Traditional breeding outperforms genetic engineering – The Hindu
By Dr. Matthew Watson
 The Hindu | Traditional breeding outperforms genetic engineering The Hindu Although exaggerated claims of rise of productivity by GM (genetically modified) crops have been made time and again in India and abroad, on closer examination these have been proved time and again to be untrue. According to a report by eminent ... |
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October 21st, 2012
ACT Announces Second Stargardt’s Disease Patient Treated with Higher Dosage of Embryonic Stem Cell-Derived Retinal …
By Dr. Matthew Watson
MARLBOROUGH, Mass.--(BUSINESS WIRE)--
Advanced Cell Technology, Inc. (ACT; OTCBB: ACTC), a leader in the field of regenerative medicine, today announced treatment of the fifth patient, the second in the second patient cohort, in its U.S. clinical trial for Stargardts Macular Dystrophy (SMD). The patient was injected with 100,000 human embryonic stem cell-derived retinal pigment epithelial (RPE) cells, as compared with the 50,000 cell dose used in the three patients of the first cohort. The patient successfully underwent the outpatient transplantation surgery yesterday, and is recovering uneventfully.
We continue to make steady progress in our ongoing clinical trials, commented Gary Rabin, chairman and CEO. We look forward to completing the third and final patient in this cohort in the U.S. clinical trial for SMD in the near future, which will mark the halfway point. We have now mapped out the series of patients to complete this cohort and the second cohort in the European trial, and have done the same in the US AMD trial, pending DSMB review. With all four trial centers in the US and both trial centers in the UK now trained and ready to treat patients, combined with the streamlined process in the European trial protocol, we anticipate an accelerated pace of generating patient data.
Initiated in July of last year, the Phase I/II trial is designed to determine the safety and tolerability of hESC-derived RPE cells following sub-retinal transplantation in patients with SMD at 12 months, the studys primary endpoint. It will involve a total of 12 patients, with cohorts of three patients each in an ascending dosage format. The company is concurrently conducting a second trial for SMD in Europe and another for dry age-related macular degeneration in the U.S.
We continue to be very encouraged with how this clinical trial is progressing, said Robert Lanza, M.D., chief scientific officer. We are confident of continued momentum in our other two trials, as well.
Further information about patient eligibility for ACTs SMD study and the concurrent studies in the U.S. and Europe (for dry age-related macular degeneration and SMD, respectively) are available at http://www.clinicaltrials.gov, with the following Identifiers: NCT01345006 (U.S. SMD), NCT01344993 (dry AMD), and NCT01469832 (E.U. SMD).
About Stargardts Disease
Stargardts disease or Stargardts Macular Dystrophy is a genetic disease that causes progressive vision loss, usually starting in children between 10 to 20 years of age. Eventually, blindness results from photoreceptor loss associated with degeneration in the pigmented layer of the retina, called the retinal pigment epithelium, which is the site of damage that the company believes the hESC-derived RPE may be able to target for repair after administration.
About Advanced Cell Technology, Inc.
Advanced Cell Technology, Inc. is a biotechnology company applying cellular technology in the field of regenerative medicine. For more information, visit http://www.advancedcell.com.
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October 20th, 2012
Stem cell model for hereditary disease developed
By Dr. Matthew Watson
ScienceDaily (Oct. 15, 2012) A new method of using adult stem cells as a model for the hereditary condition Gaucher disease could help accelerate the discovery of new, more effective therapies for this and other conditions such as Parkinson's, according to new research from the University of Maryland School of Medicine.
Scientists at the University of Maryland School of Medicine reprogrammed stem cells to develop into cells that are genetically similar to and react to drugs in a similar way as cells from patients with Gaucher disease. The stem cells will allow the scientists to test potential new therapies in a dish, accelerating the process toward drug discovery, according to the paper published online in the journal the Proceedings of the National Academy of Sciences (PNAS) on Oct. 15.
"We have created a model for all three types of Gaucher disease, and used stem cell-based tests to evaluate the effectiveness of therapies," says senior author Ricardo Feldman, Ph.D., associate professor of microbiology and immunology at the University of Maryland School of Medicine, and a research scientist at the University of Maryland Center for Stem Cell Biology and Regenerative Medicine. "We are confident that this will allow us to test more drugs faster, more accurately and more safely, bringing us closer to new treatments for patients suffering from Gaucher disease. Our findings have potential to help patients with other neurodegenerative diseases as well. For example, about 10 percent of Parkinson's disease patients carry mutations in the recessive gene for Gaucher disease, making our research possibly significant for Parkinson's disease as well."
Gaucher disease is the most frequent lipid-storage disease. It affects 1 in 50,000 people in the general population. It is most common in Ashkenazi Jews, affecting 1 in 1,000 among that specific population. The disease occurs in three subtypes -- Type 1 is the mildest and most common form of the disease, causing symptoms such as enlarged livers and spleens, anemia and bone disease. Type 2 causes very serious brain abnormalities and is usually fatal before the age of two, while Type 3 affects children and adolescents.
The condition is a recessive genetic disorder, meaning that both parents must be carriers for a child to suffer from Gaucher. However, said Dr. Feldman, studies have found that people with only one copy of a mutated Gaucher gene -- those known as carriers -- are at an increased risk of developing Parkinson's disease.
