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Category Archives: Stem Cell Therapy

California Stem Cell Agency Seeking More Help on Push for Cures

Posted: February 12, 2012 at 4:55 pm


The California stem cell agency has decided to put more manpower behind its push to drive therapies into the clinic.

The agency this week posted an opening for a senior development officer, who would be paid up to $226,108 annually.

The new hire would have a strong background in industry and an advanced degree. The job posting calls for a minimum of 10 years experience and expertise in "in developing, designing and assessing preclinical and early clinical safety and efficacy, within regulatory framework."

The position reports directly to Ellen Feigal, CIRM's VP for research and development. The job description says the person would "directly interact with investigators on CIRM’s clinically applicable research programs to help provide product development guidance from preclinical, manufacturing, and first in human to early phase clinical regulatory perspectives."

The $3 billion agency, which has yet to produce the cures promised to voters in 2004, is re-examining its strategies, particularly with an eye to backing a product that would actually be used on patients.

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A $25 Million 'Cautionary Tale': CIRM and Geron

Posted: February 12, 2012 at 4:55 pm


California's $25 million venture into the financing of what once was the first hESC clinical trial in the nation serves as a "cautionary tale" for states that use taxpayer dollars to boost technology, according to a New York public policy expert.

The comments by James W. Fossett, who directs the Rockefeller Institute of Government health, Medicaid studies and bioethics research programs, come midway through an Institute of Medicine examination of the performance of the $3 billion California stem cell agency. Its directors are also currently involved in a revision of of the agency's strategic plan.

Writing on the Rockefeller Institute's web site, Fossett analyzed the fallout from Geron's decision last fall to abandon its clinical trial after it determined the effort was too costly. Just three months earlier, the California stem cell agency had signed a $25 million loan agreement with Geron.

Fossett said,

"For the many states using taxpayer dollars to stimulate jobs in a wide range of technologies, this is a cautionary tale."

He wrote,

"(Geron's) decision has attracted widespread opprobrium from bloggers, stem cell advocacy groups, bioethicists and more than a few newspaper columnists — one blogger called it the 'stem cell misstep of the year.'

"This disapproval has also spilled over onto the California Institute for Regenerative Medicine (CIRM) — the state agency that operates the $3 billion California stem cell research program."

He continued,

"CIRM is coming under considerable political pressure to produce viable therapies to justify the large amount of money it’s been spending, and some have interpreted its hasty involvement with Geron as motivated by the desire to have something concrete to brag about."

Fossett said, however,

"There may be less here, however, than all the rhetoric would suggest. While Geron’s trial had acquired a lot of symbolic baggage because of its status as a 'first,' the decision to pull the plug only reflects one decision by one company about one therapy. The company was looking at having to spend a lot more money over a long period to get the therapy through the clinical trials process for what would likely be a small return.

"The political difficulties that Geron’s withdrawal have caused CIRM, however, have lessons for states proposing to spend significant amounts on biotechnology and other research in hopes of stimulating economic growth. Spending money on research intended to develop new therapies is highly risky. The science is difficult, expensive and evolves at a rapid pace that is difficult to integrate with earlier understandings. There are considerable cultural, political and financial obstacles to getting new products out of the lab and into the clinic."

Fossett suggested several approaches that might ease some of the risks. He cited the 2010 CIRM external review report that recommended adjusting priorities. Fossett said,

"States might experiment with providing more support to biotech companies and entrepreneurs with successful track records and less to basic research, which could increase the odds of short-term success."

At last month's CIRM board meeting, directors engaged in what CIRM is inclined to call a robust discussion of priorities for basic research vs. more focused funding for driving therapies into the clinic.

Fossett cited another external review recommendation that CIRM seek out research with a "high probability of clinical success that could 'come from either inside or outside CIRM-funded research, perhaps out of industry and even from outside of California.'" 

Fossett additionally mentioned the use of venture capital techniques that would give states "a chance to participate in the (financial) benefits of successful therapies."

