14 replies to this topic

[solbanger]

First time iPS has been applied to heart disease. Previously it was used in Parkinsons, sickle cell anemia and hemophilia A.

Quote

In this study, the researchers reprogrammed ordinary fibroblasts, cells that contribute to scars such as those resulting from a heart attack, converting them into stem cells that fix heart damage caused by infarction.

http://www.scienceda...90720163539.htm

[ImmInst]

Heart failure occurs when a damaged heart is weakened
and unable to pump enough blood around the body
(Photo: ALAMY)

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For the first time in human history, cardiac stem cells were used to repair the severely damaged hearts of 16 patients in a trial conducted by researchers from the University of Louisville in the US. "It could offer an entirely new option and a potential cure for patients who are now dying from heart failure," study author Dr. Roberto Bolli, director of cardiology at the University of Louisville in Kentucky. "The results are striking. While we do not yet know why the improvement occurs, we have no doubt now that ejection fraction increased and scarring increased."
The ejection fraction or "pumping efficiency" of the hearts of eight patients had improved by more than a whopping 12%.  These results tripled the 4% improvement the researchers were expecting to see.

"If these results hold up in future studies, I believe this could be the biggest revolution in cardiovascular medicine in my lifetime, " said an impressed Professor Bolli.

The "Schipio" trial included a total of 23 patients, all of whom suffered heart failure due to a previous heart attack.  Seven of these received standard care while the other sixteen were assigned to stem cell therapy. The groundbreaking treatment involved extracting cardiac stem cells (CSCs) from patients during bypass surgery. CSCs are self-renewing cells that rebuild hearts and arteries. After a purification process and a period of growth in the laboratory, the cardiac stem cells are then injected back into damaged regions of the patient's hearts four months later. A million of these CSCs were injected into each patient via a balloon catheter, an expandable device used to open up arteries.
Interestingly, this small Phase I study was primarily designed to assess safety rather than effectiveness of the new, cutting-edge treatment. At the start of the study, the patients had an average left ventricular ejection fraction (LVEF) of 40% or lower. Normal LVEF is 50% or higher. Over a period of 4 months, patients who received the treatment saw an 8.5% improvement in LVEF, increasing to 12.3% after one year. LVEF did not change in the seven patients of the "control" group who did not undergo the cardiac stem cell therapy. MRI scans conducted on  number of patients revealed that cardiac scarring had been reduced.

"Michael Jones, our first patient, could barely walk 30 feet [before treatment]," Dr. John H. Loughran said. "I saw him this morning. He says he plays basketball with his granddaughter, works on his farm, and gets on the treadmill for 30 minutes three times a week. It is stories like that that makes these results really encouraging."

These findings are published in the online edition of The Lancet medical journal and will be presented at the American Heart Association's Scientific Sessions meeting in Orlando, Florida. Now, Professor Bolli and his team intend on applying for funding a much bigger, multi-centre Phase II trial.
Professor Gerd Heusch from the University School of Medicine in Essen, Germany commented on the study in The Lancet: "The results from Scipio raise new optimism because the study is based on rigorous quality standards and the reported benefits are of an unexpected magnitude... we will have to see whether the further data will meet the promises of the present study. More patients will need to be followed up over a longer period."
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Reference:
"Stem Cell Test Is 'biggest Breakthrough in Treating Heart Attacks for a Generation'" The Telegraph. Telegraph Media Group Limited, 14 Nov. 2011. Web. 14 Nov. 2011.
http://www.telegraph...generation.html.

View the full article

[niner]

And yet, today Geron bailed out of the stem cell business, firing a lot of staff and looking for someone to buy their stem cell assets.  They want to concentrate on something with a quicker payoff.  Highly disappointing.  GERN hit a new low in after hours trading.

[Mind]

Sad to hear about the Geron news.

Nice to see the study of human progress in stem cell treatments. I couldn't find the old forum threads about this in a reasonable amount of time, but I remember distinctly several years ago that the first stem cell treatments for heart disease were a failure. They injected the stem cells directly into the heart muscle but then the stem cells died or did not become functional because they were not in an environment conducive to growth. The signalling factors were all coming from an "old" tissue. The stem cells need the correct signalling factors from the stem cell niche in order to "do their thing'. (I think I remember now, this information might have been from the ending aging conference 3 years ago)

Anyway, it seems this new result also came from a "brute force' method of just injecting stem cells into the heart. I wonder if they used some supportive signalling factors to make this trial more successful. Does anyone know?