"This science is a reflection of the mission of the University of Maryland School of Medicine -- to take new treatments from bench to bedside, from the laboratory to patients, as quickly as possible," says E. Albert Reece, M.D., Ph.D., M.B.A., vice president for medical affairs at the University of Maryland and John Z. and Akiko K. Bowers Distinguished Professor and dean of the University of Maryland School of Medicine. "We are excited to see where this research goes next, bringing new hope to Gaucher patients and their families."
Dr. Feldman and his colleagues used the new reprogramming technology developed by Shinja Yamanaka in Japan, who was recognized with this year's Nobel Prize for Medicine or Physiology. Scientists engineered cells taken from the skin of Gaucher patients, creating human induced pluripotent stem cells, known as hiPSC -- stem cells that are theoretically capable of forming any type of cell in the body. Scientists differentiated the cells to form white blood cells known as macrophages and neuronal cells.
A key function of macrophages in the body is to ingest and eliminate damaged or aged red blood cells. In Gaucher disease, the macrophages are unable to do so -- they can't digest a lipid present in the red blood cell membrane. The macrophages become engorged with lipid and cannot completely clear the ingested red blood cells. This results in blockage of membrane transport pathways in the macrophages lodged in the bone marrow, spleen and liver. The macrophages that the scientists created from the reprogrammed stem cells exhibited this characteristic hallmark of the macrophages taken from Gaucher patients.
To further test the stem cells, the scientists administered a recombinant enzyme that is effective in treating Gaucher patients with Type 1 disease. When the cells were treated with the enzyme, the function of the macrophages was restored -- they completely cleared the red blood cells.
"The creation of these stem cell lines is a lovely piece of stem cell research," said Curt Civin, M.D., professor of pediatrics and physiology, associate dean for research and founding director of the Center for Stem Cell Biology & Regenerative Medicine at the University of Maryland School of Medicine. "Dr. Feldman is already using these Gaucher patient-derived macrophages to better understand the disease fundamentals and to find novel medicines for Gaucher disease treatment. A major goal of our Center for Stem Cell Biology & Regenerative Medicine is to translate our fundamental discoveries into innovative and practical clinical applications that will enhance the understanding, diagnosis, treatment, and prevention of many human diseases. Clinical applications include not only transplantation of stem cells, but also the use of stem cells for drug discovery as Dr. Feldman's studies so beautifully illustrate."
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Stem cell model for hereditary disease developed
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October 16th, 2012
Cell therapy portfolio outperforms major indices year-to-date
By Dr. Matthew Watson
On August 10 we created a model portfolio in Google Finance of 29 public companies in the cell therapy sector then we compared how that portfolio was doing against the major indices year-to-date (Since 1 January 2012). See that post here. Bottom line: even though we are still in a relatively bullish market, the CT portfolio was doing better. Significantly better.
 |
| CT model portfolio compared to 3 major indices YTD |
- Cell Therapy Portfolio: +24.44%
- Dow Jones: +4.5%
- S+P 500: +6.78%
- Nasdaq: +10.26%
Regenerative Medicine
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October 14th, 2012
Yamanaka and the Frailty of Peer Review
By Dr. Matthew Watson
More than one back story exists on
Shinya Yamanaka and his Nobel Prize, but one that has received little
attention this week also raises questions about hoary practice of
peer review and publication of research – not to mention the
awarding of billions of dollars in taxpayer dollars.
article in the New Scientist magazine by Peter Aldous in which the
publication examined more than 200 stem cell papers published from
“2006 onwards.” The study showed an apparent favoritism towards
U.S. scientists. Also specifically reported were long delays in
publication of Yamanaka's papers, including in one case 295 days.
“All's fair in love and war, they
say, but science is supposed to obey more noble ideals. New findings
are submitted for publication, the studies are farmed out to experts
for objective 'peer review' and the best research appears promptly
in the most prestigious journals.
“Some stem cell biologists are crying
foul, however. Last year(2009), 14 researchers in this notoriously
competitive field wrote
to leading journals complaining of "unreasonable or
obstructive reviews". The result, they claimed, is that
'publication of truly original findings may be delayed or rejected.'
“Triggered by this protest, New
Scientist scrutinised the dynamics of publication in the most
exciting and competitive area of stem
cell research, in which cells are 'reprogrammed' to
acquire the versatility of those of an early-stage embryo. In this
fast-moving field, where a Nobel prize is arguably at stake,
biologists are racing feverishly to publish their findings in top
journals.
“Our analysis of more than 200
research papers from 2006 onwards reveals that US-based scientists
are enjoying a significant advantage, getting their papers published
faster and in more prominent journals (find
our data, methods and analyses here).
“More mysterious, given his standing
in the field, is why two of Yamanaka's papers were among the 10 with
the longest lags. In the most delayed of all, Yamanaka reported that
the tumour-suppressing gene p53 inhibits the formation of
iPS cells. The paper took 295 days to be accepted. It was eventually
published by Nature in August 2009 alongside four similar
studies. 'Yamanaka's paper was submitted months before any of the
others,' complains Austin
Smith at the University of Cambridge, UK, who coordinated
the letter sent to leading journals.
