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CIRM’s Thomas: Conflicts ‘Put to Bed’ at Stem Cell Agency

Posted: February 3, 2013 at 8:10 am

The chairman of the $3 billion
California stem cell agency, Jonathan Thomas, today hailed board
action last week as putting “to bed once and for all” questions
about financial conflicts of interest by members of the agency's
governing board.

Writing on the agency's blog, Thomas
pointed to board approval of a new policy that would bar 13 of the 29
members of the governing board from voting on any grants whatsoever.
The 13 are the members who are “appointed from an institution that
is eligible to receive money.” Three other board members have ties
to institutions that receive money. Two are employees of the institutions and one is the
chair of the University of California board of regents, Sherry
Lansing
. All three are appointed as patient advocate members of the
board. Currently all 16 are barred individually from voting on grants
to their institutions, but they can vote for awards to other
institutions.
Thomas proposed the plan last week to
the governing board, which approved it on a 23-0 vote with one
abstention. Thomas advanced the proposal in response to the
recommendations of a 17-month study by the Institute of Medicine(IOM).
CIRM paid $700,000 for the blue-ribbon report, hoping that it would
serve as the basis for continued financing of the agency beyond 2017,
when funds for new grants run out.
The IOM's far-reaching recommendations
included creation of a majority of independent members on the board,
which would mean some current members of the board would lose their
seats. No institutions would be guaranteed seats on the board.
Currently five members are appointed from the University of
California.
The Thomas plan does not deal with those recommendations.
The IOM said “far too many” members
of the board have ties to institutions that receive funds from CIRM.
Compilations by the California Stem Cell Report show that about 90
percent of the $1.7 billion that the board has awarded has gone to
institutions linked to directors.
Thomas said that the board last week
“endorsed a framework of proposals that would dramatically change
the way the board works, and directly addresses the concerns and
recommendations of the IOM, in particular their feeling that the way
our Board works could create a perception of conflict of interest.”
Concerning the change in voting for the
13 board members, Thomas wrote,

“It was not an easy change to propose
and certainly not an easy one for our board members to approve. They
all care deeply about our mission and devote a great deal of thought,
time and energy to helping us do our work. So for 13 of them to agree
to abstain from a key aspect of their work was difficult to say the
least. And yet they did it because they felt it was important for the
overall goal of the agency.”

Thomas continued,

“So why did we take this approach?
It's simple. We want people to focus on the great work we do, on the
groundbreaking research we fund, and the impact we are having on the
field of regenerative medicine not just in California but throughout
the U.S. and around the world. As long as there are perceptions of
conflict of interest hanging over the Board, this will continue to be
difficult.”

Thomas said,

“This puts the economic conflicts
issue to bed once and for all.”

Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/GHXrGjkYixw/cirms-thomas-conflicts-put-to-bed-at.html

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Loring on Patient Advocates and Their Role at the California Stem Cell Agency

Posted: February 3, 2013 at 8:10 am

The following statement by stem cell researcher Jeanne
Loring
was read at the January 23, 2013, meeting of the governing board of the California stem cell agency. Loring is director
of the Center for Regenerative Medicine at the Scripps Research
Institute
in La Jolla, CA.

“I am sorry that I
cannot attend this important meeting of the ICOC. I'm in Toronto
reviewing stem cell grants for Japan and Canada. I've asked (patient advocate) Don Reed
to read my statement.
“I am a California
stem cell scientist whose research is funded by the NIH, private
foundations, and CIRM. I am the director of one of CIRM's shared
laboratories, which has provided formal training in research and
ethics to hundreds of young stem cell scientists. My CIRM funding
supports the stem cell genomics research that is the main focus of
the lab. We have also been funded by CIRM to investigate stem cell
therapies for Alzheimer disease and multiple sclerosis. I have
leveraged CIRM grant support to obtain funding for studies of autism
through the NIH, and for Parkinson's disease from a private
foundation.
“The IOM report
recommended a number of changes in CIRM's policies. One of these
recommendations is of especially great concern to me: the suggestion
that patient advocates should have much less influence in CIRM's
decisions about what research should be funded.
“Patient advocates
are extremely valuable to us researchers. Most of us stem cell
researchers had never met a patient advocate- and perhaps not even a
patient- before CIRM was founded. In my 20 years of being funded by
the NIH, the funding agency never once suggested that I should talk
to people who have the disease, or have relatives with a disease that
I was receiving funding to study.
“With my first CIRM
grant, I started meeting patient advocates, and now I can't imagine
pursuing a disease-related research project without them. I've
learned a great deal from the advocates on the ICOC, and I greatly
enjoy talking with them. They are wonderful sources of knowledge:
Jeff Sheehy taught me about HIV/AIDS and patient activism, I learned
about Parkinson's disease from Joan Samuelson, autism from John
Shestack, and David Serrano-Sewell, Diane Winoker have educated me
about MS and ALS.
“Professional
research scientists are competitive by nature- a conversation between
scientists is often constrained by our secrecy- we need to publish,
or perish. But advocates have no such constraints, which makes ICOC
meetings more enjoyable and informative than many scientific
meetings.
“Patient advocacy has
made me a better scientist. Advocacy makes CIRM-funded research
breathtakingly relevant and uniquely powerful to change the course of
medicine.”

Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/l-jQiD3JTec/loring-on-patient-advocates-and-their.html

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Patient Advocate Reed Defends Patient Advocates on Stem Cell Board

Posted: February 3, 2013 at 8:10 am

Patient advocate Don Reed, declaring that the Institute of Medicine's (IOM) 17-month study of the $3 billion California stem cell agency is "grossly misguided," this weekend nonetheless said the agency took "the high road" in its response to the study's recommendation.

Reed, of Fremont, Ca., was particularly incensed about the IOM's recommendations concerning patient advocates on the board. The IOM said that none of the board members, including patient advocates, should vote on grant applications secretly in grant review groups. The IOM said their votes should be recorded in public at full board meetings. Other patient advocates would still have seats on the grant review group, under the IOM recommendations. But they would not also be members of the governing board.

The IOM also said that CIRM should also revise its conflict of interest standards to regulate personal conflicts of interest, such as those involving particular diseases and patient advocates. Some members of the CIRM governing board bristled at the recommendation, and the board did not act on it last week.

Last Wednesday, the CIRM board acted to permit board members who are patient advocates to continue to participate in the closed door grant review sessions, but not vote on the grants at that stage. Previously patient advocates had two cuts at applications, one in the grant review group and one at the public board meeting.

Writing on the Daily Kos blog, Reed also said that no real conflicts of interest currently exist on the board, although 90 percent of the $1.7 billion that has awarded has gone to institutions tied to board members.

Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/SmmFtyc1zXo/patient-advocate-reed-defends-patient.html

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IOM’s Shapiro Wants to See More Changes from California Stem Cell Agency

Posted: February 3, 2013 at 8:10 am

Additional mainstream media news
coverage surfaced last Friday involving the California stem cell
agency's response to the blue-ribbon report from the Institute of
Medicine(IOM)
, whose concerns about the agency ranged from conflicts of interest to grant
appeals by rejected researchers.

One of the more interesting pieces was
done by Stephanie O'Neill of Los Angeles radio station KPCC. To her
credit, she contacted the chairman of the IOM panel, Harold Shapiro,
for his fresh take on what the stem cell agency's board did on
Wednesday.
His comments were somewhat different
than those read Wednesday at the CIRM board meeting. On Friday, Shapiro was quoted as
saying the board action was “an important first step forward,”
but he added a caveat. O'Neill wrote,

“'I’m encouraged by this,' Shapiro
told KPCC. 'Presumably in the future they’ll take other steps. But
these are steps they could take without any legislative approval and
…I think it does respond in a pretty significant way to the spirit
of the report.'
“But Shapiro expressed concern that
the agency is making only 'small moves' to address a recommendation
that CIRM separate operations from oversight. Currently, the ICOC
functions 'both as an executor and as an overseer—competing duties
that compromise the ICOC’s critical role of providing independent
oversight and strategic direction,' according to the December IOM
report.
“'But  I do understand… that
would be a move that they would have to take over time so we’ll
have to wait and see,' Shapiro said.
“Thomas agreed and said that while
CIRMs recommendations more clearly define the roles of chairman and
president, more refinements will be likely over time.”

From the Los Angeles Times, came a
piece from Eryn Brown. Her article was brief and she referred her
readers to the California Stem Cell Report for details. Her first
paragraph said,

“Changes may be on the way at
California’s stem cell funding agency.”

In coverage outside the mainstream media,
the Burrill Report carried an article by Daniel Levine. The Burrill
Report is produced by Burrill & Co., a San Francisco life
sciences financial firm. Levine's straight-forward account was
largely based on the CIRM press release and the IOM report.
Two bloggers surfaced with some
coverage. UC Davis stem cell researcher Paul Knoepfler, who is a CIRM
grantee, called the Thomas plan a “bold one-year experiment” and
“biggest development for CIRM in many years.” Knoepfler said,

“I’m still not sure I’m a fan of
all of the proposed changes, but I would say the plan is bold and
creative.”

