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Bioheart Acquires Exclusive Rights to Ageless Regenerative Institute’s Adipose Cell Technology

February 14th, 2012 11:32 pm

SUNRISE, Fla., Feb. 14, 2012 (GLOBE NEWSWIRE) -- Bioheart, Inc. (BHRT.OB) announced today that it has acquired the worldwide exclusive rights to Ageless Regenerative Institute's adipose (fat) derived therapeutic cell technology for use in the cardiac field.

"The Ageless adipose stem cell technology will allow us to broaden our portfolio of product candidates for cardiac patients," said Mike Tomas, President and CEO of Bioheart. "We have successfully treated patients in Mexico and now we are ready to expand into the US."

Adipose tissue is readily available and has been shown to be rich in microvascular, myogenic and angiogenic cells. Bioheart has recently applied to the FDA to begin trials using adipose derived stem cells or LipiCell(TM) in patients with chronic ischemic cardiomyopathy. Transplantation of LipiCell(TM) will be accomplished through endocardial implantations with the MyoStar(TM) Injection Catheter under the guidance of the NOGA(R) cardiac navigation system by Biosense Webster, Inc. -- A Johnson & Johnson Company.

Under the terms of the agreement, Bioheart will have a worldwide exclusive license to all of Ageless technology for use in the heart attack and heart failure markets. The agreement provides for upfront and milestone equity payments to Ageless.

Ageless' President and Chief Executive Officer, Dr. Sharon McQuillan, MD added, "We are excited about this collaboration with Bioheart, a leader in developing cell therapies for cardiovascular disease. Together with Bioheart, we can help to revolutionize cardiovascular medicine and improve the current standard of care for these patients."

About Bioheart, Inc.

Bioheart is committed to maintaining its leading position within the cardiovascular sector of the cell technology industry delivering cell therapies and biologics that help address congestive heart failure, lower limb ischemia, chronic heart ischemia, acute myocardial infarctions and other issues. Bioheart's goals are to cause damaged tissue to be regenerated, when possible, and to improve a patient's quality of life and reduce health care costs and hospitalizations.

Specific to biotechnology, Bioheart is focused on the discovery, development and, subject to regulatory approval, commercialization of autologous cell therapies for the treatment of chronic and acute heart damage and peripheral vascular disease. Its leading product, MyoCell, is a clinical muscle-derived cell therapy designed to populate regions of scar tissue within a patient's heart with new living cells for the purpose of improving cardiac function in chronic heart failure patients.

For more information on Bioheart, visit http://www.bioheartinc.com.

About Ageless Regenerative Institute, LLC

The Ageless Regenerative Institute (ARI) is an organization dedicated to the standardization of cell regenerative medicine. The Institute promotes the development of evidence-based standards of excellence in the therapeutic use of adipose-derived stem cells through education, advocacy, and research. ARI has a highly experienced management team with experience in setting up full scale cGMP stem cell manufacturing facilities, stem cell product development & enhancement, developing point-of-care cell production systems, developing culture expanded stem cell production systems, FDA compliance, directing clinical & preclinical studies with multiple cell types for multiple indications, and more. ARI has successfully treated hundreds of patients utilizing these cellular therapies demonstrating both safety and efficacy. For more information about regenerative medicine please visit http://www.agelessregen.com.

Forward-Looking Statements: Except for historical matters contained herein, statements made in this press release are forward-looking statements. Without limiting the generality of the foregoing, words such as "may," "will," "to," "plan," "expect," "believe," "anticipate," "intend," "could," "would," "estimate," or "continue" or the negative other variations thereof or comparable terminology are intended to identify forward-looking statements.

Forward-looking statements involve known and unknown risks, uncertainties and other factors which may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. Also, forward-looking statements represent our management's beliefs and assumptions only as of the date hereof. Except as required by law, we assume no obligation to update these forward-looking statements publicly, or to update the reasons actual results could differ materially from those anticipated in these forward-looking statements, even if new information becomes available in the future.

The Company is subject to the risks and uncertainties described in its filings with the Securities and Exchange Commission, including the section entitled "Risk Factors" in its Annual Report on Form 10-K for the year ended December 31, 2010, and its Quarterly Report on Form 10-Q for the quarter ended September 30, 2011.

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Scarred Hearts Can Be Mended With Stem Cell Therapy

February 14th, 2012 11:32 pm

February 14, 2012, 3:17 PM EST

By Ryan Flinn

(Adds comment from researcher in 13th paragraph.)

Feb. 14 (Bloomberg) -- Stem cells grown from patients’ own cardiac tissue can heal damage once thought to be permanent after a heart attack, according to a study that suggests the experimental approach may one day help stave off heart failure.

In a trial of 25 heart-attack patients, 17 who got the stem cell treatment showed a 50 percent reduction in cardiac scar tissue compared with no improvement for the eight who received standard care. The results, from the first of three sets of clinical trials generally needed for regulatory approval, were published today in the medical journal Lancet.

“The findings in this paper are encouraging,” Deepak Srivastava, director of the San Francisco-based Gladstone Institute of Cardiovascular Disease, said in an interview. “There’s a dire need for new therapies for people with heart failure, it’s still the No. 1 cause of death in men and women.”

The study, by researchers from Cedars-Sinai Heart Institute in Los Angeles and Johns Hopkins University in Baltimore, tested the approach in patients who recently suffered a heart attack, with the goal that repairing the damage might help stave off failure. While patients getting the stem cells showed no more improvement in heart function than those who didn’t get the experimental therapy, the theory is that new tissue regenerated by the stem cells can strengthen the heart, said Eduardo Marban, the study’s lead author.

“What our trial was designed to do is to reverse the injury once it’s happened,” said Marban, director of Cedars- Sinai Heart Institute. “The quantitative outcome that we had in this paper is to shift patients from a high-risk group to a low- risk group.”

Minimally Invasive

The stem cells were implanted within five weeks after patients suffering heart attacks. Doctors removed heart tissue, about the size of half a raisin, using a minimally invasive procedure that involved a thin needle threaded through the veins. After cultivating the stem cells from the tissue, doctors reinserted them using a second minimally invasive procedure. Patients got 12.5 million cells to 25 million cells.

A year after the procedure, six patients in the stem cell group had serious side effects, including a heart attack, chest pain, a coronary bypass, implantation of a defibrillator, and two other events unrelated to the heart. One of patient’s side effects were possibly linked to the treatment, the study found.

While the main goal of the trial was to examine the safety of the procedure, the decrease in scar tissue in those treated merits a larger study that focuses on broader clinical outcomes, researchers said in the paper.

Heart Regeneration

“If we can regenerate the whole heart, then the patient would be completely normal,” Marban said. “We haven’t fulfilled that yet, but we’ve gotten rid of half of the injury, and that’s a good start.”

While the study resulted in patients having an increase in muscle mass and a shrinkage of scar size, the amount of blood flowing out of the heart, or the ejection fraction, wasn’t different between the control group and stem-cell therapy group. The measurement is important because poor blood flow deprives the body of oxygen and nutrients it needs to function properly, Srivastava said.

“The patients don’t have a functional benefit in this study,” said Srivastava, who wasn’t not involved in the trial.

