Washington, Feb 14 (ANI): Researchers have conducted a stem cell study in mice, which suggests a novel strategy for treating damaged cardiac tissue in patients following a heart attack.

The approach potentially could improve cardiac function, minimize scar size, lead to the development of new blood vessels - and avoid the risk of tissue rejection.

In the investigation, the researchers isolated and characterized a novel type of cardiac stem cell from the heart tissue of middle-aged mice following a heart attack.

Then, in one experiment, they placed the cells in the culture dish and showed they had the ability to differentiate into cardiomyocytes, or "beating heart cells," as well as endothelial cells and smooth muscle cells, all of which make up the heart.

In another, they made copies, or "clones," of the cells and engrafted them in the tissue of other mice of the same genetic background who also had experienced heart attacks. The cells induced angiogenesis, or blood vessel growth, or differentiated, or specialized, into endothelial and smooth muscle cells, improving cardiac function.

"These findings are very exciting," said first author Jianqin Ye, PhD, MD, senior scientist at UCSF's Translational Cardiac Stem Cell Program.

First, "we showed that we can isolate these cells from the heart of middle-aged animals, even after a heart attack." Second, he said, "we determined that we can return these cells to the animals to induce repair."

Importantly, the stem cells were identified and isolated in all four chambers of the heart, potentially making it possible to isolate them from patients' hearts by doing right ventricular biopsies, said Ye.

This procedure is "the safest way of obtaining cells from the heart of live patients, and is relatively easy to perform," he said.

"The finding extends the current knowledge in the field of native cardiac progenitor cell therapy," said senior author Yerem Yeghiazarians, MD, director of UCSF's Translational Cardiac Stem Cell Program and an associate professor at the UCSF Division of Cardiology.

"Most of the previous research has focused on a different subset of cardiac progenitor cells. These novel cardiac precursor cells appear to have great therapeutic potential."

The hope, he said, is that patients who have severe heart failure after a heart attack or have cardiomyopathy would be able to be treated with their own cardiac stem cells to improve the overall health and function of the heart.

Because the cells would have come from the patients, themselves, there would be no concern of cell rejection after therapy.

The findings suggest a potential treatment strategy, said Yeghiazarians. he study has been published online in the journal PLoS ONE. (ANI)

Link:
Patients' own cardiac stem cells could repair 'heart attack' damage

In the investigation, reported online in the journal PLoS ONE, the researchers isolated and characterized a novel type of cardiac stem cell from the heart tissue of middle-aged mice following a heart attack.

Then, in one experiment, they placed the cells in the culture dish and showed they had the ability to differentiate into cardiomyocytes, or "beating heart cells," as well as endothelial cells and smooth muscle cells, all of which make up the heart.

In another, they made copies, or "clones," of the cells and engrafted them in the tissue of other mice of the same genetic background who also had experienced heart attacks. The cells induced angiogenesis, or blood vessel growth, or differentiated, or specialized, into endothelial and smooth muscle cells, improving cardiac function.

"These findings are very exciting," said first author Jianqin Ye, PhD, MD, senior scientist at UCSF's Translational Cardiac Stem Cell Program. First, "we showed that we can isolate these cells from the heart of middle-aged animals, even after a heart attack." Second, he said, "we determined that we can return these cells to the animals to induce repair."

Importantly, the stem cells were identified and isolated in all four chambers of the heart, potentially making it possible to isolate them from patients' hearts by doing right ventricular biopsies, said Ye. This procedure is "the safest way of obtaining cells from the heart of live patients, and is relatively easy to perform," he said.

"The finding extends the current knowledge in the field of native cardiac progenitor cell therapy," said senior author Yerem Yeghiazarians, MD, director of UCSF's Translational Cardiac Stem Cell Program and an associate professor at the UCSF Division of Cardiology. "Most of the previous research has focused on a different subset of cardiac progenitor cells. These novel cardiac precursor cells appear to have great therapeutic potential."

