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Collapse of Big Pharma Deal Involving California Stem Cell Agency

By Dr. Matthew Watson

A ballyhooed deal has blown apart that
would have hooked up – for the first time – Big Pharma and the $3
billion California stem cell agency.

The breakdown of the arrangement was
quietly disclosed yesterday in background material prepared for the
Dec. 12 meeting of the stem cell agency's governing board.
The deal was first announced Oct. 25
when Viacyte, Inc., of San Diego, received a $10.1 million award to
help finance a clinical trial for a diabetes treatment involving
Viacyte and GlaxoSmithKline.
The CIRM background memo said this week, however,

“We have recently been informed that
GSK was not able to obtain the final approval required due to
business reasons in the context of GSK's overall research and
development portfolio and investment needs and not as a result of any
scientific or technical assessment of ViaCyte's program.”

The memo gave no further details about
the Glaxo decision.
CIRM staff proposed that Viacyte, which
has received $36 million from CIRM, be given another $3 million
because Glaxo has exited the trial.
The arrangement involving Glaxo,
Viacyte and CIRM was trumpeted in October, when Viacyte was awarded
the $10 million. Officials of the stem cell agency said the award
was a “watershed” for CIRM. Jason Gardner, head of the Glaxo stem
cell unit and who attended the meeting, told the California Stem Cell
Report
that the arrangement was a partnership and that the company
intended to develop a sustainable pipeline.
It was the second significant
business-connected deal that has collapsed for the $3 billion agency
within the last 13 months. In November 2011, Geron abandoned its
clinical trial for spinal injuries. CIRM had loaned Geron $25 million
for the trial just three months earlier. The company paid the money
back with interest.
CIRM staff said that advisors to the
agency remain “extremely positive” about the Viacyte research and
“strongly recommended” that the company receive the additional $3
million. The memo said that trial has a “strong potential” to be
commercialized.

Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/p-E0ivzGfr0/collapse-of-big-pharma-deal-involving.html

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Extra, Extra! CIRM Staffers Blog the World Stem Cell Summit

By Dr. Matthew Watson

Years ago, I worked with an editor who
used to advise his lagging scribes to put their noses in their
typewriters and peck.

Well, the folks at the California stem cell agency have their
noses in what passes today for typewriters and are pecking away
furiously. Their subject is the World Stem Cell Summit, which has
received only slight coverage in the mainstream media.
Today, the stem “cellists” from San
Francisco's King Street filed -- on the agency's blog -- three fulsome
items on doings at the summit, which is taking place in West Palm
Beach, Fla. Yesterday they filed four. Photos and charts were
included. More coverage is expected tomorrow.
CIRM staffers blogging the World Stem Cell Summit
covered UC Davis researcher Paul Knoepfler discussing
patient advocacy and its role in funding stem cell research. 

The CIRM writers are doing double-duty
in at least one case. Geoff Lomax, the agency's senior officer for
its standards group, is additionally speaking on a panel at the session. A
handful of other CIRM officials are also appearing at the conference,
which ends tomorrow.

The primary purpose, we presume, of
sending state employees across the country is to gather the latest
information on stem cell science and issues and to make contacts. It
is a bit of a bonus for the public to have the CIRM attendees also
file stories on the sessions.
A couple of the items caught my
attention. One dealt with patient advocates and their role in
energizing and helping to drive funding for research. Another item
discussed what appear to be growing issues with dubious stem cell treatments and the damage they can do to the field in general.
Lomax summarized the signs of a stem
cell scam like this:
  • “Claims of miracle cures for
    diseases
  • “Single treatments or cells that
    can treat any type of disease
  • “Lack of objective information,
    evidence (such as published medical reports) that a treatment is
    effective
  • “Treatment by a doctor who is
    not trained or certified to treat the specific disease
  • “No system exists to collect
    information and follow up with patients”

Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/usBXfuFwqy4/extra-extra-cirm-staffers-blog-world.html

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$80 Million in Grants, Money for Viacyte and Blue-Ribbon Report on California Stem Cell Agency

By Dr. Matthew Watson

Directors of the California stem cell
agency are expected to give away $80 million next week to 20
fortunate researchers in addition to exploring a “commercialization
and industry engagement plan.”

The subjects are on tap for the Dec. 12 meeting in Los Angeles of the governing board of the $3 billion
research effort.
The $80 million grant round is aimed at
“career development of physician scientists working in
translational stem cell research.”

“This award will fund promising
physician scientists in the critical early stages of their careers as
independent investigators and faculty members establishing their own
laboratories and programs.” 

