StemCell Therapy

The California stem cell agency is proposing to pump $30 million into new research involving reprogrammed adult stem cells and another $27 million into fresh efforts to speed development of clinical therapies.

In a memo prepared for the CIRM directors meeting next week in Los Angeles, the agency's staff said the $30 million effort could generate "disease-in-a-dish models" that "have the potential to make drug discovery faster, more efficient and more personalized to individual patients."

The "disease-in-a-dish" plan was dubbed a "human pluripotent stem cell (hPSC) initiative" by the staff. The goal is to generate high quality stem cell-based tools for use by the researchers and drug developers.

The proposal includes four elements, one of which is collaboration with the NIH to develop cell lines from patients with Huntington’s Disease, Parkinson’s Disease, and Amyotrophic Lateral Sclerosis. No cost was specified on that effort. Also recommended to directors was a $4 million disease line award round, a $16 million core hiPSC derivation round and a $10 million stem cell bank round. The RFAs would go out in May of next year with funding expected early in 2013.

The staff memo on the initiative did not mention human embryonic stem cells, but a spokeswoman for the agency said they were not excluded from the effort.

The other new grant proposals up next week grew out of a recommendations from a blue-ribbon panel that CIRM organized last year to examine its operations. One element in the plan is a $12 million "bridging fund" that would apply only to current CIRM-funded projects in three areas: disease team grants, some early translational projects and clinical development projects. The bridging fund would provide up to $3 million for up to one year for each recipient, if CIRM President Alan Trounson approves the project. Trounson would be assisted in his evaluation by staff and external consultants, if necessary.

The second part of the response to the review panel's finding is an "external innovation initiative" to support collaborative efforts of CIRM grantees to work with teams that CIRM said are "making extraordinary progress outside California."

The $15 million program would provide awards as often as two times a year. The maximum amount on each award was not specified.

Ellen Feigal, CIRM's vice president of research and development, said in a memo to directors that examples of potential projects included collaborative efforts with the NIH and work with the Harvard Stem Cell Institute and its disease-focused programs.

Some of the latest CIRM initiatives are open to biotech businesses. Others are open only to non-profit or academic researchers.

(Editor's note: An earlier version of this item did not include the sentence dealing with human embryonic stem cells.)

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Could this be a trend?

The California stem cell agency, working under the direction of a new chairman, has once again posted a handsome amount of background material well in advance of its regular board meeting – in this case the Dec. 8 session at Cedars-Sinai in Los Angeles.

For the past several years, the agency has failed to post in a timely fashion important information on many decisions to be made by agency directors, making it virtually impossible for interested parties to plan to attend meetings or prepare thoughtful suggestions or recommend possible changes.

That situation has begun to change under Chairman Jonathan Thomas, a Los Angeles bond financier, who controls the board agenda and who was elected to his post at the end of June. In August, the agency also posted in a timely fashion a healthy dollop of information on matters to come before the board.

For December's meeting, the agenda contains links to information on a proposed $5.6 million recruitment award to lure a star researcher to the Golden State, an update on CIRM's proposed changes in its strategic plan, two new initiatives totalling $27 million that would accelerate progress to the clinic, grant administration changes that could affect the hundreds of CIRM grant recipients and proposed new scientific members for the group that makes the de facto decisions on which scientists receive CIRM cash.

We will have more on the details of all this later, but readers who have a special interest might want to dip in early. All the background information can be found via the agenda, which also says a remote site in San Francisco will be available for participation of those who cannot make it to Los Angeles.

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From Canada last week came a stem cell "reality check" that pulled together a professional football quarterback, a Yankee baseball pitcher, a Republican presidential hopeful and Geron.

Timothy Caulfield, U. of Alberta Photo

What do they all have in common? Stem cell therapy, answered Timothy Caulfield, a Canadian academic, writing on the Canadian version of the Huffington Post. Declaring that stem cell treatments are being ballyhooed as a "miracle cure" and "elixir of life," Caulfield wrote,

"But does it actually work? I think not -- at least not yet."

