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Category Archives: Stem Cell Therapy

Purging Stem Cells To Make Therapy Safer

Posted: September 28, 2012 at 10:15 pm

Featured Article Academic Journal Main Category: Stem Cell Research Also Included In: Biology / Biochemistry Article Date: 28 Sep 2012 - 1:00 PDT

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The study appears in a 27 September issue of the journal Stem Cells Translational Medicine.

iPS cells have properties similar to embryonic stem cells, which are "master cells" with an unlimited capacity to differentiate into any type of tissue in the body, such as brain, lung, skin, heart, and liver. Thus their potential in regenerative medicine, where damaged or diseased tissue can be repaired or replaced by growing new tissue, is huge, as senior author Timothy Nelson explains in a press release:

"Pluripotent stem cells show great promise in the field of regenerative medicine; however, the risk of uncontrolled cell growth will continue to prevent their use as a therapeutic treatment."

Nelson is Assistant Professor of Medicine and Pharmacology and works in the General Internal Medicine department and the Transplant Center at the Mayo.

The idea of using iPS cells is for doctors to be able to take some adult tissue, for example skin cells, from the patient who needs the treatment, and then turn the cells from that tissue into iPS cells.

Then, those iPS cells are coaxed to turn into the target type of cell, for instance lung cells. As a result of the coaxing the iPS cells turn into (differentiate) the target tissue type.

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Stem cells revolutionizing veterinary medicine

Posted: September 25, 2012 at 6:15 am

(WGBA/NBC) - It is a story that gives hope to pet owners all over the country stem cell therapy for animals suffering from problems like arthritis or hip displaysia.

Stem cells are taken out of the dog's fatty tissue are harvested then injected into problem areas leaving the dogs completely healed.

"We couldn't take him on walks, he just laid around a lot," said Keith Nosowiak, Deniro's owner.

"We'd hear whimpering overnight, she'd take a few steps and she would sit down," said Luther Kortbein, Shadow's owner.

Until two months ago, Deniro suffered from severe arthritis, Shadow from hip displaysia.

Deniro's owner thought he may even have to put his German shepherd down.

"We felt we had a decision to make with his quality of life and being in pain we didn't want him to be in pain," Noskowiak said.

Shadow's owner was willing to try anything to cure her.

"Whatever the cost needed to get this done we were willing to do," Kortbein said.

Then Packerland Veterinary Center offered them stem cell therapy by using the dogs own stem cells and then injecting them back into the bloodstream joints.

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Reproducing Research Results: Removing a Scientific Roadblock

Posted: September 23, 2012 at 3:55 pm


The California stem cell agency faces
no easy task in trying to translate basic research findings into
something that can be used to treat patients and be sold commercially.

Even clinical trials, which only begin
long after the basic research is done and which involve more ordinary
therapeutic treatments than stem cells, fail at an astonishing rate.
Only one out of five that enter the clinical trial gauntlet
successfully finish the second stage, according to industry data
cited last spring by Pat Olson, executive director of scientific activities at the stem cell agency. And
then come even more challenges.
But at a much earlier stage of
research there is the “problem of irreproducible results,” in the
words of writer Monya Baker of the journal Nature. Baker last month reported on
moves by a firm called Science Exchange in Palo Alto, Ca., to
do something to ease the problem and speed up preclinical research.
The effort is called the Reproducibility Initiative and also involves
PLOS and figshare, an open science Internet project.
Elizabeth Iorns
Science Exchange Photo
Science Exchange is headed by Elizabeth
Iorns
, a scientist and co-founder of the firm. She wrote about  test-tube-to-clinic translation issues in a recent article in New
Scientist
that was headlined, “Is medical science built on shaky
foundations?”
Iorns said,

“One goal of scientific publication
is to share results in enough detail to allow other research teams to
reproduce them and build on them. However, many recent reports have
raised the alarm that a shocking amount of the published literature
in fields ranging from cancer biology to psychology is not
reproducible.”

