Archive for March, 2012

24-03-2012 07:46 This is the harvest of adipose tissue for combination with bone marrow aspirate concentrate for stem cell therapy

Read the rest here:
Adipose harvest for stem cell therapy by Dr Adelson - Video

25-03-2012 10:22 Dr Adelson aspirates bone marrow for concentration for stem cell therapy for musculoskeletal pain conditions

See the original post:
bone marrow aspiration for stem cell therapy by Dr Adelson - Video

(RTTNews.com) - An important clinical trial, which evaluated the use of autologous bone-marrow-cell therapy in patients with chronic ischemic heart failure, has failed to meet the prespecified end points of improvement in most measures of heart function, according to the results presented at the American College of Cardiology 2012 Scientific Sessions.

The trial dubbed, FOCUS - a phase II study, is the largest study to date to investigate if a patient's own bone marrow cells improved myocardial perfusion, reduced left ventricular end-systolic volume or enhanced maximal oxygen consumption in patients with coronary artery disease or LV dysfunction, and limiting heart failure or angina. The FOCUS trial was undertaken by the National Heart, Lung, and Blood Institute-sponsored Cardiovascular Cell Therapy Research Network.

Ninety two patients with chronic ischemic heart disease , having a left ventricular ejection fraction of 45% or less, a perfusion defect by single-photon emission tomography, or SPECT, who were no longer candidates for revascularization, were enrolled in the trial. Sixty one patients in the study were administered bone marrow cells through transendocardial injections while thirty one patients were administered placebo.

An assessment of primary endpoints at 6 months has revealed that there is no statistically significant difference between the treatment group and placebo arm in left ventricular end-systolic volume assessed by echocardiography, maximal oxygen consumption, and reversibility on SPECT. The secondary outcomes, including percent myocardial defect, total defect size, fixed defect size, regional wall motion, and clinical improvement, also has not exhibited any difference between the two arms.

However, according to the study authors, exploratory analyses have revealed that left ventricular ejection fraction improved in the treatment group compared with the placebo group by 2.7%.

The authors, led by Emerson Perin, concluded that the findings provide evidence for further studies to determine the relationship between the composition and function of bone marrow product and clinical end points. Understanding these relationships will improve the design and interpretation of future studies of cardiac cell therapy, the authors noted.

The results were published online March 24 in the Journal of the American Medical Association.

For comments and feedback: contact editorial@rttnews.com

http://www.rttnews.com

Visit link:
Bone Marrow Stem Cell Therapy Trial - Clues, But No Answers

3/25/2012 10:50 AM ET (RTTNews) - An important clinical trial, which evaluated the use of autologous bone-marrow-cell therapy in patients with chronic ischemic heart failure, has failed to meet the prespecified end points of improvement in most measures of heart function, according to the results presented at the American College of Cardiology 2012 Scientific Sessions.

The trial dubbed, FOCUS - a phase II study, is the largest study to date to investigate if a patient's own bone marrow cells improved myocardial perfusion, reduced left ventricular end-systolic volume or enhanced maximal oxygen consumption in patients with coronary artery disease or LV dysfunction, and limiting heart failure or angina. The FOCUS trial was undertaken by the National Heart, Lung, and Blood Institute-sponsored Cardiovascular Cell Therapy Research Network.

Ninety two patients with chronic ischemic heart disease , having a left ventricular ejection fraction of 45% or less, a perfusion defect by single-photon emission tomography, or SPECT, who were no longer candidates for revascularization, were enrolled in the trial. Sixty one patients in the study were administered bone marrow cells through transendocardial injections while thirty one patients were administered placebo.

An assessment of primary endpoints at 6 months has revealed that there is no statistically significant difference between the treatment group and placebo arm in left ventricular end-systolic volume assessed by echocardiography, maximal oxygen consumption, and reversibility on SPECT. The secondary outcomes, including percent myocardial defect, total defect size, fixed defect size, regional wall motion, and clinical improvement, also has not exhibited any difference between the two arms.

However, according to the study authors, exploratory analyses have revealed that left ventricular ejection fraction improved in the treatment group compared with the placebo group by 2.7%.

The authors, led by Emerson Perin, concluded that the findings provide evidence for further studies to determine the relationship between the composition and function of bone marrow product and clinical end points. Understanding these relationships will improve the design and interpretation of future studies of cardiac cell therapy, the authors noted.

The results were published online March 24 in the Journal of the American Medical Association.

by RTT Staff Writer

For comments and feedback: editorial@rttnews.com

View post:
FOCUS : Bone Marrow Cell Therapy Trial Fails To Meet Goals

25 March 2012 Last updated at 13:00 ET By Eleanor Bradford BBC Scotland Health Correspondent

Scientists have discovered a gene which may make some people more susceptible to flu.

The gene was found by Edinburgh University researchers working with the Wellcome Trust Sanger Institute near Cambridge.

It may explain why apparently healthy people have needed intensive care after contracting swine flu, while others were unaware they had been infected.

The findings have been published in the journal Nature.

An analysis of the DNA of 60 patients in intensive care with flu revealed an unusually high number with a variant in a gene called IFITM3.

This gene produced a protein which hinders the spread of the flu virus in the lungs. The variant in this gene means less protein is produced and the flu virus can spread more easily.

Although the genetic variation is normally rare, it was 19-times more common than expected in people who needed hospital treatment.

Dr Kenneth Baillie, an expert in genetics and critical care at Edinburgh University's Roslin Institute, said: "During the pandemic it was very unusual for a healthy person to become desperately sick with flu but it did happen to some people.

"It was a mystery why it affected those people so severely when most people were hardly affected at all. This research explains a fraction of why those individuals were so susceptible."