“Yamanaka suggests that editors may
be less excited by papers from non-US scientists, but may change
their minds when they receive similar work from leading labs in the
US. In this case, Hochedlinger submitted a paper similar to
Yamanaka's, but nearly six months after him. Ritu
Dhand, Nature's chief biology editor, says that each paper
is assessed on its own merits. Hochedlinger says he was unaware of
Yamanaka's research on p53 before publication.”
wrote of other issues dealing with peer review, but coincidentally
also dealing with iPS cells. What New Scientist and Knoepfler are
discussing is not an isolated situation. It is part of a continuum of
complaints, both serious and self-interested but exceedingly
pervasive. A Google search today on the term “problems with peer
review” turned up 10.1 million references. Writing on Ars Technica last year, Jonathan Gitlin, science policy analyst at the National
Human Genome Research Institute, summarized many of the issues, citing a “published” (our quotation marks)
study that said peer review doesn't work “any better than chance.”
Gitlin said,
“A common criticism is that peer
review is biased towards well-established research groups and the
scientific status quo. Reviewers are unwilling to reject papers from
big names in their fields out of fear, and they can be hostile to
ideas that challenge their own, even if the supporting data is good.
Unscrupulous reviewers can reject papers and then quickly publish
similar work themselves.”
agency, peer review is undergoing some modest, indirect examination
nowadays. The agency is moving towards tighter scrutiny of budgets
proposed by applicants. And, following a record wave of appeals this
summer by disgruntled applicants rejected during peer review, it is
also moving to bring the appeal process under more control.
more successfully towards development of commercial therapies, it may
do well to consider also the frailties of its peer review process and the
perils of scientific orthodoxy.
Source:Yamanaka: ‘Rejected, Slow and Clumsy’
By Dr. Matthew Watson
This week's announcement of the Nobel
Prize for Shinya Yamanaka brought along some interesting
tidbits, including who was “snubbed” as well as recollections
from the recipient.
wrote the “snubbed” piece and quoted Christopher Scott of
Stanford and Paul Knoepfler of UC Davis about the selection issues.
Bardin's piece mentioned Jamie Thomson and Ian Wilmut as scientists
who also could have been considered for the award but were not named.
Ultimately, Bardin wrote that the award committee was looking for a
“singular, paradigm shifting discovery,” which he concluded was
not the case with Thomson or Wilmut.
was another topic in the news coverage, much of it dry as dust.
However, Lisa Krieger of the San Jose Mercury News began her story
with Yamanaka's travails some 20 years ago. At the time, no one was returning his phone
calls as he looked for work, and he was rejected by
50 apparently not-so-farsighted American labs.
decided he was less than successful as an orthopedic surgeon,
according to an account in JapanRealTime. “Slow and clumsy” was
how Yamanaka described himself.
again he reported stumbling. In this case, he found a way to reduce
“bad cholesterol” but with a tiny complication – liver cancer.
That in turn sent him on a journey to learn how cells proliferate and
develop, which led him to the work that won the Nobel Prize.
orthopedic medicine was stimulated by his father along with the treatments
for injuries young Yamanaka received while playing rugby and learning judo. The JapanRealTime account continued,
“'My father probably still thinks in
heaven that I’m a doctor,' he said in the interview(with Asahi
Shimbun last April). 'IPS cells are still at a research phase and
have not treated a single patient. I hope to link it to actual
treatment soon so I will be not embarrassed when I meet my father
someday.'”
report from a high school biology teacher that said the 15-year-old
Gurdon's desire to become a scientist was “quite ridiculous.”
The teacher, who is unnamed, wrote,
“If he can’t learn simple
biological facts he would have no chance of doing the work of a
specialist, and it would be a sheer waste of time, both on his part
and of those who would have to teach him.”
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/7J31SRIukpg/yamanaka-rejected-slow-and-clumsy.html
Tighter Controls on Stem Cell Grant Budgets Hits Quorum Bump
By Dr. Matthew Watson
SAN FRANCISCO – A move to tighten
budget controls on grants from the $3 billion California stem cell
agency stalled Monday, but it appears that the plan is headed for
ultimate approval.
by the agency's directors' Science Subcommittee, which could not act
on it after it lost its quorum.
the stronger budget controls, but had questions about the specifics
of implementing the plan during closed-door reviews of grant
applications. The proposal is likely to be altered to respond to
those concerns. It would then either come back to the Science
Subcommittee or go to the full board.
recipients of large grants that approval of an application by the
agency's governing board does not provide a carte blanche to
researchers. Ellen Feigal, senior vice president for research and
development, said it can be “extremely difficult” for CIRM staff
to deal with budget problems in grants following board approval.
speed the application process on its next disease team round, which
is aimed at driving research into the clinic. The concept proposal
for that round is scheduled to come before directors later this
month. The round will be limited to “more mature stage” research
that is close to a clinical trial, if not in one. Feigal said 10 to
15 applications are expected.
to CIRM's strategic partnership program was also approved.
Source:Stem Cell Therapy
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October 14th, 2012
Yamanaka and the Golden State
By Dr. Matthew Watson
The iPierian biopharmaceutical company
in South San Francisco was quick to make a change in its web site
this morning after the Nobel Prize for medicine was announced.
scientific advisors, Shinya Yamanaka, to note that he had won the
Nobel. The bio is tucked away on the site, but it is likely that the
company, which specializes in iPS work, will figure out how to put
the news out front on its home page as well as issue a press release.
