A blue-ribbon Institute of Medicine panel is broadening its reach in its examination of the performance of the $3 billion California stem cell agency.

The group will hold a one-day public hearing next Tuesday at UC Irvine that will include independent perspectives along with comments from biotech firms, some of which have been unhappy with the paucity of CIRM funding for industry. The IOM has additionally expanded its efforts to generate responses to its questionnaires to include rejected applicants and the general public.

The hearing is the last public session scheduled in California and will be audiocast on the Internet. The IOM's fourth and final public session is scheduled for some time later this year with release of the full report in November. The stem cell agency is paying the IOM $700,000 to conduct the study. The public sessions so far have been taken up with testimony from recipients of CIRM largesse or from employees or directors of the agency.

The list of independent witnesses next week includes Stuart Drown, executive director of the state's good government agency, the Little Hoover Commission, which conducted a lengthy study of the stem cell agency. Also on tap are others including:

• Ruth Holton-Hodson, California deputy state controller, and who deals with CIRM issues for the state controller, who chairs the only state body officially charged with overseeing the agency.
• Marcy Darnovsky, associate executive director of the Center for Genetics and Society in Berkeley, an organization that has been critical of CIRM
• David Jensen, publisher of the California Stem Cell Report, which has posted more than 3,000 items on the agency since 2004 in addition to a number of freelance articles. 

The IOM has widened its efforts to secure comments from persons who cannot appear at its hearings. At the IOM's request, CIRM sent emails about the questionnaires to the 4,039 persons who have asked the agency to be notified about its RFAs. Recipients were asked by CIRM to complete the IOM surveys.

The online forms are due by April 23. Here are links in the various categories:  general public, CIRM investigators,CIRM industry partners, leadership from CIRM-funded institutions, technology transfer professionals,CIRM's international collaborators, members of the Independent Citizens' Oversight Committee (the CIRM governing board), and investigators not funded by CIRM.

The IOM said access to the Internet audiocast of the meeting can be gained on April 10 through this web page.

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Chuck Winner is a name that doesn't surface often in connection with California's $3 billion stem cell research effort.

Chuck Winner (left) at USC in 2006 USC Photo

In fact, he rarely appears in the news. Winner's name, however, did surface yesterday when Gov. Jerry Brown appointed him to the state's horse racing board. Most of the stories about the appointment were in horse racing publications. But none, including The Sacramento Bee's, mentioned the Prop. 71 campaign managed by his firm, Winner & Mandabach Campaigns of Santa Monica, Ca.

Nonetheless, he and his firm were the key to winning approval of the 2004 ballot measure that created the California Institute of Regenerative Medicine, an enterprise that is unprecedented in state or national history.

The firm's $35 million campaign for Prop. 71 attracted 59 percent of the vote. That same year, the firm also successfully managed four other ballot measures in the Golden State. Its lifetime average is remarkable. The firm's web site says it has won 90 percent of the 150 ballot measure campaigns it has run throughout the country.

Winner-Mandabach has this to say about how it pulled off the Prop. 71 campaign:

"Surveys (in 2003-04) showed that most voters supported the basic concept of expanding stem cell research. However, because of the state’s serious budget and debt problems, it was also clear that passing such a huge bond measure for any purpose would be a major challenge.

"The campaign overseen by Winner & Mandabach to overcome those odds involved a year-long coalition building effort that ultimately recruited over 40 Nobel Prize winning scientists and more than 100 patient groups, disease foundations and business groups – the largest, most diverse coalition of its kind ever formed to support a state ballot measure. The supporting groups helped mount an intense grassroots outreach and activation effort to their members, who numbered in the millions."

Winner-Mandabach continued,

"The TV advertising developed by the firm featured award-winning scientists, patients and their families, and highly-respected patient advocates like Michael J. Fox and the late Christopher Reeve. The ads focused on the potential for cures that could save millions of lives. Details of the initiative and economic issues were addressed through in-depth mail pieces and earned media efforts that included the release of an economic study showing that stem cell cures would help reduce the state’s skyrocketing health care costs. Prior to the implementation of the paid media campaign in late-September, polling showed Proposition 71 below the 50% threshold. But after an intense 6-week advertising, earned media and grassroots campaign, Prop. 71 steadily gained support, even in the face of final attacks by conservative groups and activists like Mel Gibson, and attacks from the left by some anti-biotech groups. Because of its precedent-setting nature, the Prop. 71 campaign became the most watched ballot measure campaign in the nation and generated worldwide press attention. On election day, it was approved overwhelmingly by a vote of 59% to 41%."