Iorns cited studies in Nature that
reported that Bayer cannot “replicate about two-thirds of published
studies identifying possible drug targets” and that Amgen failed at
even a higher rate. It could not “replicate 47 of 53 highly
promising results they examined.”
The California Stem Cell Report earlier
this week asked Iorns for her thoughts on the implications for the
California stem cell agency, whose motto is "Turning stem cells into cures." Here is the full text of her response.

“First, I think it is important to
accept that there is a crisis affecting preclinical research. Recent
studies estimate that 70% of preclinical research cannot be
reproduced. This is the research that should form the foundation upon
which new discoveries can be made to enhance health, lengthen life,
and reduce the burdens of illness and disability. The
irreproducibility of preclinical research is a significant impediment
to the achievement of these goals. To solve this problem requires
immediate and concrete action. It is not enough to make
recommendations and issue guidelines to researchers. Funders must act
to ensure they fund researchers to produce high quality reproducible
research. One such way to do so, is to reward, or require,
independent validation of results. The reproducibility initiative
provides a mechanism for independent validation, allowing the
identification of high quality reproducible research. It is vital
that funders act now to address this problem, to prevent the wasted
time and money that is currently spent funding non-reproducible
research and to prevent the erosion of public trust and support for
research.”

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Reproducing Research Results: Removing a Scientific Roadblock

Posted: September 23, 2012 at 3:54 pm


The California stem cell agency faces
no easy task in trying to translate basic research findings into
something that can be used to treat patients and be sold commercially.

Even clinical trials, which only begin
long after the basic research is done and which involve more ordinary
therapeutic treatments than stem cells, fail at an astonishing rate.
Only one out of five that enter the clinical trial gauntlet
successfully finish the second stage, according to industry data
cited last spring by Pat Olson, executive director of scientific activities at the stem cell agency. And
then come even more challenges.
But at a much earlier stage of
research there is the “problem of irreproducible results,” in the
words of writer Monya Baker of the journal Nature. Baker last month reported on
moves by a firm called Science Exchange in Palo Alto, Ca., to
do something to ease the problem and speed up preclinical research.
The effort is called the Reproducibility Initiative and also involves
PLOS and figshare, an open science Internet project.
Elizabeth Iorns
Science Exchange Photo
Science Exchange is headed by Elizabeth
Iorns
, a scientist and co-founder of the firm. She wrote about  test-tube-to-clinic translation issues in a recent article in New
Scientist
that was headlined, “Is medical science built on shaky
foundations?”
Iorns said,

“One goal of scientific publication
is to share results in enough detail to allow other research teams to
reproduce them and build on them. However, many recent reports have
raised the alarm that a shocking amount of the published literature
in fields ranging from cancer biology to psychology is not
reproducible.”

Iorns cited studies in Nature that
reported that Bayer cannot “replicate about two-thirds of published
studies identifying possible drug targets” and that Amgen failed at
even a higher rate. It could not “replicate 47 of 53 highly
promising results they examined.”
The California Stem Cell Report earlier
this week asked Iorns for her thoughts on the implications for the
California stem cell agency, whose motto is "Turning stem cells into cures." Here is the full text of her response.

“First, I think it is important to
accept that there is a crisis affecting preclinical research. Recent
studies estimate that 70% of preclinical research cannot be
reproduced. This is the research that should form the foundation upon
which new discoveries can be made to enhance health, lengthen life,
and reduce the burdens of illness and disability. The
irreproducibility of preclinical research is a significant impediment
to the achievement of these goals. To solve this problem requires
immediate and concrete action. It is not enough to make
recommendations and issue guidelines to researchers. Funders must act
to ensure they fund researchers to produce high quality reproducible
research. One such way to do so, is to reward, or require,
independent validation of results. The reproducibility initiative
provides a mechanism for independent validation, allowing the
identification of high quality reproducible research. It is vital
that funders act now to address this problem, to prevent the wasted
time and money that is currently spent funding non-reproducible
research and to prevent the erosion of public trust and support for
research.”

