Dexmedetomidine for Maintaining Sedation

During prolonged mechanical ventilation, sedation with midazolam or propofol is associated with serious adverse effects. Jakob and colleagues assessed the efficacy of dexmedetomidinean 2-agonist sedativecompared with either midazolam or propofol in 2 multicenter randomized trials that involved 998 patients expected to require more than 24 hours' mechanical ventilation. Among the authors' findings was that dexmedetomidine was not inferior to midazolam or propofol in maintaining light to moderate sedation or in reducing total ventilation duration compared with midazolam. However, dexmedetomidine was associated with more adverse events. In an editorial, Wunsch discusses the costs and benefits of sedative options for critically ill patients undergoing mechanical ventilation.

(ARTICLE) (ARTICLE)

Epinephrine is widely used in resuscitation of patients with out-of-hospital cardiac arrest; however, its effectiveness is not established. Hagihara and colleagues analyzed registry data from 417188 patients with out-of-hospital cardiac arrest to assess the relationship between prehospital epinephrine use and mortality and functional status among survivors. The authors report that prehospital epinephrine use was associated with increased return of spontaneous circulation before hospital arrival but decreased the likelihood of survival at 1 month or survival with good functional status. In an editorial, Callaway discusses the evidence that epinephrine use during cardiopulmonary resuscitation may not improve patient-oriented outcomes.

(ARTICLE) (ARTICLE)AND AUTHOR AUDIO INTERVIEW

Immunosuppressive induction therapyroutine in organ transplantsreduces the risk of organ rejection but is associated with adverse effects. Infusion of bone marrowderived mesenchymal stem cells, which have immunoregulatory effects, may offer an alternative immunosuppressive approach. In a randomized trial of 159 patients undergoing living-related kidney transplants, Tan and colleagues found that compared with conventional antiinterleukin 2 receptor antibodybased therapy, a regimen that involved infusion of autologous mesenchymal stem cells was associated with a lower incidence of acute rejection and better renal function at 1 year.

(ARTICLE)

The use of anesthesiologists or nurse anesthetists to administer procedural sedation during outpatient endoscopies increases costs. In a retrospective analysis of claims data from 1.1 million Medicare beneficiaries and 5.5 million commercially insured patients, Liu and colleagues found that utilization of anesthesia services during upper endoscopies and colonoscopies increased from approximately 14% in 2003 to more than 30% in 2009. The majority of anesthesia services were provided to low-risk patients and varied across geographic regions. In an editorial, Fleisher discusses factors that may contribute to increased use of anesthesia services for patients undergoing endoscopy procedures.

(ARTICLE) (ARTICLE)AND AUTHOR VIDEO INTERVIEW

Mrs N, a 75-year-old woman, has a several-year history of hearing loss, which is more bothersome to her family than herself. Pacala and Yueh discuss the prevalence, etiology, and consequences of hearing loss in older patients; its evaluation and treatment, including the selection and fitting of hearing aids; and special challenges to effective hearing aid use among older adults with multiple comorbidities.

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This Week in JAMA [This Week in JAMA]

Pluristem Therapeutics Ltd. (Nasdaq:PSTI; DAX: PJT: PLTR) today announced that its PLacental eXpanded (PLX) cells improve several parameters in acute myocardial infarction (heart attacks) in animals. The preclinical trial was conducted at the Center for Regenerative Therapies in Germany.

The trial included 20 mice, which were given induced heart attacks. Half the mice were then given either PLX cells, and the other half were given a cell-free medium as a control. Five other mice underwent a sham (placebo) operation. After four weeks, the mice underwent an ECG, and were then killed for a physical examination of their hearts. The mice which received PLX had improved cardiac muscle function compared with the control group.

Study leader Prof. Christof Stamm said, "As a cardiac surgeon, the unique ability demonstrated by Pluristem's PLX cells for the treatment of heart disease is very exciting." He added, "PLX cells showed promising results in the AMI studies."

Pluristem chairman and CEO Zami Aberman said, "These results demonstrate the potential benefits of our cells for use in the treatment of ischemic heart disease, a multi-billion dollar annual market, and one in which many pharmaceutical companies are constantly looking to provide patients with innovative and effective solutions. In addition to moving ahead with our AMI trial, we look forward to continuing to work on finding cell therapy solutions for numerous debilitating diseases."

An article in the New England Journal of Medicine states that 624,000 patients suffer an acute myocardial infarction annually in the US, a number that will most likely increase with the rising prevalence of obesity, diabetes and the aging of the population.