The key to success on any ballot measure is a firm like Winner-Mandabach, although high profile individuals – in the case of Prop. 71, Robert Klein, who became the first chairman of the stem cell agency – are often given complete credit. Top notch campaign firms have a keen understanding of voters, appropriate political timing and effective PR and TV advertising campaigns. Without Winner-Mandabach – or a firm with the same skillset – the California stem cell agency would not exist.

Chuck Winner, however, does not have an uncritical view of the ballot initiative process, which has resulted in much expensive mischief in California. He told a USC audience in 2006,

"It’s abused time and again. My opinion is that when you circumvent the legislative process or representative democracy to solve a problem, you can take it to an extreme and that extreme becomes, in some ways, worse than the problem you were trying to solve in the first place. Single-issue up or down initiative votes are very often not the best way to govern."

As for the horse racing business, Winner, a Beverly Hills resident, has been involved in horse racing since 1986. His partner, Paul Mandabach, is also involved in the sport of kings. Their firm has not disclosed their record at the track.

(Click here to see two powerful ads developed for the 2004 campaign, including the famous Christopher Reeve spot.)

Source:
http://californiastemcellreport.blogspot.com/feeds/posts/default?alt=rss

SAN FRANCISCO – A proposed $17.9 million operational budget for the California stem cell agency has cleared a key hurdle despite objections concerning the addition of another attorney to its $2.4 million annual legal effort.

The spending plan was approved yesterday by the CIRM directors' Finance Subcommittee on an 8-0 vote. The proposal is 7.2 percent higher than spending for the current fiscal year, which ends in June. The agency by law operates with a stringent budget cap of 6 percent of its bond funding.

Most of the budget goes for salaries at the agency, which has slightly more than 50 employees. The agency spends $8.4 million annually administering its 400-plus grants and developing new grant programs.

The proposal to add another lawyer to its staff drew fire from CIRM Co-vice chairman Art Torres. He asked why the agency wanted to spend more money for "a lawyer we don't need."

CIRM President Alan Trounson and CIRM General Counsel Elona Baum defended the plan, saying another lawyer was needed to deal with intellectual property and research commercialization issues. They said that grantee institutions and businesses are not dealing with the legal ramifications in a satisfactory manner.

Trounson said the agency would be "at risk" if it did not have control of the legal issues.

Torres brought up a memo on the subject, which he said did not justify the addition of a lawyer. Other directors said they had not seen the memo and asked for copies. The California Stem Cell Report has also asked for a copy.

Michael Goldberg, a venture capitalist and chair of the Finance Subcommittee, asked CIRM staff and a handful of directors to resolve the matter between now and the end of May, when the budget is expected to be approved by the full board.

Currently CIRM has five attorneys on staff, not including directors who are lawyers. The budget for the internal legal operation is $1.3 million annually. The rest of the $2.4 million goes for contracted services, including the firm of Remcho, Johansen & Purcell of San Leandro, Ca., a highly regarded political and governmentally oriented law firm that is budgeted for as much as $650,000 for the coming year, down from $695,000 this year. Another attorney is also on contract for $250,000, down from $325,000 this year.

CIRM budget documents projected savings in $190,000 in legal costs from the current year that could be used to help hire another attorney. The total legal costs for next year are budgeted at $2.44 million, compared to $2.39 million for the current year.

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SAN FRANCISCO -- The California stem cell agency scored during the weekend in a front page story in the San Francisco Chronicle that heralded a possible cancer treatment involving a "don't-eat-me-molecule."

The piece by Victoria Colliver said,

"In a potential breakthrough for cancer research, Stanford immunologists discovered they can shrink or even get rid of a wide range of human cancers by treating them with a single antibody."

The story was played prominently on the Chronicle front page on Saturday. However, the stem cell agency and its funding role was not mentioned until the last paragraph of the story. Nonetheless, on Saturday night, the Chronicle website reported that it was the most read and most emailed story on its site at that time.

When we looked at the story that evening, the article had 84 comments from readers, including several which praised the agency for its work. One reader noted, however, that other funding agencies were involved besides the California stem cell agency. The reader quoted from the Stanford press release, which said,

"This work was supported by the Joseph & Laurie Lacob Gynecologic/Ovarian Cancer Fund, the Jim & Carolyn Pride Fund, the Virginia & D.K. Ludwig Fund for Cancer Research, the Weston Havens Foundation, the National Cancer Institute, the Department of Defense, the California Institute for Regenerative Medicine and anonymous donors."

Stanford's news release said,

"It is the first antibody treatment shown to be broadly effective against a variety of human solid tumors, and the dramatic response — including some overt cures in the laboratory animals — has the investigators eager to begin phase-1 and –2 human clinical trials within the next two years."

The Los Angeles Times also carried a story last week on the research, but did not mention CIRM. The agency itself wrote about the research on its blog.

