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Archive for February, 2012

Heart's stem cells used to mend attack damage

SAN FRANCISCO -- 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 were published Tuesday in the medical journal Lancet.

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 and director of Cedars-Sinai Heart Institute.

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 12.5 million to 25 million cells using a second minimally invasive procedure.

A year after the procedure, six patients in the stem cell group had serious side effects.

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

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

First published on February 15, 2012 at 12:00 am

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Heart's stem cells used to mend attack damage

Bone Marrow Stem Cells Help Heal Heart Attack Damage

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Main Category: Stem Cell Research
Also Included In: Cardiovascular / Cardiology
Article Date: 15 Feb 2012 - 2:00 PST

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A systematic review of the evidence so far suggests stem cells derived from bone marrow moderately improves heart function after a heart attack. But the authors say larger trials are needed before we can devise guidelines for therapy practice, or draw conclusions about the long-term benefit of the treatment, such as whether it extends life.

The review, about to be published in the Cochrane Library, updates one done in 2008 that reviewed 13 trials; the new one takes into account another 20 more recent trials. Even though these later trials had longer follow ups, it was still not possible to draw firm conclusions about the long term benefits.

Lead author Enca Martin-Rendon, of the Stem Cell Research laboratory, NHS Blood and Transplant at the John Radcliffe Hospital in Oxford, UK, told the press that they found it hard to compare the 33 studies because they used so many different approaches:

"Larger trials with standardised treatment procedures would help us to know whether this treatment is really effective," said Martin-Rendon.

In order to pump blood around the body, the heart also needs its own constant supply of blood. If this supply is cut off by a blocked artery, it can cause a heart attack and damage the muscle tissue in the affected part of the heart, causing the cells to start dying, a process known as necrosis.

In the days and weeks after a heart attack, the necrosis can spread, eventually leaving a large part of the heart muscle unable to perform the job of contracting and pumping as well as it ought to. This increases the risk of further heart problems.

Stem cells are precursor cells that have the potential to mature into any cell in the body, including heart muscle cells. For this review, the researchers looked only at treatments that use stem cells derived from bone marrow. At present, such treatments are only available at centres that do research.

Another recently published study described a treatment that used stem cells derived from the patient's own heart tissue to repair heart attack damage.

For the review, Martin-Rendon and colleagues pooled data on a total of 1,765 patients from 33 trials. All the patients had already undergone the conventional treatment, angioplasty, where a balloon is inflated in the blocked artery to open it up and restore blood flow.

They concluded that stem cell therapy using bone marrow-derived stem cells (BMSCs) can result in a moderate long-term improvement in heart function, that lasts for up to 5 years. But there was not enough data to enable them to say anything firm about the effect on survival rates.

Martin-Rendon said:

"This new treatment may lead to moderate improvement in heart function over standard treatments," adding that:

"Stem cell therapy may also reduce the number of patients who later die or suffer from heart failure, but currently there is a lack of statistically significant evidence based on the small number of patients treated so far."

The authors said it was still to early to compile guidelines for standard practice, and further work would be needed before anyone can do this. For instance, more information is needed to establish cell dosage, the timing of transplantation and how best to measure heart function.

One large trial, called BAMI, is already under way. The European Society of Cardiology for Stem Cells and Cardiac Repair is conducting the trial, which is funded by the European Union Seventh Framework Programme for Research and Innovation (EU FP7-BAMI).

Anthony Mathur, a co-author of this latest Cochrane review, and principal investigator of the BAMI trial, said:

''The BAMI trial will be the largest stem cell therapy trial in patients who have suffered heart attacks and will test whether this treatment prolongs the life of these patients."

Written by Catharine Paddock PhD
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Bone Marrow Stem Cells Help Heal Heart Attack Damage

Gene therapy for epilepsy could stop seizures

The researchers used gene therapy in rats to stimulate production of somatostatin, a seizure-stopping chemical that naturally occurs in the brain. The study was published in the February issue of the journal Neuroscience Letters.

More than 3 million people in the United States have epilepsy, according to the Centers for Disease Control and Prevention. This lifelong disease is characterized by uncontrollable seizures and can keep people from living independently or holding jobs, particularly if they do not respond to seizure-controlling medication. Finding novel ways to prevent these seizures could help people with epilepsy live more normal, symptom-free lives, said Dr. Paul Carney, chief of the division of neurology in the UF College of Medicine department of pediatrics and senior author of the study.

“For years people have focused only on treating the disease, not preventing the disease,” Carney said. “The mantra is no seizures, no side effects.”

People with epilepsy tend to have lower levels of the hormone somatostatin, as do people with Alzheimer’s disease. Although somatostatin, which belongs to a group of protein-like molecules called neuropeptides, is present in the brains of people with epilepsy, scientists have shown that its levels decrease during seizures, said Rabia Zafar, the lead author of the paper and a former postdoctoral associate in Carney’s lab.

To test whether they could prevent seizures by bolstering levels of this hormone, the researchers administered a dose of the gene that triggers somatostatin expression. A harmless virus transported the gene safely through the body.

“There is some somatostatin in the brain anyway, because it’s a neuropeptide, but there was a dramatic increase after the injection,” Zafar said.

Boosting somatostatin levels led to weaker and shorter seizures, and none of the subjects that received the injection suffered the highest level of seizure. Better yet, the treatment did not result in unwanted side effects. The only side effect was positive: subjects learned better after the treatment.

“Being able to restore somatostatin up to normal levels allows the brain to heal itself and that is the idea here,” Carney said. “We’re putting something back in that is normally there and allowing the brain to pick it up as part of its normal machinery. We’re not putting in a drug.”

In addition to epilepsy, studies have shown that somatostatin may play a role in aging and neurodegenerative disorders such as Alzheimer’s disease, Carney said. Somatostatin is a neuromodulator, which means it can alter how nerve cells behave.

In this study, the researchers focused on temporal lobe epilepsy, the most common form of the disease. Although medication helps control seizures in most people with this type of epilepsy, about 30 percent of patients do not respond to therapy, Carney said.

“We need better, more effective treatments for a large population of children and adults who don’t respond to conventional treatments,” he said. “Gene therapy, as well as other forms of treatment, are emerging, and there is the hope and promise they will offer more effective and novel treatments for people with drug-resistant epilepsy.”

But the researchers caution that this study is just a first step. Additional research is needed before the technique can be attempted in humans. Researchers are particularly focused on ensuring the treatment does not cause inflammation and discovering the best way to administer it, either be injection to the brain or a less invasive intravenous infusion.

“What effect a compound is going to have partly depends on where in the seizure circuit that new compound or gene is being placed. You could put the same chemical in two places and get two different results,” said Dr. Edward Bertram III, a professor of neurology at the University of Virginia, who was not involved in the study. “That is going to be the issue as they try to develop this: Where should we be putting this to have the best effect? On the promising side, they put (the gene) in a restricted area and had an effect. That is a great first step.”

