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Geron Flight from hESC Research is ‘Powerful Blow’

By Dr. Matthew Watson


The news about Geron's abrupt departure from hESC research is rippling around the world this morning, casting a pall over the entire field.

The Financial Times of London, in a story by Andrew Jacksaid,

"Geron, the pioneering stem cell therapy company, has dealt a powerful blow to one of the most hyped areas of medicinal research by withdrawing entirely from the field."

Ron Leuty at the San Francisco Business Times said in an analysis,

"Just why would I want to invest in a space where one of the most promising companies just called it quits."

In a Washington Post article by Rob Stein, a patient advocate expressed bitterness.

"'I’m disgusted. It makes me sick,' said Daniel Heumann, who is on the board of the Christopher and Dana Reeve Foundation. 'To get people’s hopes up and then do this for financial reasons is despicable. They’re treating us like lab rats.'"

Geron, based in the San Francisco peninsula city of Menlo Park, cited financial problems when it announced yesterday that it was giving up on its stem cell efforts in favor of its cancer drug program. Geron is laying off 38 percent of its staff and says it will try to find a buyer for the stem cell program. Geron also settled its accounts with the California stem cell agency, which loaned it $25 million last May amidst considerable publicity.

The stem cell agency and other advocates expressed optimism about the long term potential of the field and noted the difficulties of bringing any therapy to production. Geron produced 21,000 pages of material over a years-long period to get FDA permission to begin only the first step in the long clinical trial process.

But the dominant tone of the news stories was negative. Heidi Ledford of Nature said Geron is "walking out on the field." Steve Johnson of the San Jose Mercury News said the decision casts "a cloud over the commercial viability of stem cell treatments."

Here are other excerpts:

San Francisco Business Times:

"What does this mean for companies that the California Institute for Regenerative Medicine, the state’s stem cell research funding agency, is pushing toward clinical trials? Will they only get so far before they, too, exit the business?" 

Fergus Walsh, medical correspondent for the BBC(see here), wrote:

"The decision does seem to be extraordinary given the huge investment of time and resources. When I visited Geron nearly three years ago, the then chief executive claimed the technology had an incredible future. 

"John Martin, professor of cardiovascular medicine at University College London said: 'The Geron trial had no real chance of success because of the design and the disease targeted. It was an intrinsically flawed study. And for that reasons we should not be describing this as a set back. 

"The first trials of stem cell that will give an answer are our own in the heart. The heart is an organ that can give quantitative data of quality.'"

Ryan Flinn of Business Week wrote,

"Geron fell 16 percent to $1.86 in extended trading. The shares have declined 58 percent this year.  

Robert Lanza, chief scientific officer of Advanced Cell Technology Inc.(of Santa Monica, Ca.), the second company to win permission from the U.S. Food and Drug Administration to test human embryonic stem cells in people, said the news wasn’t surprising, given the small patient population affected with spinal cord injuries. 

"'It was a very difficult choice to go in and treat spinal cord injury,' Lanza said in an interview. 'There was considerable concern in the scientific community that that might not have been the ideal first indication."

As first reported by the California Stem Cell Report, Geron's loan application was scored as a 66 on a scale 100 last May by scientific reviewers for the California stem cell agency. The score was not disclosed publicly at the time CIRM directors approved the award as has been the practice for all the other 400-plus awards that the agency has granted. The Geron approval process departed radically from the agency's regular procedures.

The news coverage in California of the Geron decision was marked by the absence of a story in the Los Angeles Times, the state's largest circulation newspaper. The San Francisco Chronicle carried only a brief story buried on page 6 of its business section. The California stem cell agency is based in San Francisco and the Bay Area contains one of the larger and more important biotech business and academic research communities in the world.

Source:
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Geron Quits Stem Cell Research; Move Deemed Setback to the Field

By Dr. Matthew Watson


In a surprise move, Geron today said it was terminating its stem cell business and what was the first-ever clinical trial of an hESC therapy, a potential product backed by a $25 million loan made by the California stem cell agency only six months ago.

Geron's move has "stark implications" for development of stem cell therapies in the United States, The Associated Press said. Andrew Pollack of the New York Times reported,

"The move is expected to be widely seen as a setback for the field, because of Geron’s central role."

The Menlo Park, Ca., company said it will fire 66 employees, 38 percent of its workforce, and will try to find buyers for its stem cell business.

The company's CEO, John Scarlett, cited the need to "focus our resources" given the "current environment of capital scarcity and uncertain economic conditions." The clinical trial of its spinal cord treatment will be closed to further enrollment, although it will continue to follow all four enrolled patients. The company said it now plans to focus on cancer drugs.

The company did not mention CIRM or the $25 million loan in its statement. The stem cell agency issued a press release that said,

"Geron had received $6.42 million of their loan, which the company today repaid in full with accrued interest."

In the news release, CIRM's Ellen Feigal, senior vice president for research and development, did not comment directly on Geron's move. She said CIRM remained optimistic about "many exciting stem cell programs in California." She said moving a therapy into the clinic is a "highly complicated process."

