|9/1/2011 11:00:24 AM
(Reuters) - A pioneering clinical trial to inject stem cells into the brains of patients disabled by stroke has been cleared to progress to the next stage after the treatment raised no safety concerns in the first three candidates. ReNeuron Group PLC, the British biotech behind the trial, said the independent Data Safety Monitoring Board had reviewed safety data from its ReN001 stem cell therapy and recommended the trial advance to the higher dose.
"Data from the laboratory safety tests, neurological examinations and neurofunctional tests conducted thus far indicate that the ReN001 treatment is safe and well-tolerated at the initial dose," the company said in a statement on Thursday.
The procedure involves injecting ReNeuron's neural stem cells into patients' brains in the hope they will repair areas damaged by stroke, thereby improving both mental and physical function.
It uses stem cells derived from human fetuses rather than embryos, which were used in a stem cell trial to treat patients with spinal cord injuries by Geron Corp of the United States.
ReNeuron's chief executive Michael Hunt said the clearance was an important milestone, and the preliminary data also backed up the group's other therapeutic programs using the CTX neural stem cell line that formed the basis of the ReN001 stroke treatment.
The principal investigator for the trial, Keith Muir from the University of Glasgow's Institute of Neuroscience and Psychology, said he looked forward to evaluating further patients at a higher dose.
"ReN001 has the potential to address a very significant unmet medical need in disabled stroke patients and I am pleased that our team is involved in this pioneering clinical trial," he said.
Shares in ReNeuron rose 3.3 percent in early trade.
Analysts at Matrix said ReNeuron was making excellent progress within the trial, which it believed could set the company apart from other stem-cell companies in the field, given the other advantages it has in terms of manufacturing, scalability and the off-the-shelf nature of the technology.
"The data generated thus far are all the more remarkable, in our view, given the fact that the patients receiving the cells have not been subject to immunosuppression" they said in a note.
"We look forward to the data from the next cohort within this study."
(Reporting by Paul Sandle; Editing by Helen Massy-Beresford)
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|To: Savant who wrote (3307)
|9/2/2011 1:15:02 PM
|Rick Perry's Stem Cell Opportunity
A post-partisan issue emerges for 2012.
September 2, 2011 - 12:04 am - by Julia Szabo
I am one of a growing number of Americans who find themselves increasingly frustrated with the low-tech surgical options available in this country for certain chronic medical conditions. To achieve an improved quality of life I’m willing to travel abroad for treatment, despite the fact that it’s not covered by health insurance providers. I’m in high-profile company: in early July Texas’ governor and presidential candidate Rick Perry traveled outside the United States to undergo spinal fusion surgery. The procedure included an injection of his own, adult (autologous) stem cells.
Unfortunately for his fellow Americans whose lives would be greatly improved by access to sophisticated stem cell therapy, the mainstream media is treating Perry as it does every other American who bravely goes in search of non-FDA-approved stem cell treatment: not like a pioneer, but a “medical tourist.” As we’ve seen before, the MSM botches all discussions of this important topic, grossly slacking in its duty to report medical advances fairly and accurately, wherever and however they occur.
And so, recent weeks have seen a flurry of news stories frowning on Perry’s decision: “ Doctors Question Perry’s stem cell back treatment” (AP) … “Doctors Wary of Perry’s Stem Cell Treatment” (The Boston Globe)… “Texas Gov. Rick Perry’s Stem Cell Surgery Worries Some…” (L.A. Times)… “Texas Gov. Rick Perry Received Experimental Stem Cell Treatment” (ABC News) … “Rick Perry’s Stem Cell Treatment Causes Medical, Legal Concerns” (Xinhua) … “Rick Perry’s Stem Cell Surgery Could Lead to Quackery” (International Business Times).
As is usually the case with any MSM discussion of stem cell regeneration therapy — especially high-profile cases like Perry’s — the tone of these articles is one of high anxiety and disapproval. Never mind that adult stem cells have been used successfully in countries other than the United States to improve the lives of people with multiple sclerosis and other debilitating diseases. The MSM may be counted on to ridicule and tsk-tsk stem cell success stories, dismissing them as “experimental” and “controversial” (read: dangerous) or outright “quackery.”