Provided by University of Florida (news : web)

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Gene therapy for epilepsy could stop seizures

Stem cells – ISWA project – Video

14-02-2012 08:13 STEM CELLS The dance of life Recent developments in regenerative medicine and modern biology are going to have an enormous impact on our lives. Also the way itself we face the problem of sickness, aging and death changes as the hope (or the illusion?) grows that we always can fight and delay them. Stem cell research is in fact changing our knowledge of the fundamental mechanisms of life and feeding the idea that we can increasingly contrast the cruel natural selection rules which make us fall ill, grow old and die. A new frontier opens and unpredictable changes in our culture are taking place. People's hopes and fears grow at the same time. The general properties of the stem cells is presented, namely the ability to proliferate and, under certain conditions, to differentiate in other types of cells. In this way they can generate a new tissue replacing a damaged one, and also a new organ (like blood, thrachea, liver, heart, skin, cornea and very recently retina). A stamp is shown, which was emitted by the Japanese government to celebrate the discovery of a university team, which was able to regenerate a cornea and giving the opportunity to a patient to see again. Then the innovative results is presented in applications of the stem cells to orthopedy, muscular dystrophy, cardiology and dentistry. Finally the etherogeneus perspectives is presented offered by stem cell research to treat degenerative disorders, like Alzheimer, Parkinson diseases and Multiple Sclerosis. www ...

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Stem cells - ISWA project - Video

Provia Labs Makes Chicago Midwinter Meeting Debut and Launches Store-A-Tooth™ Dental Stem Cell Preservation, Enabling …

Dentists can be at the forefront of the emerging field of regenerative medicine by offering Store-A-Tooth™ dental stem cell banking.

This service enables families to save their own adult stem cells from teeth that are naturally coming out or being extracted. Dental professionals play a role in making patients aware of this option, giving families the choice to safely and securely store their stem cells today – in a convenient and affordable way – so that they can take advantage of future therapies in regenerative medicine and dentistry.

Provia Laboratories, LLC will be exhibiting its Store-A-Tooth™ dental stem cell preservation service during the Chicago Midwinter Meeting at booth # 3346.

Lexington, MA (PRWEB) February 15, 2012

Provia Laboratories, LLC will be exhibiting during the Chicago Midwinter Meeting at booth # 3346 to showcase its Store-A-Tooth™ dental stem cell preservation service.

The Store-A-Tooth service enables families to save their own adult stem cells – from baby teeth ready to fall out; teeth pulled for orthodontic reasons; and wisdom teeth being extracted. Dental professionals play a role in making patients aware of this option, giving families the choice to safely and securely store their stem cells today – in a convenient and affordable way – so that they can take advantage of future therapies in regenerative medicine and dentistry.

The company partners with dental offices to make it easy to educate and inform patients about the option to preserve their family’s dental stem cells. For those interested in the service, Provia works with the dental team to provide high quality tooth collection, and arranges for the sample to be sent overnight to the lab, where the stem cells are harvested, tested and cryopreserved for future potential use.

“New stem cell therapies are going to change medicine as we know it, and dentists will play a leading role in enabling this transformation,” states Howard Greenman, Provia Labs CEO. “There’s been a lot of media buzz about stem cell research in general, but most people are unaware that a very potent and plentiful source of viable stem cells exits in the dental pulp of healthy teeth.”

Dental stem cells have already successfully been used in people to regenerate alveolar jaw bone and to treat periodontal disease. “One of the first routine applications in the oral cavity for the use of mesenchymal stem cells from teeth will be to promote bone growth around implants so they integrate more quickly, similar to how cellular bone matrix products are used today,” says Dr. Nicholas Perrotta, DMD, who started providing the Store-A-Tooth service in 2011.

“In addition to potential applications in regenerative dentistry, dental stem cell research may lead to new treatments for a wide range of medical conditions, including type 1 diabetes, stroke, cardiovascular disease, spinal cord injuries, and Parkinson’s disease, to name a few,” explains Peter Verlander, PhD, Chief Scientific Officer for Provia Labs. “Dental stem cell collection and preservation gives parents the peace of mind that they are now equipped to take advantage of the breakthroughs in stem cell therapies that will arise from the research community.”

“Store-A-Tooth is less expensive than collecting stem cells from umbilical cord blood. In fact, we hear from many of our customers that they are thankful to have this opportunity to store their stem cells, especially if they missed the chance to save cord blood,” states Greenman. “Our mission is to make stem cell banking accessible to the millions of children losing teeth every year.”

There are no fees or costs to dentists who wish to become an authorized Store-A-Tooth provider; in fact dentists can generate incremental revenue for assisting with tooth collection. Provia Labs supplies all participating practices with patient education materials, practice tools and dedicated support; training is simple and there is minimal impact to existing workflow.

Dental professionals share Store-A-Tooth educational materials with their patients, who enroll directly with Provia Labs. The day of the appointment, the dentist simply places the extracted tooth into the Store-A-Tooth collection kit, which includes a proven transport device called Save-A-Tooth®. In use by thousands of dentists for over 20 years, the Save-A-Tooth is an FDA-approved and ADA-accepted device for transporting avulsed teeth for reimplantation. The Store-A-Tooth collection kit is shipped overnight to the Provia Laboratories facility, where the stem cells are processed and stored.

The Store-A-Tooth service is currently available to dental offices throughout the United States and internationally. To become a provider, visit http://www.store-a-tooth.com or call 877-867-5753.

About Provia Laboratories, LLC

Headquartered in Lexington, MA, Provia Laboratories, LLC (http://www.provialabs.com) is a healthcare services company specializing in high quality biobanking (preservation of biological specimens). The company’s Store-A-Tooth™ service platform enables the collection, transport, processing, and storage of dental stem cells for potential use in future stem-cell therapies. The company advises industrial, academic, and governmental clients on matters related to the preservation of biological specimens for research and clinical use. In addition, Provia offers a variety of products for use in complex biobanking environments to improve sample logistics, security, and quality. For more information on dental stem cells, call 1-877-867-5753, visit http://www.store-a-tooth.com or http://www.facebook.com/storeatooth, or follow via twitter @StoreATooth.

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Bone gives ‘some’ heart healing

14 February 2012 Last updated at 19:10 ET By James Gallagher Health and science reporter, BBC News

Bone marrow stem cell therapy offers "moderate improvement" to heart attack patients, according to a large UK review of clinical trials.

The analysis by the Cochrane Collaboration looked at 33 trials involving more than 1,700 patients.

It said longer-term studies were needed to see if the experimental therapy affected life expectancy.

The review comes a day after doctors reported the first case of using heart cells to heal heart attack damage.

If a patient survives a heart attack, dead heart muscle is replaced with scar tissue - leaving the patient weaker and possibly on a lifetime of medicine.

Researchers are beginning to show that taking cells from a heart, growing millions of new heart cells in the laboratory and pumping those back into the heart may reduce scar tissue and lead to new heart muscle.

