters to reject
any proposal for continued funding. The board
would also give private investors more major reasons to say no to
CIRM pitches for cash.

Under Klein's leadership, the 29-member
board has rejected similar proposals for changes in the past. When
the IOM presented the study to the board just last month, the
reception was not much different. Several board members bristled. One
influential board member, Sherry Lansing, chair of the University of
California board of regents, said the directors' “hands are tied”
because some of the recommendations might require a vote of the people. Her comments echoed similar statements from Klein in 2009,
when he said board members would violate their oath of office if they
supported recommendations for changes that he opposed.

The IOM discussion in December,
however, was relatively brief and less than definitive. Klein has
been off the board since June 2011, replaced by Los Angeles bond
financier Jonathan Thomas, who is regarded as a welcome change by a
number of board members.

Nonetheless, the recommendations of the IOM could mean that some members of the board would lose their seats; others would lose important roles in the grant-award process or
within the agency itself. Conflict of interest rules would be
tightened. In some ways, the board would lose power, which would be
shifted to the president. The board would no longer vote on
individual applications – only a slate recommended by reviewers.
Applicants for CIRM awards would be directly affected, being barred
from making the sort of direct and public appeals that clogged the
CIRM board meetings last year. And that would be just the beginning.

Thomas, the CIRM chairman, is expected
to make his recommendations for action on the report, although they
have not yet been posted on the CIRM web site. Under what might be considered “normal” leadership, Thomas would be testing sentiment
among board members via personal conversations and phone calls.
However, in California that would be illegal – a violation of open
meeting laws that bar what are called “serial meetings” at nearly
all public agencies.

Thomas' task is not easy. Rounding up a
majority vote for anything significant among 29 strong-minded
individuals is not simple. But it is even more difficult when facing
a board that has a tradition of consensus management and
oversight.

The site of next week's meetings is
interesting. The nearly 100-year-old, iconic Claremont hotel has a
troubled financial history. It was up for sale for $80 million last
spring but there were no takers. In the early 20th century, the
property on which it is located was lost and won in a checkers game
in Oakland, or so the story goes.

The stakes are also high for the
California stem cell agency. Moves next week by directors could
easily determine whether CIRM becomes nothing more than an
interesting scientific footnote or establishes a path that will lead
it to long-lasting leadership in regenerative medicine.

Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/SS09uwQmVDQ/california-stem-cell-face-off-cirm.html

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Stem Cell Agency Chair Pressing for Consensus on IOM Recommendations

♫ Sunday, January 20th, 2013

The chairman of the $3 billion
California stem cell agency, Jonathan Thomas, yesterday outlined how
he intends to proceed next week when the agency's governing board
considers the far-reaching recommendations of a blue-ribbon Institute
of Medicine panel.

Writing on the agency's blog, Thomas
said,

“While some of the IOM’s
recommendations are administrative in nature and can be implemented,
others are much more complex and would require changes in (governing)
board policy or legislative changes.”

Jonathan Thomas, chairman of CIRM governing board at far right. Art
Torres (center), co-vice chair and former state Democratic party chairman,
who would play key role in dealing with lawmakers. Robert Klein is at the
left in this 2011 meeting, Klein's last as chairman of the agency and the one
in which Thomas was elected chairman.

He continued,

“My goal is to strive to reach
consensus on a course of action on the 23rd. However, if the board
isn’t able to choose a course of action at this time we will
continue the conversation and bring it up at future board meetings
until we reach agreement.”

It is worth noting that Thomas did not
mention the possibility of having to ask the people of California to
amend the state constitution, which would require a statewide election. Opponents to change at the agency have
used that possibility to discourage action. (See here and here.) An
election would be costly, politically difficult and could open the
door to additional unwelcome changes at the eight-year-old research
enterprise.

Thomas' desire for a consensus among
the 29 board members – instead of a simple majority – could be a
stumbling block as the board becomes snarled internally, perhaps for
months or more. The board normally meets only about once a month and
has a full slate of regular business on those occasions. The agency
will run out of money for new grants in less than four years, and
action on the IOM recommendations seems a necessary prelude to
winning continued financial support.

