Stem cell medicine thrown umbilical rope
By Dr. Matthew Watson
Tim and Padma Vellaichamy of Parramatta have had their new born child's umbilical cord stored cryogenically for future treatment. Pictured with their as yet unnamed three week old daughter. Picture: Adam Ward Source: The Daily Telegraph
IT'S current preservation for the future regeneration - and now umbilical cord tissue is going on ice in Australia for the first time.
Usually discarded after birth, umbilical tissue from newborn babies is being collected and cryogenically frozen to be used one day for regenerative and stem cell medicine. And it doesn't just have potential for the babies involved, either. Experts say stem cells could also be used for family members who are genetically compatible.
It is hoped the cells will eventually be able to be used to repair damaged tissues and organs, with researchers investigating its uses for treating diseases like multiple sclerosis, cerebral palsy and diabetes, as well as for bone and cartilage repair.
Although cord blood storage has been available for many years, Cell Care Australia has added cord tissue storage in anticipation of new discoveries in the regenerative medicine field.
Cell Care Australia medical director associate professor Mark Kirkland said the storage process - already popular in the US, Europe and Southeast Asia - was long overdue for Australian shores.
"The science is developing around the world and we're really behind the rest of the world in providing parents the option to store these cells and we thought it was about time it was brought here," he said.
"It's finding a way to take what would otherwise be waste tissue and turning it into something of potential future value for not only your child but also potentially for other family members.'
Parramatta couple Tim and Padma Vellaichamy are among the first to use the service in Australia.
Mr Vellaichamy, 31, said he heard of the technology while working as a dentist in India and decided to store their daughter's cord cell tissue after birth three weeks ago.
Continued here:
Stem cell medicine thrown umbilical rope
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May 21st, 2012
Medical success or boondoggle?
By LizaAVILA
Indian clinic's stem cell therapy real?
STORY HIGHLIGHTS
For more of CNN correspondent Drew Griffin's investigation of India's experimental embryonic stem cell therapy, watch "CNN Presents: Selling a Miracle," at 8 and 11 p.m. ET Sunday on CNN.
New Delhi (CNN) -- Cash Burnaman, a 6-year-old South Carolina boy, has traveled with his parents to India seeking treatment for a rare genetic condition that has left him developmentally disabled. You might think this was a hopeful mission until you learn that an overwhelming number of medical experts insist the treatment will have zero effect.
Cash is mute. He walks with the aid of braces. To battle his incurable condition, which is so rare it doesn't have a name, Cash has had to take an artificial growth hormone for most of his life.
His divorced parents, Josh Burnaman and Stephanie Krolick, are so driven by their hope and desperation to help Cash they've journeyed to the other side of the globe and paid tens of thousands of dollars to have Cash undergo experimental injections of human embryonic stem cells.
The family is among a growing number of Americans seeking the treatment in India -- some at a clinic in the heart of New Delhi called NuTech Mediworld run by Dr. Geeta Shroff, a retired obstetrician and self-taught embryonic stem cell practitioner.
Shroff first treated Cash -- who presents symptoms similar to Down Syndrome -- in 2010. "I am helping improve their quality of life," Shroff told CNN.
After five weeks of treatment, Cash and his parents returned home to the U.S.
That's when Cash began walking with the aid of braces for the first time.
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May 21st, 2012
Family hangs hope for boy on unproven therapy in India
By raymumme
Indian clinic's stem cell therapy real?
STORY HIGHLIGHTS
For more of CNN correspondent Drew Griffin's investigation of India's experimental embryonic stem cell therapy, watch "CNN Presents: Selling a Miracle," at 8 and 11 p.m. ET Sunday on CNN.
New Delhi (CNN) -- Cash Burnaman, a 6-year-old South Carolina boy, has traveled with his parents to India seeking treatment for a rare genetic condition that has left him developmentally disabled. You might think this was a hopeful mission until you learn that an overwhelming number of medical experts insist the treatment will have zero effect.
Cash is mute. He walks with the aid of braces. To battle his incurable condition, which is so rare it doesn't have a name, Cash has had to take an artificial growth hormone for most of his life.
His divorced parents, Josh Burnaman and Stephanie Krolick, are so driven by their hope and desperation to help Cash they've journeyed to the other side of the globe and paid tens of thousands of dollars to have Cash undergo experimental injections of human embryonic stem cells.
The family is among a growing number of Americans seeking the treatment in India -- some at a clinic in the heart of New Delhi called NuTech Mediworld run by Dr. Geeta Shroff, a retired obstetrician and self-taught embryonic stem cell practitioner.
Shroff first treated Cash -- who presents symptoms similar to Down Syndrome -- in 2010. "I am helping improve their quality of life," Shroff told CNN.
After five weeks of treatment, Cash and his parents returned home to the U.S.
That's when Cash began walking with the aid of braces for the first time.
Excerpt from:
Family hangs hope for boy on unproven therapy in India
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May 21st, 2012
Heart Disease, Diabetes, Depression a Deadly Mix
By Dr. Matthew Watson
Heart disease, diabetes and depression can be a lethal triple-play -- boosting
a patient's death risk by 20 percent to 30 percent, new research shows.
"We do not know what this increased risk is due to, but it could either be
that depression influences crucial aspects of self-care behaviors needed to
manage diabetes or that a more severe disease process is reflected in more
depressive symptoms," said lead researcher Anastasia Georgiades, a
research associate in the department of psychiatry and behavioral science at Duke
University in Durham, N.C.
