Appeals at the California Stem Cell Agency: Worthwhile or Worthless?
By Dr. Matthew Watson
Jon Shestack, a patient advocate member
of the governing board of the California stem cell agency, weighed in
today on the virtues of the grant application appeal process at the
$3 billion research enterprise.
filed on the Duchenne item that appeared yesterday on this site. (His
full comment can be found at the end of that item.)
$6 million CIRM grant involving Duchenne research is “a casebook
study on why the special(extraordinary) petition is worthwhile. There
was indeed new and relevant information that only became available
after grant review. Scientific staff and leadership flagged it.”
the reasons that we ran the story about Duchenne and the team at
UCLA. The extraordinary petition process is currently under fire by
both the Institute of Medicine and the stem cell agency itself, which
has appointed a task force to come up with changes. But, while the
petition process is certainly less than perfect, so is the peer
review/grant review process.
only “case study.” An application by Karen Aboody of the City of
Hope is often cited as another case. There are undoubtedly others.
several years ago by the board as a tool to manage willy-nilly
appearances of scientists before the CIRM governing board whose
applications were rejected by reviewers. Now the Institute of
Medicine has recommended the petitions be abandoned, saying they
undermine the integrity of grant review process. The IOM cited a
major controversy in Texas involving its cancer research agency as an
example of how grant reviews or the lack of them can go bad – not
to mention conflict of interest problems there. CIRM has already
started to look for better solutions regarding appeals. Many of its directors
are troubled by emotional presentations from patients in
connection with petitions and the lack of adequate information to
make informed decisions on the spot about the contested matters.
scientific box is debatable. Researchers have the right, under state
law, to address the board on any issue whatsoever. And at least some
of them will continue to do so -- regardless of any appeals changes -- when millions of dollars and their
careers are at stake.
reviewers are not holy writ. They can and do make mistakes, as we
all do. In making changes in the appeals process, the goal of the
agency should be to devise a public and transparent process rather
than enshroud it in more secrecy. CIRM also should find a way to do
a much better job of communicating to applicants the availability of
appeals and precisely how to appeal when it becomes necessary.
Source:
Stem Cell Therapy
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December 16th, 2012
LA Times: On the California Stem Cell Agency and Wasting $700,000
By Dr. Matthew Watson
The headline on the Los Angeles
Times web site this afternoon read,
"Is California's stem cell program
preparing to waste $700,000?"
Prize-winning columnist Michael Hiltzik, whowas commenting on the presentation today by the
prestigious Institute of Medicine's (IOM) on its sweeping
recommendations for changes at the state stem cell agency.
"If you're betting that
the California
stem cell agency will spurn key recommendations of a
blue-ribbon review panel that criticized its leadership and
management structures, you might want to double that bet. Several
board members showed overt hostility to the panel's recommendations
during a public meeting today."
panel and former president of Princeton University, delivered
the briefing. The group's study took 17 months and cost the stem cell
agency $700,000.
proposals, which echoed many criticisms that have been aired for
years in California. Hiltzik wrote,
"CIRM Chairman Jonathan
Thomas glided over those issues when he introduced Shapiro.
Thomas observed that the Institute of Medicine report included many
statements "validating CIRM, its process, what it was able to
achieve," which is a bit like launching the investigation of a
plane crash by focusing on all the planes that land safely every day.
Thomas did mention that the Institute of Medicine had made numerous
recommendation about how to "take something which is already a
great experience and improve it even further."
"Shapiro got only a few minutes
into his presentation before board members started interrupting him
with objections to the Institute of Medicine's recommendation for a
majority of independent members."
"Thomas promised to stage a public
workshop on the Institute of Medicine report soon and to subject them
to 'lengthy discussion.'
"Does that sound as if the board
will be taking seriously the advice that it change the way it does
business? Stay tuned, but don't hold your breath."
Source:Stem Cell Therapy
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December 16th, 2012
Winners From Today’s Awards by the California Stem Cell Agency
By Dr. Matthew Watson
The 12 winners in the latest round of grants from the California stem cell agency all come from institutions linked to directors on the agency's governing board. Board members with conflicts of interest are not allowed to vote on the grants or participate in the debate. Since the inception of the agency, more than 90 percent of its awards have gone to institutions linked to the directors. Here is a link to the CIRM press release on today's meeting.