Source:
http://californiastemcellreport.blogspot.com/feeds/posts/default?alt=rss

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Probe sought into status of stem cell therapy in the Philippines

Posted: September 23, 2012 at 12:11 pm

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Probe sought into status of stem cell therapy in the Philippines

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Solon urges Congress to conduct cursory check on the status of stem cell therapy in the country (15966897)

Posted: September 22, 2012 at 8:14 am

According to Aristotle, only the Pentacosiomedimnoi were eligible for election to high office as archons and therefore only they gained admission into the Areopagus. A modern view affords the same privilege to the hippeis. The top three classes were eligible for a variety of lesser posts and only the Thetes were excluded from all public office.

Depending on how we interpret the historical facts known to us, Solon's constitutional reforms were either a radical anticipation of democratic government, or they merely provided a plutocratic flavour to a stubbornly aristocratic regime, or else the truth lies somewhere between these two extremes.

Solon's reforms can thus be seen to have taken place at a crucial period of economic transition, when a subsistence rural economy increasingly required the support of a nascent commercial sector. The specific economic reforms credited to Solon are these: Fathers were encouraged to find trades for their sons; if they did not, there would be no legal requirement for sons to maintain their fathers in old age. Foreign tradesmen were encouraged to settle in Athens; those who did would be granted citizenship, provided they brought their families with them. Cultivation of olives was encouraged; the export of all other produce was prohibited. Competitiveness of Athenian commerce was promoted through revision of weights and measures, possibly based on successful standards already in use elsewhere, such as Aegina or Euboia or, according to the ancient account but unsupported by modern scholarship, Argos

It is generally assumed, on the authority of ancient commentators that Solon also reformed the Athenian coinage. However, recent numismatic studies now lead to the conclusion that Athens probably had no coinage until around 560 BC, well after Solon's reforms.

Solon's economic reforms succeeded in stimulating foreign trade. Athenian black-figure pottery was exported in increasing quantities and good quality throughout the Aegean between 600 BC and 560 BC, a success story that coincided with a decline in trade in Corinthian pottery. The ban on the export of grain might be understood as a relief measure for the benefit of the poor. However, the encouragement of olive production for export could actually have led to increased hardship for many Athenians since it would have led to a reduction in the amount of land dedicated to grain. Moreover an olive produces no fruit for the first six years. The real motives behind Solon's economic reforms are therefore as questionable as his real motives for constitutional reform. Were the poor being forced to serve the needs of a changing economy, or was the economy being reformed to serve the needs of the poor?

Solon's reform of these injustices was later known and celebrated among Athenians as the Seisachtheia (shaking off of burdens). As with all his reforms, there is considerable scholarly debate about its real significance. Many scholars are content to accept the account given by the ancient sources, interpreting it as a cancellation of debts, while others interpret it as the abolition of a type of feudal relationship, and some prefer to explore new possibilities for interpretation. prohibition on a debtor's person being used as security for a loan. release of all Athenians who had been enslaved.

The removal of the horoi clearly provided immediate economic relief for the most oppressed group in Attica, and it also brought an immediate end to the enslavement of Athenians by their countrymen. Some Athenians had already been sold into slavery abroad and some had fled abroad to escape enslavement Solon proudly records in verse the return of this diaspora. It has been cynically observed, however, that few of these unfortunates were likely to have been recovered. It has been observed also that the seisachtheia not only removed slavery and accumulated debt, it also removed the ordinary farmer's only means of obtaining further credit.

The seisachtheia however was merely one set of reforms within a broader agenda of moral reformation. Other reforms included: the abolition of extravagant dowries. legislation against abuses within the system of inheritance, specifically with relation to the epikleros (i.e. a female who had no brothers to inherit her father's property and who was traditionally required to marry her nearest paternal relative in order to produce an heir to her father's estate). entitlement of any citizen to take legal action on behalf of another. the disenfranchisement of any citizen who might refuse to take up arms in times of civil strife, a measure that was intended to counteract dangerous levels of political apathy.

