PUBLIC RELEASE DATE:

30-Apr-2014

Contact: Leila Gray leilag@uw.edu 206-685-0381 University of Washington

Heart cells created from human embryonic stem cells successfully restored damaged heart muscles in monkeys.

The results of the experiment appear in the April 30 advanced online edition of the journal Nature in a paper titled, "Human embryonic-stem cell derived cardiomyocytes regenerate non-human primate hearts."

The findings suggest that the approach should be feasible in humans, the researchers said.

"Before this study, it was not known if it is possible to produce sufficient numbers of these cells and successfully use them to remuscularize damaged hearts in a large animal whose heart size and physiology is similar to that of the human heart," said Dr. Charles Murry, UW professor of pathology and bioengineering, who led the research team that conducted the experiment.

A physician/scientist, Murry directs the UW Center for Cardiovascular Biology and is a UW Medicine pathologist.

Murry said he expected the approach could be ready for clinical trials in humans within four years.

In the study, Murry, along with Dr. Michael Laflamme and other colleagues at the UW Institute for Stem Cell & Regenerative Medicine, experimentally induced controlled myocardial infarctions, a form of heart attack, in anesthetized pigtail macaques.

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Stem cell therapy regenerates heart muscle damaged from heart attacks in primates

23 hours ago Marbled Salamander, Ambystoma opacum. Location: Durham County, North Carolina, United States. Photograph by Patrick Coin, via Wikipedia.

Imagine filling a hole in your heart by regrowing the tissue. While that possibility is still being explored in people, it is a reality in salamanders. A recent discovery that newt hearts can regenerate may pave the way to new therapies in people who need to have damaged tissue replaced with healthy tissue.

Heart disease is the leading cause of deaths in the United States. Preventative measures like healthful diets and lifestyles help ward off heart problems, but if heart damage does occur, sophisticated treatments and surgical procedures often are necessary. Unfortunately, heart damage is typically irreversible, which is why researchers are seeking regenerative therapies that restore a damaged heart to its original capacity.

We have known for hundreds of years that newts and other types of salamanders regenerate limbs. If you cut off a leg or tail, it will grow back within a few weeks. Stanley Sessions, a researcher at Hartwich College in Oneonta, N.Y., wondered if this external phenomenon also took place internally. To find out, he surgically removed a piece of heart in more than two dozen newts.

"To our surprise, if you surgically remove part of the heart, (the creature) will regenerate a new heart within just six weeks or so," Sessions said. "In fact, you can remove up to half of the heart, and it will still regenerate completely!"

Before the research team dove deeper into this finding, Sessions and his three undergraduate students, Grace Mele, Jessica Rodriquez and Kayla Murphy, had to determine how a salamander could even live with a partial heart. It turns out that a clot forms at the surgical site, acting much like the cork in a wine bottle, to prevent the amphibian from bleeding to death.

What is the cork made of? In part, stem cells. Stem cells have unlimited potential for growth and can develop into cells with a specialized fate or function. Embryonic stem cells, for example, can give rise to all of the cells in the body and, thus, have promising potential for therapeutics.

As it turns out, stem cells play an important role in regeneration in newts. "We discovered that at least some of the stem cells for heart regeneration come from the blood, including the clot," Sessions explained.

This finding could have exciting implications for therapies in humans with heart damage. By finding the genes responsible for regeneration in the newt, researchers may be able to identify pathways that are similar in newts and people and could be used to induce regeneration in the human heart. In fact, a clinical trial performed just last year was the first to use stem-cell therapy to regenerate healthy tissue and repair a patient's heart.

Combining advances in medical and surgical technologies with the basic pathways of heart regeneration in newts could lead to better therapies for humans. Sessions posed this hopeful question: "Wouldn't it be great if we could find a way to activate heart stem cells to bioengineer new heart tissue so that we can actually repair damaged hearts in humans?"

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Stem cells aid heart regeneration in salamanders

Welcome

The Stem Cell Center Texas Heart Institute is dedicated to the study of adult stem cells and their role in treating diseases of the heart and the circulatory system. Through numerous clinical and preclinical studies, we have come to realize the potential of stem cells to help patients suffering from cardiovascular disease.We are actively enrolling patients in studies using stem cells for the treatment of heart failure, heart attacks, and peripheral vascular disease.

Whether you are a patient looking for information regarding our research, or a doctor hoping to learn more about stem cell therapy, we welcome you to the Stem Cell Center. Please visit our Clinical Trials page for more information about our current trials.

Emerson C. Perin, MD, PhD, FACC Director, Clinical Research for Cardiovascular Medicine Medical Director, Stem Cell Center McNair Scholar

You may contact us at:

E-mail: stemcell@texasheart.org Toll free: 1-866-924-STEM (7836) Phone: 832-355-9405 Fax: 832-355-9440

We are a network of physicians, scientists, and support staff dedicatedto studying stem cell therapy for treating heart disease. Thegoals of the Network are to complete research studies that will potentially lead to more effective treatments for patients with cardiovasculardisease, and to share knowledge quickly with the healthcare community.

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The Stem Cell Center at Texas Heart Institute at St. Luke's

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When heart fails to pump out sufficient blood to the rest of the body as demanded, most often caused by heart attack and high blood pressure, heart muscles will be damaged. This is a condition called heart failure. Most people with heart failure complain of breathing difficulty that may happen during exercise, eating or even sleeping. Other common symptoms and signs are lethargy, ankle swelling, abdominal bloating, frequent urination and memory impairment.

Patient with heart failure also have a poor prognosis and high risk of developing dangerous heart rhythms triggered by the damaged tissue inside the heart.

