San Diego, CA (PRWEB) May 08, 2014

Xcelthera Inc, a major innovator in the stem cell research market and one of the first U.S. companies formed for clinical applications of human embryonic stem cell (human ES cell) therapeutic utility for unmet medical needs, and its joint research partner San Diego Regenerative Medicine Institute announced today that the U.S. Patent and Trademark Office (USPTO) has granted Patent No. 8,716,017 entitled, Technologies, Methods, and Products of Small Molecule-Directed Tissue and Organ Regeneration from Human Pluripotent Stem Cells. This newly-issued patent is the first among a portfolio of intellectual property of Xcelthera Inc covering PluriXcel human stem cell technology platform for large-scale production of high quality clinical-grade pluripotent human ES cell lines and their functional human neuronal and heart muscle cell therapy products.

Neurodegenerative and heart diseases are major health problems and cost the worldwide healthcare system more than $500 billion annually. The limited capacity of these two cell systems -- neurons and cardiomyocytes -- for self-repair makes them suitable for stem cell-based neuronal and heart therapies. Nevertheless, to date, the existing markets lack a clinically-suitable human neuronal cell source or cardiomyocyte source with adequate regenerative potential, which has been the major setback in developing safe and effective cell-based therapies for neurodegenerative and heart diseases. Xcelthera proprietary PluriXcel technology allows efficient derivation of clinical-grade human ES cell lines and direct conversion of such pluripotent human ES cells by small molecule induction into a large commercial scale of high quality human neuronal or heart muscle cells, which constitutes clinically representative progress in both human neuronal and cardiac therapeutic products for treating neurodegenerative and heart diseases.

PluriXcel technology of Xcelthera Inc is milestone advancement in stem cell research, offering currently the only available human cell therapy products with the pharmacological capacity to regenerate human neurons and contractile heart muscles that allow restitution of function of the central nervous system (CNS) and heart in the clinic. Through technology license agreement with San Diego Regenerative Medicine Institute, Xcelthera Inc has become the first in the world to hold the proprietary breakthrough technology for large-scale production of high quality clinical-grade pluripotent human ES cell lines and their functional human neuronal and heart cell therapy products for commercial and therapeutic uses.

As neurodegenerative and heart diseases incur exorbitant costs on the healthcare system worldwide, there is a strong focus on providing newer and more efficient solutions for these therapeutic needs. Millions of people are pinning their hopes on stem cell research. PluriXcel technology platform of Xcelthera Inc is incomparable, providing life scientists and clinicians with novel and effective resources to address major health concerns. Such breakthrough stem cell technology has presented human ES cell therapy derivatives as a powerful pharmacologic agent of cellular entity for a wide range of incurable or hitherto untreatable neurodegenerative and heart diseases. Introduction of medical innovations and new business opportunities based on PluriXcel technology will shape the future of medicine by providing pluripotent human ES cell-based technology for human tissue and function restoration, and bringing new therapeutics into the market.

About Xcelthera Inc.

Xcelthera INC (http://www.xcelthera.com) is a new biopharmaceutical company moving towards clinical development stage of novel and most advanced stem cell therapy for a wide range of neurological and cardiovascular diseases with leading technology and ground-breaking medical innovation in cell-based regenerative medicine. The Company was recently incorporated in the state of California to commercialize the technologies and products developed, in part, with supports by government grants to the founder, by San Diego Regenerative Medicine Institute (SDRMI), an non-profit 501C3 tax-exempt status independent biomedical research institute that is interested in licensing its PATENT RIGHTS in a manner that will benefit the public by facilitating the distribution of useful products and the utilization of new processes, but is without capacity to commercially develop, manufacture, and distribute any such products or processes. Xcelthera is a major innovator in the stem cell research market and one of the first companies formed for clinical applications of human embryonic stem cell (human ES cell) therapeutic utility for unmet medical needs. The Company is the first to hold the proprietary breakthrough technology for large-scale production of high quality clinical-grade pluripotent human ES cell lines and their functional human neuronal and heart muscle cell therapy products for commercial and therapeutic uses. The Company owns or has exclusive rights in a portfolio of intellectual property or license rights related to its novel PluriXcel human stem cell technology platforms and Xcel prototypes of human stem cell therapy products. The inception of Xcelthera is driven by the urgent need for clinical translation of human ES cell research discoveries and innovations to address unmet medical challenges in major health problems. Xcelthera breakthrough developments in human ES cell research dramatically increase the overall turnover of investments in biomedical sciences to optimal treatment options for a wide range of human diseases. The overall strategy of the Company is to use cutting-edge human stem cell technology to develop clinical-grade functional human neural and cardiac cell therapy products from pluripotent human ES cells as cellular medicine or cellular drugs to provide the next generation of cell-based therapeutic solutions for unmet medical needs in world-wide major health problems. The Company is currently offering Series A Convertible Preferred Stock to accredited investors through equity crowdfunding to raise fund for its pre-IPO business operation and filing confidential IPO as an emerging growth company according to the JOBS Act to create a public market for its common stock and to facilitate its future access to the public equity market and growth of the Company.