The hope, he said, is that patients who have severe heart failure after a heart attack or have cardiomyopathy would be able to be treated with their own cardiac stem cells to improve the overall health and function of the heart. Because the cells would have come from the patients, themselves, there would be no concern of cell rejection after therapy.

The cells, known as Sca-1+ stem enriched in Islet (Isl-1) expressing cardiac precursors, play a major role in cardiac development. Until now, most of the research has focused on a different subset of cardiac progenitor, or early stage, cells known as, c-kit cells.

The Sca-1+ cells, like the c-kit cells, are located within a larger clump of cells called cardiospheres.

The UCSF researchers used special culture techniques and isolated Sca-1+ cells enriched in the Isl-1expressing cells, which are believed to be instrumental in the heart's development. Since Isl-1 is expressed in the cell nucleus, it has been difficult to isolate them but the new technique enriches for this cell population.

The findings suggest a potential treatment strategy, said Yeghiazarians. "Heart disease, including heart attack and heart failure, is the number one killer in advanced countries. It would be a huge advance if we could decrease repeat hospitalizations, improve the quality of life and increase survival." More studies are being planned to address these issues in the future.

An estimated 785,000 Americans will have a new heart attack this year, and 470,000 who will have a recurrent attack. Heart disease remains the number one killer in the United States, accounting for one out of every three deaths, according to the American Heart Association.

Medical costs of cardiovascular disease are projected to triple from $272.5 billion to $818.1 billion between now and 2030, according to a report published in the journal Circulation.

More information: http://www.plosone.org/article/info%3Adoi%2F10.1371%2Fjournal.pone.0030329

Provided by University of California, San Francisco (news : web)

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Stem cell study in mice offers hope for treating heart attack patients

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

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

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

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

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

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

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

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

About 1.3 million Americans have a heart attack each year.

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Stem Cells Help Regrow Heart Tissue

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

In a trial of 25 heart-attack patients, 17 who got the stem cell treatment showed a 50 percent reduction in cardiac scar tissue compared with no improvement for the eight who received standard care. The results were published Tuesday in the medical journal Lancet.

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

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

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

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

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

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

See more here:
Heart's stem cells used to mend attack damage

February 15, 2012, 12:06 AM EST

By Ryan Flinn

(Adds comment from researcher in 13th paragraph.)

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

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

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

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

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

Minimally Invasive

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

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

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

Heart Regeneration

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

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

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

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

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

--Editors: Angela Zimm, Andrew Pollack

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

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

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

Go here to see the original:
Scarred Hearts Can Be Mended With Stem Cell Therapy

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Main Category: Stem Cell Research
Also Included In: Cardiovascular / Cardiology
Article Date: 14 Feb 2012 - 2:00 PST

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Details of a small clinical trial published in The Lancet on Tuesday reveal how scientists helped patients with hearts damaged by heart attack to re-grow healthy heart muscle and reduce scar tissue with an infusion of stem cells taken from the patients' own hearts.

Leading international cardiologist and heart researcher Dr Eduardo Marbán, who is director of the Cedars-Sinai Heart Institute in Los Angeles and Mark S. Siegel Family Professor, is senior author of the study. He told the press what they saw in the trial:

"... challenges the conventional wisdom that, once established, scar is permanent and that, once lost, healthy heart muscle cannot be restored."

In 2009, Marbán and his team had already shown it is possible, following a heart attack, to grow specialized stem cells from the patient's own heart tissue (called cardiosphere-derived cells or CDCs), inject them back into the patient's damaged heart, and see they reduce scars, increase muscle and boost cardiac function.

The purpose of the clinical trial (called CADUCEUS, short for CArdiosphere-Derived aUtologous stem CElls to Reverse ventricUlar dySfunction) was to assess the safety of such a procedure to repair damage in the left ventricle after a heart attack.

For the trial, which took place at two centres, the Cedars-Sinai Heart Institute and Johns Hopkins Hospital in Baltimore, the researchers enrolled 25 patients of average age 53, who had experienced heart attacks two to four weeks earlier.

