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Meager Coverage of Yesterday's Bristling IOM-CIRM Meeting
Posted: December 13, 2012 at 8:31 pm
Mainstream news coverage today was skimpy, to put it mildly, of the testy session yesterday involving the governing board of the California stem
cell agency and representatives of the prestigious Institute of
Medicine(IOM).
Only two pieces appeared, one in the
San Diego U-T and another on the web site of the Los Angeles Times. Both
discussed what the Michael Hiltzik of the Times column called “overt hostility” on the
part of several board members (see yesterday's item here). Bradley
Fikes of the San Diego paper said the patient advocates on the board
“strongly criticized” the IOM report on the grounds that it
“unfairly suggests that they have a conflict of interest.”
San Diego U-T and another on the web site of the Los Angeles Times. Both
discussed what the Michael Hiltzik of the Times column called “overt hostility” on the
part of several board members (see yesterday's item here). Bradley
Fikes of the San Diego paper said the patient advocates on the board
“strongly criticized” the IOM report on the grounds that it
“unfairly suggests that they have a conflict of interest.”
One of the recommendations of the IOM
is that the agency develop ways to manage personal conflicts of
interest dealing with patient advocates and others at the agency.
is that the agency develop ways to manage personal conflicts of
interest dealing with patient advocates and others at the agency.
Fikes wrote,
"'I'm a
colon cancer survivor,' said Art Torres, vice chairman of the
oversight committee, and a patient advocate designate. 'Does having
colon cancer make me biased?'
“Jeff
Sheehy, another patient advocate designate, protested what he called
a 'defenestration' of patient advocates, whose interests often span
multiple diseases.”
Ron Leuty of the San Francisco Business
Times skipped the IOM matter and wrote about the awarding of $36
million in grants. However, a list of the most popular stories on the
Business Times web site, ranked as No. 5 Leuty's story last week on the IOM
study, just below an article about Stanford's $111 million
concert hall.
Times skipped the IOM matter and wrote about the awarding of $36
million in grants. However, a list of the most popular stories on the
Business Times web site, ranked as No. 5 Leuty's story last week on the IOM
study, just below an article about Stanford's $111 million
concert hall.
Fikes also had a piece on ViaCyte,
which is in his area, receiving another $3 million from CIRM.
which is in his area, receiving another $3 million from CIRM.
Posted in Stem Cells, Stem Cell Therapy
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Appeals at the California Stem Cell Agency: Worthwhile or Worthless?
Posted: December 13, 2012 at 3:56 pm
Jon Shestack, a patient advocate member
of the governing board of the California stem cell agency, weighed in
today on the virtues of the grant application appeal process at the
$3 billion research enterprise.
His remarks came in a “comment”
filed on the Duchenne item that appeared yesterday on this site. (His
full comment can be found at the end of that item.)
filed on the Duchenne item that appeared yesterday on this site. (His
full comment can be found at the end of that item.)
Shestack said that the handling of the
$6 million CIRM grant involving Duchenne research is “a casebook
study on why the special(extraordinary) petition is worthwhile. There
was indeed new and relevant information that only became available
after grant review. Scientific staff and leadership flagged it.”
$6 million CIRM grant involving Duchenne research is “a casebook
study on why the special(extraordinary) petition is worthwhile. There
was indeed new and relevant information that only became available
after grant review. Scientific staff and leadership flagged it.”
The utility of the petitions is one of
the reasons that we ran the story about Duchenne and the team at
UCLA. The extraordinary petition process is currently under fire by
both the Institute of Medicine and the stem cell agency itself, which
has appointed a task force to come up with changes. But, while the
petition process is certainly less than perfect, so is the peer
review/grant review process.
the reasons that we ran the story about Duchenne and the team at
UCLA. The extraordinary petition process is currently under fire by
both the Institute of Medicine and the stem cell agency itself, which
has appointed a task force to come up with changes. But, while the
petition process is certainly less than perfect, so is the peer
review/grant review process.
The Duchenne application is not the
only “case study.” An application by Karen Aboody of the City of
Hope is often cited as another case. There are undoubtedly others.
only “case study.” An application by Karen Aboody of the City of
Hope is often cited as another case. There are undoubtedly others.