Summaries of the grant reviewers
comments and application scores should be available sometime this
week. The bare-bones agenda lacked elaboration on the
commercialization plan.
Directors are additionally scheduled to
hear a presentation on the blue-ribbon report by the Institute of
Medicine
for which the agency is paying $700,000. The report has been
17 months in the making and is scheduled to be released this
Thursday.
Other interesting matters are on the
table, although the agency has yet to produce background material
laying out any details. The subjects include:
  • More money – no amount yet specified
    – for Viacyte, Inc, of San Diego, which has received more than $36
    million from CIRM.
  • An update of the agency's response to
    the only performance audit conducted at the agency. The audit
    identified 27 areas where improvement is needed, but the governing
    board has not discussed the results publicly since they were
    disclosed last May.
  • Approval of the concept plan for
    another round of basic biology grants and adoption of conflict of
    interest code changes.

Interested parties will be able to take part at the meeting location in Los Angeles and teleconference locations in La Jolla, Oakland and UCSF. If you are interested in
the teleconference locations, you will need to contact the agency for more specific directions than are provided on the agenda.

Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/RU_xC86oAyw/80-million-in-grants-money-for-viacyte.html

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Update on Move To Curb Researcher Appeals at California Stem Cell Agency

By Dr. Matthew Watson

Directors of the $3 billion California
stem cell agency are still mulling details of changes in their
free-wheeling and sometimes emotional appeals process for grant applications
that are rejected by the agency's reviewers.

A special task force of directors met last week
for the second time to discuss the likely alterations. Kevin McCormack, spokesman for the agency, said
the group made no decisions. Another meeting will be held later at a
date to be determined. The task force's recommendations will then go
before the full board, probably in late January.
McCormack said members of the panel
have asked for “more details regarding the process that would be
employed if the appeals and extraordinary petition processes were
merged.”
The agency has an odd, bifurcated
appeals process. Early in its existence, the agency said appeals of
reviewer decisions could be based only on conflicts of interest.
However, researchers have a right under state law to speak to the
governing board in public on any issue whatsoever. As some
researchers began to use that avenue to ask for reconsideration of
their applications, the CIRM board created what it called
“extraordinary petitions” in an effort to control the process and
limit appeals. Both the “appeals” and “extraordinary petitions”
are, in fact, appeals but on different grounds and employing different
mechanisms.
The task force was created in September
after directors complained about “arm-twisting” and “emotionally charged presentations” in connection with a record number of
appeals earlier this year.
Here is a link to an item about the task force's first meeting. Here is a link to an agency summary of the task force's deliberations prior to last week's meeting. The
transcript of the session should be available on the CIRM web site
within the next two weeks. It will be found under the meetings
section of the web and then under the heading for the task force's
November session.

Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/Hkq7zcXyMsQ/update-on-move-to-curb-researcher.html

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An all natural skincare serum based on stemcells science – Video

By Sykes24Tracey


An all natural skincare serum based on stemcells science
Independent clinical trials show DRAMATIC results - 25% fewer wrinkles,30% more moisture and 10% more elasticity...in just 28 days! Our breakthrough serum revitalizes the skin at the cellular level, to restore and maintain the skin #39;s youthful vibrance. DermaStem is a mocha-hued fusion of natural oils that blends invisibly into the skin. This all-natural serum contains a velvety emulsion of the world #39;s most restorative ingredients. This revolutionary product works to reduce the signs of premature aging by supporting the work of skin stem cells, the natural renewal system of the skin. For order online or more information,please contact us at http://www.myonline.stemtechbiz.com or email to fusioncreations@gmail.com.From:Tony Lim Careen SeeViews:1 0ratingsTime:06:48More inHowto Style

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An all natural skincare serum based on stemcells science - Video

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WISE Surgical Solutions LLC Announces Project Hope: Helping People with Debilitating Conditions Including Arthritis …

By Dr. Matthew Watson

With millions of people in aggregate suffering from debilitating disease, reduced mobility, or relentless pain associated with various conditions, stem cell medicine is available now through WISE Surgical Solutions LLC by direct flight from some major cities to our Joint Commission International Accredited Johns Hopkins affiliated Punta Pacifica Hospital in Panama.

New York (PRWEB) December 06, 2012

Cathy Nenninger, Chief Executive Officer of WISE Surgical Solutions LLC, shared why this offering is important. When I ran wound centers up and down the east coast, I used to get calls from patients and family members desperate for treatments to help alleviate severe symptoms of ailments such as these. It was heartbreaking that we were not able to provide any type of help or hope to these patients. Granted, while the response and success of stem cell treatment in patients varies greatly and by disease, patients who are in extreme discomfort or experiencing reduced function or quality of life deserve to know that they have options available to them.

A significant element of PROJECT HOPE, continues Ms. Nenninger, is the opportunity for community funding of the treatment. Often, families and communities want to help someone by making donations that will collectively fund a surgery or procedure which in itself can add another chore to the already stressed world of a Care Captain (person seeking help for another); Our goal is to make the process easy. For more information on Project Hope, call (631) 942-6040 or for a quote for service, fill out a medical history form available at http://www.WISESurgicalSolutions.com.

