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DoH warns on stem cell

By daniellenierenberg

Manila, Philippines The Department of Health (DoH) warned yesterday against the proliferation of commercial establishments offering stem cell treatment for medical or aesthetic purposes.

DoH Secretary Enrique T. Ona said the use and effects of stem cell therapy is still being investigated by doctors while the Food and Drugs Administration (FDA) has yet to release the standards and regulations governing the safety of its use. Although this technology holds promise, stem cell therapy is not yet part of standard of care and is considered an investigative procedure for compassionate use. Applications of stem cells for the treatment of malignancies, blood disorders, degenerative diseases (such as Alzheimers Disease), metabolic diseases (e.g. diabetes), and immune cell therapy are still under clinical evaluation and study, Ona said in a statement.

While research has shown that adult stem cells and umbilical cord stem cells are the safest and most ethical, the public is warned that claims of preventive and curative bene ts of stem cell therapy are still on their investigative stage. Thus, the Department of Health (DoH) advises the public to be cautious with stem cell therapies being promoted in the media or through word of mouth, he added.

The DoH noted that there is an increasing demand for the use of stem cells in cancer therapy, endorgan diseases, and regenerative medicine.

But until a conclusive study has been completed, health of cials said the public is strongly advised to avoid stem cell therapies which use the following as sources for stem cells: Embryonic stem cells, aborted fetuses, and geneticallyaltered and animal fresh cells.

The DoH will soon issue guidelines for the use of stem cell therapy and the process of giving license to facilities offering such services, Ona noted. (Jenny F. Manongdo)

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DOH nagbabala vs stem cell therapy

By NEVAGiles23

MANILA, Philippines - Dapatpa ring mag-ingat ang publiko laban sa nauusong stem cell therapy para sa medical at aesthetic purposes.

Sa isang advisory, sinabi ni Health Secretary Enrique Ona na ang stem cell therapy ay hindi pa rin bahagi ng standard of care at ikinukonsidera pa rin bilang investigative procedure for compassionate use.

Ayon kay Ona, ang aplikasyon ng stem cell bilang lunas sa malignancies, blood disorders, degenerative diseases tulad ngAlzheimers Disease, metabolic diseases tulad ngdiabetes, at immune cell therapy ay isinasailalim pa rin ng clinical evaluation at pag-aaral.

Pinapayuhan rin ni Ona ang publiko na iwasan ang stem cell therapies na gumagamit ng embryonic stem cells, aborted fetuses, genetically-altered at animal fresh cells, bilang sources ng stem cells.

Magpapalabas sila ng guidelines sa paggamit ng stem cell therapy at ng proseso para sa pagpapalisensiya ng mga nag-aalok ng naturang serbisyo.

Ang stem cell bilang therapy sa oncology, end-organ diseases at regenerative medicine ay in demand ngayon at maging sa Pilipinas ay naobserbahan na rin umano ang pagdami ng mga center na nag-aalok ng stem cell at aesthetic purposes.

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New blood-vessel-generating cells with therapeutic potential discovered

By NEVAGiles23

Washington, October 17 (ANI): Researchers believe they have discovered stem cells that play a decisive role in new blood vessel growth.

If the researchers at the University of Helsinki, Finland, learn to isolate and efficiently produce these stem cells found in blood vessel walls, the cells offer new opportunities in the treatment of cardiovascular diseases, cancer and many other diseases.

The growth of new blood vessels, also known as angiogenesis, is needed in adults when repairing damaged tissue or organs.

Unfortunately, malignant tumours are also capable of growing new blood vessels to receive oxygen and nutrients. In other words, the treatment of diseases would benefit from two types of methods - ones that help launch the process of angiogenesis and ones that make it possible to prevent the process.

Medications that prevent the growth of new blood vessels have already been introduced, but their effectiveness and long-term efficacy leave much to be desired.

For more than a decade, Adjunct Professor Petri Salven from the University of Helsinki has studied the mechanisms of angiogenesis to discover how blood vessel growth could be prevented or accelerated effectively.

He has examined the birth and origin of endothelial cells, which form the thin layer that lines the interior surface of blood vessels. Endothelial cells are necessary for new blood vessel growth. Where do these highly diversified cells come from? Can their production be prevented or increased?

For a long time, it was assumed that new cells in the blood vessel walls of an adult originate in the bone marrow. In an article published in the PNAS journal in 2008, Salven's research team showed that such stem cells were not found in bone marrow.

Now Salven is ready to reveal where these mysterious stem cells originate.

"We succeeded in isolating endothelial cells with a high rate of division in the blood vessel walls of mice. We found these same cells in human blood vessels and blood vessels growing in malignant tumours in humans. These cells are known as vascular endothelial stem cells, abbreviated as VESC. In a cell culture, one such cell is able to produce tens of millions of new blood vessel wall cells," Salven said.

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Research firm reaped stem cell funds despite panel's advice

By JoanneRUSSELL25

StemCells Inc. has a history not much different from those of dozens, even hundreds, of biotech companies all around California.

Co-founded by an eminent Stanford research scientist, the Newark, Calif., firm has struggled financially while trying to push its stem cell products through the research-and-development pipeline. It collects about $1 million a year from licensing patents and selling cell cultures but spends well more than $20 million annually on R&D, so it runs deeply in the red.

