Industry-sponsored cardiovascular cell therapies. Some metrics.
By Dr. Matthew Watson
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Cell therapies for cardiovascular-related conditions is a closely watched, much studied, oft-discussed, and hotly contested segment of the cell therapy industry.
The data to-date are admittedly confusing. From a clinical perspective, the studies for which we have data have been relatively small involving a mish-mash of indications, endpoints, eligibility criterion, methods and/or route of administration, as well as the time of administration relative to event or disease progression.
Further compounding any interpretation of the data, from a technical perspective, is the fact the products have been widely varied in terms of being autologous vs allogeneic, expanded and not, genetically modified and not, from a plethora of different sources, and utilizing a wide variety of cell types from skelatal myoblasts, cardiomyocytes, mesenchymal stromal cells, mononuclear cells, etc.
All this makes it extremely difficult to draw any conclusions with respect to what's working and what's not. We will not attempt to do so.
All we do below is attempt to give a snapshot of the industry-sponsored cell therapy trials currently ongoing for cardiovascular-related conditions. So here it is:
Commercial:
Pharmicell's Heartcelligram is the only cell therapy to have received regulatory approval for commercial distribution for the treatment of a cardiac-related indication. Heartcelligram is an autologous cell therapy approved in 2011 by the Korean Food and Drug Administration (KFDA) for the treatment of Acute Mycardial Infarction (AMI). The price is reportedly $19,000 and the trial data behind the approval has not yet been published in a peer-reviewed journal.
Phase III or II/III:
There are currently only 3 active and recruiting cardiac-related, industry-sponsored cell therapy trials. Interestingly they all involve autologous products, two involve devices, two involve centralized manufacturing, two involve bone marrow cells as a source, two are only in European clinical sites, and two are targeting ischemic-related conditions.
- Baxter Therapeutics' Auto-CD34+ cells
- phase III trial actively recruiting
- Indication: refractory angina and chronic myocardial ischemia
- Estimated enrollment: 444
- Estimated primary completion: June 2016
- Cytori
- phase II/III trial actively recruiting
- Indication: ST-elevation acute myocardial infarction
- Estimated enrollment: 360
- Estimated primary completion: July 2014
- Miltenyi Biotec
- phase III trial actively recruiting
- Indication: myocardial ischemia or coronary artery disease
- Estimated enrollment: 142
- Estimated primary completion: July 2012
Mesoblast has also announced with its strategic partner, Teva, that they are proceeding with plans to conduct a phase III study of its allogeneic cell therapy product, Revascor, in chronic heart failure. Most anticipate this clinical trial application to be filed sometime in late 2012.
Phase I or II:
There are over 20 active, industry-sponsored earlier-stage trials (phase I, I/II or II) for cardiovascular-related conditions. At least 5 of these are expected to have clinical readouts this year.
Hope this is useful.
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May 27th, 2012
Psychiatry’s "Bible" Gets an Overhaul (preview)
By Dr. Matthew Watson
Editor's Note: Read our blog series on psychiatry's new rulebook, the DSM-5.
Source:Uncategorized
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May 27th, 2012
A Look at the ‘Son of CIRM’ Proposal on the June California Ballot
By Dr. Matthew Watson
In the last couple of weeks, two
well-respected Los Angeles Times columnists have visited what
might be called the "Son of CIRM" initiative on the
June ballot in California. It is aimed at fighting cancer by spending
$800 million or so annually on research with the money coming from a
$1-a-pack tax on cigarettes.
Hiltzik, said the measure, Proposition 29, is another
example of why California is a world leader in "paving the road to hell with good intentions." The other writer, George
Skelton, said,
"Prop. 29 would increase cancer
research. Reduce smoking. Save lives. Hurt the lying tobacco
companies. Good plan."
and financial news. He has written from time to time critically about
the $3 billion California stem cell agency. Skelton is a longtime
observer of the Califorrnia political scene and has been around since
Pat Brown was governor.
Sunday, Hiltzik said that the drafters of the cancer measure closely
examined Proposition 71, which created the stem cell agency in
2004, and "managed to reproduce the earlier measure's worst
features."
the trophy for doing the wrong thing in the wrong way for what sounds
like the right reasons." Hiltzik wrote,
"Proposition 71, you may recall, was sold to a gullible
public via candy-coated images of Christopher Reeve walking
again and Michael J. Fox cured of Parkinson's.
The implication was that these miracles would happen if voters
approved a $3-billion bond issue for stem cell research. Who could be
against that?