On livingbiology.com, an unidentified
CIRM grantee carried a few brief items live from the meeting.

Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/A2ayEbm2Se0/ioms-shapiro-wants-to-see-more-changes.html

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Health Canada Approves ADCETRIS® (Brentuximab Vedotin) for the Treatment of Relapsed or Refractory Hodgkin Lymphoma …

Posted: February 2, 2013 at 10:42 pm

BOTHELL, Wash.--(BUSINESS WIRE)--

Seattle Genetics, Inc. (SGEN) today announced that Health Canada has issued a Notice of Compliance with conditions (NOC/c), authorizing marketing of ADCETRIS for two lymphoma indications: (1) the treatment of patients with Hodgkin lymphoma (HL) after failure of autologous stem cell transplant (ASCT) or after failure of at least two multi-agent chemotherapy regimens in patients who are not ASCT candidates, and (2) the treatment of patients with systemic anaplastic large cell lymphoma (sALCL) after failure of at least one multi-agent chemotherapy regimen. The indications for ADCETRIS were authorized based on promising response rates demonstrated in single-arm trials. No data demonstrate increased survival with ADCETRIS.

We are focused on making ADCETRIS available globally to all eligible patients with relapsed HL and sALCL. The approval of ADCETRIS in Canada, as well as the recent approval in the European Union, are important milestones to accomplish this goal, said Clay B. Siegall, Ph.D., President and Chief Executive Officer of Seattle Genetics. Now that Health Canada has approved ADCETRIS, we are committed to working closely with public and private insurers to secure reimbursement coverage for patients in Canada.

The approval of ADCETRIS in Canada marks a significant milestone for patients with relapsed HL or sALCL who have had few new treatment options in several decades, Joseph M. Connors, M.D., FRCPC, Clinical Director, Center for Lymphoid Cancer at BC Cancer Agency in Vancouver, Canada.

Health Canada grants NOC/c, a form of market approval, on the basis of promising evidence of clinical effectiveness, for products intended for the treatment of serious, life-threatening or severely debilitating illnesses that meet a serious unmet medical need or demonstrate a significant improvement in the benefit/risk profile over existing therapies. Conditions associated with market authorization under the NOC/c policy include a requirement that Seattle Genetics conduct clinical trials designed to confirm the anticipated clinical benefit of ADCETRIS in these patients. Two confirmatory phase III clinical trials evaluating ADCETRIS in the front-line treatment setting of HL and mature T-cell lymphoma (MTCL), including sALCL, are currently underway and enrolling patients.

ADCETRIS (brentuximab vedotin) was issued marketing authorization under the NOC/c policy based on results from a single-arm, phase II pivotal trial in HL patients with relapsed or refractory disease following an ASCT and a single-arm, phase II pivotal trial in relapsed or refractory sALCL patients. ADCETRIS is administered in hospitals through IV infusion over 30 minutes every three weeks and patients who achieve stable disease or better should receive a minimum of 8 cycles and up to a maximum of 16 cycles (approximately one year).

ADCETRIS is the first in a new class of antibody-drug conjugates (ADCs) to be approved in Canada. Using Seattle Genetics proprietary technology, the ADC consists of a monoclonal antibody directed to an antigen called CD30. The monoclonal antibody is connected to a cell-killing agent by a linker system that is designed to be stable in the bloodstream but to release the cell-killing agent into CD30-expressing cells, resulting in target cell death. The CD30 antigen is known to be expressed on the Reed-Sternberg cells of HL and on sALCL, an aggressive type of T-cell non-Hodgkin lymphoma.

Health Canadas approval of ADCETRIS is the first step in getting patients access to this important therapy, said Sue Robson, Executive Director of Lymphoma Foundation Canada. The Lymphoma Foundation is committed to working with Canada provincial governments to ensure that appropriate patients have access to this new therapy.

About Lymphoma

Lymphoma is a general term for a group of cancers that originate in the lymphatic system. There are two major categories of lymphoma: Hodgkin lymphoma and non-Hodgkin lymphoma. Hodgkin lymphoma is distinguished from other types of lymphoma by the presence of one characteristic type of cell, known as the Reed-Sternberg cell. The Reed-Sternberg cell generally expresses CD30. Systemic ALCL is an aggressive type of T-cell non-Hodgkin lymphoma that also expresses CD30.