While four years would appear to an ample
period of time, making the sort of changes the IOM recommends would
require legislative action, which probably would take a minimum of a
year. Timing is important as well. The current leaders in the state
Senate and Assembly will be termed out in 2014. Starting all over
with novice leadership, changes in key committee chairmanships and so
forth would make the task even more difficult. Then there is the need
to address strategies for continued financial support. Should the
agency seek a new statewide bond measure (the current funding
mechanism)? If so campaign committees need to be formed, electoral
strategies planned and tested and tens of millions of dollars raised
for campaign expenses. If private funds instead are to be raised to
the tune of hundreds of millions of dollars(the agency spends about
$300 million a year), such an effort would also require considerable time.
To keep the funding pipeline full, all of this should be completed
well before the money runs out in 2017.

Dilly-dallying this year in drawn-out, fruitless debate over
the IOM proposals would be an unfortunate beginning should CIRM
directors actually want to continue the existence of the
organization.

In his blog item, Thomas sounded this
final note.

“It’s likely the debate will be
passionate – everyone involved in this work cares deeply about it –
and there will undoubtedly be disagreements, but ultimately we all
share the same goal, a desire to make sure that whatever we decide
helps make the stem cell agency even stronger and more effective, and
is in the best interests of the people of California.”

Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/xriRP02aekU/stem-cell-agency-chair-pressing-for.html

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StemCells, Inc., Still Looking for $40 Million from California Stem Cell Agency

♫ Sunday, January 20th, 2013

Remember StemCells, Inc., and the $40
million it was awarded by the California stem cell agency.

The Newark, Ca., firm, founded by
eminent Stanford researcher Irv Weissman, received an award of $20
million last July and then again in September. Nearly five months
later, however, the stem cell agency has yet to cut a check for the
company, a spokesman for the agency told the California Stem Cell
Report in response to a query.

The hang-up is the $40 million in
matching funds that the company promised the agency. The stem cell
agency has yet to be satisfied that StemCells, Inc., can actually
produce the match, although the spokesman did not offer details.

The StemCells, Inc., awards were
unusual in a number of ways. It was the first time that former CIRM
Chairman Robert Klein lobbied the CIRM governing board on behalf of a
company(see here and here). It was the first time that the governing
board approved an application that had been rejected twice by grant
reviewers. It was the first time that the board said explicitly in a
public session that it wanted proof of the matching funds as a
condition of the award.

It was the first time that a CIRM award
to a company received a careful and critical scrutiny from a major
California newspaper. Michael Hiltzik, a Pulitzer Prize-winning
business columnist and author, wrote in October in the Los Angeles
Times that the award was “redolent of cronyism.” He referred
particularly to longstanding ties between Klein and Weissman.

The CIRM board vote on the StemCells,
Inc., grant in September was 7-5, which amounted to 12 out of 29
members of the board.

In December, a blue-ribbon panel of the
Institute of Medicine (IOM) recommended that the agency tighten its
conflict of interest standards to avoid such perceptions as have been
generated by the StemCells, Inc., awards. The IOM said,

“(C)ompeting personal and
professional interests compromise the perceived independence of
the (governing board), introduce potential bias into the board’s decision
making, and threaten to undermine confidence in the board.”

Concerns about conflicts of interest have long been of concern to observers of the stem cell agency for years. Indeed, the prestigious journal Nature in 2008 warned of "cronyism" at the $3 billion research enterprise.

Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/5BdZ8FguJp8/stemcells-inc-still-looking-for-40.html

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UC Davis Stem Cell Researcher: ‘Ivory Tower’ IOM Recommendations Harmful to California Stem Cell Agency

♫ Sunday, January 20th, 2013

The $3 billion California stem cell
agency has funded in the neighborhood of 500 to 600 scientists and
institutions, reviving and starting careers and stimulating
construction of $1 billion in new research labs around the state.