Caulfield is not one of your stereotypical opponents of stem cell research. In fact, he describes himself as a "believer" in the likelihood of development of effective stem cell therapies. Caulfield also springs from a deep academic background. He is research director of the Health Law Institute at the University of Alberta and has published a plethora of scholarly articles related to stem cell research.

Caulfield wrote that Geron's abandonment of hESC research "underscores the cavernous gap between the well-publicized (and completely legitimate) promise of stem cell research and actual, efficacious, therapies."

He said the California company's decision "generated both shock and anger. And for the patients hoping for a near-future cure, it was nothing less than heartbreaking."

Caulfield continued,

"Not only did the company decide to stop this particular trial, it decided to get out of the field of stem cell therapies altogether. So definitive was the decision that Geron gave back millions of public research dollars(to the California stem cell agency)."

Caulfield warned, however,

"We need to be careful not to over-interpret the Geron pull out. This is one company and one trial. There are now a few other clinical experiments in the pipeline (emphasis on a few), such as one to treat a form of blindness. And we must remember that not all things that are called 'stem cell therapies' are the same. "

Caulfield continued with his "reality check,"

"First, ignore the hype. I believe there is little evidence that any of the often advertised stem cell therapies, embryonic or otherwise, work. Yes, there are a handful of decades-old treatments ….

"(Peyton) Manning, (Bartolo) Colon and (Rick)Perry may have had a positive experience (the placebo effect is a powerful thing, after all), but, to date, I believe good clinical evidence simply does not exist.

"Second, despite the hope of many, it isn't going to be easy to make money off stem cell research -- at least with a treatment that is scientifically legitimate, appropriately tested and approved by the relevant regulatory agencies (three characteristics missing from most of the stem cell therapies currently offered in clinics around the world). "Economic growth has often been one of the ways that the huge public investment in stem cell research has been justified. Just a few weeks ago, for example, the UK government announced that it was committing millions in a stem cell research centre with the hope that it will help drive the UK economic recovery.

"But the ability of emerging stem cell technologies to stimulate the economy and create jobs is far from certain. Indeed, economics is the explicit reason for the Geron pull out. The company press release stated that the decision was made after a strategic review of the costs, timelines and 'clinical, manufacturing and regulatory complexities associated' with this kind of research. In other words, stem cell research is not, from the perspective of this company, worth it."

Caulfield concluded,

"I don't mean to be a downer. In fact, I believe that stem cell research holds tremendous potential. I remain fully confident that, one day, therapies will emerge. But the inappropriate hype associated with this area hurts policy debates, leads to unmet expectations, and has the potential to mislead the public about the actual state of the science. The Geron story is a sober reminder that promise is not reality, even in a field as exciting as stem cell research."

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It was brief but pointed comment on the differences in the stem cell world of 2004 compared to the stem cell world of 2011.

Larry Ebert, a patent attorney, made the remark on his blog, IPBiz. He was writing about an observation on this website that without George Bush and his restrictions on federal hESC research, there would have been no California stem cell agency.

Ebert said,

"IPBiz notes that when the California voters voted Prop. 71 in, scientists thought Huang Woo Suk's work on hESC was real. In 2011, the current state of the art is still not up to what Huang Woo Suk falsely reported in the journal Science. Californiastemcellreport should give Huang Woo Suk some credit for the passage of Prop. 71."

Consider Woo Suk duly credited.

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Using stem cells and your own fat, Plastic Surgeons and Cosmetic Surgeons are increasing womens breast size by injecting fat into the breast along with stem cells, no longer needing Breast Implants. It can even help to rebuild a breast for patients who have had a masectomy. http://www.cosmosclinic.com.au

Read the original post:
Bigger Breasts using Stem Cells and Fat Transfer? - Video

Exploring the Neanderthal and Denisovan genomes and the genetics of human and ape stem cells. Series: "CARTA - Center for Academic Research and Training in Anthropogeny" [7/2011] [Science] [Show ID: 21955]

Continued here:
Neanderthal and Denisovan Genomes/Human and Ape Stem Cells - Video

A bit about this wonderful person Bruce H. Lipton, PhD is an internationally recognized leader in bridging science and spirit. Stem cell biologist, bestselling author of The Biology of Belief and recipient of the 2009 Goi Peace Award, he has been a guest speaker on hundreds of TV and radio shows, as well as keynote presenter for national and international conferences.

