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Archive for the ‘Stem Cell Therapy’ Category

Stem Cell Treatment Might Reverse Heart Attack Damage

Tuesday, February 14th, 2012

MONDAY, Feb. 13 (HealthDay News) -- Stem cell therapy's promise for healing damaged tissues may have gotten a bit closer to reality. In a small, early study, heart damage was reversed in heart-attack patients treated with their own cardiac stem cells, researchers report.

The cells, called cardiosphere-derived stem cells, regrew damaged heart muscle and reversed scarring one year later, the authors say.

Up until now, heart specialists' best tool to help minimize damage following a heart attack has been to surgically clear blocked arteries.

"In our treatment, we dissolved scar and replaced it with living heart muscle. Such 'therapeutic regeneration' has long been the holy grail of cell therapy, but had never been accomplished before; we now seem to have done it," said study author Dr. Eduardo Marban, director of the Cedars-Sinai Heart Institute in Los Angeles.

However, outside experts cautioned that the findings are preliminary and the treatment is far from ready for widespread use among heart-attack survivors.

The study, published online Feb. 14 in The Lancet, involved 25 middle-aged patients (average age 53) who had suffered a heart attack. Seventeen underwent stem cell infusions while eight received standard post-heart attack care, including medication and exercise therapy.

The stem cells were obtained using a minimally invasive procedure, according to the researchers from Cedars-Sinai and the Johns Hopkins Hospital in Baltimore.

Patients received a local anesthetic and then a catheter was threaded through a neck vein down to the heart, where a tiny portion of muscle was taken. The sample provided all the researchers needed to generate a supply of new stem cells -- 12 million to 25 million -- that were then transplanted back into the heart-attack patient during a second minimally invasive procedure.

One year after the procedure, the infusion patients' cardiac scar sizes had shrunk by about half. Scar size was reduced from 24 percent to 12 percent of the heart, the team said. In contrast, the patients receiving standard care experienced no scar shrinkage.

Initial muscle damage and healed tissue were measured using MRI scans.

After six months, four patients in the stem-cell group experienced serious adverse events compared with only one patient in the control group. At one year, two more stem-cell patients had a serious complication. However, only one such event -- a heart attack -- might have been related to the treatment, according to the study.

In a news release, Marban said that "the effects are substantial and surprisingly larger in humans than they were in animal tests."

Other experts were cautiously optimistic. Cardiac expert Dr. Bernard Gersh, a professor of medicine at Mayo Clinic, is not affiliated with the research but is familiar with the findings.

"This study demonstrates that it is safe and feasible to administer these cardiac-derived stem cells and the results are interesting and encouraging," he said.

Another specialist said that while provocative and promising, the findings remain early, phase-one research. "It's a proof-of-concept study," said interventional cardiologist Dr. Thomas Povsic, an assistant professor of medicine at the Duke Clinical Research Institute, in Durham, N.C.

And Dr. Chip Lavie, medical director of Cardiac Rehabilitation and Prevention at the John Ochsner Heart and Vascular Institute, in New Orleans, also discussed the results. He said that while the study showed that the cardiac stem cells reduced scar tissue and increased the area of live heart tissue in heart attack patients with moderately damaged overall heart tissue, it did not demonstrate a reduction in heart size or any improvement in the heart's pumping ability.

"It did not improve the ejection fraction, which is a very important measurement used to define the overall heart's pumping ability," Lavie noted. "Certainly, much larger studies of various types of heart attack patients will be needed before this even comes close to being a viable potential therapy for the large number of heart attack initial survivors."

Povsic concurred that much larger studies are needed. "The next step is showing it really helps patients in some kind of meaningful way, by either preventing death, healing them or making them feel better."

It's unclear what the cost will be, Povsic added. "What society is going to be willing to pay for this is going to be based on how much good it ends up doing. If they truly regenerate a heart and prevent a heart transplant, that would save a lot money."

Marban, who invented the stem cell treatment, said the while it would not replace bypass surgery or angioplasty, "it might be useful in treating 'irreversible' injury that may persist after those procedures."

As a rough estimate, he said that if larger, phase 2 trials were successful, the treatment might be available to the general public by about 2016.

More information

The U.S. National Heart, Lung, and Blood Institute describes current heart attack treatment.

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Stem Cell Treatment Might Reverse Heart Attack Damage

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Stem Cells Therapy MS1.mp4 – Video

Monday, February 13th, 2012

09-02-2012 22:12 Stem Cell Therapy latest news - Jan 2012, MS options Contact Kevin for help to raise funds for treatment part 1 of 4

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Stem Cells Therapy MS1.mp4 - Video

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Trounson Predicts — ‘Optimistically’ — Successful California Stem Cell Treatments in Five Years

Sunday, February 12th, 2012


Alan Trounson, president of the $3 billion California stem cell agency, says he is "optimistic" that some stem cell treatments developed in California will prove successful in humans in the next five years.

Trounson was quoted in The Sacramento Bee today in an opinion piece written by David Lesher, government affairs director of the Public Policy Institute of California. Lesher provided something of an overview of the agency, including pluses and minuses. He wrote,

"Those who speculate say that the most advanced stem cell treatments are still probably a decade away from becoming available to patients. And the cost to get them there will far exceed California's $3 billion investment."

But Lesher, a former political writer for the Los Angeles Times, also wrote,

"...(T)he president of the state's stem cell agency said he is 'optimistic' that at least a few California treatments will prove successful in humans in the next five years."

Lesher said,

"That may mean a genetically modified stem cell treatment to cure AIDS, (Trounson) said; it may mean a treatment that eliminates the need for some diabetics to monitor or inject insulin; there might be a treatment to restore eyesight to those suffering from a major cause of blindness.

"'These are the kind of things we need to get through,' he said. 'I hope that we have a number of them showing proof by 2015 or 2016. I'm optimistic. The caveat is that nothing is guaranteed.'"