Georgiades was expected to present the findings Friday at the American
Psychosomatic Society annual meeting in Budapest, Hungary.
In their study, the Duke team followed 933 heart patients for more than four
years. During that time, there were 135 deaths among patients with type 2
diabetes and/or depression, the researchers found.
Among patients with moderate-to-severe symptoms of depression who were also
diabetics, the researchers observed a significant 30 percent greater risk of
dying over the four-year period compared with patients with either depression
alone or diabetes alone. Read more…
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May 20th, 2012
Bipolar Kids May Focus on Different Facial Features
By Dr. Matthew Watson
Children with bipolar disorder and a similar condition called severe mood
dysregulation spend less time looking at the eyes when trying to identify
facial features, compared to children without the psychiatric disorders,
researchers say.
This new study finding may help explain why children with bipolar disorder and
severe mood dysregulation have difficulty determining other people's emotional
expressions, said the U.S. National Institute of Mental Health investigators.
The researchers tracked the eye movements of children with and without
psychiatric disorders as they viewed faces with different emotional
expressions, such as happy, sad, fearful and angry. In general, the children
spent more time looking at the eyes, the facial feature that conveys the most
information about emotion. Read more…
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May 20th, 2012
Cell-based Cancer Immunotherapies. Some metrics..
By Dr. Matthew Watson
This is true on all fronts. Cancer immunotherapy conferences are popping up everywhere. A growing number of of analysts are now covering a growing number of companies in the space with coverage ranging from bearishly critical to ebullient bullishness. Some venture capital firms are now loosening their purse strings for immunotherapy plays and both pharma venture funds and business development departments are now spending an increasing amount of time actively monitoring and exploring potential plays in the sector.
One of the best annual industry summaries of what is happening in the sector is sponsored by MD Becker Partners through its annual Cancer Immunotherapy: A Long Awaited Reality conference held each in New York, this year on October 4 and select video replays it hosts on its YouTube channel.
Some Segment Metrics
- Dendreon's Provenge
- Autologous immunotherapy for prostate cancer (1 monthly dose for 3 months)
- Efficacy: prolongs survival
- Markets: only the United States (approved April 2010)
- Next markets: submitted the marketing authorisation application to the EMA (European Medicines Agency) in early 2012 and hopes to introduce Provenge in the European market in 2013
- 2011 Revenue $290,000
- Projected 2012 Revenue: ~$380,000
Phase III or II/III:
- Argos Therapeutics' AGS-003
- phase III trial not yet recruiting
- Indication: advanced renal cell carcinoma
- Estimated enrollment: 450
- Estimated primary completion: June 2014
- Cell Medica's Adoptive Cellular Therapy (ACT)
- phase III trial actively recruiting
- Indication: cytomegalovirus infection following allogeneic stem cell transplantion
- Estimated enrollment: 90
- Estimated primary completion: June 2013
- JW Creagene's CreaVax-RCC
- phase III trial actively recruiting
- Indication: metastatic renal cell carcinoma
- Estimated enrollment: 54
- Estimated primary completion: unknown
- Kiadis Pharma's alloreactive T-cells (ATIR)
- phase II/III trial currently suspended
- Indication: infections and relapse assoc’d w/ SCT for leukemia and other hematologic malignancies
- Estimated enrollment: 70
- Estimated primary completion: TBD
- MolMed's TK
- phase III trial actively recruiting
- Indication: acute leukemia
- Estimated enrollment: 170
- Estimated primary completion: January 2014
- Newlink Genetics' HyperAcute®-Pancreas (algenpantucel-L)
- phase III trial actively recruiting
- Indication: pancreatic cancer
- Estimated enrollment: 722
- Estimated primary completion: January 2014
- NovaRx's Lucanix
- phase III trial actively recruiting
- Indication: non-small cell lung cancer
- Estimated enrollment: 506
- Estimated primary completion: June 2012
- PrimaBioMed's Cvac
- phase II/III trial actively recruiting
- Indication: epithelial ovarian cancer
- Estimated enrollment: 1,000
- Estimated primary completion: March 2015
Phase II or I/II
- 50 industry-sponsored clinical trials of cell-based immunotherapies actively recruiting, active no longer recruiting, active not yet recruiting, or anticipated to commence yet in 2012
- ~10 of these are expected to have readouts yet this year
- Trial sites in US, Canada, UK, continental Europe, Israel, South Korea, India, Australia
- Expected enrollment of 3,500+
- Bellicum Pharmaceuticals. $20M series B.
- CellMedica. $15M grant from CPRIT in Texas.
- Argos Therapeutcs. $25M Series D.
- Northwest Bio. $5.5M grant from German gov't Saxony Development Bank
-- Lee @celltherapy
p.s. As always we welcome your feedback, comments, and corrections.
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May 20th, 2012
Painful Decisions Coming Up at Stem Cell Agency
By Dr. Matthew Watson
The
Sacramento Bee today ran a piece by yours truly in its California
Forum section.
Here
is an excerpt. You can find the entire article here.
"They're
talking about pain at the $3 billion California stem
cell agency. And mortality. But not the end of life as you and I know
it.
"They're
talking about the pain that comes from cutting off millions of
dollars for scientists. They're talking about what will happen when
the state stops borrowing money to finance stem
cell research –
a final-breath moment that arrives in about five years....