Continue reading the main story “Start Quote

Stem cell therapy may also reduce the number of patients who later die or suffer from heart failure, but currently there is a lack of statistically significant evidence based on the small number of patients treated so far”

End Quote Dr Enca Martin-Rendon Lead researcher

However, the trials are at a very early stage and in only a handful of patients. Using a similar technique with cells taken from the bone marrow, which is a prime source of stem cells, has a much longer pedigree.

The report by Cochrane pooled the data from all 33 bone marrow trials which had taken place up to 2011.

It concluded that bone marrow therapy "may lead to a moderate long-term improvement" in heart function which "might be clinically very important".

Longer life uncertain

It said there was still no evidence of "any significant effect on mortality" in comparison with standard treatment. However, this may be due to the size of the studies and that patients were followed for a short period of time.

Lead author Dr Enca Martin-Rendon, from NHS Blood and Transplant at the John Radcliffe Hospital in Oxford, said: "This new treatment may lead to moderate improvement in heart function over standard treatments.

"Stem cell therapy may also reduce the number of patients who later die or suffer from heart failure, but currently there is a lack of statistically significant evidence based on the small number of patients treated so far."

Prof Anthony Mathur, from Barts and the London School of Medicine and Dentistry, is leading the largest ever trial of stem cells in heart attack patients.

It starts this year, however, he told the BBC that the results could come quite quickly. Three thousand patients across Europe will take part. They will be injected with stem cells five days after a heart attack and then followed for two years to see if the therapy affects life expectancy.

Prof Peter Weissberg, medical director at the British Heart Foundation, said: "This review reflects the consensus of opinion about these trials - cell therapy has a modestly beneficial effect.

"Despite that, no-one knows why, or even if, cell therapies will translate into better survival or sustained improvement in damaged hearts. It's much too early to judge the likely long-term benefits."

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Bone gives 'some' heart healing

Stem cell treatments improve heart function after heart attack

Public release date: 14-Feb-2012
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Contact: Jennifer Beal
healthnews@wiley.com
44-124-377-0633
Wiley-Blackwell

Stem cell therapy moderately improves heart function after a heart attack, according to a systematic review published in The Cochrane Library. But the researchers behind the review say larger clinical trials are needed to establish whether this benefit translates to a longer life.

In a heart attack, the blood supply to parts of the heart is cut off by a blocked artery, causing damage to the heart tissue. The cells in the affected area start to die. This is called necrosis and in the days and weeks that follow, the necrotic area may grow, eventually leaving a large part of the heart unable to contract and increasing the risk of further heart problems. Stem cell therapy uses cells from the patient's own bone marrow to try to repair and reduce this damage. Currently, the treatment is only available in facilities with links to scientific research.

The authors of the review drew together all the available evidence to ask whether adult bone marrow stem cells can effectively prevent and repair the damage caused by a heart attack. In 2008, a Cochrane review of 13 stem cell therapy clinical trials addressed the same question, but the new review adds 20 more recent trials, drawing its conclusions from all 33. By incorporating longer follow up, the later trials provide a better indication of the effects of the therapy several years after treatment.

The total number of patients involved in trials was 1,765. All had already undergone angioplasty, a conventional treatment that uses a balloon to open the blocked artery and reintroduce the blood supply. The review's findings suggest that stem cell therapy using bone marrow-derived stem cells (BMSCs) can produce a moderate long-term improvement in heart function, which is sustained for up to five years. However, there was not enough data to reach firm conclusions about improvements in survival rates.

"This new treatment may lead to moderate improvement in heart function over standard treatments," said lead author of the study, Enca Martin-Rendon, of the Stem Cell Research laboratory, NHS Blood and Transplant at the John Radcliffe Hospital in Oxford, UK. "Stem cell therapy may also reduce the number of patients who later die or suffer from heart failure, but currently there is a lack of statistically significant evidence based on the small number of patients treated so far."

It is still too early to formulate guidelines for standard practice, according to the review. The authors say further work is required to establish standard methods, including cell dosage, timing of cell transplantation and methods to measure heart function. "The studies were hard to compare because they used so many different methods," said Martin-Rendon. "Larger trials with standardised treatment procedures would help us to know whether this treatment is really effective.

Recently, the task force of the European Society of Cardiology for Stem Cells and Cardiac Repair received funding from the European Union Seventh Framework Programme for Research and Innovation (EU FP7-BAMI) to start such a trial. Principal Investigator for the BAMI trial, and co-author of this Cochrane review, Anthony Mathur, said, ''The BAMI trial will be the largest stem cell therapy trial in patients who have suffered heart attacks and will test whether this treatment prolongs the life of these patients."

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Stem cell treatments improve heart function after heart attack

Life Technologies Scientist Uma Lakshmipathy presents, "Solving Challenges in the Generation of Induced Pluripotent …

Dr. Uma Lakshmipathy speaks at various conferences about work on the creation of integration-free induced pluripotent stem cells at high efficiency with Sendai Virus using the CytoTune™ -iPS Reprogramming Kit. Uma Lakshmipathy's next speaking engagement will be in Mid February at the Stem Cell Banking Conference in London.

Carlsbad, California (PRWEB) February 14, 2012

Uma's last presentation about the Generation of Induced Pluripotent Stem Cells summarized here was also recorded for viewing and placed on the Life Technologies website. (http://find.lifetechnologies.com/stemcells/umavideo/article)

The CytoTune™ - iPS Reprogramming Kit is a high efficiency, integration- free, easy-to-use somatic cell reprogramming kit used in the generation of induced pluripotent stem cells. This kit utilizes Sendai Virus particles of the four Yamanaka factors, which have been shown to be critical in the successful generation of induced pluripotent stem cells.

In her presentations, Uma Lakshmipathy discusses two current challenges faced when generating iPSC including low efficiency and expertise of users.

Low Efficiency

The most common method for generation of induced pluripotent stem cells is the transfection of the four Yamanaka factors using lentivirus or retrovirus. One of the biggest challenges for scientists right now is the low efficiency of iPSC generation. With difficult to transfect cell types or cells from older patients, efficiencies can be 0.001% or lower when using lentiviral or retroviral methods.

Expertise of Users

The second challenge is for users with little expertise that have a difficult time detecting these emerging iPSC colonies. When looking for pluripotent stem cells, people can either pick them up really easily or have trouble deciding what clones to place their bet on.

Efficiency & Safety of IPSC Generation

There are several methods which improve reprogramming efficiency including viral non-integrating and small molecule methods such as mRNA, microRNA and small molecules. The developers of the CytoTune™ -iPS Reprogramming Kit concentrated on a non-integrating viral method utilizing Sendai Virus, a negative sense RNA virus. Sendai Virus is able to infect a wide variety of cell types and generates induced pluripotent stem cells at efficiencies 100-fold higher than lentiviral or retroviral methods.

When comparing efficiency vs. safety of reprogramming methods, small molecules like microRNA, RNA and protein which don’t leave a footprint are safer for cell therapy research; however, the efficiency of generating induced pluripotent stem cells with these methods is pretty low at this point in time.