The petition process was adopted
several years ago by the board as a tool to manage willy-nilly
appearances of scientists before the CIRM governing board whose
applications were rejected by reviewers. Now the Institute of
Medicine has recommended the petitions be abandoned, saying they
undermine the integrity of grant review process. The IOM cited a
major controversy in Texas involving its cancer research agency as an
example of how grant reviews or the lack of them can go bad – not
to mention conflict of interest problems there. CIRM has already
started to look for better solutions regarding appeals. Many of its directors
are troubled by emotional presentations from patients in
connection with petitions and the lack of adequate information to
make informed decisions on the spot about the contested matters.
several years ago by the board as a tool to manage willy-nilly
appearances of scientists before the CIRM governing board whose
applications were rejected by reviewers. Now the Institute of
Medicine has recommended the petitions be abandoned, saying they
undermine the integrity of grant review process. The IOM cited a
major controversy in Texas involving its cancer research agency as an
example of how grant reviews or the lack of them can go bad – not
to mention conflict of interest problems there. CIRM has already
started to look for better solutions regarding appeals. Many of its directors
are troubled by emotional presentations from patients in
connection with petitions and the lack of adequate information to
make informed decisions on the spot about the contested matters.
Whether appeals can be put in a tidy,
scientific box is debatable. Researchers have the right, under state
law, to address the board on any issue whatsoever. And at least some
of them will continue to do so -- regardless of any appeals changes -- when millions of dollars and their
careers are at stake.
scientific box is debatable. Researchers have the right, under state
law, to address the board on any issue whatsoever. And at least some
of them will continue to do so -- regardless of any appeals changes -- when millions of dollars and their
careers are at stake.
Opinions and decisions of CIRM
reviewers are not holy writ. They can and do make mistakes, as we
all do. In making changes in the appeals process, the goal of the
agency should be to devise a public and transparent process rather
than enshroud it in more secrecy. CIRM also should find a way to do
a much better job of communicating to applicants the availability of
appeals and precisely how to appeal when it becomes necessary.
reviewers are not holy writ. They can and do make mistakes, as we
all do. In making changes in the appeals process, the goal of the
agency should be to devise a public and transparent process rather
than enshroud it in more secrecy. CIRM also should find a way to do
a much better job of communicating to applicants the availability of
appeals and precisely how to appeal when it becomes necessary.
Posted in Stem Cells, Stem Cell Therapy
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Avascular necrosis stem cell therapy in mumbai – Video
Posted: December 13, 2012 at 7:48 am
Avascular necrosis stem cell therapy in mumbai
This video explores the patient #39;s condition before and after treatment.It is published by StemRx India. Avascular necrosis stem cell therapy in mumbai for more information visit http://www.stemrx.inFrom:StemRx BioScienceViews:3 0ratingsTime:04:07More inScience Technology
Read the original here:
Avascular necrosis stem cell therapy in mumbai - Video
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Randall avoids knee replacement surgery after adult stem cell therapy by Dr Harry Adelson – Video
Posted: December 13, 2012 at 7:48 am
Randall avoids knee replacement surgery after adult stem cell therapy by Dr Harry Adelson
Randall describes his experience with adult stem cell therapy by Dr Harry Adelson on his arthritic knee and ankleFrom:Harry AdelsonViews:0 0ratingsTime:01:08More inScience Technology
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Randall avoids knee replacement surgery after adult stem cell therapy by Dr Harry Adelson - Video
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BrainStorm Receives 3 Million NIS Grant from Israel’s Office of the Chief Scientist
Posted: December 13, 2012 at 7:48 am
NEW YORK & PETACH TIKVAH, Israel--(BUSINESS WIRE)--
BrainStorm Cell Therapeutics Inc. (BCLI), a leading developer of adult stem cell technologies for neurodegenerative diseases, announced today that Brainstorm Cell Therapeutics Ltd. was awarded a 3 million NIS grant from Israels Office of the Chief Scientist (OCS) for the year 2013. The grant is intended to support BrainStorms Research and Development program for its innovative stem cell therapy candidate NurOwn.
We are thankful to the OCS for its continued support of our Research and Development program. The non-dilutive capital funding from the OCS will help facilitate continuation of our clinical trials in Israel, as well as our preparations for clinical trials in the USA, said Dr. Adrian Harel, BrainStorms CEO.
