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Category Archives: Stem Cells

CIRM Board Member Prieto Critiques the IOM Stem Cell Report

Posted: February 10, 2013 at 4:13 pm

Francisco Prieto, a member of the
governing board of the $3 billion California stem cell agency, is
expressing some additional dissatisfaction with the blue-ribbon
Institute of Medicine (IOM) report for which the agency paid $700,000.

The report recommended sweeping changes
at the agency, including creation of a new majority of independent
members on the board. The IOM cited problems arising from the
built-in conflicts of interest on the board that were created by
Proposition 71, which created in the agency in 2004. Prieto's email refers to Bob Klein, who is a real estate investor and attorney. Klein
oversaw the drafting of the 10,000-word ballot measure(writing much
of it himself), ran its $35 million ballot campaign and became the
first chairman of the agency. The qualifications for chairman were written into the proposition and seemed to uniquely apply to Klein.  Prieto is a Sacramento physician who
was appointed to the board as patient advocate.
.Here is the text of Prieto's comments.
His earlier comments can be found here.

“A few more words on independence,
and the IOM.  I think Bob Klein drafted the proposition (and
remember, all of this was spelled out there – readily available to
the voters and whatever news sources they were depending on for
information) deliberately to engage patient advocates. I think  he
knew that those of us who have been active in disease advocacy have a
passion around the issue of advancing research that someone without
that background would be unlikely to have. I’m not sure exactly
what the IOM had in mind when they called for more 'independent'
members of the board, since they very unfortunately did not bother to
interview the patient advocates on the ICOC(the governing board). I
don’t know what their reason for this was, if there was one, but
they only circulated a (in my view) frankly inadequate questionnaire,
and interviewed a small handful of people. I think this was a major
flaw in their process and gave them a very limited view of our role.
It is hard for me to imagine who they might have in mind, if not
people who had been involved with some existing advocacy
organization. I think there are very few if any patient advocates who
aren’t working with some group – the only ones I might imagine
would be some independently wealthy person able to start a foundation
or research institute on their own.  With all due respect to
Bill Gates and the great work his foundation is doing with malaria
and HIV, I have written before that I think it would be absolutely
wrong and anti-democratic to create any public board or commission
that only millionaires could sit on.”

An anonymous comment was also posted
concerning the IOM report and conflicts of interest. It dealt briefly
with the issue and difficulty of managing conflicts. The comment can be found at the end of this item.

Source:
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Stem Cell Agency Board Member Defends Independence of Many on Board

Posted: February 10, 2013 at 3:06 am

A member of the governing board of the
California stem cell agency is taking exception to a statement on the
California Stem Cell Report that no independent members sit on that
body.

Francisco Prieto, a Sacramento
physician and a patient advocate member of the board, referred to the
“ethical minefield” item Feb. 5, 2013. Here is the text of what
Prieto wrote,

“I have to object to this line: 'None
of the current members are independent. The ballot measure that
created the agency required board members to be appointed from
various constituencies.' 

“I think I am absolutely independent,
and I think the same applies at the very least to most if not all of
my fellow patient advocates, and probably to the biotech
representatives as well – remember that they all must come from
companies that are not involved in stem cell research.  Although
I supported the proposition, I was not involved directly in the
campaign in any way, and I did not meet Bob Klein (the first chairman of the stem cell board) or any of my fellow
board members until the day I was sworn in at our first meeting.

“The Prop. 71 language I believe
specifies that advocates must have a record of advocating for people
with the disease or diseases they represent, and not that they belong
to or work for any specific organization.  Checking my binder,
it refers to 'groups' but does not specify those – for example, it
refers to 'representative of a California regional, state or national
HIV/AIDS disease advocacy group.' I’m not sure how you would
define 'independent' but I certainly don’t think it means
'disinterested.'”

Our take: The Institute of Medicine(IOM) called for a new majority of what it described as independent
members, obviously not finding sufficient, if any, independent
members on the agency board. The IOM, the most prestigious organization of
its kind in the country, said changes were needed because of damaging
conflict of interest issues at the stem cell agency.
Prop. 71, which created the stem cell
agency in 2004, was carefully crafted to avoid the use of the word
“independent” when describing the necessary qualifications for a
board member.
 Instead the measure required that, in some cases, they
must come from very specific education institutions. (You can find the CIRM summary of all qualifications within this document.) In other cases, the speaker of the
state Assembly appoints “one representative of a California
regional, state, or national mental health disease advocacy group.”
The leader of the state Senate appoints “one representative of a
California regional, state, or national HIV/AIDS disease advocacy
group. “ Four other statewide elected officials appoint an
executive from a “California life science commercial entity.”
Prieto is correct when he says he
believes he is “absolutely independent.” But he fills a category
that represents a special constituency. What is missing from the
board is anyone who does not come from one special constituency or
another. The board was constructed in that manner to make sure it
would win the broadest measure of support from all the various major
constituencies by guaranteeing them a seat at the table where the
money is handed out.  Ironically, the full formal name of the CIRM governing board is the "Independent Citizens Oversight Committee," a piece of political legerdemain to mask the actual nature of who would sit on the board. 