The highest efficiency so far has been achieved with viral methods such as Retrovirus and Lentivirus. More recently the CytoTune™ -iPS Reprogramming Kit actually exceeds the efficiency that can be obtained with these traditional viral systems and at the same time it is much safer because it is a non-integrating RNA virus. Therefore it will not leave a footprint in the iPSCs that are created.

The CytoTune™ -iPS Reprogramming Kit will:

    Reduce hands on time - enables successful iPS reprogramming in one simple transduction     Generate more cells - high efficiency reprogramming offers more iPS cells from a single experiment     Use in a broad range of experiments - lack of genomic integration and viral remnants allows use from basic to clinical research

Ease of Use

The CytoTune™ -iPS Reprogramming Kit provides a simple system for somatic cell reprogramming. For most cell types, the CytoTune™ -iPS Reprogramming Kit requires only one application of the virus for successful cell reprogramming, unlike other methods such as Lentivirus and mRNA which can require multiple rounds of transduction to produce iPS cells. Selection of colonies is also easier with the CytoTune™ –iPS Reprogramming Kit due to the lower number of non-induced pluripotent stem cells that are generated.

To view this presentation visit http://find.lifetechnologies.com/stemcells/umavideo/article

Uma Lakshmipathy's protocol, "Transfection of Human Embryonic Stem Cells" can be seen here http://bit.ly/y91Gpd

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Jennifer Hornstein
Life Technologies
(760) 602-4577
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Life Technologies Scientist Uma Lakshmipathy presents, "Solving Challenges in the Generation of Induced Pluripotent ...

Orthopaedic smart device provides personalized medicine

Public release date: 14-Feb-2012
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Contact: Annie Hayashi
hayashi@ors.org
847-430-5025
Orthopaedic Research Society (ORS)

Imagine a smart sensor customized to provide vital, real-time information about a patient's recent orthopaedic surgery. Instead of relying on X-rays or invasive procedures, surgeons will be able to collect diagnostic data from an implantable sensor. A study presented at the Orthopaedic Research Society 2012 Annual Meeting in San Francisco outlined this remarkable technology that promises to make post-surgical diagnosis and follow up more precise, efficient, and cost-effective.

"The sensor provides opportunities to make specific and detailed diagnostics for a particular patient and to tailor care based on very objective and quantitative measures," said Eric H. Ledet, PhD, Assistant Professor, Rensselaer Polytechnic Institute.

"This highly unique sensor is very small (4 mm diameter and 500 microns thick), is wireless, batteryless, and requires no telemetry within the body. Its simplicity makes it less prone to failure and very inexpensive to produce," Dr. Ledet explained.

The orthopaedic implant acts as a carrier for the sensor. The wireless sensor can monitor load, strain, motion, temperature, and pressure in the challenging in vivo environment. It can be placed into a spinal or fracture fixation implant, for example, to determine the patient's progress.

"For the patient that is progressing well, the information from the sensor enables the physician to determine that the patient can return to work without risk of injury," said Dr. Ledet. "The number of lost days at work is reduced."

It can also alert the physician to potential problems, indicating that additional interventions may be needed. "By maintaining a simple platform, we're able to customize the sensor and make it very, very small so it can be incorporated into a lot of different implants," said Rebecca A. Wachs, MS, Rensselaer Polytechnic Institute. "By changing one small parameter, we can change the sensitivity of the sensor itself."

Dr. Ledet reports a number of major breakthroughs with the sensor technology in the last eighteen months. Although the researchers are manually producing the sensor, they anticipate it will eventually be mass produced?driving the price down further.

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About the Orthopaedic Research Society (ORS):

The Orthopaedic Research Society (ORS) is the pre-eminent organization for the advancement of musculoskeletal research. It seeks to transform the future through global multidisciplinary collaborations?focusing on the complex challenges of orthopaedic treatment. The ORS advances the global orthopaedic research agenda through excellence in research, education, collaboration, communication and advocacy. The ORS Annual Meeting and publication of the Journal of Orthopaedic Research provide vital forums for the musculoskeletal community to communicate the current state of orthopaedic research.

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Adam Taliaferro to speak at Central York event

York, PA - Central York School District announced that Adam Taliaferro, a former PSU football standout who overcame a life-threatening spinal cord injury, will be the Keynote Speaker at the District's 6th Annual Diversity Celebration, which will be held from 11 a.m. to 3 p.m. Saturday, April 21 at Central York Middle School.

Taliaferro broke his neck in 2000 during a routine helmet-to-helmet tackle in the final minutes of Penn State's game against Ohio State. He injured his spine so severely that doctors gave him a 3 percent chance of walking again. Taliaferro's family, friends and supporters -- including the late coach Joe Paterno -- inspired him to think positive and strive to beat the odds, which he did.

Today, he is a successful attorney with Duane Morris in New Jersey, the founder of a foundation that assists individuals with spinal injuries and an inspirational speaker who shares his story of positive thinking and resiliency with thousands across the nation each year.

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Adam Taliaferro to speak at Central York event

Baxter Completes Acquisition of Synovis

DEERFIELD, Ill.--(BUSINESS WIRE)--

Baxter International Inc. (NYSE:BAX - News) announced today that the company has completed its planned acquisition of Synovis Life Technologies, Inc. (NASDAQ: SYNO - News), following approval of the transaction by Synovis shareholders. The acquisition expands Baxter’s regenerative medicine and BioSurgery franchise by adding biological and mechanical products from Synovis used for soft tissue repair and microsurgery in a variety of surgical procedures.

“The acquisition enhances Baxter’s ability to offer a broad range of tools used to repair and reconstruct soft tissue damaged by disease or injury, as well as specific tools used in a variety of microsurgical procedures,” said Ludwig Hantson, president of Baxter’s BioScience business. “We look forward to welcoming the Synovis employees and organization into Baxter as we begin the business integration process.”

Baxter’s technological leadership in the development of biosurgical and regenerative medicine products is grounded in advancing innovation, enhancing surgical techniques and improving patient outcomes. Baxter advanced the field of tissue sealing and hemostasis more than 30 years ago with the development of TISSEEL Fibrin Sealant (sold under the name TISSUCOL in several countries around the world). Today, Baxter is adding the Synovis soft tissue repair and microsurgery products to the company’s existing line of biological products and delivery devices used for hemostasis, tissue sealing, adhesion reduction, and hard tissue regeneration.

Synovis shareholders approved the offer of $28 per share, which equates to $325 million of equity value or approximately $260 million after adjusting for the net cash. Synovis reported annual sales of $82.4 million for the fiscal year ending October 31, 2011.

Synovis develops, manufactures and markets medical devices used primarily in surgical procedures for soft tissue repair, including PERI-STRIPS DRY, TISSUE-GUARD and VERITAS Collagen Matrix. These products are used in a variety of surgical procedures, including obesity surgery; patching the lining of the brain, vessels, and cardiac defects; hernia repair; and vascular surgery. The Synovis portfolio also includes products used in microsurgery, such as the COUPLER, FLOW COUPLER and GEM MICROCLIP. These products are used for joining small diameter vessels during autologous tissue breast reconstruction; sealing small blood vessels; and head, neck and hand procedures. Its newest business area is orthopedic and wound management products, with applications ranging from the repair of rotator cuff and other tendon injuries to advanced wound management. These products are primarily used by reconstructive, orthopedic, sports medicine, podiatric, and vascular surgeons.

