ETEX Corporation to Present at GTC Stem Cell Summit

CAMBRIDGE, Mass., April 17, 2012 /PRNewswire/ --ETEX Corporation, an advanced biomaterials company, today announced two presentations at the upcoming Global Technology Community 8th Stem Cell Summit, April 19-20, 2012 at the Hyatt Harborside Hotel in Boston, MA. ETEX will highlight their cell carrier development program in two concurrent tracks: Stem Cell Commercialization & Partnering as well as Stem Cell Research & Regenerative Medicine.

(Logo: http://photos.prnewswire.com/prnh/20080424/NETH117LOGO )

Brian Ennis, President and CEO of ETEX Corporation, will deliver an oral presentation entitled "Orthobiologic Market Dynamics, Vision of the Future" during the Stem Cell Commercialization & Partnering session. Mr. Ennis will highlight key elements of a product lifecycle / replacement technology business model, outlining a new approach to skeletal repair and orthopedic innovation. This approach incorporates the combination of biomaterials and hardware, localized bone treatment with systemic therapy and stem cell delivery.

Dr. David Kaplan, Tufts University and Dr. Jerry Chang, ETEX Corporation scientific team will showcase recent advancements in their Stem Cell Carrier program during the Stem Cell Research & Regenerative Medicine session. The poster & power point presentation is entitled "Calcium Phosphate Combination Biomaterials as Human Mesenchymal Stem Cell (hMSC) Delivery Vehicles for Bone Repair".

Brian Ennis comments, "As a pioneer in growth factor and cell delivery technology, ETEX is excited to participate in this important event. We believe a cell carrier/scaffold is a grossly underestimated critical element for the successful execution of cell therapy in skeletal repair and soft tissue regeneration."

Questions regarding ETEX's participation may be directed to Jerry Chang, PhD., jchang@etexcorp.com or 617-577-7270.

About ETEX Corporation Established in 1989, ETEX Corporation develops, manufactures and commercializes calcium phosphate-based biomaterials for improved orthopedic clinical outcomes. A leader in bioresorbable bone substitute materials, ETEX focuses on expanding applications through combinations with cells, biologics, or therapeutic agents delivered in minimally invasive and easy to use systems. For more information, visit http://www.etexcorp.com.

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ETEX Corporation to Present at GTC Stem Cell Summit

Cancer stem cell vaccine in development shows antitumor effect

Public release date: 2-Apr-2012 [ | E-mail | Share ]

Contact: Jeremy Moore Jeremy.Moore@aacr.org 215-446-7109 American Association for Cancer Research

PHILADELPHIA -- Scientists may have discovered a new paradigm for immunotherapy against cancer by priming antibodies and T cells with cancer stem cells, according to a study published in Cancer Research, a journal of the American Association for Cancer Research.

"This is a major breakthrough in immunotherapy research because we were able to use purified cancer stem cells to generate a vaccine, which strengthened the potency of antibodies and T cells that selectively targeted cancer stem cells," said Qiao Li, Ph.D., a research assistant professor in the department of surgery at the University of Michigan.

Cancer stem cells are tumor cells that remain present, and ultimately resistant, after chemotherapy or radiation treatment. Scientists disagree on whether these cells have unique properties, but those who support the uniqueness idea have argued that these cells regenerate the tumors that lead to relapse.

Despite the similar name, cancer stem cells are distinct from embryonic stem cells, and the two avenues of research are separate.

For the current study, Li and colleagues extracted cancer stem cells from two immunocompetent mouse models and used them to prepare the vaccine.

"We found that these enriched cancer stem cells were immunogenic and far more effective as an antigen source compared with the unselected tumor cells normally used in previous immunotherapy trials," said Li. "The mechanistic investigations found that when antibodies were primed with cancer stem cells, they were capable of targeting cancer stem cells and conferring antitumor immunity."

The researchers also found that cytotoxic T lymphocytes harvested from cancer stem cell-vaccinated hosts were capable of killing cancer stem cells in vitro.