Source:
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Riverside Newspaper: ‘Ethical Minefield’ Still Not Cleared at Stem Cell Agency

Posted: February 10, 2013 at 3:06 am

The California stem cell agency's
attempts to deal with the conflict of interest problems at the $3
billion research program amount to a minor fix that is not a “serious solution,” the Riverside Press-Enterprise editorialized yesterday.

The editorial came as the agency
launches a road trip campaign to convince newspaper editorial boards around
the state that the agency is worthy of continued financial support.
The agency will run out of money for new grants in less than four
years.
The Riverside editorial pointed to the blue-ribbon Institute of Medicine report in December that called for creation of a
new, independent majority on the 29-member board. None of the current
members are independent. The ballot measure that created the
agency required board members to be appointed from various
constituencies.
The newspaper said,

“That arrangement is hardly a model
of objective decision making. The agency so far has distributed about
$1.7 billion in grants, with about 90 percent of that money going to
institutions represented on the governing board. 

“Voluntary abstentions are not a
serious solution to that ethical minefield. Nor would that approach
eliminate potential conflicts, because the agency would still allow
the abstaining members to take part in the discussions and debate
about who should get the grants. 

“The Institute of Medicine instead
recommended remaking the board with truly independent members who
have no stake in grant awards. The stem-cell agency rejected that
step because it would require changing Prop. 71, either through a
super-majority in the Legislature or another ballot measure. That
excuse should be a vivid warning to Californians about the dangers of
passing complex, costly and inflexible initiatives. 

“Agencies handling billions of
taxpayers’ dollars should not avoid good government practice or
basic fiscal safeguards. The stem-cell institute offers minor fixes
when it needs substantial changes — and legislators should not
accept that cavalier approach.”

Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/VQ9QZ0E814c/riverside-newspaper-ethical-minefield.html

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Debunking California Stem Cell Agency Claims of ‘No Actual Conflicts’

Posted: February 10, 2013 at 3:06 am

In the wake of recent considerable
criticism concerning conflicts of interest at the $3 billion California stem
cell agency, its leaders have taken to saying “no actual conflicts”
have been found at the agency.

