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Category Archives: Stem Cell Therapy

Mayo Clinic Finds Way to Weed Out Problem Stem Cells, Making Therapy Safer

Released: 9/25/2012 1:25 PM EDT Embargo expired: 9/27/2012 9:00 AM EDT Source: Mayo Clinic

MULTIMEDIA ALERT: Video resources, including an interview with Dr. Nelson will be available for journalists at the Mayo Clinic News Network.

Newswise ROCHESTER, Minn. -- Mayo Clinic researchers have found a way to detect and eliminate potentially troublemaking stem cells to make stem cell therapy safer. Induced Pluripotent Stem cells, also known as iPS cells, are bioengineered from adult tissues to have properties of embryonic stem cells, which have the unlimited capacity to differentiate and grow into any desired types of cells, such as skin, brain, lung and heart cells. However, during the differentiation process, some residual pluripotent or embryonic-like cells may remain and cause them to grow into tumors.

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, says Timothy Nelson, Ph.D., M.D., lead author on the study, which appears in the October issue of STEM CELLS Translational Medicine.

Using mouse models, Mayo scientists overcame this drawback by pretreated stem cells with a chemotherapeutic agent that selectively damages the DNA of the stem cells, efficiently killing the tumor-forming cells. The contaminated cells died off, and the chemotherapy didnt affect the healthy cells, Dr. Nelson says.

The goal of creating new therapies is twofold: to improve disease outcome with stem cell-based regenerative medicine while also ensuring safety. This research outlines a strategy to make stem cell therapies safer for our patients while preserving their therapeutic efficacy, thereby removing a barrier to translation of these treatments to the clinic, says co-author Alyson Smith, Ph.D.

Stem cell therapies continue to be refined and improved. Researchers are finding that stem cells may be more versatile than originally thought, which means they may be able to treat a wider variety of diseases, injuries and congenital anomalies. Stem cell therapy is an emerging regenerative strategy being studied at Mayo Clinic.

By harnessing the potential of regenerative medicine, well be able to provide more definitive solutions to patients, says Andre Terzic, M.D., Ph.D., co-author and director of Mayo Clinics Center for Regenerative Medicine.

Other members of the Mayo research team included Clifford Folmes, Ph.D., Katherine Hartjes, Natalie Nelson and Saji Oommen, Ph.D. The research was supported by the Todd and Karen Wanek Family Program for Hypoplastic Left Heart Syndrome, National Institutes of Health New Innovator Award OD007015-01, and a Mayo Clinic Center for Regenerative Medicine accelerated research grant.

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Mayo Clinic Finds Way to Weed Out Problem Stem Cells, Making Therapy Safer

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Stem cells revolutionizing veterinary medicine

(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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Stem cells revolutionizing veterinary medicine

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Probe sought into status of stem cell therapy in the Philippines

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Probe sought into status of stem cell therapy in the Philippines

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Reproducing Research Results: Removing a Scientific Roadblock


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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Reproducing Research Results: Removing a Scientific Roadblock


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


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.

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

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