On the plus side, StemCells Inc. has had rather a charmed relationship with the California stem cell program, that $3-billion taxpayer-backed research fund known formally as the California Institute for Regenerative Medicine.

The firm ranks first among all corporate recipients of approved funding from CIRM, with some $40 million in awards approved this year. That's more than has gone to such established California nonprofit research centers as Cedars-Sinai Medical Center, the Salk Institute for Biological Studies, and the Sanford-Burnham Medical Research Institute.

The record of StemCells is particularly impressive given that one of the two proposals for which the firm received a $20-million funding award, covering a possible Alzheimer's treatment, was actually rejected by CIRM's scientific review panel twice. Nevertheless, the stem cell agency's governing board went ahead and approved it last month.

What was the company's secret? StemCells says it's addressing "a serious unmet medical need" in Alzheimer's research. But it doesn't hurt that the company also had powerful friends going to bat for it, including two guys who were instrumental in getting CIRM off the ground in the first place.

There's nothing improper about the state stem cell agency funding private enterprise; that's part of its statutory duties, and potentially valuable in advancing the goals of research. In part that's because CIRM is in a good position to help biotech firms leapfrog the "valley of death" the territory between basic research and the much more expensive and speculative process of moving a technology to clinical testing and, hopefully, the marketplace. Unfortunately, that's also the point where outside investment often dries up.

But private enterprise is new territory for CIRM, which has steered almost all its grants thus far to nonprofit institutions. Those efforts haven't been trouble-free: With some 90% of the agency's grants having gone to institutions with representatives on its board, the agency has long been vulnerable to charges of conflicts of interest. The last thing it needed was to show a similar flaw in its dealings with private companies too.

That brings us back to StemCells Inc. First, consider the firm's pedigree. Its co-founder was Irving Weissman, director of Stanford's Institute for Stem Cell Biology and Regenerative Medicine and a stem cell research pioneer. Weissman was one of the most prominent and outspoken supporters of Proposition 71, the 2004 ballot initiative that established the stem cell agency.

He's also been a leading beneficiary of CIRM funding, listed as the principal researcher on three grants worth a total of $24.5 million. The agency also contributed $43.6 million toward the construction of his institute's glittering $200-million research building on the Stanford campus. As of mid-April Weissman was still listed as a shareholder of StemCells, where his wife, Ann Tsukamoto, is an executive. Weissman, who is traveling in Africa, could not get back to me by deadline to talk about his relationship with the company.

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NeoStem, Inc. Announces the Redemption of the Outstanding 7% Series E Preferred Stock

By raymumme

NEW YORK, Oct. 17, 2012 (GLOBE NEWSWIRE) -- NeoStem, Inc. (NYSE MKT:NBS) ("NeoStem" or the "Company"), an emerging leader in the fast growing cell therapy market, today announced that it will redeem all outstanding shares of its Series E 7% Senior Convertible Preferred Stock ("Series E Preferred Stock").

On October 10, 2012, the Company gave notice to its Series E Preferred Stockholders that it is redeeming all of the outstanding shares of Series E Preferred Stock for an aggregate redemption price of $3.4 million, $2.5 million of which was funded by money placed into escrow when the Series E Preferred stock was issued in November 2010.

"We are pleased that we have been able to redeem this $10 million investment in full over a two year period. Equal to our focus on cell therapy product development and expanding our PCT contract development and manufacturing operations, we are committed to improving our balance sheet. Through the redemption of the Series E Preferred Stock, we will remove a significant overhang and simplify NeoStem's capital structure. The redemption of the Series E Preferred Stock is another example of a step taken by us to improve Common Stockholder value," said Dr. Robin Smith, Chairman and CEO of NeoStem. "We look forward to continued execution on our near term business strategy, including the forthcoming closing of the divestiture of our Erye China pharmaceutical subsidiary."

About NeoStem, Inc.

NeoStem, Inc. continues to develop and build on its core capabilities in cell therapy, capitalizing on the paradigm shift that we see occurring in medicine. In particular, we anticipate that cell therapy will have a significant role in the fight against chronic disease and in lessening the economic burden that these diseases pose to modern society. We are emerging as a technology and market leading company in this fast developing cell therapy market. Our multi-faceted business strategy combines a state-of-the-art contract development and manufacturing subsidiary, Progenitor Cell Therapy, LLC ("PCT"), with a medically important cell therapy product development program, enabling near and long-term revenue growth opportunities. We believe this expertise and existing research capabilities and collaborations will enable us to achieve our mission of becoming a premier cell therapy company.

Our contract development and manufacturing service business supports the development of proprietary cell therapy products. NeoStem's most clinically advanced therapeutic, AMR-001, is being developed at Amorcyte, LLC ("Amorcyte"), which we acquired in October 2011. Amorcyte is developing a cell therapy for the treatment of cardiovascular disease and is enrolling patients in a Phase 2 trial to investigate AMR-001's efficacy in preserving heart function after a heart attack. Athelos Corporation ("Athelos"), which is approximately 80%-owned by our subsidiary, PCT, is collaborating with Becton-Dickinson in the early clinical exploration of a T-cell therapy for autoimmune conditions. In addition, pre-clinical assets include our VSELTM Technology platform as well as our mesenchymal stem cell product candidate for regenerative medicine. Our service business and pipeline of proprietary cell therapy products work in concert, giving us a competitive advantage that we believe is unique to the biotechnology and pharmaceutical industries. Supported by an experienced scientific and business management team and a substantial intellectual property estate, we believe we are well positioned to succeed.