Here is the list of researchers who won awards today.
New Faculty Physician Scientist Translational Research Awards
| RN3-06530 | Robert Baloh | Cedars-Sinai Medical Center | $3,031,737.00 |
| RN3-06378 | Reza Ardehali | University of California, Los Angeles | $2,930,388.00 |
| RN3-06504 | Jason Pomerantz | University of California, San Francisco | $3,084,000.00 |
| RN3-06396 | Mana Parast | University of California, San Diego | $3,013,252.00 |
| RN3-06425 | Tracy Grikscheit | Children's Hospital of Los Angeles | $3,408,000.00 |
| RN3-06532 | Tippi MacKenzie | University of California, San Francisco | $2,661,742.00 |
| RN3-06479 | Ann Capela Zovein | University of California, San Francisco | $3,084,000.00 |
| RN3-06529 | Alan Cheng | Stanford University | $3,091,595.00 |
| RN3-06455 | Ali Nsair | University of California, Los Angeles | $3,004,315.00 |
| RN3-06460 | Emanual Maverakis | University of California, Davis | $2,964,000.00 |
| RN3-06510 | Michelle Monje | Stanford University | $2,800,536.00 |
| RN3-06525 | Ophir Klein | University of California, San Francisco | $3,084,000.00 |
| Total | $36,157,565.00 |
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/QdM4BZ5hPnc/winners-from-todays-awards-by.html
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December 16th, 2012
ViaCyte Wins Another $3 Million from California Stem Cell Agency
By Dr. Matthew Watson
The California stem cell agency, which
has awarded ViaCyte, Inc., $36 million, today pumped another $3
million in the firm following the collapse of an alliance between the
San Diego firm and GlaxoSmithKline.
arrangement was ballyhooed by the CIRM in October because it would
have been the first deal involving Big Pharma and the stem cell
agency. The resources of Big Pharma are needed to pursue the
expensive path of turning stem cell research into cures.
governing board approved the additional funds on a 13-0 vote with two abstentions. The action came following a closed door session to discuss how the funds would be spent. No details were provided publicly on that matter.
ViaCyte
has also told Biocentury that it is pursuing even more funding after
the alliance with Glaxo broke down. CIRM President Alan Trounson said ViaCyte is likely to receive another $3 million from the Juvenile Diabetes Research Foundation. Trounson also said that other sources are being examined as well.
CIRM, scientific activities said the agency's advisors continue to have faith in ViaCyte's effort to develop a treatment for diabetes. The company plans to start a clinical trial on its product in
2014.
celebration last fall. Alan Trounson, CIRM's president, said the
deal would “resound” globally. He told directors,
“This is
verification of our program. To have (the head of Glaxo regenerative
medicine program) join us through a partnership arrangement with GSK
means that a project that we've shepherded from the basic science
through to the preclinical work and is heading to the clinic we're
now going to do in partnership with a very major organization.”
Source:Stem Cell Therapy
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December 16th, 2012
Constitutional Questions Raised on Sweeping Changes at the California Stem Cell Agency
By Dr. Matthew Watson
The outside counsel to the governing board of the California stem cell agency is preparing an opinion on whether some of the major changes recommended by the blue-ribbon Institute of Medicine(IOM) study might require a vote of the people.
More than three years ago, the same issue was raised and used by the agency to resist unwanted changes.
Kevin McCormack, agency spokesman, said today that James Harrison of Remcho Johansen & Purcell of San Leandro will perform the analysis. Harrison has been counsel to the CIRM board since its inception. He also wrote part of Proposition 71, which created the stem cell agency in 2004.
Harrison's analysis was disclosed after CIRM Director Sherry Lansing, who is also chairwoman of the University of California Board of Regents, said this morning that the board's "hands are tied" concerning some of the IOM proposals because they could require a vote of the people. Other members of the board bristled at the IOM recommendations.
