Public release date: 26-Jun-2012 [ | E-mail | Share ]

Contact: Gillian Shasby gshasby@thejns.org 434-924-5555 Journal of Neurosurgery Publishing Group

Charlottesville, VA (June 26, 2012). Researchers from the Department of Neurosurgery at the David Geffen School of Medicine and the Department of Integrative Biology and Physiology at UCLA have found that a diet enriched with docosahexaenoic acid (DHA), an omega-3 fatty acid, and curcumin, a component of the Indian spice turmeric, can protect the injured spinal cord and minimize the clinical and biochemical effects of spinal cord myelopathy in rats. This finding is fleshed out in the article "Dietary therapy to promote neuroprotection in chronic spinal cord injury. Laboratory investigation," by Langston Holly, M.D., and colleagues, published today online in the Journal of Neurosurgery: Spine. DHA reduces inflammation and provides structural material to plasma membranes. Curcumin produces strong anti-inflammatory and antioxidant effects. Both agents are safe to use and have been documented to have positive effects on the injured brain. Thus the researchers hypothesized that the combined effects of DHA and curcumin could protect the spinal cord from the cascade of cellular and related biological injuries that result from chronic cord injury.

Cervical spondylotic myelopathy is the most common disorder of the spine found in middle-aged patients. Neurological deficits associated with this disorder are related to a primary mechanical spinal injury that is followed by a secondary biological injury. Wear and tear on the spine, due to age or congenital narrowing of the spinal canal, leads to mechanical compression of the spinal cord. This cord compression in turn leads to biological cell injury or death and consequent neurological dysfunction. The primary mechanical injury can usually be corrected by surgery or other management strategies; to date, the secondary biological injury has been more difficult to treat.

The authors set out to develop a noninvasive way to promote neuroprotection from the biological injury that follows spinal cord compression in cervical spondylotic myelopathy. In the laboratory, the authors studied three groups of rats. To simulate cervical spondylotic myelopathy, the researchers placed an expandable polyvinyl alcohol sponge between two laminae of the spine in the animals. This produced delayed myelopathy. After the procedure, the first group of rats was fed a "Western diet" (a form of rat chow high in saturated fats and sugar), whereas the second group was fed a diet enriched with DHA and curcumin. A third group was given a standard rat diet and the animal's spines were left intact.

The animals' walking ability was examined before the procedure and repeatedly for several weeks following it. The researchers compared each group's walking behavior before and after the procedure and noted any differences between groups. Animals fed the Western diet demonstrated significant gait dysfunction as early as three weeks postoperatively, which continued throughout the six-week test period. Animals fed a diet enriched with DHA and curcumin displayed no significant difference in walking ability compared with preoperatively and demonstrated significantly better gait function six weeks after the procedure than animals fed the Western diet. Accompanying this paper, the authors provide two videos showing differences in gait function between these two groups.

The authors also examined the effects of diet after spinal injury on the molecular level. They measured levels of 4-hydroxynonenal (4-HNE), brain-derived neurotrophic factor (BDNF), and syntaxin-3 in the region of the rat spine that was compressed as well as in a region lower in the spinethe lumbar enlargementwhere nerves controlling the lower limbs are attached to the spinal cord. The lumbar enlargement was included because cord injury can extend downward from the original site. Significantly higher levels of 4-HNE, an indication of severe cellular membrane damage, were found in both spinal sites in rats fed the Western diet. There was no significant difference between the levels of 4-HNE found in rats fed a diet enriched with DHA and curcumin and control rats with intact spines. Levels of BDNF and syntaxin-3 were significantly lower in both spinal sites in rats fed the Western diet. There were no significant differences in the levels of BDNF and syntaxin-3 between rats fed the diet enriched with DHA and curcumin and control rats. BDNF is a key factor involved in neural repair and promotes the transmission of information across synapses. Syntaxin-3 plays an important role in the release of neurotransmitters into the synapses.

This study shows that diet can play an important role in the response of the rat body to spinal injury. Rats fed a diet enriched with DHA and curcumin displayed significantly better walking ability than animals fed a "Western diet" high in saturated fats and sugar. In addition, there were significant differences in the levels of 4-HNE, BDNF, and syntaxin-3 between rats fed the Western diet and rats fed the DHA and curcuminenriched diet. On the other hand, there were no significant differences in any of the parameters examined between rats fed the enriched diet and control rats with intact spines.

On the basis of their findings, the authors conclude: "DHA and curcumin can counteract the effects of chronic spinal cord compression through several molecular mechanisms, resulting in the preservation of neurological function."

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Neuroprotective dietary supplements for chronic spinal cord injury

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HOLLISTON, Mass., June 26, 2012 (GLOBE NEWSWIRE) -- Harvard Bioscience, Inc. (HBIO), a global developer, manufacturer, and marketer of a broad range of tools to advance life science research and regenerative medicine, announces that its "InBreath" bioreactors were used for the world's first and second successful laryngotracheal implants, using synthetic laryngotracheal scaffolds seeded with cells taken from the patients' bone marrow. The surgeries took place at Krasnodar Regional Hospital in Krasnodar, Russia on June 19th and June 21st. The recipients of the implants, Julia T. and Aleksander Z., are recovering well. The implants in the procedures were grown in bioreactors developed by the regenerative medicine device business of Harvard Bioscience.