It was all part of the reaction todayin California to the Nobel for Yamanaka, who has substantial links to
the Golden State, including UCSF and the Gladstone Institutes.
deftness than iPierian. Yamanaka is a professor at UCSF and a senior
investigator at Gladstone, and the organizations quickly put together a news conference this morning that featured Yamanaka on a video
hook-up from Japan.
issued a press release that quoted the president of Gladstone, R.
Sanders Williams, who also mentioned the California stem cell agency.
Williams said,
“Dr. Yamanaka’s story is a
thrilling tale of creative genius, focused dedication and successful
cross-disciplinary science. These traits, nurtured during Dr.
Yamanaka’s postdoctoral training at Gladstone, have led to a
breakthrough that has helped propel the San Francisco Bay Area to the
forefront of stem cell research. Dozens of labs — often supported
by organizations such as the California Institute for Regenerative
Medicine (CIRM) and the Roddenberry Foundation–have adopted his
technology.”
stem cell effort, published an item on its blog quoting CIRM
President Alan Trounson. He said,
"There are few moments in science
that are undisputed as genuine elegant creativity and simplicity.
Shinya Yamanaka is responsible for one of those. The induced
pluripotent stem cells he created will allow us to interrogate and
understand the full extent and variation of human disease, will
enable us to develop new medicines and will forever change the way
science and medicine will be conducted for the benefit of mankind. An
extraordinary accomplishment by a genuinely modest and brilliant
scientist. He absolutely deserves a Nobel award.”
agency's communications manager, said that just five years after
Yamanaka's research,
“CIRM alone is funding almost $190
million in awards developing better ways of creating iPS cells and
using those cells to develop new therapies (the
full list of iPS grants is on our website).”
cash is the well-connected iPierian, which has taken in $7.1 million.
Yamanaka, however, has never received a grant from the agency, and
it is not known whether he ever applied since CIRM releases only the
names of researchers whose applications were approved.
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/RbQ09EsO8Qc/yamanaka-and-golden-state.html
Stem Cell Orthodoxy and Peer Review
By Dr. Matthew Watson
Going against the grain can be
difficult as UC Davis stem cell scientist Paul Knoepfler learned
again in connection with his research that dealt with similarities
between cancer and iPS cells.
some scientists who reviewed his paper prior to its publication in
September in Stem Cells and Development. (See here and here.)
reprogrammed adult cells are currently a hot research avenue in stem
cell research because they avoid many of the ticklish ethical and
political problems connected with human embryonic stem cells.
publication and peer review process on his blog last week. He wrote,
“Not surprisingly...there are certain
members of the stem cell field who would rather focus away from the
ideas that iPS cells are similar in some respects to cancer.”
in part by the California stem cell agency, wrote,
“Once we had a manuscript together
comparing iPS cells to cancer cells, we sent it to several high
profile journals without much luck. We thought that the fact that our
data indicated that iPS cells are similar to cancer cells might make
reviewers and editors excited. We thought that the paper was novel
and thought provoking in a number of ways. At the same time I
realized the theme of the paper would be controversial.
“I would say two general things about
the review process at the two journals that turned down the paper.
First, the reviewers at these journals were enormously helpful with
their suggestions and helped us improve the paper substantially.
Second, they were clearly very uncomfortable with the notion that iPS
cells are related in some ways to cancer so unsettled in fact that I
believe it influenced their reviews.”
findings were either “not sufficiently novel” or “trivial.”
“Little useful insights” said another. And a third said, “many
unsettling results....”
“Yeah, it may be unsettling that iPS
cells share traits with cancer cells, but if that is the reality,
isn’t it important that people know that and think about it, talk
about it, and address the issue with eyes open?”
from other researchers that can found elsewhere on the Internet
indirectly raise questions about the California stem cell agency's process
of peer review of applications for hundreds of millions of dollars in
funding, especially in the wake of this summer's unprecedented rash of appeals of decisions by grant reviewers.
amounts to scientific conventional wisdom. Obviously, no researcher
likes to see a paper rejected or a grant denied. But the record
number of appeals at CIRM and other private complaints could well indicate
that potentially profitable proposals are receiving a less than
welcome reception behind closed doors from agency reviewers.
hard-pressed to make such determinations. It is hamstrung by
procedures that do not permit it to expand an application directly –
only a staff-written summary. Names of applicants and institutions
are censored, although the board is required by law to discuss in
public most aspects of a research proposal. Exceptions are permitted for proprietary information. Additionally, a handful of the 29 members of the governing board do participate in the reviews, which come before final action by the board.
commercialize stem cell research and fulfill at least some of the
promises to voters that were made in 2004. To do that, the agency may
well have to step outside of the normal comfort zone of the good
burghers of stem cell science.