WISE Surgical Solutions LLC is based out of New York and caters to companies and patients seeking quality healthcare at an affordable price inclusive of travel. Offerings include medical, dental and surgical procedures of most types, in-vitro fertilization (IVF) and stem cell medicine. Community & group funding as well as financing options are available for patients. Media relations inquiries can be directed to (631) 909-8538 or emailed to surgsolutions(at)optimum(dot)net.

Cathy M. Nenninger, MBA Wise Surgical Solutions LLC (631) 942-6040 Email Information

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WISE Surgical Solutions LLC Announces Project Hope: Helping People with Debilitating Conditions Including Arthritis ...

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Kell – ASD – 3 day after Stem Cell Treatment Part 2 – Video

By Sykes24Tracey


Kell - ASD - 3 day after Stem Cell Treatment Part 2
For more information about ASD and Stem Cell Therapy, please visit worldstemcells.com © 2012 World Stem Cells LLCFrom:WorldStem CellsViews:2 2ratingsTime:17:14More inScience Technology

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Making Stem Cell Thearpy Safer – Mayo Clinic – Video

By daniellenierenberg


Making Stem Cell Thearpy Safer - Mayo Clinic
Mayo Clinic researchers have found a way to detect and eliminate potentially troublemaking stem cells to make stem cell therapy safer. Induced Pluripotent Stem cells, also known as iPS cells, are bioengineered from adult tissues to have properties of embryonic stem cells, which have the unlimited capacity to differentiate and grow into any desired types of cells, such as skin, brain, lung and heart cells. Study Author, Dr. Timothy Nelson provides and overview.From:mayoclinicViews:45 0ratingsTime:02:04More inScience Technology

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Precision StemCell's Neural Reprogrammed Stem Cell Therapy Yields Better-Than-Expected Results for ALS Patients

By JoanneRUSSELL25

GULF SHORES, Ala., Dec. 4, 2012 /PRNewswire/ --More than 75 percent of amyotrophic lateral sclerosis (ALS) patients who received neural reprogrammed stem cell therapy have shown a positive response to the procedure. The groundbreaking technique was introduced to the United States this year by Precision StemCell (http://www.precisionstemcell.com), an outpatient imaging and image-guided treatment facility located in Gulf Shores, Ala.

The procedure is performed by Dr. Jason R. Williams, a board-certified radiologist with extensive training in image-guided procedures. Under his care, 14 out of 18 patients diagnosed with ALS, also known as Lou Gehrig's disease, have shown signs of recovery.

"The improvements are mild, with patients reporting improved movement, breathing and speech, but we still have a long way to go," Dr. Williams stated. "Only time will tell how this therapy will affect the patients' long-term prognosis."

In Precision StemCell's neural reprogrammed stem cell therapy, fat-derived stem cells are injected into the spine of the patient. Dr. Williams uses a drug called selegeline, which has been shown to be a pre-inducer of adipose-derived stem cells into neural-like cells. Dr. Williams contends that the therapy is probably one of the largest advances seen in ALS therapy. "Before we started this therapy, I would have been happy just to see the progression of the disease halted, but to see some actual improvement, that was just shocking," he said

The first patient treated with the technique was Frank Orgel who continues to see improvement since his first treatment seven months ago. Eight years ago, Orgel's quality of life had declined to the point that he could not move his left arm or leg, walk or even stand on his own. The therapy has allowed Orgel to stand without assistance, and he continues to work with a physical therapist to regain the ability to walk. Another patient, Dexter Johnson, previously walked with a cane. After the treatment, Johnson has been able to walk without his cane for the majority of the time and he has been able to walk at a much faster pace.

The Precision StemCell center focuses on advanced imaging techniques, which include a 3T Open MRI, a low-dose 64-Slice CT Scanner, ultrasound and fluoroscopy, also known as real-time x-ray. The center is headed by Dr. Williams, who specializes in image-guided procedures, had already been performing magnetic resonance imaging (MRI), computed tomography (CT), ultrasound and fluoroscopy-guided stem cell injections for joint and orthopedic conditions.

In addition to their current work on advanced stem cell harvesting and processing with image-guided stem cell injections, Precision StemCell staff are planning to conduct further research so as to develop even more advanced techniques such as adding gene therapy to the current neural reprogramming platform. "Our therapy techniques not only hold promise for ALS patients, but also for people with other neural-related conditions such as Parkinson's and spinal cord injuries," said Dr. Williams. "There are several candidate genes that we plan to add to the adipose-derived stem cells and study in the mouse model. Though we are happy with our initial progress, our goal is to develop an effective cure."