Link:
Gene clue found for flu mystery

* Gene appears to determine people's ability to fight flu

* People could be screened for gene

* It may help develop new medicines for other viruses too

LONDON, March 25 (Reuters) - A genetic discovery could help explain why flu makes some people seriously ill or kills them, while others seem able to bat it away with little more than a few aches, coughs and sneezes.

In a study published in the journal Nature on Sunday, British and American researchers said they had found for the first time a human gene that influences how people respond to flu infections, making some people more susceptible than others.

The finding helps explain why during the 2009/2010 pandemic of H1N1 or "swine flu", the vast majority of people infected had only mild symptoms, while others - many of them healthy young adults - got seriously ill and died.

In future, the genetic discovery could help doctors screen patients to identify those more likely to be brought down by flu, allowing them to be selected for priority vaccination or preventative treatment during outbreaks, the researchers said.

It could also help develop new vaccines or medicines against potentially more dangerous viruses such as bird flu.

Paul Kellam of Britain's Sanger Institute, who co-led the study and presented the findings in a telephone briefing, said the gene, called ITFITM3, appeared to be a "crucial first line of defence" against flu.

When IFITM3 was present in large quantities, the spread of the virus in lungs was hindered, he explained. But when IFITM3 levels were lower, the virus could replicate and spread more easily, causing more severe symptoms.

Read this article:
Scientists find gene that can make flu a killer

25 March 2012 Last updated at 13:39 ET

Scientists have identified a genetic flaw that may explain why some people get more ill with flu than others.

Writing in Nature, the researchers said the variant of the IFITM3 gene was much more common in people hospitalised for flu than in the general population.

It controls a malformed protein, which makes cells more susceptible to viral infection.

Experts said those with the flaw could be given the flu jab, like other at-risk groups.

Researchers removed the gene from mice. They found that when they developed flu, their symptoms were much worse than those seen in mice with the gene.

Evidence from genetic databases covering thousands of people showed the flawed version of the gene is present in around one in 400 people.

The scientists, who came from the UK and US, then sequenced the IFITM3 genes of 53 patients who were in hospital with flu.

Three were found to have the variant - a rate of one in 20.

The researchers say these findings now need to be replicated in bigger studies. And they add it is probably only part of the genetic jigsaw that determines a person's response to flu.

Read the original:
'Severe flu' gene flaw identified

Public release date: 25-Mar-2012 [ | E-mail | Share ]

Contact: Michael Bernstein m_bernstein@acs.org 619-525-6268 (March 23-28, San Diego Press Center) 202-872-6042

Michael Woods m_woods@acs.org 619-525-6268 (March 23-28, San Diego Press Center) 202-872-6293 American Chemical Society

SAN DIEGO, March 25, 2012 Just as aspiring authors often read hundreds of books before starting their own, scientists are using decades of knowledge garnered from sequencing or "reading" the genetic codes of thousands of living things to now start writing new volumes in the library of life. J. Craig Venter, Ph.D., one of the most renowned of those scientists, described the construction of the first synthetic cell and many new applications of this work today at the 243rd National Meeting & Exposition of the American Chemical Society (ACS), the world's largest scientific society, which is underway this week.

In a plenary talk titled, "From Reading to Writing the Genetic Code," Venter described a fundamental shift in his field of genomics, and its promise for producing synthetic life that could help provide 21st century society with new fuels, medicines, food and nutritional products, supplies of clean water and other resources. Venter, a pioneer in the field, led the team at Celera Genomics that went head-to-head with the government-and-foundation-funded Human Genome Project in the race to decode the human genome. This quest, in which the 23,000 human genes were deciphered, ended with the teams declaring a tie and publishing simultaneous publications in 2001.

"Genomics is a rapidly evolving field and my teams have been leading the way from reading the genetic code deciphering the sequences of genes in microbes, humans, plants and other organisms to writing code and constructing synthetic cells for a variety of uses. We can now construct fully synthetic bacterial cells that have the potential to more efficiently and economically produce vaccines, pharmaceuticals, biofuels, food and other products."

The work Venter described at the ACS session falls within an ambitious new field known as synthetic biology, which draws heavily on chemistry, metabolic engineering, genomics and other traditional scientific disciplines. Synthetic biology emerged from genetic engineering, the now-routine practice of inserting one or two new genes into a crop plant or bacterium. The genes can make tomatoes, for instance, ripen without softening or goad bacteria to produce human insulin for treating diabetes. Synthetic biology, however, involves rearranging genes on a much broader scale that of a genome, which is an organism's entire genetic code to reprogram entire organisms and even design new organisms.

Venter and his team at the not-for-profit J. Craig Venter Institute (JCVI), which has facilities in Rockville, Maryland, and San Diego, announced in 2010 that they had constructed the world's first completely synthetic bacterial cell. Using computer-designed genes made on synthesizer machines from four bottles of chemicals, the scientists arranged those genes into a package, a synthetic chromosome. When inserted into a bacterial cell, the chromosome booted up the cell and was capable of dividing and reproducing.

In the ACS talk, Venter described progress on major projects, including developing new synthetic cells and engineering genomes to produce biofuels, vaccines, clean water, food and other products. That work is ongoing at both JCVI and at his company, Synthetic Genomics Inc. (SGI). A project at SGI for instance, aims to engineer algae cells to capture carbon dioxide and use it as a raw material for producing new fuels. Another group uses synthetic genomic advances with the goal of making influenza vaccines in hours rather than months to better respond to sudden mutations in those viruses.

Venter also described his work in sequencing the first draft human genome in 2001 while he and his team were at Celera Genomics, as well as the work on his complete diploid genome published in 2007 by scientists at JCVI, along with collaborators at The Hospital for Sick Children in Toronto and the University of California, San Diego. In addition to continued analysis of Venter's genome, he and his team are also studying the human microbiome, the billions of bacteria that live in and on people, and how these microbes impact health and disease.