Current established treatment includes medications that have been proven to alleviate symptoms and reduce the risk of death. Furthermore if the heart damage were caused by blockage of artery, then angioplasty or heart bypass operation may help as they can restore blood supply to parts of the heart that is starved of oxygen. Unfortunately none of the conventional and current treatments above could regenerate new heart muscle to replace the permanently damaged ones caused by previous heart attacks. Hence there will always be some degree of heart failure and progressive deterioration in health.

For patient with heart failure, Cardiocell treatment will repair damaged cells and provide growth of new heart muscle, hence increase the overall strength of heart and alleviate heart failure. In addition, Cardiocell replaces the scarred portions of the damaged heart with viable muscle. As these scarred areas can trigger dangerous heart rhythms and cause cardiac arrest, by replacing the scar tissue, Cardiocell not only improves heart failure but also reduces the risk of sudden death from cardiac arrest.

In studies using cells identical to Cardiocell for heart failure, patients benefited from symptom relief, improved exercise capacity and stamina, and reduction of angina. There is evidence of increased heart strength and contractility, reduction of heart swelling and scar tissue.

Cardiocell allows the heart to repair and reverse its damage that current conventional treatment cannot provide. It is therefore complementary to conventional heart failure therapy. It brings new hope and treatment option for heart failure patients who remain ill in spite of, or are ineligible for, current treatments.

Generally if you had a heart attack in the last 2 years which has resulted in severe heart failure now and you have exhausted current methods of treatment, then you may be eligible for CardiocellTM treatment. We welcome your participation in CardiocellTM pilot programme as part of Cytopeutics clinical study. However, you should consult your regular doctor or cardiologist to determine your eligibility criteria.

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Stem Cell Treatment For Heart And Knee : Cytopeutics

Two experimental approaches are showing promise for the treatment of heart failure due to dilated cardiomyopathy: gene therapy and stem cell therapy. Both of these approaches have received a lot of publicity, and you may be wondering how close they are to routine clinical use.

The answer is that they are both in the very early stages of investigation, and a lot more work has to be done before they become widely available.

In animal experiments, several genes have been tried, including genes for sarcoplasmic reticulum (a membrane within muscle cells that helps to control calcium movement); for adrenaline receptors (receptors on cell membranes that allow cells to respond to adrenaline); and for adenylyl cyclase (a protein that helps to generate energy within cells).

While the animal testing of gene therapy has shown significant promise, it has not yet become advanced enough to proceed to clinical trials.

Based on such promising findings, early stem cell therapy has now been applied, in a few small studies, in carefully selected patients.

Early human studies suggest that the transplanted stem cells do not actually take over the work of the heart, but rather, they produce certain substances (including cytokines, growth factors, and others) that help the "native" heart cells to function more efficiently. They also appear to stimulate "native" stem cells already present in the heart to differentiate into functioning cardiac cells.

There has been only a very limited experience so far using stem cells in patients with heart failure. The small studies that have been done suggest that stem cells can modestly improve cardiac function in certain patients with dilated cardiomyopathy. This improvement is shown by an improvement in the ejection fraction.

Potential risks of stem cell therapy include the possibility of ventricular tachycardia, which apparently is seen in many patients after the injection of stem cells. Because of this problem, some investigators now require patients to receive implantable defibrillators prior to certain types of stem cell therapy for heart failure. Also, observations suggest that in patients who have stents for coronary artery disease, restenosis (blockage) may be more frequent after stem cell treatment.

In summary, stem cell therapy for heart failure is still in its early stages of investigation. Major questions remain regarding what types of cells are best to use, how they should be delivered, how likely it is that there will be a significant long-term benefit, and whether the long-term safety of the technique is acceptable. While stem cell therapy has shown promise, investigators are still quite a ways from being ready for a major clinical trial, let alone for routine usage.

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Gene Therapy and Stem Cell Therapy For Heart Failure

Scientists have moved a step closer to the goal of creating stem cells perfectly matched to a patient's DNA in order to treat diseases, they announced on Thursday, creating patient-specific cell lines out of the skin cells of two adult men.

The advance, described online in the journal Cell Stem Cell, is the first time researchers have achieved "therapeutic cloning" of adults. Technically called somatic-cell nuclear transfer, therapeutic cloning means producing embryonic cells genetically identical to a donor, usually for the purpose of using those cells to treat disease.

But nuclear transfer is also the first step in reproductive cloning, or producing a genetic duplicate of someone - a technique that has sparked controversy since the 1997 announcement that it was used to create Dolly, the clone of a ewe. In 2005, the United Nations called on countries to ban it, and the United States prohibits the use of federal funds for either reproductive or therapeutic cloning.

The new study was funded by a foundation and the South Korean government.

If confirmed by other labs, it could prove significant because many illnesses that might one day be treated with stem cells, such as heart failure and vision loss, primarily affect adults. Patient-specific stem cells would have to be created from older cells, not infant or fetal ones. That now looks possible, though far from easy: Out of 39 tries, the scientists created stem cells only once for each donor.

Outside experts had different views of the study, which was led by Young Gie Chung of the Research Institute for Stem Cell Research at CHA Health Systems in Los Angeles.

Stem cell biologist George Daley of the Harvard Stem Cell Institute called it "an incremental advance" and "not earth-shattering."

Reproductive biologist Shoukhrat Mitalipov of Oregon Health and Science University, who developed the technique the CHA team adapted, was more positive. "The advance here is showing that (nuclear transfer) looks like it will work with people of all ages," he said in an interview.

A year ago, Mitalipov led the team that used nuclear transfer of fetal and infant DNA to produce stem cells, the first time that had been accomplished in humans of any age.

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In a cloning first, scientists create stem cells from ...

Stem cells injected directly into heart muscle can help patients suffering from severe heart failure by improving an ailing heart's ability to pump blood, a new Danish trial indicates.