Each patient underwent extensive imaging scans to locate and assess the severity of the scars caused by their heart attacks.

The heart attacks had left the patients with damage to their left ventricle, such that their "left ventricular ejection fraction" was between 20 and 45%, and on average, the scar tissue occupied 24% of left ventricular mass.

The patients were randomly allocated in a two to one ratio to either receive stem cell therapy or standard care (the controls). Standard care comprised conventional medical care for heart attack survivors, including prescription medicine and advice on exercise and diet.

The 17 patients assigned to receive stem cell therapy underwent a minimally invasive biopsy under local anesthetic. During this procedure, doctors inserted a catheter through a vein in the patient's neck and removed small pieces of heart tissue, about half the size of a raisin.

Back in Marbán's specialized lab at Cedars-Sinai, the researchers used the pieces of heart muscle to grow autologous CDCs.

When enough CDCs had grown (between 12 and 25 million of them), they re-introduced them into the patients' coronary arteries. This was also done with a minimally invasive catheter procedure. By this time it was 1.5 to 3 months after their heart attacks.

The results showed that:

No complications were reported within 24 hours of receiving infusions.
By month 6, no patients had died, developed cardiac tumors or a major adverse cardiac event, although four patients in the CDC group had serious adverse events compared with one control.
Imaging scans at month 6 showed that compared to controls, the CDC group had significant reductions in scar mass, increases in viable heart mass, regional contractility, and regional systolic wall thickening.
At month 12 the CDC group showed average of 50% reduction in their heart attack scars (from 24% to 12%) while the controls did not show any reduction.
However, changes in end-diastolic volume, end-systolic volume, and left ventricular ejection fraction did not differ between groups at month 6. Marbán said:

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

"This has never been accomplished before, despite a decade of cell therapy trials for patients with heart attacks. Now we have done it. The effects are substantial, and surprisingly larger in humans than they were in animal tests," he added.

Dr Shlomo Melmed, dean of the Cedars-Sinai medical faculty and the Helene A and Philip E. Hixon Chair in Investigative Medicine, describes the study as a "paradigm shift" in heart attack care.

"In the past, all we could do was to try to minimize heart damage by promptly opening up an occluded artery. Now, this study shows there is a regenerative therapy that may actually reverse the damage caused by a heart attack," said Melmed.

The trial was part of a phase I investigative study approved by the Food and Drug Administration (FDA) in the US. Funding came from the US National Heart, Lung, and Blood Institute and Cedars-Sinai Board of Governors Heart Stem Cell Center.

The method for growing CDCs in the lab was developed by Marbán when he was on the faculty of Johns Hopkins University, who have now filed for an intellectual property patent and licensed it to a company in which Marbán has a financial interest. However, that company did not provide funds for the study.

Written by Catharine Paddock PhD
Copyright: Medical News Today
Not to be reproduced without permission of Medical News Today

Visit our stem cell research section for the latest news on this subject. "Intracoronary cardiosphere-derived cells for heart regeneration after myocardial infarction (CADUCEUS): a prospective, randomised phase 1 trial"; Raj R Makkar, Rachel R Smith, Ke Cheng, Konstantinos Malliaras, Louise EJ Thomson, Daniel Berman, Lawrence SC Czer, Linda Marbán, Adam Mendizabal, Peter V Johnston, Stuart D Russell, Karl H Schuleri, Albert C Lardo, Gary Gerstenblith, Eduardo Marbán; The Lancet, published early online 14 February 2012; DOI: 10.1016/S0140-6736(12)60195-0; Link to Abstract
Additional source: Cedars-Sinai Medical Center Please use one of the following formats to cite this article in your essay, paper or report:

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Catharine Paddock PhD. "Scientists Repair Heart Attack Damage Using Patient's Own Stem Cells To Regrow Healthy Heart Muscle." Medical News Today. MediLexicon, Intl., 14 Feb. 2012. Web.
14 Feb. 2012. <http://www.medicalnewstoday.com/articles/241592.php&gt;