The OCS has supported BrainStorm Cell Therapeutics Ltd. since 2007, providing grants of a total of $1.8 million until today. The Company is required to pay royalties to the OCS, amounting to 3% - 3.5% of revenues derived from sales of the products funded with these grants, but only up to the amount equal to 100% of the grants received plus LIBOR interest.
As reported by Brainstorm on Monday December 10, the Company anticipates announcing a new date for its shareholders teleconference shortly.
About BrainStorm Cell Therapeutics, Inc.
BrainStorm Cell Therapeutics Inc. is a biotechnology company engaged in the development of first-of-its-kind adult stem cell therapies derived from autologous bone marrow cells for the treatment of neurodegenerative diseases. The Company holds the rights to develop and commercialize its NurOwn technology through an exclusive, worldwide licensing agreement with Ramot, the technology transfer company of Tel Aviv University. For more information, visit the companys website at http://www.brainstorm-cell.com.
About the Office of the Chief Scientist
The Office of the Chief Scientist (OCS) in Israels Ministry of Industry, Trade and Labor is charged with execution of government policy for support of industrial R&D. The goal of the OCS is to assist in the development of technology in Israel as a means of fostering economic growth, encouraging technological innovation and entrepreneurship, leveraging Israel's scientific potential, enhancing the knowledge base of industry in Israel, stimulating high value-added R&D and encouraging R&D collaboration both nationally and internationally.
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BrainStorm Receives 3 Million NIS Grant from Israel’s Office of the Chief Scientist
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LA Times: On the California Stem Cell Agency and Wasting $700,000
Posted: December 13, 2012 at 12:04 am
The headline on the Los Angeles
Times web site this afternoon read,
"Is California's stem cell program
preparing to waste $700,000?"
The question was raised by Pulitzer
Prize-winning columnist Michael Hiltzik, whowas commenting on the presentation today by the
prestigious Institute of Medicine's (IOM) on its sweeping
recommendations for changes at the state stem cell agency.
Prize-winning columnist Michael Hiltzik, whowas commenting on the presentation today by the
prestigious Institute of Medicine's (IOM) on its sweeping
recommendations for changes at the state stem cell agency.
Hiltzik wrote,
"If you're betting that
the California
stem cell agency will spurn key recommendations of a
blue-ribbon review panel that criticized its leadership and
management structures, you might want to double that bet. Several
board members showed overt hostility to the panel's recommendations
during a public meeting today."
Harold Shapiro, chairman of the IOM
panel and former president of Princeton University, delivered
the briefing. The group's study took 17 months and cost the stem cell
agency $700,000.
panel and former president of Princeton University, delivered
the briefing. The group's study took 17 months and cost the stem cell
agency $700,000.
Hiltzik's piece summarized the IOM
proposals, which echoed many criticisms that have been aired for
years in California. Hiltzik wrote,
proposals, which echoed many criticisms that have been aired for
years in California. Hiltzik wrote,
"CIRM Chairman Jonathan
Thomas glided over those issues when he introduced Shapiro.
Thomas observed that the Institute of Medicine report included many
statements "validating CIRM, its process, what it was able to
achieve," which is a bit like launching the investigation of a
plane crash by focusing on all the planes that land safely every day.
Thomas did mention that the Institute of Medicine had made numerous
recommendation about how to "take something which is already a
great experience and improve it even further."
"Shapiro got only a few minutes
into his presentation before board members started interrupting him
with objections to the Institute of Medicine's recommendation for a
majority of independent members."
Hiltzik concluded,
"Thomas promised to stage a public
workshop on the Institute of Medicine report soon and to subject them
to 'lengthy discussion.'
"Does that sound as if the board
will be taking seriously the advice that it change the way it does
business? Stay tuned, but don't hold your breath."
Posted in Stem Cells, Stem Cell Therapy
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Winners From Today's Awards by the California Stem Cell Agency
Posted: December 12, 2012 at 11:15 pm
The 12 winners in the latest round of grants from the California stem cell agency all come from institutions linked to directors on the agency's governing board. Board members with conflicts of interest are not allowed to vote on the grants or participate in the debate. Since the inception of the agency, more than 90 percent of its awards have gone to institutions linked to the directors. Here is a link to the CIRM press release on today's meeting.
Here is the list of researchers who won awards today.