Nonetheless, he wrote,

"Most products and most companies will likely continue to fail."

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Last Public Hearing in California for CIRM Performance Evaluation Scheduled for April

Posted: February 12, 2012 at 4:55 pm


The blue-ribbon Institute of Medicine panel looking into the performance of the $3 billion California stem cell agency will hold its final public hearing within the state on April 10 at UC Irvine.

No details have yet have been posted online about the matters to be discussed or the witnesses to be heard. So far, the panel has not heard publicly from a single independent witness. The panel's final report and recommendations are scheduled to be released this fall, following its only remaining public meeting, scheduled for Washington, D.C.

The IOM has also posted a list of documents provided to the panel during a closed session last month in South San Francisco, its only public hearing in California so far. Virtually all of documents came from the CIRM itself, which is paying the IOM $700,000 for the study.

One exception was the 2009 report by California's good government agency, the Little Hoover Commission.

In its report, the commission concluded,

"CIRM’s governance structure is not adequate to protect taxpayers’ interests or serve its own ambitious goals."

The commission recommended a number of changes to strengthen CIRM's governance structure, improve accountability and reduce conflicts of interest. They included restructuring and reducing the size of the 29-member board and eliminating the controversial dual executive arrangement at CIRM.

CIRM strongly resisted nearly all of the recommendations, some of which would have required legislative or voter approval. As of last week, the IOM panel had not contacted the Little Hoover Commission for testimony.

(Click on the "closed session summary" at this location to find the information about the documents that were provided.)

The IOM also has posted a list of topics discussed by its panel in closed session last month. They included a follow-up on bias and conflicts of interest, committee composition, discussion of the previous day's hearing and discussion of data needs.

The April meeting is being held at the Beckman Center at UC Irvine, which has received $77 million from CIRM. The agency's board of directors includes two top academicians from UC Irvine: Oswald Steward, who serves on the board as a patient advocate and is director of the Reeve-Irvine Research Center for Spinal Cord Injury, and Susan Bryant, associate executive vice chancellor for research at Irvine and who serves on the CIRM board as in her capacity as an executive officer from a UC campus with a medical school.

 

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Stem Cell Therapy for Arthritis Osteoarthritis Treatment new – Video

Posted: February 9, 2012 at 10:42 pm

05-02-2012 11:57

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Ivo Petrov, MD [Combined CCSVI

Posted: February 9, 2012 at 8:57 am

02-02-2012 09:26 CCSVI Symposium 2011 - Second Annual Meeting Crowne Plaza Hotel Times Square, Manhattan New York, NY July 15-17, 2011 http://www.ccsvicare.com Combined CCSVI and Stem Cell Treatments Ivo Petrov, MD Cardiology Department Chief Tokuda Hospital Sofia, Bulgaria [39 out of 46 videos]

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L. Grozdinski, MD [Stem Cell Therapy | CCSVI Symposium 2011 – 38 of 46] – Video

Posted: February 8, 2012 at 4:28 pm

02-02-2012 08:37 CCSVI Symposium 2011 - Second Annual Meeting Crowne Plaza Hotel Times Square, Manhattan New York, NY July 15-17, 2011 http://www.ccsvicare.com Stem Cell Therapy L. Grozdinski, MD Angiology Sector Chief Tokuda Hospital Sofia, Bulgaria [38 out of 46 videos]

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L. Grozdinski, MD [Stem Cell Therapy | CCSVI Symposium 2011 - 38 of 46] - Video

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Stem Cell Treatment Paraplegic – Video

Posted: February 7, 2012 at 10:10 pm

31-01-2012 21:38 http://www.StemCellTreatment.org Jaime Chiriboga was an active adult and ended up in a motorcycle accident and left a quadriplegic. Before receiving stem cell treatment he could not move his limbs. After his stem cell therapy he was able to move his limbs and got back almost 100% sensitivity in his body! We are very happy with the results and even more important Jaime is happy with his results! Please look at our website for more information!

