Stem Cell Lobbying Group Closing Its Doors After 12 Years - ScienceInsider


In a sign of how much the controversy over human embryonic stem cells (hESCs) has waned, the most prominent lobbying group for hESC research announced today that it is folding after 12 years. The Coalition for the Advancement of Medical Research (CAMR) will transfer its work to another group that focuses on moving hESC research into the clinic.

"We are in an era where the primary issues are not federal funding for human embryonic stem cell research," wrote CAMR President Amy Comstock Rick, who is also CEO of the Parkinson's Action Network, in an e-mail to the more than 100 patient advocacy, scientific, and other groups that belong to CAMR. "Given the progress we are seeing in the field of regenerative medicine, the policy issues we now see go beyond the historical focus of CAMR."

CAMR was founded around when President George W. Bush issued an executive order on 9 August 2001 limiting federal funding for hESC studies to existing cell lines. The coalition pushed for a bill, passed by Congress in 2005 and 2007, that would have removed those limits; Bush vetoed the bill both times. In 2009, the landscape changed when President Barack Obama issued an executive order instructing the National Institutes of Health (NIH) to lift the Bush-era constraints. The number of NIH-approved stem cell lines has since grown from 21 to more than 200, CAMR notes.

In the last couple of years, CAMR wrote amicus briefs supporting NIH's battle against a lawsuit seeking to shut down federally funded hESC research. In January, the U.S. Supreme Court threw out the suit.

Rick notes that little is now happening in Congress on the stem cell front. Even the announcement last week that researchers have achieved the long-sought goal of making personalized hESCs using cloning techniques, which opens the door to cloning a human, hasn't sparked much activity. "It's work to keep a coalition together," she says, and "the field has evolved so that many of the advocacy issues are now Food and Drug Administration issues or [insurance] reimbursement issues." As evidence, she points to recent clinical trials testing hESC-derived treatments for spinal cord injuries and eye diseases.

CAMR will now transfer its mission and resources to the Alliance for Regenerative Medicine, which includes many CAMR members but also has more representation from companies. If funding for hESC research should be threatened again, Rick adds, "ARM will pick up exactly where CAMR left off."

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May 15, 2013

ABSTRACT

Mesenchymal stromal cells (MSCs) are rare progenitor cells that can be isolated from various tissues. They exhibit multilineage differentiation potential, support regenerative processes, and interact with various immune cells. Therefore, MSCs represent a promising tool for regenerative medicine. However, source-dependent and donor-dependent differences of MSC properties including implications on their clinical application are still largely unknown. We evaluated MSCs derived from perinatal tissues umbilical cord (UC) and amniotic membrane (AM) in comparison to adult MSCs from bone marrow (BM) which were used as gold standard. We found genetic background-independent differences between MSCs from UC and AM. While AM- and UC-MSCs were closer to each other than to BM-MSCs, however, they also exhibited differences between each other. AM-MSCs from different donors but not UC-MSCs displayed high inter-donor variability. In addition, we show that although all MSCs expressed similar surface markers, MSC populations from UC and AM showed differential profiles of gene expression and paracrine factor secretion to BM-derived MSCs. Notably, pathway analysis of gene expression data revealed intriguing differences between MSCs suggesting that MSCs from UC and AM possess in general a higher potential of immunomodulatory capacity whereas BM-MSCs showed a higher potential of supporting regenerative processes as exemplified by neuronal differentiation and development. These differences between perinatal and BM-derived MSCs may be relevant for clinical applications.

ACT confirms clinical trial participant showed improvement in vision from 20/400 to 20/40 following treatment

Looks like some well-informed comments accumulating... :300 (231):

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Hey everyone,

I just wanted to let you guys no that our beloved Patti ( pm1469 ) can use our prayers and positive thoughts with her as her husband was scheduled and had surgery performed on him early this morning.

Lets all show her and her husband our support!

In a growing and rapidly developing stem cells, cell and gene therapy industry, more and more companies are starting to shine and present impressive data for promising upcoming approved therapies. The rise of these biotech companies is in great part due to their executive leadership teams.

A few years ago there were just a few companies that could be considered promising in the cell and gene therapy space with a next-to-launch status. But, today more and more companies have been emerging with promising approaches and cell and gene therapies under development.

The top 20 up-and-coming cell and gene therapy influencers contributing to this trend are highlighted in this report.