New Faculty Physician Scientist Translational Research Awards
RN3-06530 | Robert Baloh | Cedars-Sinai Medical Center | $3,031,737.00 |
RN3-06378 | Reza Ardehali | University of California, Los Angeles | $2,930,388.00 |
RN3-06504 | Jason Pomerantz | University of California, San Francisco | $3,084,000.00 |
RN3-06396 | Mana Parast | University of California, San Diego | $3,013,252.00 |
RN3-06425 | Tracy Grikscheit | Children's Hospital of Los Angeles | $3,408,000.00 |
RN3-06532 | Tippi MacKenzie | University of California, San Francisco | $2,661,742.00 |
RN3-06479 | Ann Capela Zovein | University of California, San Francisco | $3,084,000.00 |
RN3-06529 | Alan Cheng | Stanford University | $3,091,595.00 |
RN3-06455 | Ali Nsair | University of California, Los Angeles | $3,004,315.00 |
RN3-06460 | Emanual Maverakis | University of California, Davis | $2,964,000.00 |
RN3-06510 | Michelle Monje | Stanford University | $2,800,536.00 |
RN3-06525 | Ophir Klein | University of California, San Francisco | $3,084,000.00 |
Total | $36,157,565.00 |
Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/QdM4BZ5hPnc/winners-from-todays-awards-by.html
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ViaCyte Wins Another $3 Million from California Stem Cell Agency
Posted: December 12, 2012 at 11:06 pm
The California stem cell agency, which
has awarded ViaCyte, Inc., $36 million, today pumped another $3
million in the firm following the collapse of an alliance between the
San Diego firm and GlaxoSmithKline.
The now failed ViaCyte-Glaxo-CIRM
arrangement was ballyhooed by the CIRM in October because it would
have been the first deal involving Big Pharma and the stem cell
agency. The resources of Big Pharma are needed to pursue the
expensive path of turning stem cell research into cures.
arrangement was ballyhooed by the CIRM in October because it would
have been the first deal involving Big Pharma and the stem cell
agency. The resources of Big Pharma are needed to pursue the
expensive path of turning stem cell research into cures.
Meeting in Los Angeles, the CIRM
governing board approved the additional funds on a 13-0 vote with two abstentions. The action came following a closed door session to discuss how the funds would be spent. No details were provided publicly on that matter.
governing board approved the additional funds on a 13-0 vote with two abstentions. The action came following a closed door session to discuss how the funds would be spent. No details were provided publicly on that matter.
ViaCyte
has also told Biocentury that it is pursuing even more funding after
the alliance with Glaxo broke down. CIRM President Alan Trounson said ViaCyte is likely to receive another $3 million from the Juvenile Diabetes Research Foundation. Trounson also said that other sources are being examined as well.
Patricia Olson, executive director of
CIRM, scientific activities said the agency's advisors continue to have faith in ViaCyte's effort to develop a treatment for diabetes. The company plans to start a clinical trial on its product in
2014.
CIRM, scientific activities said the agency's advisors continue to have faith in ViaCyte's effort to develop a treatment for diabetes. The company plans to start a clinical trial on its product in
2014.
The ViaCyte-Glaxo-CIRM deal was cause for
celebration last fall. Alan Trounson, CIRM's president, said the
deal would “resound” globally. He told directors,
celebration last fall. Alan Trounson, CIRM's president, said the
deal would “resound” globally. He told directors,
“This is
verification of our program. To have (the head of Glaxo regenerative
medicine program) join us through a partnership arrangement with GSK
means that a project that we've shepherded from the basic science
through to the preclinical work and is heading to the clinic we're
now going to do in partnership with a very major organization.”
Posted in Stem Cells, Stem Cell Therapy
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Constitutional Questions Raised on Sweeping Changes at the California Stem Cell Agency
Posted: December 12, 2012 at 9:05 pm
The outside counsel to the governing board of the California stem cell agency is preparing an opinion on whether some of the major changes recommended by the blue-ribbon Institute of Medicine(IOM) study might require a vote of the people.
More than three years ago, the same issue was raised and used by the agency to resist unwanted changes.
Kevin McCormack, agency spokesman, said today that James Harrison of Remcho Johansen & Purcell of San Leandro will perform the analysis. Harrison has been counsel to the CIRM board since its inception. He also wrote part of Proposition 71, which created the stem cell agency in 2004.