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Strategic Analysis of the European Stem Cell Research Tools Market

Posted: February 7, 2012 at 3:38 am

NEW YORK, Feb. 6, 2012 /PRNewswire/ -- Reportlinker.com announces that a new market research report is available in its catalogue:

Strategic Analysis of the European Stem Cell Research Tools Market

http://www.reportlinker.com/p0769016/Strategic-Analysis-of-the-European-Stem-Cell-Research-Tools-Market.html#utm_source=prnewswire&utm_medium=pr&utm_campaign=Biological_Therapy

The primary objective of this study is to measure brand perceptions of tools and technologies currently at the forefront of stem cell research: bio-imaging and microscopy, cell biology tools, immunochemicals, molecular biology tools, and protein biochemistry tools. The study also looks into the usage pattern of these tools. An extensive end-user survey was conducted with 25 laboratories to assess the requirement and usage of tools. Insightful review of key industry drivers, restraints and challenges have been discussed. Leading market players and the prevailing competitive landscape for each of the segments have been discussed.

Table of ContentsExecutive Summary 10-19

Executive Summary 11-13

Market Engineering Measurements 14

Scope & Objective 15

Technologies Employed for Stem Cell Research 16

Stem Cell Research Protocol 17

CEO's Perspective 18

Exchange Rates 19

Market Overview 19

Market Overview - Definitions 20-24

Market Overview 25-26

Market Overview - Segmentation 27

European Stem Cell Research End User Trends 28

Stem Cell Research Workflow 29

Purpose of Research and Profile of Respondents 30

Stem Cells and Tools Usage Trends 31-33

Tools and Equipment Budget for Stem cell research Tools 34

Market Outlook 35

Market Age 36

Funding for Stem Cell Program 37-39

External Challenges: Drivers and Restraints 40

Industry Challenges 41-45

Drivers & Restraints 46

Key Market Participants 52

Product Line Analysis 59

Forecasts and Trends -Total Stem Cell Research Tools Market 70

Forecast Assumptions 72

Revenue Forecasts 73-74

Bio Imaging Tools In Vivo and In Vitro Segment Breakdown 75

Revenue Forecasts 77-78

Market Share Analysis 79

Cell Biology, Protein Biochemistry, and Immunochemical Tools Segment Breakdown 80

Revenue Forecasts 82-83

Market Share Analysis 84

Molecular Biology Tools Segment Breakdown 85

Revenue Forecasts 87-88

Market Share Analysis 89

Demand Analysis 90

Bioimaging Tools In Vivo and In Vitro 92

Cell Biology Tools 93

Demand Analysis Molecular Biology Tools 94

Protein Biochemistry Tools 95

Immunochemical Tools 96

European Stem Cell Research Centers 97-99

SWOT Analysis 101-102

Strategic Recommendations and Conclusions 103-106

The Last Word 107

Appendix 110

List of Figures

Total Stem Cell Research Tools Market: Market Overview, Europe, 2010 25Total Stem Cell Research Tools Market: Tools Usage Trends, Europe, 2010 32-33Total Stem Cell Research Tools Market: Market Outlook, Europe, 2010 35Total Stem Cell Research Tools Market: R&D Programs Funded, Europe, 2006–2013 37Total Stem Cell Research Tools Market: Bioimaging Tools In Vivo and In Vitro End User Analysis, Europe, 2010 92Total Stem Cell Research Tools Market: Cell Biology Tools End User Analysis, Europe, 2010 93Total Stem Cell Research Tools Market: Molecular Biology Tools End User Analysis, Europe, 2010 94Total Stem Cell Research Tools Market: Protein Biochemistry Tools End User Analysis, Europe, 2010 95Total Stem Cell Research Tools Market: Immunochemical Tools End User Analysis, Europe, 2010 96

List of Charts

Percent Revenue Breakdown Total Stem Cell Research Tools Market: Europe, 2010 27

Percent Revenue Breakdown Total Stem Cell Research Tools Market: Europe, 2017 27

Total Stem Cell Research Tools Market: Purpose of Research and Profile of Respondents, Europe, 2010 30