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See original here:
Scientists Repair Heart Attack Damage Using Patient's Own Stem Cells To Regrow Healthy Heart Muscle

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

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

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

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

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

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

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

Image: Shortkut / Shutterstock

See original here:
Stem Cells Could Help Heal Broken Hearts [Medicine]

Public release date: 13-Feb-2012
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Contact: Sally Stewart
sally.stewart@cshs.org
310-248-6566
Cedars-Sinai Medical Center

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

Patients who underwent the stem cell procedure demonstrated a significant reduction in the size of the scar left on the heart muscle by a heart attack. Patients also experienced a sizable increase in healthy heart muscle following the experimental stem cell treatments.

One year after receiving the stem cell treatment, scar size was reduced from 24 percent to 12 percent of the heart in patients treated with cells (an average drop of about 50 percent). Patients in the control group, who did not receive stem cells, did not experience a reduction in their heart attack scars.

The study appears online at http://www.thelancet.com and will be in a future issue of the journal's print edition.

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

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

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

As an initial part of the study, in 2009, Marb?n 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 re-grow healthy muscle in a heart that had been injured by a heart attack.

The 25 patients -- average age of 53 -- who participated in this completed study experienced heart attacks that left them with damaged heart muscle. Each patient underwent extensive imaging scans so doctors could pinpoint the exact location and severity of the scars wrought by the heart attack. Patients were treated at Cedars-Sinai Heart Institute and at Johns Hopkins Hospital in Baltimore.

Eight patients served as controls in the study, receiving conventional medical care for heart attack survivors, including prescription medicine, exercise recommendations and dietary advice.

The other 17 patients who were randomized to receive the stem cells underwent a minimally invasive biopsy, under local anesthesia. Using a catheter inserted through a vein in the patient's neck, doctors removed small pieces of heart tissue, about half the size of a raisin. The biopsied heart tissue was then taken to Marb?n's specialized lab at Cedars-Sinai, using methods he invented to culture and multiply the cells.

In the third and final step, the now-multiplied heart-derived cells ? approximately 12 million to 25 million ? were reintroduced into the patient's coronary arteries during a second, minimally invasive [catheter] procedure.

Patients who received stem cell treatment experienced an average of 50 percent reduction in their heart attack scars 12 months after infusion while patients who received standard medical management did not experience shrinkage in the damaged tissue.

"This discovery challenges the conventional wisdom that, once established, scar is permanent and that, once lost, healthy heart muscle cannot be restored," said Marb?n, The Mark S. Siegel Family Professor.

The process to grow cardiac-derived stem cells involved in the study was developed earlier by Marb?n when he was on the faculty of Johns Hopkins University. The university has filed for a patent on that intellectual property and has licensed it to a company in which Dr. Marb?n has a financial interest. No funds from that company were used to support the clinical study. All funding was derived from the National Institutes of Health and Cedars-Sinai Medical Center.

###

About the Cedars-Sinai Heart Institute

The Cedars-Sinai Heart Institute is internationally recognized for outstanding heart care built on decades of innovation and leading-edge research. From cardiac imaging and advanced diagnostics to surgical repair of complex heart problems to the training of the heart specialists of tomorrow and research that is deepening medical knowledge and practice, the Cedars-Sinai Heart Institute is known around the world for excellence and innovations.

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More:
First-of-its-kind stem cell study re-grows healthy heart muscle in heart attack patients

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

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

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

The study, by researchers from Cedars-Sinai Heart Institute in Los Angeles and Johns Hopkins University (43935MF) in Baltimore, tested the approach in patients who recently suffered a heart attack, with the goal that repairing the damage might help stave off failure. While patients getting the stem cells showed no more improvement in heart function than those who didn’t get the experimental therapy, the theory is that new tissue regenerated by the stem cells can strengthen the heart, said Eduardo Marban, the study’s lead author.

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

Minimally Invasive

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

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

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

Heart Regeneration

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

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

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

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

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

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

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Scarred Hearts Can Be Mended With Novel Stem Cell Therapy, Study Finds

Heart-Attack Damage Heals After Stem Cell Treatment

Feb. 13, 2012 -- A new stem cell treatment resurrects dead, scarred heart muscle damaged by a recent heart attack.