Doctors drew stem cells from patients' own bone marrow, and then injected those cells into portions of the heart where scar tissue seemed to interfere with heart function, explained lead researcher Dr. Anders Bruun Mathiasen. He is a research fellow in the Cardiac Catheterization Lab at Rigshospitalet University Hospital Copenhagen.

Within six months of treatment, patients who received stem cell injections had improved heart pumping function compared to patients receiving a placebo, according to findings that were to be presented Monday at the American Academy of Cardiology's annual meeting in Washington, D.C.

"We know these stem cells can initiate the growth of new blood vessels and heart muscle tissue," Mathiasen said. "That's what we think has happened."

If larger follow-up trials prove the treatment's effectiveness, it could provide hope for people suffering from untreatable heart failure.

"Heart failure is one of the biggest causes of death. If you can save lives or improve their symptoms, then a treatment like this would be extremely beneficial," said Dr. Cindy Grines, a cardiologist with the Detroit Medical Center and a spokeswoman for the American College of Cardiology.

The treatment could delay the need for a heart transplant and extend the lives of people who can't qualify for a transplant, Grines added.

This new clinical trial included 59 patients with severe heart failure who were considered untreatable. It is the largest randomized trial to test the potential of stem cell injections in treating heart disease, the researchers said.

In the trial, 39 patients received injections of stem cells into their heart muscle through a catheter inserted in the groin. The procedure required only local anesthesia, Mathiasen said. The other 20 received saline injections.

Doctors first mapped the patient's heart using a sensor sent through the catheter that tracks both heart movement and voltage conducted by heart tissue.

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Stem Cells Can Revive Failing Heart

George Washington University (GW) researcher Narine Sarvazyan, Ph.D., has invented a new organ to help return blood flow from veins lacking functional valves. A rhythmically contracting cuff made of cardiac muscle cells surrounds the vein acting as a 'mini heart' to aid blood flow through venous segments. The cuff can be made of a patient's own adult stem cells, eliminating the chance of implant rejection.

"We are suggesting, for the first time, to use stem cells to create, rather than just repair damaged organs," said Sarvazyan, professor of pharmacology and physiology at the GW School of Medicine and Health Sciences. "We can make a new heart outside of one's own heart, and by placing it in the lower extremities, significantly improve venous blood flow."

The novel approach of creating 'mini hearts' may help to solve a chronic widespread disease. Chronic venous insufficiency is one of the most pervasive diseases, particularly in developed countries. Its incidence can reach 20 to 30 percent in people over 50 years of age. It is also responsible for about 2 percent of health care costs in the United States. Additionally, sluggish venous blood flow is an issue for those with diseases such as diabetes, and for those with paralysis or recovering from surgery.

This potential new treatment option, outlined in a recently published paper in the Journal of Cardiovascular Pharmacology and Therapeutics, represents a leap for the tissue engineering field, advancing from organ repair to organ creation. Sarvazyan, together with members of her team, has demonstrated the feasibility of this novel approach in vitro and is currently working toward testing these devices in vivo.

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The above story is based on materials provided by George Washington University. Note: Materials may be edited for content and length.

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'Mini heart' invented to help return venous blood

When someone has chronic venous insufficiency, it means that because of faulty valves in their leg veins, oxygen-poor blood isn't able to be pumped back to their heart. The George Washington University's Dr. Narine Sarvazyan has created a possible solution, however a beating "mini heart" that's wrapped around the vein, to help push the blood through.

The mini heart takes the form of a cuff of rhythmically-contracting heart tissue, made by coaxing the patient's own adult stem cells into becoming cardiac cells. When one of those cuffs is placed around a vein, its contractions aid in the unidirectional flow of blood, plus it helps keep the vein from becoming distended. Additionally, because it's grown from the patient's own cells, there's little chance of rejection.

So far, the cuffs have been grown in the lab, where they've also been tested. Soon, however, Sarvazyan hopes to conduct animal trials, in which the cuffs are actually grown on the vein, in the body.

"We are suggesting, for the first time, to use stem cells to create, rather than just repair damaged organs," she said. "We can make a new heart outside of ones own heart, and by placing it in the lower extremities, significantly improve venous blood flow."

Scientists at Germany's Fraunhofer Institute for Manufacturing Engineering and Automation are also working on a treatment for chronic venous insufficiency, although their approach has been to create artificial venous valves that could be used to replace the defective natural ones.

A paper on Sarvazyan's research was recently published in the Journal of Cardiovascular Pharmacology and Therapeutics. One of the mini hearts can be seen beating away, in the video below.

Source: The George Washington University

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"Mini hearts" on veins could be used to treat circulatory problems

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Newswise WASHINGTON (March 27, 2014) George Washington University (GW) researcher Narine Sarvazyan, Ph.D., has invented a new organ to help return blood flow from veins lacking functional valves. A rhythmically contracting cuff made of cardiac muscle cells surrounds the vein acting as a 'mini heart' to aid blood flow through venous segments. The cuff can be made of a patients own adult stem cells, eliminating the chance of implant rejection.

We are suggesting, for the first time, to use stem cells to create, rather than just repair damaged organs, said Sarvazyan, professor of pharmacology and physiology at the GW School of Medicine and Health Sciences. We can make a new heart outside of ones own heart, and by placing it in the lower extremities, significantly improve venous blood flow.

The novel approach of creating mini hearts' may help to solve a chronic widespread disease. Chronic venous insufficiency is one of the most pervasive diseases, particularly in developed countries. Its incidence can reach 20 to 30 percent in people over 50 years of age. It is also responsible for about 2 percent of health care costs in the United States. Additionally, sluggish venous blood flow is an issue for those with diseases such as diabetes, and for those with paralysis or recovering from surgery.