For more information on NeoStem, please visit http://www.neostem.com.

Forward-Looking Statements for NeoStem, Inc.

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements reflect management's current expectations, as of the date of this press release, and involve certain risks and uncertainties. Forward-looking statements include statements herein with respect to the successful execution of the Company's business strategy, including with respect to the Company's or its partners' successful development of AMR-001 and other cell therapeutics, the size of the market for such products, its competitive position in such markets, the Company's ability to successfully penetrate such markets and the market for its contract development and manufacturing ("CDMO") business, and the efficacy of protection from its patent portfolio, as well as the future of the cell therapeutics industry in general, including the rate at which such industry may grow. Forward looking statements also include statements with respect to satisfying all conditions to closing the disposition of Erye, including receipt of all necessary regulatory approvals in the PRC. The Company's actual results could differ materially from those anticipated in these forward- looking statements as a result of various factors, including but not limited to matters described under the "Risk Factors" in the Company's Annual Report on Form 10-K filed with the Securities and Exchange Commission on March 20, 2012 and in the Company's other periodic filings with the Securities and Exchange Commission, all of which are available on its website. The Company does not undertake to update its forward-looking statements. The Company's further development is highly dependent on future medical and research developments and market acceptance, which is outside its control.

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New life for the dead: Stem cells from corpse scalp

By raymumme

By Charles Choi, LiveScience contributor

Death will come for us all one day, but life will not fade from our bodies all at once. After our lungs stop breathing, our hearts stop beating, our minds stop racing, our bodies cool, and long after our vital signs cease, little pockets of cells can live for days, even weeks. Now scientists have harvested such cells from the scalps and brain linings of human corpses and reprogrammed them into stem cells.

In other words, dead people can yield living cells that can be converted into any cell or tissue in the body.

As such, this work could help lead to novel stem cell therapies and shed light on a variety of mental disorders, such as schizophrenia, autism and bipolar disorder, which may stem from problems with development, researchers say.

Making stem cells Mature cells can be made or induced to become immature cells, known as pluripotent stem cells, which have the ability to become any tissue in the body and potentially can replace cells destroyed by disease or injury. This discovery was honored last week with the Nobel Prize.

Past research showed this same process could be carried out with so-called fibroblasts taken from the skin of human cadavers. Fibroblasts are the most common cells of connective tissue in animals, and they synthesize the extracellular matrix, the complex scaffolding between cells. [ Science of Death: 10 Tales from the Crypt ]

Cadaver-collected fibroblasts can be reprogrammed into induced pluripotent stem cells using chemicals known as growth factors that are linked with stem cell activity. Reprogrammed cells could then develop into a multitude of cell types, including the neurons found in the brain and spinal cord. However, bacteria and fungi on the skin can wreak havoc on the culturing processes used to grow cells in labs, making the process tricky to successfully carry out.

Now scientists have taken fibroblasts from the scalps and the brain linings of 146 human brain donors and grown induced pluripotent stem cells from them as well.

"We were able to culture living cells from deceased individuals on a larger scale than ever done before," researcher Thomas Hyde, a neuroscientist, neurologist and chief operating officer at the Lieber Institute for Brain Development in Baltimore, told LiveScience. Previous studies had only grown fibroblasts from a total of about a half-dozen cadavers.

The bodies had been dead up to nearly two days before scientists collected tissues from them. The corpses had been kept cool in the morgue, but not frozen.

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Human Cadaver Brains May Provide New Stem Cells

By NEVAGiles23

Death will come for us all one day, but life will not fade from our bodies all at once. After our lungs stop breathing, our hearts stop beating, our minds stop racing, our bodies cool, and long after our vital signs cease, little pockets of cells can live for days, even weeks. Now scientists have harvested such cells from the scalps and brain linings of human corpses and reprogrammed them into stem cells.

In other words, dead people can yield living cells that can be converted into any cell or tissue in the body.

As such, this work could help lead to novel stem cell therapies and shed light on a variety of mental disorders, such as schizophrenia, autism and bipolar disorder, which may stem from problems with development, researchers say.

Making stem cells

Mature cells can be made or induced to become immature cells, known as pluripotent stem cells, which have the ability to become any tissue in the body and potentially can replace cells destroyed by disease or injury. This discovery was honored last week with the Nobel Prize.

Past research showed this same process could be carried out with so-called fibroblasts taken from the skin of human cadavers. Fibroblasts are the most common cells of connective tissue in animals, and they synthesize the extracellular matrix, the complex scaffolding between cells. [Science of Death: 10 Tales from the Crypt]

Cadaver-collected fibroblasts can be reprogrammed into induced pluripotent stem cells using chemicals known as growth factors that are linked with stem cell activity. Reprogrammed cells could then develop into a multitude of cell types, including the neurons found in the brain and spinal cord. However, bacteria and fungi on the skin can wreak havoc on the culturing processes used to grow cells in labs, making the process tricky to successfully carry out.

