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Category Archives: Stem Cell Therapy

UCD’s Knoepfler’s ‘Somewhat Provocative Paper’ on iPS


UC Davis researcher Paul Knoepfler is
the rare stem cell scientist who blogs about his work as well as
writing about issues in the field.

Over the weekend, he posted an item on
what he described as a “somewhat provocative paper” published by his lab in
“Stem Cells and Development.”  He said the paper argued
that iPS cells “are very similar in some ways to cancer cells.”
Most of his item deals with the
technical details and background of the research. But at the end of
this item, Knoepfler wrote,

“So what does this mean in the big
picture? 

“I believe that iPS cells and cancer
cells are, while not the same, close enough to be called siblings. As
such, the clinical use of iPS cells should wait for a lot more study.
Even if scientists do not use iPS cells themselves for transplants,
but instead use differentiated derivatives of iPS cells, the risk of
patients getting malignant cancers cannot be ignored. 

“At the same time, the studies
suggest possible ways to make iPS cells safer and support the notion
of reprogramming cancer cells as an innovative new cancer therapy. 

“Stay tuned in the next few days for
part 2 where I will discuss what this paper went through in terms of
review, etc. to get published. It wasn’t a popular story for some
folks.”

The UC Davis press release on the
research, which was financed by the California stem cell agency and the NIH,  was picked up by several online sites, including Redorbit,
Medicalexpress and geekosystem.

Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/eNPFE1TC2TI/ucds-knoepflers-somewhat-provocative.html

Posted in Stem Cell Therapy, Stem Cells | Comments Off on UCD’s Knoepfler’s ‘Somewhat Provocative Paper’ on iPS

UCD's Knoepfler's 'Somewhat Provocative Paper' on iPS


UC Davis researcher Paul Knoepfler is
the rare stem cell scientist who blogs about his work as well as
writing about issues in the field.

Over the weekend, he posted an item on
what he described as a “somewhat provocative paper” published by his lab in
“Stem Cells and Development.”  He said the paper argued
that iPS cells “are very similar in some ways to cancer cells.”
Most of his item deals with the
technical details and background of the research. But at the end of
this item, Knoepfler wrote,

“So what does this mean in the big
picture? 

“I believe that iPS cells and cancer
cells are, while not the same, close enough to be called siblings. As
such, the clinical use of iPS cells should wait for a lot more study.
Even if scientists do not use iPS cells themselves for transplants,
but instead use differentiated derivatives of iPS cells, the risk of
patients getting malignant cancers cannot be ignored. 

“At the same time, the studies
suggest possible ways to make iPS cells safer and support the notion
of reprogramming cancer cells as an innovative new cancer therapy. 

“Stay tuned in the next few days for
part 2 where I will discuss what this paper went through in terms of
review, etc. to get published. It wasn’t a popular story for some
folks.”

The UC Davis press release on the
research, which was financed by the California stem cell agency and the NIH,  was picked up by several online sites, including Redorbit,
Medicalexpress and geekosystem.

Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/eNPFE1TC2TI/ucds-knoepflers-somewhat-provocative.html

Posted in Stem Cell Therapy, Stem Cells | Comments Off on UCD's Knoepfler's 'Somewhat Provocative Paper' on iPS

Researcher Alert: California Stem Cell Agency Tightening Budget Oversight on Grants


Some of California's top stem cell
researchers are going to have to sharpen their spreadsheets if they
want to win money from the state's $3 billion stem cell agency.

The agency is moving to beef up
scrutiny of the high-profile, big-ticket grant applications
that it will consider during the next several years. The effort may well extend to all grant programs. The move also makes
it clear to researchers that the CIRM staff is in the driver's seat
when it comes to budgeting on research projects.
The plan was laid out this week in a memo to directors of the California Institute for Regenerative Medicine (CIRM) by Ellen Feigal, the agency's senior vice
president for research and development. She said,

“Increasing the importance of
budgetary review will encourage applicants to propose rigorous,
realistic and vetted budgets, and will further our mission to be good
stewards of taxpayer dollars. These additions will not significantly
increase the workload burden on GWG members (grant reviewers) and
explicitly acknowledge that program goals, scientific plans, accurate budgeting and prudent spending are inextricably linked.”

The proposal comes before the CIRM
directors' Science Subcommittee next Monday and would alter the
closed-door grant review process in the following manner, according
to Feigal's memo.

