IRVINE, Ca.-- California's unprecedented stem cell research effort faces a tight timetable for making major progress in fulfilling promises to voters seven years ago, complicated by potential conflicts of interest, a blue-ribbon panel was told this morning.

David Jensen, editor of the California Stem Cell Report, made the comments to the Institute of Medicine panel looking into the performance of the $3 billion California Institute of Regenerative Medicine.

The panel's inquiry comes as the agency is re-evaluating its strategies as it faces loss of funding in about 2017.

Here is the full text of Jensen's statement.
Statement to IOM-CIRM Panel by California Stem Cell Report April 9, 2012

"

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IRVINE, Ca. – The Consumer Watchdog organization says that serious consideration should be given to whether the state should halt borrowing money to finance the $3 billion California stem cell agency.

The statement was prepared for delivery tomorrow here to a blue-ribbon Institute of Medicine panel evaluating the performance of the research effort, which was created by a ballot initiative in 2004. The agency's only real source of cash is bonds issued by the state, which means the agency will cost $6 billion including interest by end of its grant-making life in about 2017.

John M. Simpson, stem cell project director for Consumer Watchdog of Santa Monica, Ca., said that the political and scientific environment has changed substantially since 2004. The Bush Administration had restricted federal funding of hESC research then, causing an uproar in the scientific community. Funding has since been restored.

Simpson said the stem cell measure "made sense" seven years ago. He said the stem cell agency and its governing board "must recognize that the political, scientific and economic environment have dramatically altered since the passage of Proposition 71."

His statement continued,

"It is also appropriate to consider seriously whether issuing all $3 billion in authorized bonds is the correct policy in light of the new environment and economic realties facing the state."

Simpson was invited make his statement to the IOM panel, which is midway through its public process of looking into CIRM's operations. It is doing so at the behest of CIRM, which is paying the prestigious organization $700,000 to perform the work.

Simpson also made a number of recommendations for changes at CIRM, many of which would require a change in state law or passage of another ballot measure. Proposition 71, which created CIRM and altered the state Constitution, requires a super, super-majority vote (70 percent) by the legislature to make changes at CIRM.

The Consumer Watchdog proposals (full text below) include reducing the size of the 29-member board to 15, including public members on the board, reducing the super-majority requirement on board quorums to a majority, eliminating the controversial dual executive arrangement at CIRM, conducting grant reviews in public and publicly disclosing the financial interests of reviewers.Consumer Watchdog Statement to IOM-CIRM Panel April 9, 2012

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PR Web (press release)

Alltopics.com Offers Newest News Flashes about Biotechnology PR Web (press release) Alltopics.com has created a new section devoted to Biotechnology. The information, news and current articles are instantly available on Alltopics.com. Biotechnology.alltopics.com rates the issues by popularity. All the hot and current news, ... and more »

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By Ben Butkus

Stanford University researchers have published a method for using Fluidigm's digital PCR platform to conduct single-cell, real-time PCR to compare gene expression patterns of single cells.

The protocol is indicative of the increased use of Fluidigm's products for single-cell biology, an application area that the company has been heavily promoting over the past year.

In addition, the method may provide a powerful tool for understanding gene expression and differentiation in induced pluripotent stem cells and human embryonic stem cells for regenerative medicine, the researchers said.

In a paper published last week in Nature Protocols, researchers led by Joseph Wu, associate professor of medicine, cardiology, and radiology at Stanford University School of Medicine, described how they used Fluidigm's BioMark HD platform and Dynamic Array chips to analyze gene expression profiles of single iPSCs or hESCs approximately 11 hours after collection.

The team decided to publish the method after using it to conduct a study published last March in the Journal of Clinical Investigation that demonstrated how single-cell transcriptional profiling revealed heterogeneity in human iPSCs. "A lot of people asked us after that JCI paper how we exactly do this, so we decided to write a detailed protocol," Wu told PCR Insider.

Wu and colleagues began using Fluidigm's platform through the laboratory of fellow Stanford scientist Stephen Quake, a co-founder of the company and a co-author on the recent Nature Protocols paper.

According to Veronica Sanchez-Freire, a postdoc in Wu's lab and also a co-author on the paper, the group needed a tool to compare gene expression between individual cells in single colonies of iPSCs or hESCs with high sensitivity using a limiting amount of sample.

"We were interested in seeing how different gene expression could be in the cell depending on its position in the colony," Sanchez-Freire said. "We are looking at these iPS cells from different cell types and donors, and we always compare them to [human embryonic] stem cells, the gold standard but we also wanted to see how similar they are [to each other]."

Most traditional gene expression studies, using, for example, quantitative real-time PCR, extract RNA from a large population of cells for downstream expression analysis. "And we saw that when you do that, iPS cells and stem cells are very similar," Sanchez-Freire said. "But when you go to the single-cell level, we saw how the iPS cells are more heterogeneous than the ES cells."