Now scientists have taken fibroblasts from the scalps and the brain linings of 146 human brain donors and grown induced pluripotent stem cells from them as well.

"We were able to culture living cells from deceased individuals on a larger scale than ever done before," researcher Thomas Hyde, a neuroscientist, neurologist and chief operating officer at the Lieber Institute for Brain Development in Baltimore, told LiveScience. Previous studies had only grown fibroblasts from a total of about a half-dozen cadavers.

The bodies had been dead up to nearly two days before scientists collected tissues from them. The corpses had been kept cool in the morgue, but not frozen.

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Human Cadaver Brains May Provide New Stem Cells

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Beauty salon ‘offers’ stem cell therapy

By JoanneRUSSELL25

With all the publicity about the miraculous effects of stem cell therapy, the Department of Health (DOH) should prepare itself for the possibility that the new procedure would be performed by unqualified, and completely clueless, people.

I passed a beauty parlor recently and saw a huge poster on its door announcing the arrival of stem cell therapy. I was instantly reminded of botched breast enhancement and nose jobs performed by salon personnel who seemed to think it was as easy to learn complicated surgical procedures as it was to train to cut hair or do manicures and pedicures.

The DOH should start warning the public not to fall for these special offers just because they are available at giveaway rates.

Modern lifestyle problem

Experts have repeatedly talked about problems brought about by modern lifestyles. Changing diets and stress are two of the best known. Dr. Jaime G. Ignacio, section chief of gastroenterology at Veterans Hospital and head of the Digestive Malignancy Council of the Philippine Society of Gastroenterology, said constipation could be one of the consequences of the combination of these two factors.

Speaking at an event hosted by Boehringer Ingelheim, maker of Dulcolax (generic name Bisacodyl), a formulation for constipation relief, Ignacio, who, as a gastroenterologist is a specialist in digestive system disorders, defined the problem as having fewer than three bowel movements in a week (normal ranges from three times a week to three times a day).

He said constipation itself was not a disease but it could sometimes be a symptom of something serious, like colorectal cancer. But he said about 95 percent of cases were acuteoccurring suddenly and lasting for only a short periodresulting from some sudden lifestyle or hormonal changes, the taking of medication, lack of exercise, etc.

Ignacio said acute was easy to treat, with products like Dulcolax to solve the problem. But, if left unattended, acute constipation could lead to a chronic or long-term condition, which was the more worrisome, and would need medical attention.

He said constipation should be treated as soon as the problem had lasted for four or more days.

Constipation is part of modern living. [Like other diseases] prevention is the key. Safe and effective treatment is available [if needed], Ignacio stressed.

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Beauty salon ‘offers’ stem cell therapy

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Realizing the potential of stem cell therapy: Studies report progress in developing treatments for diseases and injuries

By daniellenierenberg

ScienceDaily (Oct. 15, 2012) New animal studies provide additional support for investigating stem cell treatments for Parkinson's disease, head trauma, and dangerous heart problems that accompany spinal cord injury, according to research findings released today.

The work, presented at Neuroscience 2012, the annual meeting of the Society for Neuroscience and the world's largest source of emerging news about brain science and health, shows scientists making progress toward using stem cell therapies to repair neurological damage.

The studies focused on using stem cells to produce neurons -- essential, message-carrying cells in the brain and spinal cord. The loss of neurons and the connections they make for controlling critical bodily functions are the chief hallmarks of brain and spinal cord injuries and of neurodegenerative afflictions such as Parkinson's disease and ALS (amyotrophic lateral sclerosis), also known as Lou Gehrig's disease.

Today's new findings show that:

Other recent findings discussed show that:

"As the fields of developmental and regenerative neuroscience mature, important progress is being made to begin to translate the promise of stem cell therapy into meaningful treatments for a range of well-defined neurological problems," said press conference moderator Jeffrey Macklis, MD, of Harvard University and the Harvard Stem Cell Institute, an expert on development and regeneration of the mammalian central nervous system. "Solid, rigorous, and well-defined pre-clinical work in animals can set the stage toward human clinical trials and effective future therapies."

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The above story is reprinted from materials provided by Society for Neuroscience (SfN), via AlphaGalileo.

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Significant Recovery Of Motor And Neurological Functions In Ischemic Stroke Rats With Neuralstem NSI-566 Cells

By daniellenierenberg

ROCKVILLE, Md., Oct. 15, 2012 /PRNewswire/ --Neuralstem, Inc. (NYSE MKT: CUR) announced that data on Neuralstem's NSI-566 spinal cord-derived neural stem cell line in a rat model of ischemic stroke was presented in a poster, "Histopathological Assessment of Adult Ischemic Rat Brains after 4 Weeks of Intracerebral Transplantation of NSI-566RSC Cell Line," at The Society for Neurosciences Annual Meeting (http://www.sfn.org/AM2012/). This study was conducted independently in the laboratory of Dr. Cesar Borlongan, who is the director at the Center of Excellence for Aging and Brain Repair at the University of South Florida College of Medicine. Post-mortem histology was conducted in collaboration with Neuralstem. Rats that suffered ischemic stroke by middle cerebral artery occlusion, were transplanted 7 days post-stroke with increasing doses of NSI-566 into the stroke area. The animals were followed for safety and behavioral response for 56 days post-transplantation. Researchers reported Saturday that there was significant improvement in both motor and neurological tests in the stem cell-treated rats. There were significant dose-dependent differences in the behavioral improvement across treatment groups at post-transplantation periods, with the highest dose showing the most significant improvement in both motor and neurological tests. Similarly, there were significant differences in the behavioral performance among treatment groups at post-transplantation periods, with the most significant improvement in both motor and neurological tests seen at day 56 post-transplantation.