None of those recipients, as far as we
know, has come forward to comment publicly on the sweeping recommendations by Institute of Medicine for changes at the agency.
Until today, that is.

UC Davis researcher Paul Knoepfler, who
may be the only stem cell scientist in the United States with a stem
cell blog, weighed in with his thoughts today, which do not align
with those of the blue-ribbon IOM panel.

“Harmful” is one word that Knoepfler, who is a stem cell agency grant recipient, used to describe the recommendations. He predicted “extremely negative repercussions” that “would
actually make CIRM less effective and less responsive to patients and
California citizens.”

He wrote that the IOM report, which
will come before stem cell agency governing board next week “...seems more like an ivory tower
intellectual exercise than an operative, realistic guide to a dynamic
agency that must operate in the real world.”

He defended the CIRM governing board,
which came under fire from the IOM for conflicts of interest.
Institutions linked to board members have received about 90 percent
of the $1.7 billion that the board has awarded, according to compilations by the California Stem Cell Report. The IOM said,

“Far too many board members
represent organizations that receive CIRM funding or benefit from
that funding. These competing personal and professional
interests compromise the perceived independence of the ICOC,
introduce potential bias into the board’s decision making, and
threaten to undermine confidence in the board."

Knoepfler said,

“(The) IOM itself admits there is no
evidence that any conflicts of interest have ever guided (the agency's governing board) decisions. Not one example.”

Knoepfler also wrote,

“Interestingly, highlighting the
extremely sensitive nature of this issue, while I’ve been talking
with many bigwigs about this, at this point no one is wiling to go on
the record with an opinion about it except one courageous soul, Don
Reed (see
his piece here).”

There is a reason for that. The IOM is the most prestigious organization of its sort. Its studies are
described as the gold standard. And it has a rareified membership
that many scientists seek to join. So few are ready to give the
organization a smack on the nose. Likewise, California researchers
are loath to publicly criticize the stem cell agency because it
holds the strings to the purse that finances their careers.

California scientists, however, should
be asking themselves a bottom-line question. Do they want to see the
stem cell agency continue for another 10 to 20 years? Under the best
of circumstances, that may be unlikely given the other pressing needs
that the state faces. But if CIRM directors do not forthrightly
address the recommendations of the IOM panel, the fate of the stem
cell agency is exceedingly uncertain.

Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/pW_1A2nkyrM/uc-davis-stem-cell-researcher-ivory.html

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Patient Advocate Says IOM Recommendations Would ‘Destroy’ California Stem Cell Agency

♫ Sunday, January 20th, 2013

California's “beloved,” $3 billion
stem cell research program should not be altered despite
recommendations from the most prestigious scientific organization of
its kind. So says longtime patient advocate Don Reed of Fremont, Ca.

Reed says the recommendations by the
Institute of Medicine (IOM) are a “threat” that would “destroy” an
agency that “is like nothing else on earth.” Reed is urging other
patient advocates to turn out at next week's critical meeting of the stem cell agency's board and lobby against alterations in how it does
business.

Reed and CIRM's Amy Adams
World Stem Cell Summit photo

Reed is a fixture in stem cell circles
nationally and in California and has been a regular at the stem cell
agency's public meetings since 2004. He is also vice president of
Americans for Cures, a private stem cell lobbying group created by
Robert Klein when he was chairman of the stem cell agency, formally known as the California Institute for Regenerative
Medicine(CIRM).

Reed has written twice about the IOM
report on his blog with duplicate publication on the Huffington Post.
Yesterday, he said IOM “defies” the voters' will when they
created the stem cell agency in 2004. On Dec. 19, he said the
$700,000, 17-month study was “staggeringly misguided.” He wrote,

“If its recommendations were enacted,
they would silence stem cell patient advocate involvement, eliminate
public debate on funding proposals, and delegate the real decisions
to secret proceedings by an out-of-state-controlled board.”

Reed described the stem cell agency as
“fantastic” and wrote,

“So why mess with it, in such a
brutal and insulting manner?”