The stem cell agency will run out of cash for new grants in 2017 and will go out of business shortly thereafter unless voters approve another multibillion dollar bond measure or it manages to secure private financing.

Lesher discussed the difficult financial environment for private financing of stem cell therapies and how it has changed since the the stem cell agency was created by voters seven years ago.

"The hope was that California's bond (financing for CIRM) would jump-start a biotech industry by building the laboratories and seeding early research to a point where private support would take over.

"But that point of commercial viability is a moving target as private investors have grown more risk averse and the regulatory path for such radical new therapies is unpredictable. So the biggest question today in the stem cell field is not whether the science will work someday. The big questions are how will we pay for it, how will regulators know when it's ready and when will it happen?"

Lesher said,

"The problem is that even the most advanced experiments in (CIRM's) translational portfolio are still a couple of years away from the same point in the regulatory pipeline where high cost and uncertainty forced Geron out of the field. And there is still no clear answer about how to resolve those same challenges, although the cost-benefit calculation will be different for other treatments."

Lesher concluded,

"Unlike high-speed rail, which continues to have strong support from the governor, the stakes surrounding California's stem cell investment have been largely invisible. That's too bad, because stem cell science is a much smaller investment for taxpayers with a greater possible return."

Our comment? In what CIRM Chairman Jonathan Thomas has declared as a "war" for public support, today's piece in The Bee was a bit of a victory. Although the article did mention difficult issues, it was generally upbeat about CIRM. The piece focused on the wonders of the science and bypassed many of the negatives about CIRM, including its built-in conflicts of interests and its reluctance to correct long-identified problems. Also absent was a discussion of how CIRM signed a $25 million loan agreement with Geron only three months before the company abandoned its clinical trial. That omission could be considered a PR plus for the agency. Overall, however, the folks at CIRM should be pleased by the article.

Source:
http://californiastemcellreport.blogspot.com/feeds/posts/default?alt=rss

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California Stem Cell Agency Seeking More Help on Push for Cures

Sunday, February 12th, 2012


The California stem cell agency has decided to put more manpower behind its push to drive therapies into the clinic.

The agency this week posted an opening for a senior development officer, who would be paid up to $226,108 annually.

The new hire would have a strong background in industry and an advanced degree. The job posting calls for a minimum of 10 years experience and expertise in "in developing, designing and assessing preclinical and early clinical safety and efficacy, within regulatory framework."

The position reports directly to Ellen Feigal, CIRM's VP for research and development. The job description says the person would "directly interact with investigators on CIRM’s clinically applicable research programs to help provide product development guidance from preclinical, manufacturing, and first in human to early phase clinical regulatory perspectives."

The $3 billion agency, which has yet to produce the cures promised to voters in 2004, is re-examining its strategies, particularly with an eye to backing a product that would actually be used on patients.

Source:
http://californiastemcellreport.blogspot.com/feeds/posts/default?alt=rss

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A $25 Million ‘Cautionary Tale’: CIRM and Geron

Sunday, February 12th, 2012


California's $25 million venture into the financing of what once was the first hESC clinical trial in the nation serves as a "cautionary tale" for states that use taxpayer dollars to boost technology, according to a New York public policy expert.

The comments by James W. Fossett, who directs the Rockefeller Institute of Government health, Medicaid studies and bioethics research programs, come midway through an Institute of Medicine examination of the performance of the $3 billion California stem cell agency. Its directors are also currently involved in a revision of of the agency's strategic plan.

Writing on the Rockefeller Institute's web site, Fossett analyzed the fallout from Geron's decision last fall to abandon its clinical trial after it determined the effort was too costly. Just three months earlier, the California stem cell agency had signed a $25 million loan agreement with Geron.

Fossett said,

"For the many states using taxpayer dollars to stimulate jobs in a wide range of technologies, this is a cautionary tale."

He wrote,

"(Geron's) decision has attracted widespread opprobrium from bloggers, stem cell advocacy groups, bioethicists and more than a few newspaper columnists — one blogger called it the 'stem cell misstep of the year.'

"This disapproval has also spilled over onto the California Institute for Regenerative Medicine (CIRM) — the state agency that operates the $3 billion California stem cell research program."

He continued,

"CIRM is coming under considerable political pressure to produce viable therapies to justify the large amount of money it’s been spending, and some have interpreted its hasty involvement with Geron as motivated by the desire to have something concrete to brag about."

Fossett said, however,

"There may be less here, however, than all the rhetoric would suggest. While Geron’s trial had acquired a lot of symbolic baggage because of its status as a 'first,' the decision to pull the plug only reflects one decision by one company about one therapy. The company was looking at having to spend a lot more money over a long period to get the therapy through the clinical trials process for what would likely be a small return.

"The political difficulties that Geron’s withdrawal have caused CIRM, however, have lessons for states proposing to spend significant amounts on biotechnology and other research in hopes of stimulating economic growth. Spending money on research intended to develop new therapies is highly risky. The science is difficult, expensive and evolves at a rapid pace that is difficult to integrate with earlier understandings. There are considerable cultural, political and financial obstacles to getting new products out of the lab and into the clinic."

Fossett suggested several approaches that might ease some of the risks. He cited the 2010 CIRM external review report that recommended adjusting priorities. Fossett said,

"States might experiment with providing more support to biotech companies and entrepreneurs with successful track records and less to basic research, which could increase the odds of short-term success."

At last month's CIRM board meeting, directors engaged in what CIRM is inclined to call a robust discussion of priorities for basic research vs. more focused funding for driving therapies into the clinic.

Fossett cited another external review recommendation that CIRM seek out research with a "high probability of clinical success that could 'come from either inside or outside CIRM-funded research, perhaps out of industry and even from outside of California.'" 