(Logo: http://photos.prnewswire.com/prnh/20061221/DCTH007LOGO )

"This study was designed to evaluate the potential therapeutic value of intracerbral dosing of human neural stem cells (NSI-566, supplied by Neuralstem) in an animal model of adult ischemic stroke," said Cesar V. Borlongan, Ph.D., University of South Florida College of Medicine, and the lead study author. "The results are very clear. The recovery of motor and neurological tests demonstrated by high-dose transplanted stroke animals was significantly better throughout the 56-day study period compared to vehicle-infused stroke animals, or low-dosed animals. In addition, there was stable improvement in the high-dose animals, and they showed a trend of better improvement over time."

A separate poster, "Survival and Differentiation of Human Neural Stem Cells (NSI-566RSC) After Grafting into Ischemia-Injured Porcine Brain," was also presented on Saturday. This study was independently carried out by Dr. Martin Marsala and his colleagues. Dr. Marsala is a professor and the head of the Neuroregeneration Laboratory at University of California San Diego and also a member of the Sanford Consortium for Regenerative Medicine. In this study, the same stem cells were transplanted into the brains of pigs that received an ischemic stroke on one side of the brain. 8-9 weeks after the ischemic event, which models chronic stroke in humans, feasibility and safety of escalating cell doses and injections were assessed. Body temperature, behavior, muscle tone and coordination, sensory function, food consumption, defecation, and micturition were monitored at least twice daily for the first 7 days, and once weekly thereafter, until termination. Up to 12 million cells in 25 cell injection deposits via 5 cannula penetrations were shown to be safe, which closely mimics the intended clinical route and method of delivery in future human clinical trials. At 6 weeks post-transplantation, there were no complications from the cell transplantation method or the cells. All animals recovered and showed progressive improvement with no distinction. All treated animals showed effective engraftment and neuronal maturation with extensive axonal projections. These data support the application of NSI-566RSC cell line to be transplanted into a chronic stage of previously ischemia-injured brain for treatment of motor deficits resulting from stroke.

"Our study was designed to evaluate the potential value of Neuralstem's cells in a chronic model of ischemic stroke and in a species that allowed for the use of human scale transplantation tools and dosing," said Martin Marsala, MD, at the University of California at San Diego Medical School, and the lead study author of the porcine study. "We have demonstrated clearly that both the route of administration and the cells are safe and well tolerated and that the cells survived and differentiated into mature neurons in the host brain tissue."

"We have demonstrated safety and efficacy of NSI-566RSC in a subacute model of ischemic stroke in rats and feasibility and safety in a chronic model of ischemic stroke in mini-pigs," said Karl Johe, PhD, Chairman of Neuralstem's Board of Directors and Chief Scientific Officer. "Together, these two studies demonstrate strong proof of principle data that our NSI-566 cells are ready to go into humans to treat paralysis in stroke patients."

Neuralstem has recently completed a Phase I trial testing the safety of NSI-566 in the treatment of amyotrophic lateral sclerosis (ALS or Lou Gehrig's disease) and has been approved to initiate a human clinical trial in ischemic stroke in China, through its subsidiary, Suzhou Neuralstem.

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.

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Protein could be key for drugs that promote bone growth

By JoanneRUSSELL25

ScienceDaily (Oct. 15, 2012) Georgia Health Sciences University researchers have developed a mouse that errs on the side of making bone rather than fat, which could eventually lead to better drugs to treat inflammatory diseases such as rheumatoid arthritis.

Drugs commonly used to treat those types of conditions -- called glucocorticoids -- work by turning down the body's anti-inflammatory response, but simultaneously turn on other pathways that lead to bone loss. The result can lead to osteoporosis and an accumulation of marrow fat, says Dr. Xingming Shi, bone biologist at the GHSU Institute of Molecular Medicine and Genetics.

The key to the body developing bone instead of fat, a small protein called GILZ, was shown in cell cultures in 2008. Now, with work by GHSU Graduate Student Guodong Pan, the work has been replicated in an animal model. Pan received the American Society for Bone and Mineral Research's Young Investigator Award for his work at the society's annual meeting Oct. 12-15 in Minneapolis.

Bone and marrow fat come from the same biological precursor -- mesynchymal stem cells. "The pathways for bone and fat have a reciprocal relationship, so we needed to find the key that disrupts the fat production pathway, which would then instead encourage bone growth," Shi says.

GILZ, Shi and Pan say, was already a known mediator of the anti-inflammatory response of glucocorticoids, and the protein also mediates bone production. Shi's early research had shown that glucocorticoids enhance bone formation in the lab because of a short "burst" of GILZ.

The protein works by inhibiting the way cells regulate fat production and turn on fat-producing genes, Shi says. "When you permanently express GILZ, the fat pathway is suppressed, so the body chooses to produce bone instead."