"CIRM's
changing priorities create 'stark tension,' said one board
member, Michael Friedman, CEO of the City of Hope in the Los Angeles
area, in January. 'We're going to have to make some really
painful and difficult decisions,' he told directors.
"CIRM's
success – or lack of it – will play a critical role in its future
finances, whether they are based on another bond measure or private
support."
http://californiastemcellreport.blogspot.com/feeds/posts/default?alt=rss
San Diego Biotech Firm Appeals Rejection of Cancer Stem Cell Grant
By Dr. Matthew Watson
Therapeutics, whose multimillion dollar grant application was
rejected by reviewers at the California stem cell agency, is asking
the agency's board to overturn the decision next Thursday.
Biogen Idec, said it is reducing its request from $3.5 million
because it has raised $2 million since it applied for the grant six
months ago. However, its appeal did not state specifically how much
it was now requesting from CIRM. The research involves cancer stem cells.
during the period following submission of its application, it has accomplished all of the activities that CIRM had identified
as the first milestone in the research project. Eclipse also said it
has accomplished a number of activities in milestones two and three.
The firm said that it is now accelerating its IND filing by one year.
$2 million in seed funding from City Hill Ventures, also of San
Diego, according to a Bioworld article by Marie Powers. The
co-founders are Peter Chu, now president of Eclipse, and Christopher
Reyes, chief scientific officer. Chu and Reyes ran Biogen Idec's
cancer stem cell program. They are also the applicants for the CIRM
grant.
letter to the CIRM board from CIRM President Alan Trounson. He made
no comment on the worthiness of the request. On
an earlier appeal from Stuart Lipton of Sanford-Burnham, Trounson's
cover letter said Lipton's letter was "without merit."
scientific score of 58 out of 100 from CIRM reviewers. CIRM, however, has not released the company's score. Two other proposals with scores of 53
were approved by reviewers.
sharply criticized for its failure to fund businesses in a
significant way. It is currently moving to engage them more closely.
If Eclipse's appeal is successful, it will be one of less than 20
business to be funded without a nonprofit partner. Businesses have
received only about 4 percent of CIRM's $1.3 billion in awards to 494enterprises.
are included in the agenda material presented to the CIRM board, but
the board does not have to act on them or discuss them. Researchers
can also appear before the board to make a case.
http://californiastemcellreport.blogspot.com/feeds/posts/default?alt=rss
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May 20th, 2012
Burnham’s Lipton Appeals Rejection of $5 Million Grant Application
By Dr. Matthew Watson
Lipton is seeking to overturn rejection of his application for a $5
million grant from the California stem cell agency, declaring that
reviewers misinterpreted the proposal and relied partly on
"grantsmanship" instead of science.
and is one of 22 rejected by CIRM's reviewers in a $95 million
round that comes before the agency's directors next Thursday.
some of the reviewers' criticism was "completely unfounded,"
"incorrect" or "in error." The two-page letter
went into specific scientific detail.
CIRM President Alan Trounson said Lipton's appeal was "without
merit." He did not go into details but said CIRM staff is
prepared to discuss it next Thursday.
was not disclosed by CIRM, but it appears to be between 62 and 53.
Two grants ranked at 53 were approved by reviewers. Appeals from
rejected scientists are included in the agenda material presented by
the board, but the board does not have to act on them or discuss them.
Researchers can also appear before the board to make a case.
Sanford-Burnham, is a member of the CIRM board. She will be barred
from taking part in any discussion of Lipton's application or voting
on it.
http://californiastemcellreport.blogspot.com/feeds/posts/default?alt=rss
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May 20th, 2012
CIRM’s Improving Openness
By Dr. Matthew Watson
week once again posted in a timely fashion important information
dealing with matters to be decided next Thursday by directors of the
$3 billion stem cell agency.
improvement in openness and transparency compared to the practices
prior to the election last June of J.T. Thomas as chairman of the
CIRM board. Previously, background material on multimillion dollar
matters was not available much of the time until shortly before the directors meeting, making it virtually impossible for interested
parties or the public to comment or attend the sessions. Even CIRM directors would complain from time to time about the laggard performance.
will include approval of $95 million in new grants, consideration of
the first-ever performance audit of which made 27
recommendations for improvement, action on the first-ever CIRM directors' code of conduct along with conflict of interest rules, changes in its loan policy and consideration of the agency's
strategy for the next five years.
Francisco, a public teleconference location will be available at UC
San Francisco, two in Los Angeles and one in La Jolla. Specific
addresses can be found on the meeting agenda.
http://californiastemcellreport.blogspot.com/feeds/posts/default?alt=rss
Conflict of Interest: CIRM to End Contract with Consultant Linked to Grant Recipient
By Dr. Matthew Watson
not renew a contract with a "special advisor" who has been
nominated to the board of directors of a firm that is sharing in a $14.5 million grant from the agency.
partner of LifeSciences Advisory, LLC, of Emerald Lake Hills, Ca.
Ramasastry has worked for CIRM since May of 2010. Last month, she was
nominated to the board of Sangamo BioSciences, Inc., of Richmond, Ca.
Her responsibilities with CIRM have included "industry analysis
and consultation." Sangamo cited her experience with CIRM in its
press release on her nomination. She was also employed as a
consultant by Sangamo, according to the firm.
conflict of interest questions. The case highlights the issues
that can arise between CIRM and the biotech industry as the agency
moves to engage industry more closely. CIRM's response additionally
demonstrates a lack of awareness of the potential for serious
mischief or worse when dealing with consultants.