Total Stem Cell Research Tools Market: General and Primary Focus on Stem Cell Research, Europe, 2010 31

Total Stem Cell Research Tools Market: Lab Budgets, Europe, 2010 34

Total Stem Cell Research Tools Market: Lab Budget Estimations, Europe, 2011 34

Total Stem Cell Research Tools Market: Segment Life Cycle Analysis, Europe, 2010 36

Total Stem Cell Research Tools Market: Industry Challenges, Europe, 2011–2017 41

Total Stem Cell Research Tools Market: Drivers and Restraints, Europe, 2010 46

Total Stem Cell Research Tools Market: Product Line Analysis, Europe, 2010 59-67

Market Overview Total Stem Cell Research Tools: Europe, 2010 71

Total Stem Cell Research Tools: Revenue Forecast, Europe, 2010–2017 73

Market Overview Bioimaging In Vivo and In Vitro Market: Europe, 2010 76

Bioimaging Tools In Vivo and In Vitro Market: Revenue Forecasts, Europe, 2010–2017 77

Bioimaging In Vivo and In Vitro Market: Market Share Analysis, Europe, 2010 79

Market Overview Cell Biology, Protein Biochemistry, and Immunochemical Tools Market: Europe, 2010 81

Cell biology, Protein Biochemistry, and Immunochemical Tools Market Revenue Forecasts, Europe, 2010–2017 82

Cell Biology, Protein Biochemistry, and Molecular Biology Tools Market: Market Share Analysis, Europe, 2010 84

Market Overview Molecular Biology Tools Market: Europe, 2010 86

Molecular Biology Tools Market: Revenue Forecasts, Europe, 2010–2017 87

Molecular Biology Tools Market: Market Share Analysis, Europe, 2010 89

Total Stem Cell Research Tools Market: Research Centers and Universities, Europe, 2010 98-100

Total Stem Cell Research Tools Market: SWOT Analysis, Europe, 2010 102

To order this report:Biological Therapy Industry: Strategic Analysis of the European Stem Cell Research Tools Market

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Benitec Biopharma and Medistem Technologies Successfully Combined in Preclinical Stem Cell Therapy for Rheumatoid …

Posted: February 7, 2012 at 3:38 am

SYDNEY, AUSTRALIA and SAN DIEGO, CA--(Marketwire -02/06/12)- Benitec Biopharma (ASX: BLT.AX - News) and Medistem (Pinksheets: MEDS.PK - News) announced today the successful treatment of rheumatoid arthritis in preclinical models using Benitec Biopharma's patented gene silencing technology applied to stem cell-derived immune system cells called dendritic cells. The studies, which were led by Dr. Wei-Ping Min of the University of Western Ontario, were published in the "Journal of Translational Medicine" on the 31st January 2012(1). Benitec Biopharma's CEO Dr Peter French and Medistem's scientist Dr Rosalia De Nochea Champion were co-authors on the paper.

"In 2003, Dr Wei-Ping Min's group, together with Medistem's CEO Dr Thomas Ichim, were the first to apply the technology of RNA Interference to the immune system, by silencing the autoimmune disease-associated gene IL-12p35(2)," said Dr. Peter French. "In the current paper, Dr. Min expanded these studies to a disease-relevant model, and using stem cell-derived dendritic cells was capable of developing promising preclinical data relevant to rheumatoid arthritis."

By specifically "silencing" various genes, Benitec Biopharma's ddRNAi technology is capable of modulating stem cells outside of the body, in order to endow them with new desired therapeutic activities. The first clinical study which combined stem cell therapy with Benitec Biopharma's ddRNAi technology was in a trial of AIDS-related lymphoma patients, the results of which were published in 2010 and showed the safety and feasibility of the approach(3).