"As it turned out, the stem cell
measure created an unwieldy bureaucracy and etched conflicts of
interest into the state Constitution. By last count about 85% of the
$1.3 billion in grants handed out by the program, or some $1.1
billion, has gone to institutions with representatives on the stem
cell board. The program is virtually immune to oversight by the
Legislature or other elected officials. For these reasons and others,
it has grappled with only mixed success with changes in stem cell
science and politics that have called its original rationale into
question."
"Proposition
29, similarly, places most spending from the tobacco tax in the hands
of a nine-member board that must comprise one cardiovascular
physician affiliated with a California academic medical center; the
chancellors of UC Berkeley, UC San Francisco and UC
Santa Cruz; two representatives of lobbying groups devoted to
tobacco-related illness (including one who has been treated for such
a disease); and three representatives from National Cancer
Institute-designated cancer centers in the state. There are
10 of the latter, including five UC campuses and the City of Hope.
Plainly, every member of the board will represent an employer that
thinks it's in line for some of the money."
he lambasted the tobacco industry for its "a
certified history of deception, distortion and lying. And let's not
forget fraud and racketeering."
being aired in California against the initiative. They criticize the
measure for its conflicts of interest and also say that the money
would be spent out of state.
"The anti-29 side is hitting this
hard: that the research money generated in California could be spent
out of state. And the politest thing possible to say about that claim
is that it's disingenuous. It's stretching something that's
conceivable into a virtual certainty."
"The anti-29 camp charges that
(the structure of the board) would allow a conflict of interest in
awarding contracts. But there are state laws that protect against
such conflicts.
"Anyway, the tobacco crowd can't have it
both ways: complaining that the money could be spent outside
California and also griping when the system is set up to practically
guarantee that it will be spent in California."
the heart of both the stem cell and cancer initiatives -- is one of the
reasons that California is staggering from one year to the next in a
perennial financial mess. Initiatives also sometimes create nasty
blowback that can damage the effort that they ostensibly serve. Such
is the case with the California stem cell agency, which suffers from
management and other minutia embedded in Proposition 71 that is virtually
politically impossible to change.
"Gov. Brown's latest budget
proposal calls for cuts of $1.2 billion in Medi-Cal and
$900 million in CalWorks (a relief program for families with
children) and steep cuts in financial aid for college students and in
court budgets. The University of California and Cal State systems are
becoming crippled by 20 years of cutbacks in state funding,
leading to soaring tuition charges. Tobacco-related illnesses create
some of the burden on Medi-Cal and other public healthcare programs,
yet a minimal portion of Proposition 29 revenue, if any, would go to
helping taxpayers carry that burden.
"With the overall state budget gap
approaching $16 billion, how can anyone make the case for diverting a
huge chunk of $800 million a year in new revenue to long-term
scientific research, whether in California or not? Even if you
believe that case can be made, the proper place to make it is in the
Legislature, where all these demands on the budget can be weighed and
balanced against one another — not at the ballot box, where the
only choice is to spend it the way the initiative's drafters choose
or not to raise it at all."
wholeheartedly.
Skelton when he was bureau chief for United Press International in
Sacramento some decades ago and consider him a friend. I am also
acquainted with Hiltzik but have not known him as long. I hold both
men in high regard.)
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May 27th, 2012
Thin Coverage of California Stem Cell Board Meeting
By Dr. Matthew Watson
million in research awards and other matters involving the California
stem cell agency was nearly non-existent today.
$3 billion enterprise is not within the attention span of the
mainstream press and electronic outlets.
only two stories involving yesterday's actions. One by Ron Leuty
appeared in the San Francisco Business Times and was a look at the grant awards. The other appeared on Nature's website.
It said,
"The California Institute of Regenerative Medicine
(CIRM) voted on 24 May to accept a new strategic planwhich
shrinks or eliminates support for basic research, facilities and
training, while funneling more of its funds toward clinical
development."
off until at least July decisions on which programs to cut and which
to expand. Basic research is not likely, however, to take a major
hit, for a variety of reasons.
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May 27th, 2012
‘Sun Never Sets on CIRM’ – California Agency Awards $69 Million to Researchers
By Dr. Matthew Watson
awarded $69 million in grants, including the first involving a collaboration with researchers in China, but none of the awards went to California
biotech businesses.
third translational round, which funds projects that are in the
initial stage of identifying drugs or cell types that could become
drug therapies.
for the round, but CIRM spokesman Kevin McCormack said that grant
reviewers determined that no applications beyond $69 million were
worthy of funding.
reviewer decision on one grant after the scientist – W. Douglas
Boyd of UC Davis -- filed an appeal. The appeals of two other
researchers, including one from a San Diego business, were not successful (see here
and here).
applications from businesses. The agency has been sharply
criticized for failing to fund businesses in a substantial way.
collaboration with researchers in Australia and Germany as well as
China. The collaborations are based on agreements worked out earlier
by CIRM with overseas groups, which fund their own countries' researchers. No CIRM cash is involved, according to the agency.
of Australia and researcher there until joining the stem cell agency,
said in a press release,
"The sun now never sets on the
CIRM collaborative projects..."