CIRM on May 6 for comment on the Sangamo-Ramasastry matter. The
questions included whether Ramasastry disclosed to CIRM her work for
Sangamo and whether CIRM took any action per the agency's conflict of
interest code. CIRM did not respond to the question of whether
Ramasastry ever disclosed her ties to Sangamo, which expects to
receive $5.2 million from the CIRM grant if it runs a full four
years.
from spokesman Kevin McCormack.
"Saira Ramasastry was an
independent contractor. As required by law, we do ask independent
consultants to complete Form 700s(statements of economic interests)
if they participate in an agency decision making role. Her role did
not fall into that category - she was identified as a 'special
advisor' in connection with our external review process - and so she
did not have to fill out a Form 700. Her contract with CIRM comes to
an end at the end of June, and she will not be elected to Sangamo's
board of directors until July. Obviously once she is a member of the
Sangamo board she will not be consulting or advising CIRM because of
our strict conflict of interest rules."
June 21, according to the company, not July.)
outside contractors. Expenditures for their services are the second
largest item in CIRM's operational budget, exceeded only by salaries
and benefits of regular employees. The responsibilities of outside
contractors cover a wide range of sensitive tasks including computer
system security, development of software that deals with proprietary
information from grant recipients, analysis of confidential business
operations of grant and loan applicants and much more.
consultants are working for besides CIRM. Whether they make decisions
for CIRM is beside the point. Gathering information that is not
normally accessible to the public can be extremely valuable to
businesses and their competitors as well as applicants for
CIRM's $3 billion. In Ramasastry's case, she was privy to a great
deal of confidential or economically useful information during her work on CIRM's external
review and likely much more.
hardly adequate to assess conflict of interest issues involving
private consultants. The form was developed in the 1970s to deal with
elected officials primarily and provides only the grossest sort of
look at financial holdings and income.
requires more scrutiny of conflicting interests – not less. NextThursday the CIRM board will deal with some of its conflict ofinterest rules. It is fine opportunity to ask for a sharper analysis
of conflict issues and consultants with an eye to strengthening CIRM
regulations and ensuring protection of the agency and its grantees'
work – not to mention the interests of the people of California.
http://californiastemcellreport.blogspot.com/feeds/posts/default?alt=rss
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May 20th, 2012
Scripps CEO Joins Stem Cell Agency Board; Love Leaves
By Dr. Matthew Watson
 |
| Michael Marletta Scripps Photo |
State Treasurer Bill Lockyer has
appointed Michael Marletta, president and CEO of the Scripps Research
Institute, to the 29-member board of directors of the $3 billion
California stem cell agency.
also a Scripps executive, who resigned last year. Scripps has
received $45.3 million in funding from CIRM.
agency, Lockyer said Marletta is a member of the National Academy of
Science, American Academy of Arts and Sciences and the Institute of
Medicine. Marletta joined Scripps in 2011 and became president in
January.
of California, Berkeley, where he once served as chairman of the
department of chemistry, among other roles. An item on the Scripps
web site said Marletta "focused his research on the intersection
of chemistry and biology. He is acknowledged as a pioneer in
discovering the role of nitric oxide, a critical player in
communication between cells."
fill. Ted Love resigned last month after serving on the board since
its inception in December 2004. CIRM said Love, executive vice
president of Onyx Pharmaceuticals, resigned for personal reasons.
State Controller John Chiang is considering a number of candidates to
replace him. Love was the only African-American on the board.
http://californiastemcellreport.blogspot.com/feeds/posts/default?alt=rss
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May 20th, 2012
$95 Million in California Stem Cell Grants: Preview the Spending
By Dr. Matthew Watson
California stem cell agency is going to spend its next $95 million,
you can check out short digests today of the 19 research grant applications, including reviewer comments, that are virtually certain of receiving the cash.
calls its "early translational III" round, which is
scheduled to be acted on by the CIRM board May 24 in San Francisco.
part of the directors' meeting agenda. They include scientific
scores, a statement from the applicant and a summary of what
reviewers had to say during their closed door sessions. But you won't
find the names of the applicants, their institutions or businesses.
The stem cell agency conceals the names of the winners until after
the board acts. Names of the unlucky ones are not disclosed by CIRM.
The agency says it does not want to embarrass anybody including the
institutions involved.
of science involved may well be able to discern at least some of the
names of applicants from the information contained in the summaries.
applicants ranged from 88 to 53. Nine grants scored higher than 53
but were rejected by reviewers(the Grants Working Group). The panel
turned down 22 applications overall. The CIRM board has final
authority on applications, but has almost never rejected a positive
decision by reviewers. Sometimes, however, it will overrule a
negative decision.
scored at 53 involved ALS. The $1.7 million proposal was approved
for "programmatic reasons," according to the summary.