CIRM Chairman J.T. Thomas and other CIRM directors have been concerned about the lack of coverage in the mainstream media – particularly favorable coverage – of the agency's work. When this writer was at a meeting yesterday afternoon at CIRM headquarters in San Francisco, Thomas pointedly presented a copy of the Chronicle front page, suggesting the article was worthy of note. Thomas is correct; the piece can certainly be counted as a favorable mention of the $3 billion research effort. Now it is up to CIRM and its new communications director, Kevin McCormack, who began work on Monday, to multiply the Chronicle piece many times over.

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Trial Provides Proof-of-Concept for Cell-Based Therapy in a Myelination Disorder

Company to Host Conference Call Today to Discuss Summary Results

NEWARK, Calif., April 2, 2012 (GLOBE NEWSWIRE) -- StemCells, Inc. (Nasdaq:STEM - News) today announced preliminary evidence of progressive and durable donor-cell derived myelination in all four patients who underwent transplantation with the Company's proprietary HuCNS-SC(R) cells (purified human neural stem cells) in its clinical trial for Pelizaeus-Merzbacher disease (PMD), a rare hypo-myelination disorder in children. In addition, clinical assessment revealed small but measureable gains in motor and/or cognitive function in three of the four patients; the fourth patient remained clinically stable. The study was conducted by researchers at the University of California, San Francisco (UCSF).

A summary of the trial results were presented Saturday, March 31, at the 2012 European Leukodystrophy Association (ELA) Families/Scientists Meeting in Paris. The findings are being submitted for publication in a peer-reviewed scientific journal.

"The results from this Phase I study are meaningful and important," said study investigator Nalin Gupta, MD, PhD, UCSF associate professor of neurological surgery and pediatrics and chief of pediatric neurological surgery at UCSF Benioff Children's Hospital. "The safety and clinical outcomes a year after transplantation in this Phase I study, combined with durable radiological signals of myelin formation, provide objective evidence of a biological effect of HuCNS-SC transplantation that addresses the fundamental basis of the pathology in the brain of PMD patients. We also wish to recognize the families' contribution to this study. These advances would not be possible without their willingness to participate in this clinical research."

Patients with PMD have a defective gene, which leads to insufficient myelin in the brain. The disease occurs only in males, and those with the most severe form of the disease, connatal PMD, are significantly disabled from birth and usually die, within the first decade of life. The study was the first to test transplantation of neural stem cells as a potential treatment for a myelination disorder. Myelin is the substance that surrounds and insulates nerve cells' communications fibers (also known as axons). Without sufficient myelination, these fibers are unable to properly transmit nerve impulses, leading to a progressive loss of neurological function, and death.

The open-label Phase I trial, conducted between February 2010 and February 2012, enrolled four patients with the connatal form of PMD, between the ages of 14 months and 5 years, and was designed to assess safety and preliminary efficacy of the intervention. The study used magnetic resonance (MR) imaging, commonly employed in other neurological diseases, to explore signs of myelination related to the transplanted neural stem cells. The HuCNS-SC transplants were surgically delivered to multiple sites within the frontal lobes of the brain. Patients also received immunosuppression for nine months following transplantation and underwent intensive follow-up neurological assessments and MR imaging for twelve months following transplantation. A separate four-year observational study will continue to monitor and report the future progress for all four patients.

At the one-year interval, MR imaging showed changes compatible with increased myelination in the region of the transplantation. The MR signs of myelination persisted after the withdrawal of immunosuppression at nine months and were also found to progress over time. The development of new myelin signals is unprecedented in patients with connatal PMD and is consistent with HuCNS-SC engraftment.

"The finding of myelin formation in this first exploratory study is indeed very encouraging," said Stephen Huhn, MD, FACS, FAAP, Vice President and Head of the CNS Program at StemCells, Inc. "We believe that the results of this trial provide proof-of-concept and a compelling rationale for the Company to begin planning for a controlled Phase II study in PMD. These results may also have implications for other leukodystrophies, as well as more common myelin disorders including transverse myelitis, multiple sclerosis and periventricular white matter injury seen in Cerebral Palsy. We are very pleased to be working with investigators at UCSF and deeply appreciate the critical research expertise they have dedicated to the trial."

Conference Call

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StemCells, Inc's Milestone Clinical Trial in Pelizaeus-Merzbacher Disease Shows Evidence of Myelination Following ...

Early in March 2012, 77-year-old Richard Poling entered a clinic in Bonita Springs, Fla., for a stem cell treatment to help with age-related heart and lung conditions.

Poling, an avid golfer and family man from Indiana, had sought several conventional therapies to alleviate his suffering with unsatisfactory results and was desperate for a treatment that would allow him to enjoy the pleasures of life again. Shortly after receiving his alleged treatment, however, Poling went into cardiac arrest at the clinic and died. According to investigators, the alleged stem cell treatment Poling received was not approved by the FDA.