The transplants, which required more than a half-year of preparation, were performed on the first two patients enrolled in an ongoing clinical trial at Krasnodar Regional Hospital. The Russian Ministry of Health has approved a clinical protocol for an unlimited number of patients in this trial, all of which will involve trachea procedures.

Each bioreactor was specifically adapted by Harvard Bioscience to the clinical requirements for each patient. Each bioreactor was loaded with a synthetic scaffold in the shape of the patient's original organ. The scaffolds were then seeded with the patient's own stem cells. Over the course of about two days, the bioreactor promoted proper cell seeding and development. Because the patients' own stem cells were used, their bodies have accepted the transplants without the use of immunosuppressive drugs.

A photo accompanying this release is available at http://www.globenewswire.com/newsroom/prs/?pkgid=13437

The procedures are the result of a global collaboration involving organizations in the US, Sweden, Russia, Germany, and Italy:

-- The bioreactors were developed, manufactured and prepared by teams at Hugo Sachs Elektronik, a German subsidiary of Harvard Bioscience and at Harvard Bioscience, based in Massachusetts, U.S.A.

-- The scaffolds were created by US-based Nanofiber Solutions.

-- The principal transplant surgeon and main coordinator for both procedures was Dr. Paolo Macchiarini, Professor of Regenerative Surgery at Karolinska Institute in Stockholm.

-- Dr. Macchiarini was assisted by a team of surgeons including Dr. Vladimir Porhanov, Chief Doctor of Krasnodar Regional Hospital and head of the Oncological and Thoracic Department of Kuban State Medical University; thoracic surgeons Dr. Igor Polyakov and Dr. Nikolay Naryzhnyi, of Krasnodar Regional Hospital; Dr. Anatoly Zavrazhnov, deputy chief of Krasnodar Regional Hospital; and Dr. Sergey Sitnick, anesthesiologist and head of Krasnodar Regional Hospital's intensive care unit.

-- Dr. Alessandra Bianco at University of Rome, Tor Vergata, performed mechanical testing during scaffold development.

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Photo Release -- Harvard Bioscience's "InBreath" Bioreactors Used in World's First Successful Regenerated ...

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ScienceDaily (June 26, 2012) Compared to normal cells, cancer cells have a prodigious appetite for glucose, the result of a shift in cell metabolism known as aerobic glycolysis or the "Warburg effect." Researchers focusing on this effect as a possible target for cancer therapies have examined how biochemical signals present in cancer cells regulate the altered metabolic state.

Now, in a unique study, a UCLA research team led by Thomas Graeber, a professor of molecular and medical pharmacology, has investigated the reverse aspect: how the metabolism of glucose affects the biochemical signals present in cancer cells.

In research published June 26 in the journal Molecular Systems Biology, Graeber and his colleagues demonstrate that glucose starvation -- that is, depriving cancer cells of glucose -- activates a metabolic and signaling amplification loop that leads to cancer cell death as a result of the toxic accumulation of reactive oxygen species, the cell-damaging molecules and ions targeted by antioxidants like vitamin C.

The research, which involved UCLA scientists from the Crump Institute for Molecular Imaging, the Institute for Molecular Medicine, the California NanoSystems Institute, the Jonsson Comprehensive Cancer Center, the Eli and Edythe Broad Center of Regenerative Medicine and Stem Cell Research, and the Department of Pathology and Laboratory Medicine, demonstrates the power of systems biology in uncovering relationships between metabolism and signaling at the network level.

"Most strikingly, our discovery that glucose withdrawal causes both cell death and increased tyrosine phosphorylation is intriguing because increased tyrosine kinase signaling is normally associated with cell growth," said Nicholas A. Graham, a senior postdoctoral scholar in Graeber's lab who helped design the project.

To explain the seemingly contradictory result that glucose deprivation reduced viability and at the same time increased signaling, the authors used an unbiased systems-biology approach that included phospho-tyrosine mass spectrometry and other biochemical profiling techniques.

Assessing the "crosstalk" between metabolism and signaling, they discovered that the glucose deprivation activates a positive feedback loop whereby the withdrawal of glucose induces increased levels of reactive oxygen species, which in turn inhibit negative regulators of tyrosine signaling. The resulting supra-physiological levels of tyrosine phosphorylation then generate additional reactive oxygen species.

"Because cancer cells live on the edge of what is metabolically feasible, this amplifying cycle of oxidative stress ultimately overwhelms and kills the cancer cell," Graeber explained. "These findings illustrate the delicate balance that exists between metabolism and signaling in the maintenance of cancer cell homeostasis."

