With recruitment that started in mid-2013, Cardio3 BioSciences has enrolled 240 patients in less than 18 months, ahead of schedule. As usual in clinical trials targeting severe indications, the Company will continue to recruit additional patients in anticipation of patient dropouts. The CHART-1 trial is currently ongoing in 12 countries in Europe and Israel.

The CHART-1 (Congestive Heart failure Cardiopoietic Regenerative Therapy) trial represents the worlds first Phase III trial for a pre-programmed cellular therapy for the treatment of heart failure.

Dr Christian Homsy, CEO of Cardio3 BioSciences, said: We are extremely pleased to have enrolled the 240thpatient of CHART-1, ahead of schedule. This represents a major achievement for the entire team involved in this trial and I am proud we succeeded in achieving this key operational objective this year. The CHART-1 trial remains solidly on track, with the interim futility readout scheduled for the end of March 2015 and the readout of the full dataset a year later. This accomplishment demonstrates our clinical expertise and gives us confidence for the upcoming CHART-2 trial, to be initiated soon in the U.S.

*** END ***

About CHART-1

CHART-1 is the Companys first Phase III clinical trial, intended to assess in Europe, the efficacy of C-Cure as a treatment for heart failure of ischemic origin. The CHART-1 Phase III trial is a prospective, multi-centre, randomized, sham-controlled, patient-and evaluator-blinded study comparing treatment with C-Cure to a sham treatment. The trial requires the recruitment of a minimum of 240 patients with chronic advanced symptomatic heart failure. The primary endpoint of the trial is a composite endpoint including mortality, morbidity, quality of life, Six Minute Walk Test and left ventricular structure and function at nine months post-procedure. The CHART-1 trial is currently ongoing in 11 countries in Europe (Sweden, Ireland, the United Kingdom, Belgium, Serbia, Bulgaria, Hungary, Spain, Italy, Poland, Switzerland) and Isral.

About C-Cure

Cardio3 BioSciences C-Cure therapy involves taking stem cells from a patients own bone marrow and through a proprietary process called Cardiopoiesis, re-programming those cells to become heart cells. The cells, known as cardiopoietic cells, are then injected back into the patients heart through a minimally invasive procedure, with the aim of repairing damaged tissue and improving heart function and patient clinical outcomes. C-Cure is the outcome of multiple years of research conducted at Mayo Clinic (Rochester, Minnesota, USA), Cardio3 BioSciences (Mont-Saint-Guibert, Belgium) and Cardiovascular Centre in Aalst (Aalst, Belgium).

To subscribe to Cardio3 BioSciences newsletter, visit http://www.c3bs.com. Follow us on Twitter @Cardio3Bio.

About Cardio3 BioSciences

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Cardio3 Biosciences Announces the Enrolment of the 240th Patient for Its Chart-1 Phase III Clinical Trial for the ...

Two men in landmark heart stem cell study tell their stories.

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Jim Dearing of Louisville, Ky., one of the first men in the world to receive heart stem cells, might have helped start a medical revolution that could lead to a cure for heart failure.

Three years after getting the experimental stem cell procedure, following two heart attacks and heart failure, Dearings heart is working normally.

2012 WebMD, LLC. All rights reserved.

The difference is clear and dramatic -- and it's lasting, according to findings now being made public for the first time.

Dearing first showed "completely normal heart function" on an echocardiogram done in 2011, says Roberto Bolli, MD, who is leading the stem cell trial at the University of Louisville. Those results have not been published before.

That was still true in July 2012, when Dearing again showed normal heart function on another echocardiogram.

Based on those tests, Bolli says, "Anyone who looks at his heart now would not imagine that this patient was in heart failure, that he had a heart attack, that he was in the hospital, that he had surgery, and everything else."

It's not just Dearing who has benefited. His friend, Mike Jones, who had even more severe heart damage, also got the stem cell procedure in 2009. Since then, scarred regions of his heart have shrunk. His heart now appears leaner and stronger than it was before.

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Stem Cell Research: Heart Stem Cells May Help Heal Hearts ...

Researchers at The University of Queensland are part of a global team that has identified a new type of artificial stem cell.

UQ Associate Professor Christine Wells (right) said Project Grandiose had revealed it could track new ways to reprogram a normal adult cell, such as skin cells, into cells similar to those found in an early embryo.

The development is expected to help researchers explore ways to arrive at new cell types in the laboratory, with important implications for regenerative medicine and stem cell science.

Associate Professor Wells, who leads the Stemformatics stem cell research support unit at UQs Australian Institute for Bioengineering and Nanotechnology, said the project involved a consortium of 50 researchers from Canada, Australia, Korea, the USA and the Netherlands

We all come from just one cell the fertilised egg and this cell contains within its DNA a series of instruction manuals to make all of the many different types of cells that make up our body, AIBN Associate Professor Wells said.

These very early stage cells can now be made in the lab by reversing this process of development.

Our research reveals the new instructions imposed on a cell when this developmental process is reversed.

Project Grandiose is a large-scale research effort to understand what happens inside a cell as it reverts to an artificial stem cell.

The role of the Stemformatics.org group was to help the researchers have access to the vast information and data they generated from the project, Associate Professor Wells said.

Our online data platform is designed to let non-specialists view the genes involved and the many ways they are regulated during cell formation.