About Precision StemCell

Located in Gulf Shores, Alabama, Precision StemCell conducts stem cell procedures using advanced imaging techniques, which include an Open 3T MRI, a low-dose 64-Slice CT scanner, ultrasound, and real time x-ray (fluoroscopy). Headed by Jason Williams, MD, a board-certified radiologist with extensive training in image-guided procedures, the facility performs advanced stem cell harvesting and processing with image-guided stem cell injections.

Contact:

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.Rejuvenare Stem Cell Therapy 888-988-5456 – Video

By JoanneRUSSELL25


.Rejuvenare Stem Cell Therapy 888-988-5456
Rejuvenare Autologous Adult Stem Cell Therapy welcome video asks and answers questions on whether someone is a candidate for stem cell therapy. More can be found at http://www.rejuvenare.comFrom:rejuvenareViews:2 0ratingsTime:01:01More inPeople Blogs

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NeoStem to Present at Multiple Conferences in December

By Sykes24Tracey

NEW YORK, Dec. 3, 2012 (GLOBE NEWSWIRE) -- NeoStem, Inc. (NYSE MKT:NBS) ("NeoStem" or the "Company"), an emerging leader in the fast growing cell therapy market, today announced that the Company and its subsidiary, Progenitor Cell Therapy ("PCT"), will present at multiple conferences in December.

World Stem Cell Summit

RedChip Small-Cap Equities Virtual Conference

Cell Therapy Manufacturing (Informa Life Sciences' 3rd Annual VIC Congress 2012)

American Society of Hematology Annual Meeting and Exposition ("ASH")

NeoStem's abstract on VSELTM Technology titled "A Lin-CD45-CD34+ Population of Extracellular Vesicles in Human Blood That Mimics Very Small Embryonic-Like Stem Cells (VSELs) by Flow Cytometry" has been selected for publication online in December in conjunction with the ASH Annual Meeting and Exposition, December 8-11, 2012. The abstract will be available at http://bloodjournal.hematologylibrary.org/site/misc/ASH_Meeting_Abstracts_Info.xhtml.

About NeoStem, Inc.

NeoStem, continues to develop and build on its core capabilities in cell therapy, capitalizing on the paradigm shift occurring in medicine. We anticipate that cell therapy will have a significant role in the fight against chronic disease and in lessening the economic burden that these diseases pose to modern society. We are emerging as a technology and market leading company in this fast developing cell therapy industry. Our multi-faceted business strategy combines a state-of-the-art contract development and manufacturing subsidiary, PCT, with a medically important cell therapy product development program, enabling near and long-term revenue growth opportunities. We believe that, with our expertise and research capabilities and collaborations, we will achieve our mission of becoming a premier cell therapy company.

Our contract development and manufacturing service business supports the development of proprietary cell therapy products. NeoStem's most clinically advanced therapeutic, AMR-001, is being developed at Amorcyte, LLC ("Amorcyte"), which we acquired in October 2011. Amorcyte is developing a cell therapy for the treatment of cardiovascular disease and is enrolling patients in a Phase 2 trial to investigate AMR-001's efficacy in preserving heart function after a heart attack. Athelos Corporation ("Athelos"), which is 80%-owned by our subsidiary, PCT, is collaborating with Becton-Dickinson in the early clinical exploration of a T-cell therapy for autoimmune conditions. In addition, pre-clinical assets include our VSELTM Technology platform as well as our mesenchymal stem cell product candidate for regenerative medicine. Our service business and pipeline of proprietary cell therapy products work in concert to create a competitive advantage that we believe is unique to the biotechnology and pharmaceutical industries. Supported by an experienced scientific and business management team and a substantial intellectual property estate, we are well positioned to succeed.

For more information, please visit http://www.neostem.com.

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NeoStem to Present at Multiple Conferences in December

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Biotechnology: Things you should know about Gene Therapy

By Dr. Matthew Watson

Introduction

Genetic disorders are becoming common nowadays due to stressful modern lifestyle. Latest technologies are the added values to create many genetic disorders. To overcome the disorders, Gene therapy is a blessing. In order to compensate abnormal genes and make a good gene, genetic material is introduced into cells. In this way, mutated gene will act as a normal gene. Let us see in detail.

Ways to insert the gene

There are indirect ways need to be followed to make a gene to function as if it is inserted directly does not function. Carrier also called as vector is used to deliver the gene. In the place of vectors, virus play the role as they are getting modified and hence people are not affected with new diseases when it is integrated into the chromosome of the human cell.

The vectors need to get injected to specific tissue in the body or outwardly patient’s cell is removed and exposed to the vector. In either of the ways need to be again returned to the patient. Successful treatment makes proper genes and genetic disorders get solved.