Read more from the original source:
J. Craig Venter, Ph.D., describes biofuels, vaccines and foods from made-to-order microbes

ScienceDaily (Mar. 25, 2012) A genetic finding could help explain why influenza becomes a life-threating disease to some people while it has only mild effects in others. New research led by the Wellcome Trust Sanger Institute has identified for the first time a human gene that influences how we respond to influenza infection.

People who carry a particular variant of a gene called IFITM3 are significantly more likely to be hospitalised when they fall ill with influenza than those who carry other variants, the team found. This gene plays a critical role in protecting the body against infection with influenza and a rare version of it appears to make people more susceptible to severe forms of the disease. The results are published in the journal Nature.

A central question about viruses is why some people suffer badly from an infection and others do not. IFITM3 is an important protein that protects cells against virus infection and is thought to play a critical role in the immune system's response against such viruses as H1N1 pandemic influenza, commonly known as 'swine flu'. When the protein is present in large quantities, the spread of the virus in lungs is hindered, but if the protein is defective or absent, the virus can spread more easily, causing severe disease.

"Although this protein is extremely important in limiting the spread of viruses in cells, little is known about how it works in lungs," explains Aaron Everitt, first author from the Wellcome Trust Sanger Institute. "Our research plays a fundamental part in explaining how both the gene and protein are linked to viral susceptibility."

The antiviral role of IFITM3 in humans was first suggested by studies using a genetic screen, which showed that the protein blocked the growth of influenza virus and dengue virus in cells. This led the team to ask whether IFITM3 protected mice from viral infections. They removed the IFITM3 gene in mice and found that once they contracted influenza, the symptoms became much more severe compared to mice with IFITM3. In effect, they found the loss of this single gene in mice can turn a mild case of influenza into a fatal infection.

The researchers then sequenced the IFITM3 genes of 53 patients hospitalised with influenza and found that some have a genetic mutant form of IFITM3, which is rare in normal people. This variant alters the IFITM3 gene and makes cells more susceptible to viral infection.

"Since IFITM3 appears to be a first line defender against infection, our efforts suggest that individuals and populations with less IFITM3 activity may be at increased risk during a pandemic and that IFITM3 could be vital for defending human populations against other viruses such as avian influenza virus and dengue virus" says Dr. Abraham Brass, co-senior author and Assistant Professor at the Ragon Institute of MGH, MIT and Harvard and the Gastrointestinal Unit of Massachusetts General Hospital.

This research was a collaboration between institutes in the United States and the United Kingdom. The samples for this study were obtained from the MOSAIC consortium in England and Scotland, co-ordinated from the Centre for Respiratory Infection (CRI) at Imperial College London, and the GenISIS consortium in Scotland at the Roslin Institute of University of Edinburgh. These were pivotal for the human genetics component of the work.

"Collectively, these data reveal that the action of a single antiviral protein, IFITM3, can profoundly alter the course of the flu and potentially other viruses in both human and mouse," explains Professor Paul Kellam, co-senior author from the Wellcome Trust Sanger Institute. "To fully understand how both the protein and gene control our susceptibility to viral infections, we need to study the mechanisms of the gene variant more closely.

"Our research is important for people who have this variant as we predict their immune defences could be weakened to some virus infections. Ultimately as we learn more about the genetics of susceptibility to viruses, then people can take informed precautions, such as vaccination to prevent infection."

Visit link:
Genetics of flu susceptibility: Why the flu is life-threatening for some, and quite mild for others

Public release date: 25-Mar-2012 [ | E-mail | Share ]

Contact: Aileen Sheehy as22@sanger.ac.uk 44-122-349-2368 Wellcome Trust Sanger Institute

A genetic finding could help explain why influenza becomes a life-threating disease to some people while it has only mild effects in others. New research led by the Wellcome Trust Sanger Institute has identified for the first time a human gene that influences how we respond to influenza infection.

People who carry a particular variant of a gene called IFITM3 are significantly more likely to be hospitalised when they fall ill with influenza than those who carry other variants, the team found. This gene plays a critical role in protecting the body against infection with influenza and a rare version of it appears to make people more susceptible to severe forms of the disease. The results are published in the journal Nature.

A central question about viruses is why some people suffer badly from an infection and others do not. IFITM3 is an important protein that protects cells against virus infection and is thought to play a critical role in the immune system's response against such viruses as H1N1 pandemic influenza, commonly known as 'swine flu'. When the protein is present in large quantities, the spread of the virus in lungs is hindered, but if the protein is defective or absent, the virus can spread more easily, causing severe disease.

"Although this protein is extremely important in limiting the spread of viruses in cells, little is known about how it works in lungs," explains Aaron Everitt, first author from the Wellcome Trust Sanger Institute. "Our research plays a fundamental part in explaining how both the gene and protein are linked to viral susceptibility."

The antiviral role of IFITM3 in humans was first suggested by studies using a genetic screen, which showed that the protein blocked the growth of influenza virus and dengue virus in cells. This led the team to ask whether IFITM3 protected mice from viral infections. They removed the IFITM3 gene in mice and found that once they contracted influenza, the symptoms became much more severe compared to mice with IFITM3. In effect, they found the loss of this single gene in mice can turn a mild case of influenza into a fatal infection.

The researchers then sequenced the IFITM3 genes of 53 patients hospitalised with influenza and found that some have a genetic mutant form of IFITM3, which is rare in normal people. This variant gene encodes a shortened version of the protein which makes cells more susceptible to viral infection.