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New UQ platform aids stem cell research

A team of scientists that included researchers from UCLA has discovered a novel mechanism of RNA regulation in embryonic stem cells. The findings are strong evidence that a specific chemical modification, or "tag," on RNA plays a key role in determining the ability of embryonic stem cells to adopt different cellular identities.

The team also included scientists from Harvard Medical School, Massachusetts General Hospital and Stanford University.

Published in the journal Cell Stem Cell, the research reveals that depleting or knocking out a key component of the machinery that places this chemical tag -- known both as m6A and N6-methyladenosine -- on RNA significantly blocks embryonic stem cells from differentiating into more specialized types of cells.

A key property of embryonic stem cells is their ability to differentiate into many specialized types of cells. However, instead of marching toward a specific fate when prompted by signals to differentiate, embryonic stem cells that have reduced ability to place m6A become stuck in a sort of suspended animation, even though they appear healthy.

Yi Xing, a UCLA associate professor of microbiology, immunology and molecular genetics, led the informatics analyses and was a co-corresponding author of the paper. Other corresponding authors were Dr. Cosmas Giallourakis, an assistant professor of medicine at Harvard Medical School and Massachusetts General Hospital, and Dr. Howard Chang, a professor of Stanford University's School of Medicine and a Howard Hughes Medical Institute investigator.

The study of naturally occurring chemical modifications on RNAs is part of an emerging field known as epitranscriptomics. The m6A tag is the most commonly occurring modification known to scientists; it is found on RNAs of thousands of protein-coding genes and hundreds of non-coding genes in a typical cell type. The tags may help regulate RNA metabolism by marking them for destruction.

Little was known about the dynamics, conservation and function of m6A in human or mouse embryonic stem cells when the authors began the project. The authors analyzed which RNAs were tagged with m6A and the location of the m6A modifications along RNAs in mouse and human embryonic stem cells.

"Our analysis revealed a high level of conservation of m6A patterns between mice and humans, suggesting that m6A has conserved functions in human and mouse embryonic stem cells," Xing said. "Moreover, RNAs with m6A tags were degraded more rapidly and lived a shorter life in the cell than those without."

The investigators then found a strikingly conserved requirement for the presence of normal levels of m6A for differentiating embryonic stem cells into multiple cell types. Depletion of METTL3, a gene encoding the enzyme that places the m6A tag on RNAs, severely blocked human embryonic stem cells from differentiating into the gut or neural precursors. Deletion of the mouse METTL3 gene also led to a severe block in the ability of embryonic stem cells to differentiate into neural and cardiac lineages.

The study suggests that m6A modifications on RNA make the transition between cell states possible by instructing the cells to physically degrade those RNAs marked by m6A in embryonic stem cells, to allow the cells to become another cell type. However, if the cells can no longer tag RNA for destruction, the cells lose the ability to change. This discovery sheds new light on gene regulation in stem cells.

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Loss of a chemical tag on RNA keeps embryonic stem cells in suspended animation

A decade ago, a dream team of researchers from Pittsburgh to South Korea claimed a medical invention that promised to reshape a culture war.

The scientists said they custom-designed stem cells from cloned human embryos. The scientific breakthrough was celebrated around the globe.

Then the bottom fell out.

A scandal erupted over fabricated data, and University of Pittsburgh biologist Gerald Schatten was forced to pull back the findings. Critics cast the 2004 discovery as a farce, a high-profile fraud that forced the journal Science into a rare retraction in January 2006.

Eight years later, the push to use stem cells as a medical treatment continues, but scholars balk at the suggestion that anyone is trying to make genetically identical individuals.

We're not here to clone human beings, for gosh sakes, said John Gearhart, a stem cell researcher and University of Pennsylvania professor in regenerative medicine. Instead, he said, scholars are working to manipulate stem cells to produce heart cells for cardiac patients, brain cells for neurological patients and other custom transplants that could match a person's genetic makeup.

Schatten's work continues at the Magee-Womens Research Institute at Pitt, where university officials cleared him of scientific misconduct, and he remains a vice chairman for research development. He focuses on educating and training physician-scientists and other scientists, a school spokeswoman wrote in a statement. She said Schatten was traveling and was unable to speak with the Tribune-Review.

Researchers have turned the onetime myth of developing stem cells into reality.

At the Oregon Health and Science University, researchers succeeded by blending unfertilized human eggs with body tissue to mold stem cells. Scholars say the cells could let doctors grow customized organs for transplants and other therapies.

The approach engineered by biologist Shoukhrat Mitalipov's research team last year in Portland is among two that scientists are using to forge laboratory-made stem cells the so-called master cells that can transform into other body parts without relying on donated human embryos. Federal law tightly controls the use of taxpayer money for embryonic research.

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Advances reshape stem cell research

Congestive Heart Failure Treatment Using Stem Cells

Congestive Heart Failureor CHF is a state wherein the heart does not have the capability to properly function as a pump. As a result of the cardiac-malfunction the oxygen pumped into the body is insufficient. Congestive heart failure is generally caused bysimultaneousillnesses. Illnesses that weaken the heart muscle,or diseases that trigger the heart muscles to become stiff, or illnesses that create an increase in oxygen demands for the body which consequently increases the supply for fresh oxygen by the body when the heart is incapable of producing oxygen-rich blood at the level needed.

Congestive heart failure and ishchemic heart disease can have an impact on numerous organs in the body. For instance, the injured areas of the heart directly affected by the sickness does not have the capability to produce enough blood for the kidneys, which then affect their capability to excrete water and salt (sodium). The distressed kidney function may cause the body to retain more fluids than needed by the body. The lungs also may develop pulmonary edema (PE).