Fossett additionally mentioned the use of venture capital techniques that would give states "a chance to participate in the (financial) benefits of successful therapies."

Nonetheless, he wrote,

"Most products and most companies will likely continue to fail."

Source:
http://californiastemcellreport.blogspot.com/feeds/posts/default?alt=rss

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Last Public Hearing in California for CIRM Performance Evaluation Scheduled for April

Sunday, February 12th, 2012


The blue-ribbon Institute of Medicine panel looking into the performance of the $3 billion California stem cell agency will hold its final public hearing within the state on April 10 at UC Irvine.

No details have yet have been posted online about the matters to be discussed or the witnesses to be heard. So far, the panel has not heard publicly from a single independent witness. The panel's final report and recommendations are scheduled to be released this fall, following its only remaining public meeting, scheduled for Washington, D.C.

The IOM has also posted a list of documents provided to the panel during a closed session last month in South San Francisco, its only public hearing in California so far. Virtually all of documents came from the CIRM itself, which is paying the IOM $700,000 for the study.

One exception was the 2009 report by California's good government agency, the Little Hoover Commission.

In its report, the commission concluded,

"CIRM’s governance structure is not adequate to protect taxpayers’ interests or serve its own ambitious goals."

The commission recommended a number of changes to strengthen CIRM's governance structure, improve accountability and reduce conflicts of interest. They included restructuring and reducing the size of the 29-member board and eliminating the controversial dual executive arrangement at CIRM.

CIRM strongly resisted nearly all of the recommendations, some of which would have required legislative or voter approval. As of last week, the IOM panel had not contacted the Little Hoover Commission for testimony.

(Click on the "closed session summary" at this location to find the information about the documents that were provided.)

The IOM also has posted a list of topics discussed by its panel in closed session last month. They included a follow-up on bias and conflicts of interest, committee composition, discussion of the previous day's hearing and discussion of data needs.

The April meeting is being held at the Beckman Center at UC Irvine, which has received $77 million from CIRM. The agency's board of directors includes two top academicians from UC Irvine: Oswald Steward, who serves on the board as a patient advocate and is director of the Reeve-Irvine Research Center for Spinal Cord Injury, and Susan Bryant, associate executive vice chancellor for research at Irvine and who serves on the CIRM board as in her capacity as an executive officer from a UC campus with a medical school.

 

Source:
http://californiastemcellreport.blogspot.com/feeds/posts/default?alt=rss

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Trounson Predicts — ‘Optimistically’ — Successful California Stem Cell Treatments in Five Years

Sunday, February 12th, 2012


Alan Trounson, president of the $3 billion California stem cell agency, says he is "optimistic" that some stem cell treatments developed in California will prove successful in humans in the next five years.

Trounson was quoted in The Sacramento Bee today in an opinion piece written by David Lesher, government affairs director of the Public Policy Institute of California. Lesher provided something of an overview of the agency, including pluses and minuses. He wrote,

"Those who speculate say that the most advanced stem cell treatments are still probably a decade away from becoming available to patients. And the cost to get them there will far exceed California's $3 billion investment."

But Lesher, a former political writer for the Los Angeles Times, also wrote,

"...(T)he president of the state's stem cell agency said he is 'optimistic' that at least a few California treatments will prove successful in humans in the next five years."

Lesher said,

"That may mean a genetically modified stem cell treatment to cure AIDS, (Trounson) said; it may mean a treatment that eliminates the need for some diabetics to monitor or inject insulin; there might be a treatment to restore eyesight to those suffering from a major cause of blindness.

"'These are the kind of things we need to get through,' he said. 'I hope that we have a number of them showing proof by 2015 or 2016. I'm optimistic. The caveat is that nothing is guaranteed.'"

The stem cell agency will run out of cash for new grants in 2017 and will go out of business shortly thereafter unless voters approve another multibillion dollar bond measure or it manages to secure private financing.

Lesher discussed the difficult financial environment for private financing of stem cell therapies and how it has changed since the the stem cell agency was created by voters seven years ago.

"The hope was that California's bond (financing for CIRM) would jump-start a biotech industry by building the laboratories and seeding early research to a point where private support would take over.

"But that point of commercial viability is a moving target as private investors have grown more risk averse and the regulatory path for such radical new therapies is unpredictable. So the biggest question today in the stem cell field is not whether the science will work someday. The big questions are how will we pay for it, how will regulators know when it's ready and when will it happen?"

Lesher said,

"The problem is that even the most advanced experiments in (CIRM's) translational portfolio are still a couple of years away from the same point in the regulatory pipeline where high cost and uncertainty forced Geron out of the field. And there is still no clear answer about how to resolve those same challenges, although the cost-benefit calculation will be different for other treatments."

Lesher concluded,

"Unlike high-speed rail, which continues to have strong support from the governor, the stakes surrounding California's stem cell investment have been largely invisible. That's too bad, because stem cell science is a much smaller investment for taxpayers with a greater possible return."

Our comment? In what CIRM Chairman Jonathan Thomas has declared as a "war" for public support, today's piece in The Bee was a bit of a victory. Although the article did mention difficult issues, it was generally upbeat about CIRM. The piece focused on the wonders of the science and bypassed many of the negatives about CIRM, including its built-in conflicts of interests and its reluctance to correct long-identified problems. Also absent was a discussion of how CIRM signed a $25 million loan agreement with Geron only three months before the company abandoned its clinical trial. That omission could be considered a PR plus for the agency. Overall, however, the folks at CIRM should be pleased by the article.

Source:
http://californiastemcellreport.blogspot.com/feeds/posts/default?alt=rss

Read More...

California Stem Cell Agency Seeking More Help on Push for Cures

Sunday, February 12th, 2012


The California stem cell agency has decided to put more manpower behind its push to drive therapies into the clinic.

The agency this week posted an opening for a senior development officer, who would be paid up to $226,108 annually.