According to multiple reports, the local cardiologist who conducted the treatment removed fat cells from Poling's abdomen and sent them to a lab that claimed to process and isolate adult stem cells from a patient's own fat. A few hours later, a second procedure was allegedly performed at the same clinic in which Poling had the stem cells injected back into his bloodstream for their regenerative properties. The entire process took one day, and during the hours between the procedures, Poling enjoyed lunch out with his family.

Poling was the second patient to die under the same doctor's care in the last two years after receiving the supposed stem cell therapy. The physician was already under order by the state of Florida to cease performing any further stem cell treatments pending further review, but the doctor allegedly continued performing various stem cell procedures -- until his license was revoked and suspended after Poling's death.

With all the marvels of modern medicine, there are still medical needs that remain unmet by our conventional health care system. When that happens, desperate people like Poling search for alternatives anywhere they can find them. One of these alternatives is stem cell therapy, a science that is no stranger to controversy.

The problem lies in that most stem cell therapies are not FDA-approved, and thus the market is under-regulated and consists of products that lack standardization and legitimacy. The lack of approved products has generated a gray market for stem cell therapeutics -- one that is dangerous and can be deadly.

Even though the United States has taken a passive approach to stem cell therapy as compared to its European and Asian counterparts, there are several U.S. companies vying for FDA approval as they develop stem cell therapies for indications such as heart disease, neurologic disorders and ophthalmologic diseases. While these companies spend hundreds of millions of dollars individually -- billions collectively -- to conduct groundbreaking research and development, rigorous safety studies, and extensive human trials to establish meaningful uses of their medical technologies, the majority of their studies occur overseas where they are sure to receive swifter review and eventual approvals.

The rest is here:
Patient Beware: When Stem Cells Harm

California's $3 billion stem cell agency, now more than 7 years old, has joined research partnerships with science and health agencies in eight foreign countries, the San Francisco institute announced.

The agreements call for collaboration in efforts aimed at speeding stem cell research from the laboratory to the hospital, where researchers hope that basic human cells will be programmed to treat scores of human degenerative diseases.

Research partnerships between American and foreign stem cell scientists are encouraged, but the California institute's funds would only be spent within the state, institute officials said.

Alan Trounson, president of the California Institute for Regenerative Medicine, signed agreements with stem cell funding agencies in Brazil and Argentina last week, he said Thursday.

"Both Brazil and Argentina have strong and robust stem cell research communities in basic science and transitional clinical science, which should create exciting synergies with many scientists in California," Trounson said in a statement.

He has signed similar pacts with stem cell agencies in Canada, Britain, France, Spain, Australia, Japan, China and Indiana.

The California institute was created in 2004 after Proposition 71, a $3 billion bond issue, was approved by California voters at a time when use of federal funds was barred for research into the promising field of embryonic stem cells.

So far the state agency has committed $1.2 billion to scientists and training centers at 56 California institutions, and the rest of the bond money should last until 2020, a spokesman said.

This article appeared on page C - 9 of the SanFranciscoChronicle

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Stem cell institute to work with foreign agencies

(HealthDay News) -- Obesity surgery-related complications in the United States declined 21 percent between 2001 and 2006, and payments to hospitals for obesity surgery decreased by as much as 13 percent, partly because there were fewer patient readmissions due to complications, a new study reports.

The findings from a study by the U.S. Agency for Healthcare Research and Quality are based on an analysis of more than 9,500 patients under age 65 who had obesity surgery, also known as bariatric surgery, at 652 hospitals between 2001 and 2002 and between 2005 and 2006.

The researchers found that the complication rate among obesity surgery patients dropped from 24 percent to about 15 percent. Contributing to that decrease were declines in post-surgical infection rates (58 percent lower), abdominal hernias, staple leakage, respiratory failure and pneumonia (29 percent to 50 percent lower).

There was little change in rates of other complications such as ulcers, dumping (involuntary vomiting or defecation), hemorrhage, wound re-opening, deep-vein thrombosis and pulmonary embolism, heart attack and stroke, the researchers noted. Read more...

AyurGold for Healthy Blood

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Berkeley Daily Planet

Stakeholders Weigh in on UC Berkeley GMO Complex Berkeley Daily Planet By Richard Brenneman A forum critical of UC Berkeley's plans to ramp up genetic engineering research at a planned massive new second campus of Lawrence Berkeley National Laboratory in Richmond drew a capacity crowd to the David Brower Center Thursday ...