[dasheenster]

in 2002, already, it was known that heart microvessels and mycardial tissue could be regrown in mice using stem cell therapy. "With further studies, these cells could provide a source of human endothelial cells that could be beneficial for potential applications such as engineering new blood vessels, endothelial cell transplantation into the heart for myocardial regeneration, and induction of angiogenesis for treatment of regional ischemia" (http://www.pnas.org/...pe2=tf_ipsecsha).

in 2004, it was shown that a similar technique of therapy could potentially work in humans (http://circres.ahajo...pe2=tf_ipsecsha).

comprehensive guide to cardiac stem cells:
http://physrev.physi.../85/4/1373.full

it would be nice to have more up-to-date info on stem cell therapy.

[Mind]

I know there are hundreds of thousands of heart disease patients in the U.S. alone that would jump at the chance to see this type of improvement with the stem cell treatment. How do we move this forward? How do we alert more of the medical community? How can we improve upon it? Do we know any researchers with grants and available patients?

[Florin Clapa]

According to media reports, the difference between this successful trial and others that produced mixed results was in the kinds of cells that they used—more specialized cardiac stem cells instead of stem cells derived from bone marrow. The reason that bone stem cells were used for the less successful trials was that those kind of stem cells are much easier to extract and prepare.

[Florin Clapa]

I'm beginning to think that most of us have only two ways to make a significant difference. First, we can encourage mainstream researchers and organizations to pursue underfunded areas of SENS research such as ApoptoSENS (i.e., killing off senescent cells), GlycoSENS (i.e., breaking protein cross-links), and LysoSENS (e.g., getting rid of atherosclerotic lesions) and certain areas of AmyloSENS (e.g., getting rid of amyloids that lead to organ dysfunction) and RepleniSENS (i.e., rejuvenating the immune system). MitoSENS probably won't be popular with the mainstream since it's not linked to any age-related disease that other approaches won't take care of (except for high blood pressure perhaps). OncoSENS (i.e., curing cancer) has massive amounts of mainstream funding, but most of it doesn't seem to be going toward innovative research and WILT seems too hard to be appealing. Second, those that have the means might want to donate really large amounts every year for a few years to fund those underfunded SENS strands (which have a gigantic deficient of about $59 to $99 million per year every year according to Aubrey de Grey) as quickly as possible. For instance, if 1,000 people donated $10k every year for three years, that would total $30 million. Yes, I know that seemingly similar Facebook Causes haven't been successful, but those weren't quite the same. They asked a lot of people to donate small amounts; this effort would ask a relatively small number of hardcore SENS supporters to donate a large amount. Anyhow, it should be tried since it seems that there's nothing to lose.

[mpe]

Its a terrible shame about Geron. The FDA fucks the people of the USA and a large section of the world yet again. I know the US is the wealthiest market in the world, but maybe its about time companies like Geron turned their backs on the US and developed their technologies for the rest of the world. After all the US is only 350 million, the human population is 7 billion.

Reason at Fight Aging is absolutely right
"The US Food and Drug Administration is a ball and chain holding back progress; its policies form a straitjacket of regulation that is heavy and stifling even by modern Western standards of governance, in which bureaucratic bodies intervene aggressively in near every aspect of life and economic activity. Interventions in clinical development, scientific research, and application of medical products impose staggering costs, and so what little can get through the onerous FDA process is made very expensive. But costs come in more forms than just the financial - there are the many beneficial forms of medicine that are simply not developed, or that exist but are not available in the US because FDA regulations make it impossible to offer them profitably. There is the research that is not funded because the end results cannot be brought to the clinic under present FDA rules.
That last point is particularly important for longevity science and the future of rejuvenation biotechnology. It is illegal in the US to bring therapies for aging to the clinic, because the FDA doesn't recognize aging as a legitimate use for medicine. Medical research moves fast these days, but it can still take five to ten years and millions of dollars in lining lobbyists' and politicians' pockets to get the FDA to recognize a new medical condition - which is only the start of spending hundreds of millions more to jump through the largely unnecessary hurdles of clinical trials as they are presently structured.
The FDA, like all bureaucratic organizations, long ago came to serve its own continuance above and beyond all other goals. Its own continuance as a political organization depends on releasing as few new medical advances as possible. Approval of medicine that never causes problems gains the bureaucrats no reward, while approval of medicine that does at some point cause problems results in punishment - there is no such thing as an absolutely safe medicine, of course, and the popular media will pillory the FDA for events that are well within the expected range of risk and reward in medicine. A low rate of approval of new technologies causes little harm to the bureaucrats, in comparison, and thus is acceptable for their needs, which is to say a job and a career. Thus the self-interest of those in charge of the FDA at all levels leads to an organization structured to actively sabotage its original goals; this is more or less the place in which all government organizations wind up.
In any case, here is an example of the cost of the FDA, with some numbers, and a line of research abandoned as being too expensive under the present regulations:

