08-02-2012 01:41 A UCSF stem cell study conducted in mice 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, 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 the mice who had had the heart attacks. The cells induced angiogenesis, or blood vessel growth, or differentiated, or specialized, into endothelial and smooth muscle cells, improving cardiac function. Because the cells were transplanted back into the mice from which they originated, the body did not reject them.

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Stem Cell Study in Mice Offers Hope for Treating Heart Attack Patients - Video

27-01-2012 00:12 Mouse embryonic stem cells were coaxed into becoming heart cells. Protocol adapted from Maltsev et al 1993. The cells can be seen beating under low magnification. Sweet!

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Stem cells becoming heart cells - Video

08-02-2012 18:24 (October 25, 2011) Associate Professor at the Stanford School of Medicine, Joseph Wu explores how stem cells may be used in the future to repair hearts that have failed. This course is a single-quarter, focused follow-up to the the yearlong Mini Med School that occurred in 2009-10. The course focuses on diseases of the heart and cardiovascular system. The course is sponsored by Stanford Continuing Studies and the Stanford Medical School. Stanford University http://www.stanford.edu Stanford Continuing Studies http:///continuingstudies.stanford.edu/ Stanford University School of Medicine med.stanford.edu Stanford University Channel on YouTube: http://www.youtube.com

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5. Stem Cells for Cardiac Repair | Mini Med School - Video

08-02-2012 18:45 (October 18, 2011) Associate Professor of Mechanical Engineering Beth Pruitt discusses his work in human embryonic stem-cell-derived cardiac myosites and future opportunities to use heart cells for regenerative therapy. This course is a single-quarter, focused follow-up to the the yearlong Mini Med School that occurred in 2009-10. The course focuses on diseases of the heart and cardiovascular system. The course is sponsored by Stanford Continuing Studies and the Stanford Medical School. Stanford University http://www.stanford.edu Stanford Continuing Studies http://www.continuingstudies.stanford.edu Stanford University School of Medicine http://www.med.stanford.edu Stanford University Channel on YouTube: http://www.youtube.com

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4. Bioengineering Cardiovascular Tools | Mini Med School - Video

SAN BRUNO, Calif., Feb. 16, 2012 /PRNewswire/ -- Cord Blood Registry (CBR) is the exclusive partner for a growing number of clinical researchers focusing on the use of a child's own cord blood stem cells to help treat pediatric brain injury and acquired hearing loss. To ensure consistency in cord blood stem cell processing, storage and release for infusion, three separate trials have included CBR in their FDA-authorized protocol—including two at the University of Texas Health Science Center at Houston (UTHealth) working in partnership with Children's Memorial Hermann Hospital, and a third at Georgia Health Sciences University, home of the Medical College of Georgia (MCG). This makes CBR the only family stem cell bank pairing researchers with prospective patients for these studies. 

(Logo: http://photos.prnewswire.com/prnh/20120216/AQ54476LOGO)

"Partnering with a series of specialists who want to research the use of a child's own newborn blood stem cells on a variety of disease states allows CBR to help advance medical research for regenerative therapies by connecting the child whose family banked with CBR to appropriate researchers," said Heather Brown, MS, CGC, Vice President of Scientific & Medical Affairs at Cord Blood Registry.  "The pediatric specialists from UTHealth, Children's Memorial Hermann Hospital, and Georgia Health Sciences University are at the forefront of stem cell research as they evaluate cord blood stem cells' ability to help facilitate the healing process after damage to nerves and tissue."

Hearing Loss and Traumatic Brain Injury Clinical Trials Break New Ground

Sensorineural hearing loss affects approximately 6 per 1,000 children by 18 years of age, with 9 percent resulting from acquired causes such as viral infection and head injury.(1,2,3)  The Principal Investigator of the hearing loss study is Samer Fakhri, M.D., surgeon at Memorial Hermann-Texas Medical Center and associate professor and program director in the Department of Otorhinolaryngology – Head & Neck Surgery at UTHealth.  He is joined by James Baumgartner, M.D., sponsor of the study and guest research collaborator for this first-of-its-kind FDA-regulated, Phase 1 safety study of the use of cord blood stem cells to treat children with acquired hearing loss. The trial follows evidence from published studies in animals that cord blood treatment can repair damaged organs in the inner ear. Clients of CBR who have sustained a post-birth hearing loss and are 6 weeks to 2 years old may be eligible for the year-long study. "The window of opportunity to foster normal language development is limited," said James Baumgartner, M.D.  "This is the first study of its kind with the potential to actually restore hearing in children and allow for more normal speech and language development."