Read the rest here:
Bruce Lipton,making the connections part 2 - Video

A bit about this wonderful person Bruce H. Lipton, PhD is an internationally recognized leader in bridging science and spirit. Stem cell biologist, bestselling author of The Biology of Belief and recipient of the 2009 Goi Peace Award, he has been a guest speaker on hundreds of TV and radio shows, as well as keynote presenter for national and international conferences.

More:
Bruce Lipton,making the connections part 1 - Video

Man with degenerative arthritis with a prognosis for hip and knee replacements and unusable right hand goes to Panama for stem cell treatment is cured in 7 days.

See the article here:
Man Cured of Arthritis Using Stem Cells at Clinic in Panama - Video

This video is a preview of Module 2 in the Stem Cell Fellowship through the American Academy of Anti-Aging Medicine. For more information visit http://www.a4m.com

More here:
A4M Stem Cell Fellowship Module II Preview - Video

It has taken President Obama less than a week to make a u-turn on such workings of the Bush Administration like stem cell research and exhaust emissions. Civil rights organisations hope cuts to wiretapping will be next.

See the rest here:
Obama to cut US wiretapping? - Video

Taylor prize winner Rudolph Jaenisch lectures on stem cell research as part of the Robarts Research Institute's Taylor Symposium.

Read more from the original source:
Jaenisch: Stem cells

William Bruyea, host of StemCellTV, on location in Dallas Texas, talks to John Harkey, managing director of BioLife Cell Bank about his other ventures and interests.

Continue reading here:
Video Biography of John Harkey, Managing Director, BioLife Cell Bank - Video

http://www.StemCellTreatment.org Stem cell therapy is the #1 highest rated procedure for getting results using alternative medicine. The American Stem Cell

Originally posted here:
Stem Cell Therapy - Video

http://www.StemCellTreatment.org Stem cell therapy is the #1 highest rated procedure for getting results using alternative medicine.

See the original post:
Stem Cell Therapy - Video

William Bruyea talks to David Angeloni, Chief Scientist for Millennium Medical Technologies about the recent study result showing improved fat and stem cell viability using Tickle Lipo.

Excerpt from:
Clinical Scientist David Angeloni Discuss Fat Viability Using Tickle Lipo - Video

(HealthDay News) -- Annual low-dose CT scans cut the death rate from lung cancer by 20 percent in heavy smokers and formerly heavy smokers, compared to those who get annual chest X-rays, according to the results of a major National Cancer Institute study released on Wednesday.

Experts are calling the findings a major advance in efforts to combat lung cancer deaths. By catching the cancer early, the tumors can be removed surgically -- hopefully before they've spread and become very difficult to cure.

"This is a momentous time in the history of public health research," said Dr. Otis Brawley, chief medical officer of the American Cancer Society. "The NLST [National Lung Screening Trial] is the best-designed and best-performed lung cancer screening study in history."

Yet the findings raise as many questions as they answer, said Dr. Harold Sox, a professor emeritus of medicine at Dartmouth Medical School who wrote an accompanying editorial to the study published in the June 30 issue of the New England Journal of Medicine. Read more...

Cardiofy Heart Care Supplement

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I'm proud to use every available resource at our disposal, including this blog, to highlight the efforts of the charity we support - especially during this holiday season.  


I would be so delighted to have you join me in supporting Sabrina Cohen and her efforts.  You can start by buying next year's calendar!

The Sabrina Cohen Foundation
The Sabrina Cohen Foundation for Stem Cell Research (SCF) is an internationally recognized nonprofit organization dedicated to building a global network of top scientists and clinicians in the field of Regenerative Medicine, while simultaneously funding cutting edge research and innovative therapies that will reverse spinal cord injury and effectively treat other impairments of the Central Nervous System.