PE occurs when the fluid in the lungs diminishes a persons ability to exercise normally. Fluid might likewise accumulate inside the liver, which directly affects it function by impairing the livers capability to create important proteins and also in helping clear the body of harmful elements and/ortoxins. The intestines might also turn out to be much less effective in being able to absorb the vitamins, nutrients and medicines a human needs. The fluids in the body can also accumulate quickly which could result to edema (severe swelling) of the ankles and feet.

An Ejection fraction of 20% would be considered a dangerous level and therefore indicates a highly advanced stage of heart failure. Healthy people usually have ejection fractions in between 52% and 68%.

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Stem Cell Treatment Congestive Heart Failure | CHF Stem ...

Researchers at the Cedars-Sinai Heart Institute have found that injections of cardiac stem cells might help reverse heart damage caused by Duchenne muscular dystrophy, potentially resulting in a longer life expectancy for patients with the chronic muscle-wasting disease.

The study results were presented today at a Breaking Basic Science presentation during the American Heart Association Scientific Sessions in Chicago. After laboratory mice with Duchenne muscular dystrophy were infused with cardiac stem cells, the mice showed steady, marked improvement in heart function and increased exercise capacity.

Duchenne muscular dystrophy, which affects 1 in 3,600 boys, is a neuromuscular disease caused by a shortage of a protein called dystrophin, leading to progressive muscle weakness. Most Duchenne patients lose their ability to walk by age 12. Average life expectancy is about 25. The cause of death often is heart failure because the dystrophin deficiency leads to cardiomyopathy, a weakness of the heart muscle that makes the heart less able to pump blood and maintain a regular rhythm.

"Most research into treatments for Duchenne muscular dystrophy patients has focused on the skeletal muscle aspects of the disease, but more often than not, the cause of death has been the heart failure that affects Duchenne patients," said Eduardo Marbn, MD, PhD, director of the Cedars-Sinai Heart Institute and study leader. "Currently, there is no treatment to address the loss of functional heart muscle in these patients."

During the past five years, the Cedars-Sinai Heart Institute has become a world leader in studying the use of stem cells to regenerate heart muscle in patients who have had heart attacks. In 2009, Marbn and his team completed the world's first procedure in which a patient's own heart tissue was used to grow specialized heart stem cells. The specialized cells were then injected back into the patient's heart in an effort to repair and regrow healthy muscle in a heart that had been injured by a heart attack. Results, published in The Lancet in 2012, showed that one year after receiving the experimental stem cell treatment, heart attack patients demonstrated a significant reduction in the size of the scar left on the heart muscle.

Earlier this year, Heart Institute researchers began a new study, called ALLSTAR, in which heart attack patients are being infused with allogeneic stem cells, which are derived from donor-quality hearts.

Recently, the Heart Institute opened the nation's first Regenerative Medicine Clinic, designed to match heart and vascular disease patients with appropriate stem cell clinical trials being conducted at Cedars-Sinai and other institutions.

"We are committed to thoroughly investigating whether stem cells could repair heart damage caused by Duchenne muscular dystrophy," Marbn said.

In the study, 78 lab mice were injected with cardiac stem cells. Over the next three months, the lab mice demonstrated improved pumping ability and exercise capacity in addition to a reduction in heart inflammation. The researchers also discovered that the stem cells work indirectly, by secreting tiny fat droplets called exosomes. The exosomes, when purified and administered alone, reproduce the key benefits of the cardiac stem cells.

Marbn said the procedure could be ready for testing in human clinical studies as soon as next year. The process to grow cardiac-derived stem cells was developed by Marbn when he was on the faculty of Johns Hopkins University. Johns Hopkins has filed for a patent on that intellectual property and has licensed it to Capricor, a company in which Cedars-Sinai and Marbn have a financial interest. Capricor is providing funds for the ALLSTAR clinical trial at Cedars-Sinai.

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Cardiac stem cell therapy may heal heart damage caused by Duchenne muscular dystrophy

Page 1

Section: Animal Cell Technology

Enhanced cardiac differentiation of mouse embryonic stem cells by use of the slow-turning, lateral vessel (STLV) bioreactor

Sasitorn Rungarunlert Nuttha Klincumhom Istvan Bock Csilla Nemes Mongkol Techakumphu Melinda K. Pirity Andras Dinnyes

S. Rungarunlert N. Klincumhom I. Bock Cs. Nemes MK. Pirity A. Dinnyes BioTalentum Ltd., Aulich Lajos u. 26. H-2100, Godollo, Hungary

S. Rungarunlert N. Klincumhom M. Techakumphu Department of Obstetrics, Gynaecology and Reproduction, Faculty of Veterinary Science, Chulalongkorn University, Bangkok, 10330 Thailand

I. Bock A. Dinnyes Molecular Animal Biotechnology Laboratory, Szent Istvan University, H-2100 Gdll, Hungary Corresponding author: andras.dinnyes@biotalentum.hu; Phone: +36/20/510-9632, Fax: +36/28/526-151

Emails: Sasitorn Rungarunlert nut_vs@yahoo.com Nuttha Klincumhom nuttha.klincumhom@biotalentum.hu Istvan Bock istvan.bock@biotalentum.hu Csilla Nemes csilla.nemes@biotalentum.hu Mongkol Techakumphu Mongkol.T@chula.ac.th Melinda K. Pirity melinda.pirity@biotalentum.hu