"We found that when we overexpressed the protein in these mice, it increased bone formation," Pan added. "This supports our original hypothesis that GILZ mediates the body's response to glucocorticoids and encourages bone growth." In fact, the genetically modified mice showed a significant increase in bone mineral density and bone volume as well, he found.

"That means GILZ is a potential new anti-inflammatory drug candidate that could spare people from the harmful effects associated with glucocorticoid therapy," Pan said

Long-term goals, Shi said, are developing the GILZ-like pill that is anti-inflammatory and protects or even increases bone production.

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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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University of Maryland School of Medicine scientists develop stem cell model for hereditary disease

By daniellenierenberg

Public release date: 15-Oct-2012 [ | E-mail | Share ]

Contact: Karen Robinson karobinson@som.umaryland.edu 410-706-7590 University of Maryland Medical Center

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 (Panicker et.al.).

The study was funded with $1.7 million in grants from the Maryland Stem Cell Research Fund; researchers received a start-up grant for $200,000 in 2007 and a larger, five-year grant for $1.5 million in 2009.

"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.

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Realizing the potential of stem cell therapy

By NEVAGiles23

Public release date: 15-Oct-2012 [ | E-mail | Share ]

Contact: Kat Snodgrass 202-962-4090 Society for Neuroscience

NEW ORLEANS New animal studies provide additional support for investigating stem cell treatments for Parkinson's disease, head trauma, and dangerous heart problems that accompany spinal cord injury, according to research findings released today. The work, presented at Neuroscience 2012, the annual meeting of the Society for Neuroscience and the world's largest source of emerging news about brain science and health, shows scientists making progress toward using stem cell therapies to repair neurological damage.

The studies focused on using stem cells to produce neurons essential, message-carrying cells in the brain and spinal cord. The loss of neurons and the connections they make for controlling critical bodily functions are the chief hallmarks of brain and spinal cord injuries and of neurodegenerative afflictions such as Parkinson's disease and ALS (amyotrophic lateral sclerosis), also known as Lou Gehrig's disease.

Today's new findings show that:

Other recent findings discussed show that:

"As the fields of developmental and regenerative neuroscience mature, important progress is being made to begin to translate the promise of stem cell therapy into meaningful treatments for a range of well-defined neurological problems," said press conference moderator Jeffrey Macklis, MD, of Harvard University and the Harvard Stem Cell Institute, an expert on development and regeneration of the mammalian central nervous system. "Solid, rigorous, and well-defined pre-clinical work in animals can set the stage toward human clinical trials and effective future therapies."

###

This research was supported by national funding agencies such as the National Institutes of Health, as well as private and philanthropic organizations.

Todd Bentsen, (202) 962-4086

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Realizing the potential of stem cell therapy

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State licensing hearing for Bonita Springs stem cell doctor to begin Tuesday

By raymumme

The Grekos hearing is scheduled to begin at 9 a.m. Tuesday. The location has changed to the Collier County Courthouse in room 4-D, according to a case filing Monday.

The hearing before J. Lawrence Johnson, an administrative law judge from Tallahassee, will begin at 9 a.m. The hearing is scheduled to last four days. The Collier County Courthouse is located at 3315 U.S. 41 E.

Photo by Allie Garza

Zannos Grekos

BONITA SPRINGS Bonita Springs physician Zannos Grekos, whose license is in jeopardy for controversial stem cell therapy, is getting his day before a judge.

Barring a last-minute delay or settlement, an administrative hearing is scheduled to begin Tuesday in Naples for the 47-year-old. He is fighting to get his license back in good standing from a suspension order, while the state Department of Health is pursuing more discipline and potentially revocation of his license.

Trained as a cardiologist, he's been licensed in Florida since 1996.

The trial-like proceeding, without a jury, is scheduled for four days before an administrative law judge. The proceeding is open to the public. The case against Grekos has garnered considerable media attention, including CNN and inquiries from European media.

A Texas father, Jimmy Bell, will be tracking what happens. Last year, he paid $57,000 upfront for his 5-year-old son, Jason, to undergo stem cell therapy to fight pulmonary hypertension. Despite pleas that his boy was weakening by the day, the treatment was never scheduled and Jason died. Bell received a $10,000 refund.

"He's taking advantage of people and it's more for personal gain," Bell said. "I'd like to see that stopped."

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Claim of first human stem cell trial unravels

By LizaAVILA

It has been a crazy week for stem cell research. After the high of a Nobel prize for Japan's Shinya Yamanaka, the pioneer of cellular reprogramming, events took an alarming and surreal turn when a little-known compatriot Hisashi Moriguchi claimed to have already run a clinical trial in which similarly reprogrammed cells were injected into people.

But Moriguchi's claims quickly unravelled. "I have not found a single person to say anything concrete indicating that this has really happened," says Paul Knoepfler, a stem cell researcher at the University of California, Davis, who tracked the unfolding story on his blog.

In a poster presented at a meeting of the New York Stem Cell Foundation, Moriguchi who claimed to work at Harvard Medical School and the University of Tokyo described results from a trial in which cardiac muscle cells were grown from induced pluripotent stem (iPS) cells, and transplanted into six US patients with severe heart failure.

The Yomiuri Shimbun newspaper Japan's biggest splashed the story, based on an interview with Moriguchi, who claimed he had received ethical approval from Harvard Medical School's Institutional Review Board (IRB).