In 2009, Harrison tackled a similar task in connection with related, proposed structural changes at the $3 billion stem cell research effort. In reaction to proposals by the Little Hoover Commission, the state's good government agency, Harrison said,
“The Little Hoover Commission’s proposals would effect drastic and disruptive changes to CIRM’s governance and operating systems. Such changes run counter to the voters’ intent, and do not further Proposition 71’s purposes.”
The California Stem Cell Report wrote at the time,
"The 10-page legal memo hung most of its arguments on a provision in Prop. 71 that states that it can only be amended by the legislature if the changes 'enhance the ability of the institute to further the purposes of the grant and loan programs.'
"Harrison's memo said the Hoover proposals (in question) could only be enacted through another ballot measure...."
The Little Hoover proposals dealt with the structure of the board and the conflicting responsibilities of the president and the chairman. The IOM has recommended major changes in both areas and approvingly cited the Hoover study .
Harrison's analysis will also delineate which IOM recommendations can be implemented by board action and which will require legislative approval.
cell agency $700,000, recommended a host of changes that critics for
years have said are needed. But the 17-month study also went beyond
what the critics had proposed. The IOM said that the 29-member
governing board should be stripped of power to approve individual grants.
Instead, the board would be limited to voting for or against a slate
of applications.
changes to remove conflict of interest problems, clean up a troubling
dual-executive arrangement and fundamentally change the nature of the
governing board. The recommendations would greatly strengthen the
role of the agency's president, significantly alter the role of
patient advocates on the governing board and engage the biotech
industry more vigorously.
the San Francisco Chronicle said that prompt and major changes are
needed at the agency.
recommendations clearly require either a rare, super, supermajority vote of
the legislature (70 percent) and the signature of the governor or
another ballot initiative, which is very unlikely. Achieving the 70
percent vote is exceedingly difficult except on the most
noncontroversial matters before the legislature. The requirement
permits only 13 members of the 40-member Senate to block any CIRM
legislation, giving minority viewpoints extraordinary power over the
content of any CIRM legislation.
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/6UqNIAVe5JY/constitutional-questions-raised-on.html
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December 16th, 2012
A Singular Scientific Story: Duchenne’s Disease, a Family and the California Stem Cell Agency
By Dr. Matthew Watson
including a tie to the $3 billion California stem cell agency,
surround a promising scientific development reported today by a
husband and wife research team at UCLA.
muscular dystrophy (DMD), an inherited disease that afflicts about
one in 3,600 boys and results in muscle degeneration and, eventually,
death.
 |
| Carrie Miceli UCLA photo |
Miceli, said they have discovered a promising FDA-approved drug that
could advance the fight against the affliction.
son, Dylan, with the disease. They have been studying the affliction
for some time, but their most recent and ambitious research plan was
rejected earlier this year by stem cell agency grant reviewers, a process that
normally kills an application. Undaunted, Miceli and Nelson appealed
to the full stem cell agency board last July. Backed by an emotional
presentation involving patient advocates, they won approval of a $6
million grant.
process known as an “extraordinary petition,” which the Institute
of Medicine (IOM) last week said should be abandoned because it undermines
the integrity of the CIRM grant review process.
 |
| Stan Nelson UCLA photo |
the CIRM board was moving to restrict its free-wheeling
appeals procedures.
journal Science Translational Medicine. However, the money was not used in the study reported today.
the (Duchenne) therapy currently being tested in clinical trials,”
according to a UCLA press release.
“(The researchers) hope this one-two
punch used in combination will overcome the genetic mutations that
cause DMD, restore a missing protein needed for proper muscle
function and allow those affected by the disease to lead relatively
normal lives.”“Their youngest son, Dylan, 11, was
diagnosed with DMD in 2004. While he’s still ambulatory – many
DMD patients require the use of wheelchairs by about age 10 – Dylan
can no longer run or climb stairs and he can’t shoot a basketball
over his head like other boys his age. Despite these
challenges, Miceli said Dylan remains a happy, funny and engaged boy,
full of life and passion.“'We entered into this field because
of the diagnosis of our son, but we hope our research can help many
others,' she said. 'There are drugs that can help manage the symptoms
of the disease, but nothing that changes its course dramatically.