Pluristem's share price rose 5.1% by mid-afternoon on the TASE today to NIS 8.50, after closing at $2.15 on Nasdaq yesterday, giving a market cap of $95 million. The share is up 6.5% in premarket trading on Nasdaq today.

Published by Globes [online], Israel business news - http://www.globes-online.com - on March 20, 2012

Copyright of Globes Publisher Itonut (1983) Ltd. 2012

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Pluristem reports success in stem cell heart attack treatment

Public release date: 15-Mar-2012 [ | E-mail | Share ]

Contact: Diane Schrick diane.schrick@gladstone.ucsf.edu 415-734-2538 Gladstone Institutes

SAN FRANCISCO, CAMarch 15, 2012Gladstone Institutes Senior Investigator Deepak Srivastava, MD has won the prestigious 2012 Abraham White Scientific Achievement Award from The George Washington University. Dr. Srivastava, who directs cardiac and stem cell research at Gladstone will share the award with Dr. Luigina Romani, professor of microbiology at the University of Perugia.

Dr. Srivastava is being recognized for his findings concerning how the protein thymosin beta 4 is vital to protect and repair cells that become damaged in a heart attackpointing the way to its potential use in treating cardiac disease. His research has shown that thymosin beta 4 is not only critical to the development of a heart, but that it also prevents heart cells from dyingwhile stimulating new blood vessels to form.

"Dr. Srivastava's pioneering studies and scientific contributions have significantly advanced our understanding of the role of thymosin beta 4 in the development and function of the human heart," said Allan Goldstein, PhD, professor and emeritus chairman of The George Washington University. "His studies have provided the scientific foundation for the potential use of thymosin beta 4 to treat heart attacks and other heart diseases."

Dr. Srivastava, who joined Gladstone in 2005, uses modern genetic and stem cell technologies to identify the molecular events that instruct progenitor cells to become cardiac cellsand subsequently fashion a functioning heart. In addition to his research with thymosin beta 4, Dr. Srivastava and his lab have successfully reprogrammed connective tissue in the heart directly into beating heart cellsa process that may help regenerate damaged heart muscle.

"Heart disease is the leading cause of death in the United States and basic research in this field is vital to identifying and understanding the causes of human heart disease," said Dr. Srivastava, who is also a professor of pediatrics, biochemistry and biophysics at the University of California, San Francisco (UCSF), with which Gladstone is affiliated. "I am honored to receive this award and hope our efforts ultimately lead to important new treatments for patients with heart conditions."

George Washington University presents the Abraham White Scientific Achievement Award annually to honor individuals who have made unique contributions to science and medicine. Notable past recipients include Nobel laureates Bengt Samuelsson, MD, Julius Axelrod, MD, Michael Brown, MD, Joseph Goldstein, MD and Tim Hunt, PhD in addition to a number of other distinguished scientists. The award will be presented today at a special ceremony in Washington D.C.

"We are delighted that George Washington University has acknowledged Dr. Srivastava's exceptional achievements in the field of cardiovascular research," said Gladstone President R. Sanders Williams, MD. "He richly deserves this recognition due to the creativity and innovation evident in his workand because of its potential to benefit the millions of individuals suffering from cardiac disorders."

Before joining Gladstone, Dr. Srivastava was a professor in the department of pediatrics and molecular biology at the University of Texas Southwestern (UTSW) Medical Center in Dallas. He has received numerous honors and awards, including endowed chairs at UTSW and UCSF, as well as election to the American Society for Clinical Investigation, the Society for Pediatric Research, the American Academy of Arts and Sciences and the American Association for the Advancement of Science.

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Gladstone director receives 2012 Abraham White Scientific Achievement Award

Editor's Choice Academic Journal Main Category: Heart Disease Also Included In: Cardiovascular / Cardiology;Stem Cell Research Article Date: 09 Mar 2012 - 4:00 PST

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The paper's lead author, Kenneth Chien from Harvard University in the USA explains:

Until now, clinical trials have been based on heart attacks, chronic heart failure as well as dilated cardiomyopathy, but regardless of the fact that regenerative therapies that are based on various non-cardiac cell types seem to be safe, their efficacy has not yet been tested in a clinical trial.

However, possible new targets and treatment strategies are now emerging due to recent progress in cardiac stem cell research and regenerative biology.

Scientists used to think that the heart only has a minimal capacity for self-renewal and saw no prospect in reversing the loss of healthy heart muscle and function. This perception has been altered because of recent findings, such as the discovery of several distinct embryonic progenitor cell types of which some are found in the heart.