The finding, just in time for Valentine's Day, is the clearest evidence yet that literally broken hearts can heal. All that's needed is a little help from one's own heart stem cells.

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

Marban, director of the Cedars-Sinai Heart Institute in Los Angeles, led the study. He invented the "cardiosphere" culture technique used to create the stem cells and founded the company developing the treatment.

It's the first completed, controlled clinical trial showing that scarred heart tissue can be repaired. Earlier work in patients with heart failure, using different stem cells or bone-marrow stem cells, also showed that the heart can regenerate itself.

"These findings suggest that this therapeutic approach is feasible and has the potential to provide a treatment strategy for cardiac regeneration after [heart attack]," write University of Hong Kong researchers Chung-Wah Siu and Hung-Fat Tse. Their editorial accompanies the Marban report in the Feb. 14 advance online issue of The Lancet.

Heart Regenerates With Stem Cell Help

The stem cells don't do what people think they do, Marban says.

It's been thought that the stem cells multiply over and over again. In time, they were supposed to be turning themselves and their daughter cells into new, working heart muscle.

But the stem cells seem to be doing something much more amazing.

"For reasons we didn't initially know, they stimulate the heart to fix itself," Marban says. "The repair is from the heart itself and not from the cells we give them."

Exactly how the stem cells do this is a matter of "feverish research" in Marban's lab.

The phase I clinical trial enrolled 25 patients who had just had a heart attack. On average, each patient had lost a quarter of his heart muscle. MRI scans showed massive scars.

Eight patients got standard care. The other 17 received increasing infusions of what Marban calls stem cells. The cells were grown in the lab from tiny amounts of heart cells taken from the patients' own hearts via biopsy. Six to 12 weeks later, the cells were infused directly back into patients' hearts.

A year later, the mass of scar tissue in the treated patients' hearts got 42% smaller. And healthy heart muscle increased by 60%. No such regeneration was seen in the patients who got standard care.

Because all of the patients were doing relatively well, there was no dramatic difference in clinical outcome. However, treated patients had a bit better exercise endurance.

"This discovery challenges the conventional wisdom that, once established, cardiac scarring is permanent and that, once lost, healthy heart muscle cannot be restored," Marban and colleagues conclude.

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Scarred Hearts Healed After Heart Attack

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

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

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

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

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

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

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

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

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

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Study: Cardiac stem cells can reverse heart attack damage

They also help to reduce scar size

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

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

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

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

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

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

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

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

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

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Cardiac stem cells can restore heart muscles, says study

30-01-2012 06:10 Professor Michael Schneider of Imperial College tells Alan Keys about how stem cell research is leading to treatments for heart disease. Michael describes how the availability of stem cells allows his team to determine the molecules involved in heart cell death and also how to protect those cells from death during a heart attack. Michael foresees a near future where stem cells are combined with other therapies to both repair hearts and enable hearts to self-repair. Alan Keys had his own heart repaired during an operation some years ago and currently chairs a British Heart Foundation patients committee. The British Heart Foundation part-fund the work of Michael's team at Imperial College. This interview was edited down from the original 35 minutes conversation. Read the transcript here: bit.ly Read more about Michael here: bit.ly and here: bit.ly

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Stem cells and heart repair - Video

13-01-2012 08:41 This is human heart muscle in a dish, beating spontaneously. It was made by Dr Lei Ye of the Stem Cell Institute from human induced pluripotent stem cells (hiPSC). These were made by our iPSC facility from human skin cells into which 4 specific genes were temporarily introduced. The heart muscle cells were enabled to develop from the iPSC using a special medium and substrate. It is hoped to use cells like this for the treatment of heart disease by replacing heart muscle that has been destroyed.