In the current paper, ddRNAi was used to generate dendritic cells that acted as a "tolerogenic vaccine," which specifically blocked the pathological immune response in rheumatoid arthritis, without blocking healthy immune responses. It is contemplated that by blocking pathological immunity, ddRNAi-modified stem cell-based therapies, such as those being developed by Medistem, could provide novel treatment and curative approaches to tissue that has been damaged. In the case of rheumatoid arthritis the tissue would be cartilage and synovium.

"Medistem is the first company to take a stem cell from discovery to clinical trials in the short span of four years," said Dr. Weiping Min. "This is a unique example of merging basic research, as performed in my laboratory with the translational expertise of Dr. Ichim's company."

Medistem has previously published work in the area of rheumatoid arthritis, however the company's main efforts are currently focused on heart failure, for which it has started the RECOVER-ERC 60 patient double blind, dose escalating, placebo controlled trial using its Endometrial Regenerative Cell (ERC) universal donor stem cell. The company also has a critical limb ischemia trial recently approved by the FDA.

"In our opinion the Benitec Biopharma technology platform is the only means of inducing the stable expression of gene silencing in a stem cell," said Dr. Ichim, CEO of Medistem. "Given that Benitec Biopharma has pioneered ddRNAi for human therapy, and has been involved in applying it to stem cell manipulation, we are eager to continue our collaborations and finding means of leveraging the unique properties of the ERCs with the transformational technology of ddRNAi to develop novel cell therapies for a range of chronic life-threatening human diseases."

"Benitec Biopharma and Medistem are in discussions as to how to advance this work both in rheumatoid arthritis and in a range of other disease states that would lend themselves to such a novel combination therapy," Dr. French added.

About Medistem
Medistem Inc. is a biotechnology company developing technologies related to adult stem cell extraction, manipulation, and use for treating inflammatory and degenerative diseases. The company's lead product, the endometrial regenerative cell (ERC), is a "universal donor" stem cell being developed for critical limb ischemia and heart failure. A publication describing the support for use of ERC for this condition may be found at http://www.translational-medicine.com/content/pdf/1479-5876-6-45.pdf.

Cautionary Statement This press release does not constitute an offer to sell or a solicitation of an offer to buy any of our securities. This press release may contain certain forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking statements are inherently subject to risks and uncertainties, some of which cannot be predicted or quantified. Future events and actual results could differ materially from those set forth in, contemplated by, or underlying the forward-looking information. Factors which may cause actual results to differ from our forward-looking statements are discussed in our Form 10-K for the year ended December 31, 2007 as filed with the Securities and Exchange Commission.

About Benitec Biopharma

Benitec Biopharma Ltd is developing novel treatments for chronic and life-threatening conditions based on targeted gene-silencing activity using a transformational technology: DNA-directed RNA interference (ddRNAi) -- sometimes called expressed RNAi. The technology's potential to address unmet medical needs and to cure disease results from its demonstrated ability to permanently silence genes which cause the condition. Importantly, this technology's target gene and related gene pathways will rarely have presented as a therapeutic avenue for research for the traditional small molecule agents, currently accounting for the majority of today's pharmaceutical products.

Benitec now either owns or exclusively licenses from CSIRO more than 40 granted or allowed patents in the field of RNA interference for human therapeutic applications. Patents have been granted in key territories such as the USA, the UK, Japan, Europe, Canada and Australia. In addition, Benitec has almost 50 patent applications pending for which it is the owner or exclusive licensee from CSIRO, and has further intellectual property under development as a result of its pipeline program.

Founded in 1997 and trading publicly since 2001, Benitec Biopharma is listed on the Australian Securities Exchange (ASX) under the symbol "BLT." Benitec aims to deliver a range of novel ddRNAi-based therapeutics to the clinic in partnership with the pharmaceutical industry. In addition to its focused R&D strategy in infectious diseases, cancer and chronic cancer-associated pain, Benitec Biopharma is pursuing programs with licensees.

