From Nature magazine

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One day in early 1995 a man named bob massie walked into my office at the outpatient clinic of Massachusetts General Hospital in Boston. Massie told me he had been infected with HIV--the virus that causes AIDS--for 16 years and yet had never shown any symptoms. My physical examination confirmed he was healthy, in stark contrast to all other patients I saw that day. At that time, a new combination of drugs was being tested that would eventually slow the progressive decline in immune function that HIV caused. In 1995, however, most people who had been infected with HIV for a decade or more had already progressed to AIDS--the stage marked by the inability to fight off other pathogens. The young man standing before me had never taken anti-HIV medication and strongly believed that if I learned the secret to his good fortune, the information could help others to survive what was then generally thought to be a uniformly fatal disease.

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Tears and a runny nose can be unpleasant on a windy day, but these mucosal secretions play a vital role in protecting the body from viruses and other malicious microbes. Unfortunately, mucus is also adept at washing away medication designed to treat infections and inflammation that occur when an infectious agent is successful in penetrating the body's defenses [More]

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Proposition 71 last week once again
stood in the way of action by the $3 billion California stem cell
agency.

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A bit of irony popped up this
week in the wake of approval of $151 million in awards by the
California stem cell agency.

"We will take CIRM money last. We
don't want to be in a position where, years from now, we are actually
forced to sell [our products] in California at a loss."

“We are extremely grateful to CIRM
for its support.”

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Gant Daily

EDC Relocates to Barnes Center; Clients will Benefit in Clarion Gant Daily Representatives of Clarion University and its Small Business Development Center gather with the leadership of Clarion County Economic Development Corporation to celebrate CCEDC's relocation at Gregory Barnes Center for Biotechnology and Business ...

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Aug. 5, 2012, 3 a.m.

A GROWING number of overseas clinics touting stem cell therapy for conditions ranging from sexual disorders to HIV are targeting Australia, where such treatments are restricted.

Australian scientists have raised concerns about so-called ''stem cell tourism'', saying many of the treatments offered are unproven, untested and potentially deadly.

The Swiss firm Fetal Cell Technologies International has been advertising in Australia since last year and Emcell, based in Ukraine, started promoting its services last month.

It is estimated as many as 200 Australians have travelled overseas for the therapy. The secretary for science policy at the Australian Academy of Science, Bob Williamson, said he empathised with the desperation of seriously ill people but warned against the unproven therapies, which can cost up to $60,000.

''The therapies are almost all untested and unproven and sometimes they have killed people,'' Professor Williamson said. The Sun-Herald's calls to Emcell's Melbourne office were not returned.

Stem Cells Australia's Megan Munsie, who is conducting a study into stem cell tourism with Monash University, said many people she interviewed were unaware of the risks of therapy overseas.

''We're not talking about rubbing something into your skin or taking a capsule, we are talking about often a very invasive procedure,'' she said.

See original here:
Fears over 'stem cell tourism' Save

A GROWING number of overseas clinics touting stem cell therapy for conditions ranging from sexual disorders to HIV are targeting Australia, where such treatments are restricted.

Australian scientists have raised concerns about so-called ''stem cell tourism'', saying many of the treatments offered are unproven, untested and potentially deadly.

The Swiss firm Fetal Cell Technologies International has been advertising in Australia since last year and Emcell, based in Ukraine, started promoting its services last month.

It is estimated as many as 200 Australians have travelled overseas for the therapy. The secretary for science policy at the Australian Academy of Science, Bob Williamson, said he empathised with the desperation of seriously ill people but warned against the unproven therapies, which can cost up to $60,000.

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''The therapies are almost all untested and unproven and sometimes they have killed people,'' Professor Williamson said. The Sun-Herald's calls to Emcell's Melbourne office were not returned.

Stem Cells Australia's Megan Munsie, who is conducting a study into stem cell tourism with Monash University, said many people she interviewed were unaware of the risks of therapy overseas.

''We're not talking about rubbing something into your skin or taking a capsule, we are talking about often a very invasive procedure,'' she said.

See the rest here:
Fears over 'stem cell tourism'

MANILA, Philippines Talent manager Annabelle Rama revealed that she will be undergoing stem cell therapy in September.

She confirmed this report to The Philippine Stars entertainment columnist Ricky Lo.

Rama said shes been suffering from several illnesses and that stem cell therapy may help make her feel better.

Im suffering from high-blood pressure, high-blood sugar and other ailments and from what I heard, after the therapy I would feel better. Lahat daw yon gagaling, she said.

Rama said her son Richard Gutierrez, who will be paying for the whole procedure, also urged her to have her back problem checked.