The technology is being developed by closely held Capricor Inc., which will further test it in 200 patients for the second of three trials typically required for regulatory approval. Marban is a founder of the Los Angeles-based company and chairman of its scientific advisory board. His wife, Linda Marban, is also a founder and chief executive officer.

“We’d like to study patients who are much sicker and see if we can actually spare them early death, or the need for a heart transplant, or a device,” Eduardo Marban said.

--Editors: Angela Zimm, Andrew Pollack

#<184845.409373.2.1.99.7.25># -0- Feb/14/2012 17:13 GMT

To contact the reporter on this story: Ryan Flinn in San Francisco at rflinn@bloomberg.net

To contact the editor responsible for this story: Reg Gale at rgale5@bloomberg.net

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Scarred Hearts Can Be Mended With Stem Cell Therapy

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Dog Receives First-Ever Stem Cell Therapy in Kansas City

February 14th, 2012 11:32 pm

KANSAS CITY, Mo. — An 11-year-old yellow Labrador suffering from severe arthritis underwent stem cell therapy on Valentine’s Day. It’s the first time a dog has received in-clinic adult stem cell therapy in Kansas City.

According to Stanley Veterinary Clinic where Jake the dog is being treated, adult animal stem cell technology uses the body`s own regenerative healing power to help cure dogs, cats and horses suffering from arthritis, hip dysplasia and tendon, ligament and cartilage injuries and other ailments.

Fat tissue is removed from the animal, the stem cells are separated from the fat and activated, and then injected into the affected areas.

Within two months of the procedure, Jake should be moving well, with little or no pain.

Severe arthritis affects up to 40 percent of the 164 million dogs and cats in the United States.

As for Jake, FOX 4’s Kim Byrnes will have an update on his condition tonight on FOX 4 News at 5 and 6.

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Dog Receives First-Ever Stem Cell Therapy in Kansas City

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Stem Cells May Help Regenerate Heart Muscle

February 14th, 2012 11:32 pm

A promising stem cell therapy approach could soon provide a way to regenerate heart muscle damaged by heart attacks.

Researchers at Cedars-Sinai Heart Institute and The Johns Hopkins University harvested stem cells from the hearts of 17 heart attack patients and after prepping the cells, infused them back into the patients' hearts. Their study is published in the current issue of The Lancet.

The patients received the stem cell infusions about three months after their heart attacks.

Researchers found that six months after treatment, patients had significantly less scarring of the heart muscle and also showed a considerable increase the amount of healthy heart muscle, compared to eight post-heart attack patients studied who did not receive the stem cell infusions. One year after, scar size was reduced by about 50 percent.

"The damaged tissue of the heart was replaced by what looks like healthy myocardium," said Dr. Peter Johnston, a study co-author and an assistant professor of medicine at The Johns Hopkins University School of Medicine. "It's functioning better than the damaged myocardium in the control subjects, and there's evidence it's starting to contract and generate electrical signals the way healthy heart tissue does."

While this research is an early study designed to demonstrate that this stem cell therapy is safe, cardiologists say it's an approach that could potentially benefit millions of people who have suffered heart attacks. Damage to the heart muscle is permanent and irreparable, and little can be done to compensate for loss of heart function.

"In the U.S., six million patients have heart failure, and the vast majority have it because of a prior heart attack," said Johnston.

The damaged scar tissue that results from a heart attack diminishes heart function, which can ultimately lead to enlargement of the heart.

At best, Johnston said, there are measures doctors can try to reduce or compensate for the damage, but in many cases, heart failure ultimately sets in, often requiring mechanical support or a transplant.

"This type of therapy can save people's lives and reduce the chances of developing heart failure," he said.

Cardiac Regeneration A Promising Field

Other researchers have also had positive early results in experiments with stem cell therapy using different types of cells, including bone marrow cells and a combination of bone marrow and heart cells.

"It's exciting that studies using a number of different cell types are yielding similar results," said Dr. Joshua Hare, professor of cardiology and director of the University of Miami Interdisciplinary Stem Cell Institute.

The next steps, he said, include determining what the optimal cell types are and how much of the cells are needed to regenerate damaged tissue.

"We also need to move to larger clinical trials and measure whether patients are improving clinically and exhibiting a better quality of life after the therapy."

In an accompanying comment, Drs. Chung-Wah Siu amd Hung-Fat Tse of the University of Hong Kong wrote that given the promising results of these studies, health care providers will hopefully recognize the benefits that cardiac regeneration can offer.

And Hare added that someday, this type of regeneration can possibly offer hope to others who suffered other types of organ damage.

"This stategy might work in other organs," he said. "Maybe this can work in the brain, perhaps for people who had strokes."

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VistaGen Updates Pipeline of Stem Cell Technology-Based Drug Rescue Candidates

February 14th, 2012 11:32 pm

SOUTH SAN FRANCISCO, CA--(Marketwire -02/14/12)- VistaGen Therapeutics, Inc. (OTC.BB: VSTA.OB - News) (OTCQB: VSTA.OB - News), a biotechnology company applying stem cell technology for drug rescue and cell therapy, has identified its initial Top 10 drug rescue candidates and plans to launch two formal drug rescue programs by the end of next quarter.

VistaGen's goal for each of its stem cell technology-based drug rescue programs is to generate and license a new, safer variant of a once-promising large market drug candidate previously discontinued by a pharmaceutical company no earlier than late-preclinical development.

"We are now at an advanced stage in our business model," said Shawn Singh, VistaGen's Chief Executive Officer. "After more than a decade of focused investment in pluripotent stem cell research and development, we are now at the threshold where game-changing science becomes therapeutically relevant to patients and commercially relevant to our shareholders. We have positioned our company and our stem cell technology platform to pursue multiple large market opportunities. We plan to launch two drug rescue programs by the end of the next quarter."

Over the past year, VistaGen, working with its network of strategic partners, identified over 525 once-promising new drug candidates that meet the Company's preliminary screening criteria for heart toxicity-focused drug rescue using CardioSafe 3D™, its human heart cell-based bioassay system. After internally narrowing the field to 35 compounds, VistaGen, working together with its external drug rescue advisors, including former senior pharmaceutical industry executives with drug safety and medicinal chemistry expertise, analyzed and carefully narrowed the group of 35 to the current Top 10.

About VistaGen Therapeutics

VistaGen is a biotechnology company applying human pluripotent stem cell technology for drug rescue and cell therapy. VistaGen's drug rescue activities combine its human pluripotent stem cell technology platform, Human Clinical Trials in a Test Tube™, with modern medicinal chemistry to generate new chemical variants of once-promising small-molecule drug candidates. These are once-promising drug candidates discontinued by pharmaceutical companies during development due to heart toxicity, despite positive efficacy data demonstrating their potential therapeutic and commercial benefits. VistaGen uses its pluripotent stem cell technology to generate early indications, or predictions, of how humans will ultimately respond to new drug candidates before they are ever tested in humans.