MSM news outlets don’t bother to be fair or balanced. They cannot bring themselves to admit that in the past five years more than 50,000 scientific studies on stem cells were published and posted in the National Institutes of Health medical library, according to America’s leading adult stem cell scientist, Dr. Christian Drapeau, MSc, author of Cracking the Stem Cell Code and Stem Cell Theory of Renewal. They don’t bother to float the suggestion that maybe, just maybe, stem cell regeneration therapy is not quackery at all.
No, the MSM is too busy quoting the ISSCR — the International Society for Stem Cell Research — whose members all support embryonic stem cell research and slam adult stem cell medicine. The ISSCR happens to be the MSM’s go-to quote factory. Here’s Dr. George Q. Daley of Children’s Hospital Boston and the Harvard Stem Cell Institute, a past president of ISSCR, on the governor’s decision to undergo adult stem cell treatment, as quoted by AP:
As a highly influential person of power, Perry’s actions have the unfortunate potential to push desperate patients into the clinics of quacks. … I would never in a million years accept for one of my family members to undergo this.
Substituting opinion for facts, most of the recent articles on Perry’s procedure neglect to mention the names and exact locations of the hospitals that offer adult stem cell treatment — you’d think they would, just to start a guessing game — and Perry isn’t talking. Instead of making it hard for readers to find the doctors who could help them, the MSM should rather do a public service by featuring the facilities around the globe that are pioneering this health technology.
Perry knew exactly where to go: outside the country. A longtime proponent of adult stem cell medicine, Perry urged the Texas Medical Board to consider enhancing the state’s position on adult stem cell research. In his 2009 State of the State address, Perry called for greater investment in the adult stem cell industry and displayed real leadership material:
Let’s get Texas in on the ground floor and invest in adult stem cell research, the one area of that field that is actually proven to expedite cures. Expertise in this emerging and increasingly promising field will not only bring healing to the suffering and create jobs for Texans, it will also establish an appropriate firewall protecting the unborn from exploitation.
It’s refreshing to hear a presidential candidate discuss this topic with such clarity. The MSM, on the other hand, spreads confusion about cell medicine, promoting the widespread misconception that all stem cells come from dead fetuses and treating all adult stem cell procedures like so many back-alley abortions — even if the patient is a right-wing Christian presidential candidate. In fact, the MSM studiously avoids the subject of stem cells — unless, that is, you’re talking embryonic stem cells.
These are the controversial cells, harvested from dead human fetuses, that most people presume to be the foundation of all cell medicine. For the MSM, embryonic stem cells are not quackery; they are cool, cutting-edge, sexy. They are headline-grabbers. They have the highly mediagenic property of “pluripotency” – i.e., the ability to morph into any type of cell in the body. Adult stem cells are proven more effective and less risky than embryonic cells. And yet, only embryonic stem cells and their supporters merit coverage in the MSM, despite the fact that fetal cells do not perform successfully in clinical trials, as adult stem cells do.
As we’ve seen before, pro-life doesn’t have to mean anti-science. The Vatican — which opposes embryonic stem cell research for the obvious reason that it involves the destruction of human fetuses — strongly supports adult stem cell research.
The MSM is biased against compelling facts like these. Instead of hailing this moment in medical history as the first to see science and religion on the same page, the MSM remains queasy about reporting on non-embryonic stem cells that are pro-life. Doing so would blur a church-state line by promoting a medical therapy approved by religious entities and individuals.
But adult stem cells aren’t just ethically correct, as Perry points out; they are more therapeutically effective than embryonic cells which replicate indefinitely (not unlike cancer cells). There’s a wide generation gap between adult tissue and embryonic cells, as Dr. Fabio Solano, a Costa Rican physician, explains: “Adult stem cells play a natural role in repair of damaged tissue in the adult; in contrast, fetal stem cells do not properly ‘know’ how to communicate with adult tissue.” Plus, when harvested from the patient’s own fat, adult stem cells carry no risk of rejection.