"Since IFITM3 appears to be a first line defender against infection, our efforts suggest that individuals and populations with less IFITM3 activity may be at increased risk during a pandemic and that IFITM3 could be vital for defending human populations against other viruses such as avian influenza virus and dengue virus" says Dr. Abraham Brass, co-senior author and Assistant Professor at the Ragon Institute and Gastrointestinal Unit of Massachusetts General Hospital.

This research was a collaboration between institutes in the United States and the United Kingdom. The samples for this study were obtained from the MOSAIC consortium in England and Scotland, co-ordinated from the Centre for Respiratory Infection (CRI) at Imperial College London, and the GenISIS consortium in Scotland at the Roslin Institute of the University of Edinburgh. These were pivotal for the human genetics component of the work.

The rest is here:
Genetics of flu susceptibility

25-03-2012 10:22 Dr Adelson aspirates bone marrow for concentration for stem cell therapy for musculoskeletal pain conditions

Read more from the original source:
bone marrow aspiration for stem cell therapy by Dr Adelson - Video

24-03-2012 07:46 This is the harvest of adipose tissue for combination with bone marrow aspirate concentrate for stem cell therapy

Here is the original post:
Adipose harvest for stem cell therapy by Dr Adelson - Video

3/25/2012 10:50 AM ET (RTTNews) - An important clinical trial, which evaluated the use of autologous bone-marrow-cell therapy in patients with chronic ischemic heart failure, has failed to meet the prespecified end points of improvement in most measures of heart function, according to the results presented at the American College of Cardiology 2012 Scientific Sessions.

The trial dubbed, FOCUS - a phase II study, is the largest study to date to investigate if a patient's own bone marrow cells improved myocardial perfusion, reduced left ventricular end-systolic volume or enhanced maximal oxygen consumption in patients with coronary artery disease or LV dysfunction, and limiting heart failure or angina. The FOCUS trial was undertaken by the National Heart, Lung, and Blood Institute-sponsored Cardiovascular Cell Therapy Research Network.

Ninety two patients with chronic ischemic heart disease , having a left ventricular ejection fraction of 45% or less, a perfusion defect by single-photon emission tomography, or SPECT, who were no longer candidates for revascularization, were enrolled in the trial. Sixty one patients in the study were administered bone marrow cells through transendocardial injections while thirty one patients were administered placebo.

An assessment of primary endpoints at 6 months has revealed that there is no statistically significant difference between the treatment group and placebo arm in left ventricular end-systolic volume assessed by echocardiography, maximal oxygen consumption, and reversibility on SPECT. The secondary outcomes, including percent myocardial defect, total defect size, fixed defect size, regional wall motion, and clinical improvement, also has not exhibited any difference between the two arms.

However, according to the study authors, exploratory analyses have revealed that left ventricular ejection fraction improved in the treatment group compared with the placebo group by 2.7%.

The authors, led by Emerson Perin, concluded that the findings provide evidence for further studies to determine the relationship between the composition and function of bone marrow product and clinical end points. Understanding these relationships will improve the design and interpretation of future studies of cardiac cell therapy, the authors noted.

The results were published online March 24 in the Journal of the American Medical Association.

by RTT Staff Writer

For comments and feedback: editorial@rttnews.com

See the article here:
Bone Marrow Stem Cell Therapy Trial - Clues, But No Answers

Published on Mar 25, 2012

CHICAGO (AFP) - Patients with advanced heart disease who received an experimental stem cell therapy showed slight improvements in blood pumping but no change in most of their symptoms, United States researchers said on Saturday.

Study authors described the trial as the largest to date to examine stem cell therapy as a route to repairing the heart in patients with chronic ischemic heart disease and left ventricular dysfunction.

Previous studies have established that the approach is safe in human patients, but none had examined how well it worked on a variety of heart ailments.

The clinical trial involved 92 patients, with an average age of 63, who were picked at random to get either a placebo or a series of injections of their own stem cells, taken from their bone marrow, into damaged areas of their hearts.

Read more:
Stem cell therapy could repair some heart damage: Study

ScienceDaily (Mar. 24, 2012) Use of a patient's bone marrow cells for treating chronic ischemic heart failure did not result in improvement on most measures of heart function, according to a study appearing in JAMA. The study is being published early online to coincide with its presentation at the American College of Cardiology's annual scientific sessions.

Cell therapy has emerged as an innovative approach for treating patients with advanced ischemic heart disease, including those with heart failure. "In patients with ischemic heart disease and heart failure, treatment with autologous [derived from the same individual] bone marrow mononuclear cells (BMCs) has demonstrated safety and has suggested efficacy. None of the clinical trials performed to date, however, have been powered to evaluate specific efficacy measures," according to background information in the article.

Emerson C. Perin, M.D., Ph.D., of the Texas Heart Institute and St. Luke's Episcopal Hospital, Houston and colleagues conducted a study to examine the effect of transendocardial administration (use of a special catheter and injection procedure to deliver stem cells to the heart muscle) of BMCs to patients with chronic ischemic heart disease and left ventricular (LV) dysfunction with heart failure and/or angina. The patients in the phase 2 randomized trial were receiving maximal medical therapy at 5 National Heart, Lung, and Blood Institute-sponsored Cardiovascular Cell Therapy Research Network (CCTRN) sites between April 2009 and April 2011. Patients were randomized to receive transendocardial injection of BMCs or placebo. The primary outcomes measured for the study, assessed at 6 months, were changes in left ventricular end-systolic volume (LVESV) assessed by echocardiography, maximal oxygen consumption, and reversibility of perfusion (blood flow) defect on single-photon emission tomography (SPECT). Of 153 patients who provided consent, a total of 92 (82 men; average age: 63 years) were randomized (n = 61 in BMC group and n = 31 in placebo group).