"The
Chinese Ministry of Science and Technology has committed roughly
$850,000 in collaboration with a team at UCSF to study liver failure.
This is the stem cell agency’s first joint effort with scientists
in China, which is home to a fast-growing stem cell research
community."
Willenbring, whose goal is "to develop a source of autologous
therapeutic cells for patients with liver disease who otherwise would
require a liver transplant," according to the CIRM review summary.
The agency did not spell out the details of how the collaboration
would work.
exception of a Salk researcher, work for institutions linked to at
least one of the 29-members of the CIRM governing board. CIRM
directors, however, are barred from voting or even discussing applications in which CIRM attorneys have determined there is a conflict
of interest.
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May 27th, 2012
Stem Cell Agency Board Sticks with More Financial Disclosure
By Dr. Matthew Watson
The governing board of the $3 billion
California stem cell agency today rejected a proposal that would have
restricted transparency surrounding the financial interests of its
directors and top executives.
decided it would stick with the more complete disclosure rules that it
has operated under since 2005. CIRM staff had offered changes that would have narrowed the amount of economic
information that the board members and the executives would have been
required to disclose.
Hollywood film studio CEO and chair of the subcommittee, said at the time,
"I personally feel strongly that
because of CIRM's unique mission and the agency's incredibly
long-standing commitment to transparency, i believe that we should
continue to set an example by requiring the broadest disclosure for
members of the board and high level staff."
rules comes at a time when more conflicts may arise. The agency is
moving to engage the biotech industry more closely as it pushes to
develop stem cell therapies. Already one case of conflict has arisen this
year dealing with industry. It involves a "special advisor"
to CIRM who was nominated to become director of a firm sharing in a
$14.5 million grant. She also was working for the firm. (See here and
here.)
conflicts of interest, written into the law by Proposition 71, which
created the agency. About 92 percent of the $1.3 billion awarded so
far has gone to institutions tied to members of the CIRM governing
board. Board members are not permitted, however, to vote on or
discuss grants to their institutions. But it is fair to say that if
California voters had foreseen that nearly all of the grants would
have gone to directors' institutions, they would not have
approved creation of the stem cell agency.
move for CIRM to retain more transparency rather than less. As one of
the Moss Adams staffers said today – in a different context –
during the presentation of the first-ever performance audit of CIRM,
"When people have to fill a void
in information, they assume the worst."
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May 27th, 2012
California Stem Cell Agency Launches Five-Year Push for Cures
By Dr. Matthew Watson
The $3 billion California stem cell
today officially embarked on a course that will mean closer ties to
the biotech industry in hopes of fulfilling the campaign promises to voters to
turn stem cells into cures.
changes in the seven-year-old agency's strategic plan. The action
will likely mean less money for some activities that enjoyed more cash in the past, but directors put off action until at least late July. The plan also sets the course for what may be the last years of life
for the unprecedented state research program. Authorization to borrow
more money (state bonds) for its grants will run out in about 2017.
During a brief discussion of the plan, which has been debated for some months, CIRM Director Jeff Sheehy noted that the agency has now entered "the realm of trade-offs." Ellen Feigal, CIRM's senior vice president for research and development, told the board that the plan will require hard decisions and sharp focus on priorities.
investment that focus on products. Another five-year goal explicitly calls for financing at least 10 therapies in early-phase
clinical trials, affecting at least five diseases. Overall, the plan seeks to achieve clinical proof-of-concept for stem cell therapies.
campaign rhetoric, CIRM's strategic plan acknowledges that developing therapies takes a very long time,
often decades.
board for spending the agency's remaining $836 million for grants and
loans. One would allocate $506 million for development research, $195
for translational research and $135 million for basic research, but
nothing for training and "facilities/core resources."
million for development research, $160 million for translational
research, $105 for basic research, $60 million for training and $25
million for "facilities/core resources."
The first scenario would mean a $85 million cut in training and shared lab programs – cash that helps to finance researchers and that benefits the many institutions that have representation on the CIRM board.
The board put off action on either scenario after CIRM President Alan Trounson said he wanted more time to prepare a complete analysis of the scenarios.
platform to enable grantees, disease foundations, venture capitalists
and others to purse CIRM's mission when its state bond funding runs
out. The possibility exists that another bond measure would be submitted to voters. But in either case, CIRM will need a solid record to attract support.