We’re trying to correct the defect that causes DMD with highly
personalized genetic medicine.'”
used for “longer term studies of their drug combination therapy in
mouse models to ensure it can restore dystrophin levels to normal or
near normal levels. They also will explore whether DMD patients with
other mutations can benefit from the combination therapy.”
spokesman for the stem cell agency, said today's findings "are certainly
very encouraging." He continued,
"Clearly there is still a long way
to go before we know if this approach will work in people but we're
delighted that funding from the stem cell agency is helping the
researchers move their work forward....This is what voters set out to
do when they approved Proposition 71 to create the stem cell agency."
Source:Stem Cell Therapy
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December 16th, 2012
Some California Stem Cell Board Members Bristle at IOM Recommendations
By Dr. Matthew Watson
Some directors of the $3 billion California stem cell agency today sharply challenged recommendations by the Institute of Medicine(IOM) concerning conflicts of interest and the role of patient advocates on the governing board.
Much of the criticism came from the 10 patient advocate members on the board, whose roles would be significantly altered under the IOM recommendations. Jeff Sheehy, a patient advocate for HIV/AIDs and vice chairman of the agency's grant review group, said he saw no evidence in the IOM report for its recommendations regarding patient advocates. He said,
"If you had some here, I would be more comfortable."
He continued,
"We are not all powerful. We are a minority on the (29-member) board."
Jonathan Shestack, another patient/adovcate director, said the IOM's conclusions on "conflicts of interest could not possibly be more incorrect than they are." He said,
"Advocates are here to advocate."
Harold Shapiro, chairman of the IOM study, said, "We are not against patient advocates." He said that the IOM supports advocates and that its recommendations could increase the role of patient advocates, albeit in a different manner.
Shapiro added that conflicts of interest do not necessary bar participation by board members. He said, however, they must be disclosed and managed.
Director Robert Price of UC Berkeley said,
"We have gone to great lengths to manage conflicts of interest."
The IOM recommended that all board members be removed from the grant review process, which would be turned over to the CIRM president. The board would only vote on a slate of applications, not individual grants. More disclosure would be required of personal conflicts of interest, including health matters, that the board said research has shown can create bias.
The IOM report said,
“Far too many board members
represent organizations that receive CIRM funding or benefit from
that funding. These competing personal and professional
interests compromise the perceived independence of the ICOC(the
CIRM governing board), introduce potential bias into the board’s
decision making, and threaten to undermine confidence in the board.”
More than 90 percent of the $1.7 billion that the CIRM board has awarded has gone to institutions that are represented on the CIRM governing board.
J.T. Thomas, chairman of the CIRM board, said that the agency takes the recommendations "very seriously" and that they would discussed further at a board workshop in early January. The workshop is scheduled to be public but the date and location has not been announced. Thomas said the recommendations will receive "lengthy discussion" thereafter and review by appropriate subcommittees of directors.
No one from the public commented during the roughly 90 minute discussion. Eighteen out of 29 board members were present at the beginning of today's meeting.
Source:Stem Cell Therapy
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December 16th, 2012
IOM Report: Many Major Changes at Stem Cell Agency Require Legislation
By Dr. Matthew Watson
As the Institute of Medicine began its presentation today to the governing board of the $3 billion California stem cell agency, one of its key directors, Sherry Lansing, pointed out that some of the IOM recommendations require legislative action and perhaps a vote of the people.
Her essential point was that the agency is hamstrung by the very measure that created it in 2004. She did not elaborate on her comment, but here is a look at some of matters she was talking about. (Lansing is chairwoman of the UC board of regents and former CEO of a Hollywood film studio.)
The ballot measure locked in management minutia and more, and then slapped on tight restrictions that make it nearly politically impossible to alter even such matters as who is in charge of production of the annual report. (By order of law, the chairman, in case you are wondering.)