Page 2

Abstract Embryoid body (EB) formation is a common intermediate during in vitro differentiation of pluripotent stem cells into specialized cell types. We have optimized the slow-turning, lateral vessel (STLV) for large scale and homogenous EB production from mouse embryonic stem cells. The effects of inoculating different cell numbers, time of EB adherence to gelatin-coated dishes, and rotation speed for optimal EB formation and cardiac differentiation were investigated. Using 3x105 cells/ml, 10 rpm rotary speed and plating of EBs onto gelatin-coated surfaces three days after culture, were the best parameters for optimal size and EB quality on consequent cardiac differentiation. These optimized parameters enrich cardiac differentiation in ES cells when using the STLV method.

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Enhanced cardiac differentiation of mouse embryonic stem ...

The ASTIS trial (Autologous Stem cell Transplantation International Scleroderma), launched in 2001, evaluated the efficacy of autologous haematopoietic stem cell transplantation (HSCT) in patients with systemic sclerosis. A key point to safe use of HSCT is a correct evaluation of cardiac condition, and a close follow up for cardiac complications. In a letter to the Editor published in The Journal of the American Medical Association, entitled Cardiac Assessment Before Stem Cell Transplantation for Systemic Sclerosis, Dr. Burt at the Division of Immunotherapy, Northwestern University and colleagues highlight the importance of performing extensive cardiopulmonary screening in patients with severe forms of systemic sclerosis before administrating HSCT.

HSCT therapy first involves harvestingpatients stem cells. Since Scleroderma, also known as systemic sclerosis, is a chronic systemic autoimmune disease (autoimmune diseases are characterized by a hyper-reactive response of the immune response against substances, and tissues normally present in the body), thesecond step of the process involves destroyingpatients hyper-reactive immune system usingchemotherapy. Afterward, the patients harvested stem cells will be injected back into the body. The objective is to reset the patient immune system to normal standards and thus stop the process of scleroderma.

Systemic sclerosis is associated with many cardiac complications, including intrinsic myocardial ischemia and fibrosis, left ventricular diastolic dysfunction, and pericardial disease. While the criteria for exclusion inthe ASTIS trial was mean pulmonary artery pressure greater than 50 mm Hg by echo-cardiogram or cardiac catheterization, theauthors emphasize that this does not exclude pulmonary arterial hypertension. Despite the fact that2009 guidelines updatedtheir information and described pulmonary arterial hypertension as a mean pulmonary artery pressure higher than 25 mm Hg, the authors cautioned that a significant amount of attention has to be dedicated toassessing cardiac risks in these patients to prevent treatment-related mortality.

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New Insights For Cardiac Assessment Before Administering ...

Enliven: Journal of Anesthesiology and Critical Care Medicine ISSN : 2374 - 4448 I e001
Left Ventricular Assist Device and Resident Cardiac Stem Cells in Heart Failure: Human Heart #39;s Potential Matter.

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Newswise Hematopoietic stem cells (HSCs) give rise to all blood and immune cells throughout the life of vertebrate organisms, from zebrafish to humans. But details of their genesis remain elusive, hindering efforts to develop induced pluripotent stem cell (iPSC) replacements that might address a host of blood disorders.

In a paper published Nov. 20 in the journal Cell, researchers at the University of California, San Diego School of Medicine describe the surprising and crucial involvement of a pro-inflammatory signaling protein in the creation of HSCs during embryonic development, a finding that could help scientists to finally reproduce HSCs for therapeutic use.

The recent breakthrough of induced pluripotency has made the concept of patient-specific regenerative medicine a reality, said principal investigator David Traver, PhD, professor in the Department of Cellular and Molecular Medicine. The development of some mature cell lineages from iPSCs, such as cardiac and neural, has been reasonably straightforward, but not with HSCs. This is likely due, at least in part, to not fully understanding all of the factors used by the embryo to generate HSCs. We believe the discovery that pro-inflammatory cues are important in vivo will help us recapitulate instruction of HSC fate in vitro from iPSCs.

Traver and colleagues specifically looked at the role of a cytokine (a type of cell signaling protein) called tumor necrosis factor alpha or TNFa, which plays a pivotal role in regulating systemic inflammation and immunity. The work extended previous research by Spanish biologist Victoriano Mulero, who had reported that TNFa was important in the function of the embryonic vascular system and that in animal models where TNF function was absent, blood defects resulted.

The Cell papers first author Raquel Espin-Palazon, a postdoctoral researcher in Travers lab and a former colleague of Muleros, determined that TNFa was required for the emergence of hematopoietic stem cells during embryogenesis in zebrafish a common animal model.

Traver said the finding was completely unexpected because HSCs emerge relatively early in embryonic formation when the developing organism is considered to be largely sterile and devoid of infection.

Thus, there was no expectation that pro-inflammatory signaling would be active at this time or in the blood-forming regions, Traver said. Equally surprising, we found that a population of embryonic myeloid cells, which are transient cells produced before HSCs arise, are the producers of the TNFa needed to establish HSC fate. So it turns out that a small subset of myeloid cells that persist for only a few days in development are necessary to help generate the lineal precursors of the entire adult blood-forming system.