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Cancer stem cell vaccine in development shows antitumor effect

Advocacy group linked to stem cell industry asks medical board for less-strict rule

By Mary Ann Roser

AMERICAN-STATESMAN STAFF

An Austin-based group funded mainly by a company that develops stem cell therapies is petitioning the Texas Medical Board for a less-strict rule on adult stem cells an issue the board has struggled with for more than a year.

The board will hold a hearing April 13 on its proposed rule, which would require doctors to get informed consent from patients before performing a stem cell procedure as well as approval from an institutional review board.

Such boards review research to protect patients and are overseen by the U.S. Food and Drug Administration.

At the meeting, the board must either adopt or pull down the much-revised rule, said Mari Robinson, executive director of the medical board.

The group, MedRebels Foundation, which seeks to raise awareness and educate the public about stem cells, will present its petition at the hearing. It has more than 2,500 signatures, many of them gathered near the company's Red River Street office during the South by Southwest Music Conference and Festival, Executive Director Shay McBurney said Friday. The office space is provided by SpineSmith and its parent, Celling Biosciences, which develops products and therapies using a person's own adult stem cells.

The petition asks the board not to put any additional restrictions on adult stem cells that are obtained from a patient's own body, provided they are used in the same medical procedure and not extensively processed or grown outside the body, frozen or stored.

"We were pretty amazed at how many people came and signed our petition," McBurney said.

MedRebels hopes the medical board recognizes that there are different types of stem cells, unlike its proposed rule, which "would classify all stem cells in the same bucket," said Matthew Murphy, a senior scientist at Celling Biosciences who spoke on behalf of MedRebels.

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Advocacy group linked to stem cell industry asks medical board for less-strict rule

The fight to walk

Daniel Leonard is doing all he can to walk again, and after a recent course of stem cell treatment hes as close as he has been since a few months after the 2005 injury that put him a wheelchair.

He was 22 years old and about to begin his third year of college when he woke up one August morning on the floor at his familys Johnson City home unable to move and struggling to breathe.

While the cause of his injury remains a mystery, what is known is that three vertebrae near the top of his spine had been crushed, leaving him paralyzed from the neck down, on a ventilator and not expected to never walk or even breathe on his own again.

Six months after undergoing surgery to remove the bone fragments from his spinal cord, Leonard, who had played several sports in high school and was boxing at the Johnson City Athletic club prior to his injury, was exceeding all expectations.

In treatment at the Patricia Neal Rehabilitation Center in Knoxville, he was not only breathing independently, he was pulling himself up on parallel bars and being fitted with leg braces to help him take his first steps.

Then the unthinkable happed, again. Because there had been nothing done to stabilize his damaged vertebrae, his spine collapsed at the site of his injury and all of his progress was lost.

I worked my butt off to get to the point I was about to start walking, he said. But the gains he had made in upper body strength were erased and there was no longer any movement in his legs.

After a second surgery to fuse the bones, his condition was labeled as incomplete paraplegia characterized by limited movement and sensation in all the muscles below his neck and none at all in his legs. Doctors told his family he would never be able to move his legs, and for many years he could not.

For a while, he lived independently with the assistance of a caregiver. When his caregiver left, he moved to a nursing home, expecting to stay only long enough to find another place and another caregiver. But without money to finance that plan, months turned into years and the Four Oaks Health Care Center in Jonesborough became his home for the long term.

Early last year, things took a turn for the better when for reasons unknown he began to regain some movement in his legs. Encouraged, Leonard once again threw all his effort into physical therapy. In October, he began working out regularly with Amy Caperton, a personal trainer at the Tri-Cities Lifestyles fitness center in Johnson City, and coupled that with physical therapy at the new Mountain States Rehabilitation Center.

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The fight to walk

Stem cell study aids quest for motor neuron disease therapies

ScienceDaily (Mar. 26, 2012) A breakthrough using cutting-edge stem cell research could speed up the discovery of new treatments for motor neuron disease (MND).

The international research team has created motor neurons using skin cells from a patient with an inherited form of MND.