And if the 29-member governing board -- so sized and specified to every nit and nat by the ballot measure -- wants to make the sweeping changes recommended by the IOM, agency directors face a formidable task in California's Capitol.
Many of
the most important recommendations for the California stem cell
agency require a vote of the California legislature and
signature of the governor. The IOM's choice of words – that these proposals “may” need legislation – is conservative. There is little doubt that legislative action would be needed to fully implement the recommendations below.
super-majority (70 percent) of each house. The requirement was also written into state law by Proposition 71, the 10,000-word ballot initiative
that created the stem cell agency. The 70 percent requirement gives extraordinary power to minority viewpoints that must be dealt with to win passage of legislation. In the state Senate, for example, it would take only 13 senators to block a bill.
planning, oversee financial performance and legal compliance, assess
the performance of the president and the board, and develop a plan
for transitioning CIRM to sustainability. The board should oversee
senior management but should not be involved in day-to-day
management. The chair and the board should delegate day-to-day
management responsibilities to the president. Each of the three
working groups should report to management rather than to the ICOC.
the Board and Working Groups
restructure the board to have a majority of independent members,
without increasing the size of the board. It should include
representatives of the diverse constituencies with interests in stem
cell research, but no institution or organization should be
guaranteed a seat on the board. Consideration should be given to
adding members from the business community. The terms of board
members should be staggered to balance fresh perspectives with
continuity.
be prohibited from serving on the working groups. During the
reconstitution of the working groups, the current level of
representation of disease advocates should be maintained, such board
members being replaced with other disease advocates who are not board
members.
Definitions and Policies
conflict of interest to recognize conflicts arising from nonfinancial
interests, such as the potential for conflict arising from an
individual’s interest in a specific disease, and should reassess
its policies for managing conflict of interest in light of this
broader definition.
Funding Process
review and funding process to separate oversight and strategic
planning from day-to-day operations. The ICOC should remain
responsible for oversight and articulation of an overall strategic
plan. However, grant management, funding recommendations, and grant
administration should be the responsibility of the CIRM scientific
staff, reporting to the president. This restructuring would help
mitigate concerns related to conflicts of interest and would also put
the review and funding process in the hands of those best equipped to
make those decisions.
changes pertaining to the development and approval of RFAs,
composition of the Grants Working Group, reordering of rankings by
CIRM staff, notification of applicants, and process for making final
decisions.
Aspects of CIRM Organization
the Scientific Advisory Board, the Standards Working Group, and the
Grants Working Group should be enhanced to leverage industry’s
expertise and resources in product development, manufacturing, and
regulatory approval in support of the ultimate goal of bringing
therapies to patients.
Property Policies with Policies of Bayh-Dole Act
other sources of funding for stem cell research become available and
as the field of regenerative medicine advances from the laboratory to
the clinic, the ICOC should reconsider whether its goal of developing
cures would be better served by harmonizing CIRM’s IP policies
wherever possible with the more familiar policies of the Bayh-Dole
Act.
Source:Stem Cell Therapy
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December 16th, 2012
Stem Cells Regenerate New Finger! – Video
By JoanneRUSSELL25
Stem Cells Regenerate New Finger!