Like so many patients who have experienced first-hand the healing power of adult stem cells, Perry has an opportunity — a divine calling, if you will — to become a medical evangelist, to speak out on behalf of Americans like himself who would also benefit from cellular medicine. Let’s hope he will make the most of it by 1) morally supporting his fellow Americans who also seek medical help that simply isn’t available in the United States; 2) putting pressure on the FDA to approve the medical use of adult stem cells, pronto; and 3) strategizing a viable plan for increasing employment opportunity by keeping American patient spending on U.S. shores.
What the governor has here is a rare opportunity to win new followers on both sides of the political fence. Voters on the Christian Right are an easy sell — it so happens that many Americans who travel abroad for stem cell therapy are, like Perry, devout Christian churchgoers — but I wager that even some agnostic Democrats would started taking “Governor Goodhair” seriously too, especially if they or their loved ones are coping with a chronic disease that can most efficiently be treated with adult stem cells.
I voted for Obama (I know, I know), but I’ll campaign for Perry if he makes a solemn promise to get adult stem cells approved by the FDA.
Journalist and author Julia Szabo wrote the Pets column for the Sunday New York Post, for 11 years and now pens the "Living With Dogs" column for Dogster.com. Follow her on Twitter @PetReporter1
Perry, Allies Lay Groundwork for TX Stem Cell Industry by Emily Ramshaw 8/4/2011
Over the last two months, Rick Perry, a state representative with multiple sclerosis and the spine surgeon who performed the governor's July 1 adult stem cell infusion have been laying the foundation for the commercialization of the controversial procedure in Texas.
In the month before Dr. Stanley Jones injected Perry with his own lab-grown stem cells during a spinal fusion — designed to speed recovery of the possible presidential hopeful’s back injury — lawmakers passed a health care bill that quietly authorized creation of a state adult stem cell bank. That amendment was added, with input from the governor’s office, by Rep. Rick Hardcastle, R-Vernon, who has MS and says he is about to start receiving stem cell infusions from Jones as part of a new human trial.
And in the weeks since Perry’s stem cell infusion, the Texas Medical Board has held a stakeholder meeting — largely at the governor's and Jones’ direction — to discuss how to regulate the procedure in Texas. It’s pretty clear where Perry stands: Two days before last week’s Medical Board meeting, Perry sent a letter to the board chair espousing the economic and life-altering potential of adult stem cells and asking members to recognize “the sound science and good work that is already being done” as they consider new regulations.
Injecting patients with their own stem cells is a hotly debated practice: While some physicians swear by the procedure’s restorative properties, others argue it has little clinical evidence of success. The procedure has sparked a national debate over where doctors’ medical autonomy ends and FDA regulation begins.
Central to the debate in Texas is Jones, a Houston orthopedic surgeon and personal friend of both Perry's and Hardcastle's who believes he was cured of debilitating arthritis by having an infusion of his own stem cells in Japan. Jones is working, along with a Korean company best known for cloning dogs and marketing “stem cell cosmetics,” to launch the adult stem cell business in Texas.
A first step could be a stem cell bank. The amendment Hardcastle stuck onto an omnibus health care bill during June’s special session authorizes the state’s health and human services commissioner to establish an “autologous” adult stem cell bank — meaning a place for patients to store their own stem cells for future use.
Hardcastle said the governor’s office didn’t ask him to carry it — as the only member of the Legislature with MS, he said, it’s been on his mind for “a long time” — but one of the governor’s staffers did advise him on it. Somewhat involved, Hardcastle said, was Jones, who has already removed some of Hardcastle’s stem cells to prepare them for re-injection.