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May 27th, 2012
CIRM Directors Pleased with Performance Audit Findings
By Dr. Matthew Watson
The $3 billion California stem cell
agency received a "very favorable" performance audit report
compared to other government agencies, CIRM directors were told
today.
was paid $234,944 by CIRM for the study, made the comments during a
presentation today to the agency's 29 directors. During their
comments, CIRM executives and directors focused on the favorable
aspects of the findings of the six-month study.
report showed that CIRM is "doing better than being on the right
track." Co-vice chairman Art Torres said,
"Comparatively we
have done very well."
of the CIRM staff – "a high caliber group" – and noted
the seven-year-old agency is both "ramping up and ramping down"
at the same time – a reference to the end of state bond funding for
CIRM in 2017.
President Alan Trounson said the staff would review the findings and
come up with a plan for the board at its July meeting. The agency is
already implementing some of the recommendations.
state law that also allowed CIRM to hire more than 50 persons, a cap
imposed by Proposition 71, which created the agency. The audit found a need for improvement in 27 areas and made recommendations. Of the 20 recommendations with the highest priority,
half involved how CIRM manages its information, much of which is
needed for good decision-making. The audit did not assess the
scientific performance of the agency.
Seattle firm's San Francisco office, said,
"CIRM board members and senior
management do not receive regularly updated, enterprise-level
performance information. The ability to evaluate performance against
strategic goals is critical to effective leadership and program
monitoring, evaluation, and reporting. CIRM does not currently have a
formal performance reporting program."
information, Moss Adams called for improvements in the agency's
long-troubled grants management system, better grant outcome
tracking, development of a results-based communications plan,
creation of a comprehensive, formal business development plan,
formulation of a comprehensive information technology plan that would
include steps to establish clear responsibility for CIRM's website
and improved monitoring of invention disclosure forms from grantee
institutions.
agency hired a director for information technology, who is expected
to solve many of the problems cited in the audit.
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May 27th, 2012
Live Coverage of Tomorrow’s California Stem Cell Meeting
By Dr. Matthew Watson
The California Stem Cell Report will
provide live coverage of tomorrow's meeting of the governing board of
the $3 billion California stem cell agency. Directors are expected to
make major decisions about the agency's future direction, hear the results
of the first-ever performance audit and award about $95 million in
grants or loans.
Francisco airport with another public teleconference location at UC
San Francisco. Los Angeles will also have two public teleconference
locations. Another will be in La Jolla.
the Internet, which the California Stem Cell Report will monitor from its
base in Panama near the Pacific entrance to the Panama Canal.
audiocast can be found on the agenda along with specific addresses
for the public teleconference locations. The meeting is scheduled to
begin at 9 a.m. PDT.
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May 27th, 2012
Michael J. Fox Backs Away From Stem Cell Cure for Parkinson’s
By Dr. Matthew Watson
It was not exactly a case of "Back
to the Future," the hit movie starring Michael J. Fox,
but it did offer a reflection on the past.
changing views on stem cell research in connection with Parkinson's
disease, which he has had since the 1990s.
 |
| Fox's 2004 Ad |
support of human embryonic stem cell research. ABC News
recently described him as having become "one of the country’s
most visible advocates for stem cell research." In California, Fox was a prominent promoter of the ballot initiative, Proposition 71,
that created the $3 billion California stem cell agency in 2004. "
aired widely during the 2004 campaign to create the stem cell agency,
declaring,
"It could save the life of someone you love."
confident. In an interview last week with ABC, he cited "problems
along the way." Fox said,
“It’s not so much that [stem cell
research has] diminished in its prospects for breakthroughs as much
as it’s the other avenues of research have grown and multiplied and
become as much or more promising. So, an answer may come from stem
cell research but it’s more than likely to come from another area.”
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May 27th, 2012
Third Researcher Appealing Grant Rejection to Stem Cell Agency Board
By Dr. Matthew Watson
The director of robotics and biosurgery
at UC Davis is appealing rejection of his application for a
$4.9 million grant from the California stem cell agency.
noted that his proposal was given a scientific score of 67, which was
one point below the cutoff for most grants approved by CIRM's
Grants Working Group. Thirteen grants fell in the 68 to 53
range, including Boyd's. Reviewers approved four in that range,
including two with scores of 53.
letter of support from an Indiana firm, Cook Biotech, Inc.,
that would supply the "material and technical expertise to
create a new bioengineered cardiac patch
appeals(see here and here), will be given to CIRM directors in the agenda material for their meeting tomorrow in San Francisco. The
board does not have to act on the petitions or discuss them.
Researchers can also appear before the board to make a case.
Davis Health Systems, is a member of the CIRM board. She
will be barred from taking part in any discussion of Boyd's
application or voting on it.