Gene therapy for treating cancer

Cancer is the dangerous disease and there are many ways to cure cancer including surgery, chemotherapy, and radiation. But cancerous cells in due course again spread and hence it is a deadly disease. Gene therapy is the best way discovered nowadays for treating cancer.
Let us see the basic fundamentals of cells. cells include packets of data in genes, created either from DNA or RNA. Sequence is there for DNA and if it is in the order, there will be no problem. But at the same time If there is disorder occurs in portion of the genes either turning or changing the position, cells lost their control and abnormal growth is seen which result in cancerous tumors. It can spread in mouth, breast, lung etc.,

Specialists in Gene therapy analyze the patient’s criticality first and follow the treatment procedures. One way is they replace missing or mutated genes into wholesome genes. Inserting totally new genes for fighting cancer, placing DNA into cancerous cells to undergo chemotherapy and radiation or injecting bad gene to destroy them etc., Mesothelioma type of cancers are not at all responded in formal therapies and hence one need to undergo gene therapy essentially. Need to have consultations with doctors to overcome their deadly disease.

Gene therapy importance

Doctors decide whether gene therapy is suitable by the following approaches. If genetic disorders are from mutations in one or more genes or whether a normal copy of the gene that is available in the patient is enough to fix the problems in the affected cells, then doctors determine that gene therapy will be more helpful rather than going for traditional methods.

Conclusion

Genetic engineering is a vast topic. Latest Science innovations in the field of genetic engineering yields for gene therapy. Doctors and scientists together working to find out whether gene therapy is the best suitable way for treating deadly diseases like cancer and others. Let us salute for the positive force of gene therapy.

 

Source:
http://www.biotechblog.org/entry/biotechnology-gene-therapy/

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Gene Patents Draw High Court Review in Biotechnology Test – Businessweek

By Dr. Matthew Watson


Today's THV
Gene Patents Draw High Court Review in Biotechnology Test
Businessweek
The U.S. Supreme Court agreed to consider whether human genes can be patented, taking up an issue that has split the medical community and will shape the future of personalized health care and the biotechnology industry. The justices yesterday said ...
US Supreme Court to Review Patents on Human GenesWall Street Journal
Supremes to Decide Others Can Own Your GenesNational Review Online (blog)
US top court to rule if companies can patent genesAFP
Philadelphia Inquirer
all 313 news articles »

Source:
http://news.google.com/news/url?sa=t&fd=R&usg=AFQjCNHkE9GDvUDADfqatAhvvW4OD3C8XA&url=http://www.businessweek.com/news/2012-11-30/gene-patents-draw-high-court-review-in-biotechnology-test

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DuBiotech: The Silicon Valley of Biotechnology – Genetic Engineering News

By Dr. Matthew Watson


Genetic Engineering News
DuBiotech: The Silicon Valley of Biotechnology
Genetic Engineering News
Ahmed Taha from DuBiotech, the Dubai Biotechnology & Research Park, has two questions for GEN readers: “Do you have a biotech idea that you'd like to develop rapidly, conveniently, and inexpensively?” Or alternatively, “Do you have an existing biotech ...

and more »

Source:
http://news.google.com/news/url?sa=t&fd=R&usg=AFQjCNEk4rtzm46lE_25U_ZbxuqBzc6dnA&url=http://www.genengnews.com/insight-and-intelligence/dubiotech-the-silicon-valley-of-biotechnology/77899729/

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Six steps to fighting non-compliant cell therapy treatments. — The stuff of grey shades, spades, ivory towers and (ahem) balls.

By Dr. Matthew Watson



Today an article entitled "Professors Critique Stem Cell Medical Tourism" appeared in the online version of The Harvard Crimson summarizing a recent panel discussion hosted in least in part by Harvard Law School assistant professor I. Glenn Cohen and University of Alberta law professor Timothy Caulfield.  The article concludes thusly:

The panelists emphasized that more accurate information should be provided to the public regarding stem cell treatments.

Certainly what Cohen and Caulfield concluded is true.  It has now been true for several years.  We keep saying it.  But are we listening to ourselves?  Are we doing anything meaningful to address this?  If so, is it enough?

Sadly (in my opinion, of course) the answer is 'not nearly enough'.*

For several years now, experts and organizations in the cell therapy sector have been saying that more must be done to educate and assist patients who are seeking stem cell or other cell-based treatments which do not comply with existing regulation and/or widely accepted medical or clinical research practices (hereafter called "non-compliant cell therapies").  
In my opinion, attempts to address this need by the sector's professional organizations, while important, have been unnecessarily feeble, not gone nearly far enough, and legitimately appear by many to be high-minded and pedantic. 



Almost all efforts to-date to address this issue by ISSCR, CIRM, ISCT and others including authors such as Caufield - as laudable and needed as they are - have been focused on helping distinguish between compliant and non-compliant treatments (and providers).  This is certainly much needed.  But what is left, I submit, is an even greater unmet need.