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Stanford Group Publishes Fluidigm-Based Method for Gene Expression Profiling of Single Stem Cells

HOUSTON, April 12, 2012 /PRNewswire/ --Bellicum Pharmaceuticals, Inc. announced today the appointment of David M. Spencer, Ph.D. to Chief Scientific Officer. Dr. Spencer, a co-founder of Bellicum, joins the Company from Baylor College of Medicine where he was Vice Chairman of Pathology and Immunology.Dr. Spencer is the co-inventor of chemical induction of dimerization (CID), a technology used to control a wide range of biologic functions in cells, and applied in the Company's two lead product candidates.

(Photo: http://photos.prnewswire.com/prnh/20120412/NY85667 )

"We're pleased to have David join Bellicum and bring with him a singularly unique knowledge of the science behind our products," commented Tom Farrell, CEO of Bellicum Pharmaceuticals. "I look forward to his many contributions as we evaluate two new potentially breakthrough product candidates."

Dr. Spencer received The Michael E. DeBakey, M.D., Excellence in Research Award from Baylor College of Medicine in 2007 for his work developing a novel immune therapy-based approach to treating cancer, which relies on a small-molecule, CID, to improve dendritic cell function. In one iteration, Dr. Spencer's team used CID technology, which he co-invented, to create a much more potent vaccine against poorly immunogenic self-peptides. Dr. Spencer also developed a series of state-of-the-art, non-immunogenic suicide genes for gene therapy, which utilize endogenous caspase family proteases and CID technology. These inducible caspases are likely to become increasingly important as a safety switch for retrovirus-based gene therapy and cellular therapies, in general. This technology is the basis of two Bellicum clinical programs, including CaspaCIDe for the management of graft-versus-host disease (GVHD).

Phase 1 results from an ongoing clinical trial of CaspaCIDe were published in the New England Journal of Medicine in November of last year. The study reported that the "suicide gene" effectively caused the rapid and complete reversal of GVHD in acute leukemia patients who underwent stem cell transplant.

Dr. Spencer earned his Ph.D. from the Massachusetts Institute of Technology and completed his postdoctoral degree at Stanford University.

About Bellicum Pharmaceuticals

Bellicum Pharmaceuticals, Inc. is developing clinical applications of chemical induction of dimerization (CID), a drug-based remote control technology that extends the physician's reach beyond the point at which a treatment has been administered. Bellicum's mission is to leverage this smart technology to bring safe, effective, innovative cell therapies to market for patients with serious and life threatening diseases. The company's DeCIDe vaccines are designed to kill targeted cells by inducing a potent, durable, fully activated antigen-specific T cell immune response. Lead product BPX-101, an autologous DeCIDe vaccine, is in clinical development for patients with metastatic castrate resistant prostate cancer (mCRPC). CaspaCIDe is a cell therapy safety switch, permitting the rapid elimination of cells in the event of toxicity. CaspaCIDe DLI is a donor lymphocyte infusion administered following a hematopoietic stem cell transplant, in which the safety switch may be activated to resolve graft-versus-host disease (GVHD). For more information, visit http://www.bellicum.com

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Bellicum Appoints Baylor College of Medicine's David M. Spencer as Chief Scientific Officer

IRVINE, Calif.--(BUSINESS WIRE)--

California Stem Cell, Inc. (CSC)s Hans S. Keirstead, Ph.D. will speak at todays Global Emerging Leaders Forum in New York City, participating in a panel of the worlds leading innovators, philanthropists, and business thought-leaders who have gathered to discuss global issues. This symposium is the latest in a series of thought leadership and panel discussion appearances by CSC team members in recent months.

The NYC-based Global Emerging Leadership Forum was founded in 2011 to support emerging professionals through the discussion of the top social and economic issues of today, as well as emerging trends of the future. Dr. Keirstead will speak at 1pm in New York Citys Kaufmann Concert Hall, joining a diverse panel of influential and forward-thinking leaders in their respective fields. Attendees will gain valuable insight into the future of global society, global citizenship, corporate responsibility, and the politics of being an emerging global leader.

In February of this year, Dr. Keirstead presented at Singularity Universitys FutureMed event Exploring the Future of Healthcare. He delivered a presentation highlighting the powerful potential uses of stem cells for spinal cord injury and beyond. More recently, California Stem Cells Gabriel Nistor, M.D. participated in an Institute of Medicine (IOM) hosted review of the California Institute of Regenerative Medicine (CIRM)s programs, operations, strategies, and performance.

Details of California Stem Cell pubic speaking appearances are at: http://californiastemcell.com/press_cal

More information about the Global Emerging Leadership Forum: http://www.emergingleadersnyc.com/

More information about FutureMed: http://futuremed2020.com/

About California Stem Cell

California Stem Cell Inc. (CSC) is an Irvine, CA based company with proprietary methods to generate human stem cell lines, expand them to clinically and commercially useful numbers, and differentiate them at extremely high purity using fully-defined, proprietary media and GMP processes. CSC is able to supply its human cell populations to companies and institutions worldwide for use in the development of therapies, efficacy screening or the creation of toxicity profiles for candidate drugs, and experimental research tools.

CSC is currently focused on the development of stem cell based therapies for spinal muscular atrophy (SMA), amyotrophic lateral sclerosis (ALS, or Lou Gehrigs Disease), and metastatic cancers.