Harrison's analysis was disclosed after CIRM Director Sherry Lansing, who is also chairwoman of the University of California Board of Regents, said this morning that the board's "hands are tied" concerning some of the IOM proposals because they could require a vote of the people. Other members of the board bristled at the IOM recommendations.
In 2009, Harrison tackled a similar task in connection with related, proposed structural changes at the $3 billion stem cell research effort. In reaction to proposals by the Little Hoover Commission, the state's good government agency, Harrison said,
“The Little Hoover Commission’s proposals would effect drastic and disruptive changes to CIRM’s governance and operating systems. Such changes run counter to the voters’ intent, and do not further Proposition 71’s purposes.”
The California Stem Cell Report wrote at the time,
"The 10-page legal memo hung most of its arguments on a provision in Prop. 71 that states that it can only be amended by the legislature if the changes 'enhance the ability of the institute to further the purposes of the grant and loan programs.'
"Harrison's memo said the Hoover proposals (in question) could only be enacted through another ballot measure...."
The Little Hoover proposals dealt with the structure of the board and the conflicting responsibilities of the president and the chairman. The IOM has recommended major changes in both areas and approvingly cited the Hoover study .
Harrison's analysis will also delineate which IOM recommendations can be implemented by board action and which will require legislative approval.
The IOM report, which cost the stem
cell agency $700,000, recommended a host of changes that critics for
years have said are needed. But the 17-month study also went beyond
what the critics had proposed. The IOM said that the 29-member
governing board should be stripped of power to approve individual grants.
Instead, the board would be limited to voting for or against a slate
of applications.
cell agency $700,000, recommended a host of changes that critics for
years have said are needed. But the 17-month study also went beyond
what the critics had proposed. The IOM said that the 29-member
governing board should be stripped of power to approve individual grants.
Instead, the board would be limited to voting for or against a slate
of applications.
The IOM also proposed far-reaching
changes to remove conflict of interest problems, clean up a troubling
dual-executive arrangement and fundamentally change the nature of the
governing board. The recommendations would greatly strengthen the
role of the agency's president, significantly alter the role of
patient advocates on the governing board and engage the biotech
industry more vigorously.
changes to remove conflict of interest problems, clean up a troubling
dual-executive arrangement and fundamentally change the nature of the
governing board. The recommendations would greatly strengthen the
role of the agency's president, significantly alter the role of
patient advocates on the governing board and engage the biotech
industry more vigorously.
CIRM's governing board and its first chairman, Robert Klein, an attorney who directed the writing of the stem cell initiative and wrote parts of it, have mightily resisted related proposals. In 2009, Klein even warned of lawsuits if legislative action were initiated for reforms (see here and here).
In an editorial today, The Sacramento Bee said changes are long overdue at the agency. The Bee said CIRM has "been consumed by a siege mentality that has prevented any real introspection.” In another editorial earlier this week,
the San Francisco Chronicle said that prompt and major changes are
needed at the agency.
the San Francisco Chronicle said that prompt and major changes are
needed at the agency.
Many of the more significant
recommendations clearly require either a rare, super, supermajority vote of
the legislature (70 percent) and the signature of the governor or
another ballot initiative, which is very unlikely. Achieving the 70
percent vote is exceedingly difficult except on the most
noncontroversial matters before the legislature. The requirement
permits only 13 members of the 40-member Senate to block any CIRM
legislation, giving minority viewpoints extraordinary power over the
content of any CIRM legislation.
recommendations clearly require either a rare, super, supermajority vote of
the legislature (70 percent) and the signature of the governor or
another ballot initiative, which is very unlikely. Achieving the 70
percent vote is exceedingly difficult except on the most
noncontroversial matters before the legislature. The requirement
permits only 13 members of the 40-member Senate to block any CIRM
legislation, giving minority viewpoints extraordinary power over the
content of any CIRM legislation.
Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/6UqNIAVe5JY/constitutional-questions-raised-on.html
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A Singular Scientific Story: Duchenne's Disease, a Family and the California Stem Cell Agency
Posted: December 12, 2012 at 7:00 pm
Unusual and personal conditions,
including a tie to the $3 billion California stem cell agency,
surround a promising scientific development reported today by a
husband and wife research team at UCLA.
including a tie to the $3 billion California stem cell agency,
surround a promising scientific development reported today by a
husband and wife research team at UCLA.