What almost all efforts to-date have failed to recognize or address is that where real help is needed is in helping patients distinguish between the many shades of grey among non-compliant treatments (and providers).

Emerging organizations like ICMS (now in partnership with AABB) have recognized and attempted to address this unmet need through a commitment to create some level of certification, accreditation or standardization of clinics participating in this business of selling non-compliant cell therapies.

While their intentions appear on-target as one meaningful way to address this unmet need and certainly their willingness to tackle this issue in a bold way is to be lauded, the ICMS is inexperienced and underfunded.  I remain hopeful that now through their new partnership with AABB they will be able to provide something that really addresses this unmet need but the jury remains out on whether they will succeed.
Anyone who has followed this blog and/or my threads on LinkedIn know I have been thinking about and discussing this issue for some time. In a desire to move to very concrete suggestions, I want to recommend the following 6 steps to my industry colleagues and professional organizations:

1.  50 shades of grey. Let's admit that this issue is not black-and-white but, as is almost always, involves a broad spectrum of grey in the middle.  


In addition to helping patients distinguish between compliant and non-compliant treatments (and providers) there are a lot of ways to help patients distinguish between non-compliant cell therapy  treatments (and providers) which are more or less risky.  


Let me use examples.  

On the one end of the non-compliant spectrum I would put forward a clinical like Okyanos Heart Institute which (as I understand it) intends to provide cell therapy treatments in the Bahamas to US patients using the Cytori system for cardiac conditions as soon as such treatments are perfectly legal and available to European patients but years before such treatments will be available in the US.  
Non-compliant?  Yes.  But certainly no evidence I'm aware of to support a belief that seeking treatment from them would be any more risky than travelling to Europe to receive the same treatment in a manner perfectly compliant with European regulations.
On the other end of the spectrum are the kinds of clinics highlighted recently by 60 minutes or which are the subject of ongoing lawsuits.

In between - in my opinion - are clinics like Stem Cell Institute and StemCellMD.

2.  Step out of the ivory tower.  Let's recognize that in certain circumstances patients are going to go pay for non-compliant cell therapies and we must do more to help these patients than simply shake our finger and tell them they mustn't.
For some, helping patients distinguish between the better and worst non-compliant clinics might involve a fair amount of nose-pinching but this is the equivalent of the methadone clinic for heroine addicts.  By supporting the better of two evils we are not endorsing it as 'good', we are simply recognizing it is better.

This is a recognition that we cannot just abandon people because they made (or are going to make) decisions with which we ultimately disapprove.   It is a recognition that sometimes the most righteous thing to do is not only to help people do what we would ideally want them to do but to help them do the best they can in their circumstances and on their terms - even terms with which we may ultimately disagree.


3.  A risk-based strategy.  Let's recognize that even the FDA triages their response to non-compliance and we would do well to do the same.  As a regulated industry we are perfectly comfortable with risk-based assessments and it should be applied here.  
Rather than treating all non-compliance as equally evil, let's apply some risk-based analysis to the situation and develop a strategy to root out the worst (highest-risk) offenders.  
4.  This is not just about tourism anymore - the problem has come home to roost. Let's recognize that this is no longer just a problem of patients leaving a regulated jurisdiction seeking a non-compliant treatment in a jurisdiction with no or more permissive regulation.  
Non-compliant treatments are growing rapidly even in the most highly regulated jurisdictions.  No where is this more true than in the United States.
5. Take responsibility.  Let's recognize that we cannot expect our regulatory enforcement agencies to do it all.  They are under-staffed and under-funded.  They - and the people we all serve - need our active participation in dealing with offenders and those risking patient safety.  
From a self-interested perspective, we owe it to our industry to help crack down on those who put the credibility and legitimacy of cell therapies at highest risk.
6.  Let's grow a pair and call a spade a spade.  If a non-compliant clinic is providing treatments that we believe represent a high-risk to patient safety and the industry's credibility, let's have the b*lls to call them on it.  They can't sue everyone.  
ISSCR backed down on their stem cell tourism initiative after being threatened by lawsuits. Who has stepped up in their absence?  Individual bloggers and authors like Paul Knoeplfer, Alexey Bresenev, Leigh Turner, and myself all who have been threatened with litigation several times for having the audacity to call certain non-compliant clinics out for what we deem - in our own risk-based analysis - to be the worst offenders.  

By way of example, several of my colleagues have recently committed to doing all they can do to call out David Steenblock and his non-compliant cell therapy treatments, many of which are provided at his clinic in California for a plethora of conditions.  In their opinion, many of his treatments represent some of worst examples of non-compliance in the United States right now.  There are many faces or fronts to his practice including http://www.davidsteenblock.comhttp://www.stemcellmd.org, http://www.strokedoctor.com, http://www.davidsteenblock.net, etc.