Visit Xcelthera Inc. at http://www.xcelthera.com.

For more information or investment opportunity about Xcelthera series A round, please contact: Xuejun H Parsons, PhD, Chief Executive Officer Xcelthera Inc. http://www.xcelthera.com 888-706-5396 or 858-243-2046 investors(at)xcelthera.com or parsons(at)xcelthera.com

About San Diego Regenerative Medicine Institute

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Xcelthera Inc Secures First U.S. Patent for Large-Scale Production of High Quality Human Embryonic Stem Cells and ...

The entire heart muscle in young children may hold untapped potential for regeneration, new research suggests.

For decades, scientists believed that after a child's first few days of life, cardiac muscle cells did not divide. Instead, the assumption was that the heart could only grow by having the muscle cells become larger.

Cracks were already appearing in that theory. But new findings in mice, scheduled for publication in Cell, provide a dramatic counterexample -- with implications for the treatment of congenital heart disorders in humans.

Researchers at Emory University School of Medicine have discovered that in young mice 15 days old, cardiac muscle cells undergo a precisely timed spurt of cell division lasting around a day. The total number of cardiac muscle cells increases by about 40 percent during this time, when the rest of the body is growing rapidly. [A 15-day-old mouse is roughly comparable to a child in kindergarten; puberty occurs at day 30-35 in mice.]

The burst of cell division is driven by a surge of thyroid hormone, the researchers found. This suggests that thyroid hormone could aid in the treatment of children with congenital heart defects. In fact, doctors have already tested thyroid hormone supplementation in this setting on a small scale.

The findings also have broader hints for researchers developing therapies for the heart. Activating the regenerative potential of the muscle cells themselves is a strategy that is an alternative to focusing on the heart's stem cells, says senior author Ahsan Husain, PhD, professor of medicine (cardiology) at Emory University School of Medicine.

"It's not as dramatic as in fish or amphibians, but we can show that in young mice, the entire heart is capable of regeneration, not just the stem cells," he says.

The Emory researchers collaborated with Robert Graham, MD, executive director of the Victor Change Cardiac Research Institute in Australia. Co-first authors of the paper are Nawazish Naqvi, PhD, assistant professor of medicine at Emory and Ming Li, PhD, at Victor Chang.

The researchers tested how much mice, at the age of day 15, can recover from the blockage of a coronary artery. Consistent with previous research, newborn (day 2) mice showed a high level of repair after such an injury, but at day 21, they did not. The day 15 mice recovered more than the day 21 mice, indicating that some repair is still possible at day 15.

The discovery came unexpectedly during the course of Naqvi and Husain's investigation of the role of the gene c-kit -- an important marker for stem cells -- in cardiac muscle growth. Adult mice with a disabled c-kit gene in the heart have more cardiac muscle cells. The researchers wanted to know: when does this difference appear?

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Spurt of heart muscle cell division seen in mice well after birth: Implications for repair of congenital heart defects

Cleveland, Ohio (PRWEB) May 08, 2014

ChanTest announces a new Heart-in-a-Dish in vitro cardiac safety assessment tool to support this critical component of the drug development process for biopharmaceutical companies.

ChanTest has developed this breakthrough in safety assessment by taking advantage of the pairing of two recent technologies stem cell-derived human cardiomyocytes, and Multi-Electrode Array (MEA) recording -- to open a new avenue toward simplifying the cardiac risk assessment process.

Adult human cells can be reprogrammed to simulate induced pluripotent stem cells (iPSC). These iPSCs can be differentiated into heart cells (myocytes) and can be grown in culture dishes to form a spontaneously beating layer of myocytes that display the electrical properties similar to an intact human heart.