Selection criteria

This ranking was built based on research conducted with leading and emerging companies working in the stem cells, cell and gene therapies space, as well as regulators, patient groups and academic institutions. The selection criteria included:
• Recent increased clinical attrition
• The ability to deploy capital formation strategies
• Published studies
• Awareness across different markets
• Personal recognition Did we miss anyone? Let us know – I value your feedback!

André Singer
Conference Manager
Stem Cells & Regenerative Medicine Congress
+1 646 619 1797
andre.singer@terrapinn.com


13. Gary Rabin, Chairman & CEO, Advanced Cell Technology

Gary has been at the helm of one of the most exciting new generation stem cell biotechs out there today, Advanced Cell Technology. ACT’s two ES cell-based FDA-approved clinical trials have shown quite promising preliminary safety data and the company holds an impressive pipeline including potentially iPS cell-related products such as platelets.

Gary Rabin's 25-year career in finance and operations has primarily encompassed investing in, managing and raising capital for small-cap and emerging growth companies. From 2007 to 2010, he was Managing Partner at GR Advisors, LLC, a hedge fund focused on media and communications. From 2005 to 2007, he was a Portfolio Manager at MACInvestment Management, LLC ("MAC"), a hedge fund concentrating on technology, communications and healthcare. Prior to that he was a Managing Director and Portfolio Manager at Marketus Associates, a hedge fund focused on communications, healthcare services and energy. Before that, he was Managing Director and Co-Head of the Media and Telecom Investment Banking Group at CIBC World Markets ("CIBC"), where he was responsible for all corporate finance and M&A, financial restructurings and principal investing activities (both debt and equity) within the sector. Before joining CIBC, Mr. Rabin served as Chief Strategy Officer of CAIS Internet, Inc. ("CAIS"), a broadband services company, where he was responsible for securing over $500 million in financing commitments. Mr. Rabin has also served as Managing Director and Head of the Global Telecom Investment Banking Group at ING Barings Furman Selz and was a founder of the telecom group at UBS Securities. He began his career in finance in 1987 and concentrated on energy, utilities and metals until 1993. Mr. Rabin earned an AB in Economics from the University of Michigan.

Gary has been at the helm of one of the most exciting new generation stem cell biotechs out there today, Advanced Cell Technology. ACT’s two ES cell-based FDA-approved clinical trials have shown quite promising preliminary safety data and the company holds an impressive pipeline including potentially iPS cell-related products such as platelets.

Attached Files

• cell-and-gene-therapy-influencers.pdf (1.02 MB)

An experimental stem cell treatment has restored a man's vision so well that his eyesight is considered strong enough for him to be able to drive.

According to New Scientist, the treatment was administered as part of a trial for Advanced Cell Technology, a Massachusetts-based company that has created the technique. The trial has treated 22 people who suffer from either age-related macular degeneration, a relatively common disorder that causes people to develop a black hole in the middle of their line of sight, and Stargardt's macular dystrophy, a hereditary illness that leads to a person becoming blind prematurely. Both conditions strike the retinal pigment epithelial (RPE) cells, which remove the debris that accumulates on the retina and provide nutrients and energy to photoreceptors, which catch light and send signals to the brain. RPE cells are considered vital to sight.

The treatment was just supposed test whether the stem cell technique was safe, but it provided boosts to many of the participants' vision ability. One person saw a particularly dramatic boost. Originally, his vision was measured to be 20/400, which is considered to be virtually blind. After the treatment, his vision was measured to be 20/40, which means that he can see.

"There's a guy walking around who was blind, but now can see," says Gary Rabin, the chief executive officer of Advanced Cell Technology, said to New Scientist. "With that sort of vision, you can have a driver's [license]."

The treatment takes human embryonic stem cells and converts them into RPE cells. Then those cells are implanted into the retina of one of the person's eyes.

Human embryonic stem cells are considered to be quite controversial because of the source, though recent research may eliminate many of the hurdles.

According to io9, for many people who are blind and who regain sight, the new ability is more difficult than sighted people would imagine, because the brain needs to not only be able to see an object but to recognize it. That should be less difficult for the participants in the study, though, who were once able to see.

25. January 2013

In order to further encourage the general field of research involving stem cells, what needs to be done? What gaps still exist?