Additionally, VistaGen's oral small molecule prodrug candidate, AV-101 (4-Cl-KYN), is in Phase 1b development for treatment of neuropathic pain. Unlike other NMDA receptor antagonists developed previously, AV-101 readily crosses the blood-brain barrier and is then efficiently converted into 7-chlorokynurenic acid (7-Cl-KYNA), one of the most potent and specific glycineB site antagonists currently known, and has been shown to reduce seizures and excitotoxic neuronal death. Neuropathic pain, a serious and chronic condition causing pain after an injury or disease of the peripheral or central nervous system, affects approximately 1.8 million people in the U.S. alone. To date, VistaGen has been awarded over $8.5 million from the NIH for development of AV-101. The Company anticipates pursuing Phase 2 development for neuropathic pain and other neurological indications, including depression, epilepsy, and/or Parkinson's disease in the event it receives additional non-dilutive development grant funding from the NIH or private foundations.

Visit VistaGen at http://www.VistaGen.com, follow VistaGen at http://www.twitter.com/VistaGen or view VistaGen's Facebook page at http://www.facebook.com/VistaGen.

Cautionary Statement Regarding Forward Looking Statements

The statements in this press release that are not historical facts may constitute forward-looking statements that are based on current expectations and are subject to risks and uncertainties that could cause actual future results to differ materially from those expressed or implied by such statements. Those risks and uncertainties include, but are not limited to, risks related to the success of VistaGen's stem cell technology-based drug rescue activities, ongoing AV-101 clinical studies, its ability to enter into drug rescue collaborations and/or licensing arrangements with respect to one or more drug rescue variants, risks and uncertainties relating to the availability of substantial additional capital to support VistaGen's research, drug rescue, development and commercialization activities, and the success of its research and development plans and strategies, including those plans and strategies related to AV-101 and any drug rescue variant identified and developed by VistaGen. These and other risks and uncertainties are identified and described in more detail in VistaGen's filings with the Securities and Exchange Commission (SEC). These filings are available on the SEC's website at http://www.sec.gov. VistaGen undertakes no obligation to publicly update or revise any forward-looking statements.

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Radiation therapy transforms breast cancer cells into cancer stem cells

February 14th, 2012 6:03 am

Washington, Feb 14 (ANI): Researchers have shown for the first time that radiation treatment -despite killing half of all tumour cells during every cycle - transforms other cancer cells into treatment-resistant breast cancer stem cells.

According to researchers with the UCLA Department of Radiation Oncology at UCLA's Jonsson Comprehensive Cancer Center, the generation of these breast cancer stem cells counteracts the otherwise highly efficient radiation treatment.

If scientists can uncover the mechanisms and prevent this transformation from occurring, radiation treatment for breast cancer could become even more effective, said study senior author Dr. Frank Pajonk, an associate professor of radiation oncology and Jonsson Cancer Center researcher.

"We found that these induced breast cancer stem cells (iBCSC) were generated by radiation-induced activation of the same cellular pathways used to reprogram normal cells into induced pluripotent stem cells (iPS) in regenerative medicine," said Pajonk, who also is a scientist with the Eli and Edythe Broad Center of Regenerative Medicine at UCLA.

"It was remarkable that these breast cancers used the same reprogramming pathways to fight back against the radiation treatment."

"Controlling the radiation resistance of breast cancer stem cells and the generation of new iBCSC during radiation treatment may ultimately improve curability and may allow for de-escalation of the total radiation doses currently given to breast cancer patients, thereby reducing acute and long-term adverse effects," the study stated.

There are very few breast cancer stem cells in a larger pool of breast cancer cells. In this study, Pajonk and his team eliminated the smaller pool of breast cancer stem cells and then irradiated the remaining breast cancer cells and placed them into mice.

Using a unique imaging system Pajonk and his team developed to visualize cancer stem cells, the researchers were able to observe their initial generation into iBCSC in response to the radiation treatment.

The newly generated iBCSC were remarkably similar to breast cancer stem cells found in tumors that had not been irradiated, Pajonk said.

The team also found that the iBCSC had a more than 30-fold increased ability to form tumors compared to the non-irradiated breast cancer cells from which they originated.

Pajonk said that the study unites the competing models of clonal evolution and the hierarchical organization of breast cancers, as it suggests that undisturbed, growing tumors maintain a small number of cancer stem cells.

However, if challenged by various stressors that threaten their numbers, including ionizing radiation, the breast cancer cells generate iBCSC that may, together with the surviving cancer stem cells, repopulate the tumour.

"What is really exciting about this study is that it gives us a much more complex understanding of the interaction of radiation with cancer cells that goes far beyond DNA damage and cell killing," Pajonk said.

"The study may carry enormous potential to make radiation even better."

Pajonk stressed that breast cancer patients should not be alarmed by the study findings and should continue to undergo radiation if recommended by their oncologists.

"Radiation is an extremely powerful tool in the fight against breast cancer," he said.

"If we can uncover the mechanism driving this transformation, we may be able to stop it and make the therapy even more powerful," Pajonk added.

The study has been published in the online edition of peer-reviewed journal Stem Cells. (ANI)

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Cardiac stem cells can restore heart muscles, says study

February 14th, 2012 6:03 am

They also help to reduce scar size

Infusion of cardiac stem cells into persons who suffered heart attack recently can help to regenerate their heart muscles, says a study published on February 14, in The Lancet.

Phase I of the study was conducted on 17 patients, who received stems cells, and eight, who received standard care (control group), at the Cedars-Sinai Heart Institute in Los Angeles and Johns Hopkins Hospital, Baltimore. All of them had had heart attacks about a month before the study began in May 2009. The stem cells were created from the patients' heart tissues.

Visible improvements were seen in those who received infusion of stem cells, compared with the control group at the end of six months and a year. While no change in the scar size was seen in the control group, there was more than 12 per cent reduction in the size at the end of six months in the treatment group.

As scar size is directly related to scar mass, a reduction of 8.4 gram (28 per cent) and almost 13 gram (42 per cent) in scar mass was seen in the treatment group at the end of six months and 12 months.

Surprisingly, scar mass reduction was accompanied by an increase in viable myocardial mass. In fact, on an average, the increase in viable myocardial mass was “about 60 per cent more than scar reduction.” This is significant as it had led to a “partial restoration of lost left ventricular mass in patients with CDCs [cardiosphere-derived cells],” the authors of the study noted.

The study thus “challenges the conventional wisdom that once established, cardiac scarring is permanent, and that, once lost, healthy heart muscle cannot be restored.”

However, a change in scar size was accompanied by only 2 per cent increase in ejection factor (the amount of blood pumped by the heart), which is not considered significant.

While “the reasons for the discrepancy are unclear,” the study noted that “ejection factor at baseline was only moderately impaired, leaving little room for improvement.”

Of the six patients in the treatment group who had serious adverse events, only one was found to be related to the study.

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Study: Cardiac stem cells can reverse heart attack damage

February 14th, 2012 6:03 am

Dr. Eduardo Marbán, in his laboratory at the Cedars-Sinai Heart Institute. (Cedars-Sinai Heart Institute)

By Eryn Brown, Los Angeles Times / for the Booster Shots blog

February 13, 2012, 5:45 p.m.

Researchers have used cardiac stem cells to regenerate heart muscle in patients who have suffered heart attacks, also known as myocardial infarction.

The small preliminary study, which was conducted by the Cedars-Sinai Heart Institute in Los Angeles, involved 25 patients who had suffered heart attacks in the previous one and a half to three months. 

Seventeen of the study subjects received infusions of stem cells cultured from a raisin-sized chunk of their own heart tissue, which had been removed via catheter. The eight others received standard care. 