Role of protein

Using patient stem cells to model MND in a dish offers untold possibilities for how we study the cause of this terrible disease as well as accelerating drug discovery by providing a cost-effective way to test many thousands of potential treatments said Professor Siddharthan Chandran, Director of the University's Euan MacDonald Centre for MND Research.

The study discovered that abnormalities of a protein called TDP-43, implicated in more than 90 per cent of cases of MND, resulted in the death of motor neuron cells.

This is the first time that scientists have been able to see the direct effect of abnormal TDP-43 on human motor neurons.

The study, led by the University of Edinburgh's Euan MacDonald Centre for Motor Neuron Disease Research, was carried out in partnership with King's College London, Columbia University, New York and the University of San Francisco.

Motor neuron disease

MND is a devastating, untreatable and ultimately fatal condition that results from progressive loss of the motor nerves -- motor neurons -- that control movement, speech and breathing.

The study, funded by the MND Association, is published in the journal Proceedings of the National Academy of Sciences.

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Stem cell study aids quest for motor neuron disease therapies

Cell Therapy Improves Damaged Heart In Study

March 27, 2012

According to a new study, using a patients own bone marrow may help repair damaged areas of the heart caused by heart failure.

Researchers found that left ventricular ejection fraction increased by 2.7 percent in patients who received stem cell therapy.

The study, which was presented at the American College of Cardiologys 61st Annual Scientific Session, revealed that the improvement in ejection fraction correlated with the number of CD34+ and CD133+ cells in the bone marrow.

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

The study included 92 patients who were randomly selected to receive stem cell treatment or placebo. The patients all had chronic ischemic heart disease and an ejection fraction of less than 45 percent along with heart failure.

Doctors placed a catheter in the hearts left ventricle to inject 3 ccs, or 100 million stem cells, into an average of 15 sites of the stem cell patients hearts.

The doctors used electromechanical mapping of the heart to measure the voltage in areas of the heart muscle and create a real-time image of the heart.

With this mapping procedure, we have a roadmap to the heart muscle, said Dr. Perin. Were very careful about where we inject the cells; electromechanical mapping allows us to target the cell injections to viable areas of the heart.

The trial was designed to determine whether left ventricular end systolic volume and myocardial oxygen consumption improved in patients who received stem cell treatment.

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Cell Therapy Improves Damaged Heart In Study

Stem cell therapy possibly helpful in heart failure patients

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

Contact: Beth Casteel bcasteel@acc.org 240-328-4549 American College of Cardiology

CHICAGO -- A new study found that using a patient's own bone marrow cells may help repair damaged areas of the heart caused by heart failure, according to research presented today at the American College of Cardiology's 61st Annual Scientific Session. The Scientific Session, the premier cardiovascular medical meeting, brings cardiovascular professionals together to further advances in the field.

Millions of Americans suffer from heart failure, the weakening of the heart muscle and its inability to pump blood effectively throughout the body. If medications, surgery, or stents fail to control the disease, doctors often have few treatment options to offer.

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 CD34+ and CD133+ cells in the bone marrow information that will be helpful in evaluating and designing future therapies and trials.

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

This multi-center study was conducted by the Cardiovascular Cell Therapy Research Network and took place between April 2009 and 2011. At five sites, 92 patients were randomly selected to receive stem cell treatment or placebo. The patients, average age 63, all had chronic ischemic heart disease and an ejection fraction of less than 45 percent along with heart failure and/or angina, and were no longer candidates for revascularization.

"Studies such as these are able to be completed much faster because of the team approach of the network," said Sonia Skarlatos, PhD, deputy director of the division of cardiovascular sciences at the National, Heart, Lung and Blood Institute, and program director of the network.

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, doctors inserted a catheter into the heart's left ventricle to inject a total of 3 ccs comprising 100 million stem cells into an average of 15 sites that showed damage on the electromechanical mapping image of the heart. Dr. Perin said the procedure is relatively quick and painless, involving only an overnight stay at the hospital.