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May 27th, 2012
Stem Cell Agency Hires Tech Chief to Solve a Myriad of Problems
By Dr. Matthew Watson
In a move that was long overdue, the $3
billion California stem cell agency last week hired a director of
information technology to straighten out key problems ranging from
its grants management system to how it handles its website.
governing board faces the results of its first-ever performance audit, which is markedly critical of how the agency handles its
information. Half of the audit's 20 highest priority recommendations for improvement focus on information deficiencies, including
critical information necessary for CIRM executives to determine the
agency's performance.
the shoulders of Bill Gimbel, who is no stranger to CIRM. He has been
working with the agency as an information technology advisor since
2010 through a contract with Infonetica, Inc., of Pleasanton, Ca., according to CIRM spokesman Kevin McCormack. Gimbel is now the first staff person in a chief technology position at CIRM since October 2007, when about 25 percent of CIRM employees left.
 |
| Bill Gimbel |
paid $180,000 annually, has a broad range of experience in computer
technology and software dating back to 1992. According to his
Linkedin web site, he was most recently director of IT at Infonetica.
He lists himself as owner of aptReader, an app for reference books.
He has also worked for LearningExpress and Scholastic, Inc.
management system has been an issue at least since 2007, when
directors were told its costs would not exceed $757,000. No figures
for the total spent since then have been made public by CIRM, which
is attempting to build a custom system, but the amount clearly and
easily surpasses the 2007 estimate, based on some of the outside
consulting costs. Although the agency hopes to resolve many of the
problems by the end of this calendar year, the grant system was the
target of considerable attention by Moss Adams, the firm that
prepared the performance audit.
intermittent, sketchy CIRM staff reports about the grants management
system, but the Moss Adams discussion is the most
comprehensive.
"Integration
of website content management has not been an integral part of the
GMS (grants management system) development process, which could
result in suboptimal operational efficiency and effectiveness."Grants management system
development is effectively managed at a tactical level, but it lacks
dedicated, strategic governance and oversight, which has resulted in
an elongated development process and requirements conflicts."
"The new grants management system
intellectual property module, currently under development, does not
include provisions to address commercialization activity."
said,
"CIRM board members and senior
management do not receive regularly updated, enterprise-level
performance information. The ability to evaluate performance against
strategic goals is critical to effective leadership and program
monitoring, evaluation, and reporting. CIRM does not currently have a
formal performance reporting program."
information technology topics:
"Data and document access are
inefficient as a result of CIRM operating without a document
management system.....In most cases, CIRM staff cannot access
information without human interface. Information is stored in
multiple locations, which are not linked or indexed."
tried to solve its information problems without a plan.
"CIRM’s
information system needs have been met by a variety of tools,
including in-house developed applications, off-the-shelf
applications, databases, and spreadsheets, most of which are not
integrated," the audit stated.
wasted time when CIRM's tiny staff tries to extract information from
the hodge-podge of systems. It is time that cannot be spared as the
workload increases in the next few years, as it is certain to do.
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May 27th, 2012
SD scientists get $18 million in stem cell funds
By daniellenierenberg
San Diego scientists will receive about $18.1 million in the latest round of funding from the California Institute of Regenerative Medicine (CIRM), the agency that's distributing $3 billion in stem cell research money made available through Proposition 71.
Since funding began, San Diego County researchers have been awarded at least $258 million, making the region one of the largest stem cell research clusters in the country.
Extended U-T science coverage on Facebook
Here's a sample of the latest grants:
Mark Tuszynski, UC San Diego, $4.7 million for research on novel stem cell therapies to treat spinal cord injuries.
Peter Schutlz, The Scripps Research Institute, $4.3 million for research to treat multiple sclerosis.
Juan Carlos Izpisua Belmonte, Salk Institute, $2.3 million for research that would help repair damaged blood vessels.
Yang Xu, UC San Diego, $1.8 million for research that would help treat heart failure.
Eric Adler, UC San Diego, $1.7 million for research to help treat Danon disease, which causes major abnormalities in heart and skeletal muscles.
David Schubert, Salk Institute, $1.7 million for research aimed at treating Alzheimer's disease
See the article here:
SD scientists get $18 million in stem cell funds
Spinal Cord Stem Cells
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May 27th, 2012
Former Zumba instructor with cancer encourages Hispanics to donate bone marrow
By Dr. Matthew Watson
Photo by Rachel Denny Clow, Corpus Christi Caller-Times // Buy this photo
Rachel Denny Clow/Caller-Times Cristina Rodriguez sits with her dogs Coby (left) and Flower at her home Thursday. Rodriguez, who has non-Hodgkin lymphoma, is having a Zumba benefit on Sunday and inviting people to register to donate bone marrow. Rodriguez is a former Zumba instructor.