During a heart attack, heart tissue is damaged, leaving a scar.  On average, scars in patients who had the stem cell infusions dropped in size from 24% to 12% of the heart, said Dr. Eduardo Marbán, director of the Cedars-Sinai Heart Institute and lead researcher on the study, which was published online Monday in the journal The Lancet.  (The journal has provided an abstract of the study; subscription is required for the full text.)

In an email, Marbán said he believed that the stem cells repaired the damaged heart muscle "indirectly, by stimulating the heart's endogenous capacity to regrow [which normally lies dormant]." He said that the most surprising aspect of the research team's finding was that the heart was able to regrow healthy tissue. Conventional wisdom holds that cardiac scarring is permanent.

A follow-up study involving about 200 patients is planned for later this year, Marbán added.

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Stem Cells Could Help Heal Broken Hearts [Medicine]

February 14th, 2012 6:03 am

Even after recovery, heart attacks can leave a lasting mark on your ticker—scar tissue weakens the muscle and prevents it from functioning as well as it did before seizing up. A pioneering stem-cell procedure, however, could cut the damage in half.

According to the results of a small safety trial by the Cedars-Sinai Heart Institute and published in the Lancet medical journal, introducing stem cells derived from the patient's own heart have shown an "unprecedented" ability to reduce scarring as well as regenerate healthy cardiac tissue.

During a heart attack, the organ is deprived of oxygen and its tissue begins to die off. As the heart heals from the attack, any damaged muscle is replaced by scar tissue, which prevents the heart from beating properly and pumping the requisite blood flow the body needs.

The CADUCEUS (CArdiosphere-Derived aUtologous stem CElls to Reverse ventricUlar dySfunction) study involved 25 patients—eight serving as the control group, the other 17 actually receiving the treatment. Researchers first performed extensive imaging scans to identify location and severity of scarring, then biopsied a half-raisin-sized piece the patient's heart tissue. Doctors then isolated and cultured stem cells from it and injected the lab-grown stem cells—roughly 12-25 million of them—back into the heart.

After a year, scarring in patients that received the treatment decreased by an astounding fifty percent while the control group showed no decrease in scarring. "These results signal an approaching paradigm shift in the care of heart attack patients," said Shlomo Melmed, dean of the Cedars-Sinai medical faculty. The scars were once believed to be permanent but this technique shows promise as a means to regenerate the damaged muscle. It should be noted however, that the heart's ability to pump did not increase as the scar tissue disappeared.

"While the primary goal of our study was to verify safety, we also looked for evidence that the treatment might dissolve scar and regrow lost heart muscle," Eduardo Marbán, director of the Cedars-Sinai Heart Institute, told PhysOrg. "This has never been accomplished before, despite a decade of cell therapy trials for patients with heart attacks. Now we have done it. The effects are substantial, and surprisingly larger in humans than they were in animal tests."

Researchers hope to soon begin an expanded clinical trial and, if the results are as promising as these, eventually use the procedure to assist the US's annual 770,000 coronary disease sufferers. [The Lancet via Physorg - BBC News]

Image: Shortkut / Shutterstock

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Cells 'heal' heart attack scars

February 14th, 2012 6:03 am

13 February 2012 Last updated at 19:52 ET By James Gallagher Health and science reporter, BBC News

Damage caused by a heart attack has been healed using stem cells gathered from the patient's own heart, according to doctors in the US.

The amount of scar tissue was halved in the small safety trial reported in the Lancet medical journal.

The authors said there was also an "unprecedented" increase in new heart muscle.

The British Heart Foundation said it was "early days", but could "be great news for heart attack patients".

A heart attack happens when the organ is starved of oxygen, such as a clot blocking the flow of blood to the heart.

As the heart heals, the dead muscle is replaced with scar tissue, but because this does not beat like heart muscle the ability to pump blood around the body is reduced.

Doctors around the world are looking at ways of "regenerating" the heart to replace the scar tissue with beating muscle. Stem cells, which can transform into any other type of specialised cell, figure prominently in their plans.

Heart to heart

This trial, at the Cedars-Sinai Heart Institute, was designed to test the safety of using stem cells taken from a heart attack patient's own heart.

Continue reading the main story Healing the heart

This is the second group of doctors to report using cells taken from a heart to heal a heart.

In November 2011, another safety trial showed the cells could be used to heal the hearts of heart failure patients who were having heart bypass surgery.

The heart is not the only source for these stem cells and other fields are much further ahead.

The largest ever trial of stem cell therapy in heart attack patients is about to get under way in Europe.

The BAMI trial will inject 3,000 heart attack patients with stem cells taken from their bone marrow within five days of the heart attack.

Within a month of a heart attack, a tube was inserted into a vein in the patient's neck and was pushed down towards the heart. A sample of heart tissue, about "half the size of a raisin", was taken.

This was taken to the laboratory where the stem cells were isolated and grown. Up to 25 million of these stem cells were then put into the arteries surrounding the heart.

Twenty five patients took part in the trial. Before the treatment, scar tissue accounted for an average of 24% of their left ventricle, a major chamber of the heart. It went down to 16% after six months and 12% after a year.

Healthy heart muscle appeared to take its place. The study said the cells, "have an unprecedented ability to reduce scar and simultaneously stimulate the regrowth of healthy [heart] tissue".

One of the researchers Dr Eduardo Marban said: "While the primary goal of our study was to verify safety, we also looked for evidence that the treatment might dissolve scar and regrow lost heart muscle.

"This has never been accomplished before, despite a decade of cell therapy trials for patients with heart attacks. Now we have done it.

Continue reading the main story “Start Quote

These cells have been proven to form heart muscle in a Petri dish but now they seem to be doing the same thing when injected back into the heart as part of an apparently safe procedure”

End Quote Prof Jeremy Pearson British Heart Foundation

"The effects are substantial, and surprisingly larger in humans than they were in animal tests."

However, there was no increase in a significant measure of the heart's ability to pump - the left ventricle ejection fraction: the percentage of blood pumped out of the left ventricle.

Prof Anthony Mathur, who is co-ordinating a stem cell trial involving 3,000 heart attack patients, said that even if the study found an increase in ejection fraction then it would be the source of much debate.

He argued that as it was a proof-of-concept study, with a small group of patients, "proving it is safe and feasible is all you can ask".

"The findings would be very interesting, but obviously they need further clarification and evidence," he added.

Prof Jeremy Pearson, associate medical director at the British Heart Foundation, said: "It's the first time these scientists' potentially exciting work has been carried out in humans, and the results are very encouraging.

"These cells have been proven to form heart muscle in a petri dish but now they seem to be doing the same thing when injected back into the heart as part of an apparently safe procedure.

"It's early days, and this research will certainly need following up, but it could be great news for heart attack patients who face the debilitating symptoms of heart failure."