This is a CBS news feature on the exciting world of regenerative medicine ie stem cell therapy which is used to treat injuries with the help of regeneration of new tissues. The uploaded video is not the property of Stemade Biotech Pvt. Ltd. ("the Company"), and the Company shall not be held responsible for the authenticity and accuracy of information presented in this video.From:StemadeBiotechViews:5 0ratingsTime:04:09More inScience Technology
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December 15th, 2012
Stem cell therapy is one of the best treatments – Video
By Dr. Matthew Watson
Stem cell therapy is one of the best treatments
http://www.angeleshealth.com - A stem cell therapy in Mexico provides specialised treatment methods to get rid of certain ailments that can be cured using this therapy.From:Adron SteaveViews:1 0ratingsTime:01:19More inPeople Blogs
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December 15th, 2012
Curing of diseases through stem cell therapy – Video
By Dr. Matthew Watson
Curing of diseases through stem cell therapy
http://www.ccsvi.mx - Stem cell therapy is one of the updated and most advanced types of treatment in modern world of medical science. This treatment technology is a big revolution in the history of medical science across the whole world.From:Zack BerenViews:1 0ratingsTime:01:08More inPeople Blogs
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December 15th, 2012
AXA y Ponle Freno, promoting road safety ® AXA VÃdeo Oficial – Video
By Dr. Matthew Watson
AXA y Ponle Freno, promoting road safety ® AXA Vídeo Oficial
Fun running race #39;Ponle Freno #39; 4th edition took place in Madrid on November 25. It was the first action since AXA entered into strategic partnership with Ponle Freno social platform. And because of that, we did our best to make it a resounding success. The outcome couldn #39;t be better: bull; Record number of participants, with a large number of AXA employees and their relatives running bull; Fundraising record. Money will support a research project on stem cell therapy for spinal cord injury at Puerta de Hierro Hospital (Madrid). bull; Launching of new app ( #39;Corremos Juntos #39;) that allowed thousands of people to participate in the race all over the world for the first time. bull; AXA employees showed their engagement and commitment to the project, with hundreds running in Madrid and also in some other cities in Spain thanks to the app. In short, an unforgettable day for all people worried about road safety, as shown in the video above. axa.es "Like Music" by Admiral Bob (feat. snowflake) ccmixter.org is licensed under a Creative Commons license: creativecommons.orgFrom:AXASEGUROSESViews:33 0ratingsTime:03:21More inNonprofits Activism
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December 14th, 2012
Benefits of Live Cell Therapy | Live Cell Therapy For Cellular Regeneration – Video
By Dr. Matthew Watson
Benefits of Live Cell Therapy | Live Cell Therapy For Cellular Regeneration
stemcellmalaysia.com Live cell therapy renders more than beauty and anti-aging. Live cell therapy regenerates and renews the cells, tissues, organs and glands of our body. The regeneration and renewal within result in the outward expression of youthfulness and aging reversal. The processes of internal regeneration and renewal invariably result in disease treatment and recovery from illnesses looming within the body. For more information on live cell therapy benefits, please visit Stem Cell Malaysia at stemcellmalaysia.comFrom:stemcells2012Views:0 1ratingsTime:09:01More inScience Technology
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December 14th, 2012
Trachea regenerated using stem cell therapy – Video
By daniellenierenberg
Trachea regenerated using stem cell therapy
An interview with the President of Harvard Bioscience, who played a key role in the regeneration of the trachea which was implanted at the time of surgical resection of tumorous trachea using the patient #39;s own stem cells. The uploaded video is not the property of Stemade Biotech Pvt. Ltd. ("the Company"), and the Company shall not be held responsible for the authenticity and accuracy of information presented in this video.From:StemadeBiotechViews:0 0ratingsTime:07:55More inScience Technology
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December 14th, 2012
Randall avoids knee replacement surgery after adult stem cell therapy by Dr Harry Adelson – Video
By Sykes24Tracey
Randall avoids knee replacement surgery after adult stem cell therapy by Dr Harry Adelson
Randall describes his experience with adult stem cell therapy by Dr Harry Adelson on his arthritic knee and ankleFrom:Harry AdelsonViews:0 0ratingsTime:01:08More inScience Technology
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December 13th, 2012
Neuralstem Investigator Presents New ALS NSI-566 Data at International Symposium on ALS/MND
By LizaAVILA
ROCKVILLE, Md., Dec. 10, 2012 /PRNewswire/ --Neuralstem, Inc. (NYSE MKT: CUR) announced that Jonathon Glass, MD, Director of the Emory ALS Center, presented new data from the Phase I trial of Neuralstem's human spinal cord stem cells, NSI-566, in amyotrophic lateral sclerosis (ALS or Lou Gehrig's disease) at the International Symposium on ALS/MND in Chicago, sponsored by the Motor Neurone Disease Association. In a Thursday presentation, "RESULTS OF PHASE 1 TRIAL OF SPINAL CORD TRANSPLANTATION OF NEURAL PROGENITOR CELLS IN ALS (THE NEURALSTEM, INC. TRIAL)," Dr. Glass revealed that researchers were able to establish the long-term survival of Neuralstem's transplanted spinal cord stem cells in autopsied patients, through a technology called DNA fingerprinting. Dr. Glass, who is the principal site investigator of the trial at Emory, also announced that the study team has received a grant from the National Institutes of Health (NIH) to cover a majority of the cost of an upcoming Phase II trial.