Often, programmatic motions for approval are made by CIRM board
members sitting on the review panel. However, the summary did not
disclose who made the motion or the vote. The summary said,
"The programmatic reasons provided
were that ALS is a devastating disease that is not well-represented
in CIRM's portfolio."
scored at 53 sought $6.3 million for research involving heart
disease. The summary did not clearly identify the specific reason for
approving the grant on a programmatic motion. But it said,
"The
GWG (grants working group) ... advised as a condition for funding
that the applicant consult additional vector specialists with
translational and clinical experience to select a more appropriate
vector to move this program towards the clinic."
motion and the name of the person who made the motion.
reviewers can appeal to the full board. So far no appeals have been
publicly posted by CIRM. The success rate on such appeals is mixed.
both academics and businesses, which have received a tiny fraction of
CIRM's $1.3 billion in spending so far. Some businesses have
complained publicly and, as well, to a panel of the Institute of
Medicine that is evaluating CIRM's performance.
yesterday asked CIRM for the number of businesses that applied in the
translational round, including the pre-application process, which is
used to whittle down the total number of applications. The request included total numbers as well. CIRM spokesman
Kevin McCormack declined to produce the figures prior to the CIRM
board meeting, saying they "won't be ready" until after the
session.
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May 20th, 2012
IP to Grant Oversight: Study Calls for Host of Improvements at California Stem Cell Agency
By Dr. Matthew Watson
agency is laboring under a range of problems that include protection of
its intellectual property and management of its nearly 500 grants plus an inadequate ability to track its own performance, a seven-month
study said yesterday.
firm of Seattle, Wash., made 27 recommendations for improvements,
including more effort to ease strain connected to the agency's
controversial dual executive arrangement. The study said that the
nearly eight-year-old agency has many "opportunities" to
"enhance performance reporting and decision making, strengthen
effectiveness and efficiency, retain essential human resources and
leverage technology."
cell agency said, "(M)anagement concurs with the findings and
recommendations....The recommendations are focused and constructive.
CIRM is already implementing many of these recommendations, and we
will be investigating the others in the coming months."
made of the California Institute for Regenerative Medicine. The
audit is required by state law and was commissioned by the agency at
a cost of $234,944. For years, the agency for years had resisted calls for a
performance audit until it sought legislative approval in 2010 for
removal of a 50-person cap on its staff. Originally, the performance
audit legislation would have put the study in the hands of the only
state body charged with oversight of the agency and its board. CIRM,
however, was successful in lobbying to have that provision removed.
again a number of issues that have troubled the stem cell agency for
some years. Moss made 12 top priority recommendations, many of which
dealt with information technology and grants management. Many of the
recommendations focused on providing better and faster information on
performance outcomes, which the audit said has been slow to come and
hard to generate.
"Key performance information is
not readily available to CIRM leadership and other stakeholders on an
ongoing basis. 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 effectively
communicate outcome-based performance internally or externally. As
such, CIRM does not focus on performance metrics as part of its
(staff) meeting process."
"CIRM does not have an integrated
financial information system....The use of spreadsheets results in
labor intensive processes to generate reports and respond to
information inquiries, since data must be pulled from multiple
spreadsheets, a process that may be prone to error. ...Spreadsheets
are not linked to each other or a master report. CIRM does not have a
comprehensive list of spreadsheets or instructions for how to
maintain the files or generate reports from them."
a better job in "bond forecasting," a reference to the
California state bonds that finance virtually every aspect of the
agency's operations. CIRM directors were caught by surprise a few
years ago when they suddenly learned the agency was up against a
major cash crunch.
require more work from CIRM grantees and their technology transfer
offices in an effort to track intellectual property and grant outcomes.
The report also recommended a speed-up in CIRM's review of progress
reports from grant recipients, which have been lagging completion by
several months.
was written into law by Prop. 71, has troubled CIRM since nearly day
one. CIRM's own external review panel also identified it as problem
two years ago. The executive structure is virtually impossible to
change because of the political difficulty in making alterations in
the ballot initiative.
"The working relationship between
the chairman’s office and the president’s office has vastly
improved over the past year, but there are still opportunities for
improvement."
"Make every effort to manage and
operate as one cohesive organization, while recognizing the varying
roles, responsibilities, and authorities that exist with positions in
both the chairman’s office and president’s office."
involved CIRM's public relations/communications effort. CIRM
Chairman J.T. Thomas told directors last June that the agency was in
a "communications war."
"CIRM does not have a
communication plan, and there is lack of clarity on how to address
mission-based communication to CIRM’s various target audiences,
especially the general public....The best way to facilitate
results-based communications is to 1) quantify goals and outcomes in
CIRM’s strategic plan and 2) report on achievement of those goals
and outcomes by enhancing CIRM’s annual report with additional
performance-based information."
stem cell agency is also underway. It is being conducted by the
prestigious Institute of Medicine and is costing CIRM $700,000. That
report is expected this fall.
to consider the Moss Adams report at its meeting May 24.
recommendations of the performance audit were delicately worded in
many cases, they brought out issues that need to be addressed, many
of which have been around for a great deal of time. At their meeting
next week, CIRM directors should act very directly on the
recommendations. They can do that by requiring a written report each
month from CIRM Chairman J.T. Thomas and CIRM President Alan Trounson
on the specific steps that they are taking to implement the
performance audit's recommendations. Otherwise, the inevitable drift
will set in.
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May 20th, 2012
California Budget Slashing Misses Stem Cell Agency
By Dr. Matthew Watson
agency dodged the governor's financial knife today.
announced sweeping cuts throughout California state government as he
attempted to close a new, $15.7 billion deficit. A report in the Los
Angeles Times said the governor was "grabbing any spare change available." But this afternoon, in response to a
query, Kevin McCormack, CIRM's spokesman, said,
"The answer is no, we won't be
affected."
financial picture is much bleaker than it was just four months ago.