Analysis of data indicated no statistically significant differences between the groups for the primary end points of changes in LVESV index, maximal oxygen consumption, and reversible defect. There were also no differences in any of the secondary outcomes, including percent myocardial defect, total defect size, fixed defect size, regional wall motion (the movement of the wall of the heart during contraction), and clinical improvement.

In an exploratory analysis, the researchers did find that when LVEF was assessed, patients age 62 years or younger showed a statistically significant effect of therapy. Patients in the BMC group demonstrated an average increase in LVEF of 3.1 percent from baseline to 6 months, whereas patients in the placebo group showed a decrease of -1.6 percent.

"In the largest study to date of autologous BMC therapy in patients with chronic ischemic heart disease and LV dysfunction, we found no effect of therapy on prespecified end points. Further exploratory analysis showed a significant improvement in LVEF associated with treatment. Our findings provide evidence for further studies to determine the relationship between the composition and function of bone marrow product and clinical end points. Understanding these relationships will improve the design and interpretation of future studies of cardiac cell therapy," the authors write.

Share this story on Facebook, Twitter, and Google:

Other social bookmarking and sharing tools:

Story Source:

The above story is reprinted from materials provided by JAMA and Archives Journals.

Original post:
Treatment of ischemic heart failure with bone marrow cells does not show improvement for certain heart function measures

Published on Mar 25, 2012

CHICAGO (AFP) - Patients with advanced heart disease who received an experimental stem cell therapy showed slight improvements in blood pumping but no change in most of their symptoms, United States researchers said on Saturday.

Study authors described the trial as the largest to date to examine stem cell therapy as a route to repairing the heart in patients with chronic ischemic heart disease and left ventricular dysfunction.

Previous studies have established that the approach is safe in human patients, but none had examined how well it worked on a variety of heart ailments.

The clinical trial involved 92 patients, with an average age of 63, who were picked at random to get either a placebo or a series of injections of their own stem cells, taken from their bone marrow, into damaged areas of their hearts.

Visit link:
Stem cell therapy could repair some heart damage: Study

ScienceDaily (Mar. 24, 2012) Use of a patient's bone marrow cells for treating chronic ischemic heart failure did not result in improvement on most measures of heart function, according to a study appearing in JAMA. The study is being published early online to coincide with its presentation at the American College of Cardiology's annual scientific sessions.

Cell therapy has emerged as an innovative approach for treating patients with advanced ischemic heart disease, including those with heart failure. "In patients with ischemic heart disease and heart failure, treatment with autologous [derived from the same individual] bone marrow mononuclear cells (BMCs) has demonstrated safety and has suggested efficacy. None of the clinical trials performed to date, however, have been powered to evaluate specific efficacy measures," according to background information in the article.

Emerson C. Perin, M.D., Ph.D., of the Texas Heart Institute and St. Luke's Episcopal Hospital, Houston and colleagues conducted a study to examine the effect of transendocardial administration (use of a special catheter and injection procedure to deliver stem cells to the heart muscle) of BMCs to patients with chronic ischemic heart disease and left ventricular (LV) dysfunction with heart failure and/or angina. The patients in the phase 2 randomized trial were receiving maximal medical therapy at 5 National Heart, Lung, and Blood Institute-sponsored Cardiovascular Cell Therapy Research Network (CCTRN) sites between April 2009 and April 2011. Patients were randomized to receive transendocardial injection of BMCs or placebo. The primary outcomes measured for the study, assessed at 6 months, were changes in left ventricular end-systolic volume (LVESV) assessed by echocardiography, maximal oxygen consumption, and reversibility of perfusion (blood flow) defect on single-photon emission tomography (SPECT). Of 153 patients who provided consent, a total of 92 (82 men; average age: 63 years) were randomized (n = 61 in BMC group and n = 31 in placebo group).

Analysis of data indicated no statistically significant differences between the groups for the primary end points of changes in LVESV index, maximal oxygen consumption, and reversible defect. There were also no differences in any of the secondary outcomes, including percent myocardial defect, total defect size, fixed defect size, regional wall motion (the movement of the wall of the heart during contraction), and clinical improvement.

In an exploratory analysis, the researchers did find that when LVEF was assessed, patients age 62 years or younger showed a statistically significant effect of therapy. Patients in the BMC group demonstrated an average increase in LVEF of 3.1 percent from baseline to 6 months, whereas patients in the placebo group showed a decrease of -1.6 percent.

"In the largest study to date of autologous BMC therapy in patients with chronic ischemic heart disease and LV dysfunction, we found no effect of therapy on prespecified end points. Further exploratory analysis showed a significant improvement in LVEF associated with treatment. Our findings provide evidence for further studies to determine the relationship between the composition and function of bone marrow product and clinical end points. Understanding these relationships will improve the design and interpretation of future studies of cardiac cell therapy," the authors write.

Share this story on Facebook, Twitter, and Google:

Other social bookmarking and sharing tools:

Story Source:

The above story is reprinted from materials provided by JAMA and Archives Journals.

Read the original here:
Treatment of ischemic heart failure with bone marrow cells does not show improvement for certain heart function measures

SATURDAY, March 24 (HealthDay News) -- An innovative approach using patients' own bone marrow cells to treat chronic heart failure came up short in terms of effectiveness, researchers report.

Use of stem cell therapy to repair the slow, steady damage done to heart muscle and improve heart function is safe, but has not been shown to improve most measures of heart function, the study authors said.

"For the measures we paid most attention to, we saw no effect, there is no question about that," said researcher Dr. Lemuel Moye, a professor of biostatistics at the University of Texas School of Public Health in Houston.

"Ultimately, this is going to pay off handsomely for individuals and for public health in general, but it's going to take years of work," Moye said. "We are the vanguard looking for new promising lines of research."