CORPUS CHRISTI Had Cristina Rodriguez's cancer been more aggressive, had it penetrated her bones, things might have been different.
And while she has had chemotherapy, she has lost her hair and needs a stem cell treatment, but she doesn't need a bone-marrow transplant.
And for that, she's lucky.
Hispanics needing bone marrow have a harder time finding matching donors than do other ethnicities because few Hispanics have registered to donate.
"That could've easily been me," Rodriguez said.
That's why Rodriguez, 31, is trying to raise awareness about the importance for Hispanics to give bone marrow. The former Zumba instructor is hosting a Zumba event Sunday afternoon that partly is a fundraiser for her ongoing cancer treatments and partly a campaign to encourage more people to become donors.
Among the 8 million people signed up as bone marrow donors, 800,000 or 10 percent, identify themselves as Hispanic or Latino. Though Hispanics comprise more than one-third of Texas' population, only 17 percent of registered bone marrow donors in the state are Hispanic.
Overall, Hispanics have a 72 percent chance of finding a bone marrow donor, compared with whites, who have a 93 percent chance, according to the donor program. Only blacks fare worse, with a 63 percent likelihood of finding a donor.
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Former Zumba instructor with cancer encourages Hispanics to donate bone marrow
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May 27th, 2012
Scientists turn skin cells into healthy heart tissue
By daniellenierenberg
Scientists turn skin cells into healthy heart tissue
Kate Kelland (Reuters) / 26 May 2012
The researchers said there were still many years of testing and refining ahead. But the results meant they might eventually be able to reprogramme patients cells to repair their own damaged hearts.
We have shown that its possible to take skin cells from an elderly patient with advanced heart failure and end up with his own beating cells in a laboratory dish that are healthy and young - the equivalent to the stage of his heart cells when he was just born, said Lior Gepstein, who led the work.
The researchers, whose study was published in the European Heart Journal on Wednesday, said clinical trials of the technique could begin within 10 years.
Heart failure is a debilitating condition in which the heart is unable to pump enough blood around the body. It has become more prevalent in recent decades as advances in medical science mean many more people survive heart attacks. At the moment, people with severe heart failure have to rely on mechanical devices or hope for a transplant.
Researchers have been studying stem cells from various sources for more than a decade, hoping to capitalise on their ability to transform into a wide variety of other kinds of cell to treat a range of health conditions.
There are two main forms of stem cells - embryonic stem cells, which are harvested from embryos, and reprogrammed human induced pluripotent stem cells (hiPSCs), often originally from skin or blood.
Gepsteins team took skin cells from two men with heart failure aged 51 and 61 and transformed them by adding three genes and then a small molecule called valproic acid to the cell nucleus.
They found that the resulting hiPSCs were able to differentiate to become heart muscle cells, or cardiomyocytes, just as effectively as hiPSCs that had been developed from healthy, young volunteers who acted as controls for the study.
Originally posted here:
Scientists turn skin cells into healthy heart tissue
Skin Stem Cells
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May 27th, 2012
5 scientists receive stem-cell research grants
By daniellenierenberg
Five scientists from the University of California, San Diego and its School of Medicine have been awarded almost $12 million in new grants from the California Institute for Regenerative Medicine (CIRM) to conduct stem cell-based research into regenerating spinal cord injuries, repairing gene mutations that cause amyotrophic lateral sclerosis and finding new drugs to treat heart failure and Alzheimer's disease.
The awards mark the third round of funding in CIRM's Early Translational Awards program, which supports projects that are in the initial stages of identifying drugs or cell types that could become disease therapies. More than $69 million in awards were announced yesterday, including funding for first-ever collaboratively funded research projects with China and the federal government of Australia.
"With these new awards, the agency now has 52 projects in 33 diseases at varying stages of working toward clinical trials," said Jonathan Thomas, JD, PhD and CIRM governing board chair. "Californians should take pride in being at the center of this worldwide research leading toward new cures. These projects represent the best of California stem cell science and the best international experts who, together, will bring new therapies for patients."
The five new UC San Diego awards are:
CIRM was established in November 2004 with the passage of Proposition 71, the California Stem Cell Research and Cures Act. The statewide ballot measure provided $3 billion in funding for stem cell research at California universities and research institutions and called for the establishment of an entity to make grants and provide loans for stem cell research, research facilities, and other vital research opportunities.
The May 24 grants bring UC San Diego's total to more than $112 million in CIRM funding since the first awards in 2006.