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Dr. Ramaswamy on Dormant Tumor Cells and Resistance – Video

February 14th, 2012 6:03 am

13-02-2012 12:31 Sridhar Ramaswamy, MD, Tucker Gosnell Investigator and Associate Professor of Medicine, Massachusetts General Hospital Cancer Center, Harvard Medical School, Broad Institute of Harvard and MIT, and Harvard Stem Cell Institute, discusses ongoing research into drug tolerance and resistance, specifically the roll of dormant cancer cells. If a tumor goes into remission as a result of a cancer drug and then recurs it is likely that the tumor will still respond to the initial treatment. In the dormant state the cells are resistance, in the original they are sensitive. The exact mechanism behind this has yet to be discovered. In some cases giving a course, stopping, and then continuing later on can create an additive effect, an idea that Ramaswamy calls a drug holiday. A comparison is underway between drug and non-drug induced dormant cells in order to find the mechanism that causes resistance. The ultimate goal of the research is to be able to predict and stop drug resistance.

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Dr. Ramaswamy on Dormant Tumor Cells and Resistance - Video

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Morning Report: Balboa Park's Future

February 14th, 2012 6:03 am

Posted: Monday, February 13, 2012 7:30 am | Updated: 1:35 pm, Mon Feb 13, 2012.

 

The time is ticking toward the 100th anniversary of when Balboa Park became a jewel. We need to move quickly if we want to make the park look more like it did when it first sparkled in front of a worldwide audience in 1915.

There seems to be a general consensus that the park could use some work. But an embittered battle has erupted over exactly what needs to be nipped, tucked and relocated.

Our Scott Lewis ponders the debate over the park's future in the latest of his look at stories to watch in 2012.

He notes that the group planning for a big 2015 celebration has hired a new CEO and says the City Council could decide as soon as June whether to remove cars from the Plaza de Panama (the section of the park between the art museum and the organ pavilion). Preservationist leaders have lined up against the plan.

Lewis says it helps to think of it as the same type of argument that may precede major elective surgery. Find out how.

• This is part of a series of 12 stories Lewis thinks should pay attention to for the next year. Here was No. 12: the Chargers; No. 11: the Convention Center; No. 10: The city of San Diego's financial problems; No. 9: the San Diego Police Department; and No. 8: affordable housing.

In Escondido, a Donor Keeps Streets Smooth

For years, we've been following what we call "the dissolving city" as San Diego has increasingly left it to residents to take care of things like building maintenance and school expenses. Scott Lewis explained the concept here for the city and here for the schools.

When the mayor admitted the city would never have the funds to take care of Balboa Park while introducing the conservancy, that was part of the trend.

But parks have always attracted donor support. In Escondido, a local contractor has taken things to an extreme: He's donated as much as $100,000 a year to help the city fill hundreds of potholes.

The contractor's crew boosted the city's pothole-filling services by about a third, the NC Times reports.

• Related, in New York City, the City Council will begin identifying city needs and helping businesses and civic groups use the crowdfunding service Kickstarter to fund them. On Kickstarter, you pitch an idea for a effort that needs donations and people can pledge support. If you meet your goal, then the project is kickstarted.

Last Day to Decry Football Blackouts

Many San Diegans are horrified when home Chargers games get blacked out because too few people buy tickets. Some fans feel obliged to go outside, where there's a disturbing shortage of couches, beer commercials and TV screens. Shudder.

Well, you can try do something about the blackouts, but you better hurry. The Federal Communications Commission is reviewing the rules and accepting public comment, but only until today. "Aggrieved fans in Cincinnati, Tampa, Oakland, San Diego, Buffalo, Jacksonville — you have the floor," says deadspin.com. A website says it will accept your comments and ideas online and deliver them to the FCC.  

Beep No More

If you're like me -- and please see a doctor if that lasts more than four hours -- you're always setting off security gate alarms even though you're not a shoplifter. Those flapping security gate things at libraries are a special problem for me, perhaps due to my electric personality.

Well, now I'm in luck and you may be too: the city's libraries have quietly stopped turning on their security gate systems, and the county library system has dumped the gates entirely, the U-T reports.

Numbers from the city library system suggest that thefts may be on the rise, big-time, but the meaning of the statistics is fuzzy. 

"Long story short: People steal from libraries. U-T wants to blame the libraries, but can't figure out how," wrote the mayor's special projects man Gerry Braun, a former U-T columnist, on Twitter.

In Focus at UCSD: Occupiers, Dead Bees, Stem Cells

The folks at UCSD's media relations department may deserve a raise. The university's faculty has gotten plenty of press lately:

• A stem cell scientist explains in a Sacramento Bee commentary why the public has to support the kind of research he does because venture capitalists aren't cough up money as much as before.

• USA Today says a professor's new course on social movements is focusing on the Occupy Wall Street protesters

• A biology professor tells alternet.org that "pesticides, disease, parasites, and human mismanagement" are responsible for the big bee die-off.

Check our earlier stories for details about UCSD's research into why so many bees have gone to that big hive in the sky.

A Kiss Before Leaving

"Unconditional Surrender," the hulking statue honoring the famous kissing sailor-nurse couple from V-J day, drives some naysayers around the bend. Former U-T art critic Robert Pincus was forced to turn to the words of noted philosopher Woody Allen to find the perfect way to describe his disgust: "It's a travesty of a mockery of a sham of a travesty of two mockeries of a sham.”  

But tourists love it. Just check out all the photos of it online. (Not all are from here, though, since the statue has many twins).

Now, the 6,000-pound statue -- a "foam-urethane object," as the U-T not-so-smoothly describes it -- is scheduled to move on and torture art critics somewhere else. But there's a catch, and no, it's not the unwillingness of anyone else to take the thing.

A local architect wants to raise almost $1 million to keep the statue here in town permanently, the U-T reports. The port's public art committee rejected the proposal in December, although it was divided.

If the "foam-urethane object" does stick around, here's hoping the port makes triple-sure that it's earthquake-safe. Otherwise, some unsuspecting bystander -- like, say, me -- may give a new meaning to the statue's name the next time the ground shakes.

Please contact Randy Dotinga directly at randydotinga@gmail.com and follow him on Twitter: twitter.com/rdotinga.

 

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Stem cell injection successfully treats urinary incontinence

February 14th, 2012 6:03 am

It started when Deborah Bishop was still in her 20s.

Always athletic -- she had participated in field hockey, speed skating and baseball -- Ms. Bishop was doing jumping jacks when she noticed to her embarrassment that she had leaked urine.

As the weeks wore on, the Canadian woman began to have more and more of these accidents. It wasn't just strenuous exercise that caused them, but also being tickled or coughing or sneezing.

The condition is known as stress urinary incontinence, and researchers say it may affect hundreds of millions of people around the world, primarily women, who are more susceptible because of their anatomy.

Today, Ms. Bishop, 54, is "90 percent" normal on her urinary leakage, she said -- all because of an injection of her own stem cells that she received three years ago.

The cells, known officially as autologous muscle-derived cells, were taken out of her thigh, multiplied several times over in the lab, and then injected into the muscles around her urethra, the opening at the neck of the bladder.

While many people still associate the phrase "stem cells" with ethical debates over using embryos, these stem cells have nothing to do with that.

All of us have stem cells in various parts of our bodies that can develop into mature cells and are used to repair muscle, nerve and tissue damage.

In this case, researcher Johnny Huard at the University of Pittsburgh developed a technique for finding stem cells in muscle tissue and then purifying and multiplying them. The biomedical firm Cook MyoSite Inc. bought the licensing rights to his technique and is overseeing the current tests on treating stress urinary incontinence.