Quote:Biotechnology firm Geron said last night that it would discontinue its stem-cell research program and halt a pioneering clinical study in people with spinal-cord injury. The decision brings to a halt the world's largest and longest-running program to develop medical treatments from embryonic stem cells, versatile cells able to form many other types of human tissue.
...
The company denied it had given up on stem cells for scientific reasons. "We're not doing this because we were souring on the field, or as a result of any problems - we have not had any safety issues at all," Scarlett told Bloomberg news.
...
The attempt to study stem cells in humans had proved stupendously expensive and slow-moving for Geron. The company estimated that it spent $45 million just to win FDA approval for the initial safety trial of its treatment, known as GRNOPC1. As of October, however, only four patients had been treated, and the company would have had to spend tens of millions more in order to finish the study.

We can be fairly certain that, because embryonic stem cells were a political topic for some years, career-minded heads at the FDA found all sorts of ways to make it more costly for Geron to satisfy their requirements, and at greater cost. If a bureaucrat sees a raised likelihood of review, blame, and greater attention, then he will require far more effort from those he is regulating. More data, more cast iron assurances, more studies, and so forth. Though of course if you read much of the mainstream press on the topic, you'll see no commentary on the role of the FDA and the related costs in this end result. A cynic would not be surprised."

[Florin Clapa]

Florin Clapa, on 16 November 2011 - 11:55 PM, said:

...underfunded SENS strands (which have a gigantic deficient of about $59 to $99 million per year every year according to Aubrey de Grey)....

Correction: $49 to $99 million

[dasheenster]

Not to get political, but I feel as if the worker bees of society are largely powerless to help the great problems of the world. I think Ron Paul offers a good amount of hope for the world compared to other candidates.

[Mind]

I hate to derail this topic from the science of it (even more) but I want to also offer a possible route to spurring further research and treatments in specific areas, such as this stem cell treatment. By the way Florin, good job plugging SENS funding.

Perhaps we could make heart disease patients more aware of this treatment. I am sure this news created quite a stir in many circles but not among the hundreds of thousands of patients who are not all that plugged into the health media/internet nexus. If we could get a large percentage of these people, in desperate need of effective treatment to start asking for it, then maybe there would be some faster movement. Perhaps we could contact heart disease support groups, or patient networks, heart disease charities, etc... and tell them to turn UP THE VOLUME! If more people were asking "how come I can't get this treatment?", maybe more trials would ensue, more lives could be extended.

[Florin Clapa]

The first people to reach should probably be the ones that make the research and funding decisions. Going after patients would take much longer.

Since stem cell research (i.e., RepleniSENS) is relatively well-funded, the focus should mostly be on the under-funded SENS strands that I've mentioned earlier.

Edited by Florin Clapa, 18 November 2011 - 03:58 AM.

[dennis]

Mind, on 17 November 2011 - 10:07 PM, said:

Perhaps we could make heart disease patients more aware of this treatment. I am sure this news created quite a stir in many circles but not among the hundreds of thousands of patients who are not all that plugged into the health media/internet nexus. If we could get a large percentage of these people, in desperate need of effective treatment to start asking for it, then maybe there would be some faster movement. Perhaps we could contact heart disease support groups, or patient networks, heart disease charities, etc... and tell them to turn UP THE VOLUME! If more people were asking "how come I can't get this treatment?", maybe more trials would ensue, more lives could be extended.

Yes there is merit to the approach. Would patients in heart health forums (if there are such forums) be a first possible line of action?

[dennis]

niner, on 15 November 2011 - 05:18 AM, said:

And yet, today Geron bailed out of the stem cell business, firing a lot of staff and looking for someone to buy their stem cell assets.  They want to concentrate on something with a quicker payoff.  Highly disappointing.  GERN hit a new low in after hours trading.

Warning - the following note is refers to stuff that is a bit political, but on occasions it may help us understand certain things in it's context.
The news of Geron pulling the plug on (embryonic) stem cell trail may not be a surpise to some. While this somewhat political document:
http://www.vescell.c...illion-Scam.pdf
calls the whole embryonic stem cell thing a scam. I think it's simply to do with the way research proceeds - some areas just turn up as a dead end.

On a  side note I've been trying to access the credibility of www.vescell.com (see this thread of mine: http://www.longecity...anyone-who-has/ ) and it is in this context that I came across that document.

It would be a pity if http://www.vescell.com did offer  treatment that is clearly more beneficial than mainstream treatments. Documents like that (written by the founder of that hospital) in my mind obscure tangible services they offer. Or  may be the guy who wrote it is indeed justified in doing so - I should not judge. I would have be as furious if people ignored me if I'm on to something that is clearly more beneficial than mainstream treatments.