And the stem cell agency's only real source of cash is money borrowed
by the state -- general obligation bonds.
agency in 2004, the bond funds flow directly to the agency without
intervention by the legislature or the governor. However, Brown has
been chary of additional bond sales since they create an increasing
burden in the form of interest costs. Those costs must be financed
out of money that otherwise might go to the University of
California, K-12 schools and medical help for the poor.
state, which should take care of its needs until January. The cash is
coming from short-term borrowing by the state instead of bonds.
The Brown Administration has cut back
on bond borrowing and intends to cut more this fall. According to the state Department of Finance, the cost of borrowing
has declined $173 million this fiscal year, down to $5.2 billion.
CIRM's share of the debt service is more than $200,000 a day.
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May 20th, 2012
StemCells, Inc. Reports Positive Interim Safety Data From Spinal Cord Injury Trial
By LizaAVILA
NEWARK, Calif., May 17, 2012 (GLOBE NEWSWIRE) -- StemCells, Inc. (Nasdaq:STEM - News) today announced completion of the first planned interim safety review of the Company's Phase I/II spinal cord injury clinical trial, which indicated that the surgery, immunosuppression and the cell transplants have been well-tolerated. The trial, which is designed to evaluate the safety and preliminary efficacy of the Company's proprietary HuCNS-SC(R) cells (purified human neural stem cells), represents the first time that neural stem cells have been transplanted as a potential therapeutic agent for spinal cord injury. A summary of the data will be presented by Armin Curt, M.D., principal investigator for the clinical trial, at the Interdependence 2012 Global SCI Conference, which is being held in Vancouver, British Columbia, from May 15 to 17, 2012.
The interim data is from the first cohort of patients, all of whom suffered a complete spinal cord injury in which there is no neurological function below the level of the injury. All patients enrolled were transplanted with a dose of 20 million cells at the site of injury in the thoracic spinal cord. There were no abnormal clinical, electrophysiological or radiological responses to the cells, and all the patients were neurologically stable through the first four months following transplantation of the cells. Changes in sensitivity to touch were observed in two of the patients. The data from multiple evaluations of the patients during this four month period have been reviewed by an independent Data Safety Monitoring Committee, which has recommended that the study advance to enrollment of patients with incomplete neurological injury. Enrollment is now underway and is open to patients in Europe, the United States and Canada with incomplete spinal cord injury. The trial, which is being conducted at Balgrist University Hospital, Zurich, Switzerland, is the only ongoing clinical trial evaluating neural stem cell transplantation in spinal cord injury.
"We are very encouraged by the interim safety outcomes for the first cohort," said Dr. Curt, who is Professor and Chairman of the Spinal Cord Injury Center at the University of Zurich, and Medical Director of the Paraplegic Center at Balgrist University Hospital. "The patients in the trial are being closely monitored and undergo frequent clinical examinations, radiological assessments by MRI and sophisticated electrophysiology testing of spinal cord function. The comprehensive battery of tests provides important safety data and is very reassuring as we progress to the next stage of the trial."
The Interdependence 2012 Global SCI Conference is intended to bring together international healthcare and research facilities to showcase their work through presentations, workshops and exhibits and to discuss how to advance research, implement new best practices and shape the next generation of spinal cord injury research. Interdependence 2012 is jointly organized by the Rick Hansen Institute, a Canadian not-for-profit organization committed to accelerating the translation of discoveries and best practices into improved treatments for people with spinal cord injuries, and the Rick Hansen Foundation.
About the Spinal Cord Injury Clinical Trial
The Phase I/II clinical trial of StemCells, Inc.'s HuCNS-SC(R) purified human adult neural stem cells is designed to assess both safety and preliminary efficacy. Twelve patients with thoracic (chest-level) neurological injuries at the T2-T11 level are planned for enrollment. The Company has dosed the first three patients all of whom have injuries classified as AIS A, in which there is no neurological function below the injury level. The second and third cohorts will be patients classified as AIS B and AIS C, those with less severe injury, in which there is some preservation of sensory or motor function. The injuries are classified according to the American Spinal Injury Association Impairment Scale (AIS). In addition to assessing safety, the trial will assess preliminary efficacy based on defined clinical endpoints, such as changes in sensation, motor and bowel/bladder function.
All patients will receive HuCNS-SC cells through direct transplantation into the spinal cord and will be temporarily immunosuppressed. Patients will be evaluated regularly in the post-transplant period in order to monitor and assess the safety of the HuCNS-SC cells, the surgery and the immunosuppression, as well as to measure any recovery of neurological function below the injury site. The Company intends to follow the effects of this therapy long-term, and a separate four-year observational study will be initiated at the conclusion of this trial.
The trial is being conducted at Balgrist University Hospital, University of Zurich, a world leading medical center for spinal cord injury and rehabilitation, and is open for enrollment to patients in Europe, Canada and the United States. If you believe you may qualify and are interested in participating in the study, please contact the study nurse either by phone at +41 44 386 39 01 or by email at stemcells.pz@balgrist.ch.
Additional information about the Company's spinal cord injury program can be found on the StemCells, Inc. website at http://www.stemcellsinc.com/Therapeutic-Programs/Clinical-Trials.htm and at http://www.stemcellsinc.com/Therapeutic-Programs/Spinal-Cord-Injury.htm, including video interviews with Company executives and independent collaborators.