The new hire would have a strong background in industry and an advanced degree. The job posting calls for a minimum of 10 years experience and expertise in "in developing, designing and assessing preclinical and early clinical safety and efficacy, within regulatory framework."

The position reports directly to Ellen Feigal, CIRM's VP for research and development. The job description says the person would "directly interact with investigators on CIRM’s clinically applicable research programs to help provide product development guidance from preclinical, manufacturing, and first in human to early phase clinical regulatory perspectives."

The $3 billion agency, which has yet to produce the cures promised to voters in 2004, is re-examining its strategies, particularly with an eye to backing a product that would actually be used on patients.

Source:
http://californiastemcellreport.blogspot.com/feeds/posts/default?alt=rss

Read More...

A $25 Million ‘Cautionary Tale’: CIRM and Geron

Sunday, February 12th, 2012


California's $25 million venture into the financing of what once was the first hESC clinical trial in the nation serves as a "cautionary tale" for states that use taxpayer dollars to boost technology, according to a New York public policy expert.

The comments by James W. Fossett, who directs the Rockefeller Institute of Government health, Medicaid studies and bioethics research programs, come midway through an Institute of Medicine examination of the performance of the $3 billion California stem cell agency. Its directors are also currently involved in a revision of of the agency's strategic plan.

Writing on the Rockefeller Institute's web site, Fossett analyzed the fallout from Geron's decision last fall to abandon its clinical trial after it determined the effort was too costly. Just three months earlier, the California stem cell agency had signed a $25 million loan agreement with Geron.

Fossett said,

"For the many states using taxpayer dollars to stimulate jobs in a wide range of technologies, this is a cautionary tale."

He wrote,

"(Geron's) decision has attracted widespread opprobrium from bloggers, stem cell advocacy groups, bioethicists and more than a few newspaper columnists — one blogger called it the 'stem cell misstep of the year.'

"This disapproval has also spilled over onto the California Institute for Regenerative Medicine (CIRM) — the state agency that operates the $3 billion California stem cell research program."

He continued,

"CIRM is coming under considerable political pressure to produce viable therapies to justify the large amount of money it’s been spending, and some have interpreted its hasty involvement with Geron as motivated by the desire to have something concrete to brag about."

Fossett said, however,

"There may be less here, however, than all the rhetoric would suggest. While Geron’s trial had acquired a lot of symbolic baggage because of its status as a 'first,' the decision to pull the plug only reflects one decision by one company about one therapy. The company was looking at having to spend a lot more money over a long period to get the therapy through the clinical trials process for what would likely be a small return.

"The political difficulties that Geron’s withdrawal have caused CIRM, however, have lessons for states proposing to spend significant amounts on biotechnology and other research in hopes of stimulating economic growth. Spending money on research intended to develop new therapies is highly risky. The science is difficult, expensive and evolves at a rapid pace that is difficult to integrate with earlier understandings. There are considerable cultural, political and financial obstacles to getting new products out of the lab and into the clinic."

Fossett suggested several approaches that might ease some of the risks. He cited the 2010 CIRM external review report that recommended adjusting priorities. Fossett said,

"States might experiment with providing more support to biotech companies and entrepreneurs with successful track records and less to basic research, which could increase the odds of short-term success."

At last month's CIRM board meeting, directors engaged in what CIRM is inclined to call a robust discussion of priorities for basic research vs. more focused funding for driving therapies into the clinic.

Fossett cited another external review recommendation that CIRM seek out research with a "high probability of clinical success that could 'come from either inside or outside CIRM-funded research, perhaps out of industry and even from outside of California.'" 

Fossett additionally mentioned the use of venture capital techniques that would give states "a chance to participate in the (financial) benefits of successful therapies."

Nonetheless, he wrote,

"Most products and most companies will likely continue to fail."

Source:
http://californiastemcellreport.blogspot.com/feeds/posts/default?alt=rss

Read More...

Last Public Hearing in California for CIRM Performance Evaluation Scheduled for April

Sunday, February 12th, 2012


The blue-ribbon Institute of Medicine panel looking into the performance of the $3 billion California stem cell agency will hold its final public hearing within the state on April 10 at UC Irvine.

No details have yet have been posted online about the matters to be discussed or the witnesses to be heard. So far, the panel has not heard publicly from a single independent witness. The panel's final report and recommendations are scheduled to be released this fall, following its only remaining public meeting, scheduled for Washington, D.C.

The IOM has also posted a list of documents provided to the panel during a closed session last month in South San Francisco, its only public hearing in California so far. Virtually all of documents came from the CIRM itself, which is paying the IOM $700,000 for the study.

One exception was the 2009 report by California's good government agency, the Little Hoover Commission.

In its report, the commission concluded,

"CIRM’s governance structure is not adequate to protect taxpayers’ interests or serve its own ambitious goals."

The commission recommended a number of changes to strengthen CIRM's governance structure, improve accountability and reduce conflicts of interest. They included restructuring and reducing the size of the 29-member board and eliminating the controversial dual executive arrangement at CIRM.

CIRM strongly resisted nearly all of the recommendations, some of which would have required legislative or voter approval. As of last week, the IOM panel had not contacted the Little Hoover Commission for testimony.

(Click on the "closed session summary" at this location to find the information about the documents that were provided.)

The IOM also has posted a list of topics discussed by its panel in closed session last month. They included a follow-up on bias and conflicts of interest, committee composition, discussion of the previous day's hearing and discussion of data needs.

The April meeting is being held at the Beckman Center at UC Irvine, which has received $77 million from CIRM. The agency's board of directors includes two top academicians from UC Irvine: Oswald Steward, who serves on the board as a patient advocate and is director of the Reeve-Irvine Research Center for Spinal Cord Injury, and Susan Bryant, associate executive vice chancellor for research at Irvine and who serves on the CIRM board as in her capacity as an executive officer from a UC campus with a medical school.