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Human heart muscle in a dish, beating spontaneously. - Video

14-12-2011 20:22 Human tissue cells derived from induced pluripotent stem (iPS) cells recapitulate many of the characteristics and functionality expected of in vivo cell types. iCell® Cardiomyocytes are derived from human IPS cells and are currently being used in both drug discovery and basic research in Industrial and Academic settings. Dr. Eric Chiao of Hoffmann-La Roche Inc. (Roche) will lead this presentation and provide data showing the characterization and utility of iCell Cardiomyocytes, how they are being used in drug development, and how they are increasing our understanding of basic human cardiomyocyte cellular biology.

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Utilizing Stem Cell-derived Cardiomyocytes for Early Safety Screening - Webinar Presentation - Video

Posted: Monday, February 6, 2012 10:00 am | Updated: 11:50 am, Mon Feb 6, 2012.

Researchers at Rice University and Texas Children's Hospital have turned stem cells from amniotic fluid into cells that form blood vessels.

Their success offers hope that such stem cells may be used to grow tissue patches to repair infant hearts.

"We want to come up with technology to replace defective tissue with beating heart tissue made from stem cells sloughed off by the infant into the amniotic fluid," said Rice bioengineer Jeffrey Jacot, who led the study. "Our findings serve as proof of principle that stem cells from amniotic fluid have the potential to be used for such purposes."

The results were published online by the journal Tissue Engineering Part A. The research was conducted at Texas Children’s Hospital.

According to the American Heart Association, about 32,000 infants a year in the United States are born with congenital heart defects, 10,000 of which either result in death or require some sort of surgical intervention before they're a year old.

Jacot, an assistant professor of bioengineering based at Rice's BioScience Research Collaborative and of the Pediatric Cardiac Bioengineering Laboratory at the Congenital Heart Surgery Service at Texas Children’s Hospital, hopes to grow heart patches from the amniotic stem cells of a fetus diagnosed in the womb with a congenital heart defect. He said, because the cells would be a genetic match, there would be no risk of rejection.

"Between 60 and 80 percent of severe heart defects are caught by ultrasound," he said. "Ultimately, when a heart defect is diagnosed in utero, we will extract amniotic cells. By birth, we will have made tissue for the repair out of the infant's own cells. The timing is critical because the surgery needs to be done within weeks of the infant's birth."

Surgeons currently use such nonbiological materials as Dacron or Teflon, which do not contract or grow with the patient, or native pericardium, the membrane that surrounds the heart. Pericardium generally forms scar tissue and can only be used in the first operation. Both solutions require further operations and raise the risk of cardiac arrest, Jacot said.

Stem cells, the focus of both great hope and great controversy, are the cells in every organism that differentiate into specialized cells in the body. Stem cells drawn from human embryos are known to have great potential for treatment of defects and disease, but research into their use has been limited by political and other concerns, Jacot said.

That isn't the case with cells found in amniotic fluid, he said. Amniotic fluid is the liquid that protects and nourishes a fetus in the womb. Fluid is sometimes taken from pregnant women through amniocentesis, but cells for the Jacot lab's studies were drawn from women undergoing treatment for twin-twin transfusion syndrome.

"This is where two identical twins share a placenta and one is getting more blood than the other. It's not common," he said, noting that Texas Children's is one of the few hospitals that treat the syndrome. "Part of the general treatment is to remove fluid with the goal of saving both lives, and that fluid is usually discarded."

Jacot said other labs have tested amniotic fluid as a source of stem cells with promising results.

"Our work is based on five years of work from other labs in which they've discovered a very small population of amniotic stem cells – maybe one in every 10,000 – that naturally express markers characteristic of embryonic and mesenchymal stem cells."

Jacot and his team created a population of amniotic stem cells through a complex process that involved extracting cells via centrifugation and fluorescence-activated sorting. They sequestered cells with a surface receptor, c-kit, a marker associated with stem cells.

The cells were cultured in endothelial growth media to make them suitable for growing into a network of capillaries, Jacot said. When the cells were placed in a bio-scaffold, a framework used for tissue engineering, they did just that.