The personal modesty and frugality of the rich and powerful men of Athens in the city's subsequent golden age have been attested to by Demosthenes. Perhaps Solon, by both personal example and legislated reform, established a precedent for this decorum. A heroic sense of civic duty later united Athenians against the might of the Persians. Perhaps this public spirit was instilled in them by Solon and his reforms. Also see Solon and Athenian sexuality

The literary merit of Solon's verse is generally considered unexceptional. Solon the poet can be said to appear 'self-righteous' and 'pompous' at times and he once composed an elegy with moral advice for a more gifted elegiac poet, Mimnermus. Most of the extant verses show him writing in the role of a political activist determined to assert personal authority and leadership and they have been described by the German classicist Wilamowitz as a "versified harangue" (Eine Volksrede in Versen). According to Plutarch however, Solon originally wrote poetry for amusement, discussing pleasure in a popular rather than philosophical way. Solon's elegiac style is said to have been influenced by the example of Tyrtaeus. He also wrote iambic and trochaic verses which, according to one modern scholar, are more lively and direct than his elegies and possibly paved the way for the iambics of Athenian drama.

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Solon urges Congress to conduct cursory check on the status of stem cell therapy in the country (15966897)

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StemCells, Inc., Discloses How it Will Generate $40 Million in Matching Funds

Posted: September 16, 2012 at 3:56 pm


StemCells, Inc., said yesterday that it
will come up with the $40 million needed to match loans from the California
stem cell agency through “existing infrastructure and overhead”
and will not be issuing stocks or warrants to the agency.

In a statement to shareholders, Martin
McGlynn
, CEO of the publicly traded firm, discussed the $40 million in loans awarded by agency this summer, including $20 million last
week. The stem cell agency's governing board, after it emerged from
an executive session on the matter, last Wednesday night adopted a
motion requiring the company to demonstrate that it has the matching
funds.
CIRM Chairman J.T. Thomas, a Los Angeles bond financier, said that
concerns were expressed during the executive session that the agency
“would account for such a large part of the assets of the company.”
At his suggestion, the board approved the loan on the condition that
“it show it has access” to the $20 million in matching funds that
company offered during the application process. StemCells, Inc., also
offered a $20 million match on another loan approved in July by CIRM.
The latest financial reports from
StemCells, Inc., which is based in Newark, Ca., show that it had
assets of $17 million as of June 30 and liabilities of $11.6 million.
The company reported net income for the second quarter of $833,522
compared to a loss of $4 million for the same period a year ago.
In its filing with the SEC, the company
said,

“We have incurred significant
operating losses since inception. We expect to incur additional
operating losses over the foreseeable future. We have very limited
liquidity and capital resources and must obtain significant
additional capital and other resources in order to provide funding
for our product development efforts....”

In his statement yesterday, McGlynn
said the California stem cell agency had “doubled down” on
StemCells, Inc., in approving the two loans. He said the company is
not concerned about meeting the matching requirements. McGlynn said, 
Martin McGlynn
StemCells, Inc., Photo

“To be clear, we do not interpret the
diligence requirement as an obligation to raise a specific amount of
money in a particular period of time, and we wish to correct the
misstatements made by some uninformed third parties that the ICOC is
requiring us to raise $20 million in matching funds. In
point of fact, we expect that a substantial amount of our
contribution towards these projects will come from existing
infrastructure and overhead, salaries for our existing personnel, and
other contributions in kind. Furthermore, we will soon be
reviewing the budgets for both projects in detail with CIRM
staff. Because each disease team budget was prepared on a
stand-alone basis, we expect to see significant economies and
efficiencies now that the company has in fact been awarded funding
for both.”

McGlynn also said,

"Under this particular CIRM
program (RFA 10-05), funding for companies will be in the form of
unsecured, non-recourse, interest-bearing, term loans, which will be
forgivable in the event the funded research fails to result in a
commercialized product. On the other hand, should the product be
successfully commercialized, CIRM would earn milestone payments
depending on how successful the product becomes. Because CIRM
shares the downside risk, and could participate handsomely on the
upside, the structure makes the loan about as close to 'equity' as one could, without having to dilute existing shareholders in order
to gain access to significant amounts of capital.  The company
will not issue stock, warrants or other equity to CIRM in connection
with these awards. 

"Of course, we realize that CIRM
prefers that applicants from industry provide evidence of their
ability to secure whatever additional funds may be needed to complete
any CIRM-funded project, in this case the filing of an IND for each
indication. This is stated in the text of RFA 10-05 itself and
was repeated in various comments by CIRM staff during the application
process. When making the second award on September 5, the
ICOC naturally recognized the sizeable commitment it was making
to StemCells, so it instructed CIRM staff to satisfy themselves
of the company's ability to access the capital needed to fund the
project, namely the Alzheimer's program through to the filing of the
IND.”