 

Source:
http://californiastemcellreport.blogspot.com/feeds/posts/default?alt=rss

Read More...

Stem Cell Therapy for Osteoarthritis and Sports Injuries: A Case Study – Video

Friday, February 10th, 2012

08-02-2012 11:12 Stem Cell Treatment of Pro/Am dancer and orthodontist, Dr. Janet Vaughan. In attempt to get her dancing career back on track, Dr. Vaughan decided to undergo stem cell therapy at the Stem Cell Institute in Panama City, Panama. Dr. Jorge Paz, Medical Director at the Stem Cell Institute presents Dr. Vaughan's case discussing her injuries and subsequent recovery. After being unable to compete for 2 years, Dr. Vaughan is once again slated to compete on the professional dance circuit with her current professional partner, Mr. Eddie Stutts (Professional 10-Dance World Champion). From 2007-2009, Dr. Vaughan partnered with World Champion Tony Dovolani and competed extensively in the US, winning a National Reserve Pro/Am Rhythm title. Tony Dovolani is best known for his appearances on ABC's hit reality series, "Dancing with the Stars", and has teamed up with Chynna Phillips, Wendy Williams, Audrina Partridge, Kate Gosselin, Kathy Ireland, Susan Lucci, Jane Seymour and other celebrities on the show.

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Stem Cell Therapy for Osteoarthritis and Sports Injuries: A Case Study - Video

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L. Grozdinski, MD [Stem Cell Therapy | CCSVI Symposium 2011 – 38 of 46] – Video

Wednesday, February 8th, 2012

02-02-2012 08:37 CCSVI Symposium 2011 - Second Annual Meeting Crowne Plaza Hotel Times Square, Manhattan New York, NY July 15-17, 2011 http://www.ccsvicare.com Stem Cell Therapy L. Grozdinski, MD Angiology Sector Chief Tokuda Hospital Sofia, Bulgaria [38 out of 46 videos]

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L. Grozdinski, MD [Stem Cell Therapy | CCSVI Symposium 2011 - 38 of 46] - Video

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US begins stem cell trial for hearing loss

Wednesday, February 8th, 2012

The phase I trial follows promising studies on mice showing that such transplants were able to rebuild the structures of the inner ear, and some anecdotal evidence from humans, sparking hope of a cure for some forms of deafness.

One of those people is two-year-old Finn McGrath, who suffered brain damage after being deprived of oxygen during a prolonged and complicated delivery, according to his mother, Laura.

"His doctors told us he was at high risk for cerebral palsy, vision issues, hearing problems and mental retardation," she said in an interview with AFP.

Finn's early days were an all-out struggle to survive, so for his parents, learning that he had failed his hearing tests and had damaged hair cells -- the sensory receptors in the inner ear that pick up sounds -- was almost an afterthought.

He had organ failure, breathing problems, and his cerebral palsy left him unable to roll, crawl or walk, hold his head up, talk or eat.

As his parents searched for ways to help him, they came upon stories online that told of studies using cord blood to help children with cerebral palsy and other disorders.

Prior to his birth, the McGraths had arranged to privately bank his umbilical cord blood, a procedure that costs around $2,000 plus storage fees, and remains controversial among pediatricians.

Private companies such as the Cord Blood Registry, which is funding the Texas study on hearing loss, urge expecting parents to bank their umbilical cord blood and reserve it for personal use as a way to protect their family.

That advice runs counter to the guidelines issues by the American Academy of Pediatrics in 2007, which calls such claims "unsubstantiated" and says banking for personal or family use "should be discouraged" but is "encouraged" if it is to be stored in a bank for public use.

Since Finn's parents had already banked his, they enrolled him in cord blood trial for cerebral palsy in North Carolina and he received his first transplant in November 2009 when he was about seven weeks old.

A second transfusion followed and by May, his parents began to notice a change.

Nighttime noises, like an alarm on his food pump or the sound of ripping medical tape, would suddenly startle him awake, his mother recalled.

"He started vocalizing sounds and we could tell that he was anticipating things that we would say. Like, if he had heard a story a number of times or a song, he would smile like he recognized the song or the story."

Finn had a third infusion in September 2010, when he was one year old. Four months later, an otoacoustic emissions test (OAE), which plays a sound and picks up vibrations in the cochlea and hair cells, came back normal.

The early hearing tests that showed hearing loss were not exactly the same as the later tests that came back normal, so McGrath is cautious about comparing them directly, but she believes the cord blood transfusions may have helped.

"All I can tell you is anecdotally he was not able to hear for probably the first three or four months of his life, and then when he was about six to eight months old, he started hearing."

The hearing trial in Texas aims to take a first step in testing the safety, and later the efficacy, of transfusing cord blood in children age six weeks to 18 months who have sustained post-birth sensorineural hearing loss.

Some reasons that children lose their hearing at or after birth may include oxygen deprivation, head injury, infection, strong doses of antibiotics or loud noises.

Sensorineural hearing loss affects approximately six per 1,000 children, and there is no available medical treatment. Hearing aids or cochlear implants are typically offered to boost the ability of the damaged tissues.

"Stem cell therapy may potentially repair the damaged structures of the inner ear and restore normal hearing," lead investigator Sami Fakhri told AFP.

"We are at the initial stages of this process and the results are looking promising," Fakhri added.

Research using stem cells in cord blood, known as hematopoietic cells, is already under way on some types of brain injury, cerebral palsy, juvenile diabetes, kidney and lung disease, he said.

The new study at Memorial Hermann-Texas Medical Center is being funded by the Cord Blood Registry, a private bank, and those eligible must have already banked their own umbilical cord blood with CBR.

But to Stephen Epstein, an otolaryngologist in Maryland, that does not pose a conflict of interest, because separate medical institutions in Texas and Georgia are conducting the Food and Drug Administration-approved research.