A certain number of these cells can be activated in people with cardiac injuries and are now targeted by scientists to develop novel cardiac regenerative therapeutics either by delivery of the cells, or by new methods that activate expansion and conversion of functioning heart cells.

For instance, clinical studies conducted a short while ago demonstrated that scar formation following a heart attack can be reduced by taking cells from the patient's own heart tissue. Even though it remains uncertain whether the delivered cells are indeed stem cells, these studies nevertheless demonstrate that this is a small, educational step towards the goal of utilizing the heart's potential for self-healing.

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Heart Disease Stem Cell Therapies - Development Must Come From Several Specialties

Study Aims to Deliver Adult’s Own Cells As Treatment for Chronic Myocardial Ischemia

DEERFIELD, Ill.--(BUSINESS WIRE)--Baxter International Inc. (NYSE:BAX) announced today that it has initiated a phase III pivotal clinical trial to evaluate the efficacy and safety of adult autologous (an individual’s own) CD34+ stem cells to increase exercise capacity in patients with chronic myocardial ischemia (CMI).

Chronic myocardial ischemia (CMI) is one of the most severe forms of coronary artery disease, causing significant long-term damage to the heart muscle and disability to the patient. It is often diagnosed based on symptoms of severe, refractory angina, which is severe chest discomfort that does not respond to conventional medical management or surgical interventions.

“The prospect of using a person’s own adult stem cells to restore and repair blood flow in CMI is a very exciting concept based on a biological regenerative approach,” said Norbert Riedel, Ph.D., Baxter’s chief science and innovation officer. “The goals of this phase III trial are aligned with Baxter’s overall mission to develop life-saving and life-sustaining therapies and it will help us determine if the therapy can make a meaningful difference for CMI patients.”

The trial will enroll approximately 450 patients across 50 clinical sites in the United States, who will be randomized to one of three arms: treatment with their own autologous CD34+ stem cells, treatment with placebo (control), or unblinded standard of care. The primary objective is to evaluate the efficacy of treatment with CD34+ stem cells to improve the functional capacity of patients with CMI, as measured by a change in total exercise capacity at 12 months following treatment. Secondary objectives include reduced frequency of angina episodes at 12 months after treatment and the safety of targeted delivery of the cells.

After stem cell mobilization, apheresis (collecting the cells from the body) and cell processing, participants will receive CD34+ stem cells or placebo in a single treatment via 10 intramyocardial injections into targeted areas of the heart tissue. Efficacy will be measured by a change in total exercise capacity during the first year following treatment and safety data will be collected for two years. Stem cell processing will be conducted in GMP facilities in the United States by Progenitor Cell Therapy (PCT), a subsidiary of NeoStem, Inc. To learn more or enroll, visit http://www.renewstudy.com or http://www.clinicaltrials.gov.

This trial is being initiated based on the phase II data, which indicated that injections of patients’ own CD34+ stem cells may improve exercise capacity and reduce reports of angina episodes in patients with chronic, severe refractory angina.

“The phase II trial provided evidence that this strategy, leveraging the body’s own natural repair mechanisms, can improve exercise capacity and reduce chest pain, the first time these endpoints have been achieved in a population of patients who have exhausted conventional treatment options,” said Douglas Losordo, MD, vice president of new therapeutic development at Baxter.

CD34+ cells, which are blood-forming stem cells derived from bone marrow, are comprised of endothelial progenitor cells (EPCs), which develop into new blood vessels. Previous preclinical studies investigating these cells have shown an increase in capillary density and improved cardiac function in models of myocardial ischemia.

About Baxter

Baxter International Inc., through its subsidiaries, develops, manufactures and markets products that save and sustain the lives of people with hemophilia, immune disorders, infectious diseases, kidney disease, trauma, and other chronic and acute medical conditions. As a global, diversified healthcare company, Baxter applies a unique combination of expertise in medical devices, pharmaceuticals and biotechnology to create products that advance patient care worldwide.

This release includes forward-looking statements concerning the use of adult autologous stem cells to treat CMI, including expectations with respect to the related phase III clinical trial. These statements are based on assumptions about many important factors, including the following, which could cause actual results to differ materially from those in the forward-looking statements: clinical results demonstrating the safety and effectiveness of the use of autologous stem cells to treat CMI; timely submission of regulatory filings; satisfaction of regulatory and other requirements; actions of regulatory bodies and other governmental authorities; the enrollment of a sufficient number of qualified participants in the phase III clinical trial; the successful provision of stem cell processing by PCT, a third party; and other risks identified in Baxter’s most recent filing on Form 10-K and other SEC filings, all of which are available on Baxter’s website. Baxter does not undertake to update its forward-looking statements.