About Baxter

Baxter International Inc., through its subsidiaries, develops, manufactures and markets products that save and sustain the lives of people with hemophilia, immune disorders, infectious diseases, kidney disease, trauma, and other chronic and acute medical conditions. As a global, diversified healthcare company, Baxter applies a unique combination of expertise in medical devices, pharmaceuticals and biotechnology to create products that advance patient care worldwide.

Full prescribing information for TISSEEL can be found at: http://www.baxter.com/downloads/healthcare_professionals/products/Tisseel_PI.pdf

This release includes forward-looking statements concerning the company’s acquisition of Synovis Life Technologies, Inc. The statements are based on assumptions about many important factors, including the following, which could cause actual results to differ materially from those in the forward-looking statements: the company’s ability to successfully integrate Synovis into its existing operations; demand for and market acceptance of new and existing products; actions of regulatory bodies and other governmental authorities including changes to applicable laws and regulations; product quality or patient safety concerns; the impact of U.S. healthcare reform and global austerity measures; and other risks identified in the company’s most recent filing on Form 10-K and other SEC filings, all of which are available on the company’s website. The company does not undertake to update its forward-looking statements.

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Baxter Completes Acquisition of Synovis

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

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

Stem Cells Help Regrow Heart Tissue

Stem cells harvested from a patient's own heart can be used to help repair muscle damaged during a heart attack, according to a preliminary study published online Monday in The Lancet. While it's too soon to know if the technique will help patients live longer, the study is the second small, promising study of cardiac stem cells in three months.

The new study involved 25 patients who had suffered very serious heart attacks; 24% of their heart's major pumping chamber had been replaced by scar tissue. One year later, doctors saw no improvement in those randomly assigned to get standard care. Among the 17 given stem cells, however, "we reversed about half the injury to the heart," said study author Eduardo Marban, director of the Cedars-Sinai Heart Institute in Los Angeles, in an e-mail. "We dissolved scar and replaced it with living heart muscle."

Warren Sherman, director of stem cell research and regenerative medicine at Columbia University Medical Center in New York, says the study was an important proof of the potential of stem cells - harvested from patients, grown in the lab, then injected back into patients' hearts.

Doctors don't yet know exactly how the stem cells reduce the size of the dead zone of scar tissue, says Kenneth Margulies, director of heart failure and transplant research at the University of Pennsylvania. And while the shrinking suggests that the stem cells are replacing dead cells with living ones, doctors can't definitely prove that without doing a biopsy of the actual cells, he says.

The new study's encouraging results seem to confirm the findings of another small study of heart stem cells, published in The Lancet in November, which also showed an improvement in heart-attack survivors who received the treatment, Margulies says. On the other hand, a third study, found no benefit from stem cells created from patients' own bone marrow.

Four stem-cell patients developed serious complications, compared to only one of the other patients, the study says. That suggests stem-cell therapy has a "satisfactory" safety record, but "is not risk-free," Margulies says.

The idea of regenerating heart tissue "was a pretty far-out idea" only 10 to 20 years ago, Margulies says. There's some evidence that heart tissue is capable of making some small repairs on its own, although not enough to help people who've had a heart attack.

Marban developed the process of growing heart stem cells while working at Johns Hopkins University, which has filed an application for a patent on the idea and licensed it to a company in which Marban has a financial interest. No money from that company was used to pay for the study, which was funded by Cedars-Sinai and the National Institutes of Health.

About 1.3 million Americans have a heart attack each year.

USA Today

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Stem Cells Help Regrow Heart Tissue

Scarred Hearts Can Be Mended With Stem Cell Therapy

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

Stem cells could fix broken hearts

WHEN a piece of muscle in a person's heart dies from lack of blood flow, it scars over and is lost.

But a team of researchers from the Cedars Sinai Heart Institute in Los Angeles has proven that those muscles may not necessarily be gone forever.

In a study that may change how heart attacks are treated, Eduardo Marban and his team used stem cells to re-grow damaged heart muscle. In the 17 patients who received the therapy, Mr Marban measured an average 50 per cent reduction in the size of the scar tissue.

"One of the holy grails in medicine has been the use of medicine to achieve regeneration," he said. "Patients that were treated not only experienced shrinkage of their scars, but also new growth of their heart muscle, which is very exciting."

The stem cells were not derived from embryos, but instead were developed from the patients' own hearts. Mr Marban's team inserted a catheter into the diseased hearts and took a small biopsy of muscle. In the laboratory, the tissue was manipulated into producing stem cells to re-inject into the patients' hearts.

Over the course of a year, the cells took root in cardiac tissue, encouraging the heart to create new muscle and blood vessels. In other words, the heart actually began to mend itself.

While similar research has been done using stem cells from bone marrow, this is the first time that stem cells derived from a patient's own cardiac tissue have been used.

Mr Marban believes this therapy could be broadly used in many of the five to seven million Americans who suffer from heart disease every year. And he said the applications could go well beyond diseased hearts.

"If we can do that in the heart, I don't see any reason, conceptually, why we couldn't do it in kidneys for example, or pancreas or other organs that have very limited regenerative capacity," he said.

While the procedure may be a revolutionary medical technique, there are still a few more puzzling questions about the research that Mr Marban would like to investigate further.

For example, while the patients grew new heart muscle and saw a dramatic reduction in scar tissue, the actual function of their hearts did not show a significant improvement. And it appeared the stem cells themselves may not have turned into cardiac muscle, but rather they stimulated the heart to produce new muscle cells.

Nonetheless, the potential success of this research could hold a lot of promise for the millions of Americans who suffer from heart disease each and every year, which is the leading cause of death in the United States.

If his future experiments yield the same results as this initial study, Mr Marban said he could be offering this therapy to patients within four years - and that could go a long way in mending all of America's broken hearts.

Read more here.

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Stem cells could fix broken hearts

Stem cells a fix for 'broken hearts'?

When a piece of muscle in a person’s heart dies from lack of blood flow, it scars over and is lost.  But a team of researchers from the Cedars-Sinai Heart Institute in Los Angeles has proven that those muscles may not necessarily be gone forever.

In a ground-breaking study that may change how heart attacks are treated, Dr. Eduardo Marban and his team used stem cells to re-grow damaged heart muscle.  In the 17 patients who received the therapy, Marban measured an average 50 percent reduction in the size of the scar tissue

“One of the holy grails in medicine has been the use of medicine to achieve regeneration,” Marban said.  “Patients that were treated not only experienced shrinkage of their scars, but also new growth of their heart muscle, which is very exciting.”

The stem cells were not derived from embryos, but instead were developed from the patients’ own hearts.  Marban’s team inserted a catheter into the diseased hearts and took a small biopsy of muscle.  In the laboratory, the tissue was manipulated into producing stem cells.  After a few weeks of marinating in culture, researchers had enough stem cells to re-inject them into the patients’ hearts.  Over the course of a year, the stem cells took root in cardiac tissue, encouraging the heart to create new muscle and blood vessels.  In other words, the heart actually began to mend itself.