(Logo: http://photos.prnewswire.com/prnh/20061221/DCTH007LOGO )
"We are quite pleased by our ability to perform all of the surgeries planned for the Phase I trial without evidence of significant surgical or medical complications, including those patients who received both lumbar and cervical transplantations," said Dr. Glass. "We can also report that we found evidence of cell survival in all of the patients who came to autopsy, including our first patient who died 30 months after transplantation.
This is very positive news, supporting our plan to accelerate this study by increasing the dose of stem cells delivered to the cervical spinal cord in the hopes of delaying respiratory failure and prolonging life. The next phase of the study has been partially funded by a generous grant from the National Institutes of Health, and we will begin once the FDA approves our new protocol," Dr. Glass concluded.
"This is a major finding," said Karl Johe, Ph.D., Neuralstem Chairman of the Board and Chief Scientific Officer. "There is currently no way to confirm the survival of the cells in patients while they are alive. Levels of functional recovery, or a slowdown in the progression of the disease in various patients, have given us reason to believe the cells have survived. Now, cell survival has been demonstrated by definitive evidence.
Among the six patients autopsied (five died of ALS disease progression and one, of unrelated heart failure), the survival period, from stem cell transplantation to death, ranged from 196 921 days. Five of these patients had discontinued all immune suppression medications for 57 638 days prior to death, but showed the stem cell DNA content in the range of 0.67% - 5.4% of total DNA in some spots of cord treated with the stem cells. There was no correlation of DNA content to survival period without immune suppression medication. These data, therefore, suggest that long-term immuno suppression of patients is not required for long-term survival of our cells, which points towards the feasibility of needing only transient immune suppression in future ALS trials," Dr. Johe concluded.
About Neuralstem
Neuralstem's patented technology enables the ability to produce neural stem cells of the human brain and spinal cord in commercial quantities, and the ability to control the differentiation of these cells constitutively into mature, physiologically relevant human neurons and glia. Neuralstem has recently treated the last patient in an FDA-approved Phase I safety clinical trial for amyotrophic lateral sclerosis (ALS), often referred to as Lou Gehrig's disease, and has been awarded orphan status designation by the FDA.
In addition to ALS, the company is also targeting major central nervous system conditions with its NSI-566 cell therapy platform, including spinal cord injury, ischemic stroke and glioblastoma (brain cancer). The company has submitted an IND (Investigational New Drug) application to the FDA for a Phase I safety trial in spinal cord injury.
Neuralstem also has the ability to generate stable human neural stem cell lines suitable for the systematic screening of large chemical libraries. Through this proprietary screening technology, Neuralstem has discovered and patented compounds that may stimulate the brain's capacity to generate new neurons, possibly reversing the pathologies of some central nervous system conditions. The company is in a Phase Ib safety trial evaluating NSI-189, its first neurogenic small molecule compound, for the treatment of major depressive disorder (MDD).Additional indications could include chronic traumatic encephalopathy (CTE), Alzheimer's disease, and post-traumatic stress disorder (PTSD).
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Neuralstem Investigator Presents New ALS NSI-566 Data at International Symposium on ALS/MND
Spinal Cord Stem Cells
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December 11th, 2012
Stem Cell Therapy and Medical Tourism: Of Promise and Peril? – Video
By LizaAVILA
Stem Cell Therapy and Medical Tourism: Of Promise and Peril?