Richard wants me to have my scoliosis checked and my lumbar region which are giving me so much pain. So I will have two more injections for that, each costing an extra one thousand euros, she said.

Lo said in his article that the whole package, which will include nine injections, will cost around P1 million.

Meanwhile, although she earlier vented on Twitter her disappointment that her family is against her plan to run for Congress, it seems that her children have changed their mind about politics.

Rama said she is hoping that she will feel renewed after her upcoming stem cell therapy so she will be ready to file her certificate of candidacy as a Cebu congresswoman when she comes back.

Richard and my other children want me to be physically fit for the campaign, Rama said.

See the rest here:
Annabelle to undergo stem cell therapy

The Rockefeller University Newswire

Jeffrey Ravetch wins 2012 Sanofi – Institute Pasteur Award The Rockefeller University Newswire Jeffrey V. Ravetch, head of the Leonard Wagner Laboratory of Molecular Genetics and Immunology at Rockefeller University, has been given the 2012 Sanofi – Institut Pasteur Award for discovering mechanisms by which antibodies carry out their diverse ...

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Gustavus Adolphus College News (blog)

Nobel Conference 48 Presenter Profile: Barbara Block Gustavus Adolphus College News (blog) Top researchers in biogeochemistry, oceanography, deep-sea biology, molecular genetics, and coral ecology are coming together on Oct. 2-3, 2012, for “Our Global Ocean,” the 48th annual Nobel Conference at Gustavus Adolphus College. They will meet to ...

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ESPN (blog)

Aaron Craft still tougher than you ESPN (blog) “The best thing about it is, he's got two 'bear' classes right now, molecular genetics and physics. The one, he is in class for four hours Tuesday through Friday, and he tells me he enjoys it because he can sit in the front of the classroom and put his ... Ohio State Buckeyes PM links: After years of tolerating chipped ankle, Aaron ...Plain Dealer (blog) all 7 news articles »

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iScienceTimes.com

Mutations in autism susceptibility gene increase risk in boys Medical Xpress Mutations in X chromosome genes only affect boys, who have one X chromosome. Girls have a second copy of the gene that can compensate. The results were published July 5 in the journal Human Molecular Genetics. "Our data suggest that AFF2 could be ... Why Are Boys More Prone To Autism? It's In The GenesiScienceTimes.com all 6 news articles »

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Canadian National Newspaper

Common diabetes drug promotes brain stem cells Canadian National Newspaper The study, led by Dr. Freda Miller, Professor in the Department of Molecular Genetics at the University of Toronto and Senior Scientist at The Hospital for Sick Children (SickKids) is published in the July 5 advance online edition of Cell Stem Cell ... Common diabetes drug promotes development of brain stem cellsHealthCanal.com all 136 news articles »

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As followers of this blog will know I've been blogging about Regenerative Sciences and predicting their eventual run-in with the FDA since my first post in September 2008 (Cell Therapy is Not the Practice of Medicine) and again in February 2009 (Regenexx vs the FDA 2009).  When the FDA finally proceeded with an injunction against RSI in August 2010,I helped spread the news (here).

I've watched the development of the fight between RSI and the FDA with interest.  In September 2001 I posted a rather lengthy commentary about the potential impact of the case (Potential far-reaching implications of the ongoing fight over point-of-care autologous cell therapy.

Since then I have welcomed other bloggers and commentators who are now following and commenting on the case much more closely and frequently than I including @LeighGTurner (on Twitter) and Paul Knoepfler (@PKnoepfler on Twitter and his Knoeplfer Lab Stem Cell Blog).  Recently I enjoyed being interviewed by Paul on the issue of unregulated stem cell activity and touched on the case for his blog.

Consequently I read with interest yesterday's federal court ruling upholding the FDA's injunction against RSI and the immediate commentary from the New Scientist, Stanford's Scope Blog and Knopfler's multiple posts (here and here). As a long-term follower of this case, I've been asked to comment.  Here is my brief reaction:

This is a case that was always destined for the appellate courts regardless of which way the initial court ruled.    The fact the federal court ruled in the FDA's favor certainly now sets the onus on RSI and what is anticipated to be a gamut of intervenors but taking this case to the appellate courts is what the legal team have anticipated and legal arguments designed for all along.

This is just the beginning of what will be a long and interesting battle.  The ruling was nothing more than the granting of an injunction in response to the government's motion for summary judgement.  In granting the injunction the court  agreed with the government's position that it was acting under the authority given it under the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 321(g) but it provided little-to-no rationale for its ruling.