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Via Scoop.it – inPharmatics

On March 29, 2012, Oracle announced that it has agreed to acquire ClearTrial, a leading provider of cloud-based Clinical Trial Operations and analytics products that make the planning, sourcing, and tracking of clinical projects and financial performance…

Via http://www.oracle.com

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The California stem cell agency has issued a statement from its president, Alan Trounson, concerning the cancellation of a Vatican stem cell conference at which Trounson was scheduled to speak.

According to the Catholic News Agency, the meeting was terminated because of the scheduled appearances of researchers such as Trounson, who support hESC research. The Catholic church opposes such research.

The news agency last week quoted one Vatican insider as saying the conference had generated a scandal within the higher echelons of the church. However, the Vatican later claimed it was cancelling the meeting because of "organizational, logistical and economic factors."

Trounson's statement said,

"I am disappointed that the decision was made to cancel the conference because it offered the opportunity for a constructive dialogue on all types of stem cell research.

"Open dialogue can enhance the field as a whole and accelerate our efforts to provide new therapies for patients in need."

Source:
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The proposed $17.8 million operational budget for the California stem cell agency will receive more public scrutiny at a meeting next week in San Francisco, with additional public participation sites ranging from Boston to La Jolla.

The spending plan for 2012-13 is 7.2 percent higher than the estimated expenditures for the current year. By law, CIRM's budget is not subject to cuts by the legislature or the governor, who are trying to find solutions to the state's ongoing financial crisis.

Next week's hearing will be the last before approval of the budget in late May by the directors of the $3 billion research program. No significant changes are expected from the document to be presented on Monday.

Public sites where the public can participate in the CIRM directors' Finance Subcommittee meeting include South San Francisco, Stanford, Berkeley and Boston. You can find more information about the specific locations on the meeting agenda, but if you are interested in attending you need even more details from CIRM prior to the actual meeting. Email a request to info@cirm.ca.gov.

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Myjoyonline.com

Adopt Genetically Modified crops to increase yields - Prof Nketsia-Tabiri Myjoyonline.com Professor Josephine Nketsia-Tabiri, Director of Biotechnology and Nuclear Agriculture Research Institute (BNARI), has called on farmers to embrace the application of Genetically Modified Organisms (GMOs) to increase crop yields and help sustain ... and more »

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Is your child about to lose her milk tooth? Instead of throwing it away, you can now opt to use it to harvest stem cells in a dental stem cell bank for future use in the face of serious ailments. Now thats a tooth fairy story coming to life.

Still relatively new in India, dental stem cell banking is fast gaining popularity as a more viable option over umbilical cord blood banking.

Stem cell therapy involves a kind of intervention strategy in which healthy, new cells are introduced into a damaged tissue to treat a disease or an injury.

The umbilical cord is a good source for blood-related cells, or hemaotopoietic cells, which can be used for blood-related diseases, like leukaemia (blood cancer). Having said that, blood-related disorders constitute only four percent of all diseases, Shailesh Gadre, founder and managing director of the company Stemade Biotech, said.

For the rest of the 96 percent tissue-related diseases, the tooth is a good source of mesenchymal (tissue-related) stem cells. These cells have potential application in all other tissues of the body, for instance, the brain, in case of diseases like Alzheimers and Parkinsons; the eye (corneal reconstruction), liver (cirrhosis), pancreas (diabetes), bone (fractures, reconstruction), skin and the like, he said.

Mesenchymal cells can also be used to regenerate cardiac cells.

Dental stem cell banking also has an advantage when it comes to the process of obtaining stem cells.

Obtaining stem cells from the tooth is a non-invasive procedure that requires no surgery, with little or no pain. A child, in the age group of 5-12, is any way going to lose his milk tooth. So when its a little shaky, it can be collected with hardly any discomfort, Savita Menon, a pedodontist, said.

Moreover, in a number of cases, when an adolescent needs braces, the doctor recommends that his pre-molars be removed. These can also be used as a source for stem cells. And over and above that, an adults wisdom tooth can also be used for the same purpose, Gadre added.

Therefore, unlike umbilical cord blood banking which gives one just one chance - during birth - the window of opportunity in dental stem cell banking is much bigger.

Continued here:
Your child’s milk tooth can save her life

Dublin - Research and Markets (http://www.researchandmarkets.com/research/bac5f5c5/strategic_developm) has announced the addition of the "Strategic Development of Neural Stem & Progenitor Cell Products" report to their offering.

Overview: Neurogenesis is the process by which neurons are created. This process is most active during pre-natal development when neurogenesis is responsible for populating the growing brain. Neural stem cells (NSCs) are the self-renewing, multipotent cells that differentiate into the main phenotypes of the nervous system. These cell types include neurons, astrocytes, and oligodendrocytes. Neural progenitor cells (NPCs) are the progeny of stem cell division that normally undergo a limited number of replication cycles in vivo.