Absent from CIRM's press release were any comments from its new chairman, Jonathan Thomas, and CIRM President Alan Trounson.

Dropping stem cell research will improve Geron's cash situation. The New York Times' Pollack said,

"Geron will be able to last without needing to raise new money until it receives results of clinical trials of its cancer drugs over the next 18 months. By contrast, Dr. Scarlett said, given all the precautions in the stem cell field, he did not think there would be results from the stem cell trial until 2014."

The AP quoted stock analyst Steve Brozak of WBB Securities as saying Geron had encountered difficulty in finding partners for its stem cell program. He said potential partners wanted to see "later stage results." Of the clinical trial, Brozak said,

"It could be outsourced to a place like China very easily. In that case, this would be the de facto abdication of U.S. leadership in biotechnology."

With Geron's departure, Advanced Cell Technology of Santa Monica, Ca., is the only company with a clinical trial involving hESC, one targeting macular degeneration. ACT has never received an award from the California stem cell agency although it relocated its headquarters to California in the wake of the passage of Prop. 71, which created the state's $3 billion research program.

ACT was widely believed to have applied in CIRM's financing round last spring involving Geron.

CIRM directors approved the loan to Geron last May in a meeting that departed radically from its normal awards process.

As reported by the California Stem Cell Report in August,

"The Geron application was not given a public scientific score, standard practice for all the other 433 applications that the agency has approved over the last six years. The usual summary of grant reviewer comments was not provided to the public or the board. The three other applicants in the $50 million round all withdrew prior to presentation to the CIRM board – another first in CIRM's grant program. And no public explanation was provided at the time for the departures from long-established procedures." 

Source:
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$127 Million in ‘Good News’ for San Diego Stem Cell Researchers

By Dr. Matthew Watson


Earlier today, an anonymous reader posted a comment on the California Stem Cell Report wondering where the "good news" was about the stem cell agency. We are not sure whether the reader was wondering about the content of this site or the mainstream media or both.

Sanford Consortium lab from live Webcam shot this weekend
on the Sanford web site. 

But the comment came less than 24 hours after a San Diego area newspaper published a glowing piece about the opening of a new stem cell research building under the auspices of five powerful research organizations – Salk, Scripps, Sanford Burnham, UC San Diego and the La Jolla Institute for Allergy and Immunology, a recent addition to the consortium.

Bradley Fikes of the North County Times wrote the story. He may be the last reporter in California to regularly, albeit infrequently, cover California stem cell issues for a mainstream newspaper.

Fikes' story heralded the $127 million structure. (The cost includes equipment.) He wrote,

"San Diego County's bid for supremacy in the fast-growing field of stem cell research will gain an iconic new image Nov. 29, when a gleaming headquarters for some of San Diego County's top stem cell researchers officially opens.

"The 132,000 square-foot building off in La Jolla will become the headquarters of the Sanford Consortium for Regenerative Medicine...."

The consortium was formed in the wake of voter approval of Prop. 71, which created California's $3 billion stem cell program and provided hundreds of millions of dollars for new labs. Edward Holmes, formerly vice chancellor at UC San Diego, is president and CEO of the consortium. Holmes is also chairman of the National Medical Research Council in Singapore. (For Holmes perspective on the consortium, see this 2010 interview.)

The building was financed with $43 million from the California stem cell agency, $65 million in bonds guaranteed by the University of California and $19 million from T. Denny Sanford, a South Dakota billionaire banker.

After CIRM approved funding for the building in May 2008, the consortium struggled with finding cash beyond what CIRM provided. The roadblocks delayed work on the facility, which was supposed to be completed by May 2010 at a cost of $155 million, according to the stem cell agency.

Like the other new labs assisted by $271 million in stem cell agency construction funds, the San Diego building is touted as conducive to bringing scientists together. Indeed, it has been dubbed a "collaboratory."

Fikes wrote,

"Even the staircases have been designed in keeping with the goal of making as much space as possible serve collaboration. The Sanford Consortium's staircases are wide, open and airy. They connect multiple 'laboratory neighborhoods' on different levels, so that scientists from different labs and floors will inevitably pass each other on their way to work."

Fikes said that at each level the staircases include areas with tables and chairs for quick chats. He quoted Louis Coffman, chief operating officer of the consortium, as saying,

"It's a lively interlude between floors. It creates an interesting space. More than that, it connects the physical locations of two different floors. So whereas people on different floors, who would otherwise be as disconnected as they would be in different buildings, hopefully they're going to make connections."

Source:
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Dr. Jordan Pomeroy discusses xeno-Free Derivation and Maintenance of Pluripotent Cell Lines – Video

By Dr. Matthew Watson

Dr. Jordan Pomeroy, from the Eli and Edythe Broad Center for Regenerative Medicine and Stem Cell Research at the Keck School of Medicine of the University of Southern California, presents his work on the derivation and characterization of new pluripotent stem cell lines for clinical applications.

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Stem Cell Therapy for Arthritis – Osteoarthritis Treatment – Video

By daniellenierenberg

Prominent Texan, Dusty Durrill, discusses his improvements after undergoing stem cell therapy for osteoarthritis at the Stem Cell Institute in Panama City, Panama.