Click here to see an animation of how the process works.

“We’ve achieved what we have achieved using adult stem cells – in this case – actually specifically from a patient’s own heart back into the same patient.   There’s no ethical issues with that – there’s no destruction of embryos.  There’s no reason to worry about immune rejection."

While similar research has been done using stem cells from bone marrow, this is the first time that stem cells derived from a patient’s own cardiac tissue have been used.

Marban believes this therapy could be broadly used in many of the 5 to 7 million Americans who suffer from heart disease every year.  And he said the applications could go well beyond diseased hearts.

“If we can do that in the heart, I don’t see any reason, conceptually, why we couldn’t do it in kidneys for example, or pancreas or other organs that have very limited regenerative capacity,” Marban said.

While the procedure may be a revolutionary medical technique, there are still a few more puzzling questions about the research that Marban would like to investigate further.  For example, while the patients grew new heart muscle and saw a dramatic reduction in scar tissue, the actual function of their hearts did not show a significant improvement.  And it appeared the stem cells themselves may not have turned into cardiac muscle, but rather they stimulated the heart to produce new muscle cells.

Because this was a “Phase 1” study, it was really meant to measure whether the procedure was safe.  Of the 17 patients who were given the stem cell injections, six experienced “serious adverse events,” but only one was regarded to be possibly related to the treatment.  

The potential success of this research could hold a lot of promise for the millions of Americans who suffer from heart disease each and every year, which is the leading cause of death in the United States.  If his future experiments yield the same results as this initial study, Marban believes he could be offering this therapy to patients within four years – and that could go a long way in mending all of America’s broken hearts.

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Stem cells a fix for 'broken hearts'?

Stem Cells Regrow Healthy Heart Muscle In Heart Attack Patients

Stem cells are proving themselves beneficial once again after scientists used the controversial building blocks to resurrect dead, scarred heart muscle damaged by recent heart attack.

Results from a Cedars-Sinai Heart Institute clinical trial show that treating heart attack patients with an infusion of their own heart-derived cells helps damaged hearts re-grow healthy heart muscle.

Reporting in The Lancet medical journal, the researchers said this is the clearest evidence yet that broken hearts can heal. All that is needed is a little help from one’s own heart stem cells.

“We have been trying as doctors for centuries to find a treatment that actually reverses heart injury,” Eduardo Marban, MD, PhD, and lead author of the study, told WebMD. “That is what we seem to have been able to achieve in this small number of patients. If so, this could change the nature of medicine. We could go to the root of disease and cure it instead of just work around it.”

Marban invented the “cardiosphere” culture technique used to create the stem cells and founded the company developing the treatment.

“These findings suggest that this therapeutic approach is feasible and has the potential to provide a treatment strategy for cardiac regeneration after [heart attack],” wrote University of Hong Kong researchers Chung-Wah Siu and Hung-Fat Tse in an accompanying editorial of Marban’s paper.

The British Heart Foundation told James Gallagher of BBC News that this could “be great news for heart attack patients” in the future.

A heart attack occurs when the heart is starved of oxygen, such as when a clot is blocking the blood flow to the organ. As the heart heals, the dead muscle is replaced by scar tissue, which does not beat like heart muscle. This in turn reduces the hearts ability to pump blood around the body.

Doctors have long been searching for ways to regenerate damaged heart muscle, and now, it seems heart stem cells are the answer. And the Cedars-Sinai trial was designed to test the safety of using stem cells taken from a heart attack patient’s own heart.

The researchers found that one year after receiving the treatment, scar size was reduced from 24 percent to 12 percent of the heart in patients treated with heart stem cells. Patients in the control group, who did not receive stem cells, did not experience a reduction in their heart attack scar tissues.

“While the primary goal of our study was to verify safety, we also looked for evidence that the treatment might dissolve scar and re-grow lost heart muscle,” Marban said in a statement. “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.”

“These results signal an approaching paradigm shift in the care of heart attack patients,” said Shlomo Melmed, MD, dean of the Cedars-Sinai medical faculty and the Helene A. and Philip E. Hixon Chair in Investigative Medicine. “In the past, all we could do was to try to minimize heart damage by promptly opening up an occluded artery. Now, this study shows there is a regenerative therapy that may actually reverse the damage caused by a heart attack.”

Marban cautioned that stem cells do not do what people generally think they do. The general idea has been that stem cells multiply over and over again, and, in time, they turn themselves and their daughter cells into new, working heart muscle.

But Marban said the stem cells are actually doing something more amazing.

“For reasons we didn’t initially know, they stimulate the heart to fix itself,” he told Daniel J. DeNoon of WebMD. “The repair is from the heart itself and not from the cells we give them.”

Exactly how the stem cells invigorate the heart to do this was a matter of “feverish research” in the lab.

The CArdiosphere-Derived aUtologous stem CElls to reverse ventricUlar dySfunction (CADUCEUS) clinical trial was part of a Phase I study approved by the US Food and Drug Administration (FDA) and supported by the National Heart, Lung, and Blood Institute.

Marban used 25 volunteer patients who were of an average age of 53 and had recently suffered a heart attack that left them with damaged heart muscle. Each patient underwent extensive imaging scans so doctors could pinpoint the exact location and severity of the scars. Patients were treated at Cedars-Sinai in LA and at Johns Hopkins Hospital in Baltimore.

Eight of the 25 patients served as a control group, receiving conventional medical treatment. The other 17 patients who were randomized to receive the stem cell treatments underwent a minimally invasive biopsy, under local anesthesia. Using a catheter inserted through a vein in the neck, doctors removed a small sample of heart tissue, about half the size of a raisin. The heart tissue was then taken to the lab at Cedars-Sinai and cultured and multiplied the cells using specially developed tools.

The doctors then took the multiplied heart-derived cells — roughly 12 million to 25 million of them per patient — and reintroduced them into the patient’s coronary arteries during another minimally invasive catheter procedure.

The process used in the trial was developed earlier by Marban when he was on the faculty at Johns Hopkins. Johns Hopkins has filed for a patent on the intellectual property and has licensed it to a company in which Marban has a financial interest. However, no funds from that company were used to support the clinical study. All funding was derived from the National Institutes of Health and Cedars-Sinai Medical Center.

This study followed another in which doctors reported using cells taken from the heart to heal the heart. That trial reported in November 2011 that cells could be used to heal the hearts of heart failure patients who were having heart bypass surgery.

And another trial is about to get underway in Europe, which will be the largest ever for stem cell therapy in heart attack patients.

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.

Marban said despite the heart’s ability to re-grow heart muscle with the help of heart stem cells, they found 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.

Professor Anthony Mathur, a coordinating researcher for the upcoming BAMI trial, said that even if the Marban trial found an increase in ejection fraction then it would be the source of much debate. 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 told BBC News.