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5 scientists receive stem-cell research grants
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May 26th, 2012
Israeli Scientists Reprogram Skin Cells into Beating Heart Tissue: Stem Cell Research Pays Off – Video
By raymumme
24-05-2012 09:53 For the first time ever, scientists have transformed normal skin cells into healthy beating heart tissue. Researchers based in Haifa in Israel, say they hope that the breakthrough will one day lead to new treatments for patients suffering from heart failure. Head of Research Professor Lior Gepstein "We were able to demonstrate the ability to take skin cells from very sick patients with significant heart failure, heart disease, and show that cells, skin cells from these patients can be eventually differentiated to become healthy heart cells in the dish. So one can take skin cells from a very sick individual, who has very sick heart cells, to reprogram them to become induced pluripotent stem cells and then make heart cells that are healthy, that are young and resemble heart cells at the day that the patient was born." At the moment, people with severe heart failure have to rely on mechanical devices or hope for a transplant. However, by studying stem cells from various sources for more than a decade, researchers are hoping to capitalise on their ability to transform stem cells into a wide variety of other kinds of cell. Head of Research Professor Lior Gepstein "These cells can be transplanted into hearts of animals, survive and function in synchrony with existing heart tissue. This study open the road, hopefully, to future clinical trials, in a decade or so, that will test the ability of such heart cells to repair the patient's own heart," There may be a lot to do before ...
Cardiac Stem Cells
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May 26th, 2012
State awards stem cell grants to medical researchers
By JoanneRUSSELL25
SACRAMENTO California's stem cell agency today approved two grants to UC Davis Health System researchers for their innovative work in regenerative medicine.
Kyriacos A. Athanasiou, distinguished professor of orthopaedic surgery and professor and chair of biomedical engineering, and the Child Family Professor of Engineering at UC Davis, is investigating the use of skin-derived stem cells to heal cartilage injuries and debilitating conditions of the knee such as osteoarthritis.
W. Douglas Boyd, professor of surgery, plans to further refine a novel approach to treating cardiovascular injuries suffered during a heart attack by using stem cells and a tissue-like scaffold to repair cardiac damage.
The pair received individual grants totaling approximately $6.6 million from the California Institute for Regenerative Medicine's (CIRM) governing board.
Athanasiou's and Boyd's multi-year grants were among the proposals submitted to CIRM for its third round of Early Translational Awards, which are intended to enable clinical therapies to be developed more rapidly.
"Both of these scientists are conducting exciting research that could have far-reaching implications in health care," said Jan Nolta, director of the UC Davis Institute for Regenerative Cures and the university's stem cell program director. "Dr. Athanasiou is bioengineering new cartilage that could have the same physiological integrity as the cartilage a person is born with. Dr. Boyd is developing a treatment that uses a paper-thin patch embedded with stem cells to harness their regenerative powers to repair damaged heart muscle."
Boyd, who's a pioneering cardiothoracic surgeon, pointed out in his CIRM proposal that heart disease is the nation's number-one cause of death and disability. An estimated 16.3 million Americans over the age of 20 suffer from coronary heart disease, which in 2007 accounted for an estimated 1 in 6 deaths in the U.S. Boyd plans to use bone-marrow derived stem cells -- known as mesenchymal stem cells -- in combination with a bioengineered framework known as an extracellular matrix, to regenerate damaged heart tissue, block heart disease and restore cardiac function, something currently not possible except in cases of a complete and very invasive heart transplant.
An expert in biomedical engineering, Athanasiou is focusing on developing a cellular therapy using stem cells created from an individual's own skin -- known as autologous skin-derived stem cells -- which have shown great promise in animal models. He plans to use the new funding to conduct extensive toxicology and durability tests to determine the technique's long-term safety and efficacy. Such tests are among the many steps needed to advance toward human clinical trials.
Cartilage is the slippery tissue that covers the ends of bones in joints, allowing bones to glide over each other and absorbing the shock of movement. Cartilage defects from injuries and lifelong wear and tear can eventually degenerate into osteoarthritis. According to the National Institute of Arthritis and Musculoskeletal and Skin Diseases, osteoarthritis is the most common form of arthritis and affects an estimated 27 million Americans over the age of 25.
"For anyone suffering from osteoarthritis or other debilitating cartilage conditions, Dr. Athanasiou's goal of using stem cells to regenerate new tissue could have enormous quality-of-life and economic benefits," said Nolta, who is the recipient of a prior translational grant from CIRM to develop potential therapies for Huntington's disease . "Dr. Boyd's work is equally promising because he's using a bioengineered structure to encourage cardiac tissue repair, which could have important benefits in the treatment of heart disease."