That assertion is simply not true.
Nonetheless, the statement has been
repeated in some news stories, published in at least one agency press
release and peddled by stem cell advocates and some members of the
governing board of the California Institute for Regenerative Medicine
(CIRM), as the agency is formally known.
The reason? Conflicts of interest were
cited prominently as a major problem at CIRM by the blue-ribbon
Institute of Medicine (IOM) report. In December, the IOM recommended that a new majority of independent members be created on the stem
cell agency's governing board. The existing stem cell board has
ignored that recommendation and wants to settle for something considerably less as it tries to find a way to build support for
continued financing of its efforts.
The facts are that the agency has a
long history of problems involving conflicts of interest, “actual”
and otherwise. Here is a rundown on what has been reported on the
California Stem Cell Report.
In 2009, board member John Reed, then
CEO of the Sanford-Burnham Institute, was warned by the state's Fair Political Practices Commission about his violation of conflict of interest rules. Reed's intervention on behalf of a grant was made at the suggestion of then CIRM Chairman Robert Klein, an attorney who
led the drafting of Proposition 71, the ballot initiative that created the stem cell
agency in 2004.
In 2007, other violations involving five board members resulted in voiding applications from 10
researchers seeking $31 million. And then the agency shamefully scapegoated employees for the problem.
In 2011, the chairman of the CIRM grant review group resigned from his position as the result of another
violation, which the agency felt necessary to report to the
California legislature.
In 2009, then board member Ted Love,
who has deep connections to the biomedical industry, served as the
agency's interim chief scientific officer and helped to develop the agency's first, signature $225 million disease team round while also
serving on the CIRM board. As chief scientific officer, Love
presumably would have had access to proprietary information and trade
secrets contained in grant applications. In 2009, in response to
questions from the California Stem Cell Report, the agency said that Love would only serve as a part-time adviser to the agency president, not as chief scientific officer. Nonetheless, in 2012, the board
passed a resolution with high praise for Love and his performance as the chief scientific officer.
Since 2010, a stem cell firm, iPierian,Inc., whose major investors contributed nearly $6 million to the ballot measure that created the stem cell agency, has received $7.1
million in awards from the agency. The contributions were 25 percent
of the total in the campaign, which was headed by Klein.
Another firm, StemCells, Inc., last
fall was awarded $40 million by the CIRM board despite having one of
its $20 million applications rejected twice by grant reviewers. The
action came after the board was vigorously lobbied by former Chairman
Klein. Researcher Irv Weissman of Stanford, who founded StemCells, Inc., and
is on its board, was featured in a TV campaign ad for Proposition 71 and helped to raise millions for the ballot campaign. 
In 2008, public complaints by one
applicant from industry about conflicts of interest on the part of a
reviewer were brushed off by Klein. He told the applicant the board needed to discuss naming CIRM-funded labs and then go to lunch. 
The agency has hired at least two
industry consultants in positions that raise conflict of interest
problems, in 2010 and again in 2012.
Sometimes groups expect to see
increased funding as the result of the appointment of sympathetic
individuals to the board. That occurred last fall when Diane Winokur
was appointed. The chief scientist for The ALS Association, said
Winokur will be “a tremendous asset in moving the ALS research field forward through CIRM funding."
The conflict issue even surfaces in picayune ways. In 2006, board members from various institutions spent
considerable time debating a minor requirement involving press
releases. They were concerned that the proposal would make their
institutions subordinate to the interests of CIRM. At the end of the
discussion, the institutional directors prevailed and kept their PR
departments from having to notify CIRM about press releases dealing
with the hundreds of millions of dollars in state grants that they
receive.
All this, and yet on Jan. 24, 2013,
CIRM Chairman Jonathan Thomas was quoted in a CIRM press release as
saying “no one has found any actual conflicts” at the
agency.
In the media, some of the recent news
stories have reported that the IOM did not find any “actual”
conflicts at the agency. The explanation for that is simple, but
mainly omitted from the articles. The IOM did not look for any
conflicts of “inappropriate behavior,” as its report clearly
states. The California Stem Cell Report last weekend asked the
chairman of the IOM panel, Harold Shapiro, why it did not look for
conflicts. He replied,

“Our committee was given a set of
defined tasks from the IOM(which was under a $700,000 contract with
CIRM), and we followed them."

Nonetheless, the IOM report said “far
too many” board members are linked to institutions that receive
funds from CIRM. A compilation by the California Stem Cell Report
shows that about 90 percent of the $1.7 billion that the board has
awarded has gone to institutions linked to past and present board
members.
The fundamental conflict problem with
the CIRM board is that nearly all the California institutions that stood to
benefit from the agency's largess were given seats at the table where the
money is handed out, under the terms of Proposition 71.
Conflict problems are not unique to
CIRM and government agencies. They are also a matter of concern at
nonprofit, grant-making foundations, which in some ways CIRM
resembles.
The Council on Foundations, a
national nonprofit association of more than 1,700 grant-making
organizations, takes pains on its web site to explain the
importance of managing and avoiding conflicts of interests. In its advice to its members, the group makes it clear that the issue goes
well beyond simple financial conflicts. It says,

“(Board) members must represent
unconflicted loyalty to the interest of the foundation. This
accountability supersedes any conflicting loyalty such as that to
advocacy or interest groups, business interests, personal interests or paid or volunteer service
to other organizations.”

In the case of the stem cell agency,
the “unconflicted loyalty” is to the people of California. Perhaps the California stem cell agency
can convince state leaders, both public and private, and its voters
that no conflicts exist at the state agency. But it is a big bet and
probably carries with it the entire future of what the board and many
believe is an exceedingly promising scientific effort.
Perhaps it would be wise for the board
to step back and say, “Yes, there are serious conflict problems at
CIRM. We recognize that and are working on additional measures to
create an independent board as recommended by the IOM.”

Source:
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MS treatment: Clinical trials due as human stem cells research shows promise

Posted: February 10, 2013 at 1:48 am

The first clinical trials of a revolutionary approach to treating multiple sclerosis with stem cells derived from the patients own skin could begin soon following research showing that it works well on laboratory mice, scientists said.

A study has for the first time found that human skin cells converted into stem cells can be used to treat laboratory mice with a condition similar to multiple-sclerosis, where the fatty covering surrounding the nerves is lost.