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Stem Cell Therapy and Medical Tourism: Of Promise and Peril? - Video
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December 11th, 2012
Gordon Camp (Parkinson’s Disease) Stem Cell Therapy – Video
By LizaAVILA
Gordon Camp (Parkinson #39;s Disease) Stem Cell Therapy
New Project 46From:OmarGonzalezMDViews:0 0ratingsTime:06:29More inScience Technology
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Gordon Camp (Parkinson's Disease) Stem Cell Therapy - Video
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December 11th, 2012
Photo Release — GIOSTAR and the Government of India to Enter $2 Billion Stem Cell Therapy Program – Official State …
By Sykes24Tracey
SAN DIEGO, Dec. 10, 2012 (GLOBE NEWSWIRE) -- The Global Institute Of Stem-cell Therapy And Research (GIOSTAR) announced today a collaborative treatment plan to serve the local population suffering from a genetic disease, Sickle Cell Anemia. President and CEO, Mr. Deven Patel and his team met with Honorable Chief Minister Shri Arjun Munda of State of Jharkhand, India in November 2012 to address the local population's medical needs.
A photo accompanying this release is available at http://www.globenewswire.com/newsroom/prs/?pkgid=16184.
As a follow-up, a government delegation representing the state of Jharkhand, India; Chief Minister, Principal Health Secretary, Chief Secretary and many other officials are visiting GIOSTAR in San Diego on December 14, 2012 to finalize the proposed two (2) billion U.S. dollar contract to be serviced over the next 15 years.
Bob Filner, Mayor of San Diego and City Council Members are among the invited guests for this state visit along with representatives from Belize and the island nation of Saint Vincent and the Grenadines.
Two hundred (200) jobs are estimated to be created in San Diego and it is expected that the dialog would include an economic development program between City of San Diego and State of Jharkhand, India.
GIOSTAR is a Global Private Funding (Global) incubated company. "Global is a private equity firm that focuses on funding projects and initiatives that are job-creation centric rather than just profit centric. We believe that a venture that draws the best minds and hearts to a unified goal, driven by a unified vision tends to be far stronger and less prone to failure than one driven by just profit. We invest in people, not the business," said Dr. Sam Senev, Chairman and CEO of Global. Senev added that GIOSTAR is a showcase client focused on both serving mankind through quality of life and job creation.
GIOSTAR, headquartered in San Diego, California (USA), was formed with the vision to provide stem cell based therapy to aid those suffering from degenerative or genetic diseases around the world. We are the leaders in developing innovative stem cell based technology.
The Chairman and Cofounder of GIOSTAR, Dr. Anand Srivastava and our team of scientists and clinicians have been associated with leading universities and research institutions throughout USA. GIOSTAR team has extensive research and clinical experience in the field of Stem cell, which is documented by several publications in revered scientific journals.
GIOSTAR in July 2011, inaugurated the world's first dedicated stem cell treatment hospital, a 125-bed, contemporary facility with the most advanced on-site stem cell laboratory. This hospital is fully operational. GIOSTAR is developing the world's largest, a three hundred thousand square-foot (300,000SF) state-of-the-art, Stem Cell Treatment Hospital in the Surat Civil Hospital Campus in collaboration with the government of Gujarat. Negotiations are ongoing with China, Philippines, Bahamas, Belize, Thailand, Ukraine and the Middle East to open regional stem cell treatment hospitals and satellite clinics throughout those countries and regions. "We are expanding the GIOSTAR footprint and is in negotiations to open locations near Austin Texas, Phoenix Arizona, and Savannah South Carolina" said Michael Andersen, Vice President of Venture Management at Global. Global and Empyrean West, EB-5 administrators, plan to invest over one hundred and eighty million ($180M) in economic development investments for GIOSTAR projects.
The Global Institute of Stem Cell Therapy and Research company logo is available at http://www.globenewswire.com/newsroom/prs/?pkgid=16183.
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Photo Release -- GIOSTAR and the Government of India to Enter $2 Billion Stem Cell Therapy Program - Official State ...
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December 11th, 2012
Stem Cell Therapy for Animals Q
By daniellenierenberg
Stem Cell Therapy for Animals Q A at Animal Clinic of
- Captured Live on Ustream at http://www.ustream.tvFrom:HawaiiWellnessDirViews:1 0ratingsTime:39:36More inPeople Blogs
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December 10th, 2012