The terms neuronal and neural also need to be defined. Technically speaking, neuronal means pertaining to neurons, and neural means pertaining to nerves, which are the cordlike bundles of fibers made up of neurons. Since both terms ultimately are descriptive of neurons, the scientific community uses the terms "neuronal" and "neural" interchangeably. The complexity of this issue is explored from a marketing perspective within this report.

In 1992, Reynolds and Weiss were the first to isolate neural stem cells from the striatal tissue of adult mice brain tissue, including the subventricular zone, which is a neurogenic area. Since then, neural progenitor and stem cells have been isolated from various areas of the adult brain, including non-neurogenic areas like the spinal cord, and from other species, including humans. During the development of the nervous system, neural progenitor cells can either stay in the pool of proliferating undifferentiated cells or exit the cell cycle and differentiate.

This market report focuses on recent advances in NSC research applications, explores research priorities by market segment, highlights individual labs and end-users of neuronal stem cell research products, explores the competitive environment for NSC research products, and provides 5-year growth and trend analysis. It provides detailed guidance for companies that wish to offer strategically positioned NSC research products, including cells, kits, assays, and related media and reagents.

This Market Report Includes:

- Recent advances in NSC research applications

- Research priorities by market segment

- Competitive analysis of NSC research supply companies

- Segmentation of existing NSC products

Read the rest here:
Research and Markets: Strategic Development of Neural Stem & Progenitor Cell Products

The Catholic Church has never had a particularly easy relationship with science. After all, this is the institution that sentenced Galileo Galilei as a heretic for his theories on the universe during the Roman Inquisition. Two thousand years later, the church forgave Galileo and called the whole misunderstanding a tragic mutual incomprehension but it remains safe to say the Vatican doesnt have a great track record when it comes to empirical open-mindedness.

So onlookers were surprised when the Vatican announced it would be hosting a global conference on the highly controversial issue of stem-cell research in Rome over four days in late April. The church held a similar conference in 2010 and 2011, which focused on its recommendation that stem-cell research should be limited to adult cells that can be harvested from live donors, not embryonic cells that destroy the source. But this years conference schedule featured some of the worlds foremost experts in embryonic research as keynote speakersleading some scientists to think that the Vatican might actually be looking for enlightenment on the topic.

That was not exactly case. Instead, the Vatican seems to have hoped that by including embryonic researchers in the program, it would appear that these scientists actually endorsed the Vaticans stance.

It might have worked to some extent, but after some of the speakers declined to censor their speeches, the Vatican abruptly canceled the conference altogether. According to the conference website, the event was canceled due to serious economic and logistic-organizational reasons that have completely jeopardized the success of the 3rd International Congress on Responsible Stem Cell Research. The scientists who were planning to attend say they are being stifled instead. I think the only interpretation is that we are being censored, Alan Trounson, president of the California Institute for Regenerative Medicine in San Francisco, said in a statement. It is very disappointing that they are unwilling to hear the truth.

Just what was the Vatican thinking? Inviting embryonic stem-cell researchers to a conference and then denying them the right to talk about their field of expertise was a major gamble. Had the speakers agreed to avoid reference to embryonic research, it would have given the disingenuous impression that they endorse the Holy Sees recommendation on adult stem-cell research only. Did the Vatican really think they could control the scientific community? Apparently so. Father Scott Borgman of the Pontifical Academy for Life, which co-organized the conference, had reportedly asked the speakers to limit their discussions to adult stem-cell research only. George Daly, a leading embryonic researcher with the Childrens Hospital in Boston, says he was actually told not to make embryonic researchhis field of expertisea focal point of his talk. When he told Borgman that he would still be touching on the topic in a historical context, higher-ups in the Vatican reportedly panicked. I had been encouraged to think that the Congress would be a forum for discussion of many areas of common interest to the Vatican and stem cell scientists, regardless of the disagreements over embryonic stem cells, Daly told The Daily Beast. We should all agree that clinical trials of new medical treatments based on stem cells should proceed according to rigorous principles to ensure patients are kept as safe as possible and free from exploitation. And we should all agree that premature claims of therapeutic efficacy and direct marketing of unproven interventions to vulnerable patients is a threat to legitimate attempts to develop experimental stem cell medicines.

Pope Benedict looks on during the mass in solemnity of the chair of St. Peter with new Cardinals in St. Peter's basilica at the Vatican on February 19, 2012. The Vatican stands by its decision to cancel the controversial conference as having a purely business motive. , Alberto Pizzoli, AFP / Getty Images

With the cancelation of the event, discourse between the two diverse entities will not have a venue. One Vatican official told the Catholic News Service that many of the Vaticans leaders were secretly glad the conference failed. I am infinitely relieved that the church has avoided a major blunder which would have confused the faithful for decades to come, the unnamed source said. The Holy Spirit has certainly shown to be present through those faithful members who drew attention to the ambiguity of the choice of speakers. I hope and pray that a review will be affected of the basis on which these congresses are planned.