Source:StemCells, Inc. Awarded Broad U.S. Patent Covering Expandable Liver Cells
By Dr. Matthew Watson
NEWARK, Calif., Oct. 12, 2012 (GLOBE NEWSWIRE) -- StemCells, Inc. (STEM) today announced the issuance of U.S. Patent Number 8,283,164 titled "Liver engrafting cells, assays, and uses thereof." The patent broadly covers purified populations of human liver cells, including the Company's human liver engrafting cells (hLEC). hLEC cells were first isolated by Company researchers in the late 1990s, and Company scientists have repeatedly demonstrated the cells' engraftment and robust bioactivity in vivo and that they are expandable. While the Company's hLEC cells are purified from donated adult livers not suitable for transplant, the newly issued '164 patent importantly claims cells independent of tissue source. Therefore, the '164 patent has potential relevance to those deriving liver cells from iPS or ESC platforms. The term of the '164 patent extends into 2022.
"This new patent extends our IP protection around hLEC cells and should be of interest to those searching for an expandable human liver cell," said Martin McGlynn, President and Chief Executive Officer of StemCells, Inc. "Because the liver is such a key organ, finding an expandable, reliable and well-characterized liver cell population is an important step forward in both medical research and drug development. For example, liver disease afflicts some 25 million Americans and transplantation of an expandable liver cell could potentially address many of the shortcomings of whole liver transplantation. Moreover, the right liver cells could make profound contributions to drug screening and toxicity testing."
In October 2011, StemCells formed a wholly-owned subsidiary to focus on both the therapeutic and research tool applications of its hLEC technologies and to serve as an investment vehicle for those interested in a "pure play" liver cell company. The '164 patent is one of several patents issued to the Company on a worldwide basis claiming expandable liver cells, including U.S. Patent Nos. 7,811,818 and 7,211,404, Japan Patent No. 4445876, Australian Patent No. 2002315392, and European Patent No. 1406998. Patent prosecution in the family is ongoing on a worldwide basis, including China application 02816528.4.
About StemCells, Inc.
StemCells, Inc. is engaged in the research, development, and commercialization of cell-based therapeutics and tools for use in stem cell-based research and drug discovery. The Company's lead therapeutic product candidate, HuCNS-SC(R) cells (purified human neural stem cells), is currently in development as a potential treatment for a broad range of central nervous system disorders. The Company recently reported results from a Phase I clinical trial in Pelizaeus-Merzbacher disease (PMD), a fatal myelination disorder in children. The trial results showed preliminary evidence of progressive and durable donor-derived myelination in all four patients transplanted with HuCNS-SC cells. The Company is also conducting a Phase I/II clinical trial in chronic spinal cord injury in Switzerland and a Phase I/II clinical trial in dry age-related macular degeneration in the United States. In addition, the Company is pursuing preclinical studies of its HuCNS-SC cells in Alzheimer's disease. StemCells also markets stem cell research products, including media and reagents, under the SC Proven(R) brand. Further information about StemCells is available at http://www.stemcellsinc.com.
The StemCells, Inc. logo is available at http://www.globenewswire.com/newsroom/prs/?pkgid=7014
Apart from statements of historical fact, the text of this press release constitutes forward-looking statements within the meaning of the Securities Act of 1933, as amended, and the Securities Exchange Act of 1934, as amended, and is subject to the safe harbors created therein. These statements include, but are not limited to, statements regarding the prospect of enforcing the Company's intellectual property against infringers, the potential breadth and length of patent protection in the United States or in any other geography; and the likelihood that any of the Company's intellectual property will be found to be valid and enforceable. These forward-looking statements speak only as of the date of this news release. The Company does not undertake to update any of these forward-looking statements to reflect events or circumstances that occur after the date hereof. Such statements reflect management's current views and are based on certain assumptions that may or may not ultimately prove valid. The Company's actual results may vary materially from those contemplated in such forward-looking statements due to risks and uncertainties to which the Company is subject, including the Company's ability to obtain the increased capital resources needed to continue its current operations and to conduct the research, preclinical development and clinical trials necessary for regulatory approvals and for continued patent prosecution efforts; uncertainty regarding the validity and enforceability of the Company's existing patents; and other factors that are described under the heading "Risk Factors" in the Company's Annual Report on Form 10-K for the year ended December 31, 2011, and in its subsequent reports on Form 10-Q and Form 8-K.
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StemCells, Inc. Awarded Broad U.S. Patent Covering Expandable Liver Cells
Spinal Cord Stem Cells
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October 14th, 2012
Safety results of intra-arterial stem cell clinical trial for stroke presented
By Dr. Matthew Watson
ScienceDaily (Oct. 11, 2012) Early results of a Phase II intra-arterial stem cell trial for ischemic stroke showed no adverse events associated with the first 10 patients, allowing investigators to expand the study to a targeted total of 100 patients.
The results were presented October 11 by Sean Savitz, M.D., professor of neurology and director of the Stroke Program at The University of Texas Health Science Center at Houston (UTHealth), at the 8th World Stroke Congress in Brasilia, Brazil.
The trial is the only randomized, double-blind, placebo-controlled intra-arterial clinical trial in the world for ischemic stroke. It is studying the safety and efficacy of a regenerative therapy developed by Aldagen Inc., a wholly-owned subsidiary of Cytomedix, Inc., that uses a patient's own bone marrow stem cells, which can be administered between 13 and 19 days post-stroke.