"If both of them can reproduce the same results then I would say it has some validity to it," said Epstein, who is not involved in the study.

"This is certainly a welcome, acceptable experiment, but it should be looked at with caution and time will tell."

One patient is already enrolled and the study, which runs for one year, has room for nine more.

While Finn McGrath still faces many challenges due to his cerebral palsy, his mother is grateful for the things he can do.

"I don't know how much worse off he would have been without the stem cell transfusion," McGrath said, pointing to his normal cognition, lack of seizures, good hearing and vision.

"We remain hopeful that he will continue to improve."

(c) 2012 AFP

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US begins stem cell trial for hearing loss

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$30 million donation from Boris family will help McMaster turn stem cell research into therapy

Tuesday, February 7th, 2012

McMaster University is on its way to moving stem cell research “from the bench to the bedside” thanks to a $30 million boost from a local family.

The Marta and Owen Boris Foundation made the large donation to establish a human stem cell therapy centre and a unique clinic for patients with complex health conditions.

Owen, the founder of Mountain Cablevision, was in talks with McMaster about investing in their work before he died last April. His children and wife contacted the university a month later and carried out his vision, firming up their commitment last November.

The Boris Family Centre in Human Stem Cell Therapies will be developed as part of the McMaster Stem Cell and Cancer Research Institute using $24 million of the funds.

“It’s getting over that chasm from the bench to the bedside that this (donation) is going to allow us to do,” the institute’s scientific director Dr. Mick Bhatia said.

The centre will give scientists the resources to focus on converting McMaster’s breakthroughs — such as the ability to make blood or types of neural cells with stem cells — into clinical applications through investigative trials, Bhatia said.

“In the absence of this donation, I think we would not be in the position to move our discoveries forward,” he said. “This is a huge leg-up. I’m hoping what it’s really going to do is have a ripple effect to change the way McMaster views translating basic science.”

They plan on developing human stem cell therapies targeting leukemia and possibly neural diseases such as Alzheimer’s and Parkinson’s, said Dr. John Kelton, dean and vice-president of the faculty of health sciences.

The remaining $6 million will go toward building a clinic in partnership with Hamilton Health Sciences (HHS) where patients with complex health issues can see specialists and undergo tests in one visit.

This was a result of his parents’ frustrating experiences in recent years with co-ordinating specialists and getting diagnostic testing done in Canada, said Owen’s son, Les Boris.

They ended up going to Mayo Clinic in Rochester, Minn., where they had a case manager who co-ordinated their appointments with specialists and made sure testing was done in-house, he said. “They like the idea of a one-stop shop … (My father) said: ‘This is the kind of model we need here in this country.’”

Kelton said the medical clinic, which will be built in the university’s medical centre, will look for rapid turnaround times and avoid duplications of lab tests. McMaster and HHS will also evaluate the clinic’s success and keep an electronic medical record that patients could access, he said.

Kelton and Owen met three years ago and had their last meeting about the projects three days before the philanthropist died.

Owen had worked on the Avro Arrow and was frustrated with Canada’s lost opportunity of making jet planes for the world, Kelton said.

“He said, ‘Tell me about some opportunities (that) – if we invested in it – could make Hamilton and McMaster world-class. What are some of the areas like an Avro Arrow?’”

The funds for the human stem cell therapy centre will go toward hiring a research chair in blood stem cells and a research chair in neural stems cells, setting up several fellowships and technician positions, and building the facility.

Bhatia says they hope to bring in new scientists and fellows by the early summer.

The Boris family previously donated $6 million to addiction research at St. Joseph’s Healthcare for its new mental health hospital being built on the Mountain and another $5 million for the da Vinci SI Surgical Robotic System.

“We’re very appreciative that we’re in a position to be doing something for the community,” Les said. “And it was the community that put us in the position to do this.

dawong@thespec.com

905-526-2468 | @WongatTheSpec

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Stem Cell Therapy for Type 1 Diabetes (UCSD, PDRC) – Video

Tuesday, February 7th, 2012

20-01-2012 16:12 A conversation Dr. CC King, Ph.D., Associate Research Scientist at the UC, San Diego Pediatric Diabetes Research Center, about his work on stem cell therapy for type 1 (and type 2) diabetes.

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Stem Cell Therapy for Type 1 Diabetes (UCSD, PDRC) - Video

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Suzanne Somers Uses Stem Cell Therapy for Breast Reconstruction

Tuesday, February 7th, 2012

Suzanne Somers, a breast cancer survivor who’s become known for her controversial advice against chemotherapy, has done something that other women can truly find hope in. She turned to stem-cell techniques to successfully reconstruct her breasts.

The actress, 65, underwent a lumpectomy and radiation 12 years ago, and since then, she says, she wasn’t happy with the appearance of her breasts.  The radiation, she told “People” magazine, "left what breast I had flatter and flatter. I had a Double D on one side and on the other side I could hardly fill a B."

Dissatisfied with conventional breast-reconstruction procedures,  the “Three’s Company” veteran researched further and discovered that  Dr. Kotaro Yoshimura, a Japanese surgeon, had  developed stem-cell breast reconstruction in 2004. After talking with Yoshimura, Somers was convinced and decided to go with an American doctor for the operation.

So she began a clinical trial that has been ongoing at Hollywood Presbyterian Medical Center.  The first patient to participate, Somers had fat removed from her stomach via liposuction. Then her surgeon, Dr. Joel Aronowitz, harvested stem cells from half the fat and combined it with the remaining amount.

After that, Aronowitz injected the mixture back into Somers’ breast until it matched her left one in size.  (Somers had reduced her DD left breast to a C.)

Somers said she’s thrilled with the result and the implications for other breast-cancer survivors. I am so ensconced in what's cutting edge," she told “People.” "I get my thrill out of passing on information to women so they can have a better quality of life."