Matthias Steger:

There are certainly a lot of gaps that need to be filled. At the moment, all we really see are opportunities or potential. We have not seen any evidence yet, either through a disease model or a safety/toxicology model, of something that we can refer to as proof – it has all been models so far. All the models we have used up to now have been animal-based. Validating disease models from patients – for example, when modeling Alzheimer’s disease – can now be done via human models, not mouse models. But is it really possible to model a disease that has been naturally developing over 80 years in five days in a dish? All the pathways can be found, but this does not really reflect the causes of the disease and we still need to have proof of the concept.

There are also the interdependencies of these cell lines – how much is really based on genetics and individuals versus what we can generalize. The question is, how much do we need to make it really reliable?

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What the man is thinking now ?

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Dr Ron - Today, 01:53 PM - permalink
Hi Ceasar and all palace addicts,

I do not believe significant compassionate use will occur until peer reviewed literature supporting such use is published. Also surgeons will need public statements supporting such use from retina surgeon leaders as well as 3rd party support[retinal organizations or American Academy of Ophthalmology]. Operating without such protection would make malpractice risk too high.Remember ALL surgeries have complications. Eventually some patients will experience retinal tears,retinal detachments, and infection--some will experience severe vision loss. These may in no way be related to our cells or surgical negligence.Also remember no informed consent prevents litigation. A patient can not consent to negligence.After a complication patients memories of consent are often far different than the surgeons.Despite watching a consent video,taking a post video quiz in writing,having the surgeon in his own writing document the discussion, initialing each paragraph in the written informed consent , signing the consent in front of witnesses who sign, and writing in their own hand writing that risks and complications have been explained---most patients that sue will claim inadequate informed consent. No consent--bad news for the surgeon.Most cases are won by the doctor.Unfortunately many are caused by other doctors unfamiliar with case telling the patient that" if they only had seen them first" or "you never should have had that surgery".Now imagine our retinal doctor who implanted the rpe cells on the witness stand having to admit that this is not currently standard of care,no surgical organizations support it as such,and there is no or scanty peer reviewed literature to support its use.The patient simply cries that they just wanted to see and that they trusted the surgeon and now its worse. The plaintiff attorney presents horror stories about fraudulent stem cell products harming patients for profit---and this surgeon is one of those heartless greedy scum that could not wait to get the victims cash.Even if the surgeon did nothing wrong---he is in deep trouble with the jury.I had one case go to trial many years ago.Thankfully I won---but it took seven years. Not a day went by without me thinking about it many times.The trial took about a week--a horrible experience despite knowing I had done nothing wrong.In Wisconsin , if a judgement exceeds our private malpractice insurance another fund that we pay into covers the rest--so we never lose personal assets in a settlement. In most states that is not the case. Potentially a surgeon could lose ALL his assets in a large judgement.Even drugs or devices approved by the FDA sometimes will be recalled later as problems show up---lawyers are close behind.Most policies WILL NOT COVER TREATING IN AN UNAPPROVED MANNER.So bankruptcy with any problem could be imminent.Doctors participating in trials are given a degree of protection. Competition to participate in phase 2 will be fierce. But until 3rd party support,peer reviewed articles, and malpractice coverage are present---their will be limited compassionate use.Send all plaintiff malpractice attorneys to the space shuttle ,then we have a different story.

On the bright side, Rabin and our surgeons KNOW THIS. Their strategy will expedite compassionate use in a manner to not only protect surgeons but convince them that this is the NEW STANDARD OF CARE.Patience.
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lou - Today, 02:04 PM - permalink
Dr Ron,

Excellent post!

Lou
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felixthecatatonic - Today, 02:05 PM - permalink
Dr. Ron,

Can you copy and paste to the main thread where this same discussion is going on. If for no other reason, then I can give it a "like."
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Ceasar de Cuenca - Today, 02:09 PM - permalink
Hi Dr. Ron,

I agree with you.

This is the main reason, why I would like the "Compassionate Use Process to Still be Under the Umbrella of a Separate Cohort under the Management of ACTC and the FDA".

Thanks for your note.

Cuenca
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stemboat - Today, 02:12 PM - permalink
I got it, understand and agree.
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Ceasar de Cuenca - Today, 02:12 PM - permalink
Hi Dr. Ron,

Let me move this whole conversation to the main board. Thanks.

Cuenca
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CYTOMEDIX, INC. : CYTOMEDIX TO PRESENT AT THE WORLD STEM CELLS ...
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