The newly discovered role of TNFa in HSC development mirrors a parallel discovery regarding interferon gamma (INFg), another cytokine and major mediator of pro-inflammatory signaling, highlighting multiple inputs for inflammatory signaling in HSC emergence. Traver said the crucial roles of TNFa and INFg in HSC emergence are likely similar in humans because of the highly conserved nature of HSC development across vertebrate evolution.

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Before There Will Be Blood

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Newswise LA JOLLAResearchers at the Salk Institute have healed injured hearts of living mice by reactivating long dormant molecular machinery found in the animals cells, a finding that could help pave the way to new therapies for heart disorders in humans.

The new results, published November 6 in the journal Cell Stem Cell, suggest that although adult mammals dont normally regenerate damaged tissue, they may retain a latent ability as a holdover from development like their distant ancestors on the evolutionary tree. When the Salk researchers blocked four molecules thought to suppress these programs for regenerating organs, they saw a drastic improvement in heart regeneration and healing in the mice.

The findings provide proof-of-concept for a new type of clinical treatment in the fight against heart disease, which kills about 600,000 people each year in the United Statesmore than AIDS and all cancer types combined, according to the U.S. Centers for Disease Control and Prevention.

Organ regeneration is a fascinating phenomenon that seemingly recapitulates the processes observed during development. However, despite our current understanding of how embryogenesis and development proceeds, the mechanisms preventing regeneration in adult mammals have remained elusive, says the studys senior author Juan Carlos Izpisua Belmonte, a professor in the Gene Expression Laboratory at Salk.

Within the genomes of every cell in our bodies, we have what information we need to generate an organ. Izpisua Belmontes group has for many years focused on elucidating the key molecules involved in embryonic development as well as those potentially underlying healing responses in regenerative organisms such as the zebrafish.

Indeed, back in 2003, Izpisua Belmontes laboratory first identified the signals preceding zebrafish heart regeneration. And in a 2010 Nature paper, the researchers described how regeneration occurred in the zebrafish. Rather than stem cells invading injured heart tissue, the cardiac cells themselves were reverting to a precursor-like state (a process called dedifferentiation), which, in turn, allowed them to proliferate in tissue.

Although in theory it might have seemed like the next logical step to ask whether mammals had evolutionarily conserved any of the right molecular players for this kind of regenerative reprogramming, in practice it was a scientific risk, recalls Ignacio Sancho-Martinez, a postdoctoral researcher in Izpisua Belmontes lab.

When you speak about these things, the first thing that comes to peoples minds is that youre crazy, he says. Its a strange sounding idea, since we associate regeneration with salamanders and fish, but not mammals.

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Salk Scientists Discover a Key to Mending Broken Hearts

Korean stem cells regenerate coach Hiddinks worn-out knee cartilage NOVEMBER 06, 2014 03:02 Korean stem cells regenerate coach Hiddinks worn-out knee cartilage . NOVEMBER 06, 2014 03:02. . Guus Hiddink, the legendary soccer coach who led the Korean national team to the semifinals at the 2002 World Cup Korea-Japan, has been reborn as a figure symbolizing excellence of Korean stem cell treatment. Hiddink, who was suffering from severe arthritis, had his knee cartilage almost completely worn out. Rejecting recommendations to take artificial joint surgery by hospitals in the U.S. and Germany, Hiddink chose to take stem cell treatment in Korea. He started treatment in January this year, and was declared as having fully recovered from the illness 10 months later.

The treatment that gave coach Hiddink a second life is Cartistem, which is made from cord blood stem cells. Cartistem, which was developed by Medipost, a bio venture firm, received product licensure as treatment for knee cartilage that has been damaged due to degenerative conditions and repeated injuries from the Korea Food and Drug Ministry in January 2012. It was the first to receive licensure among stem cell treatments in the world. The treatment is undergoing clinical trials in the U.S. to acquire licensure from the Food and Drug Administration. Despite a highly costly price that is not covered by the national health insurance system, the treatment has been used in more than 1,600 patients thus far.

Stem cell treatments developed in Korea include Hearticellgram, a treatment for cardiac infarction, and Cupistem, a treatment for fistulous opening (a disease that causes holes in tissue between rectums and anus), as well as Cartistem. Hearticellgram and Cupistem use stem cells from tissues of the patients own body. Umbilical cord stem cells and autologous stem cells do not derive from human eggs and hence are free from controversy of bioethics. They are results of steadfast research and investment in stem cells by Korean biotech firms.

In tune with the aging society and a growing number of people with chronic diseases, the bio industry is considered a cash cow industry of the future. Notably, the stem cell sector that treats abnormal bodily organs is the most promising field. Not only bio powerhouses such as the U.S., Japan and the European Union but also China have jumped into the industry. As research on induced pluripotent stem cells (iPS) won the Nobel Prize in physiology and medicine recently, countries worldwide are having mounting interest in the field. The Korean government should create an environment to enable Korean biotech firms to take a leap forward in the global market, by providing generous support for investment and putting in place prompt and predictable licensure and approval process.

The treatment that gave coach Hiddink a second life is Cartistem, which is made from cord blood stem cells. Cartistem, which was developed by Medipost, a bio venture firm, received product licensure as treatment for knee cartilage that has been damaged due to degenerative conditions and repeated injuries from the Korea Food and Drug Ministry in January 2012. It was the first to receive licensure among stem cell treatments in the world. The treatment is undergoing clinical trials in the U.S. to acquire licensure from the Food and Drug Administration. Despite a highly costly price that is not covered by the national health insurance system, the treatment has been used in more than 1,600 patients thus far.