If, as an industry, we act with more cohesion (collaboratively applying a risk-based assessment of non-compliant clinics) and speak with a more cohesive voice in terms of calling out those clinics and treatments which we conclude pose the greatest risk based on an objective set of criterion, this will present a multi-pronged, formidable and existential threat to clinics that they can't ignore or threaten away.
___

I will be taking these 6 recommendations to any organization who will listen.  I hope you will consider doing the same.



In the meantime - as always - I welcome your comments.


___

* This is my opinion not necessarily the opinion of any clients I represent or organizations I serve. Judge me - not them - accordingly.


Source:
http://feedproxy.google.com/~r/CellTherapyBlog/~3/2b8Ffw4b1pU/six-steps-to-fighting-non-compliant.html

To Read More: Six steps to fighting non-compliant cell therapy treatments. — The stuff of grey shades, spades, ivory towers and (ahem) balls.
categoriaRegenerative Medicine commentoComments Off on Six steps to fighting non-compliant cell therapy treatments. — The stuff of grey shades, spades, ivory towers and (ahem) balls. | dataDecember 2nd, 2012
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World Changing Ideas 2012 (preview)

By Dr. Matthew Watson

Scientists and engineers dream about big advances that could change the world, and then they try to create them. On the following pages, Scientific American reveals 10 innovations that could be game changers: an artificial alternative to DNA, oil that cleans water, pacemakers powered by our blood, and more. These are not pie-in-the-sky notions but practical breakthroughs that have been proved or prototyped and are poised to scale up greatly. Each has the potential to make what may now seem impossible possible. -- The Editors

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Source:
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To Read More: World Changing Ideas 2012 (preview)
categoriaUncategorized commentoComments Off on World Changing Ideas 2012 (preview) | dataDecember 2nd, 2012
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Stem Cell Board Members Lubin and Sheehy Honored

By Dr. Matthew Watson


A couple of members of the governing
board of the $3 billion California stem cell agency were honored for
their work this month.

Jeff Sheehy
UCSF Photo
One is Jeff Sheehy, a UCSF
communications manager and nationally known HIV/AIDS advocate, who
has served on the CIRM board since its inception. He was named by POZ
magazine as one of the top 100 “soldiers” in the fight against
HIV/AIDS.
CIRM's Amy Adams filed an item on
Sheehy on the agency's blog yesterday. She said, 

“Jeff once told me
that when he joined CIRM’s board eight years ago, he didn’t see a
role for stem cells in an HIV/AIDS treatment. Now, CIRM has committed
$40 million toward HIV/AIDS projects and two teams of researchers
from City
of Hope 
and UCLA are
working toward clinical trials.”

Sheehy was also invited to the White
House to commemorate World AIDs day Dec. 1.
Bert Lubin
Childrens Hospital Photo
Also honored was Bert Lubin, CEO of
Childrens Hospital in Oakland, where he has worked since 1973, a
remarkable achievement in today's world of transitory employment. The
San Francisco Business Times named Lubin as the “most admiredCEO” in the San Francisco Bay Area. The newspaper said that since
he took charge at Childrens in 2009,

“He recruited a new senior management
team, chopped away at the pediatric hospital’s operating deficit
and worked to heal relationships with the local community and
governmental and political leaders that were deeply frayed...”

On a personal note, a friend who has
long volunteered at Childrens gives him high marks as well, citing
several encounters where he exceeded the usual CEO effort.

Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/9b9s3mW2ebM/stem-cell-board-members-lubin-and.html

To Read More: Stem Cell Board Members Lubin and Sheehy Honored
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Diane Winokur, Veteran ALS Patient Advocate, Named to California Stem Cell Agency Board

By Dr. Matthew Watson


Longtime ALS patient advocate Diane
Winokur
of San Francisco, who has lost two sons to the disease, has
been appointed to the governing board of the $3 billion California
stem cell agency.

She fills the vacancy left by David
Serrano Sewell
, who resigned from the 29-member panel earlier this
year after serving since the agency's inception. CIRM has 10 patient advocates
on its board.
Diane Winokur
Photo -- Legal Momentum
Winokur is well-known in ALS circles.
She sat for five years on the governing board of the national ALS
advocacy group and currently serves on the board for the California
state group, the Golden West chapter. She also served for six years on the board of
trustees for the Sanford- Burnham Institute in La Jolla, which has received $37 million from the stem cell agency. She left Sanford in 2011.
Last summer Winokur appeared before the
CIRM board to successfully seek approval of an $18 million ALS grant
that was rejected by the agency's reviewers. Researcher Clive
Svendsen
of Cedars-Sinai in Los Angeles appealed the denial to the
full board and was supported in emotional testimony by other patient
advocates as well, including persons with the affliction.(See here for video of some of the testimony.)
The agency has awarded about $30.6
million, including the Svendsen grant, for research directly related
to ALS.
Golden
West issued a press release Nov. 21, lauding the Winokur appointment
by California Lt. Gov. Gavin Newsom. The release quoted Lucie Bruijn,
chief scientist of The ALS Association, as saying,

"Her
contributions have been invaluable and she will be a tremendous asset
in moving the ALS research field forward through CIRM
funding."