About Balgrist University Hospital
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StemCells, Inc. Reports Positive Interim Safety Data From Spinal Cord Injury Trial
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May 19th, 2012
Stem Cells for Spinal Cord Injury: Some Patients Have Long-Term Improvement
By LizaAVILA
Thirty Percent of Patients Show Improved Functioning after Stem Cell Therapy
Philadelphia, Pa. (May 17, 2012) One of the first long-term studies of stem cell treatment for spinal cord injury shows significant functional and other improvements in three out of ten patients, reports a study in the May issue of Neurosurgery, official journal of the Congress of Neurological Surgeons. The journal is published by Lippincott Williams & Wilkins, a part of Wolters Kluwer Health.
The results support the safety of mesenchymal stem cells (MSCs) derived from the patient's own bone marrow, showing "continuous and gradual motor improvement" in at least some patients with disability caused by spinal cord injury. The lead author of the new study was Dr. Sang Ryong Jeon of University of Ulsan College of Medicine, Seoul, South Korea.
Evidence of Improved Function after MSC Treatment for Spinal Cord Injury The researchers performed MSC transplantation in ten patients with permanent motor (movement) deficits or paralysis (paraplegia or quadriplegia) after spinal cord injury. Mesenchymal stem cells are a type of "multipotent" cell that can be cultured from adult bone marrow and induced to develop into many different types of cells.
The cultured MSCs were injected directly into the injured spinal cord and the surrounding (intradural) space. Additional cells were injected after another four and eight weeks. The results were assessed by measuring improvement in the patients' ability to move their arms and hands and to perform key activities of daily living. Imaging scans and tests of muscle activity were performed as well.
During the first six months after MSC transplantation, six of the ten patients showed improvement in motor power of the arms and hands. Of these, three patients had gradual improvement in the ability to perform daily activitiesfor example, preparing meals and typing on a keyboard.
These three patients also showed significant changes on MRI scans of the spinal cord, including evidence of healing around the injured area of the spine. They also had improvement in electrophysiologic studies of muscle electrical activity.
No Long-Term Safety Problems of MSC Transplant None of the ten patients had any permanent complications related to MSC transplantation. This helps to alleviate concerns that MSC injection could lead to later problems like the development of tumors or calcifications.
Previous studies have shown promising results with MSC transplantation in animals and humans with spinal cord injury. Mesenchymal cells have some important potential advantages for stem cell therapy, as they are a relatively easily accessible source of the patient's own cells. The ten patients treated by Dr. Jeon and colleagues represent the first attempt at direct spinal injection of MSCs for the treatment of spinal cord injury in humans.
Following up on a previous study reporting initial improvement in six patients, the new paper describes continued improvementincluding meaningful gains in the ability to perform everyday functional tasksin three patients. Dr. Jeon and colleagues note that all three patients with progressive improvement had some "residual neurological function." They write, "Therefore, MSC treatment is more likely to enhance the remaining neurological function rather than rengeneration." They call for further studies to understand the mechanism of improvement after MSC treatment and to clarify which patients with spinal cord injury are most likely to benefit.
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May 19th, 2012
Cardio3 BioSciences Has Been Selected to Present C3BS-CQR-1 Trial Data in Late Breaking Clinical Trial Session at …
By LizaAVILA
MONT-SAINT-GUIBERT, Belgium, May 18, 2012 /PRNewswire/ --
The Belgian biotechnology company, Cardio3 BioSciences (C3BS), a leader in the discovery and development of regenerative and protective therapies for the treatment of cardiovascular diseases, today announces that the final results of its Phase II clinical trial of C3BS-CQR-1 is will be presented at the late breaking clinical trial session at the European Society of Cardiology 2012 Heart Failure Congress in Belgrade, Serbia taking place on May 19-22.
Andr Terzic, M.D., Ph.D, Director at Center of Regenerative Medicine, Mayo Clinic, the co-lead investigator on the trial, will present new final follow up data on the Company's stem cell therapy for heart failure, C3BS-CQR-1, which is based on "Cardiopoiesis" proprietary technology. The presentation will be held on Sunday, May 20th in Belgrade, Serbia.
Dr. Christian Homsy, CEO of Cardio3 BioSciences, said: "Being selected to present the final follow-up data in the late breaking clinical trial session at this prestigious cardiology congress highlights the quality of our technology and reiterates our belief in C3BS-CQR-1 as a potential treatment for patients with heart failure, a condition with a significant unmet medical need. We look forward to advancing the product into Phase III."
About Cardio3 BioSciences
Cardio3 BioSciences is a Belgian leading biotechnology company focused on the discovery and development of regenerative and protective therapies for the treatment of cardiac diseases. The company was founded in 2007 and is based in the Walloon region of Belgium. Cardio3 BioSciences leverages research collaborations in the US and in Europe with Mayo Clinic and the Cardiovascular Center Aalst, Belgium.
The Company's lead product candidate C3BS-CQR-1 is an innovative pharmaceutical product consisting of autologous cardiac progenitor stem cells. C3BS-CQR-1 is based on ground breaking research conducted at Mayo Clinic that allowed discovery of cardiopoiesis, a process to mimic in adult stem cells the natural signals triggered in the early stages of life during the cardiac tissue development. Cardio3 BioSciences has also developed C-Cath, the next-generation injection catheter with superior efficiency of delivery of bio therapeutic agents into the myocardium.