"Anything we make will need a blood supply," he said. "That's why the first cell type we looked for is one that can form blood vessels. We need to know we can get a capillary network throughout tissue that we can then connect to the infant's blood supply."

Jacot said the cells they tested grow very fast.

"We've done calculations to show that, with what we get from amniocentesis, we could more than grow an entire heart by birth," he said. "That would be really tough, but it gives us confidence that we will be able to quickly grow patches of tissue outside of the body that can then be sewn inside."

He said construction of a functional patch is some years away, but his lab is making progress. While embryonic cells have the most potential for such a project, amniotic cells already show signs of an ability to turn into heart muscle, he said.

Co-authors are graduate students Omar Benavides and Jennifer Petsche, both of Rice; and Kenneth Moise Jr. and Anthony Johnson, now professors at the Texas Center for Maternal and Fetal Treatment at The University of Texas Health Science Center at Houston with appointments at Children's Memorial Hermann Hospital.

The research was supported by the National Institutes of Health, the National Science Foundation Graduate Research Fellowship and CAREER programs, the Houston-Rice Alliance for Graduate Education and the Professoriate, the Howard Hughes Medical Institute Med into Grad Program and the Virginia and L.E. Simmons Family Foundation.

(Submitted by Rice University; Posted by Emiy Moser, emoser@hcnonline.com)

Link:
Rice University, Texas Children’s Hospital researchers makes strides towards fixing infants hearts

29-01-2012 23:26 Fourteen patients were randomized to see if adipose-derived adult stem cells would help limit the damage from an acute heart attack. Infarct size was decreased by 50%, the perfusion defect was 17% smaller, and the left ventriclular ejection fraction was increased about 6% better than the control group. Stem cell vocabulary was reviewed and highlighted that there are embryonic stem cells and adult stem cells and that sources of stem cell are from bone marrow, adipose tissue, blood, umbilical cord blood and from cloned embryonic cell lines. Stem cells can develop into 200 different cell types.

The rest is here:
Stem Cells Help Heart Attack Victims - Video

JUPITER, Fla., Jan. 31, 2012 /PRNewswire/ -- BioRestorative Therapies, Inc. (OTCQB: BRTX) ("BRT") today announced that it has entered into a License Agreement with Regenerative Sciences, LLC ("RS") with respect to certain stem cell-related technology and clinical treatment procedures developed by RS. The treatment is an advanced stem cell injection procedure that may offer relief from lower back pain, buttock and leg pain, or numbness and tingling in the legs or feet as a result of bulging and herniated discs.

To date, over 40 procedures have been performed on patients. It is a minimally invasive out-patient procedure, and objective MRI data and patient outcomes for this novel injection procedure show positive results with limited patient downtime. BRT intends to utilize the existing treatment and outcome data, as well as further research, to prepare for clinical trials in the United States.

Pursuant to the agreement, BRT will obtain an exclusive license to utilize or sub-license a certain medical device for the administration of specific cells and/or cell products to the precise locations within the damaged disc and/or spine (and other parts of the body, if applicable) and an exclusive license to utilize or sublicense a certain method for culturing cells for use in repairing damaged areas. The agreement contemplates a closing of the license grant in March 2012, subject to the fulfillment of certain conditions. 

Mark Weinreb, Chairman and CEO of BRT, said, "This possible alternative to back surgery represents a large market for BRT once it begins offering the procedure to patients who might be facing spinal fusions or back surgery (which often times is unsuccessful). By delivering a particular cell population using a proprietary medical device that inserts a specialized needle into the disc and injects cells for repair and re-population, BRT hopes to revolutionize how degenerative disc disease will be treated." 