This potential new treatment option, outlined in a recently published paper in the Journal of Cardiovascular Pharmacology and Therapeutics, represents a leap for the tissue engineering field, advancing from organ repair to organ creation. Sarvazyan, together with members of her team, has demonstrated the feasibility of this novel approach in vitro and is currently working toward testing these devices in vivo.

The study, titled Thinking Outside the Heart: Use of Engineered Cardiac Tissue for the Treatment of Chronic Deep Venous Insufficiency, is available at http://cpt.sagepub.com/content/early/2014/01/20/1074248413520343.full.

Media: To interview Dr. Sarvazyan about her research, please contact Lisa Anderson at lisama2@gwu.edu or 202-994-3121.

###

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Researcher Invents 'Mini Heart' to Help Return Venous Blood

PUBLIC RELEASE DATE:

27-Mar-2014

Contact: Lisa Anderson lisama2@gwu.edu 202-994-3121 George Washington University

WASHINGTON (March 27, 2014) George Washington University (GW) researcher Narine Sarvazyan, Ph.D., has invented a new organ to help return blood flow from veins lacking functional valves. A rhythmically contracting cuff made of cardiac muscle cells surrounds the vein acting as a 'mini heart' to aid blood flow through venous segments. The cuff can be made of a patient's own adult stem cells, eliminating the chance of implant rejection.

"We are suggesting, for the first time, to use stem cells to create, rather than just repair damaged organs," said Sarvazyan, professor of pharmacology and physiology at the GW School of Medicine and Health Sciences. "We can make a new heart outside of one's own heart, and by placing it in the lower extremities, significantly improve venous blood flow."

The novel approach of creating 'mini hearts' may help to solve a chronic widespread disease. Chronic venous insufficiency is one of the most pervasive diseases, particularly in developed countries. Its incidence can reach 20 to 30 percent in people over 50 years of age. It is also responsible for about 2 percent of health care costs in the United States. Additionally, sluggish venous blood flow is an issue for those with diseases such as diabetes, and for those with paralysis or recovering from surgery.

This potential new treatment option, outlined in a recently published paper in the Journal of Cardiovascular Pharmacology and Therapeutics, represents a leap for the tissue engineering field, advancing from organ repair to organ creation. Sarvazyan, together with members of her team, has demonstrated the feasibility of this novel approach in vitro and is currently working toward testing these devices in vivo.

###

The study, titled "Thinking Outside the Heart: Use of Engineered Cardiac Tissue for the Treatment of Chronic Deep Venous Insufficiency," is available at http://cpt.sagepub.com/content/early/2014/01/20/1074248413520343.full.

Media: To interview Dr. Sarvazyan about her research, please contact Lisa Anderson at lisama2@gwu.edu or 202-994-3121.

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GW researcher invents 'mini heart' to help return venous blood

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Newswise LOS ANGELES (March 27, 2014) Two Cedars-Sinai Heart Institute physician-researchers have been named recipients of prestigious awards from the American College of Cardiology.

Eduardo Marbn, MD, PhD, director of the Cedars-Sinai Heart Institute and a pioneer in developing cardiac stem cell treatments, will be awarded the 2014 Distinguished Scientist Award (Basic Domain) by the 40,000-member medical society during its 63rd Annual Scientific Session on March 31.

Sumeet Chugh, MD, associate director of the Heart Institute and a leading expert on heart rhythm disorders such as sudden cardiac arrest and atrial fibrillation, is to receive the Simon Dack Award for Outstanding Scholarship in recognition of Chughs contributions to the organizations peer-reviewed medical journals.

Dr. Marbn has earned the prestigious title of Distinguished Scientist by pioneering the development of stem cell treatments that can regenerate healthy heart muscle, said Shlomo Melmed, MD, senior vice president of Academic Affairs, dean of the Cedars-Sinai medical faculty and the Helene A. and Philip E. Hixon Chair in Investigative Medicine. Dr. Chugh is leading the quest to unlock the mysteries of how to prevent sudden cardiac arrest, which is 99 percent fatal. Their work is advancing life-saving treatments for patients all over the world and is a testament to the outstanding work of the Heart Institute.

Using techniques that he invented to isolate and grow stem cells from a patient's own heart tissue, Marbn designed and completed the first-in-human cardiac stem cell trial, called CADUCEUS, funded by the National Institutes of Health. The study was the first to show that stem cell therapy can repair damage to the heart muscle caused by a heart attack. Currently, a new, multicenter stem cell clinical trial called ALLSTAR is measuring the effectiveness of donor heart stem cells in treating heart attack patients.

A native of Cuba, Marbn came to the United States with his parents at age 6 as a political refugee. He earned his bachelor's degree in mathematics from Wilkes College in Pennsylvania, and then attended the Yale University School of Medicine in a combined MD/PhD program. Among the many honors Marbn has received are the Basic Research Prize of the American Heart Association the Research Achievement Award of the International Society for Heart Research, the Gill Heart Institute Award and the Distinguished Scientist Award of the American Heart Association.

Chugh, the Pauline and Harold Price Chair in Cardiac Electrophysiology, is an expert in the performance of radio frequency ablation procedures as well as the use of pacemakers, defibrillators and biventricular devices to correct heart rhythm problems. The author of more than 250 articles and abstracts in professional journals, Chugh initiated and directs the ongoing Oregon Sudden Unexpected Death Study, a large, comprehensive assessment of sudden cardiac arrest in a community of 1 million residents. Chugh leads the World Health Organization panel that is charged with performing a worldwide assessment of heart rhythm disorders for the Global Burden of Disease Study.