Stem cell treatments developed in Korea include Hearticellgram, a treatment for cardiac infarction, and Cupistem, a treatment for fistulous opening (a disease that causes holes in tissue between rectums and anus), as well as Cartistem. Hearticellgram and Cupistem use stem cells from tissues of the patients own body. Umbilical cord stem cells and autologous stem cells do not derive from human eggs and hence are free from controversy of bioethics. They are results of steadfast research and investment in stem cells by Korean biotech firms.

In tune with the aging society and a growing number of people with chronic diseases, the bio industry is considered a cash cow industry of the future. Notably, the stem cell sector that treats abnormal bodily organs is the most promising field. Not only bio powerhouses such as the U.S., Japan and the European Union but also China have jumped into the industry. As research on induced pluripotent stem cells (iPS) won the Nobel Prize in physiology and medicine recently, countries worldwide are having mounting interest in the field. The Korean government should create an environment to enable Korean biotech firms to take a leap forward in the global market, by providing generous support for investment and putting in place prompt and predictable licensure and approval process.

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Heart Disease

With respect to the heart, stem cells have the ability to not only home into the damaged areas but also to initiate a cascade of biological events which both culminate in healing of the heart muscle. For example, animal studies have demonstrated that stem cell therapy will cause new muscle cells to be formed through stimulation of dormant stem cells that are already inside the heart muscle. In these studies, the administered stem cell also transformed into new heart muscle cells.

At Stem Cell Institute, our stem cell treatment protocol for heart failure involves administration of mesenchymal stem cells harvested from human umbilical cord tissue.

The adult stem cells used to treat heart failure at the Stem Cell Institute come from human umbilical cord tissue (allogeneic mesenchymal). These stem cells are expanded at Medistem Panamas state-of-the-art laboratory.

The mesenchymal stem cells we use are recovered from donated umbilical cords following normal, healthy births. Each mother has her medical history screened and is tested for infectious diseases. Proper consent is received from each family prior to donation.

All umbilical cord-derived stem cells are screened for infectious diseases to International Blood Bank Standards before they are cleared for use in patients.

Approximately 1 in 10 donated umbilical cords pass our rigorous screening process.

Through retrospective analysis of our cases, weve identified proteins and genes that allow us to screen several hundred umbilical cord donations to find the ones that we know are most effective. We only use these cells and we call them golden cells.

We go through a very high throughput screening process to find cells that we know have the best anti-inflammatory activity, the best immune modulating capacity, and the best ability to stimulate regeneration.

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Stem Cell Therapy || Heart Failure || Stem Cell Treatment ...

Using stem cells to repair damaged heart muscle in patients with chronic heart failure is safe and beneficial, whether the cells come from patients own bone marrow or from a healthy volunteer, according to a preliminary study by researchers at the Johns Hopkins University School of Medicine and the University of Miami Miller School of Medicine. In a study of 31 patients, the therapy reduced heart muscle scar tissue and improved their quality of life. For many patients in the study, the therapy also enhanced their hearts pumping ability.

An article describing the study, "Comparison of Allogeneic vs. Autologous Bone Marrow-Derived Mesenchymal Stem Cells Delivered by Transendocardial Injection in Patients with Ischemic Cardiomyopathy," is published in the Journal of the American Medical Association (JAMA) on Nov. 6. Results are scheduled to be presented that same day at the American Heart Association Scientific Sessions in Los Angeles.

The researchers say this is the first study to compare autologous stem cells, which are derived from the patients' own bone marrow, to allogeneic stem cells, taken from the marrow of healthy volunteers, in patients with heart disease. The advantage of using allogeneic cells is the potential for developing an off-the-shelf therapy that could be delivered in a more timely way, rather than requiring a bone marrow biopsy from heart failure patients and waiting for the cells to be processed. Also, stem cells from the patients themselves may not be as robust.

All of the study patients had longstanding ischemic cardiomyopathy - chronic heart failure caused by a prior heart attack that blocked blood flow to the heart and damaged heart muscle. The condition affects about 70 percent of the six million people in the United States who suffer from heart failure.

"The primary focus of our study was to determine the safety of the therapy, specifically within 30 days of the treatment," says Gary Gerstenblith, M.D., professor of medicine at the Johns Hopkins University School of Medicine and co-author of the study. "We found that the treatment was safe and also that many of the patients experienced significant improvement, whether they had received the allogeneic or the autologous stem cells," he says.

Patients in the study were randomly selected to have either their own stem cells or donated cells injected directly into their heart muscle. They were monitored for treatment-associated complications, such as death, heart attack, stroke, hospitalization for worsening heart failure and dangerous heart arrhythmias. All of the patients were still alive 12 months after the treatment.

The researchers were especially interested in learning whether the patients immune system would recognize the allogeneic (donated) stem cells as foreign and mount an immune response to reject the cells. Only 3.7 percent of the patients receiving the donated cells had such a response. The cells were injected into the heart muscle just once during a cardiac catheterization procedure.

The particular cells used for the therapy, mesenchymal stem cells, are less likely to stimulate an immune response and rejection than most other stem cells. They have the ability to repair muscular tissues and to reduce inflammation.

Patients in the allogeneic and autologous groups were further divided according to the doses of the stem cells they received. Three different doses were tested: 20 million cells, 100 million cells and 200 million cells.