This writer has known Reed since the
early days of the stem cell agency and respects him. But in this
case he has many of his facts wrong. To mention just a few key
points: Patient advocates would not be silenced; their role would be
changed. Public comment would not be eliminated. Scientists could
still appeal negative decisions by reviewers to the full board if
they so choose, although the “extraordinary petition” process
would be eliminated. The voters' will would not be defied; they provided for a mechanism for making changes in the stem cell program.

While Bob Klein has not been heard from
publicly on the IOM report, some of Reed's comments reflect Klein's
past positions against altering the agency. Klein, an attorney and
real estate investment banker, might well be considered the father of
the agency. He directed the writing of the 10,000-word measure, Prop. 71, that created the program and wrote much of ballot initiative himself. The initiative contained a detailed description of the
qualifications for the chairman, which fit only one person in
California. It was no surprise when he won the post.

In years past, Klein has been extraordinarily protective of the ballot measure, at one point boxing
in the board on earlier proposals for changes that he disliked and that the IOM report now echoes.

In 2010, he was the prime
advocate for commissioning the IOM report which he expected
to serve as the basis for continued funding of the agency. It will
run out of cash for new grants in 2017.

To keep the money rolling in, Klein
said the IOM report would constitute a “gold standard” that would
generate increased enthusiasm for the research.

According to the transcript of the Aug.18, 2010, governing board meeting, Klein declared,

“(We will) never convince the people
that are adamant against us. But for the public and for the
constituent groups that are reasoned and prepared to look at
evidence, this is a very important validation that they can look to
to separate out what is a false claim from real performance.”

Also writing yesterday about the IOM
study was Bradley Fikes of the San Diego U-T, the dominant daily
newspaper in that area.

He summarized Reed's latest item as well as this on the California Stem Cell Report yesterday. Fikes
plans to file his own story within the next few days.

Feel free to file your own comments by
clicking on the word “comment” below or with the stem cell agency
at info@cirm.ca.gov. Anonymous
comments are permitted on this blog.

Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/wX7BEi46lc8/patient-advocate-says-iom.html

♫ Posted in Stem Cell Therapy, Stem Cells | | Comments Off»

Live Audiocast Available for Next Week’s CIRM-IOM Meetings

♫ Sunday, January 20th, 2013

The California stem cell agency will
provide a live audiocast of next week's critical discussions of
action on the sweeping recommendations proposed for the agency by the
Institute of Medicine.

Instructions for hooking into the
telephonic arrangement can be found on the agendas for Wednesday and
Thursday. Also expected to be posted soon on the Wednesday agenda are
recommendations by CIRM Chairman J.T. Thomas.

The audiocast will only provide the
opportunity to listen and no opportunity to provide testimony. If you
are interesting in making suggestions or comments ahead of the
meeting, email them to info@cirm.ca.gov. The public can also testify at the board meeting.

The meeting is scheduled for the
Claremont Hotel in the Berkeley hills across the bay from CIRM's San
Francisco headquarters.

Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/XiZzHp3Zp_s/live-audiocast-available-for-next-weeks.html

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California Stem Cell Face-Off: CIRM Directors Wrestle with Tough IOM Recommendations

♫ Sunday, January 20th, 2013

Two days next week at the posh
Claremont Hotel in the Berkeley hills could settle the fate of
California's $3 billion stem cell agency.

At 9 a.m. next Wednesday, the governing
board of the state research effort will begin a critical, two-day
public session. On the table will be the $700,000, blue-ribbon
report from the prestigious Institute of Medicine (IOM). The study
recommends sweeping changes in the structure and operations of the
California Institute of Regenerative Medicine (CIRM), as the stem
cell agency is formally known.

The IOM report alone poses major
challenges for the agency. But the recommendations are freighted with
even more significance. Below the surface lies the hard fact of
CIRM's dwindling resources and possible demise. In less than four
years – without either renewed public support or private
contributions – the research effort will begin a shriveling,
downward spiral.