The therapy, called ALD-401, consists of stem cells that are identified using Aldagen's proprietary technology to isolate cells that express high levels of an enzyme that serves as a marker of stem cells. Pre-clinical studies found that these cells enhance recovery after stroke in mice. The cells are administered into the carotid artery. Patients are followed for 12 months to monitor safety and to assess mental and physical function.
"We have been approved by the Data Safety Monitoring Board (DSMB) to move the study into the next phase, which will allow us to expand the number of sites in order to complete enrollment," said Savitz, senior investigator for the multi-center study. As per the protocol for the trial, the Food and Drug Administration required a review by the DSMB prior to advancing to the next phase.
Preclinical research, including research at the UTHealth Medical School, has suggested that stem cells can promote the repair of the brain after an ischemic stroke, which is caused by a blood clot in the brain. Stroke is a leading cause of disability and the fourth-leading cause of death in the United States, according to 2008 statistics reported by the Centers for Disease Control and Prevention.
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The above story is reprinted from materials provided by University of Texas Health Science Center at Houston.
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Safety results of intra-arterial stem cell clinical trial for stroke presented
Bone Marrow Stem Cells
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October 12th, 2012
Neural-like stem cells from muscle tissue may hold key to cell therapies for neurodegenerative diseases
By Dr. Matthew Watson
ScienceDaily (Oct. 12, 2012) Scientists at Wake Forest Baptist Medical Center have taken the first steps to create neural-like stem cells from muscle tissue in animals.
Details of the work are published in two complementary studies published in the September online issues of the journals Experimental Cell Research and Stem Cell Research.
"Reversing brain degeneration and trauma lesions will depend on cell therapy, but we can't harvest neural stem cells from the brain or spinal cord without harming the donor," said Osvaldo Delbono, M.D., Ph.D., professor of internal medicine at Wake Forest Baptist and lead author of the studies.
"Skeletal muscle tissue, which makes up 50 percent of the body, is easily accessible and biopsies of muscle are relatively harmless to the donor, so we think it may be an alternative source of neural-like cells that potentially could be used to treat brain or spinal cord injury, neurodegenerative disorders, brain tumors and other diseases, although more studies are needed."
In an earlier study, the Wake Forest Baptist team isolated neural precursor cells derived from skeletal muscle of adult transgenic mice (PLOS ONE, Feb. 3, 2011).
In the current research, the team isolated neural precursor cells from in vitro adult skeletal muscle of various species including non-human primates and aging mice, and showed that these cells not only survived in the brain, but also migrated to the area of the brain where neural stem cells originate.
Another issue the researchers investigated was whether these neural-like cells would form tumors, a characteristic of many types of stem cells. To test this, the team injected the cells below the skin and in the brains of mice, and after one month, no tumors were found.
"Right now, patients with glioblastomas or other brain tumors have very poor outcomes and relatively few treatment options," said Alexander Birbrair, a doctoral student in Delbono's lab and first author of these studies. "Because our cells survived and migrated in the brain, we may be able to use them as drug-delivery vehicles in the future, not only for brain tumors but also for other central nervous system diseases."
In addition, the Wake Forest Baptist team is now conducting research to determine if these neural-like cells also have the capability to become functioning neurons in the central nervous system.
Co-authors of the studies are Tan Zhang, Ph.D., Zhong-Min Wang, M.S., Maria Laura Messi, M.S., Akiva Mintz, M.D., Ph.D., of Wake Forest Baptist, and Grigori N. Enikolopov, Ph.D., of Cold Spring Harbor Laboratory.
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Neural-like stem cells from muscle tissue may hold key to cell therapies for neurodegenerative diseases
Skin Stem Cells
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October 12th, 2012
Riken to test iPS cells in human trial
By Dr. Matthew Watson
Friday, Oct. 12, 2012
Stem cells derived from a mouse's skin won Shinya Yamanaka the Nobel Prize in physiology or medicine on Monday. Now researchers in Japan are seeking to use his pioneering technology for an even greater prize: restoring sight.
Scientists at the Riken Center for Developmental Biology in Kobe plan to use induced pluripotent stem (iPS) cells in a human trial using patients with macular degeneration, a disease in which the retina becomes damaged and results in loss of vision, Yamanaka, a Kyoto University professor, told reporters the same day in San Francisco.
Companies including Pfizer Inc. are already planning trials of stem cells derived from human embryos, but Riken's will be the first to use a technology that mimics the power of embryonic cells while avoiding the ethical controversy that accompanies them.
"The work in that area looks very encouraging," John B. Gurdon, 79, a professor at the University of Cambridge who shared this year's Nobel Prize with Yamanaka, said in an interview in London.
Yamanaka and Gurdon split the 8 million Swedish kronor (about 94 million) award for experiments 50 years apart demonstrating that mature cells in latent form retain all of the DNA they had as immature stem cells, and that they can be returned to that potent state.
Their findings offer the potential for a new generation of therapies against hard-to-treat diseases like macular degeneration.
In a study published in 1962, Gurdon took a cell from a tadpole's gut, extracted the nucleus and inserted it into the egg cell of an adult frog whose own nucleus had been removed. The reprogrammed egg cell developed into a tadpole with the genetic characteristics of the original tadpole, and subsequent trials yielded adult frogs.
Yamanaka, 50, built on Gurdon's work by adding four genes to a skin cell from a mouse, returning it to its immature state as a stem cell with the potential to become any cell in the body.