After earning his medical degree from Government Medical College Patiala, India, Chugh spent the first year of his internal medicine residency at Tufts Newton Wellesley Hospital in Boston and the next two years at Hennepin County Medical Center in Minneapolis. He completed a fellowship in cardiology at the University of Minnesota and a fellowship in clinical cardiac electrophysiology at Mayo Clinic in Rochester, Minn.

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Two Cedars-Sinai Heart Institute Physicians Honored by American College of Cardiology

The review retrospectively evaluates and correlates the different approaches employed in cardiac regeneration over the past decade and underscores the recent advances in the purification and lineage specification of stem cells.

The review points to the safety and feasibility of cell-based therapy as worldwide, thousands of patients to date have been treated using autologous approaches. The authors state that the main factors limiting adoption of cell therapies comprise the poor definition of cell types used, diversity in cell handling procedures and functional variability intrinsic to autologously-derived cells.

The outcomes of the various trials analyzed in the review suggest that cardiac-progenitors confer therapeutic benefit. Cardiac progenitors could be either derived from the heart or be cardiac lineagespecified, the latter a method used to generate C-Cure. Cardiac lineage-specified cells are guided ex vivo to differentiate into cardioreparative cells.

In the C-Cure trial, heart failure patients were treated with C-Cure which consists of cardiac progenitor (cardiopoietic) cells. The findings of the study indicate that the use of cardiac progenitor cells (CP-hMSC) is feasible and safe and documents a statistically significant improvement of Left Ventricular Ejection Fraction, a measure of heart function, versus baseline compared to no change for the control group who were treated with standard of care. Based on these results, C-Cure is being tested in a Phase III study in Europe and Israel (CHART-1) and has been authorized by the FDA to be tested in the U.S (CHART-2). These phase III therapeutic studies highlight advances in regenerative science.

Dr Christian Homsy, CEO of Cardio3 BioSciences, comments: Being recognized in this review published in Nature Reviews Cardiology highlights Cardio3 BioSciences technology and leadership in bringing new therapeutic options to patients. By choosing the route of lineage specification, we once again demonstrate that we are at the forefront of the cardiac regenerative medicine industry.

1Behfar, A. et al. Nat. Rev. Cardiol. 11, 232246 (2014) doi:10.1038/nrcardio.2014.9 Published online 04 March 2014

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About Cardio3 BioSciences

Cardio3BioSciences is a Belgian leading biotechnology company focused on the discovery and development of regenerative and protective therapies for the treatment of cardiac diseases. The company was founded in 2007 and is based in the Walloon region of Belgium. Cardio3BioSciences leverages research collaborations in the US and in Europe with Mayo Clinic and the Cardiovascular Centre Aalst, Belgium.

The Companys lead product candidate C-Cure is an innovative pharmaceutical product that is being developed for heart failure indication. C-Cure consists of a patients own cells that are harvested from the patients bone marrow and engineered to become new heart muscle cells that behave identically to those lost to heart disease. This process is known as Cardiopoiesis.

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Cardio3 BioSciences Cell Therapy Approach for Cardiac Repair Recognized in Nature Reviews Cardiology

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Newswise Beverly, MA, March 24, 2014 Reports of the two earliest tissue-engineered whole organ transplants using a windpipe, or trachea, created using the patient's own stem cells, were hailed as a breakthrough for regenerative medicine and widely publicized in the press. However, two leading transplant surgeons in Belgium warn of the dangers of media attention, and urge that tracheal bioengineering be demonstrated as both effective and safe before further transplants take place. Their views are published in an Editorial in The Journal of Thoracic and Cardiovascular Surgery, an official publication of the American Association for Thoracic Surgery.

In 2008, surgeons repopulated a donor trachea with cells from a 30-year-old woman, which they then transplanted into the patient. In 2011, a 36-year-old man who had been suffering from late-stage tracheal cancer was given a new trachea made from a synthetic scaffold seeded with his own stem cells. Both procedures were carried out by Professor Paolo Macchiarini and colleagues (Barcelona, 2008, and Sweden, 2011).

In 2012, an article in The New York Times, A First: Organs Tailor-Made With Bodys Own Cells, recognized tracheal regeneration as the first regenerative medicine procedure designed to implant bioartificial organs. The achievement was touted as the beginning of complex organ engineering for the heart, liver, and kidneys, and it was suggested that allotransplantation along with immunosuppression might become problems of the past.

Major medical breakthroughs deserve the necessary press attention to inform the medical community and public of the news, say Pierre R. Delaere, MD, PhD, and Dirk Van Raemdonck, MD, PhD, from the Department of Otolaryngology Head & Neck Surgery and the Department of Thoracic Surgery, University Hospital Leuven, Belgium. Unfortunately, misrepresentation of medical information can occur and is particularly problematic when members of the professional and public press are misled to believe unrealistic medical breakthroughs.

The authors raise doubts regarding whether a synthetic tube can transform into a viable airway tube, pointing out that the mechanism behind the transformation from nonviable construct to viable airway cannot be explained with our current knowledge of tissue healing, tissue transplantation, and tissue regeneration. Cells have never been observed to adhere, grow, and regenerate into complex tissues when applied to an avascular or synthetic scaffold and, moreover, this advanced form of tissue regeneration has never been observed in laboratory-based research, say the authors.

Delaere and Van Raemdonck reviewed the information gathered from published reports on three patients who received bioengineered tracheas and unpublished reports on an additional 11 patients. Although there were differences between the techniques used, production of the bioengineered trachea in all cases produced similar results, and the different approaches worked in comparable ways.

The results show that mortality and morbidity were very high. Several patients died within a three-month period, and the patients who survived longer functioned with an airway stent that preserved the airway lumen, they observe.