This was surprising, given the safety concerns that surround iPS cells adult cells that have been reprogrammed to an embryonic state. Support for the claim quickly disintegrated: within hours, Harvard released a statement noting that Moriguchi had no current affiliation with the university, nor any ethical approval to run a clinical trial.

Moriguchi's poster describing the clinical trial was taken down after the New York Stem Cell Foundation learned of Harvard's statement but a summary was published on Knoepfler's blog. This suggested an improvement of 41.5 per cent in "ejection fraction" a measure of heart output in patients whose hearts were injected with iPS-derived cells, compared to 4.1 per cent in a placebo group.

That would have been an astonishing claim, says Michael Laflamme at the University of Washington in Seattle, who is working to develop cell therapies for heart attack: "I'm not aware of any clinical trial that reported anything of this magnitude."

Indeed, similar studies involving adult stem cells have typically found improvements of less than 5 per cent (European Journal of Hearth Failure, doi.org/crq5k6).

Moriguchi did not respond to emails from New Scientist. But on Saturday he admitted to reporters that for five of the patients he was actually describing "planned" procedures. Still, Moriguchi maintained that he had transplanted cells into one patient at an unidentified hospital in Boston.

New Scientist's enquiries raise further questions about Moriguchi's work. In papers published earlier this year, he described experiments on freezing human ovarian tissue (Scientific Reports, doi.org/jht), and a remarkable claim to be able to eliminate liver tumour cells using a reprogramming technique (Scientific Reports, doi.org/jhv). Both gave Harvard and University of Tokyo affiliations, and claimed ethical approval from each institution.

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Director of Operations for GeneCell International, Jose Cirino, Accentuates the Importance Surrounding the Minority …

By LizaAVILA

Miami, FL (PRWEB) October 15, 2012

Leveraging more than a decade of experience in the biotech industry and a founding member of GeneCell International, Jose Cirino, Director of Operations, is an industry expert for expanding awareness in the field of adult stem cells worldwide. Cirino plays a pivotal role in GeneCell Internationals success, managing all operational aspects of a company thats at the forefront of the biotech industry. While providing leadership and direction for the company, he is responsible for all strategic planning to help advance GeneCells mission and objectives, as well as the expansion of product, service and development at the national and international levels. Currently, Cirino is not only working on the expansion and awareness of cord blood services, but on the implementation of other adult stem cells sources, such as umbilical cord tissue, dental pulp, and adipose (fat) tissue into other countries. He has presentation talks in the advantage of adult cord blood banking to health and biotech industry organizations, conferences and small group meetings (both English and Spanish). Cirino was a key player in the expansion of GeneCell International into Miami, Florida, as the first and only stem cell laboratory of its kind in the South Floridian market and the gateway to international countries.

Through his field of work, Cirinos aspiration and passion is being able to assist individuals in potentially saving their life when a debilitating immune deficiency or disorder arises. Though, Cirino continuously asks himself, Why isn't everyone banking these cells?

His best assumption is that people are not informed about stem cell banking and what is most disheartening, some have never even heard of it. Most people are not aware they have stem cells in their body. Others believe that stem cells only come from only human embryos since this is whats mainly discussed in politics and the news today. May this be the reason they are choosing to have no part in it and ignore it? If so, this is not the case, these cells are found in adults and there are not controversial, moral, ethical or have any political issues surrounding them. The amazing thing about these cells, aside from their potential to treat a variety of different diseases, is that for the most part they can be harvested from the individual through relatively minimally invasive procedures and can be cryogenically frozen (at a temperature of -321 F (-196 C)) and stored for decades until a disease manifests itself or the needed for cell-based therapies arises," said Cirino.

Due to this lack of awareness, there is a massive shortage of stem cell units stored for future treatments. This shortage, or lack of availability, is mostly affecting patients of African, Asian, Hispanic and Native American Indian descent. I, being a minority member of this group, am very concerned by this shortage. Since patients who need a transplant are more likely to find a match within their own genetic background, Cirino adds it is important that the pool of donors reflects the overall community.

A persons blood stem cell type is inherited, which means a patient is more likely to find a matched donor from within their own ethnic group, more than half of cord blood donations and privately banked cord blood in the United States are from Caucasians while minorities remain underrepresented, significantly. By increasing awareness of the advantages of cord blood among minorities, there is a potential for increased access to therapies for more people.

Umbilical cord blood preservation is a process by which blood is collected from the umbilical cord of a newborn baby and is stored cryogenically in a specially-designated bank. According to the National Marrow Donor Program, cord blood contains cells that can be transfused to a patient to treat various diseases, including lymphoma and leukemia. Currently, there are approximately 80 treatable diseases and the list of illnesses continues to grow. Cord blood is rich in stem cells and because certain immune cells found in the cord blood are not mature, there is less risk for the recipients immune system to reject these cells. Cord blood can be used to treat the child from whom the blood was collected as well as some first-degree relatives who are a close genetic match, such as immediate family members. Additionally, patients can get the treatment in about three weeks - as opposed to six to eight for bone marrow from an adult donor.