With the application of multiple electrodes, this Heart-in-a-Dish will generate a signal that closely resembles an EKG which has been recorded in the doctors office. Now imagine a miniature version of this system. By miniaturizing the recording system in the form of multi-well MEA assay plates, this enables simultaneous, parallel measurements from this Heart-in-a-Dish in order to detect potentially dangerous arrhythmias before human clinical trials.

This powerful system rapidly tests the safety of multiple compounds, at multiple concentrations and time points, explained Chris Mathes, Ph.D., Chief Commercial Officer at ChanTest. And the new offering keeps ChanTest on the cutting edge of providing services tuned to the current regulatory environment for drug discovery.

ChanTest has developed this Heart-in-a-Dish multi-well MEA assay that enables the recording of EKG-like signals to identify side effects from drugs. This new tool can allow biopharmaceutical companies and other drug discovery teams to screen compounds in an informative and robust manner, prior to implementing in vivo animal or human studies.

About ChanTest The Ion Channel Expert ChanTests mission is to serve the drug discovery and development needs of customers worldwide. Since its start in 1998, the Contract Research Organization has tested compounds for more than 300 global pharmaceutical and biotechnology companies. ChanTest also partners with these companies to accelerate the drug development process for the release of better, safer drugs. ChanTest offers integrated ion channel and GPCR services (GLP and non-GLP) and reagents. The companys library of validated ion channel cell lines, and nonclinical cardiac risk assessment service portfolio, is the most comprehensive commercial library available today.

Because of ChanTests influential role in the cardiac safety field, along with the companys uncompromising commitment to quality, an independent survey has named ChanTest the most trusted and most used fee-for-service provider since 2006. ChanTest is based in Cleveland, Ohio.

Visit http://www.chantest.com to learn more about ChanTest.

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ChanTest Launches new Heart-in-a-Dish Cardiac Safety Assessment Tool

Karen Weintraub, Special for USA TODAY 2:49 p.m. EDT April 30, 2014

A study in "Nature" said researchers showed that they could repair damaged hearts by injecting versatile stem cells into macaque monkeys, like this one in Thailand.(Photo: Apichart Weerawong, AP)

Two new studies out today show both the incredible promise of stem cell research and its current limitations.

In one, published in the journal Nature, researchers showed that they could repair damaged hearts by injecting these versatile stem cells into macaque monkeys. Heart disease is the leading cause of death, and if the same process can work in people, it could benefit hundreds of thousands a year.

In the other study, published in Science Translational Medicine, five men were able to regrow leg muscles destroyed by accidents or military service. The researchers, from the University of Pittsburgh, inserted into the men's muscles a "scaffold" of muscle tissue from a pig. Through aggressive physical therapy right after the surgery, the men's own stem cells were encouraged to populate the scaffold and substantially rebuild their leg muscles.

Nothing had been able to help these men before, including multiple surgeries and years of physical therapy, said Stephen Badylak, the study's senior author.

"Frankly, most of these patients have been through hell," he said at a Tuesday news conference.

David Scadden, a physician and co-director of the Harvard Stem Cell Institute, said he was impressed with the rigor and promise of both studies.

It's long been a goal of stem cell research to figure out how to help the body regrow damaged tissue, he said, and both studies mark a significant step toward that goal.

Both studies also showed that stem cells respond to cells around them, he said, with the heart cells learning to beat in sync with the monkey cells and the muscle cells learning to go where they were needed. "Once the cells get to a certain point, it appears they can then follow the lead of their neighbors," he said.

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Stem cells used to repair animal hearts and human muscle

Chaiwat Subprasom/Reuters/Corbis

Many companies around the world offer stem-cell treatments to patients with heart disease.

An analysis of clinical studies that use adult stem cells to treat heart disease has raised questions about the value of a therapy that many consider inappropriately hyped.

Early-phase clinical trials have reported that adult stem cells are effective in treating heart attack and heart failure, and many companies are moving quickly to tap into this potentially lucrative market. But a comprehensive study that looked at discrepancies in trials investigating treatments that use patients own stem cells, published this week in the journal BMJ (ref. 1), finds that only trials containing flaws, such as design or reporting errors, showed positive outcomes. Error-free trials showed no benefit at all.

The publication comes as two major clinical trials designed to conclusively test the treatments efficacy are recruiting thousands of patients.