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Suzanne Somers Uses Stem Cell Therapy for Breast Reconstruction

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Bonita stem cell doctor's attorney quits, state hearing still scheduled

Monday, February 6th, 2012

Interview with Dr. Zannos Grekos Grekos contests that his office has done ...

The state took action against Dr. Zannos Grekos because of the death of a 69-year-old breast cancer patient April 4, 2010, after undergoing the treatment at his Bonita Springs practice, at 9500 Bonita Beach Road, Suite 310.

BONITA SPRINGS — Dr. Zannos Grekos may not have an attorney representing him at a hearing next month against a state complaint that he performed an unauthorized stem cell procedure on a patient who later died.

Or maybe the Bonita Springs cardiologist will have new counsel for the three-day administrative hearing scheduled to begin March 20.

His original attorney, Greg Chaires of Orlando, withdrew from the case Jan. 24, less than two months before the hearing. He's been Grekos' attorney since the state filed an administrative complaint against the doctor a year ago.

Grekos couldn't be reached for comment at his practice, Regenocyte Therapeutic, 9500 Bonita Beach Road, Suite 310.

Chaires stated in his withdrawal notice to the judge that he had good cause to stop representing him, but didn't elaborate.

Florida health department spokeswoman Jennifer Hirst said this past week that Grekos has two weeks to hire a new attorney "and regardless of whether he does or not, the trial date will not change."

The case, which stems from events in early 2010, culminated a year later on Feb. 22, 2011, when the health department imposed an emergency restriction against his license. The restriction prohibits him from doing any procedures with bone marrow or stem cells in his practice.

If the administrative law judge sides with the state, Grekos could face sanctions or permanent restriction or revocation of his license.

At issue was Grekos' treatment of a 69-year-old woman who went to him for a consult on Feb. 25, 2010, for numbness and tingling in her arms and legs after chemotherapy.

Grekos ordered imaging of her carotid arteries and her brain and later injected her own aspirated bone marrow into her cerebral circulatory system.

At home that evening, she fell and was hospitalized. She had suffered a severe brain stem injury and was taken off life support on April 2, 2010.

Licensed in Florida since 1992, Grekos' cardiology practice in recent years has focused more on stem cell therapy to repair damaged heart muscle, lungs and other tissue.

He sends a sample of a patient's lung to Israel to cultivate new stem cells and the blood gets sent to a clinic or hospital in the Dominican Republic. The patient travels to the Dominican Republic, where the stem cells are injected into the damaged tissue.

Grekos has established a relationship with doctors and clinicians in the Dominican Republic who do the injections on his behalf; he isn't licensed to practice medicine there.

The case has captured widespread attention among Grekos' supporters who swear their once-chronic illnesses have undergone dramatic improvement since having the therapy through him. Detractors say he is taking advantage of a vulnerable population with congestive heart failure, lung failure and other illnesses for which conventional treatments no longer are effective.

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Bonita stem cell doctor's attorney quits, state hearing still scheduled

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Funding for Personalized Medicine Research

Sunday, February 5th, 2012

The Cancer Stem Cell Consortium (CSCC) is a partner in the 2012 Large-Scale Applied Research Project Competition of Genome Canada, in collaboration with the first phase of the Personalized Medicine Signature Initiative of the Canadian Institutes of Health Research (CIHR). Genome Canada is leading the research competition. An excerpt from Fact Sheet: The Potential of Personalized Medicine:

Funding of $67.5M will come from Genome Canada ($40 million), CIHR ($22.5 million) and the Cancer Stem Cell Consortium ($5 million). Projects will be funded for a maximum of four years. To qualify for funding, researchers must obtain matching funding that at is least equal to that provided through the competition, which will bring the total investment in this research area to close to $140 million. Matching funding is typically derived from provincial, academic, private sector or international sources.

Details about the competition are available here.

Press releases, dated January 31, 2012, about the federal government's support for personalized medicine, are available here and here.

Source:
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PRWEB: Absorption Systems Expands In Vivo Drug and Medical Device Testing Capabilities

Sunday, February 5th, 2012
Preclinical contract research organization renovates facility, adding state-of-the-art technology and upgrading ocular testing services.
Exton, PA (PRWEB) January 31, 2012
Absorption Systems announces the latest in a series of milestones in the continuing expansion of its AAALAC-accredited and GLP-compliant facility in San Diego, CA. The facility is undergoing extensive renovations to upgrade and expand the company’s in vivo testing capabilities for drugs and medical devices, including the construction of a dedicated ocular testing laboratory with state-of-the-art equipment, including a Heidelberg Spectralis® optical coherence tomography (OCT) unit. This instrument produces detailed digital images of the retina, enabling precise monitoring of the efficacy and toxicity of drugs and medical devices. Absorption Systems’ San Diego facility, in the midst of a major expansion of staff, equipment, and capabilities in the specialized area of preclinical ocular drug and device testing, continues to see significant growth year-over-year early in 2012.
Glenwood Gum, M.S., Ph.D., who joined Absorption Systems in 2011 as Associate Director, Preclinical Studies, commented, “This OCT technology gives a huge boost to our ocular testing capabilities, which will immediately benefit our rapidly expanding client base.” Dr. Gum is an expert in preclinical ocular studies, having developed or co-developed many of the preclinical models of glaucoma, age-related macular degeneration (AMD), retinoblastoma, uveitis, and diabetic retinopathy that are used all over the world for drug testing. His expertise, along with dedicated staff and the addition of state-of-the-art equipment and facilities, are key to Absorption Systems’ strategy to aggressively pursue new business opportunities in the preclinical ocular testing arena.
Dr. Gum will be a featured speaker on Preclinical Glaucoma and CNV Models at the 4th Ocular Diseases and Drug Discovery conference in Las Vegas, NV February 27-28, 2012.
Patrick Dentinger, President and CEO of Absorption Systems, said, “For Absorption Systems, being a market leader in whatever endeavor we pursue is a cornerstone of our business philosophy. This requires scientific expertise, state-of-the-art equipment and facilities, and access to emerging technologies. These factors, combined with Absorption Systems’ customer-centric approach, make our commitment to being a top-tier ocular service provider a reality in 2012.”
Absorption Systems’ preclinical ocular test portfolio includes in vivo ocular pharmacokinetics, efficacy, and safety in multiple species, as well as in vitro ocular permeability and metabolism. For example, the human corneal orb is a unique in vitro permeability model available as a service platform only through Absorption Systems. The corneal orb, cultured from human pluripotent stem cells, was developed by Lifeline Cell Technology, Inc., a wholly-owned subsidiary of International Stem Cell Corporation, and has been validated by Absorption Systems as an in vitro corneal permeability test system.
About Absorption Systems
Absorption Systems, founded in 1996, assists pharmaceutical and medical device companies in identifying and overcoming ADMET (Absorption, Distribution, Metabolism, Excretion and Toxicity) barriers in the development of drugs and medical devices. The company's mission is to continually develop innovative research tools that can be used to accurately predict human outcomes or to explain unanticipated human outcomes when they occur. The CellPort Technologies® platform, a suite of human cell-based test systems for drug transporter characterization, exemplifies Absorption Systems' commitment to innovation and is soon to be an industry assay standard for in vitro drug interaction assessment. Absorption Systems has facilities near Philadelphia, PA, and San Diego, CA, and serves customers throughout the world. For information on the company's comprehensive contract services and applied research programs, please visit http://www.absorption.com.