They also question whether the trachea can really be considered to be the first bioengineered organ. From the 14 reports reviewed, they concluded that the bioengineered tracheal replacements were in fact airway replacements that functioned only as scaffolds, behaving in a similar way to synthetic tracheal prostheses.

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Leading Surgeons Warn Against Media Hype About Tracheal Regeneration

Miami (PRWEB) March 20, 2014

Joseph Purita, M.D. and Maritza Novas, R.N., M.S.N. of Global Stem Cells Group Inc., and Bioheart, Inc. Chief Scientific Officer Kristin Comella will be featured speakers at the 31st American Association of Orthopedic Medicine Annual Conference (AAOM) Conference and Scientific Seminar in Clearwater Beach, Florida April 9-12, 2014. Co-sponsored by the American Board of Quality Assurance and Utilization Review Physicians, Inc. (ABQAURP), the conference, titled Sports, Spine and Beyond: Latest Advances in Regenerative Orthopedic Medicine, will focus on the newest breakthroughs in the field of orthopedic medicine.

Purita, Novas and Comella will present the latest advances in stem cell therapies in sports medicine, regenerative orthopedic medicine and interventional pain medicine, including techniques for extracting stem cells from adipose tissue to use in patient treatments. Purita is a pioneer in the use of stem cells in orthopedics and founder of the Institute of Regenerative and Molecular Orthopedics in Boca Raton, Florida. Novas is a lead trainer and part of the research and development team for Stem Cell Training, a Global Stem Cells Group subsidiary.

Comella has more than 15 years experience in cell culturing and developing stem cell therapies for degenerative diseases and experience in corporate entities, with expertise in regenerative medicine, training and education, research, product development and senior management.

The conference will explore advances in other non-traditional treatments in sports and regenerative orthopedic medicine including manual medicine, nutrition, bioidentical hormone replacement therapy, musculoskeletal ultrasound and more. The goal of the AAOM Conference is to bring sports medicine physicians, PM&R specialists (physiatrists), family medicine physicians, orthopedic surgeons, neurologists and interventional pain physiciansincluding anesthesiologists and osteopathic pain physiciansthe latest state-of-the-art techniques and technologies to help treat their patients performance-related pain and injuries, overuse syndromes and chronic pain.

For more information on the 31st AAOM Annual Conference and Scientific Seminar, visit the AAOM website.

About the Global Stem Cells Group:

Global Stem Cells Group, Inc. is the parent company of six wholly owned operating companies dedicated entirely to stem cell research, training, products and solutions. Founded in 2012, the company combines dedicated researchers, physician and patient educators and solution providers with the shared goal of meeting the growing worldwide need for leading edge stem cell treatments and solutions. With a singular focus on this exciting new area of medical research, Global Stem Cells Group and its subsidiaries are uniquely positioned to become global leaders in cellular medicine.

Global Stem Cells Groups corporate mission is to make the promise of stem cell medicine a reality for patients around the world. With each of GSCGs six operating companies focused on a separate research-based mission, the result is a global network of state-of-the-art stem cell treatments.

To learn more about Global Stem Cells Group, Inc.s companies and for investor information, visit the Global Stem Cells Group website, email bnovas(at)regenestem(dot)com, or call 305-224-1858.

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Joseph Purita, M.D. and Maritza Novas, R.N., M.S.N. of Global Stem Cells Group, Inc. and Bioheart CSO Kristin Comella ...

12 hours ago Levels of the regulatory protein GtaC, tagged with green fluorescent protein, increase in the nucleus every six minutes. GtaC turns on genes that prepare cells to move. The image is a compilation of eight photos, taken at 3.5 minute intervals, showing GtaC's location in a single cell as it moves. Credit: Huaqing Cai

Johns Hopkins biologists have discovered that when biological signals hit cells in rhythmic waves, the magnitude of the cells' response can depend on the number of signaling cyclesnot their strength or duration. Because such so-called "oscillating signaling cycles" are common in many biological systems, the scientists expect their findings in single-celled organisms to help explain the molecular workings of phenomena such as tissue and organ formation and fundamental forms of learning.

In a report to be published online in the journal Science on March 21, the investigators say their experiments in amoebae show how repeated pulses of a signal cause short bursts of specific gene activity, the products of which linger and build with each new pulse. The cumulative amount of these gene products ultimately affects changes in cell fate.

"The mechanism we discovered here illustrates how a single cell can keep track of the number of times it has received a signal," says Peter Devreotes, Ph.D., professor and director of the Department of Cell Biology. "In most signaling systems, the cellular response depends on the strength or duration of the signal. This system allows the cells to count."

The Devreotes team says they figured out this signaling system in the amoeba Dictyostelium discoideum, a single-celled organism that can cluster to form a multi-celled structure that helps it survive when resources are scarce. At the heart of this process, they say, is a communication molecule called cAMP, a chemical released by starving cells in periodic spurtsevery six minutesthat is sensed by other cells nearby. The signal triggers a series of steps needed for the cells to join together and form specialized types of cells within the group makeup.

Devreotes says, "We have known since the 1970s that the cAMP signals achieve their best effect when they arrive every six minutesnot more and not lessbut we had no idea why."

To find out, the Johns Hopkins team focused on the behavior of a regulatory protein called GtaC, which is similar to the human GATA genes known to control stem cell fate in many tissues. Amoebae that lack GtaC can't activate the genes that enable the initially similar cells to cluster and to become the specialized cell types of the multicellular structure.

When the researchers attached GtaC to a protein that glows green, they saw that it entered the amoeba cell nucleus, left the nucleus and then entered again at a pace like the six-minute pulses of cAMP. If the researchers gave the cells a continuous supply of cAMP, GtaC would leave the nucleus after a brief lag and remain outside of it for as long as cAMP was present. When they removed cAMP, GtaC would re-enter the nucleus.