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May 26th, 2012
Recovery From Multiple Sclerosis By Growth Factor In Stem Cells
By JoanneRUSSELL25
Editor's Choice Main Category: Multiple Sclerosis Article Date: 24 May 2012 - 14:00 PDT
Current ratings for: 'Recovery From Multiple Sclerosis By Growth Factor In Stem Cells'
4.7 (10 votes)
4.5 (2 votes)
Animals that were injected with hepatocyte growth factor were noted to have grown new neural cells and lower levels of inflammation. Most significantly, the researchers noted that the protective envelope of myelin, the myelin sheath, which surrounds the core of a nerve fiber and facilitates the transmission of nerve impulses, re-grew and covered lesions that were caused by MS.
Robert H. Miller, professor of neurosciences at the School of Medicine and vice president for research at Case Western Reserve University declared: "The importance of this work is we think we've identified the driver of the recovery."
MS is caused by damage to the myelin sheath, the protective covering that surrounds nerve cells. The nerve damage is caused by inflammation, which occurs when the body's own immune cells attacks the nervous systems located in areas of the brain, the optic nerve, and spinal cord. This damage can cause an interruption of the nerve signals, which results in loss of balance and coordination, cognitive ability, as well as in other functions and in time, these intermittent losses may become permanent. In 2009, Caplan and Miller discovered that mice with MS injected with human mesenchymal stem cells recovered from the type of damage that was brought on by MS. A clinical trial is currently underway based on their research, whereby patients with MS are injected with their own stems cells.
During this trial, the team decided to first establish whether the presence of stem cells or other cells induce recovery. They injected a total of 11 animals with MS with the medium, in which mesenchymal stem cells that were taken from bone marrow grew, discovering that all animals displayed a rapid reduction in functional deficits. An analysis demonstrated that unless the injected molecules had a certain size or weight, i.e. between 50 and 100 kiloDaltons, the course of the disease remained unchanged.
Other research, as well as the team's own studies, suggested that this was likely to be instigated by the hepatocyte growth factor, which is secreted by mesenchymal stem cells.
The team then injected the animals with either 50 or 100 nanograms of the growth factor on alternate days for a 5-day period and observed a decrease in the level of signaling molecules that promote inflammation, whilst the level of signaling molecules that oppose inflammation increased. The researchers noted a growth of neural cells, whilst nerves that were exposed because of MS were rewrapped with myelin. Recovery was marginally better in those mice that received the 100-nanogram injections compared with those receiving the 50-nanogram injections.
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Recovery From Multiple Sclerosis By Growth Factor In Stem Cells
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May 26th, 2012
Skin Cells From Heart Failure Patients Made Into Healthy New Heart Muscle Cells
By Dr. Matthew Watson
Editor's Choice Main Category: Cardiovascular / Cardiology Article Date: 25 May 2012 - 0:00 PDT
Current ratings for: 'Skin Cells From Heart Failure Patients Made Into Healthy New Heart Muscle Cells'
4 (1 votes)
This achievement is significant, as it opens up the prospect of treating heart failure patients with their own, human-induced pluripotent stem cells (hiPSCs) to fix their damaged hearts.
Furthermore, the cells would avoid being rejected as foreign as they would be derived from the patients themselves. The study is published in the European Heart Journal. However, the researchers state that it could take a minimum of 5 to 10 years before clinical trials could start due to the many obstacles that must be overcome before using hiPSCs in humans is possible.
Although there has been advances in stem cell biology and tissue engineering, one of the major problems scientists have faced has been lack of good sources of human heart muscle cells and rejection by the immune system. Furthermore, until now, scientific have been unable to demonstrate that heart cells created from hiPSCs could integrate with existing cardiovascular tissue.
"What is new and exciting about our research is that we have shown that it's possible to take skin cells from an elderly patient with advanced heart failure and end up with his own beating cells in a laboratory dish that are health and young - the equivalent to the stage of his heart cells when he was just born," said Professor Lior Gepstein, Professor of Medicine (Cardiology) and Physiology at the Sohnis Research Laboratory for Cardiac Electrophysiology and Regenerative Medicine, Technion-Israel Institute of Technology and Rambam Medical Center in Haifa, Israel, who led the study.
In the study, Professor Gepstein, Ms Limor Zwi-Dantsis, and their colleagues retrieved skin cells from two male heart failure patients, aged 51 and 61 years, and reprogrammed the cells by delivering 3 transcription factors (Sox2, Oct4, and Klf4) in addition to a small molecule called valproic acid, to the cell nucleus. The team did not include a transcription factor called c-Myc as it is a known cancer-causing gene.
Professor Gepstein said:
In addition, the team used an alternative strategy involving a virus transferred reprogramming data to the cell nucleus. However, the team removed the virus after the information had been transferred in order to avoid insertional oncogenesis.
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Skin Cells From Heart Failure Patients Made Into Healthy New Heart Muscle Cells
Skin Stem Cells
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May 26th, 2012