The idea is that the stem cells will create new cells that will strengthen the muscles that control urination. Even though the initial trials were focused on testing the safety of the procedure, 60 to 70 percent of the women have shown a significant decrease in their urinary leakage, said Ryan Pruchnic, Cook MyoSite's director of operations.

Lesley Carr, Ms. Bishop's physician and a urologist at Sunnybrook Health Sciences Centre in Toronto, said there is no medication that helps with this most prevalent form of incontinence. Up to now, the primary last-resort therapy has been surgical insertion of a mesh sling around the urethra.

The surgery is effective, Dr. Carr said, but "there are rare but recognized complications," including pain and infections, and women face up to six weeks of restricted activity after the operation.

That was a big obstacle for Ms. Bishop, not only because she is so physically active, but because she was in the middle of a house renovation when she sought help for her condition.

"I told Dr. Carr I couldn't afford to be out of commission for six weeks," she recalled, "and that's when she must have mentioned the stem cell trial to me."

In July 2009, she had a piece of her outer thigh muscle removed under local anesthesia, a procedure she admits left her feeling "like I'd been kicked by a horse" for about a week.

Researchers then located and multiplied the stem cells in her muscle tissue, and the following September, she had them injected into the muscles around her urethra. The entire injection took about five minutes, she said, and she felt nothing.

The improvement was gradual after that. "I noticed a difference in a couple months," she said, "and a significant difference in four or five months. I thought what made it really unique was that it was using my own muscle cells."

The procedure means that today, she can do her strenuous morning exercises of standing broad jumps and stride jumps without having to wear heavy pads to absorb leakage.

The latest trials with the stem cells are the first to enroll women who will either get real stem cells or placebo injections. Cook MyoSite hopes to have solid results and be able to bring the procedure to market by 2015, Mr. Pruchnic said.

The company has also begun initial tests of the muscle stem cells in people who have had heart attacks or are experiencing chronic heart failure, in hopes they will restore the strength and flexibility of cardiac muscle.

By using a person's own cells, Dr. Carr noted, there is no need for patients to take immunosuppressive medications. She believes such regenerative medicine "will be the wave of the future in most fields" of health care.

Ms. Bishop is certainly sold.

"I've got a girlfriend who's had three children and is very physically active, and she's struggling with stress incontinence now, and so I'm an advocate for this.

"It was an excellent experience for me, and I would highly recommend it to anyone."

Mark Roth: mroth@post-gazette.com or 412-263-1130.

First published on February 13, 2012 at 12:00 am

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ACT Announces Third Patient with Stargardt’s Disease Treated in U.S. Clinical Trial with RPE Cells Derived from …

February 14th, 2012 6:03 am

MARLBOROUGH, Mass.--(BUSINESS WIRE)--

Advanced Cell Technology, Inc. (“ACT”; OTCBB: ACTC), a leader in the field of regenerative medicine, announced today the dosing of third patient in its Phase 1/2 trial for Stargardt’s macular dystrophy (SMD) using retinal pigment epithelial (RPE) cells derived from human embryonic stem cells (hESCs). The patient was treated on Monday (Feb. 6) by Steven Schwartz, M.D., Ahmanson Professor of Ophthalmology at the David Geffen School of Medicine at the University of California, Los Angeles (UCLA) and retina division chief at UCLA’s Jules Stein Eye Institute. The outpatient transplantation surgery was performed successfully and the patient is recovering uneventfully.

“With the treatment of this third Stargardt’s patient at Jules Stein Eye Institute, we have now completed the treatment of the first cohort of patients under our clinical protocol for phase I/II of our U.S. SMD trial,” said Gary Rabin, chairman and chief executive officer of ACT. “We will continue to regularly monitor the three SMD patients in this trial, and by early spring anticipate review of their progress and safety-related data by the Data and Safety Monitoring Board (DSMB). With approval of the DSMB, we would then advance to the next cohort of patients and administer a higher dosage of RPE cells. In the context of all three trials we have running, this patient is the fifth person worldwide to be treated with our hESC-derived RPE cells. To date, there have been no complications or side effects due to the RPE cells, and we remain cautiously optimistic that our ongoing clinical programs will demonstrate the safety and tolerability of ACT’s stem cell-derived RPE cells.”

Each of the three clinical trials being undertaken by the company in the U.S. and Europe will enroll 12 patients, with cohorts of three patients each in an ascending dosage format. These trials are prospective, open-label studies, designed to determine the safety and tolerability of hESC-derived RPE cells following sub-retinal transplantation into patients with SMD or dry age-related macular degeneration (dry AMD) at 12 months, the study’s primary endpoint. Preliminary results relating to both early safety and biological function for the first two patients in the United States, one SMD patient and one dry AMD patient, were recently reported in The Lancet. On January 20, 2012, the first SMD patient to be enrolled in the Company’s U.K. clinical trial was treated at Moorfields Eye Hospital in London.

Further information about patient eligibility for the SMD study and the concurrent study on dry AMD is also available on www.clinicaltrials.gov; ClinicalTrials.gov Identifiers: NCT01345006 and NCT01344993.

About Stargardt's Disease

Stargardt’s disease or Stargardt’s Macular Dystrophy is a genetic disease that causes progressive vision loss, usually starting in children between 10 to 20 years of age. Eventually, blindness results from photoreceptor loss associated with degeneration in the pigmented layer of the retina, called the retinal pigment epithelium, which is the site of damage that the company believes the hESC-derived RPE may be able to target for repair after administration.

About Advanced Cell Technology, Inc.

Advanced Cell Technology, Inc., is a biotechnology company applying cellular technology in the field of regenerative medicine. For more information, visit http://www.advancedcell.com.

Forward-Looking Statements

Statements in this news release regarding future financial and operating results, future growth in research and development programs, potential applications of our technology, opportunities for the company and any other statements about the future expectations, beliefs, goals, plans, or prospects expressed by management constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Any statements that are not statements of historical fact (including statements containing the words “will,” “believes,” “plans,” “anticipates,” “expects,” “estimates,” and similar expressions) should also be considered to be forward-looking statements. There are a number of important factors that could cause actual results or events to differ materially from those indicated by such forward-looking statements, including: limited operating history, need for future capital, risks inherent in the development and commercialization of potential products, protection of our intellectual property, and economic conditions generally. Additional information on potential factors that could affect our results and other risks and uncertainties are detailed from time to time in the company’s periodic reports, including the report on Form 10-K for the year ended December 31, 2010. Forward-looking statements are based on the beliefs, opinions, and expectations of the company’s management at the time they are made, and the company does not assume any obligation to update its forward-looking statements if those beliefs, opinions, expectations, or other circumstances should change. Forward-looking statements are based on the beliefs, opinions, and expectations of the company’s management at the time they are made, and the company does not assume any obligation to update its forward-looking statements if those beliefs, opinions, expectations, or other circumstances should change. There can be no assurance that the Company’s clinical trials will be successful.

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Vet offers stem cell therapy for dogs

February 14th, 2012 6:03 am

COLUMBIA, SC (WIS) - Cutting-edge arthritis treatment for our four-legged family members is now available in Columbia.

Banks Animal Hospital is the first in the area to offer in-house Stem Cell therapy. It uses your pets own body to heal itself.

Take 13-year-old Maggie, for example. The energetic pup has a limp that usually keeps her from jumping or going up stairs.