“It’s the first time these scientists’ potentially exciting work has been carried out in humans, and the results are very encouraging,” Professor Jeremy Pearson, associate medical director at the British Heart Foundation, told BBC News.

“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,” he added. “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.”

On the Net:

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Stem Cells Regrow Healthy Heart Muscle In Heart Attack Patients

Stem Cells Help Heal Broken Hearts

Click here to listen to this podcast

Valentine's Day can lead to plenty of broken hearts. But for cardiac wounds that time alone won't heal, science has made some major advances. When it comes to heart attack, for example, a big development is emerging from a tiny source. Stem cells are coming of age. 

Stem cells, harvested from a patient's own bone marrow, have been heralded as a potential quick fix for damaged heart tissue. But can these progenitor cells actually work to heal massive muscle damage?

A new review of 33 studies assessed data from more than 1,700 heart attack patients. The review researchers found that those patients treated with stem cells—in addition to the standard care of angioplasty—had stronger tickers for years to come than those who had not gotten stem cell therapy. The review article is published in The Cochrane Library. [David Clifford et al., Stem Cell Treatment for Acute Myocardial Infarction, link to come]

It's too early to say whether those with stem cell treatments will live longer, according to the new analysis. But for affairs of the heart, it's more evidence that good things can come in very small packages.

—Katherine Harmon

[The above text is a transcript of this podcast]  
 

Follow Scientific American on Twitter @SciAm and @SciamBlogs. Visit ScientificAmerican.com for the latest in science, health and technology news.
© 2012 ScientificAmerican.com. All rights reserved.

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Stem Cells Help Heal Broken Hearts

Dog Receives First-Ever Stem Cell Therapy in Kansas City

Stanley, Kan. — It’s a special Valentine’s Day gift for Jake the dog.  His family gave him a stem cell treatment that they hope will extend his life.

Jake is an 11-year-old yellow lab.  He’s been part of the LeBlanc family since he was a puppy.  Jake’s owner, Elizabeth LeBlanc, calls him her “first baby.”  But then Mia and Aidan were born and at ages eight and five years old, they love to play with Jake.

When the LeBlanc’s noticed Jake was having trouble getting around they wanted to help.  They tried medication, but say it didn’t work for very long.  Then Mia saw a segment about a stem cell treatment for dogs on t.v. and asked if they could get it for Jake.  The LeBlanc’s called their veterinarian and found out the Stanley Veterinary Clinic in Stanley, Kansas is the only place in the metro where they can do the entire procedure in house.

Dr. Les Pelfrey, D.V.M. explained the procedure.

“We’re going to collect about 20 grams of fat surgically and then we’re going to process it in our lab here in house then we’re going to reintroduce those stem cells after we activate them back into the affected joints,” said Dr. Les Pelfrey.

The procedure can cost $3000. The dog’s fatty tissue has to be sent off to a lab for the stem cells to be extracted.  But at the Stanley Veterinary Clinic they can process the stem cells in their own lab, cutting the cost to $1800.00.

Jake’s arthritis is affecting his hips, knees, one elbow and one shoulder.  Dr. Pelfrey made an incision and removed the fatty tissue from Jake.  Then veterinary technician Stephanie Pierce took it to the lab to break it down, cook it and then spin it.  The final product?  Stem cells that were then re-injected into Jake’s joints to help him grow cartilage.  Pierce says Jake will “act like a puppy again as far as moving around.”

The LeBlancs can’t wait to see the results.

“For 12 years he’s given us love and joy so we just want to give him a better quality of life,” LeBlanc said.

Jake will spend the night at the Stanley Veterinary Clinic.  He should be able to head home tomorrow.  Jake and the LeBlancs should notice results in the next few weeks.

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Dog Receives First-Ever Stem Cell Therapy in Kansas City

Bone gives 'some' heart healing

14 February 2012 Last updated at 19:10 ET By James Gallagher Health and science reporter, BBC News

Bone marrow stem cell therapy offers "moderate improvement" to heart attack patients, according to a large UK review of clinical trials.

The analysis by the Cochrane Collaboration looked at 33 trials involving more than 1,700 patients.

It said longer-term studies were needed to see if the experimental therapy affected life expectancy.

The review comes a day after doctors reported the first case of using heart cells to heal heart attack damage.

If a patient survives a heart attack, dead heart muscle is replaced with scar tissue - leaving the patient weaker and possibly on a lifetime of medicine.

Researchers are beginning to show that taking cells from a heart, growing millions of new heart cells in the laboratory and pumping those back into the heart may reduce scar tissue and lead to new heart muscle.

Continue reading the main story “Start Quote

Stem cell therapy may also reduce the number of patients who later die or suffer from heart failure, but currently there is a lack of statistically significant evidence based on the small number of patients treated so far”

End Quote Dr Enca Martin-Rendon Lead researcher

However, the trials are at a very early stage and in only a handful of patients. Using a similar technique with cells taken from the bone marrow, which is a prime source of stem cells, has a much longer pedigree.

The report by Cochrane pooled the data from all 33 bone marrow trials which had taken place up to 2011.

It concluded that bone marrow therapy "may lead to a moderate long-term improvement" in heart function which "might be clinically very important".

Longer life uncertain

It said there was still no evidence of "any significant effect on mortality" in comparison with standard treatment. However, this may be due to the size of the studies and that patients were followed for a short period of time.

Lead author Dr Enca Martin-Rendon, from NHS Blood and Transplant at the John Radcliffe Hospital in Oxford, said: "This new treatment may lead to moderate improvement in heart function over standard treatments.

"Stem cell therapy may also reduce the number of patients who later die or suffer from heart failure, but currently there is a lack of statistically significant evidence based on the small number of patients treated so far."

Prof Anthony Mathur, from Barts and the London School of Medicine and Dentistry, is leading the largest ever trial of stem cells in heart attack patients.

It starts this year, however, he told the BBC that the results could come quite quickly. Three thousand patients across Europe will take part. They will be injected with stem cells five days after a heart attack and then followed for two years to see if the therapy affects life expectancy.

Prof Peter Weissberg, medical director at the British Heart Foundation, said: "This review reflects the consensus of opinion about these trials - cell therapy has a modestly beneficial effect.

"Despite that, no-one knows why, or even if, cell therapies will translate into better survival or sustained improvement in damaged hearts. It's much too early to judge the likely long-term benefits."

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Bone gives 'some' heart healing

Stem cell treatments improve heart function after heart attack

Public release date: 14-Feb-2012
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Stem cell therapy moderately improves heart function after a heart attack, according to a systematic review published in The Cochrane Library. But the researchers behind the review say larger clinical trials are needed to establish whether this benefit translates to a longer life.

In a heart attack, the blood supply to parts of the heart is cut off by a blocked artery, causing damage to the heart tissue. The cells in the affected area start to die. This is called necrosis and in the days and weeks that follow, the necrotic area may grow, eventually leaving a large part of the heart unable to contract and increasing the risk of further heart problems. Stem cell therapy uses cells from the patient's own bone marrow to try to repair and reduce this damage. Currently, the treatment is only available in facilities with links to scientific research.