• “To assist GWG review,
appropriate expertise on budget and financial matters (e.g., this
could be in the form of a specialist reviewer, or can also be
assigned to a GWG reviewer with the appropriate background and
expertise), will review applications for sound budgeting and provide
comments or questions to the GWG for consideration by the reviewers
before the reviewer’s final scores are entered.
• “If the financial/budgetary
matter potentially directly impacts on the design or feasibility of
conducting the project, the GWG may consider this issue in the
scoring; otherwise, budgetary and financial issues and questions will
not contribute to the scientific score.
• “As appropriate, review summaries
sent to the ICOC (the CIRM governing board) will identify scientific
as well as budget or other issues. To the extent endorsed by the
GWG, the review summaries will also identify potential resolution
should the ICOC approve a given award with budget issues.
• “CIRM officers should be provided
explicit discretion to consider the budget comments, as well as
budget or other issues. To the extent endorsed by the GWG, the
review summaries will also identify potential resolution should the
ICOC approve a given award with budget issues.”

Feigal's memo clearly indicates that
CIRM staff has experienced push-back from recalcitrant researchers
when efforts have been made to bring costs under control. She noted that
the agency's staff examines a research project's budget during the
“prefunding” review that follows board approval. However, Feigal
said, at that stage, “It is often challenging to make substantive
changes to the budget, based on appropriateness of study activities
and costs, given the ICOC approval at a given budget amount.”
The agency has already examined some
budgets prior to board approval. One grant review in a $200
million-plus round this summer, for example, declared that costs to
prepare regulation packages had “overlap” and were “excessive,”
along with costs dealing with manufacturing and per patient expenses.
That was for a high-scoring application by Antoni Ribas of UCLA, and
he was not alone.
In her memo, Feigal listed other cases
of budgetary shortcomings in recent applications:,

• “Budget does not align with the
program deliverables and milestones. For example, the budget
includes activities not relevant to project objective(s) or that are
out of scope.
•”Budget does not contain adequate
expenses for known costs. For example, an applicant may budget
$100,000 for a GMP manufacturing run of a biologic in which it is
generally accepted knowledge that the actual expenses are typically
much greater.
•“Budget item significantly exceeds
a known cost or seems excessive without adequate justification. For
example, an applicant may propose a surgical expense of $100,000 per
patient for a procedure with Medicare reimbursement set at $15,000.
•“Cost allocations are not done
properly. For example, an applicant is developing the same
therapeutic candidate for 3 indications, and is applying for CIRM
funding for 1 of the 3, but is charging CIRM for the cost of the
entire manufacturing run.”

Initially, the budgetary review would
be used in disease team, early translational, strategic partnership
rounds, and any new rounds “as deemed appropriate.” Feigal said,
however, that “all applications for CIRM awards should be
carefully examined for budgetary appropriateness.”
Our take: This seems to be a
well-advised move, albeit one that is not likely to find favor with
researchers accustomed to loose oversight. It moves budgetary review
to an earlier stage and gives the CIRM directors a chance to weigh in
on those matters prior to approval of grants, instead of creating a
sense of entitlement on the part of recipients that may pop up
following board approval of their applications. Indeed, the plan
makes such good sense that it raises the question why it was not in
place years ago.
A final note: Feigal's memo is an
excellent example of the type of information that clarifies issues
and helps CIRM directors make the best possible decisions. It
provides some history, good evidence for a change and an explanation
of benefits. Additionally, the memo is timely, having been posted on
the CIRM website sufficiently in advance of next week's meeting to give affected parties and others time to comment
and make constructive suggestions. The memo is also far superior to
the Power Point presentations that are often submitted to the board
minus any nuanced, written discussion of the issue at hand.
Next week's meeting will be based in
San Francisco but also has teleconference locations in Irvine (2), La
Jolla, Stanford, Pleasanton, Oakland and Los Angeles where the public
and researchers can participate. The specific addresses can be found on the agenda.

Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/30DY8fml4zE/researcher-alert-california-stem-cell.html

Posted in Stem Cell Therapy | Comments Off on Researcher Alert: California Stem Cell Agency Tightening Budget Oversight on Grants

UCD’s Knoepfler’s ‘Somewhat Provocative Paper’ on iPS


UC Davis researcher Paul Knoepfler is
the rare stem cell scientist who blogs about his work as well as
writing about issues in the field.