McGlynn also said firm's bid for
another $10 million from CIRM could come in the form of a grant
instead of a loan. He said,

"Finally, I can confirm that in
June of this year the Company applied for up to $10
million under CIRM's Strategic Partnership I program
(RFA 12-05). Unlike the disease team awards under RFA
10-05, if companies are approved for funding under RFA 12-05, they
may elect to take such funding in the form of a grant, not a
loan. Our application under RFA 12-05 is for a controlled Phase
II clinical trial of HuCNS-SC cells in Pelizaeus-Merzbacher disease
(PMD), a rare myelination disorder. StemCells completed a Phase
I study in PMD in February 2012 and in April announced that
all of the patients from that study showed evidence of cell-derived
myelination and three of the four patients in the study showed
measurable gains in motor and/or cognitive function.”

According to CIRM, the awards in the strategic partner round will be approved either next month or in December. 
StemCells, Inc. stock was trading at
$1.85 at the time of this writing. Last week, it rose to $2.43.
During the last 12 months, its high was $2.67 and its low was 59
cents.

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Road to Commercialization: California Stem Cell Agency Seeking Top Level Product Development Execs

Posted: September 16, 2012 at 3:56 pm


Looking for a good job at an
enterprise that is on the cutting edge of biotechnology?

Nine positions are open at the $3
billion California stem cell agency, headquartered in San Francisco.
Some of them could pay more than $200,000 a year.
Several of the new jobs are closely
aligned with the agency's fresh focus on commercializing stem cell
research and driving therapies into the clinic. Scientists and
lawyers are being recruited along with a business development
officer. For some of the positions, travel is required.
One new, high-level position is
described as a senior development officer. The job posting calls for
“expertise in product development for stem cell therapies.” The
person would “directly interact with investigators on CIRM’s
clinically applicable research programs to help provide product
development guidance from preclinical, manufacturing, and first in
human to early phase clinical regulatory perspectives.” An M.D. or
Ph.D. degree in a biomedical science is required. Pay tops out at
$232,891. This person would report to Ellen Feigal, senior vice
president for research and development.
A second, high-level position reporting to Feigal is senior medical officer, who would manage the
agency's portfolio aimed at commercialization of stem cell research,
specifically “focused on IND enabling and clinical development
projects.” This also requires an M.D. or Ph.D. and substantial professional experience in development of biomedical research and
products. Pay also could run as high $232.891 annually.
A third new job at CIRM is
business development officer. That person would help generate
“outside investment in stem cell research in California for both
CIRM-funded and not currently CIRM-funded programs by
biopharmaceutical strategic partners; equity investors (venture
capital and others); and disease foundations.” The salary range
hits $216,270 annually. It wouldn't be surprising if the person in
this job also became involved in developing a funding mechanism for
CIRM after it runs out of state cash in 2017 or so. 
This position reports to Elona Baum,
general counsel and vice president, business development.
And yet another new position is called
director of alliance management. The job deals with the agency's
extensive collaborative funding partnerships, many of which are
abroad. CIRM wants somebody with a law degree, experience in
intellectual property and business law along with strong negotiating
skills. The pay range for the post tops out at $232,891 annually. This position reports to CIRM President
Alan Trounson.
Other open positions include: deputy
general counsel, two science officers and office manager.

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California Stem Cell Firsts: From Emotional Appeals to $40 Million Awards

Posted: September 16, 2012 at 3:56 pm


During the last few months, the $3 billion California stem cell
agency, which is approaching its eight-year anniversary, has chalked up a
number of important firsts.