About BioRestorative Therapies, Inc.
BioRestorative Therapies, Inc.'s goal is to become a medical center of excellence using cell and tissue protocols, primarily involving a patient's own (autologous) adult stem cells (non-embryonic), allowing patients to undergo cellular-based treatments. In June 2011, the Company launched a technology that involves the use of a brown fat cell-based therapeutic/aesthetic program, known as the ThermoStem™ Program.  The ThermoStem™ Program will focus on treatments for obesity, weight loss, diabetes, hypertension, other metabolic disorders and cardiac deficiencies and will involve the study of stem cells, several genes, proteins and/or mechanisms that are related to these diseases and disorders.  As more and more cellular therapies become standard of care, the Company believes its strength will be its focus on the unity of medical and scientific explanations for clinical procedures and outcomes for future personal medical applications.  The Company also plans to offer and sell facial creams and products under the Stem Pearls™ brand.

This press release contains "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, and such forward-looking statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. You are cautioned that such statements are subject to a multitude of risks and uncertainties that could cause future circumstances, events or results to differ materially from those projected in the forward-looking statements as a result of various factors and other risks, including those set forth in the Company's Form 10, as amended, filed with the Securities and Exchange Commission. You should consider these factors in evaluating the forward-looking statements included herein, and not place undue reliance on such statements. The forward-looking statements in this release are made as of the date hereof and the Company undertakes no obligation to update such statements.

CONTACT:  Mark Weinreb, CEO, Tel: (561) 904-6070, Fax: (561) 429-5684

Read more here:
BioRestorative Therapies Signs License Agreement for Stem Cell Disc/Spine Procedure

06-10-2011 17:25 A doctor becomes patient and gives his testimony on stem cell treatment he received to overcome heart failure.

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Stem Cell Treatment for Heart Failure - Video

Of all the body’s organs, the human heart is probably the one most primed for performance and efficiency. Decade after decade, it continues to pump blood around our bodies. However, this performance optimisation comes at a high price: over the course of evolution, almost all of the body’s own regeneration mechanisms in the heart have become deactivated. As a result, a heart attack is a very serious event for patients; dead cardiac cells are irretrievably lost. The consequence of this is a permanent deterioration in the heart’s pumping power and in the patient’s quality of life.

In their attempt to develop a treatment for the repair of cardiac tissue, scientists are pursuing the aim of growing replacement tissue in the laboratory, which could then be used to produce replacement patches for the repair of damaged cardiac muscle. The reconstruction of a three-dimensional structure poses a challenge here. Experiments have already been carried out with many different materials that could provide a scaffold substance for the loading of cardiac muscle cells.

“Whether natural or artificial in origin, all of the tested fibres had serious disadvantages,” says Felix Engel, Research Group Leader at the Max Planck Institute for Heart and Lung Research in Bad Nauheim. “They were either too brittle, were attacked by the immune system or did not enable the heart muscle cells to adhere correctly to the fibres.” However, the scientists have now found a possible solution in Kharagpur, India.

At the university there, coin-sized disks are being produced from the cocoon of the tasar silkworm (Antheraea mylitta). According to Chinmoy Patra, an Indian scientist who now works in Engel’s laboratory, the fibre produced by the tasar silkworm displays several advantages over the other substances tested. “The surface has protein structures that facilitate the adhesion of heart muscle cells. It’s also coarser than other silk fibres.” This is the reason why the muscle cells grow well on it and can form a three-dimensional tissue structure. “The communication between the cells was intact and they beat synchronously over a period of 20 days, just like real heart muscle,” says Engel.

Despite these promising results, clinical application of the fibre is not currently on the agenda. “Unlike in our study, which we carried out using rat cells, the problem of obtaining sufficient human cardiac cells as starting material has not yet been solved,” says Engel. It is thought that the patient’s own stem cells could be used as starting material to avoid triggering an immune reaction. However, exactly how the conversion of the stem cells into cardiac muscle cells works remains a mystery.

More information: Chinmoy Patra, Sarmistha Talukdar, Tatyana Novoyatleva, Siva R. Velagala, Christian Mühlfeld, Banani Kundu, Subhas C. Kundu, Felix B. Engel
Silk protein fibroin from Antheraea mylitta for cardiac tissue engineering, Biomaterials, Advance Online Publication Januar 10, 2012

Provided by Max-Planck-Gesellschaft (news : web)

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Scientists use silk from the tasar silkworm as a scaffold for heart tissue