The court chose, in its wisdom, not to address the bulk of the RSI's legal arguments which are largely jurisdictional in nature. These are the kinds of arguments which the lower courts prefer be dealt with by appellate courts and frankly the judge did us all a favor by ruling quickly, succinctly and punting the case where we all knew it was inevitably headed.

In my opinion, other than chalking one up in the government's win column there is little to be gleaned from this ruling in terms of how RSI's arguments will be received in appellate court.  The interesting day is yet to come.

In terms of a short-term practical impact, frankly I see very little.  RSI has already ceased distributing Regenexx within the US so there will be little-to-no impact there.  As for the potential impact on other companies or clinics who might be operating on the fringes of FDA regulation within the US, I suspect it will be business as usual.

Most of the clinics/companies offering cell-based treatments/products which are arguably in contravention of FDA regulation are operating under the clear knowledge of what they are doing and where the FDA stands with respect to the treatments/products they offer and yet they persist and continue.


 For the truly fraudulent there is the risk of criminal charges and/or litigation but for those companies or practitioners who are operating in this shade of grey which are not shady (and they do exist), the  risks associated with this practice are barely higher than in the routine practice of medicine. 


In reality, with the exception of the most fraudulent examples, it takes a fair long-time for the FDA to catch up with these folks and there is good money to be made in the interim.  When they get caught, they will stop. If they've recouped their initial investment (which is nominal and the margins are high) there is very little penalty to this course of action.  Perhaps they set up shot elsewhere or simply enjoy the proceeds.  I doubt we will see much of a slow-down of this kind of activity.  Indeed it may strengthen the resolve of those committed to the cause.

In my opinion yesterday's ruling was in interesting and important milestone in a continuing evolution in the debate of how best to regulate the use of cells in treating people but I'm not sure it's the seminal pivot point that some believe.  I suspect we will not see any radical shift in terms of FDA or industry activity until (if then) the appellate courts rule.

Just my two cents....

--Lee

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

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The California stem cell agency today
enjoyed substantial, if sparse, news coverage of the

“For Melissa Biliardi of Santa
Maria, the (CIRM board) vote symbolizes hope. Her son, James
Birdsall, 32, was diagnosed four years ago with Huntington's disease.
The degenerative brain disorder could prove fatal over the next 10 to
15 years. There is currently no cure or treatment, but with the
grant, UC Davis researchers hope to deliver an effective therapy in
four years.
"'This is the most hope we've ever
had for a cure or treatment,' Biliardi said.”

“California's stem cell funding
agency on Thursday approved nearly $100 million in grants for
research into heart disease, cancer and spinal cord injuries, and to
the cheers of dozens of patients and their supporters, it also
awarded money to rare but devastating diseases with no cure.”

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Directors of the California stem cell agency today referred two additional research applications for $37 million in disease team funding back to reviewers for further consideration.

Both were the subjects of appeals by researchers whose proposals were rejected by grant reviewers.

One was from Timothy Hoey of OncoMed Pharmaceuticals in Redwood City, who sought $20 million.  The other was from Henry Klassen of UC Irvine, who sought $17 million. (See here and here for their appeals.)

The  board began the day by directing staff to come back to the board in early September. But with the large number of grants to be reassessed, it was acknowledged some might not be acted on until the board's meeting in late October.

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Directors of the California stem cell
agency approved an additional
$20 million disease team grant today before adjourning their
meeting. The grant brought the disease team round to a total of $151 million.

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Directors of the California stem cell
agency today approved $151 million in research awards aimed at
commercializing stem cell research and pushing therapies into
clinical treatment.


Patients and researchers cheered when the action was announced. 


The awards of up to $20 million each
were ratified by CIRM's governing board, which added two to the
six applications approved by reviewers. The original
six totalled $113 million. Directors budgeted $243 million
for today's round.


Five of the applications involving
appeals were sent back by the board for more review.
(See here, here and here.)
They will be considered again in early September or October.

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Andy McMahon Harvard photo

The governing board of the California stem cell agency this afternoon approved a $5.7 million grant to lure a Harvard researcher to the University of Southern California in Los Angeles.

The scientist is Andrew McMahon, who serves on the executive committee of the Harvard Stem Cell Institute. CIRM officials said McMahon is ready to begin his work immediately at USC.

McMahon won stellar reviews from CIRM's grant reviewers who said he was an “exceptional scientist and one of the leading young developmental biologists.” Reviewers gave his proposal a score of 90 and, in summary, said,

“Major strengths include the candidate's exceptional productivity and contributions to the fields of mammalian embryology and kidney development, the significance and potential of the research program, the PI's proven leadership capabilities, and the outstanding institutional commitment.”

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