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Stem Cell Based Therapies for Blindness: David Hinton – CIRM Science Writer’s Seminar – Video

By NEVAGiles23

(Part 6 of 9) David Hinton, Ph.D., spoke at the Scientific Writer's Seminar, a workshop presented on September 17, 2008 at CIRM headquarters in San Francisco. Hinton has a CIRM grant to study the therapeutic potential of retinal pigment epithelial cell lines derived from human embryonic stem cells for retinal degeneration. Hinton is a professor of pathology, neurosurgery, and ophthalmology at the Keck School of Medicine at the University of Southern California.

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Human Embryonic Stem Cells for Predictive Toxicology – Video

By LizaAVILA

(Part 3 of 4) Michael McMaster, PhD, spoke at a seminar about stem cell research and environmental health held on September 30, 2009 at the California Institute for Regenerative Medicine. McMaster summarized the challenges of predictive toxicology and described how he has applied human embryonic stem cells as a model system for studying the toxicological effects of nicotine

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Stem Cell Skin Care Jeunesse- Dr Newman FAQ – Video

By NEVAGiles23

http://www.smootherskin.info Dr Newman is the innovator who formulated our anti-aging skin care line. Watch as he answers some inportant questions regarding the stem cell skin care.

Link:
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Getting Stem Cell Therapies Approved: Ann Tsukamoto – CIRM Science Writer’s Seminar – Video

By Dr. Matthew Watson

(Part 7 of 9) Ann Tsukamoto, Ph.D., spoke at the Scientific Writer's Seminar, a workshop presented on September 17, 2008 at CIRM headquarters in San Francisco. Tsukamoto is the Chief Operating Officer at Stem Cells, Inc., a Palo Alto based company that has begun a stem cell based human clinical trial for the treatment of Batten disease.

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Austin Forum – Nov 1st (Highlights) – Video

By daniellenierenberg

Stem Cell Therapy in the Treatment of Patients with Ischemic Heart Failure Emerson Perin, MD, PhD., Director, Clinical Research for Cardiovascular Medicine and the Medical Director of the Stem Cell Center, Texas Heart Institute, St. Luke's Episcopal Hospital Scientific advancements in the stem cell field can lead to new treatments and therapies for diseases and medical disorders for which we have few or no effective medications or treatment options.

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AVS Stem Cell Therapy – Video

By daniellenierenberg

Watch as the veterinary surgeons at Affiliated Veterinary Specialists perform a breakthrough stem cell therapy to treat arthritis. The patient is Maggie Mae, a ten-year-old Australian Shepherd.

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AVS Stem Cell Therapy - Video

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StemCellTV – From National Geographic – The Skin Gun – Healing Burns with Stem Cells – Video

By Dr. Matthew Watson

Courtesy of National Geographic TV, StemCellTV reports on the skin gun. McGowan Institute of Regenerative Medicine takes a burn victims stem cells from his skin and regenerates skin to heal him in 4 days.

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Beating Cardiomyocytes in Cell Culture – Video

By Dr. Matthew Watson

The cells shown are beating cardiomyocytes derived from human induced pluripotent stem cells.

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SCIPIO: Cardiac stem cells and postinfarction heart failure – Video

By NEVAGiles23

Mark Sussman, PhD, interviews Piero Anversa, MD, FAHA and Roberto Bolli, MD on the results of the SCIPIO trial at the American Heart Association's Scientific Sessions 2011.

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Adult Stem Cell Success Stories – Amy Daniels – Video

By LizaAVILA

StemCellResearchFacts.com - Amy Daniels was terrified when she learned that she had Scleroderma- a disease that causes the tissue in the skin, blood vessels, and muscles to harden.

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Bone Marrow Stem Cell Injections – Video

By NEVAGiles23

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Beating iCell® Cardiomyocytes – Video

By Dr. Matthew Watson

A synchronously beating monolayer of cardiomyocytes (heart cells) derived from induced pluripotent stem cells.

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Where Do The Stem Cells Come From? Hollywood | Los Angeles – Video

By NEVAGiles23

metromd.net Where Do The Stem Cells Come From? A discussion of the different sources of stem cells for therapy and autologous treatment by Alex Martin, MD

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Macular degeneration – Stem Cell therapy (English subtitles) – Video

By NEVAGiles23

This video, is a testimonial of a patient from Argentina that went to Progencell, for a Stem cell treatment for his Macular degeneration. Talks about his experience, his trip, the procedure, the outcome and some suggestions. Language Spanish with english subtitles, 6 min duration aprox.

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Perspectives of a Stem Cell Donor Family – Video

By daniellenierenberg

"Your twin daughters have an extremely rare, fatal disease called Niemann Pick Type C and there's nothing you can do for them." Those were the devastating words that Chris Hempel and her husband first heard in 2007. Rather than just give in to this fate, the Hempels are proactively engaging researchers to try to save Addi and Cassi's lives. This journey includes donating skin samples to cell banks so that researchers can create induced pluripotent stem (iPS) cells, a promising technology which may help undercover treatments for their daughters

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