C3BS-CQR-1, C-Cure, C-Cath, Cardio3 BioSciences and the Cardio3 BioSciences and C-Cath logos are trademarks or registered trademarks of Cardio3 BioSciences SA, in Belgium, other countries, or both. Mayo Clinic holds equity in Cardio3 BioSciences as a result of intellectual property licensed to the company. In addition to historical facts or statements of current condition, this press release contains forward-looking statements, which reflect our current expectations and projections about future events, and involve certain known and unknown risks, uncertainties and assumptions that could cause actual results or events to differ materially from those expressed or implied by the forward-looking statements. These risks, uncertainties and assumptions could adversely affect the outcome and financial effects of the plans and events described herein. These forward-looking statements are further qualified by important factors, which could cause actual results to differ materially from those in the forward-looking statements, including timely submission and approval of anticipated regulatory filings; the successful initiation and completion of required Phase III studies; additional clinical results validating the use of adult autologous stem cells to treat heart failure; satisfaction of regulatory and other requirements; and actions of regulatory bodies and other governmental authorities. As a result, of these factors investors and prospective investors are cautioned not to rely on any forward-looking statements. We disclaim any intention or obligation to update or review any forward-looking statement, whether as a result of new information, future events or otherwise.
For more information contact:
Cardio3 BioSciences: http://www.c3bs.com Dr Christian Homsy, CEOTel : +32-10-39-41-00 Anne Portzenheim, Communication Manager aportzenheim@c3bs.com
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Cardio3 BioSciences Has Been Selected to Present C3BS-CQR-1 Trial Data in Late Breaking Clinical Trial Session at ...
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May 19th, 2012
MURRIETA: Surprise cord-blood find is 'godsend' for ailing boy
By JoanneRUSSELL25
After half a year of blood transfusions to treat life-threatening anemia, 9-year-old Ricky Martinez was running out of time.
The Murrieta boy needed a bone marrow transplant to save his life. Although his parents had held numerous drives seeking a match for their son, the perfect donor eluded them.
Then another option appeared ---- doctors found Ricky's own blood from his umbilical cord, banked at birth, and stored in a medical facility.
"I had donated it at birth, when I delivered," said Ricky's mother, Cynthia Martinez. "I had no idea that I'd be using it for him nine years later."
The cord blood discovery represents a "godsend" for the family, Martinez said, because Ricky's body began rejecting the transfusions that keep him alive.
Cord blood contains stem cells ---- undifferentiated cells that can spur production of healthy tissue to help treat various diseases. Doctors believe it could jump-start Ricky's bone marrow, allowing his body to resume normal blood production.
But it's not a guarantee.
Ricky's condition, aplastic anemia, is an extremely rare disease, and cord blood transplantation is an experimental procedure for the condition, said David Buchbinder, a hematologist and transplant physician who is treating Ricky at Children's Hospital Orange County, in the city of Orange.
Although the procedure offers few risks of complications, it also pushes the boundaries of medical practice, placing Ricky in a realm of mixed medical opinions and uncertain results, Buchbinder said.
His parents say they're willing to go there to save their son's life.
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MURRIETA: Surprise cord-blood find is 'godsend' for ailing boy
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May 19th, 2012
Industry Consultant Gregory Bonfiglio Joins California Stem Cell Board of Directors
By JoanneRUSSELL25
IRVINE, Calif.--(BUSINESS WIRE)--
California Stem Cell, Inc. (CSC) announced today that well-known stem cell & regenerative medicine industry veteran Gregory A. Bonfiglio, J.D. has joined its Board of Directors.
Gregory Bonfiglio has over 25 years of experience working with technology companies, and was an early investor in the stem cell industry. He is Managing Partner of Proteus Venture Partners, an investment & advisory firm he founded in early 2006 to provide venture funding and strategic advisory services in the stem cell & regenerative medicine space. Mr. Bonfiglio is on the Boards of VistaGen Therapeutics and StemCyte, Inc.; he is the Chairman of the Board of the Centre for Commercialization of Regenerative Medicine (RM Translation Center in Toronto, Canada). In addition, Mr. Bonfiglio sits on the Advisory Board and Finance Committee of the International Society for Stem Cell Research (ISSCR); he is on the Commercialization Committee of the International Society for Cellular Therapy (ISCT).
Mr. Bonfiglio brings to CSC an extensive background in strategic consulting, having held partnership positions with various legal and venture firms, and having successfully led a team that took pioneering stem cell company Advanced Cell Technology public in early 2005. Were thrilled to welcome to our board someone with the breadth of industry experience that Greg has, and are very much looking forward to his participation in the continued growth of this Company, said COO Chris Airriess.
This appointment coincides with a ramp up of commercial product sales as well as advancements of CSCs active Phase II clinical trial in metastatic melanoma.
About California Stem Cell
California Stem Cell Inc. (CSC) is an Irvine, CA based company which has developed proprietary methods to generate human stem cell lines, expand them to clinically and commercially useful numbers, and differentiate them at extremely high purity using fully-defined, proprietary media and GMP processes. CSC is able to supply its human cell populations to companies and institutions worldwide for use in the development of therapies, efficacy screening or the creation of toxicity profiles for candidate drugs, and experimental research tools.
CSC is focused on the development of stem cell based therapies for spinal muscular atrophy (SMA), amyotrophic lateral sclerosis (ALS, or Lou Gehrigs Disease), and metastatic cancers.
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Industry Consultant Gregory Bonfiglio Joins California Stem Cell Board of Directors
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May 19th, 2012