Most of them came during the July and
September meetings of its 29-member governing board and were related to strenuous efforts by researchers to win approval of awards of up to
$20 million each. Several firsts involved the agency's former
chairman, Robert Klein, who could be considered the father of the
state's stem cell research effort.
So here is the California Stem Cell
Report's
list of firsts at the California Institute of Regenerative
Medicine
(as CIRM, the stem cell agency, is formally known) for the
summer of 2012.
It was the first time that a single
company – in this case, StemCells, Inc. , of Newark, Ca. –
received two awards in the same round.
It was the first time any company has
been awarded as much as $40 million. Again, StemCells, Inc.
It was the first time that Klein has lobbied his former board (see here and here) on
behalf of a particular grant application. That occurred in both July
and September with one of StemCells, Inc.'s application.
It was the first time that the board
has approved an application that has been rejected twice by
reviewers, again the StemCells, Inc., proposal backed by Klein.
It was the first time that board has
received such a large outpouring of appeals by rejected applicants.
It was the first time that the board
has received such lengthy presentations of emotional appeals by
patient advocates on behalf of rejected applicants.
It was the first time that action on a
grant round has been extended over three months(see here and here). The disease team
round began in July. Action will not be completed until the end of
October.
It was the first time that the
governing board has sent so many applications back for re-review –
five, six if the one to be acted on in October is included.
It was also the first time that the
board has ordered a full-blown review of its grant appeal process
with an eye to making making major changes in it.
Several reasons exist for the number of
firsts racked up by CIRM. One is the high stakes involved in the
disease team round that began in July and the low number approved by reviewers – six compared to the 12 approved by the board, as of
today, out of 21 applications. Another reason involves the
increasing understanding on the part of many scientists that they can
appeal directly to the board when reviewers reject their
applications. However, it is also clear that not all applicants
grasp the full range of appeal possibilities. A third reason involves
the agency's muddled appeal process, which has been a problem for
years. And a fourth reason involves the board's push to drive research into
the clinic and commercialization, which applicants are quickly
learning how to exploit.
Readers should feel free to add their
own firsts to this list. They can do so – even, anonymously – by
clicking on the word “comments” at the end of this item.

Source:
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Road to Commercialization: California Stem Cell Agency Seeking Top Level Product Development Execs

Posted: September 16, 2012 at 3:55 pm


Looking for a good job at an
enterprise that is on the cutting edge of biotechnology?

Nine positions are open at the $3
billion California stem cell agency, headquartered in San Francisco.
Some of them could pay more than $200,000 a year.
Several of the new jobs are closely
aligned with the agency's fresh focus on commercializing stem cell
research and driving therapies into the clinic. Scientists and
lawyers are being recruited along with a business development
officer. For some of the positions, travel is required.
One new, high-level position is
described as a senior development officer. The job posting calls for
“expertise in product development for stem cell therapies.” The
person would “directly interact with investigators on CIRM’s
clinically applicable research programs to help provide product
development guidance from preclinical, manufacturing, and first in
human to early phase clinical regulatory perspectives.” An M.D. or
Ph.D. degree in a biomedical science is required. Pay tops out at
$232,891. This person would report to Ellen Feigal, senior vice
president for research and development.
A second, high-level position reporting to Feigal is senior medical officer, who would manage the
agency's portfolio aimed at commercialization of stem cell research,
specifically “focused on IND enabling and clinical development
projects.” This also requires an M.D. or Ph.D. and substantial professional experience in development of biomedical research and
products. Pay also could run as high $232.891 annually.
A third new job at CIRM is
business development officer. That person would help generate
“outside investment in stem cell research in California for both
CIRM-funded and not currently CIRM-funded programs by
biopharmaceutical strategic partners; equity investors (venture
capital and others); and disease foundations.” The salary range
hits $216,270 annually. It wouldn't be surprising if the person in
this job also became involved in developing a funding mechanism for
CIRM after it runs out of state cash in 2017 or so. 
This position reports to Elona Baum,
general counsel and vice president, business development.
And yet another new position is called
director of alliance management. The job deals with the agency's
extensive collaborative funding partnerships, many of which are
abroad. CIRM wants somebody with a law degree, experience in
intellectual property and business law along with strong negotiating
skills. The pay range for the post tops out at $232,891 annually. This position reports to CIRM President
Alan Trounson.
Other open positions include: deputy
general counsel, two science officers and office manager.

Source:
http://californiastemcellreport.blogspot.com/feeds/posts/default?alt=rss

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