Prior to founding GeneCell, Cirino served as the President of the International Division to a cord blood laboratory in Boston, Massachusetts, where he was responsible for identifying, evaluating and selecting international representatives for affiliate programs to expand the services internationally. In doing so, he coordinated laboratory development protocol license agreements and implemented these programs throughout various international countries. After the expansion into other countries, Cirino would manage the company owned offices as well as provide support to the affiliate offices, from Mexico and South America, to the UK and the Middle East. He also represented the company at international health and biotech industry conferences, implemented new sales tools and processes for all international divisions of the company, and oversaw all accounting tasks as a method of monitoring its sales projections. Cirino joined the company as the Accounting Manager, where he was responsible for all aspects of U.S. and international accounting functions. He is a seasoned accounting professional, holding various accounting positions within large companies such as Sir Speedy Printing Centers of Boston and Harvard Institute for International Development. He has served as a member within various industry organizations including the International Cord Blood Society, and New England Fertility Society, as well as participated in the International Federation of Gynecology and Obstetrics (FIGO), The Mexican Federation of Ultrasounds, The World Cord Blood Congress, and Stem Cells USA-Regenerative Medicine conferences.

In addition to cord blood, Cirinos implementation projects of other adult stem cells sources, in the U.S. and other countries, include Cord Tissue Segment, Dental Pulp and Adipose Tissue:

About Cord Tissue Segment - A gelatinous substance, which functions as the primary connective tissue of the umbilical cord and is referred to as Whartons Jelly. This segment contains an important amount of Mesenchymal stem cells. These cells are an excellent candidate for regenerative medicine and tissue engineering applications. Mesenchymal stem cells have shown great promise in the potential treatment of diseases such as heart attack, Parkinsons disease, Alzheimers disease, type I diabetes, assist in bone and dental regeneration and expedite wound healing. In the past, the umbilical cord has been viewed as medical waste and discarded, resulting in the loss of this potential life-saving resource. By storing the stem cells extracted from your umbilical cord tissue segment along with your babys cord blood, youll have access to a wider variety of stem cells as new scientific discoveries are made.

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Cell transformation earns Nobel Prize

By NEVAGiles23

About a week ago, the Nobel Prize winners in medicine were revealed as Sir John B. Gurdon and Shinya Yamanaka for their work in cell research.

The award was given to these two doctors for the discovery that mature cells can be reprogrammed to become pluripotent." That is, any mature cells can go back to their original state, thus reversing the process of cell aging.

Yamanaka was able to draw this conclusion due to a combination of his own research and the research of Gurdon done 40 years earlier.

In 1962, Gurdon was able to take the nucleus from a frogs intestine and place it into a frogs egg. From this, a normal frog was born. Gurdons research was inspiration to Yamanakas experiment, where he wanted to reverse the process of cell maturity without using an egg.

He was able to figure out a gene combination, which he inserted into a mature cell, so that the cell was able to go back to its primitive state.

According to Yamanaka, whats significant about this technology is not only can we avoid the ethical controversy of using embryos, but also a transplant patient can avoid organ rejection because the treatment will be done by using the patients own cells and not somebody elses.

Past controversy of stem cell research has come from the fact that in order to examine a brand new cell, the scientist would have to kill an embryo. Yamanaka also mentions that this discovery may some day be a possible cure for Parkinsons disease.

Since, Yamanakas discovery was made in 2006, classroom textbooks have already been changed and biology teachers have been informing their students about this new method.

DePaul professor Dr. Elizabeth LeClaire talked to her biology students about the research Thursday.

I dont think [the research] will revolutionize the world of medicine, said LeClaire. This may not be the answer you want to hear, but most diseases are very common and are caused by diet and exercise.

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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.
So how is the sector portfolio doing now that we've been through three quarters?
CT model portfolio compared to 3 major indices YTD
In case you can't read the image above, the blue line represents the cell therapy portfolio and here are the stats on performance since 1 January 2012:
  • Cell Therapy Portfolio:  +24.44%
  • Dow Jones:  +4.5%
  • S+P 500:  +6.78%
  • Nasdaq:  +10.26%
The only change I've made to the portfolio of 29 companies listed in our August 10 post is to add Thermogenesis (KOOL).  Today its stock is at .968 up from .7 at the beginning of the year.
You do or should know, I'm no financial analyst.  I'm not entirely sure what assumptions are behind this 'model portfolio' or precisely what one should take from this snapshot but what is clear to me is that at least from one perspective the sector is treating investors fairly well.
I certainly welcome comments from more sophisticated investors or analysts.  In fact, if anyone with that kind of experience or expertise wants to write a guest post on this blog providing a more sophisticated commentary on what this all means, I would very much welcome the contribution.
In the meantime, I hope this helps.
_________________
Post-publication addition:
Carter Gould, Associate Biotech Analyst at Dawson James Securities emailed me to point out that the cell therapy portfolio is simply riding the bull wave of biotech in general and and the portfolio has not done even half as well as the broader biotech (BTK) index which is up 45% YTD.  All very true.  Here is a YahooFinance snapshot of the BTK performance vs the three major indices.















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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.

The Yamanaka tale goes back to a 2010
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.
Here is part of what Aldous wrote,

“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.”

Last week, Paul Knoepfler of UC Davis
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.” 

At the $3 billion California stem cell
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.
As the agency tries to move faster and
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.   

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