Some stem-cell researchers are also relieved the conference wont go on. I personally am very uncomfortable with a scientific meeting run by a church, and one at which only certain types of science and scientists are allowed to attend, blogged Paul Knoepfler, an associate professor of Cell Biology and Human Anatomy at UC Davis School of Medicine who blogs about stem cell research at IPCell.com. Also I cant help but wonder, what would be the reaction if someone like Daley spent a few minutes of his talk discussing his embryonic cell research in a very nonconfrontational way? Would he be tasered or drop through some trap door straight to Hell?

Still, Knoepfler was hopeful. I view the canceled Vatican stem-cell meeting as a missed opportunity for a very much needed, open dialogue about stem cells, he told The Daily Beast. More specifically, I believe the reasons for the cancellation reflect an anti-scientific attitude by the highest level of Vatican leaders. More simply put, the attitude might be summed up by the phrase If you do not think like us, you are not welcome at our meeting, and well go so far as to cancel the whole thing to avoid your presence.

Inviting embryonic stem-cell researchers to a conference and then denying them the right to talk about their field of expertise was a major gamble.

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Vatican’s Stem-Cell Censorship Sham

As the basketball frenzy that accompanies March Madness draws to the fever pitch of the Final Four, it brings to mind that basketball is a high contact sport. A quick peek at the NBA injured list reveals a catalog of breaks and tears that affect tendons, ligaments and bones.

The pressure to improve performance and search for quick recoveries has led some celebrity athletes to seek out stem cell treatments overseas and in the U.S. Among NBA players to get stem cell treatments are Jason Kidd, Tracy McGrady, Amar Stoudemire, Allan Houston and Kenyon Martin, according to a Sports Illustrated article.

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Dragoo said in a phone interview that the publicity has actually had a negative impact on the development of clinically proven stem cell therapies for orthopedic medicine and how it is perceived. Because of this market pressure, private clinics have been offering stem cells treatments both here in the USA as well as around the world. Often, these treatments have not been studied and are not regulated in any way. FDA [U.S. Food and Drug Administration] regulations have also severely limited new clinical trials in stem cell therapy in the USA.

The ethical debate of using embryonic stem cells taken from fetuses has been sidestepped to some extent by the viability of adult stem cells for stem cell therapy. Although the FDA permits cells being extracted from individuals and transformed into stem cells, and re-inserted back into the same person, it requires that the conversion involve no more than water, preservatives and storage products. Anything more than that, the FDA policy states, would be classified as a drug therapy and need to go through the proper application protocol.

But a much-awaited decision by the U.S. District Court in Washington, D.C. expected in May that may resolve a four-year-old battle between the FDA and Regenerative Science in Colorado could represent a sea change in how autologous adult stem cell treatments are regulated. The FDA is seeking to prevent the company from providing autologous adult stem cell treatment for musculoskeletal and spinal injuries. If the FDA were to lose, anyone with a medical license could develop autologous stem cells and inject them back into patients, without any regulatory oversight, according to a Cell Press article.

Although stem cells are the focus of numerous clinical trials, they are mainly for cancer and rare diseases, most are being conducted outside the United States. While there have been some developments for sports medicine applications produced by research from academic institutions, there have been no clinical trials for stem cell treatments in sports medicine in the United States because of the FDAs reservations about using adult stem cells. Despite the laxer regulations in Japan, China and Europe, its not in the financial interest of companies there to spend the money to do clinical trials if they dont have to.

Among the most interesting applications for orthopedic medicine are the restoration of articular cartilage and patching defects in joint cartilage, with the hope of resurfacing arthritic joints in the future, Dragoo said. Stanford is preparing to initiate its own clinical trial next year looking at inducible stem cells.

This technique takes adult cells and makes them young again by inserting four genes, which makes the cells immature and allows them to be directed into different types of tissues, Dragoo said.