The authors of the review drew together all the available evidence to ask whether adult bone marrow stem cells can effectively prevent and repair the damage caused by a heart attack. In 2008, a Cochrane review of 13 stem cell therapy clinical trials addressed the same question, but the new review adds 20 more recent trials, drawing its conclusions from all 33. By incorporating longer follow up, the later trials provide a better indication of the effects of the therapy several years after treatment.

The total number of patients involved in trials was 1,765. All had already undergone angioplasty, a conventional treatment that uses a balloon to open the blocked artery and reintroduce the blood supply. The review's findings suggest that stem cell therapy using bone marrow-derived stem cells (BMSCs) can produce a moderate long-term improvement in heart function, which is sustained for up to five years. However, there was not enough data to reach firm conclusions about improvements in survival rates.

"This new treatment may lead to moderate improvement in heart function over standard treatments," said lead author of the study, Enca Martin-Rendon, of the Stem Cell Research laboratory, NHS Blood and Transplant at the John Radcliffe Hospital in Oxford, UK. "Stem cell therapy may also reduce the number of patients who later die or suffer from heart failure, but currently there is a lack of statistically significant evidence based on the small number of patients treated so far."

It is still too early to formulate guidelines for standard practice, according to the review. The authors say further work is required to establish standard methods, including cell dosage, timing of cell transplantation and methods to measure heart function. "The studies were hard to compare because they used so many different methods," said Martin-Rendon. "Larger trials with standardised treatment procedures would help us to know whether this treatment is really effective.

Recently, the task force of the European Society of Cardiology for Stem Cells and Cardiac Repair received funding from the European Union Seventh Framework Programme for Research and Innovation (EU FP7-BAMI) to start such a trial. Principal Investigator for the BAMI trial, and co-author of this Cochrane review, Anthony Mathur, said, ''The BAMI trial will be the largest stem cell therapy trial in patients who have suffered heart attacks and will test whether this treatment prolongs the life of these patients."

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Stem cell treatments improve heart function after heart attack

Study backs breast cancer gene test

Hundreds of women with breast cancer should be tested for an aggressive form of the disease resulting from a genetic fault, according to new research.

Women with mutations in the BRCA1 gene have a much higher chance of developing breast cancer but also a higher risk of ovarian cancer.

These patients have up to a 65% chance of developing breast cancer by the time they are 70 and a 40% chance of ovarian cancer.

Researchers are now arguing that all women under 50 who are diagnosed with triple-negative (TN) breast cancer should also be offered testing for faults in the BRCA1 gene.

This could identify hundreds of extra women every year who may benefit from tailored therapy for BRCA1 breast cancer, such as platinum-based chemotherapy.

Clinical trials on radiotherapy have also suggested a certain type of radiotherapy could benefit women with BRCA1 mutations more than others.

Women would also be able to tell their families if they have the BRCA1 gene, meaning close relatives could be tested for the hereditary gene.

The research, published in the British Journal of Cancer, looked at more than 300 women with TN breast cancer. Almost one in five diagnosed under the age of 50 were found to have the BRCA1 mutation. This fault means breast cancer is more likely to develop at a younger age.

Current guidance from the National Institute for Health and Clinical Excellence (Nice) recommends BRCA1 testing is offered if the likelihood of detecting a mutation is greater than 20%.

However, based on their findings, researchers from the Institute of Cancer Research estimate more than one in three women with TN breast cancer caused by BRCA1 mutations would not have been tested using the current criteria.

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Study backs breast cancer gene test

American Clinical Laboratory Association Welcomes Pathway Genomics as New Member

SAN DIEGO--(BUSINESS WIRE)--

Pathway Genomics, a genetic testing laboratory specializing in genetic testing for nutrition and exercise response, inherited disease, prescription drug response and health condition risks, has received membership in the American Clinical Laboratory Association (ACLA). As the nation’s leading industry group to advocate lab interests with the U.S. Food and Drug Administration (FDA) and Congress, ACLA was created in 1971 and is committed to promoting public awareness about the value of laboratory services in preventing illness, diagnosing disease, and monitoring medical treatment.

“ACLA is proud to welcome Pathway Genomics as its newest member,” said Alan Mertz, president of ACLA. “Pathway Genomics is another example of our nation’s laboratories that are at the forefront of genetic testing and personalized medicine.”

In addition to Pathway’s ACLA membership, the San Diego-based company was recently accredited by the College of American Pathologists (CAP), and the recipient of a Certificate of Accreditation from the U.S. Department of Health and Human Services’ Centers for Medicare and Medicaid, under the Clinical Laboratory Improvement Amendments (CLIA) of 1988.

“ACLA is an essential organization within the laboratory community,” said Jim Plante, Pathway’s founder and CEO. “The approval of our membership is representative of the importance of genetic testing, and the promise and value of personalized health care.”

Using saliva samples collected from patients, Pathway provides genetic tests for drug responses, nutrition and exercise response, inherited genetic conditions, and risk of many diseases. Pathway consists of more than 40 scientific and medical professionals, including medical doctors, molecular geneticists, and genetic counselors, as well as an expert scientific advisory board.

About Pathway Genomics

Pathway Genomics owns and operates an on-site genetic testing laboratory that is accredited by the College of American Pathologists (CAP), accredited in accordance with the U.S. Health and Human Services’ Clinical Laboratory Improvement Amendments (CLIA) of 1988, and licensed by the state of California. The company uses customized and scientifically validated genetic testing technologies to generate personalized genetic reports, which address a variety of genetic issues, including an individual’s carrier status for recessive genetic conditions, food metabolism and exercise response, prescription drug response, and propensity to develop certain diseases, such as heart disease, type 2 diabetes, and cancer. Pathway’s services are available to patients through their physicians and select health management programs.

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American Clinical Laboratory Association Welcomes Pathway Genomics as New Member

Seattle Genetics drops after providing no ADCETRIS sales guidance

Seattle Genetics (SGEN) reported Q4 EPS of (24c), compared with analysts' consensus estimate of (31c). The company's revenue also came in higher than expected. Seattle Genetics added that it expects its revenue from collaboration and licenses in 2012 to be $55M-$65M. Over the next year, the company expects to initiate multiple Phase III trials of its ADCETRIS drug for various indications, including CTCL and Hodgkin lymphoma. However, the company declined to provide guidance for ADCETRIS sales, saying on its conference call that it does not have enough experience with the market. Moreover, in a note to investors, Leerink Swann lowered its 2012-2014 U.S. ADCETRIS sales estimates, as the firm believes that the drug's uptake will be slower than it had previously expected. Seattle Genetics' guidance for an increase in gross-to-net discounts for the drug also was a factor in the firm's decision to reduce its sales estimates. However, Leerink continues to have a positive overall outlook on the company and maintains an Outperform rating on the shares. In early trading, Seattle Genetics fell 59c, or 3.11%, to $18.37.

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Seattle Genetics drops after providing no ADCETRIS sales guidance

Scarred Hearts Can Be Mended With Stem Cell Therapy

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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