SOURCE: http://www.prweb.com/releases/2012/1/prweb9153045.htm

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IOM Coming Up Short on Independent Analysis of the California Stem Cell Agency

Sunday, February 5th, 2012


The blue-ribbon panel examining the performance of the $3 billion California stem cell agency is midway through its public process and is yet to hear from a single independent witness during its open sessions.

The panel's report and recommendations are due this fall and are expected to have a major impact on the seven-year-old agency and its future.

So far, the IOM panel has heard only from employees or directors of the agency and persons representing institutions that have received $418 million in CIRM cash.

The panel of scientists and academics was put together by the prestigious Institute of Medicine under a $700,000 contract with the stem cell agency itself. At the 2010 meeting during which agency directors approved the contract, they expressed hope that the IOM panel's findings would bolster public support for another multibillion dollar bond measure for the agency, which expects to run out of funds for new grants in 2017.

Last week, the California Stem Cell Report asked the IOM about its plans to gather independent or critical information about the stem cell agency's performance. With only one more California public meeting scheduled, the IOM said that it is seeking the "full range of perspectives" but did not respond directly to questions about the specifics of how it is going to fulfill that task.

None of the four organizations in California that have an independent perspective on CIRM have been contacted by the IOM, the California Stem Cell Report has been told. They are the state's Little Hoover Commission, the Center for Genetics and Society, Consumer Watchdog and the Citizens Financial Accountability and Oversight Committee, which is the only state body specifically charged with oversight of CIRM and its directors and which is chaired by the state's top fiscal officer, Controller John Chiang. A spokeswoman for the IOM panel said, however, it plans to touch base with at least some of the four.

In response to questions from the California Stem Cell Report, Christine Stencel, the IOM spokeswoman, said the IOM also wants to hear comments from businesses whose applications have been rejected by CIRM. However, she said the panel is still working on "ways to get them." She did not respond directly to questions about how many of such businesses would be interviewed or how they would be selected. The tiny number of CIRM grants to business is a sore spot with industry. Even directors and CIRM's own "external review" panel have said much more is needed.

In response to a question about complaints about conflicts of interest on the part of CIRM reviewers, Stencel was also non-specific, saying only that the panel wants to "obtain all relevant insights." She did not respond directly to a question about whether the panel would examine "private complaints" filed with CIRM by rejected applicants.

Currently the IOM has forms posted online that interested parties, if they know about the existence of the forms, can use to comment on CIRM. We asked whether the panel plans to do more than passively post the forms, specifically whether it plans to email them to all CIRM applicants who were rejected. We also asked about IOM plans to follow up to generate an adequate response. Stencel said the IOM is "proactively working" to get survey responses but did not say what specific steps it was taking.

Our comment?

The IOM has a well-deserved reputation for rigor and thoroughness. However, the IOM is all but unknown to 99 pecent of the public, which will be the ultimate consumer of its findings on the stem cell agency. The fact that the IOM is being paid $700,000 by CIRM will undoubtedly raise questions in the minds of some about IOM's own objectivity. The panel itself consists of persons who have like-minded interests and sympathy with CIRM and its 485 grant recipients. No member of the panel is likely to publicly discourage more scientific research, even if CIRM is deemed to be failing to fulfill the voters expectations in 2004 when they created the agency. All the more reason to aggressively seek out those with contrary views about CIRM's performances, if the IOM's report is to have maximum credibility.

Earlier this week we heard from a knowledgeable and longtime observer of the research scene, who said that the IOM looks at things "differently than regular people" and views scientists who receive funding from CIRM as "independent." The IOM's Stencel responded by reiterating that the IOM is seeking the full range of information from the full range of sources.

The IOM evaluation of CIRM's performance is much too far along not to have progressed further with its attempts to hear from independent and critical voices about CIRM. Generalizations to the effect that "we are going to get to it" do not serve the panel well. The IOM should lay out publicly and quite specifically its plans to aggressively seek thoughtful analysis from parties that do not have financial or professional links to CIRM, as well as from those who feel they have received a short shrift from the $3 billion enterprise.

You can read the full text of the questions from the California Stem Cell Report and the IOM responses here.

Source:
http://californiastemcellreport.blogspot.com/feeds/posts/default?alt=rss

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