He dubbed them induced pluripotent stem cells.
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Riken to test iPS cells in human trial
10/11/2012 10:05 JAPAN Nobel Prize for Yamanaka, scientific research and ethics must go hand in hand
By Dr. Matthew Watson
10/11/2012 10:05 JAPAN Nobel Prize for Yamanaka, scientific research and ethics must go hand in hand by Pino Cazzaniga Research on iPS (induced pluripotent stem cells) can produce stem cells from adult cells, for use in regenerative medicine. Shinya Yamanakas discovery reveals that research on embryonic stem cells is unnecessary, saving the lives of many embryos. The Japanese researcher has searched for new ways driven by ethical question.
Tokyo (AsiaNews) - Shinya Yamanaka, fresh from the Nobel Prize for medicine, states that science and ethics must go hand in hand. Interviewed by the Mainichi Shimbun after the award, he said: "I would like to invite ethical experts as teachers at my laboratory and work to guide iPS [induced pluripotent stem] cell research from that direction as well. The work of a scientific researcher is just one part of the equation. "
Yamanaka, 50, found that adult cells can be transformed into cells in their infancy, stem cells (iPS), which are, so to speak, the raw material for the reconstruction of tissue irreparably damaged by disease. For regenerative medicine the implications of Yamanaka's discovery are obvious. Adult skin cells can for example be reprogrammed and transformed into any other cell that is desired: from the skin to the brain, from the skin to the heart, from the skin to elements that produce insulin.
"Their discovery - says the statement of the jury that awarded him the Nobel Prize on October 8 - has revolutionized our understanding of how cells and organisms develop. Through the programming of human cells, scientists have created new opportunities for the study of diseases and development of methods for the diagnosis and therapy ".
These "opportunities" are not only "scientific", but also "ethical". Much of the scientific research and global investment is in fact launched to design and produce stem cells from embryos, arriving at the point of manipulating and destroying them, facing scientists with enormous ethical problems.
" Ethics are really difficult - Yamanaka explainsto Mainichi - In the United States I began work on mouse experiments, and when I returned to Japan I learned that human embryonic stem cells had been created. I was happy that they would contribute to medical science, but I faced an ethical issue. I started iPS cell research as a way to do good things as a researcher, and I wanted to do what I could to expand the merits of embryonic stem cells. If we make sperm or eggs from iPS cells, however, it leads to the creation of new life, so the work I did on iPS cells led to an ethical problem. If we don't prepare debates for ethical problems in advance, technology will proceed ahead faster than we think.. "
The "ethical question" Yamanaka pushed to find a way to "not keep destroying embryos for our research."
Speaking with his co-workers at the University of Kyoto, immediately after receiving the award, Yamanaka showed dedication and modesty.
"Now - he said - I strongly feel a sense of gratitude and responsibility" gratitude for family and friends who have supported him in a demanding journey of discovery that lasted decades; responsibility for a discovery that gives hope to millions of patients. Now iPS cells can grow into any tissue of the human body allowing regeneration of parts so far irretrievably lost due to illness.
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10/11/2012 10:05 JAPAN Nobel Prize for Yamanaka, scientific research and ethics must go hand in hand
IPS Cell Therapy
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October 11th, 2012
Stem Cell Science Q & A
By Dr. Matthew Watson
Shinya Yamanaka MD, PhD
Here are answers to frequently asked questions about induced pluripotent stem cells, or iPS cells, the type of cell that has been reprogrammed from an adult cell, such as a skin or blood cell.
What are induced pluripotent stem cells?
Induced pluripotent stem cells, or iPS cells, are a type of cell that has been reprogrammed from an adult cell, such as a skin or blood cell. iPS cells are pluripotent cells because, like embryonic stem cells, they can develop into virtually any type of cell. iPS cells are distinct from embryonic stem cells, however, because they are derived from adult tissue, rather than from embryos. iPS cells are also distinct from adult stem cells, which naturally occur in small numbers in thehuman body.
In 2006, Shinya Yamanaka developed the method for inducing skin cells from mice into becoming like pluripotent stem cells and called them iPS cells. In 2007, Yamanaka did the same with adult human skin cells.
Yamanakas experiments revealed that adult skin cells, when treated with four pieces of DNA (now called the Yamanaka factors), can induce skin cells to revert back to their pluripotent state. His discovery has since led to a variety of methods for reprogramming adult cells into stem cells that can become virtually any cell type such as a beating heart cell or a neuron that can transmit chemical signals in the brain. This allows researchers to create patient-specific celllines that can be studied and used in everything from drug therapies to regenerative medicine.
How are iPS cells different from embryonic stem cells?
iPS cells are a promising alternative to embryonic stem cells. Embryonic stem cells hold tremendous potential for regenerative medicine, in which damaged organs and tissues could be replaced or repaired. But the use of embryonic stem cells has long been controversial. iPS cells hold the same sort of promise but avoid controversy because they do not require the destruction of human embryos. Nor do they require the harvesting of adult stem cells. Rather, they simply require a small tissue sample from a living human.
Why is iPS cell technology so important?