The BMJ paper is concerning because the therapeutic approach is already being commercialized, argues stem-cell researcher Paolo Bianco at the Sapienza University of Rome. Premature trials can create unrealistic hopes for patients, and divert resources from the necessary basic studies we need to design more appropriate treatments.

Therapies that use adult stem cells typically involve collecting mesenchymal stem cells from bone marrow taken from the patients hip bone. The cells are then injected back into the patient, to help repair damaged tissue. Original claims that they differentiated into replacement cells have been rejected2, and many clinicians now believe that the cells act by releasing molecules that cause inflammation, with an attendant growth of oxygen-delivering small blood vessels, in the damaged tissue.

The approach has spawned international commercialization of various forms of the therapy, with companies offering treatments for disorders ranging from Parkinsons disease to heart failure. But the effectiveness of such therapies remains unproven.

I have a lot of hope for regenerative medicine, but our results make me fearful.

The BMJ study, led by cardiologist Darrel Francis at Imperial College London, examined 133 reports of 49 randomized clinical trials published up to April last year, involving the treatment of patients who had had a heart attack or heart failure. It included all accessible randomized studies, and looked for discrepancies in design, methodology and reporting of results.

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Doubts over heart stem-cell therapy : Nature News & Comment

Thanks to a study with monkeys, the idea of using stem cells to accomplish heart repair on a clinical scale seems more realistic. Stem cells have shown promise in small-animal models, that is, in mice and rats. Still, it was unclear whether human embryonic-stem-cell-derived cardiomyocytes (hESC-CMs) could be produced in adequate numbers, and cryopreserved with sufficient viability, to even approach human application.

In a step up from small-animal models, scientists at the University of Washington used a monkey model of myocardial infarction to test how well hESC-CMs could replace damaged tissue with new heart cells and restore failing hearts to normal function. The scientists injected 1 billion heart muscle cells derived from hESC-CMs into the infarcted muscle of pigtail macaques (Macaca nemestrina). This was 10 times more of these types of cells than researchers have ever been able to generate before.

The researchers found that over subsequent weeks, the stem-cell derived heart muscle cells infiltrated into the damaged heart tissue, then matured, assembled into muscle fibers, and began to beat in synchrony with the macaque heart cells. After three months, the cells appeared to have fully integrated into the macaque heart muscle.

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 Charles Murry, M.D., Ph.D., professor of pathology and bioengineering, who led the research team that conducted the experiment.

The research team published its results April 30 in Nature, in an article entitled Human embryonic-stem-cell-derived cardiomyocytes regenerate non-human primate hearts. In this article, the authors indicated that their work demonstrated that hESCs can be grown, differentiated into cardiomyocytes, and cryopreserved at a scale sufficient to treat a large-animal model of myocardial infarction.

With further refinements in manufacturing, the scale up to trials in human patients seems feasible, the researchers wrote. Large-animal models are important forerunners to human trials, because they impart real-world rigor to issues such as cell production, delivery, and end-point analyses, while permitting mechanistic studies not possible in patients.

On average, the transplanted stem cells regenerated 40% of the damaged heart tissue. Ultrasound studies of the macaques hearts showed that the ejection fraction, an indication of the hearts ability to pump blood, improved in some of the treated animals but not all. The researchers also found that arteries and veins from the macaques hearts grew into the new heart tissue, the first time it has been shown that blood vessels from a host animal will grow into and nurture a large stem-cell derived graft of this type.

The most concerning complications were arrhythmias that occurred in the weeks after the macaques received the stem cell injections, Dr. Murry said. None of the macaques, however, appeared to have symptoms during these episodes, which disappeared after two to three weeks as the stem cells matured and became more electrically stable.

The researchers also cautioned that in their macaque model, the infarcts they had induced were smaller than the clinically severe infarcts that might benefit most from hESC-CM therapy. The researchers added that larger infarcts, in human hearts, might manifest more arrhythmias.

Because ventricular arrhythmias can be life threatening, they need to be understood mechanistically and managed en route to safe clinical translation, the authors noted. Nevertheless, the extent of remuscularization and electromechanical coupling seen here encourages further development of human cardiomyocyte transplantation as a clinical therapy for heart failure.

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GEN | News Highlights:Human Stem Cells Repair Heart Damage ...

Image Caption: This image shows an implanted graft of cardiac cells derived from human stem cells (green) meshed and beat with primates' heart cells (red). Credit: Murry Lab/University of Washington

April Flowers for redOrbit.com Your Universe Online

When a heart attack occurs, the oxygen-rich blood that normally flows through is interrupted by the blockage in an artery. The longer that blood flow is restricted or cut off, the more tissue and muscle in the area dies or is scarred. The eventual result can be heart failure, especially if one heart attack is followed by another.