References
(1) Li, R et al. Gene silencing of IL-12 in dendritic cells inhibits autoimmune arthritis. "Journal of Translational Medicine" 2012, 10:19 doi:10.1186/1479-5876-10-19.
(2) Hill JA et al. Immune modulation by silencing IL-12 production in dendritic cells using small interfering RNA. "The Journal of Immunology," 2003, 171: 691-696.
(3) DiGiusto DL et al. RNA-based gene therapy for HIV with lentiviral vector-modified CD34+ cells in patients undergoing transplantation for AIDS-Related Lymphoma. "Science Translational Medicine," 2(36): 36ra43.

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Benitec Biopharma and Medistem Technologies Successfully Combined in Preclinical Stem Cell Therapy for Rheumatoid ...

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$30 million donation from Boris family will help McMaster turn stem cell research into therapy

Posted: February 6, 2012 at 11:09 am

McMaster University is on its way to moving stem cell research “from the bench to the bedside” thanks to a $30 million boost from a local family.

The Marta and Owen Boris Foundation made the large donation to establish a human stem cell therapy centre and a unique clinic for patients with complex health conditions.

Owen, the founder of Mountain Cablevision, was in talks with McMaster about investing in their work before he died last April. His children and wife contacted the university a month later and carried out his vision, firming up their commitment last November.

The Boris Family Centre in Human Stem Cell Therapies will be developed as part of the McMaster Stem Cell and Cancer Research Institute using $24 million of the funds.

“It’s getting over that chasm from the bench to the bedside that this (donation) is going to allow us to do,” the institute’s scientific director Dr. Mick Bhatia said.

The centre will give scientists the resources to focus on converting McMaster’s breakthroughs — such as the ability to make blood or types of neural cells with stem cells — into clinical applications through investigative trials, Bhatia said.

“In the absence of this donation, I think we would not be in the position to move our discoveries forward,” he said. “This is a huge leg-up. I’m hoping what it’s really going to do is have a ripple effect to change the way McMaster views translating basic science.”

They plan on developing human stem cell therapies targeting leukemia and possibly neural diseases such as Alzheimer’s and Parkinson’s, said Dr. John Kelton, dean and vice-president of the faculty of health sciences.

The remaining $6 million will go toward building a clinic in partnership with Hamilton Health Sciences (HHS) where patients with complex health issues can see specialists and undergo tests in one visit.

This was a result of his parents’ frustrating experiences in recent years with co-ordinating specialists and getting diagnostic testing done in Canada, said Owen’s son, Les Boris.

They ended up going to Mayo Clinic in Rochester, Minn., where they had a case manager who co-ordinated their appointments with specialists and made sure testing was done in-house, he said. “They like the idea of a one-stop shop … (My father) said: ‘This is the kind of model we need here in this country.’”

Kelton said the medical clinic, which will be built in the university’s medical centre, will look for rapid turnaround times and avoid duplications of lab tests. McMaster and HHS will also evaluate the clinic’s success and keep an electronic medical record that patients could access, he said.

Kelton and Owen met three years ago and had their last meeting about the projects three days before the philanthropist died.

Owen had worked on the Avro Arrow and was frustrated with Canada’s lost opportunity of making jet planes for the world, Kelton said.

“He said, ‘Tell me about some opportunities (that) – if we invested in it – could make Hamilton and McMaster world-class. What are some of the areas like an Avro Arrow?’”

The funds for the human stem cell therapy centre will go toward hiring a research chair in blood stem cells and a research chair in neural stems cells, setting up several fellowships and technician positions, and building the facility.

Bhatia says they hope to bring in new scientists and fellows by the early summer.

The Boris family previously donated $6 million to addiction research at St. Joseph’s Healthcare for its new mental health hospital being built on the Mountain and another $5 million for the da Vinci SI Surgical Robotic System.

“We’re very appreciative that we’re in a position to be doing something for the community,” Les said. “And it was the community that put us in the position to do this.

dawong@thespec.com

905-526-2468 | @WongatTheSpec

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