Scientists in the US said initial clinical trials on human patients using a similar approach could begin in 2015, with full-scale studies soon after. The skin cells were first genetically engineered to become induced pluripotent stem cells (iPS) before being converted to the specialised cells that make the fatty myelin sheaths, which insulate nerve cells in a similar way to the plastic covering of an electrical wire. The myelin is gradually degraded in MS patients.

Scientists were able to turn the iPS cells into oligodendrocyte progenitor cells which were injected into the mice. These progenitor cells went on to become fully specialised oligodendrocytes, the cells responsible for making the myelin sheath.

The new population of oligodendrocyte progenitor cells and oligodendrocytes was dense, abundant and complete. In fact, they re-myelination process appeared more rapid and efficient than with other cell sources, said neurologist Steven Goldman of Rochester University Medical Centre in New York. Induced pluripotent stem cells are created by adding several genes to ordinary skin cells. This has the effect of reprogramming them back to an earlier, embryonic-like state, but has the ethical advantage over true embyronic stem cells in that they do not require the creation of human embryos.

Clinical trials of human induced pluripotent stem cells on MS patients are being funded by an organisation called New York State Stem Cell Science, which has already approved initial trials using stem cells, which are due to begin within two years.

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MS treatment: Clinical trials due as human stem cells research shows promise

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Plastic and stem cells heal broken bones

Posted: February 10, 2013 at 1:48 am

The use of bone stem cells combined with a degradable rigid material inserted into shattered bones can encourage real bone to re-grow, they found.

Researchers developed the material with a honeycomb scaffold structure to allow blood to flow through it, enabling stem cells from the patient's bone marrow to attach to it.

Over time, the plastic slowly degrades as the implant is replaced by newly grown bone.

The development was made by teams based at the universities of Edinburgh and Southampton, with the focus now moving towards human clinical evaluation after successful results in animal testing.

The discovery is the result of a seven-year partnership between the two universities.

Scientists blended three types of plastic together after testing hundreds of combinations to develop a surface that was robust, lightweight and able to support bone stem cells.

Professor Mark Bradley, of the University of Edinburgh's school of chemistry, said: "We were able to make and look at hundreds of candidate materials and rapidly whittle these down to one which is strong enough to replace bone and is also a suitable surface upon which to grow bone.

"We are confident that this material could soon be helping to improve the quality of life for patients with severe bone injuries, and will help maintain the health of an ageing population."

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GGN: Record Snow Hits Russia, 3-D Printed Stem Cells?, Paris Pants Ban Dropped – Video

Posted: February 8, 2013 at 3:48 pm


GGN: Record Snow Hits Russia, 3-D Printed Stem Cells?, Paris Pants Ban Dropped
Part Three (3) PLEASE SUBSCRIBE Please visit: http://www.ggnonline.com or http for the latest news commentary by Global Government News DONATIONS WELCOME Visit http://www.ggnonline.com to make a PayPal donation because it would be greatly appreciated. Thank you. -Darko HEADLINES WITH LINKS #39;Historic #39; Snow Storm Looms for New England bit.ly Heaviest Snowfall in a Century Hits Moscow bit.ly Anti-snow chemicals used in Moscow take 1.3bn years to dissolve -- report bit.ly Thousands of dead herring wash up in Iceland bit.ly 2 Great Lakes Hit Record Lows on Water Level bit.ly What Punched a Hole in these Clouds? (HAARP?) wxch.nl What to Do with Thousands of Tons of Radioactive Scrap Metal? Recycle It Into Consumer Goods bit.ly KFC hit by chicken chem food scare bit.ly Food Manufacturers are Fraudulently Diluting High-Quality Food with Inferior Quality Junk bit.ly Safety Group Blows Lid on #39;Secret Virus #39; Hidden in GMO Crops bit.ly Nearly Half of All US Farms Now Have Superweeds bit.ly Widow of 81 starved to death after council forgot about her for nine days: It did nothing when care agency was shut by police bit.ly Meet the #39;Stay-at-Home Dude #39; bit.ly New Research Indicates Doing Household Chores May Turn Men Gay bit.ly The power of TV: watching 20 hours a week halves sperm count, according to new study ind.pn Married men and women far less likely to suffer heart attack: study bit.ly 3D-Printed Human Embryonic Stem Cells Created for First Time yhoo.it North Dakota Senate passes personhood ...