Over the weekend, he posted an item on
what he described as a “somewhat provocative paper” published by his lab in
“Stem Cells and Development.”  He said the paper argued
that iPS cells “are very similar in some ways to cancer cells.”
Most of his item deals with the
technical details and background of the research. But at the end of
this item, Knoepfler wrote,

“So what does this mean in the big
picture? 

“I believe that iPS cells and cancer
cells are, while not the same, close enough to be called siblings. As
such, the clinical use of iPS cells should wait for a lot more study.
Even if scientists do not use iPS cells themselves for transplants,
but instead use differentiated derivatives of iPS cells, the risk of
patients getting malignant cancers cannot be ignored. 

“At the same time, the studies
suggest possible ways to make iPS cells safer and support the notion
of reprogramming cancer cells as an innovative new cancer therapy. 

“Stay tuned in the next few days for
part 2 where I will discuss what this paper went through in terms of
review, etc. to get published. It wasn’t a popular story for some
folks.”

The UC Davis press release on the
research, which was financed by the California stem cell agency and the NIH,  was picked up by several online sites, including Redorbit,
Medicalexpress and geekosystem.

Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/eNPFE1TC2TI/ucds-knoepflers-somewhat-provocative.html

Posted in Stem Cell Therapy | Comments Off on UCD’s Knoepfler’s ‘Somewhat Provocative Paper’ on iPS

Multiple miRNA Markers Associated with Angiogenesis and Tissue Injury Repair Expressed in Cytori’s Cell Therapy

SAN DIEGO--(BUSINESS WIRE)--

Cytori Therapeutics (CYTX) announced that three oral presentations related to its cell therapy are being presented today at the 10th annual International Federation for Adipose Therapeutics and Sciences meeting. The findings provide insights into the mechanisms-of-action for Cytoris cell therapy. One study identified high levels of micro-RNA (miRNA) markers in human tissue thought to play a role in the repair of tissue injury resulting from ischemia, or lack of blood flow. Two additional characterization and comparative analysis studies on human tissue reaffirmed cellular characteristics of Cytoris cell therapy and distinguished the safety, viability and cell make-up as compared to cell outputs derived from alternate approaches.

Results from all three studies have important implications for how the cells repair injured tissue and on the safety and viability of cell-based treatments derived from adipose tissue, said John Fraser, Ph.D., Chief Scientist of Cytori Therapeutics. Mechanisms identified in our miRNA analysis are consistent with our prior clinical and preclinical data, which suggest these mechanisms include angiogenesis, immune-modulation, and remodeling and wound repair. The miRNA study provides baseline data, which we can apply to our U.S. ATHENA clinical trial in refractory heart failure patients and other activities including our recently announced contract with BARDA for thermal burns.

In one study, miRNA profiles were assessed in adipose-derived stem and regenerative cells (ADRCs) derived from human tissue samples. The purpose was to determine which miRNA markers are expressed, miRNA variability from patient to patient, cellular functions of miRNA, and to establish a baseline miRNA population on healthy patients to compare against patients with a specific disease. Specifically, miRNA markers associated with angiogenesis, tissue remodeling and wound repair, and modulation of the immune response were found to be highly represented in ADRCs.

Our two additional characterization and comparative analysis studies evaluated alternate processing techniques and reaffirmed our proprietary enzyme-based process using Celution is the clear gold standard, added Dr. Fraser. If the composition of a cell population extracted from adipose tissue by an alternative process is not equivalent to Cytoris ADRC population, one cannot claim equivalence to ADRCs in terms of safety or efficacy in preclinical or clinical outcomes.

The characterization and comparative analysis studies reaffirmed the high cell yield and viability as well as the heterogeneity in Cytoris cell therapy approach. Cytoris cells are derived with a proprietary formulation of clinical grade enzymes which break up the connective tissue and which are removed at the end of the process. Cytoris cell mixture includes adipose-derived stem cells, based on the measure of colony forming units, and a high yield of CD34+ cells. By contrast, data in these studies showed that alternate approaches such as ultrasound or emulsification, contained little to no adipose-derived stem cells, a high concentration of red and white blood cells, and did not meet the key criteria for safe clinical use.