The researchers then engineered GtaC to stay put in the nucleus and found that the cells began to come together and specialize prematurely. However, in cells that lacked cAMP, the team found that these processes were not turned on even with GtaC in the nucleus.

To better understand the role of GtaC, the researchers used a protein that can glow to show when GtaC turned on a particular gene. What they found was another rhythmic, six-minute pattern of activity: The glowing spots indicating gene activity peaked in intensity approximately every six minutes and lagged about three minutes behind the peak of GtaC accumulation in the nucleus. According to Devreotes, this three-minute lag is likely due to the time it takes for the gene to be turned on and seen.

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Cellular 'counting' of rhythmic signals synchronizes changes in cell fate

Freeport, Bahamas (PRWEB) March 18, 2014

Okyanos Heart Institute, whose mission it is to bring a new standard of care and a better quality of life to patients with coronary artery disease (CAD) using adult stem cell therapy, announced today it has raised $8.9 million in its Series B offering. Passion Group founder Ali Shawkat led the round and is a visionary entrepreneur-investor with success in a diverse set of industries including cellular services, telecom, media and healthcare.

Okyanos has the vision, medical leadership, adult stem cell technology and business model to better the lives of millions of patients, their families and society, said Shawkat. Cell therapy promises to be a new pillar of medicine as it is based on the natural biology of the body.

"This funding brings Okyanos' total funding to $14.2 million. Financial strength is integral to our commitment to treat patients with cardiac cell therapy at the highest standards of safety and care, stated Matthew Feshbach, co-founder and CEO of Okyanos.

Okyanos' cardiac cell therapy utilizes cells known as adipose-derived stem and regenerative cells (ADRCs), processed by Cytori Therapeutics (NASDAQ: CYTX) Celution system, a technology which has been approved and is commercially available in Europe, Australia, New Zealand, Singapore and other international jurisdictions for various indications of use.

The company has procured a state-of-the-art Philips cath lab and is building out a center of excellence capable of treating over 1000 patients per year in Freeport, The Bahamas. Based on the recommendations of the Bahamas Stem Cell Task Force, which thoroughly studied the safety and efficacy of adult stem cell therapy, the Bahamas passed stem cell legislation in August, 2013.

Feshbach further stated, We have a sophisticated, entrepreneurial group of investors who are like-minded in our purpose to safely improve the quality of life of patients suffering from illnesses such as CAD, using adult stem cells derived from adipose (fat) tissue, added Feshbach. We appreciate the significant leadership and support of Mr. Shawkat who shares the Okyanos commitment.

The company will begin treating patients with coronary artery disease using their own stem cells in the summer of 2014.

About Okyanos Heart Institute: (Oh key AH nos) Based in Freeport, The Bahamas, Okyanos Heart Institutes mission is to bring a new standard of care and a better quality of life to patients with coronary artery disease using cardiac stem cell therapy. Okyanos adheres to U.S. surgical center standards and is led by Chief Medical Officer Howard T. Walpole Jr., M.D., M.B.A., F.A.C.C., F.S.C.A.I. Okyanos Treatment utilizes a unique blend of stem and regenerative cells derived from ones own adipose (fat) tissue. The cells, when placed into the heart via a minimally-invasive procedure, can stimulate the growth of new blood vessels, a process known as angiogenesis. Angiogenesis facilitates blood flow in the heart, which supports intake and use of oxygen (as demonstrated in rigorous clinical trials such as the PRECISE trial). The literary name Okyanos, the Greek god of rivers, symbolizes restoration of blood flow. For more information, go to http://www.okyanos.com.

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Okyanos Heart Institute Announces Completion of Investment Funding

PUBLIC RELEASE DATE:

18-Mar-2014

Contact: Bei Shi shi_bei2147@126.com Society for Experimental Biology and Medicine

Bei Shi, Xianping Long, Ranzun Zhao, Zhijiang Liu, Dongmei Wang and Guanxue Xu, researchers at the First Affiliated Hospital of Zunyi Medical College within the Guizhou Province of China, have reported an approach for improving the use of stem cells for improvement of infarcted heart function and damage to the arteries in the March 2013 issue of Experimental Biology and Medicine. They have discovered that mesenchymal stem cells (MSCs) transfected with a recombinant adenovirus containing the human receptor activity-modifying protein 1 (hRAMP1) gene (EGFP-hRAMP1-MSCs) when transplanted into rabbit models for both Myocardial infarction (MI) and carotid artery injury inhibit vascular smooth muscle cell (VSMC) proliferation within the neointima, and greatly improved both infarcted heart function and endothelial recovery from artery injury more efficiently than the control EGFP-MSCs.

MSCs have good applicability for cell transplantation because they possess self-renewal and multiple differentiation potential. With addition of either environmental or chemical substances, MSCs can differentiate into a variety of cell types. Numerous animal experiments and small clinical trials have shown that MSC transplantation can promote the formation of new blood vessels and reduce myocardial infarct size, and diminish the formation of scar tissue and ventricular remodeling, and improve cardiac functions. Nevertheless, MSCs have the potential to differentiate into VSMCs and may be the source of proliferating VSMCs during neointima formation after vascular injury. Recently, genetically modified MSCs, such as heme oxygenase-1(HO-1), granulocyte colony-stimulating factor (G-CSF) over-expressing MSCs, have proven to be more efficient at ameliorating infarcted myocardium than administering MSCs alone.

Calcitonin gene related protein (CGRP) is one of the most well-known potent vasodilators and can regulate vascular tone and other aspects of vascular function. The receptors for CGRP include the calcitonin receptor-like receptor (CRLR), RAMP1, and the receptor component protein. RAMP1 confers ligand specificity for CGRP. The relaxation of the artery in response to CGRP is dependent on RAMP1 expression. The response to CGRP is augmented after the increased expression of RAMP1 in VSMCs in culture.