Photos/Multimedia Gallery Available: http://www.businesswire.com/cgi-bin/mmg.cgi?eid=50183372&lang=en

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Baxter Initiates Phase III Adult Stem Cell Clinical Trial for Chronic Cardiac Condition

(RTTNews.com) - Baxter International Inc. (BAX) said it has initiated a phase III pivotal clinical trial to evaluate the efficacy and safety of adult autologous CD34+ stem cells to increase exercise capacity in patients with chronic myocardial ischemia.

Chronic myocardial ischemia is one of the most severe forms of coronary artery disease, causing significant long-term damage to the heart muscle and disability to the patient.

The company said that the trial will enroll approximately 450 patients across 50 clinical sites in the United States, who will be randomized to one of three arms, namely treatment with their own autologous CD34+ stem cells, treatment with placebo (control), or unblinded standard of care. The primary objective is to evaluate the efficacy of treatment with CD34+ stem cells to improve the functional capacity of patients with chronic myocardial ischemia, as measured by a change in total exercise capacity at 12 months following treatment.

Efficacy will be measured by a change in total exercise capacity during the first year following treatment and safety data will be collected for two years.

The company noted that the trial is being initiated based on the phase II data, which indicated that injections of patients' own CD34+ stem cells may improve exercise capacity and reduce reports of angina episodes in patients with chronic, severe refractory angina.

For comments and feedback: contact editorial@rttnews.com

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Baxter Begins Phase III Adult Stem Cell Trial For Chronic Cardiac Condition

In a new study, Harvard researchers say they have found stem cells in women that can be used to grow new eggs. Not surprisingly, this has raised much discussion about whether a woman’s biological clock can be stopped – why worry about running out of eggs if you can just make new ones whenever you  need them?

The work described in the paper, published online Sunday by the journal Nature Medicine, is still a long way from being useful to women in need of fertility treatments. And many scientists remain skeptical that these ovarian stem cells really can mature into healthy eggs.

But as long as we’re in the pie-in-the-sky realm, let’s consider another way that the ability to grow an abundant supply of eggs would be helpful: to make human embryonic stem cell lines that would be perfectly matched to patients.

This was a hot area of research in the middle of the last decade. While many scientists studied stem cells made from embryos that were no longer needed for fertility treatments, a smaller group was pursuing a derivation method called somatic cell nuclear transfer, or SCNT. It’s better known as “therapeutic cloning.”

Here’s the idea: You take an egg and remove all the DNA in the cell nucleus. Then you replace it with DNA from a patient. You give the egg an electric shock so it starts dividing and growing into an early-stage embryo.

But instead of implanting this embryo into a uterus and producing a baby that’s a genetic copy of another person, you would use it to make a line of human embryonic stem cells. Then you can use those stem cells to make replacement parts – new cardiac cells for patients who suffered heart attacks, for instance, or nerve cells that would replace those lost after a spinal cord injury. In theory, the new cells would work perfectly because they’d be a perfect genetic match. This is the vision of regenerative medicine.

For a few months back in 2005, it looked like this vision was on the verge of reality. South Korean researcher Hwang Woo Suk published a landmark paper in the journal Science in which he claimed to have made 11 lines of stem cells that were genetic matches to patients with Type 1 diabetes, spinal cord injuries and the so-called Bubble Boy disease. Scientists rejoiced, as did doctors and patients. But a few months later, Hwang was accused of faking the results. The study was retracted, and Hwang was prosecuted for embezzling research money and violating ethics laws.

Since then, researchers at Oregon Health & Sciences University have managed to clone monkey embryos in order to create embryonic stem cells. But in a 2007 study in the journal Nature, they said they had to use 304 eggs to make just two viable cell lines.

It’s hard to imagine how scientists would ever get their hands on 304 human eggs, especially since they generally aren’t allowed to pay women who might be willing to donate eggs for research purposes. It’s also not clear that a few hundred eggs would be enough to guarantee at least one line of stem cells. South Korean investigators eventually discovered that Hwang used 2,236 eggs in his studies that failed to produce a single embryo.

This is one of the major reasons why SCNT studies fell by the wayside. (For more on that, read this story from 2006.) But if there were a relatively simple way to grow hundreds – or thousands – of eggs in the lab, some scientists are confident they could create stem cells through therapeutic cloning.

If so, that would make the research at Harvard relevant to a whole lot of people besides women who hear their biological clocks ticking.

A summary of the Nature Medicine study is online here.

Return to the Booster Shots blog.

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Eggs made from stem cells could treat more than just fertility

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

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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)

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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

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