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California Stem Cell Chairman Hans Keirstead Speaks at Prominent Global Emerging Leadership Forum

AUSTIN - The Texas Medical Board Friday approved rules regulating adult stem cell therapy, concerned that the proliferation of the experimental treatment constitutes "an emergency state."

Despite opposition from some board members concerned that its action could wind up putting more patients in danger of harm from the unproven, unlicensed therapy, the board approved a policy that allows doctors to use it as long as they get the patient's consent and the approval of a review board that evaluates clinical research for safety. The therapy has been in the news since Gov. Rick Perry received it for an ailing back last year.

"We know this is far from a perfect policy, but our hope is that this affords people in Texas seeking this therapy some protection," said Dr. Irwin Zeitler, the board president. "The wheels of the federal government move so slowly - we're not willing to wait to protect our patients."

The board, which voted 10-4 to approve the regulations, promised it would work to improve them, pledging to bring revisions to its June meeting. No date has been set for when the policy approved Friday will take effect, but it will be at least 30 days, board staff said.

The policy, thought to be the first of its kind, has drawn criticism nationally and internationally for appearing to circumvent the Food and Drug Administration and for making the therapy commercially available before it has been proven safe and effective. The treatment is not approved by the FDA and patients typically must pay tens of thousands of dollars for it.

Adult stem cells, which multiply to replenish dying cells, have long been used to treat leukemia and other cancers, but in the last decade they have shown promise for tissue repair in many other diseases. Less versatile than embryonic stem cells, they are championed by many as a more ethical alternative because no embryo is destroyed.

But they are mostly in early-stage clinical trials and considered five to 10 years away from FDA approval.

The therapy gained national attention after it was revealed Perry received it last summer. Houston surgeon Stanley Jones injected the governor during his July 1 back surgery and intravenously in follow-up appointments.

todd.ackerman@chron.com

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Medical board approves controversial adult stem-cell rules

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A little more than three years ago a medical team from Berlin published the results of a unique experiment that astonished HIV researchers. The German group had taken bone marrow--the source of the body’s immune cells--from an anonymous donor whose genetic inheritance made him or her naturally resistant to HIV. Then the researchers transplanted the cells into a man with leukemia who had been HIV-positive for more than 10 years. Although treatment of the patient’s leukemia was the rationale for the bone marrow transplant therapy, the group also hoped that the transplant would provide enough HIV-resistant cells to control the man’s infection. The therapy exceeded the team’s expectations. Instead of just decreasing the amount of HIV in the patient’s blood, the transplant wiped out all detectable traces of the virus from his body, including in multiple tissues where it could have lain dormant. The German researchers were so surprised by the spectacularly positive results that they waited nearly two years before publishing their data.

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Antidepressants restore well-being to many people, but sometimes at the cost of such side effects as weight gain or loss of interest in sex. And these side effects can be just part of the frustration. As Robin Marantz Henig wrote in " Lifting the Black Cloud ," in the March issue of Scientific American , the drugs that have long dominated the market--the selective serotonin reuptake inhibitors (SSRIs) and the serotonin and norepinephrine reuptake inhibitors (SNRIs)--"do not help everyone and eventually fail in more than a third of users. A pill that seems to be working today might well stop helping tomorrow. And the drugs can take several weeks to start having a marked effect." Equally disturbing, some major pharmaceutical houses, such as GlaxoSmithKline , are pulling back from developing psychiatric medicines.

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A young woman who calls herself blue­berryoctopus had been taking anti­depressants for three years, mostly for anxiety and panic attacks, when she recounted her struggles with them on the Web site Experience Project. She said she had spent a year on Paxil, one of the popular SSRIs (selective serotonin reuptake inhibitors), but finally stopped because it destroyed her sex drive. She switched to Xanax, an ­antianxiety drug , which brought back her libido but at the cost of renewed symptoms. Then Paxil again, then Lexapro (another SSRI), then Pristiq, a member of a related class of antidepressants, the SNRIs (serotonin and norepinephrine reuptake inhibitors). At the time of the post, she was on yet another SSRI, Zoloft, plus Wellbutrin (a cousin of SNRIs that affects the activity of dopamine as well as norepinephrine), which was intended to counteract the sexual side effects of Zoloft. “I don’t notice much of a difference with the Wellbutrin, but I’m on the lowest dose now,” she wrote. “I’m going back to my psychiatrist next week, so maybe he’ll up it. Who knows.”

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Via Scoop.it – inPharmatics

 Quintiles and the American Diabetes Association announced a strategic agreement in which Quintiles’ Digital Patient Unit will provide the Association’s millions of website users access to Quintiles’ medication monitoring service.

The Association’s constituents who opt in for the service will receive free safety checks of their medications to identify potential interactions and other risk factors, which are already provided to the 2.5 million registered users of Quintiles’ http://www.MediGuard.org. Registrants will also be eligible to participate in select direct-to-patient programs to benefit their medical conditions and advance global diabetes patient care.

The Association’s constituents may opt in to this service from the Association’s website http://www.Diabetes.org

Via http://www.quintiles.com

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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:
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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.

Source:
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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.

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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...

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