Although the neurologic outcome for nearly all types of brain injury (with the exception of abuse) is better for children than adults,(4,5) trauma is the leading cause of death in children,(6) and the majority of the deaths are attributed to head injury.(7) Distinguished professor of pediatric surgery and pediatrics at UTHealth, Charles S. Cox, M.D. launched an innovative study building on a growing portfolio of research using stem cell-based therapies for neurological damage. The study will enroll 10 children ages 18 months to 17 years who have umbilical cord blood banked with CBR and have suffered a traumatic brain injury (TBI) and are enrolled in the study within 6-18 months of sustaining the injury. Read more about the trial here.

"The reason we have become interested in cord blood cells is because of the possibility of autologous therapy, meaning using your own cells. And the preclinical models have demonstrated some really fascinating neurological preservation effects to really support these Phase 1 trials," says Charles S. Cox, M.D., principle investigator of the trial. "There's anecdotal experience in other types of neurological injuries that reassures us in terms of the safety of the approach and there are some anecdotal hints at it being beneficial in certain types of brain injury."

Georgia Health Sciences University (GHSU) Focuses on Cerebral Palsy

At the GHSU in Augusta, Dr. James Carroll, professor and chief of pediatric neurology, embarked on the first FDA-regulated clinical trial to determine whether an infusion of stem cells from a child's own umbilical cord blood can improve the quality of life for children with cerebral palsy. The study will include 40 children whose parents have stored their cord blood at CBR and meet inclusion criteria. 

"Using a child's own stem cells as a possible treatment is the safest form of stem cell transplantation because it carries virtually no threat of immune system rejection," said Dr. Carroll. "Our focus on cerebral palsy breaks new ground in advancing therapies to change the course of these kinds of brain injury—a condition for which there is currently no cure."

Cerebral palsy, caused by a brain injury or lack of oxygen in the brain before birth or during the first few years of life, can impair movement, learning, hearing, vision and cognitive skills. Two to three children in 1,000 are affected by it, according to the Centers for Disease Control.(8)

Cord Blood Stem Cell Infusions Move From the Lab to the Clinic

These multi-year studies are a first step to move promising pre-clinical or animal research of cord blood stem cells into clinical trials in patients. Through the CBR Center for Regenerative Medicine, CBR will continue to partner with physicians who are interested in advancing cellular therapies in regenerative applications.

"The benefits of cord blood stem cells being very young, easy to obtain, unspecialized cells which have had limited exposure to environmental toxins or infectious diseases and easy to store for long terms without any loss of function, make them an attractive source for cellular therapy researchers today," adds Brown. "We are encouraged to see interest from such diverse researchers from neurosurgeons to endocrinologists and cardiac specialists."

About CBR

CBR® (Cord Blood Registry®) is the world's largest and most experienced cord blood bank.  The company has consistently led the industry in technical innovations and supporting clinical trials. It safeguards more than 400,000 cord blood collections for individuals and their families. CBR was the first family bank accredited by AABB and the company's quality standards have been recognized through ISO 9001:2008 certification—the global business standard for quality. CBR has also released more client cord blood units for specific therapeutic use than any other family cord blood bank. Our research and development efforts are focused on helping the world's leading clinical researchers advance regenerative medical therapies. For more information, visit http://www.cordblood.com.

(1)  Bergstrom L, Hemenway WG, Downs MP. A high risk registry to find congenital deafness. Otolaryngol Clin North Am. 1977;4:369-399.
(2)  Billings KR, Kenna MA. Causes of pediatric sensorineural hearing loss: yesterday and today. Arch Otolaryngol Head Neck Surg. 1999 May;125(5):517-21.
(3)  Smith RJ, Bale JF Jr, White KR. Sensorineural hearing loss in children. Lancet. 2005;365(9462):879-890.
(4)  Faul M, Xu L, Wald MM, Coronado VG. Traumatic brain injury in the United States: emergency department visits, hospitalizations, and deaths. Atlanta (GA): Centers for Disease Control and Prevention, National Center for Injury Prevention and Control; 2010.
(5)  Schnitzer, Patricia, PH.D., "Prevention of Unintentional Childhood Injuries", American Academy of Family Physicians, 2006.
(6)  Centers for Disease Control and Prevention, "10 Leading Causes of Death, United States, 1997-2007", WISQARS, National Center for Health Statistics (NCHS), National Vital Statistics System
(7)  Marquez de la Plata, Hart et al, National Institutes of Health, "Impact of Age on Long-term Recovery From Traumatic Brain Injury", Arch Phys Med Rehabilitation, May 2008.
(8)  Centers for Disease Control and Prevention, http://www.cdc.gov/Features/dsCerebralPalsy, accessed February 6, 2012

Continued here:
Groundbreaking Clinical Trials Study Cord Blood Stem Cells to Help Treat Brain Injury and Hearing Loss

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

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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

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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
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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

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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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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.

Read more from the original source:
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