A spokeswoman with the Health and Human Services Commission said the agency is in the very early stages of considering whether to create the stem cell bank. A few weeks ago, the agency received a letter from Houston Reps. Beverly Woolley, a Republican, and Senfronia Thompson, a Democrat, expressing their “serious concern” with the measure, for fear it might hinder the work of public and private scientists.
Meanwhile, Texas Medical Board spokeswoman Leigh Hopper said the regulatory agency held a stem cell stakeholder meeting last week — “at the governor’s behest, via Dr. Jones” — to start dialogue about adult stem cell treatments in Texas. The question? If Americans are — like Jones — increasingly flying all over the world to get promising stem cell treatments, shouldn’t Texas be a scientific and economic center for it?
Perry wrote as much in a letter he sent to Texas Medical Board president Irvin Zeitler Jr., two days before the stakeholder meeting, and three weeks after his own infusion.
“It is my hope that Texas will become the world’s leader in the research and use of adult stem cells,” he wrote.
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|To: FJB who wrote (3308)
|9/3/2011 10:48:04 AM
|That piece doesn't seem to be well researched, or it was a political pump piece.
"It’s refreshing to hear a presidential candidate discuss this topic with such clarity. The MSM, on the other hand, spreads confusion about cell medicine, promoting the widespread misconception that all stem cells come from dead fetuses and treating all adult stem cell procedures like so many back-alley abortions — even if the patient is a right-wing Christian presidential candidate. In fact, the MSM studiously avoids the subject of stem cells — unless, that is, you’re talking embryonic stem cells. "
"The procedure involves injecting ReNeuron's neural stem cells into patients' brains in the hope they will repair areas damaged by stroke, thereby improving both mental and physical function.
It uses stem cells derived from human fetuses rather than embryos, which were used in a stem cell trial to treat patients with spinal cord injuries by Geron Corp of the United States. "
The fact is that a great deal of "adult" stem cell research derives the cells from human fetuses.
"Moral Issues Surrounding the Sources of Stem Cells At present, there are three possible sources of stem cells: adult stem cells derived from pediatric or adult donors; embryo germ cell stem cells ( EG cells) derived from aborted fetuses; and embryonic stem cells ( ES cells) derived from disaggregated preimplantation embryos. The first of these sources poses no special ethical problems for the majority of people. Adults and children can donate tissue so long as the appropriate conditions of consent are respected. Individuals who do not object to induced abortion will be less concerned about the use of EG cells than those opposed to abortion.
The least ethically problematic case would be to harvest stem cells from spontaneously aborted fetuses. There are, however, several obstacles to obtaining useful EG cells from spontaneously aborted tissue. Foremost is the problem of the harvesting healthy cells from fetuses. For the foreseeable future, extracting and culturing stem cells will be more of an art than an established technology. The amount of material that can be derived this way is limited even under the best circumstances. Results from several studies indicate that about 60% of all spontaneous abortions arise as a result of specific fetal anomalies; specific chromosomal abnormalities were identified in about 20% of those. While stem cells with damaged genetic complements may be useful for a limited number of experiments, they are unlikely to be the basis of experiments leading to useful “normal” tissue. Finally, there is the matter of timing. EG cells can only be obtained during a narrow developmental phase, within the first eight weeks after conception. Most spontaneous abortions that occur during this period do not take place in a hospital or clinic where the tissue can be readily obtained."
Which leaves the question that pro-adult stem cell articles never seem to get around to. Where do stem cells for non-autologous treatments come from? The answer seems to be aborted fetuses.
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|To: FJB who wrote (3311)
|9/26/2011 11:45:38 AM
|From: The Ox
|Many capital intensive stocks, like GERN, are getting sold to levels not seen since the Fall 08/winter09 decline.
Long term thinking isn't on most people's to-do-list.
Some will make it, others won't. I don't know enough about their pipeline to address GERN specifically but I do follow quite a few small/micro cap bios and most, if not 90% are being sold off hard. Maybe it's just the stocks I'm following but I tend to doubt it. I believe that it's long term investing that's being sold off. This creates great opportunities to accumulate stocks at very low, if not fire sale prices.
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