"Today when everybody's out there filming her little limp it's not as pronounced because she wants to please," said Maggie's owner, Beth Phibbs. "She's just a great dog."

But a great attitude wasn't enough to repair a bad case of cervical spine arthritis.

So Monday, Beth brought Maggie to Banks Animal Hospital for the Stem Cell therapy. Like many, Beth had never heard of Stem Cell work in animals. "Until Dr. Banks mentioned it to me I was like, beg your pardon?"

"There's no down side, no side effects because you're using your own cells," said Dr Ken Banks.

Banks and his staff first gather some of Maggie's blood and fat. Both are good places to find the repair cells they're after. Adult stem cells, not the controversial embryonic kind, are then separated and spun down.

"The repair system in Maggie's body has failed," said Jason Richardson of MediVet-America. "It's fallen asleep at the wheel, we're taking these repair cells, activating them so a chronic condition like osteo arthritis to Maggie will now be an acute illness."

This kind of treatment used to take days with material being shipped across the country, but now it can be done in hours.

"The ability to do it same day, convenience, the ability to do it in clinic saves a lot of money to the doctor which he can then pass on to the patient," said Richardson.

The treatment will still run you around $2,000, but Richardson says that's half of what the similar treatment use to cost.

When it's over, Maggie should be able to live out her life pain and drug free -- something Phibbs is looking forward to.

"I'm hoping in a couple of weeks she's gonna have a new lease on life," said Phibbs.

Copyright 2012 WIS. All rights reserved.

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Scarred Hearts Can Be Mended With Stem Cell Therapy, Study Shows

February 14th, 2012 6:03 am

February 14, 2012, 12:22 AM EST

By Ryan Flinn

Feb. 14 (Bloomberg) -- Stem cells grown from patients’ own cardiac tissue can heal damage once thought to be permanent after a heart attack, according to a study that suggests the experimental approach may one day help stave off heart failure.

In a trial of 25 heart-attack patients, 17 who got the stem cell treatment showed a 50 percent reduction in cardiac scar tissue compared with no improvement for the eight who received standard care. The results, from the first of three sets of clinical trials generally needed for regulatory approval, were published today in the medical journal Lancet.

“The findings in this paper are encouraging,” Deepak Srivastava, director of the San Francisco-based Gladstone Institute of Cardiovascular Disease, said in an interview. “There’s a dire need for new therapies for people with heart failure, it’s still the No. 1 cause of death in men and women.”

The study, by researchers from Cedars-Sinai Heart Institute in Los Angeles and Johns Hopkins University in Baltimore, tested the approach in patients who recently suffered a heart attack, with the goal that repairing the damage might help stave off failure. While patients getting the stem cells showed no more improvement in heart function than those who didn’t get the experimental therapy, the theory is that new tissue regenerated by the stem cells can strengthen the heart, said Eduardo Marban, the study’s lead author.

“What our trial was designed to do is to reverse the injury once it’s happened,” said Marban, director of Cedars- Sinai Heart Institute. “The quantitative outcome that we had in this paper is to shift patients from a high-risk group to a low- risk group.”

Minimally Invasive

The stem cells were implanted within five weeks after patients suffering heart attacks. Doctors removed heart tissue, about the size of half a raisin, using a minimally invasive procedure that involved a thin needle threaded through the veins. After cultivating the stem cells from the tissue, doctors reinserted them using a second minimally invasive procedure. Patients got 12.5 million cells to 25 million cells.

A year after the procedure, six patients in the stem cell group had serious side effects, including a heart attack, chest pain, a coronary bypass, implantation of a defibrillator, and two other events unrelated to the heart. One of patient’s side effects were possibly linked to the treatment, the study found.

While the main goal of the trial was to examine the safety of the procedure, the decrease in scar tissue in those treated merits a larger study that focuses on broader clinical outcomes, researchers said in the paper.

Heart Regeneration

“If we can regenerate the whole heart, then the patient would be completely normal,” Marban said. “We haven’t fulfilled that yet, but we’ve gotten rid of half of the injury, and that’s a good start.”

While the study resulted in patients having an increase in muscle mass and a shrinkage of scar size, the amount of blood flowing out of the heart, or the ejection fraction, wasn’t different between the control group and stem-cell therapy group. The measurement is important because poor blood flow deprives the body of oxygen and nutrients it needs to function properly, Srivastava said.

“The patients don’t have a functional benefit in this study,” said Srivastava, who wasn’t not involved in the trial.

The technology is being developed by closely held Capricor Inc., which will further test it in 200 patients for the second of three trials typically required for regulatory approval. Marban is a founder of the Los Angeles-based company and chairman of its scientific advisory board. His wife, Lisa Marban, is also a founder and chief executive officer.

--Editors: Angela Zimm, Andrew Pollack

-0- Feb/13/2012 22:32 GMT

To contact the reporter on this story: Ryan Flinn in San Francisco at rflinn@bloomberg.net

To contact the editor responsible for this story: Reg Gale at rgale5@bloomberg.net

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Dogs who got stem cell therapy are well

February 14th, 2012 6:03 am

WALKER, Mich. (WOOD) - Dogs who received the first in-clinic stem cell therapy in West Michigan returned to the vets who treated them Monday morning.

Boris and Natasha returned to Kelley's Animal Clinic for their 60-day checkup after receiving stem cell treatment in December 2011.

Dr. James Kelley and his staff of vets removed fat tissue from the dogs and activated it with an enzyme before injecting it into their back legs.

This adult animal stem cell technology is different from the controversial embryonic stem cell therapy.

Kelley said both dogs are doing amazingly well and that the procedure has done more than just help their arthritis.

"We're finding that not only the joints are affected, the rest of the animal is affected as well," said Kelley. "The skin is better. The attitude in these dogs is much improved."

Kelley and his staff have done 16 stem cell treatments since the first on Boris and Natasha, and he said all the dogs are showing signs of improvement after a short period of time.

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Stem Cell Treatment Might Reverse Heart Attack Damage

February 14th, 2012 6:03 am

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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U.S. and Canadian Scientists Form a Global Alliance for Nano-Bio-Electronics in Order to Rapidly Find Solutions for …

February 14th, 2012 6:02 am

LOS ANGELES, Feb. 13, 2012 /PRNewswire/ -- The Society for Brain Mapping and Therapeutics (SBMT) announced today that the organization will hold its 9th Annual World Congress on Brain, Spinal Cord Mapping, and Image Guided Therapy from June 2-4, 2012 in Toronto, Canada.  The world's top brain and spinal cord scientists and surgeons will converge on the Toronto Metro Convention Center to find solutions to some of the most difficult to treat neurological disorders, including traumatic brain and spinal cord injuries, Parkinson's Disease, Alzheimer's Disease, and neurological cancers. 

The 2012 World Congress of SBMT is jointly supported by the American Association of Neurological Surgeons, the Government of Canada, the University of Toronto, and MaRS innovation; it is endorsed by the International Society for Magnetic Resonance Imaging in Medicine.