"We generally think the more the better, but in fact, the lowest dose of 20 million cells appeared to be the most effective at improving the hearts pumping ability as well as reducing the extent of scar tissue," says Peter Johnston, M.D., assistant professor of medicine at Johns Hopkins and co-author of the study.

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Stem Cell Therapy Safely Repairs Damaged Heart Muscle in ...

2 hours ago A cross section through a histotripsy lesion created in bovine liver tissue with the liquified cellular contents washed out revealing the remaining extracellular matrix. The scale bar represents 5mm. Credit: T.Khoklova/UW

Researchers at the University of Washington have developed a way to use sound to create cellular scaffolding for tissue engineering, a unique approach that could help overcome one of regenerative medicine's significant obstacles. The researchers will present their technique at the 168th meeting of the Acoustical Society of America (ASA), held October 27-31, 2014, at the Indianapolis Marriott Downtown Hotel.

The development of the new technique started with somewhat of a serendipitous discovery. The University of Washington team had been studying boiling histotripsy - a technique that uses millisecond-long bursts of high-intensity ultrasound waves to break apart tissue - as a method to eliminate cancerous tumors by liquefying them with ultrasound waves. After the sound waves destroy the tumors, the body should eliminate them as cellular waste. When the researchers examined these 'decellularized' tissues, however, they were surprised by what the boiling left intact.

"In some of our experiments, we discovered that some of the stromal tissue and vasculature was being left behind," said Yak-Nam Wang, a senior engineer at the University of Washington's Applied Physics Laboratory. "So we had the idea about using this to decellularize tissues for tissue engineering and regenerative medicine."

The structure that remains after decellularizing tissues is known as the extracellular matrix, a fibrous network that provides a scaffold for cells to grow upon. Most other methods for decellularizing tissues and organs involve chemical and enzymatic treatments that can cause damage to the tissues and fibers and takes multiple days. Histrostipsy, on the other hand, offers the possibility of fast decellularization of tissue with minimal damage to the matrix.

"In tissue engineering, one of the holy grails is to develop biomimetic structures so that you can replace tissues with native tissue," Wang said. Stripping away cells from already developed tissue could provide a good candidate for these structures, since the extracellular matrix already acts as the cellular framework for tissue systems, Wang said.

Due to its bare composition, the matrix also induces only a relatively weak immune response from the host. The matrix could then theoretically be fed with stem cells or cells from the same person to effectively re-grow an organ.

"The other thought is that maybe you could just implant the extracellular matrix and then the body itself would self-seed the tissues, if it's just a small patch of tissue that you're replacing," Wang said. "You won't have any immune issues, and because you have this biomimetic scaffold that's closer to the native tissue, healing would be better, and the body would recognize it as normal tissue."

Wang is currently investigating decellularization of kidney and liver tissue from large animals. Future work involves increasing the size of the decellularized tissues and assessing their in-vivo regenerative efficacy.

Explore further: The future of regenerative medicine

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High-intensity sound waves may aid regenerative medicine

12 hours ago Fruit fly larva are used to study stem cells key features. Credit: Wikipedia

The study, performed with fruit flies, describes a gene that determines whether a specialized cell conserves the capacity to become a stem cell again. Unveiling the genetic traits that favour the retention of stem cell properties is crucial for regenerative medicine. Published in Cell Reports, the article is the fruit of collaboration between researchers at IRB Barcelona and CSIC.

One kind of stem cell, those referred to as 'facultative', form parttogether with other cellsof tissues and organs. There is apparently nothing that differentiates these cells from the others. However, they have a very special characteristic, namely they retain the capacity to become stem cells again. This phenomenon is something that happens in the liver, an organ that hosts cells that stimulate tissue growth, thus allowing the regeneration of the organ in the case of a transplant. Knowledge of the underlying mechanism that allows these cells to retain this capacity is a key issue in regenerative medicine.

Headed by Jordi Casanova, research professor at the Instituto de Biologa Molecular de Barcelona (IBMB) of the CSIC and at IRB Barcelona, and by Xavier Franch-Marro, CSIC tenured scientist at the Instituto de Biologa Evolutiva (CSIC-UPF), a study published in the journal Cell Reports reveals a mechanism that could explain this capacity. Working with larval tracheal cells of Drosophila melanogaster, these authors report that the key feature of these cells is that they have not entered the endocycle, a modified cell cycle through which a cell reproduces its genome several times without dividing.

"The function of endocycle in living organisms is not fully understood," comments Xavier Franch-Marro. "One of the theories is that endoreplication contributes to enlarge the cell and confers the production of high amounts of protein". This is the case of almost all larval cells of Drosophila.

The scientists have observed that the cells that enter the endocycle lose the capacity to reactivate as stem cells. "The endocycle is linked to an irreversible change of gene expression in the cell," explains Jordi Casanova, "We have seen that inhibition of endocycle entry confers the cells the capacity to reactivate as stem cells".

Cell entry into the endocycle is associated with the expression of the Fzr gene. The researchers have found that inhibition of this gene prevents this entry, which in turn leads to the conversion of the cell into an adult progenitor that retains the capacity to reactivate as a stem cell. Therefore, this gene acts as a switch that determines whether a cell will enter mitosis (the normal division of a cell) or the endocycle, the latter triggering a totally different genetic program with a distinct outcome regarding the capacity of a cell to reactivate as a stem cell.