While the hoped-for results didn't materialize, there appeared to be a small improvement in some patients, he said. "When we looked at another commonly used measure of heart function called ejection fraction, or the strength of the heart's pumping, that's where all the action was," Moye noted.

It's hard to know which measures of heart function to look at, Moye explained. "We have had some difficulty with that," he said.

Future research will look at other measures of heart function, pay more attention to the characteristics of the cells that are injected and determine which cells are best, he added.

Cardiac cells and other types of specially prepared cells are available now that were not accessible when this study started in 2009, Moye pointed out.

The results of the trial, which was sponsored by the U.S. National Heart, Lung, and Blood Institute, were to be presented Saturday at the American College of Cardiology's annual meeting in Chicago. The report was also published online March 24 in the Journal of the American Medical Association.

For the study, Moye and colleagues worked with 92 patients, average age 63 and mostly male, who had heart failure with and without chest pain. They were randomly assigned to receive either an injection of 100 million bone marrow cells from their own bone marrow, or an inactive placebo. Patients in both groups also received aggressive medical therapy.

Read more here:
Stem-Cell Trial Failed to Treat Heart Failure

CHICAGO - Patients with advanced heart disease who received an experimental stem cell therapy showed slightly improved heart function, researchers said at a major U.S. cardiology conference on Saturday.

The clinical trial involved 92 patients, with an average age of 63, who were picked at random to get either a placebo or a series of injections of their own stem cells, taken from their bone marrow, into damaged areas of their hearts.

The patients all had chronic heart disease, along with either heart failure or angina, and their left ventricles were pumping at less than 45 per cent of capacity.

All the participants in the study were ineligible for revascularization surgery, such as coronary bypass to restore blood flow, because their heart disease was so advanced.

Those who received the stem cell therapy saw a small but significant boost in the heart's ability to pump blood, measuring the increase from the heart's main pumping chamber at 2.7 per cent more than placebo patients.

Study authors described the trial as the largest to date to examine stem cell therapy as a route to repairing the heart in patients with chronic ischemic heart disease and left ventricular dysfunction.

"This is the kind of information we need in order to move forward with the clinical use of stem cell therapy," said lead investigator Emerson Perin, director of clinical research for cardiovascular medicine at the Texas Heart Institute.

Perin's research, which was conducted between 2009 and 2011 across five U.S sites, was presented at the annual American College of Cardiology Conference in Chicago.

The technique involved taking bone marrow samples from the patients and processing the marrow to extract stem cells. Doctors then injected the cells via catheter into the heart's left ventricle.

The injections, comprising some 100 million stem cells in all, were specifically targeted at damaged areas, identified by real-time electromechanical mapping of the heart.

More here:
Stem cell treatment could repair heart damage

Public release date: 24-Mar-2012 [ | E-mail | Share ]

Contact: Kristin Wincek kwincek@mhif.org 612-863-0249 Minneapolis Heart Institute Foundation

CHICAGO Cell therapy may present an option for patients with ischemic heart disease to use their own bone marrow cells to repair the damaged areas of their hearts, and may pave the way for future treatment options, according to the FOCUS trial, which will be presented as a late-breaking clinical trial March 24 at the 61st annual American College of Cardiology (ACC) scientific session.

This is the largest study to date to look at stem cell therapy, using a patient's own stem cells, to repair damaged areas of the heart in patients with chronic ischemic heart disease and left ventricular dysfunction. Researchers found that left ventricular ejection fraction (the percentage of blood leaving the heart's main pumping chamber) increased by a small but significant amount (2.7 percent) in patients who received stem cell therapy. The study also revealed that the improvement in ejection fraction correlated with the number of progenitor cells (CD34+ and CD133+) in the bone marrow; and this information will help in evaluating and designing future therapies and trials.

"FOCUS is an incredibly important trial, as it has informed the cell therapy community how to better treat this high-risk patient population, and allows us to enter into an exciting, next generation of stem cell therapy armed with more data," said study investigator Timothy D. Henry, MD, an interventional cardiologist at the Minneapolis Heart Institute (MHI) at Abbott Northwestern Hospital in Minneapolis and director of research with the Minneapolis Heart Institute Foundation.

This multicenter study was conducted by the Cardiovascular Cell Therapy Research Network (CCTRN), which is supported through a research grant from the National Institutes of Health's National, Heart, Lung and Blood Institute (NHLBI), with the goal to evaluate novel stem cell-based treatment strategies for individuals with cardiovascular disease.

FOCUS will be presented at ACC.12 by its lead investigator Emerson C. Perin, MD, PhD, director of clinical research for cardiovascular medicine at the Texas Heart Institute, one of the five sites in the CCTRN. The Minneapolis Heart Institute is another site of the five in the network, and a large number of CCTRN patients were enrolled in Minnesota.

For this study, which took place between April 2009 and April 2011, the five sites randomly selected 92 patients to receive stem cell treatment or placebo. The symptomatic patients, with an average age 63, all had chronic ischemic heart disease and an ejection fraction of less than 45 percent (baseline 34 percent) along with heart failure and/or angina and were no longer candidates for revascularization. "These patients had no other options, as medical management failed to improve their symptoms," explained the study's co-investigator Jay Traverse, MD, an interventionalist cardiologist at the Minneapolis Heart Institute at Abbott Northwestern Hospital and physician researcher with the Minneapolis Heart Institute Foundation.

Bone marrow was aspirated from the patients and processed to obtain just the mononuclear fraction of the marrow. In patients randomly selected to receive stem cell therapy, physicians inserted a catheter into the heart's left ventricle to inject 100 million stem cells in more than 15 sites that showed damage on the electromechanical mapping image of the heart.