The ‘CELLebrity’ Doctors Calendar
The 2012 CELLebrity Doctors calendar is now available for purchase from http://www.CELLebrityDocsCalendar.com.  All proceeds from calendar sales benefit the Sabrina Cohen Foundation for Stem Cell Research, a 501c3 non-profit organization directly funding stem cell clinical research.   

--Lee


_________________________________________________________________

On the night of November 12, David Porosoff’s Artrageous Gallery hotspot was converted into something likely never imagined -- a hotbed of stem cell research.  Sabrina Cohen fused the vividly artistic backdrop and venue with gambling, cuban music, great food, and beautiful people all to further her mission of raising money and awareness for stem cell research.

Dr. Sally Temple with Sabrina Cohen

Dubbed the Havana Casino Night, the event had several highlights including the granting of the 2011 Sabrina Cohen Foundation award to stem cell researcher Dr. Sally Temple.  


Representing the 3rd recipient of the annual SCF award, Dr. Sally Temple is studying how neural progenitor cells may be employed to create cell-based therapies for neurodegenerative disorders.  Dr. Temple is the co-Founder and Scientific Director of the Neural Stem Cell Institute located in Rensselaer, NY.  NSCI is the first independent, non-profit stem cell research institute in the USA.


The night, sponsored in part by DMR, Evensky & Katz and Harke Clasby & Bushman, raised $10,000 which will be dedicated toward next year’s SCF Award for Stem Cell Research.  


The event also marked the lauch of the the Foundation’s 2012 CELLebrity Doctors Calendar, this year featuring women in the field of stem cell research.  The calendar features academics, industry executives, physicians, and advocates primarily from the United States but also representing Sweden, Australia and Canadian covergirl, Dr. Fiona Costello.


“In science you don't have to accept anything anyone tells you, you can come up with a hypothesis and test it yourself. And you can be the first one to do it,” says Dr. Costello, whose research focus is on multiple sclerolsis and other impairments of the central nervous system. 


“Stem cell science is often accused of being ‘hyped,” says Cohen, “but that doesn’t necessarily translate into monetary support for or society recognition of the enormous contributions made by stem cell resarchers.  They often toil in anonymity making significant discoveries at great personal sacrifice.  I consider it my job to find a way to financially support their work and bring profile to them as people.”  


The ‘CELLebrity’ Doctors Calendar
The 2012 CELLebrity Doctors calendar is now available for purchase from http://www.CELLebrityDocsCalendar.com.  All proceeds from calendar sales benefit the Sabrina Cohen Foundation for Stem Cell Research, a 501c3 non-profit organization directly funding stem cell clinical research.   


The Sabrina Cohen Foundation
The Sabrina Cohen Foundation for Stem Cell Research (SCF) is an internationally recognized nonprofit organization dedicated to building a global network of top scientists and clinicians in the field of Regenerative Medicine, while simultaneously funding cutting edge research and innovative therapies that will reverse spinal cord injury and effectively treat other impairments of the Central Nervous System.


Sabrina Cohen is the Executive Director and President of the foundation. She graduated from the University of Miami with a degree in Communications, double majoring in Advertising and Psychology, and holds a post-graduate degree in Copywriting from the Miami Ad School.  She is a C5 Quadriplegic, as the result of a spinal cord injury from a car accident in 1992. In 2006, she established SCF to raise funds for research because she believes the field of Regenerative Medicine will lead to the greatest advances of our time. Sabrina is a Motivational Speaker & Spokesperson continuously speaking in schools, universities and community centers. She has spoken at scientific conferences around the country, including the "World Stem Cell Summit" at the University of Wisconsin, Harvard University, Stanford University, Baylor College of Medicine at the University of Texas, and at the United Nations. Sabrina believes her wheelchair is a vehicle to promote change.  


Sabrina Cohen was recognized by WebMD Magazine as a 2009 "American Health Hero”.  Sabrina is currently available for interviews highlighting the 2012 “CELLebrity” Doctors Calendar.

http://www.celltherapyblog.com hosted by http://www.celltherapygroup.com

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Jonathan Thomas, chairman of the $3 billion California stem cell agency, took to the blogosphere today with an item promoting CIRM's progress, declaring that it is a record of which Californians can be proud.