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Basketball’s influence on stem cell treatments in sports medicine

28-03-2012 10:17 Dr Joshua Hare is Professor of Medicine and Director of the Interdisciplinary Stem Cell Institute at the University of Miami. The interview was conducted on 25 March 2012 at the American College of Cardiology's (ACC's) 61st Annual Scientific Session & Expo in Chicago. See more ACC.12 Coverage: http://www.getinsidehealth.com

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Stem cell therapy for the repair of myocardium in heart failure patients - Video

ROCKVILLE, Md., March 28, 2012 /PRNewswire/ --Neuralstem, Inc. (NYSE Amex: CUR) announced that safety results from the first 12 patients with amyotrophic lateral sclerosis (ALS or Lou Gehrig's disease) to receive its stem cells were reported online in the peer-reviewed publication, STEM CELLS, on March 13th. "Lumbar Intraspinal Injection of Neural Stem Cells in Patients with ALS: Results of a Phase I Trial in 12 Patients" (http://www.ncbi.nlm.nih.gov/pubmed/22415942.1) reports that one patient has shown improvement in his clinical status, even though researchers caution that the study was not designed to show efficacy. Additionally, there was no evidence of accelerated disease progression due to the intervention in any of the 12 patients, who were followed from 6-18 months after they were transplanted with the cells. All of the patients, who received transplants in the lumbar (lower back) region, tolerated the treatment without any long-term complications related to either the surgery or the cells.

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

The 12 patients, part of the ongoing Phase I trial to evaluate the safety of Neuralstem's stem cells and transplantation procedure in patients with ALS, were the first in the world to receive intraspinal stem cell injections. Results from these patients were also were reported at the American Academy of Neurology Annual Meeting last September.

Based on a positive safety assessment, the trial has now been approved by the FDA to progress to transplanting ALS patients in the cervical (upper back) region of the spine, where the goal is to protect the motor neurons which affect respiratory function, and possibly prolong life. The fourteenth patient was transplanted earlier this month. All patients were treated at Emory University Hospital in Atlanta, Georgia.

"For these first 12 patients, we have met the objective of the Phase I trial, demonstrating safety for both the procedure of intraspinal injection and the presence of the neural stem cells in the spinal cords of ALS patients," said Jonathan Glass, MD, lead author of the publication. "We are encouraged by these results and have now advanced our trial to injections into the cervical spinal cord, targeting the motor neurons that control respiratory function." Dr. Glass is Professor of Neurology and Pathology at Emory University School of Medicine, as well as the Director of the Emory ALS Center.

"This important peer-reviewed publication reinforces our belief that we have demonstrated a safe, reproducible and robust route of administration into the spine for these spinal cord neural stem cells," said Eva Feldman, MD, PhD, Director of the A. Alfred Taubman Medical Research Institute and Director of Research of the ALS Clinic at the University of Michigan Health System. "The publication covers data up to 18 months out from the original surgery. However, we must be cautious in interpreting this data, as this trial was neither designed nor statistically powered to study efficacy." Dr. Feldman is senior author on the study, principal investigator (PI) of the ALS trial and serves as a consultant to Neuralstem as part of her University of Michigan activities.

"As this article points out, our experience in the lumbar spinal cord has been overwhelmingly positive," commented Karl Johe, PhD, study author and Neuralstem Chairman and Chief Scientific Officer. "We have already transplanted two patients in the cervical spinal cord, where we believe we can affect patients' lives the most by improving their breathing. We are in active discussions with the FDA to increase the number of cells and the number of injections as well."

"We wish to thank the teams at Michigan and Emory for the tireless efforts required to refine this breakthrough method of administration of our neural stem cells. We'd also like to thank the patients and families involved in the trial," said Richard Garr, Neuralstem CEO and President. "The progress we have made to date is both substantial, and a true team effort."

About the Study

Safety results were reported on the first 12 patients in an ongoing Phase I study to evaluate the safety of Neuralstem's spinal cord stem cells (HSSC's), as well as the transplantation technique, in the treatment of ALS (amyotrophic lateral sclerosis, or Lou Gehrig's disease).

Read more from the original source:
Neuralstem ALS Stem Cell Trial Interim Results Reported in the Journal, STEM CELLS

Arkansas State University-Newport will host a Bone Marrow Donor Drive on campus Thursday, March 29 from 10am until 7pm and Saturday, March 31 from 9am until 1pm in the Student/Community Center, Merchants & Planters Insurance and Investments room. A bone marrow transplant is a lifesaving treatment for people with leukemia, lymphoma and many other diseases. First, patients undergo chemotherapy and sometimes radiation to destroy their diseased marrow. Then a donor's healthy blood-forming stem cells are transfused directly into the patient's bloodstream, where they can begin to function and multiply. For a patient's body to accept these healthy cells, the patient needs a donor who is a close match. Seventy percent of patients cannot find a matching donor within their family and depend on the national registry to find an unrelated bone marrow donor. Even with a registry of millions, 6 out of 10 patients NEVER receive the lifesaving transplant they need. Donors of all ethnicities are needed to change this. To see if you can be a bone marrow donor and to read about the process of testing and donating, go to http://www.dkmsamericas.org and click on Get Educated.

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ASUN to host Bone Marrow Donor Drive