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Health Canada Approves ADCETRIS® (Brentuximab Vedotin) for the Treatment of Relapsed or Refractory Hodgkin Lymphoma ...

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Norman's Stemlogix Stem Cell Therapy Treatment at County Animal Clinic – Video

Posted: February 2, 2013 at 10:42 pm


Norman #39;s Stemlogix Stem Cell Therapy Treatment at County Animal Clinic
This is a video of live news coverage courtesy of WHIO TV of Dayton, Ohio. NORMAN A 5 YEAR OLD BLACK LAB SUFFERED A STROKE, AND WAS BROUGHT TO THE COUNTY ANIMAL CLINIC FOR A STEMLOGIX STEM CELL TREATMENT. THIS CREATED QUITE A BIT OF INTEREST FROM THE NEWS MEDIA. NOW AFTER 2 INFUSIONS NORMAN IS ALREADY SHOWING SIGNS OF RECOVERY.

By: StemLogixLLC

Originally posted here:
Norman's Stemlogix Stem Cell Therapy Treatment at County Animal Clinic - Video

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Stem Cell Face Lift Costs – Video

Posted: February 2, 2013 at 7:41 pm


Stem Cell Face Lift Costs
What are the risk factors or a stem cell face-lift? Is there a greater risk? According to Dr. Robet Brueck, a stem cell face-lift is a very safe procedure. This is because the doctor is using the patient #39;s own tissue. There are no foreign materials. It is not a graph that you are putting in from one person to another person. It #39;s using your own fat, stem cells, and blood, which make it very safe. It is an idea that will find more indications, for example, the treatment of burns. The possibilities are limitless. The only constraint is one #39;s own imagination. Subscribe for more Mental Health Videos: http://www.youtube.com Visit: http://www.americanhealthjournal.com

By: AHJDietNWeightLoss

Originally posted here:
Stem Cell Face Lift Costs - Video

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Face Lift Procedure – Video

Posted: February 2, 2013 at 7:41 pm


Face Lift Procedure
Robert Brueck, MD, of Associates in Cosmetic Surgery in Fort Myers, describes what he calls a stem cell facelift. Dr. Brueck explains how adult derived stem cells taken from the patient #39;s own fat are put under the skin to rejuvenate the face from the inside out. He says a stem cell facelift can be done in conjunction with a traditional facelift procedure. A facelift is a surgical method that removes excess facial skin to make the face appear younger. However, the aging face not only loses skin elasticity and develops looser droopy skin, but also loses fat and muscle tone. Additional procedures which may be necessary to achieve the best results include: necklift, blepharoplasty which is eyelid surgery, liposuction, autologous fat injection, removal of cheek fat pad, forehead lift, browlift, chemical or laser peel, and malar which is cheek, submalar or chin implants. The traditional facelift procedure is performed through an incision starting in the hair or hairline above and in front of the ear the temporal region. The incision is extended downward in front of the ear, comes under the ear and then upward behind the ear ending in the hair or hairline behind the ear. The skin and fatty tissues are then lifted off the underlying muscle and fascia connective tissue as far forward as is necessary to correct the loose skin problem. The underlying muscle and fascia can be tightened with sutures if the surgeon feels it is necessary. The skin is pulled back and upward and the ...

By: AHJDietNWeightLoss

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Face Lift Procedure - Video

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A bit of history about stem cells – Video

Posted: February 2, 2013 at 7:41 pm


A bit of history about stem cells
http://www.stemcellsarthritistreatment.com Early work by Friedenstein and associates provided intriguing information on the potential for bone marrow to differentiate into stem cells. They cultured bone marrow cells and removed cells that didn #39;t appear to adhere to each other. After further culture, they found that the most adherent cells were spindle shaped and resembled deposits of cartilage and bone. Other groups confirmed the findings and they found that these cells were multipotent and could differentiate into bone cells, cartilage cells, fat cells, and muscle cells. The name they gave to these multipotent cells was "mesenchymal stem cells." http

By: Nathan Wei

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A bit of history about stem cells - Video

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Epithelial to Mesenchymal Transition – Video

Posted: February 2, 2013 at 7:41 pm


Epithelial to Mesenchymal Transition
These are mouse embryonic stem cells expressing a fluorescent reporter of Wnt/Beta-Catenin activity. As they are differentiated towards mesoderm, there is a huge increase in reporter activity and cells begin the process of an epithelial to mesenchymal transition (EMT).

By: amalabgenetics

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Epithelial to Mesenchymal Transition - Video

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