In his debut performance as a blogger, Thomas declared that the agency has 43 research projects that are in various stages of moving towards clinical trials. He wrote on CIRM's research blog,

"Given that it normally takes a decade or longer for a basic science discovery to reach clinical trials, 43 projects seemed to me like quite an achievement – an achievement that the people of California should take pride in supporting. Not only is CIRM driving stem cell science in our state, but through our national and international collaborations California has become a stem cell hub that accelerates stem cell progress worldwide."

Thomas, a Los Angeles bond financier, pointed to a new document from CIRM, titled "Funding therapies: Fueling Hope." It summarizes some of the agency's work and touts the "incredible potential" of stem cells.

The document also explains the laborious process for creating a therapy before it can be brought to market and actually used to treat patients. The document said,

"Altogether, carrying out the basic research, translational work and preclinical data leading up to a clinical trial can take a decade or longer, and that's just to start the clinical trial. CIRM’s funding approach speeds that timeline by providing stable funding that eliminates pauses in the research to raise new funds, by strategically funding areas thought to be barriers to the clinic and by forming teams of researchers who work in parallel rather than sequentially to reach clinical trials faster."

When Thomas was elected chairman of the agency last June, he told directors that the agency was in a "communications war" in which its record was not fully appreciated by the public. He made telling the CIRM story one of his top priorities.

Today's blog posting by Thomas and, more particularly the "Fueling Hope" document, will be useful to CIRM in dealing with the overblown expectations of rapid cures that were generated by the hype of the 2004 ballot initiative campaign that created the stem cell research program.

The campaign generated impressions among voters that cures – specifically human embryonic stem cell cures – were just around the corner and that the Bush Administration, with its restrictions on hESC research, was the only thing standing in the way. Indeed, without George Bush, there would be no state stem cell agency  since his stand against hESC created an apparent need for alternative funding. For voters who expected instant cures, however, CIRM must be a sad disappointment since it has developed no therapy that is being used to treat people.

Managing expectations is a critical task for CIRM, which will run out of funds in 2017 and which is expected to be asking voters for another multibillion dollar bond measure sometime in the next few years.

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The $25 million loan that the California stem cell agency awarded to Geron was the largest ever made by the research enterprise.

Directors approved the loan last May during a hearing that was a major departure from its usual procedures. The loan agreement was signed Aug. 1., about three months before Geron announced that it was abandoning the hESC business.

Geron last week repaid the $6.42 million that it had received from CIRM up to that point. Geron also paid the agency $36,732.33 in interest. CIRM additionally received 537,893 warrants to buy Geron stock at $3.98, CIRM told the California Stem Cell Report. Geron closed at $1.50 yesterday. The warrants expire in 10 years.

Last summer the California Stem Cell Report requested copies of the loan documents, which can be found at the end of this item, although the agency blacked out much of the information.

In a note accompanying the documents, Ian Sweedler, deputy legal counsel to CIRM, said,

"Geron requested and justified redactions to the milestone document, to those parts that describe specific activities, plans and data within the overall project.  Geron asserted and justified a claim that these details meet the legal standard for trade secrets that are exempt from production.  For the milestones, Geron agreed to leave enough unredacted to give a sense of the intent, at a level of detail that is not confidential.  For example, it will be possible to see that a milestone refers to enrolling a certain number of patients, but not what that number is, or other specifics about that stage of the project.  There are also accompanying comments with technical details and alternative approaches considered.  For these comments, we were unable to find a way to leave any meaningful text that would not disclose trade secret information.  The comments have therefore been completely redacted.

"Geron similarly justified redaction of information about how it will divide funds among different aspects of the project.  They explained that their internal costs, processes, and sequences are confidential, competitive trade secret information.  The redacted versions therefore show the amount of funding CIRM will provide, but not when and how Geron will allocate that to different activities."

Here are the loan documents.
CIRM-Geron 8-1-11 Loan Agreement

CIRM 7-28-11 Geron Loan Term Letter

Geron-CIRM Loan Agreement Appendix B

Geron-CIRM Loan Timetable Appendix C

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