The theme of this year's World Congress is "Nano-Bio-Electronics," which focuses on the integration of nanotechnology, stem cell research, and biomedical engineering, and imaging of the brain and spinal cord to make progress in the fight against neurological diseases. The aim of the Congress is to provide a multidisciplinary forum for health professionals in the fields of neurosurgery, neurology, psychiatry, radiology, neuroscience, engineering, as well as policymakers, to collaborate as a global alliance to rapidly advance treatment of neurological disorders.

"The meeting will help us kick start a unique and efficient consortium, which will unite scientists and consolidate resources in order to help us quickly come up with solutions for the devastating neurological diseases affecting millions and costing billions in the US alone," said Babak Kateb, Chairman of the Board of SBMT, President of the Brain Mapping Foundation, and Director of the National Center for Nano-Bio-Electronics (NCNBE). Dr. Kateb states, "The purpose of the Nano-Bio-Electronic alliance is to facilitate integration of nanotechnology, Stem cell and cellular therapy with medical devices and imaging. This consortium will impact global biomedical science and healthcare delivery through national and international partnerships with governments, universities, leading organizations and industries."

Among the notable participants of the 2012 World Congress includes Canadian Surgeon General Hans W. Jung, U.S. Navy Surgeon General Matthew Nathan, and Canadian Parliament Member Kirsty Duncan.  Dr. Duncan, an advocate for brain research in Canada and a global voice for neuroscience initiatives, stated "I am honored to participate in this important conference.  It is vital that we work to enhance our understanding of brain health through research and collaboration."  She added, "We must also affirm our commitment to improving the quality of life of those who live with a brain condition and of their families and informal caregivers."

Toronto was chosen for this year's meeting because of the city's strong and globally-connected network of neuroscientists, biomedical engineers, and investors in the biomedical and nanotechnology fields.   Michael Fehlings, chairman of the local organizing committee, Professor of Neurosurgery, and Director of the Neuroscience Program at the University of Toronto, said "The meeting will showcase Canadian and international neuroscience talent in a broad range of disciplines and will highlight the latest advances in imaging, molecular and cellular mechanisms, bioengineering and surgical intervention."

Parimal Nathwani, Vice President of MaRS Innovation, added, "Forums like this represent an excellent opportunity for reviewing technologies and supporting collaboration across different institutions for more effective translation and commercialization opportunity."

The 9th Annual World Congress is still accepting abstract proposals for the meeting's workshops, lectures, and presentation sessions. Abstract submission  is open now until March 15th 2012.

For the full list of 2012 speakers to register, or support of the 9th Annual World Congress of SBMT on Brain, Spinal Cord Mapping, and Image-Guided Therapy, please visit http://www.worldbrainmapping.org&nbsp; or call (310) 500-6196.

Society of Brain Mapping and Therapeutics
SBMT is a non-profit society organized for the purpose of encouraging basic and clinical scientists who are interested in areas of Brain Mapping and Intra-operative Surgical planning to improve the diagnosis, treatment and rehabilitation of patients afflicted with neurological disorders.

This society promotes the public welfare and improves patient care through the translation of new technologies into life saving diagnostic and therapeutic procedures. The society is committed to excellence in education, and scientific discovery. The society achieves its mission through multi-disciplinary collaborations with government agencies, patient advocacy groups, educational institutes and private sector (industry) as well as philanthropic organization. http://www.IBMISPS.org

University of Toronto Neuroscience Program
The University Of Toronto Faculty Of Medicine established the U of T Neuroscience Program (UTNP) as a new academic program and appointed Professor Michael G. Fehlings as its first Director on September 1, 2008. The UTNP is a robust, integrated and collaborative academic program in neurosciences that leverages the unparalleled health science network at the University of Toronto, which includes U of T's many departments and institutes, health science faculties, 9 fully-affiliated research hospitals and 20 community-affiliated hospitals and clinical care sites.

MaRS Innovation
MaRS Innovation provides an integrated commercialization platform that harnesses the economic potential of the exception discovery pipeline of 16 leading academic institutions in Ontario. MaRS Innovation is a not-for-profit organization with an independent industry- led board of directors, funded through the Government of Canada's Networks of Centres of Excellence, the Province of Ontario through the Ministry of Research and Innovation, and contributions of its member institutions. Designed to enhance the commercial output of Toronto's outstanding scientific research cluster, MaRS Innovation will make a significant contribution to Canada's economic outlook and the quality of life for Canadians and others around the world. MaRS Innovation will advance commercialization through industry partnerships, licensing and company creation. The MaRS Innovation mission is to put Canada on the global innovation stage, by better connection of research with industry and strengthening Canada's competitive capacity in the knowledge based business – in short, to launch a new generation of robust high growth Canadian companies.  www.marsinnovation.com

American Association of Neurological Surgeons
The American Association of Neurological Surgeons (AANS) is the organization that speaks for all of neurosurgery. The AANS is dedicated to advancing the specialty of neurological surgery in order to promote the highest quality of patient care.  http://aans.org

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Seattle Genetics Loss Narrows; But Stock Down – Update

February 14th, 2012 6:01 am

(RTTNews.com) - Biotechnology company Seattle Genetics Inc. (SGEN) Monday reported a loss for the fourth quarter that narrowed from a year ago, due mainly to sales of Hodgkin Lymphoma drug Adcetris approved last August. Loss for the quarter was smaller when compared to analyst estimates, while revenues too came in ahead of expectations.

Looking ahead, Seattle Genetics detailed its revenue forecast for 2012. Nonetheless, investors were not too impressed with the results, sending Seattle Genetics shares down 7 percent in after hours trade on the Nasdaq.

The Bothell, Washington-based company reported fourth-quarter net loss of $27 million or $0.24 per share compared to net loss of $34.5 million or $0.34 per share last year.

On average, 14 analysts polled by Thomson Reuters expected a loss of $0.31 per share for the quarter. Analysts' estimates typically exclude special items.

Results for the 2011 quarter include an $8.7 million valuation adjustment related to holdings in auction rate securities.

The company reported revenues of $48.9 million, compared to $8.1 million in the prior year. Street analysts expected revenues of $39.12 million.

Adcetris product sales for the quarter was $33.2 million. Adcetris (brentuximab vedotin) was approved by the FDA last August for the treatment of patients with Hodgkin lymphoma after failure of autologous stem cell transplant (ASCT) or after failure of at least two prior multi-agent chemotherapy regimens in patients who are not ASCT candidates.

The drug has been also approved for the treatment of patients with systemic anaplastic large cell lymphoma after failure of at least one prior multi-agent chemotherapy regimen. Adcetris is the first drug approved by the FDA for Hodgkin lymphoma in more than 30 years.

CEO Clay Siegall said, "...We are also executing on a broad clinical development program of Adcetris to evaluate its potential in earlier lines of therapy for Hodgkin lymphoma and mature T-cell lymphomas, as well as in other CD30-positive malignancies."

Total expenses for the quarter rose to $67.6 million from $43 million last year, reflecting higher selling expenses related to the launch of Adcetris, and increased research expenses.

Seattle Genetics expects full year 2012 revenues from collaboration and license agreements between $55 million and $65 million.

Analysts currently expect the company to report revenues of $196.21 million for 2012.

SGEN closed Monday on the Nasdaq at $18.96, up $0.36 or 1.96%, on a volume of 1.6 million shares. In after hours, the stock lost $1.34 or 7.07%.

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Seattle Genetics Loss Narrows; But Stock Down - Update

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