About Cytori

Cytori Therapeutics, Inc. is developing cell therapies based on autologous adipose-derived regenerative cells (ADRCs) to treat cardiovascular disease and repair soft tissue defects. Our scientific data suggest ADRCs improve blood flow, moderate the immune response and keep tissue at risk of dying alive. As a result, we believe these cells can be applied across multiple "ischemic" conditions. These therapies are made available to the physician and patient at the point-of-care by Cytori's proprietary technologies and products, including the Celution system product family. http://www.cytori.com

Cautionary Statement Regarding Forward-Looking Statements

This press release includes forward-looking statements regarding events, trends and business prospects, which may affect our future operating results and financial position. Such statements including our ability to apply this data to our ATHENA study and other projects are subject to risks and uncertainties that could cause our actual results and financial position to differ materially. Some of these risks and uncertainties include our history of operating losses, the need for further financing, inherent risk and uncertainty in the protection of intellectual property rights, regulatory uncertainties regarding the collection and results of, clinical data, dependence on third party performance, and other risks and uncertainties described under the "Risk Factors" in Cytori's Securities and Exchange Commission Filings, including its annual report on Form 10-K for the year ended December 31, 2011. Cytori assumes no responsibility to update or revise any forward-looking statements contained in this press release to reflect events, trends or circumstances after the date of this press release.

Continued here:
Multiple miRNA Markers Associated with Angiogenesis and Tissue Injury Repair Expressed in Cytori’s Cell Therapy

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Bernard Siegel to Deliver Keynote Addresses at Midwest Conference on Stem Cell Biology and Therapy and BioFlorida …

PALM BEACH, Fla.--(BUSINESS WIRE)--

Genetics Policy Institute (GPI) announced today that Bernard Siegel, Executive Director of GPI, will make two keynote presentations this month at regional conferences: Midwest Conference on Stem Cell Biology and Therapy October 5-7 in Rochester, Michigan and BioFlorida Conference 2012 October 7-9 in Miami, Florida.

Siegel will present a keynote address titled The Power of Advocacy at the Midwest Conference on Stem Cell Biology and Therapy. The Genetics Policy Institute joined with the Oakland University William Beaumont Institute for Stem Cell and Regenerative Medicine (ISCRM) as a collaborating partner for the event. Researchers from hospitals, medical organizations, academic institutions and the business community throughout the Midwest will discuss not only the latest advances in this rapidly expanding field of medical science, but the ethical and moral issues that surround it.

"I am pleased to participate in these important conferences, which showcase the latest scientific developments in their respective regions and beyond. ISCRM and the World Stem Cell Summit have a strong connection, as the Institute was officially launched at our 2010 Summit in Detroit, said Bernard Siegel, GPI's Executive Director and founder of the annual World Stem Cell Summit.

BioFloridas 15th annual Conference is the premier event for Floridas bioscience community. This years meeting will bring together more than 500 professionals from across Florida, the Southeast and the nation to discuss major trends and issues, including topics related to product development, scientific research, business development, financing and public policy.

Siegels keynote address at BioFlorida is titled: The Mandate to Deliver Cures: Aligning Patient Advocacy, Industry and Science. Former Governor Jeb Bush will deliver the second keynote at BioFloridas annual Conference.

The 2012 World Stem Cell Summit is in West Palm Beach, Florida this December, so we have been working closely with the biotechnology community here. I am delighted to partner with BioFlorida as they advance Floridas bioscience industry," said Siegel, who also serves on the Executive Committee of the Alliance for Regenerative Medicine and Board of the Coalition for Advancement of Medical Research. He serves as spokesperson for the Stem Cell Action Coalition.

ABOUT GPI:The Genetics Policy Institute (GPI) supports stem cell research to develop therapeutics and cures. GPI pursues its mission by honoring leadership through the Stem Cell Action Awards, producing the World Stem Cell Summit, publishing theWorld Stem Cell Report, organizing educational initiatives and fostering strategic collaborations. For more information, visitwww.genpol.org.

ABOUT THE WORLD STEM CELL SUMMIT:The 2012 World Stem Cell Summit is presented by GPI and is co-organized by the Interdisciplinary Stem Cell Institute (ISCI) at the University of Miami Miller School of Medicine, Diabetes Research Institute, Beckman Research Institute at City of Hope, Karolinska Institute (home of the Nobel Prize in Physiology and Medicine), International Translational Regenerative Medicine Center (ITRC) and the Institute for Integrated Cell-Material Sciences (iCeMS) at Kyoto University. The Summit is the flagship meeting of the world stem cell community. The 2012 Summit will be held at the Palm Beach County Convention Center in West Palm Beach, Florida, December 3-5, 2012. For more information, visit http://www.worldstemcellsummit.com.

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Bernard Siegel to Deliver Keynote Addresses at Midwest Conference on Stem Cell Biology and Therapy and BioFlorida ...

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