"Studies such as these are able to be completed much faster because of the team approach of the network" said Sonia I. Skarlatos, PhD, NHBLI's deputy director of the division of cardiovascular sciences and program director of CCTRN.

Read the rest here:
Cell therapy using patient's own bone marrow may present option for heart disease

Public release date: 24-Mar-2012 [ | E-mail | Share ]

Contact: Jade Waddy Jade.Waddy@uth.tmc.edu 713-500-3030 JAMA and Archives Journals

Use of a patient's bone marrow cells for treating chronic ischemic heart failure did not result in improvement on most measures of heart function, according to a study appearing in JAMA. The study is being published early online to coincide with its presentation at the American College of Cardiology's annual scientific sessions.

Cell therapy has emerged as an innovative approach for treating patients with advanced ischemic heart disease, including those with heart failure. "In patients with ischemic heart disease and heart failure, treatment with autologous [derived from the same individual] bone marrow mononuclear cells (BMCs) has demonstrated safety and has suggested efficacy. None of the clinical trials performed to date, however, have been powered to evaluate specific efficacy measures," according to background information in the article.

Emerson C. Perin, M.D., Ph.D., of the Texas Heart Institute and St. Luke's Episcopal Hospital, Houston and colleagues conducted a study to examine the effect of transendocardial administration (use of a special catheter and injection procedure to deliver stem cells to the heart muscle) of BMCs to patients with chronic ischemic heart disease and left ventricular (LV) dysfunction with heart failure and/or angina. The patients in the phase 2 randomized trial were receiving maximal medical therapy at 5 National Heart, Lung, and Blood Institutesponsored Cardiovascular Cell Therapy Research Network (CCTRN) sites between April 2009 and April 2011. Patients were randomized to receive transendocardial injection of BMCs or placebo. The primary outcomes measured for the study, assessed at 6 months, were changes in left ventricular end-systolic volume (LVESV) assessed by echocardiography, maximal oxygen consumption, and reversibility of perfusion (blood flow) defect on single-photon emission tomography (SPECT). Of 153 patients who provided consent, a total of 92 (82 men; average age: 63 years) were randomized (n = 61 in BMC group and n = 31 in placebo group).

Analysis of data indicated no statistically significant differences between the groups for the primary end points of changes in LVESV index, maximal oxygen consumption, and reversible defect. There were also no differences in any of the secondary outcomes, including percent myocardial defect, total defect size, fixed defect size, regional wall motion (the movement of the wall of the heart during contraction), and clinical improvement.

In an exploratory analysis, the researchers did find that when LVEF was assessed, patients age 62 years or younger showed a statistically significant effect of therapy. Patients in the BMC group demonstrated an average increase in LVEF of 3.1 percent from baseline to 6 months, whereas patients in the placebo group showed a decrease of 1.6 percent.

"In the largest study to date of autologous BMC therapy in patients with chronic ischemic heart disease and LV dysfunction, we found no effect of therapy on prespecified end points. Further exploratory analysis showed a significant improvement in LVEF associated with treatment. Our findings provide evidence for further studies to determine the relationship between the composition and function of bone marrow product and clinical end points. Understanding these relationships will improve the design and interpretation of future studies of cardiac cell therapy," the authors write.

###

(JAMA. 2012;307(16):doi:10.1001/jama.2012.418. Available pre-embargo to the media at http://www.jamamedia.org)

Originally posted here:
Study examines treatment of heart failure with bone marrow cells

SATURDAY, March 24 (HealthDay News) -- An innovative approach using patients' own bone marrow cells to treat chronic heart failure came up short in terms of effectiveness, researchers report.

Use of stem cell therapy to repair the slow, steady damage done to heart muscle and improve heart function is safe, but has not been shown to improve most measures of heart function, the study authors said.

"For the measures we paid most attention to, we saw no effect, there is no question about that," said researcher Dr. Lemuel Moye, a professor of biostatistics at the University of Texas School of Public Health in Houston.

"Ultimately, this is going to pay off handsomely for individuals and for public health in general, but it's going to take years of work," Moye said. "We are the vanguard looking for new promising lines of research."

While the hoped-for results didn't materialize, there appeared to be a small improvement in some patients, he said. "When we looked at another commonly used measure of heart function called ejection fraction, or the strength of the heart's pumping, that's where all the action was," Moye noted.

It's hard to know which measures of heart function to look at, Moye explained. "We have had some difficulty with that," he said.

Future research will look at other measures of heart function, pay more attention to the characteristics of the cells that are injected and determine which cells are best, he added.

Cardiac cells and other types of specially prepared cells are available now that were not accessible when this study started in 2009, Moye pointed out.

The results of the trial, which was sponsored by the U.S. National Heart, Lung, and Blood Institute, were to be presented Saturday at the American College of Cardiology's annual meeting in Chicago. The report was also published online March 24 in the Journal of the American Medical Association.

For the study, Moye and colleagues worked with 92 patients, average age 63 and mostly male, who had heart failure with and without chest pain. They were randomly assigned to receive either an injection of 100 million bone marrow cells from their own bone marrow, or an inactive placebo. Patients in both groups also received aggressive medical therapy.

Link:
Stem-Cell Trial Failed to Treat Heart Failure

CHICAGO - Patients with advanced heart disease who received an experimental stem cell therapy showed slightly improved heart function, researchers said at a major U.S. cardiology conference on Saturday.

The clinical trial involved 92 patients, with an average age of 63, who were picked at random to get either a placebo or a series of injections of their own stem cells, taken from their bone marrow, into damaged areas of their hearts.

The patients all had chronic heart disease, along with either heart failure or angina, and their left ventricles were pumping at less than 45 per cent of capacity.