By: DDarko2013

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GGN: Record Snow Hits Russia, 3-D Printed Stem Cells?, Paris Pants Ban Dropped - Video

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Stem cells beauty by Dr. Diaz on “Kumustahan Live” – Video

Posted: February 8, 2013 at 3:48 pm


Stem cells beauty by Dr. Diaz on "Kumustahan Live"

By: nolidpogi2

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Stem cells beauty by Dr. Diaz on "Kumustahan Live" - Video

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Researchers look at stem cells for burn victim skin repair

Posted: February 8, 2013 at 3:48 pm

Researchers at the University of Calgary are hoping skin stem cells will improve skin grafts for burn victims.

The project is focused on people who require skin grafts after a deep burn injury where many layers of skin have been destroyed.

Right now, doctors only use the outer layers, or epidermis, to repair the wound, but those layers lack some important functions found in deeper skin, or dermis.

"The dermis is important because that's where all the nerve endings, the hair follicles, the oil glands and sweat glands are," said Dr. Vincent Gabriel.

Don Adamson required 15 surgeries to repair his skin after his gas tank exploded while he was driving home.

Adamson says he found the new skin simply did not work the same way after the skin grafts.

"I noticed [the] first time I went out and tried to shovel snow I nearly froze my hands and I didn't know it," said Adamson.

Dr. Jeff Biernaskie says this project will try to recreate normal skin.

"It may be possible to generate dermal stem cells from the patient and actually transplant them into the skin graft in order to regenerate the dermis and improve the overall function of that grafted skin."

Researchers estimate about 1,500 skin grafts are performed in Alberta each year.

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Researchers look at stem cells for burn victim skin repair

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RNL BIO filed Phase II/III Clinical Trial with KFDA to Treat Cerebral Palsy Using Autologous Fat Derived Stem Cells

Posted: February 8, 2013 at 3:48 pm

SEOUL, South Korea, Feb. 8, 2013 /PRNewswire/ -- RNL BIO CO LTD (RNL) announced today the filing of an Investigational New Drug (IND) application with the Korean Food and Drug Administration (KFDA) to initiate clinical trials phase II and III assessing the company's RNL-Astrostem stem cell drug in patients with cerebral palsy. The purpose of this study is to assess conclusive efficacy of stem cells for the treatment of cerebral palsy in 45 subjects over 11 months. The study is to be conducted through Kyung Hee University Hospital at Gangdong and THE Bethesda Hospital.

RNL-Astrostem, has already completed a phase I trial to assure safety, including tests to rule out toxicity or tumorigenicity. This trial was conducted at the Seoul National University's Clinical Research Institute. In addition, thephase I study has confirmed the safety of stem cells infused by IV, as published in a leading peer-reviewed journal, Stem Cells and Development ("Safety of intravenous infusion of human adipose tissue-derived mesenchymal stem cells in animals and humans," February 2011). In the course of successful safety trials, scientists found significant evidence suggesting the potential for efficacy of stem cells in treatment of cerebral palsy. In addition, a case report with obvious result of improvement was published in another internationally renowned journal. RNL BIO believes that with successful trials and approval of the KFDA, it will be possible to commercialize RNL-Astrostem by 2014, revolutionizing the possibility to cure this incurable disease of children, which can only be managed with current technologies.

Cerebral Palsy is caused by non-progressive brain damage from single or multiple defect(s) on thenerve/muscular system and results in disorder in motion and sensory integration. According to Health Insurance Review and Assessment Service, the prevalence of cerebral palsy is 3.5 per 1000 male to 2.8 per 1000 female children, averaged at 3.2 per 1000 children, which is expected to increase due to reduction of premature death.

In the clinical study investigators employ a variety of methods to assess efficacy: K-ABC: Kaufman Assessment Battery for Children, Gross Motor Function Measure, (GMFM), box and block test, Modified Asworth Scale, MAS, finger tapping test, Brain SPECT and MRI.

Dr. JC Ra, president of RNL BIO Stem Cell Technology Institute, said, "It is our mission to find cures for incurable diseases, such as the terrible pediatric curse of cerebral palsy, through autologous stem cell technology."

About RNL BIO

RNL BIO is a premier biotechnology company focused on the research and development of adult derived stem cell technologies. RNL has completed one phase I trial for spinal cord injury and one Phase II clinical trial for Osteoarthritis and is near to the completion of Buerger's Disease trial. RNL has been a supporter of UN Global Compact's free program to work with children who suffer from cerebral palsy, as major sponsor of the Bethesda Life Foundation. RNL is a publicly traded company on the Korean Stock Exchange (Code 003190) and is expanding its operations throughout the world.

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RNL BIO filed Phase II/III Clinical Trial with KFDA to Treat Cerebral Palsy Using Autologous Fat Derived Stem Cells

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