In 2013, Harvard Health Publications released a report taking a look at the state of stem cell research into the problem of regenerating heart tissue, and the results were mixed.

A new study from the University of Washington, however, reveals improvement in those results. The findings, published online in Nature, demonstrate that damaged heart muscles in monkeys have been restored by the use of heart cells created from human embryonic stem cells. The exciting implication, according to the research team, is that their approach should also be feasible in humans.

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 and director of the UW Center for Cardiovascular Biology, in a recent statement.

Murray, who collaborated with Dr. Michael Laflamme and other colleagues at the UW Institute for Stem Cell & Regenerative Medicine, predicts clinical trials with humans within the next four years.

[ Watch the Video: Regenerating Heart Muscle Damage With Stem Cell Therapy ]

For the study, the researchers induced controlled myocardial infarctions, a type of heart attack, in anesthetized pigtail macaques, by blocking the coronary artery for 90 minutes. This is the accepted practice for studying myocardial infarction in primates.

Coronary artery disease is the primary culprit in myocardial infarctions in humans. The infarcted heart muscle, damaged by a lack of oxygen, does not grow back, leaving the heart less able to pump blood. This often leads to heart failure, the leading cause of cardiovascular death. Researchers hope to use new heart cells created from stem cells in order to restore normal function to the failing heart.

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Heart Muscles Repaired After Heart Attack Using Human Embryonic Stem Cells

It shows for the first time that we can do regeneration at a scale that the world has never seen before, said Dr Charles Murry, professor of pathology and bioengineering, at the University of Washington.

"Before this study, it was not known if it is possible to produce sufficient numbers of these cells and use them to re-muscularise damaged hearts in a large animal whose heart size and physiology is similar to that of the human heart."

Weve shown that (stem cells) will survive and they will organise to form new heart muscle and they will connect with the surrounding cardiac muscle cells and beat in synchrony.

The green area shows the regenerated heart muscle

Currently heart muscle cannot be repaired and people with severe heart failure must wait for a heart transplant.

In the study the team induced heart attacks, in anesthetised macaque monkeys.

Over the course of two weeks they injected one billion heart muscle cells derived from human embryonic stem cells.

The researchers found that the stem cells infiltrated into the damaged heart tissue, matured, and knitted into muscle fibers, before beginning to beat in rhythm with the macaque heart cells.

After three months, the cells had fully integrated into the heart. On average the transplanted stem cells regenerated 40 percent of the damaged heart tissue and improve the ability of the heart to pump blood.

Although the study has been carried out on macaque monkeys, the researchers at the University of Washington said "the approach should be feasible in humans".

Originally posted here:
Stem cell injections may take place of heart swaps

An implanted graft of cardiac cells derived from human stem cells (green) meshed with a monkey's own heart cells (red). Picture: Murry Lab/University of Washington/PA

Stem cell heart repair treatments could be tested on human patients within four years following a ground-breaking study of monkeys.

Scientists successfully restored damaged cardiac muscle in macaque monkeys suffering the after-effects of experimentally induced heart attacks, paving the way to clinical trials.

Researchers injected 1bn immature heart muscle cells derived from human embryonic stem cells into each animals heart.

Over several weeks, the new cells developed, assembled into muscle fibres, and began to beat in correct time. On average, 40% of the damaged heart tissue was regenerated.

It is the first time stem cell therapy for damage caused by heart attacks has been shown to work in a primate.

Lead scientist Prof Charles Murry, director of the Centre for Cardiovascular Biology at the University of Washington in Seattle, said: Before this study, it was not known if it is possible to produce sufficient numbers of these cells and successfully use them to remuscularise damaged hearts in a large animal whose heart size and physiology is similar to that of the human heart.

He expects the treatment to be ready for clinical trials in human patients within four years.

Heart attack symptoms were triggered in the monkeys by blocking the coronary artery the main artery supplying the heart with blood for 90 minutes.

In humans, the reduced blood flow caused by narrowing of the arteries has a similar effect. Lack of blood flow to the heart damages the heart muscle by depriving it of oxygen.

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Stem cell breakthrough in treating heart attacks

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.

Websitein Spanish (En espaol)

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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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'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

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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