RAMP1 over-expression increased CGRP-induced vasodilation and protected against angiotensin II-induced endothelial dysfunction as well as prevented VSMCs proliferation. In this study, we tested the effects of human RAMP1-over-expressing MSCs on infarcted heart function and intimal hyperplasia by means of cell transplantation in rabbit models for MI reperfusion and carotid artery injury. Bei Shi said "Our data has shown that hRAMP1 over-expression in MSCs through genetic modification significantly inhibits neointimal proliferation and improves infarcted heart function."

Dr. Steven R. Goodman, Editor-in-Chief of Experimental Biology and Medicine said "The effect of stem cell therapy with the RAMP1 expressing MSCs has been shown, by Bei Shi and colleagues, to reduce neointimal proliferation in the carotid angioplasty and myocardial infarction animal models. This approach could be important for the treatment of damaged vessels and the infracted heart".

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Effect of receptor activity-modifying protein-1 on vascular smooth muscle cells

17 hours ago

One of the most promising technologies for the treatment of various cancers is nanotechnology, creating drugs that directly attack the cancer cells without damaging other tissues' development. The Laboratory of Cellular Oncology at the Research Unit in Cell Differentiation and Cancer, of the Faculty of Higher Studies (FES) Zaragoza UNAM (National Autonomous University of Mexico) have developed a therapy to attack cervical cancer tumors.

The treatment, which has been tested in animal models, consists of a nanostructured composition encapsulating a protein called interleukin-2 (IL -2), lethal to cancer cells.

According to the researcher Rosalva Rangel Corona, head of the project, the antitumor effect of interleukin in cervical cancer is because their cells express receptors for interleukin-2 that "fit together" like puzzle pieces with the protein to activate an antitumor response .

The scientist explains that the nanoparticle works as a bridge of antitumor activation between tumor cells and T lymphocytes. The nanoparticle has interleukin 2 on its surface, so when the protein is around it acts as a switch, a contact with the cancer cell to bind to the receptor and to carry out its biological action.

Furthermore, the nanoparticle concentrates interleukin 2 in the tumor site, which allows its accumulation near the tumor growth. It is not circulating in the blood stream, is "out there" in action.

The administration of IL-2 using the nanovector reduces the side effects caused by this protein if administered in large amounts to the body. These effects can be fever, low blood pressure, fluid retention and attack to the central nervous system, among others.

It is known that interleukin -2 is a protein (a cytokine, a product of the cell) generated by active T cells. The nanoparticle, the vector for IL-2, carries the substance to the receptors in cancer cells, then saturates them and kills them, besides generating an immune T cells bridge (in charge of activating the immune response of the organism). This is like a guided missile acting within tumor cells and activating the immune system cells that kill them.

A woman immunosuppressed by disease produces even less interleukin. For this reason, the use of the nanoparticle would be very beneficial for female patients.

The researcher emphasized that his group must meet the pharmaceutical regulations to carry their research beyond published studies and thus benefit the population.

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New nanoparticle that only attacks cervical cancer cells

5 hours ago Schematic illustrating how mechanical properties of substrates affect where YAP/TAZ protein localization in cardiac stem cells (left) and how this affects stem cell development and function (right).

Proteins associated with the regulation of organ size and shape have been found to respond to the mechanics of the microenvironment in ways that specifically affect the decision of adult cardiac stem cells to generate muscular or vascular cells.

Cell development for specific functionsso-called cell differentiationis crucial for maintaining healthy tissue and organs. Two proteins in particularthe Yes-associated protein (YAP) and WW domain-containing transcription regulator protein 1 (WWTR1 or TAZ)have been linked with control of cell differentiation in the tissues of the lymphatic, circulatory, intestinal and neural systems, as well as regulating embryonic stem cell renewal. An international collaboration of researchers has now identified that changes in the elasticity and nanotopography of the cellular environment of these proteins can affect how heart stem cells differentiate with implications for the onset of heart diseases.

Researchers at the International Center for Materials Nanoarchitectonics (MANA), National Institute for Materials Science (NIMS) collaborated with researchers in Finland, Italy, the Netherlands, Saudi Arabia and the Czech Republic in the study.

They engineered YAP and TAZ proteins that expressed green fluorescent protein so that their location within the cell could be tracked. They then prepared cell substrates from smart biomaterials displaying dynamic control of elasticity and nanostructure with temperature. "Our data provide the first evidence for YAP/TAZ shuttling activity between the nucleus and the cytoplasm being promptly activated in response to dynamic modifications in substrate stiffness or nanostructure," explain the researchers.

Observations of gene expression highlighted the key role of YAP/TAZ proteins in cell differentiation. In further investigations on the effect of substrate stiffness they also found that cell differentiation was most efficient for substrates displaying stiffness similar to that found in the heart.

The authors suggest that understanding the effects of microenvironment nanostructure and mechanics on how these proteins affect cell differentiation could be used to aid processes that maintain a healthy heart. They conclude, "These proteins are indicated as potential targets to control cardiac progenitor cell fate by materials design."

Explore further: Study identifies gene important to breast development and breast cancer

More information: Hippo pathway effectors control cardiac progenitor cell fate by acting as dynamic sensors of substrate mechanics and nanostructure. Diogo Mosqueira, et al. 2014 ACS Nano; DOI: 10.1021/nn4058984

A new study in Cell Reports identifies a gene important to breast development and breast cancer, providing a potential new target for drug therapies to treat aggressive types of breast cancer.

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Heart cells respond to stiff environments