The stem cell agency posted a blog item
on Winokur's appointment in addition to a press release. CIRM
Chairman J.T. Thomas said,

“Her knowledge, expertise and
leadership will be a tremendous addition to the ICOC (the stem cell
agency governing board) and help guide us in our work.”

Patient advocate Don Reed of Fremont,
Ca., described Winokur in a 2008 blog item as “small, elegant, full
of energy, an exclamation point of a person.”

(Editor's note: Based on information from CIRM and Golden West, an earlier version of this item incorrectly stated that Winokur is a current member of the Sanford-Burnham board.

Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/dITcyP7WJbs/diane-winokur-veteran-als-patient.html

To Read More: Diane Winokur, Veteran ALS Patient Advocate, Named to California Stem Cell Agency Board
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Knoepfler Award Update: More than a Baker’s Dozen Nominated

By Dr. Matthew Watson


As of this week, 14 persons have been
recommended for the Knoepfler “Stem Cell Person of the Year”
Award.

The total was reported by Paul
Knoepfler
, the UC Davis stem cell scientist and blogger, who is
putting up $1,000 for the winner of the honor.
Knoepfler announced his award plans earlier this month, declaring that he wanted to recognize scientists or others who “truly made a difference” in the stem
field. Risk-taking is one important criteria.
Knoepfler said,

“It’s something that I’m hoping I
can do every year. It would also be a reward for risk taking,
creativity and be breaking with tradition and be something new in
that regard.” 

The award has drawn some modest
attention outside of Knoepfler's blog. A few days after he introduced
the award on his blog, UC Davis decided to put out a press release and video on it. The California Stem Cell Report followed with an item. Then CIRM blogged it as well.
So far we have not detected any stories
about the award in the mainstream media, but things could change.
Deadline for entries is Dec. 17.

Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/cLYLc5HQUSY/knoepfler-award-update-more-than-bakers.html

To Read More: Knoepfler Award Update: More than a Baker’s Dozen Nominated
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“Fountain of Youth” technique rejuvenates aging stem cells – Study moves scientists one step closer to creating …

By JoanneRUSSELL25

Study moves scientists one step closer to creating youthful heart patches from old cells

TORONTO, ON A new method of growing cardiac tissue is teaching old stem cells new tricks. The discovery, which transforms aged stem cells into cells that function like much younger ones, may one day enable scientists to grow cardiac patches for damaged or diseased hearts from a patients own stem cellsno matter what age the patientwhile avoiding the threat of rejection.

Stem cell therapies involving donated bone marrow stem cells run the risk of patient rejection in a portion of the population, argues Milica Radisic, Canada Research Chair in Functional Cardiovascular Tissue Engineering at the Institute of Biomaterials and Biomedical Engineering (IBBME) and Associate Professor in the Department of Chemical Engineering and Applied Chemistry at the University of Toronto.

One method of avoiding the risk of rejection has been to use cells derived from a patients own body. But until now, clinical trials of this kind of therapy using elderly patients own cells have not been a viable option, since aged cells tend not to function as well as cells from young patients.

Its a problem that Radisic and her co-researcher, Dr. Ren-Ke Li, think they might have an answer for: by creating the conditions for a fountain of youth reaction within a tissue culture.

Li holds the Canada Research Chair in Cardiac Regeneration and is a Professor in the Division of Cardiovascular Surgery, cross-appointed to IBBME. He is also a Senior Scientist at the Toronto General Research Institute.

Radisic and Li first create a micro-environment that allows heart tissue to grow, with stem cells donated from elderly patients at the Toronto General Hospital.

The cell cultures are then infused with a combination of growth factorscommon factors that cause blood vessel growth and cell proliferationpositioned in such a way within the porous scaffolding that the cells are able to be stimulated by these factors.

Dr. Li and his team then tracked the molecular changes in the tissue patch cells.

We saw certain aging factors turned off, states Li, citing the levels of two molecules in particular, p16 and RGN, which effectively turned back the clock in the cells, returning them to robust and healthy states.

See more here:
“Fountain of Youth” technique rejuvenates aging stem cells - Study moves scientists one step closer to creating ...

To Read More: “Fountain of Youth” technique rejuvenates aging stem cells – Study moves scientists one step closer to creating …
categoriaBone Marrow Stem Cells commentoComments Off on “Fountain of Youth” technique rejuvenates aging stem cells – Study moves scientists one step closer to creating … | dataDecember 1st, 2012
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