The study used electromechanical mapping of the heart to measure the voltage in areas of the heart muscle and create a real-time image of the heart.

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Stem cell therapy possibly helpful in heart failure patients

Houston study shows stem-cell's potential for heart treatment

Houston researchers are reporting that adult stem cells have a modest benefit in younger patients with heart failure, the first large-scale evidence that the controversial yet promising new therapy can be developed to help millions of people with the disease.

In a study presented at a cardiology conference Saturday, Texas Heart Institute doctors presented results of a clinical trial showing that cells derived from patients' own bone marrow produce a small but significant increase in the heart's ability to pump oxygen-rich blood.

"This study moves us one step closer to being able to help patients with severe heart failure who lack other alternatives," said Dr. James Willerson, president of the Texas Heart Institute and the study's principal investigator. "It also points to a future in which stem cells regenerate the heart."

The study did not find improvements in a number of heart function measures, but Willerson and other study leaders said it yielded key information about the specific adult stem cells with the greatest therapeutic potential. The trial used a number of stem cell types.

Transplants limited

About 6 million people in the United States have heart failure, a progressive and eventually fatal disease in which the heart loses the ability to effectively pump sufficient amounts of blood to the body's organs. Better therapy is needed because the limited availability of donor hearts makes transplants an option for only about 2,300 people in the United States annually.

Adult stem cells have become the subject of studies for a variety of conditions - the Texas Heart Institute has many involving the heart - since laboratory research in the late 1990s showed they have the ability to grow into most any kind of tissue. This is the first intermediate-stage study in the United States, characterized by multiple centers and many dozens of patients.

The idea of therapy involving adult stem cells formerly was considered non-controversial, a more ethical alternative to destroying embryos to obtain their stem cells. But it has come under fire recently because it is increasingly being used outside of research studies and for profit, particularly in Texas, where Gov. Rick Perry received it last year for his ailing back. The unregulated activity has prompted complaints to the U.S. Food and Drug Administration and a Texas Medical Board draft policy requiring oversight for any use of experimental drugs.

3.1 percent increase

The new study, presented at an American College of Cardiology conference and to be published in the Journal of the American Medical Association, involved 92 patients at five locations - two-thirds at the Texas Heart Institute - whose hearts were pumping at less than 45 percent of capacity and could not be treated with surgery. Doctors injected patients' own stem cells or placebos into their hearts.

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Houston study shows stem-cell's potential for heart treatment

Stem cell, heart heath study

HOUSTON -

Doctors from the Texas Heart Institute at St. Luke's Episcopal Hospital have found that patients with heart failure may be able to repair the damaged areas of the heart with stem cells from the patient's own bone marrow.

Doctors presented the findings at the American College of Cardiologys 61st Annual Scientific Session Saturday.

The results are from a multi-center clinical study that measured the possible benefits of using a patients own bone marrow cells to repair damaged areas of the heart suffering from severe heart failure, a condition that affects millions of Americans.

The study, which was the largest such investigation to date, found that the hearts of the patients receiving bone marrow derived stem cells showed a small but significant increase in the ability to pump oxygenated blood from the left ventricle, the hearts main pumping chamber, to the body.

The expectation is that the study will pave the way for potential new treatment options and will be important to designing and evaluating future clinical trials.

This is exactly the kind of information we need to move forward with the clinical use of stem cell therapy, said Emerson Perin, MD, PhD, Director of Clinical Research for Cardiovascular Medicine at THI, and one of the studys lead investigators.

The bone-marrow derived stem cells are helpful to the injured heart when they are themselves biologically active, added Dr. James T. Willerson, the studys principal investigator and President and Medical Director of THI.

This study moves us one step closer to being able to help patients with severe heart failure who have no other alternatives.

The study was conducted by the Cardiovascular Cell Therapy Research Network, the national consortium to conduct such research funded by the National Institutes of Healths National Heart, Lung, and Blood Institute.

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Stem cell, heart heath study

Bone Marrow Stem Cell Therapy Trial – Clues, But No Answers

(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

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