Explore further: Autophagy helps fast track stem cell activation

More information: Specification of Differentiated Adult Progenitors via Inhibition of Endocycle Entry in the Drosophila Trachea, Nareg J.-V. Djabrayan, Josefa Cruz, Cristina de Miguel, Xavier Franch-Marro, Jordi Casanova, Cell Reports (2014) DOI: dx.doi.org/10.1016/j.celrep.2014.09.043

In spite of considerable research efforts around the world, we still do not know the determining factors that confer stem cells their main particular features: capacity to self-renew and to divide and proliferate. The scientist ...

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A mechanism that allows a differentiated cell to reactivate as a stem cell revealed

Glossary

Below is a glossary of terms related to stem cell research and clinical trials at the Stem Cell Center. For questions about any of these terms, please call the center at 832-355-9405.

Acute myocardial infarction (AMI)The medical term for a "heart attack."Acute myocardial infarction results from a blockage in one or more of the blood vessels leading to the heart. Damage to the heart muscle results, due to the lack of blood flow.

Adult stem cellAn undifferentiated cell found among differentiated cells in a tissue or organ.Thestemcellcan renew itself and change to yield all the specialized cell types of the tissue or organ.

AkinesiaA lack of myocardial wall motion.

AllogeneicA graft or tissue from someone other than the patient such as a donor or other third-party source.

Angina or angina pectorisChest pain that occurs when diseased blood vessels restrict blood flow to the heart.

AngiogenesisA new blood vessel growth.

AngiographyAn x-raytechniqueinwhichdye is injected into the chambers of your heart or the arteries that lead to your heart (the coronary arteries). The test lets doctors measure the blood flow and blood pressure in the heart chambers and see if the coronary arteries are blocked.

AngioplastyA nonsurgical technique for treating diseased arteries by temporarily inflating a tiny balloon inside an artery.

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Stem Cell Education Center - Texas Heart Institute at St ...

KYOTO A team of Japanese researchers has successfully created cardiac tissue sheets generated from human induced pluripotent stem cells, according to a study in the online British journal Scientific Reports.

The team said it is the first time iPS cells have produced an integrated cardiac tissue sheet that includes vascular cells as well as cardiac muscle cells and is close to real tissue in structure.

The stem cell team, led by Kyoto University professor Jun Yamashita, hopes the achievement will contribute to the development of new treatments for heart disease, because it has already found evidence that transplanting the sheets into mice with failing hearts improves in their cardiac condition.

The team used a protein called VEGF, which is related to the growth of blood vessels, as a replacement for the Dkk1 protein previously used to create cardiac muscle sheets from iPS cells.

As a result, iPS cells were simultaneously differentiated to become cardiac muscle cells, vascular mural cells, and the endothelial cells that line the interior surface of blood vessels. The cells were cultivated into a sheet about 1 cm in diameter.

Three-layer cardiac tissue sheets were then transplanted into nine mice with dead or damaged heart muscle caused by heart attacks. In four of the mice, blood vessels formed in the area where the sheets were transplanted, leading to improved cardiac function.

The weak point of iPS cells is that there is a risk of developing cancer, but the cells did not become cancerous within two months of transplantation, the team said.

About 72 percent of the cardiac tissue sheet was made of cardiac muscle cells, while 26 percent of it consisted of endothelial cells as well as vascular mural cells. But the sheet contained a small portion of cells that had not changed, leading the team to call attention to the possibility that a cancerous change might take place over the longer term.

Yamashita said in the study that he believed the new form of cardiac sheets attached well.

Oxygen and nourishment were able to reach cardiac muscle through blood because there were blood vessels, he said.

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Japanese team develops cardiac tissue sheet from human iPS cells

KYOTO A team of Japanese researchers has successfully created cardiac tissue sheets generated from human induced pluripotent stem cells, according to a study in the online British journal Scientific Reports.

The team said it is the first time iPS cells have produced an integrated cardiac tissue sheet that includes vascular cells as well as cardiac muscle cells and is close to real tissue in structure.

The stem cell team, led by Kyoto University professor Jun Yamashita, hopes the achievement will contribute to the development of new treatments for heart disease, because it has already found evidence that transplanting the sheets into mice with failing hearts improves in their cardiac condition.

The team used a protein called VEGF, which is related to the growth of blood vessels, as a replacement for the Dkk1 protein previously used to create cardiac muscle sheets from iPS cells.

As a result, iPS cells were simultaneously differentiated to become cardiac muscle cells, vascular mural cells, and the endothelial cells that line the interior surface of blood vessels. The cells were cultivated into a sheet about 1 cm in diameter.

Three-layer cardiac tissue sheets were then transplanted into nine mice with dead or damaged heart muscle caused by heart attacks. In four of the mice, blood vessels formed in the area where the sheets were transplanted, leading to improved cardiac function.

The weak point of iPS cells is that there is a risk of developing cancer, but the cells did not become cancerous within two months of transplantation, the team said.

About 72 percent of the cardiac tissue sheet was made of cardiac muscle cells, while 26 percent of it consisted of endothelial cells as well as vascular mural cells. But the sheet contained a small portion of cells that had not changed, leading the team to call attention to the possibility that a cancerous change might take place over the longer term.

Yamashita said in the study that he believed the new form of cardiac sheets attached well.

Oxygen and nourishment were able to reach cardiac muscle through blood because there were blood vessels, he said.

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