Their research involves Duchenne
muscular dystrophy (DMD), an inherited disease that afflicts about
one in 3,600 boys and results in muscle degeneration and, eventually,
death.
muscular dystrophy (DMD), an inherited disease that afflicts about
one in 3,600 boys and results in muscle degeneration and, eventually,
death.
Carrie Miceli UCLA photo |
The researchers, Stan Nelson and Carrie
Miceli, said they have discovered a promising FDA-approved drug that
could advance the fight against the affliction.
Miceli, said they have discovered a promising FDA-approved drug that
could advance the fight against the affliction.
Miceli and Nelson have an 11-year-old
son, Dylan, with the disease. They have been studying the affliction
for some time, but their most recent and ambitious research plan was
rejected earlier this year by stem cell agency grant reviewers, a process that
normally kills an application. Undaunted, Miceli and Nelson appealed
to the full stem cell agency board last July. Backed by an emotional
presentation involving patient advocates, they won approval of a $6
million grant.
son, Dylan, with the disease. They have been studying the affliction
for some time, but their most recent and ambitious research plan was
rejected earlier this year by stem cell agency grant reviewers, a process that
normally kills an application. Undaunted, Miceli and Nelson appealed
to the full stem cell agency board last July. Backed by an emotional
presentation involving patient advocates, they won approval of a $6
million grant.
Adding to all this, their appeal used a
process known as an “extraordinary petition,” which the Institute
of Medicine (IOM) last week said should be abandoned because it undermines
the integrity of the CIRM grant review process.
process known as an “extraordinary petition,” which the Institute
of Medicine (IOM) last week said should be abandoned because it undermines
the integrity of the CIRM grant review process.
Stan Nelson UCLA photo |
Even prior to the IOM recommendation,
the CIRM board was moving to restrict its free-wheeling
appeals procedures.
the CIRM board was moving to restrict its free-wheeling
appeals procedures.
As for the $6 million CIRM grant, it will carry the important burden of advancing the findings that were published in the
journal Science Translational Medicine. However, the money was not used in the study reported today.
journal Science Translational Medicine. However, the money was not used in the study reported today.
The research showed that dantrolene, the FDA-approved drug, “provides a powerful boost to
the (Duchenne) therapy currently being tested in clinical trials,”
according to a UCLA press release.
the (Duchenne) therapy currently being tested in clinical trials,”
according to a UCLA press release.
The news release said,
“(The researchers) hope this one-two
punch used in combination will overcome the genetic mutations that
cause DMD, restore a missing protein needed for proper muscle
function and allow those affected by the disease to lead relatively
normal lives.”“Their youngest son, Dylan, 11, was
diagnosed with DMD in 2004. While he’s still ambulatory – many
DMD patients require the use of wheelchairs by about age 10 – Dylan
can no longer run or climb stairs and he can’t shoot a basketball
over his head like other boys his age. Despite these
challenges, Miceli said Dylan remains a happy, funny and engaged boy,
full of life and passion.“'We entered into this field because
of the diagnosis of our son, but we hope our research can help many
others,' she said. 'There are drugs that can help manage the symptoms
of the disease, but nothing that changes its course dramatically.
We’re trying to correct the defect that causes DMD with highly
personalized genetic medicine.'”
UCLA said the grant from CIRM will be
used for “longer term studies of their drug combination therapy in
mouse models to ensure it can restore dystrophin levels to normal or
near normal levels. They also will explore whether DMD patients with
other mutations can benefit from the combination therapy.”
used for “longer term studies of their drug combination therapy in
mouse models to ensure it can restore dystrophin levels to normal or
near normal levels. They also will explore whether DMD patients with
other mutations can benefit from the combination therapy.”
Asked for comment, Kevin McCormack, a
spokesman for the stem cell agency, said today's findings "are certainly
very encouraging." He continued,
spokesman for the stem cell agency, said today's findings "are certainly
very encouraging." He continued,
"Clearly there is still a long way
to go before we know if this approach will work in people but we're
delighted that funding from the stem cell agency is helping the
researchers move their work forward....This is what voters set out to
do when they approved Proposition 71 to create the stem cell agency."
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