In addition to avoiding the controversial use of embryonic stem cells, iPS cell technology also represents an entirely new platform for fundamental studies of human disease. Rather than using models made in yeast, flies or mice for disease research, iPS cell technology allows human stem cells to be created from patients with a specific disease. As a result, the iPS cells contain a complete set of the genes that resulted in that disease and thus represent the potential of a farsuperior human model for studying disease and testing new drugs and treatments. In the future, iPS cells could be used in a Petri dish to test both drug safety andefficacy for an individual patient.
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Stem Cell Science Q & A
Stem cell experts win Nobel prize
By Dr. Matthew Watson
8 October 2012 Last updated at 09:58 ET By James Gallagher Health and science reporter, BBC News
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British scientist John Gurdon told a news conference he still keeps a bad report given to him by his school science teacher
Two pioneers of stem cell research have shared the Nobel prize for medicine or physiology.
John Gurdon from the UK and Shinya Yamanaka from Japan were awarded the prize for changing adult cells into stem cells, which can become any other type of cell in the body.
Prof Gurdon used a gut sample to clone frogs and Prof Yamanaka altered genes to reprogramme cells.
The Nobel committee said they had "revolutionised" science.
The prize is in stark contrast to Prof Gurdon's first foray into science when his biology teacher described his scientific ambitions as "a waste of time".
"I believe Gurdon has ideas about becoming a scientist; on his present showing this is quite ridiculous; if he can't learn simple biological facts he would have no chance of doing the work of a specialist, and it would be a sheer waste of time, both on his part and of those who would have to teach him."
When a sperm fertilises an egg there is just one type of cell. It multiplies and some of the resulting cells become specialised to create all the tissues of the body including nerve and bone and skin.
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Stem cell experts win Nobel prize
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October 9th, 2012
Regenerative medicine could be 'next big thing' for Va. biotech
By Dr. Matthew Watson
Regenerative medicine, a field that didn't exist 20 years ago and contains techniques seemingly straight out of science fiction, could be the next big thing in Virginia's biotechnology sector.
That's the opinion of Roy Ogle, an expert in the field who works at Old Dominion University as head of its new school of Medical Diagnostic and Translational Sciences.
So what is regenerative medicine? Simply put, it's the process of re-growing human cells to repair damaged tissues and organs.
In a meeting Thursday hosted by the Virginia Biotechnology Association, Ogle and Brian Pollok, principal of Rapidan BioAdvisors, discussed one of the field's newest developments: induced pluripotent stem cells, or iPSCs.
Let's go back to high school biology: Perhaps you remember embryonic stem cells. These cells can differentiate into different types of cells skin, blood, bone, muscle before a baby is born. But their use in scientific research has become controversial and difficult.
So scientists needed a new way to develop stem cells. iPSCs are already formatted cells that are "induced," or returned, to their original state as a stem cell. Then that stem cell can be reprogrammed to become a different type of cell. For example, a researcher can take a red blood cell, turn it into an iPSC, and then turn that into a muscle cell. (Yeah, our jaw dropped at this point, too). So you get most of the benefits of an embryonic stem cell without the controversy.
What's that mean for the business community?
"Ten or 20 years from now, we could have a way to do cell replacements and make a new spinal cord or new and healthy muscles," Ogle said. "But right now, there are genetic discoveries and methods of development with a giant potential that a small company can sell to (pharmaceutical giants such as) Roche or Sanofi-Aventis."
Ogle said this sort of intermediate work after invention but before the science is proven enough for big pharma to get involved is the perfect space for startups, especially those affiliated with research universities. He said small companies are best placed to do this work and sell the results to big companies because a startup is better suited to tolerate the risk and uncertainty.
"While we think about the long-term development as scientists, there are applications right now where we could serve society and make a lot of money," he said.
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Regenerative medicine could be 'next big thing' for Va. biotech
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October 8th, 2012
The Dangers of Genetic Engineering – Topanga Messenger
By Dr. Matthew Watson
 Kansas City Star | The Dangers of Genetic Engineering Topanga Messenger In November, Californians will be voting on Proposition 37: “A Mandatory Labeling of Genetically Engineered Food Initiative,” that will require labeling of raw or processed food if the food is made from plants or animals with genetic material changed ... Companies, activists gear up for battleThe Desert Sun LA Times encourages California voters to reject Proposition 37CattleNetwork.com Valley farmers fear 'modified' wording in Prop. 37Fresno Bee JD Supra (press release) -U.S. Politics Today -Natural Products INSIDER all 506 news articles » |
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October 7th, 2012
Genetic engineering fails to deliver: Studies – Deccan Chronicle
By Dr. Matthew Watson
Deccan Chronicle | Genetic engineering fails to deliver: Studies Deccan Chronicle Genetic engineering has been hailed as a panacea for the problem of global hunger and population explosion, but research studies reveal that it has failed to deliver the goods. At the same time, it has created more problems than it could solve. The ... |
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October 7th, 2012
Genetic Engineering Labeling – Capitol News Service
By Dr. Matthew Watson
 Capitol News Service | Genetic Engineering Labeling Capitol News Service Genetic Engineering Labeling. October 2nd, 2012 by Whitney Ray. Do you know what you're eating? Food activists say you probably don't. Food and Water Watch, a group calling for more transparency in grocery stores held a protest at the state capitol today. |
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October 7th, 2012