All the participants in the study were ineligible for revascularization surgery, such as coronary bypass to restore blood flow, because their heart disease was so advanced.

Those who received the stem cell therapy saw a small but significant boost in the heart's ability to pump blood, measuring the increase from the heart's main pumping chamber at 2.7 per cent more than placebo patients.

Study authors described the trial as the largest to date to examine stem cell therapy as a route to repairing the heart in patients with chronic ischemic heart disease and left ventricular dysfunction.

"This is the kind of information we need in order to move forward with the clinical use of stem cell therapy," said lead investigator Emerson Perin, director of clinical research for cardiovascular medicine at the Texas Heart Institute.

Perin's research, which was conducted between 2009 and 2011 across five U.S sites, was presented at the annual American College of Cardiology Conference in Chicago.

The technique involved taking bone marrow samples from the patients and processing the marrow to extract stem cells. Doctors then injected the cells via catheter into the heart's left ventricle.

The injections, comprising some 100 million stem cells in all, were specifically targeted at damaged areas, identified by real-time electromechanical mapping of the heart.

More here:
Stem cell treatment could repair heart damage

Public release date: 24-Mar-2012 [ | E-mail | Share ]

Contact: Kristin Wincek kwincek@mhif.org 612-863-0249 Minneapolis Heart Institute Foundation

CHICAGO Cell therapy may present an option for patients with ischemic heart disease to use their own bone marrow cells to repair the damaged areas of their hearts, and may pave the way for future treatment options, according to the FOCUS trial, which will be presented as a late-breaking clinical trial March 24 at the 61st annual American College of Cardiology (ACC) scientific session.

This is the largest study to date to look at stem cell therapy, using a patient's own stem cells, to repair damaged areas of the heart in patients with chronic ischemic heart disease and left ventricular dysfunction. Researchers found that left ventricular ejection fraction (the percentage of blood leaving the heart's main pumping chamber) increased by a small but significant amount (2.7 percent) in patients who received stem cell therapy. The study also revealed that the improvement in ejection fraction correlated with the number of progenitor cells (CD34+ and CD133+) in the bone marrow; and this information will help in evaluating and designing future therapies and trials.

"FOCUS is an incredibly important trial, as it has informed the cell therapy community how to better treat this high-risk patient population, and allows us to enter into an exciting, next generation of stem cell therapy armed with more data," said study investigator Timothy D. Henry, MD, an interventional cardiologist at the Minneapolis Heart Institute (MHI) at Abbott Northwestern Hospital in Minneapolis and director of research with the Minneapolis Heart Institute Foundation.

This multicenter study was conducted by the Cardiovascular Cell Therapy Research Network (CCTRN), which is supported through a research grant from the National Institutes of Health's National, Heart, Lung and Blood Institute (NHLBI), with the goal to evaluate novel stem cell-based treatment strategies for individuals with cardiovascular disease.

FOCUS will be presented at ACC.12 by its lead investigator Emerson C. Perin, MD, PhD, director of clinical research for cardiovascular medicine at the Texas Heart Institute, one of the five sites in the CCTRN. The Minneapolis Heart Institute is another site of the five in the network, and a large number of CCTRN patients were enrolled in Minnesota.

For this study, which took place between April 2009 and April 2011, the five sites randomly selected 92 patients to receive stem cell treatment or placebo. The symptomatic patients, with an average age 63, all had chronic ischemic heart disease and an ejection fraction of less than 45 percent (baseline 34 percent) along with heart failure and/or angina and were no longer candidates for revascularization. "These patients had no other options, as medical management failed to improve their symptoms," explained the study's co-investigator Jay Traverse, MD, an interventionalist cardiologist at the Minneapolis Heart Institute at Abbott Northwestern Hospital and physician researcher with the Minneapolis Heart Institute Foundation.

Bone marrow was aspirated from the patients and processed to obtain just the mononuclear fraction of the marrow. In patients randomly selected to receive stem cell therapy, physicians inserted a catheter into the heart's left ventricle to inject 100 million stem cells in more than 15 sites that showed damage on the electromechanical mapping image of the heart.

"Studies such as these are able to be completed much faster because of the team approach of the network" said Sonia I. Skarlatos, PhD, NHBLI's deputy director of the division of cardiovascular sciences and program director of CCTRN.

Excerpt from:
Cell therapy using patient's own bone marrow may present option for heart disease

As South Allegheny's first participant in the University of Pittsburgh Gene Team, junior Shannon Wygonik is sharing her love for science with elementary students in her home district.

Hosted by Pitt's biological sciences department, the Gene Team combines research and educational components to foster an interest in science.

Gene Team coordinator Marcie H. Warner believes the inquiry-driven education model inspires high school participants as well as the young students they encounter through the Science Corps portion of the team's program.

"It aims to ignite a love of science in middle and elementary school students by bringing them together with high school students with an interest in science," Warner said. "These high school 'science mentors' come to the classrooms of younger students and present short interactive science lessons that touch on topics such as respiration, natural selection and genetics."

Shannon shared the Science Corps mission Friday with SA fourth-graders in a presentation called "What's in My Pizza?" The lesson focused on yeast's role in the dough-making process and how respiration of the tiny organisms produces carbon dioxide, which causes dough to rise.

Fourth-grader Anessa Short thought the lesson was easy to grasp.

"We got to interact and touch and feel the dough," Anessa said. "It was exciting. It was fun."

Shannon said she loves to see youngsters play with science.

"I really want to share what I know with them," she said. "It gives me an opportunity to teach the kids something exciting something as simple as pizza and how it relates to science."

Gene Team coordinator Brian DiRienzo said passion is what the program strives to achieve.

Here is the original post:
Pitt Gene Team member shares love of science