In addition, the authors showed the possibility of exploiting this positive feedback loop for therapeutic intervention. Combining short-term glucose deprivation with an inhibitor of tyrosine phosphatases, they demonstrated synergistic cell death in a cancer cell line.

"Understanding the links between metabolism and signaling will empower new therapeutic approaches toward inducing this metabolic catastrophe," Graham said. "This study provides a framework for rational design of combinatorial therapeutics targeting both metabolism and signaling in cancer."

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Glucose deprivation activates feedback loop that kills cancer cells, study shows

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Researchers in Japan who evaluated the risks and efficacy of transplanting two varieties of stem cells into mouse cochlea have concluded that both adult-derived induced pluripotent stem (iPS) cells and mouse embryonic stem (ES) cells demonstrate similar survival and neural differentiation capabilities. However, there is a risk of tumor growth associated with transplanting iPS cells into mouse cochleae. Given the potential for tumorigenesis, they concluded that the source of iPS cells is a critical issue for iPS cell-based therapy.

Their study is published in a recent issue of Cell Transplantation (21:4), now freely available online.

"Hearing loss affects millions of people worldwide," said Dr. Takayuki Nakagawa of the Department of Otolaryngology, Graduate School of Medicine, Kyoto University, Japan. "Recent studies have indicated the potential of stem-cell based approaches for the regeneration of hair cells and associated auditory primary neurons. These structures are essential for hearing and defects result in profound hearing loss and deafness."

The authors noted that embryonic stem cells have previously been identified as promising candidates for transplantation, however they have also been associated with immune rejection and ethics issues. Consequently, this study compared the survival and neural differentiation capabilities of ES and three clones of mouse iPS cells.

"Our study examined using induced pluripotent stem cells generated from the patient source to determine if they offer a promising alternative to ES cells," explained Dr. Nakagawa. "In addition, the potential for tumor risk from iPS cells needed clarification."

Four weeks after transplantation, the researchers found that the majority of cochleae that had been transplanted exhibited the settlement of iPS or ES-derived neurons. However, there was a difference in the number of cells present based on cell lines. They noted that the number of cells able to be transplanted into cochleae is limited because of the cochleae's tiny size. Thus, the number of settled cells is low.

They also noted the formation of a teratoma (encapsulated tumor) in some cochlea after transplantation with one group of iPS cells.

"To our knowledge, this is the first documentation of teratoma formation in cochleae after cell transplantation," said Dr. Nakagawa.

The researchers concluded that the teratoma formation in one iPS cell line indicated the necessity for selecting appropriate iPS cell lines for avoiding tumorigenesis. They also noted the need for developing methods to eliminate undifferentiated cells after neural induction in order to establish safe iPS-based therapy for the inner ear.

"While this study did not look at the ability of the transplanted cells to repair hearing loss, it does provide insight into the survival and fate of transplanted cells. It highlights the importance of factors such as knowing the original source of the cells and their degree of undifferentiation to enable the cells to be ranked in order of their likelihood of forming tumors" said Dr. John Sladek, professor of neurology and pediatrics at the University of Colorado School of Medicine.

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Stem cell transplantation into mouse cochlea may impact future hearing loss therapies

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Optimal stem cell therapy delivery to damaged areas of the heart after myocardial infarction has been hampered by inefficient homing of cells to the damaged site. However, using rat models, researchers in France have used a magnet to guide cells loaded with iron oxide nanoparticles to key sites, enhancing the myocardial retention of intravascularly delivered endothelial progenitor cells.

The study is published in a recent issue of Cell Transplantation (21:4), now freely available online.

"Cell therapy is a promising approach to myocardial regeneration and neovascularization, but currently suffers from the inefficient homing of cells after intracavitary infusion," said Dr. Philippe Menasche of the INSERM U633 Laboratory of Surgical Research in Paris. "Our study was aimed at improving and controlling homing by loading human cord-blood-derived endothelial progenitor cells (EPCs) for transplant with iron oxide nanoparticles in order to better position and retain them in the hearts of myocardial-injured test rats by using a subcutaneously implanted magnet."

The researchers found that the cells were sufficiently magnetic to be able to be remotely manipulated by a magnet subsequent to implantation.

According to the researchers, an objective assessment of the technique to enhance the homing of circulating stem cells is the ability to track their fate in vivo. This was accomplished by visualization with MRI.

"We found a good correlation between MRI non-invasive follow-up of the injected cells and immunofluoresence or quantitative PCR data," said Dr. Menasche. The researchers concluded that further studies were needed to follow cell homing at later time points. They noted that the magnitude of homing they experienced may have been reduced by the relatively small number of cells used, owing to their large size and the subsequent risk of coronary thrombosis.

"In a rat model of myocardial infarction, this pilot study suggested homing of circulating stem cells can be improved by magnetic targeting and warrants additional benchwork to confirm the validity of concept," said Dr. Menasche. "There is also a need to optimize the parameters of targeting and assess the relevance of this approach in a clinically relevant large animal model."

"This study highlights the use of magnets to target transplanted cells to specific sites which could increase their regenerative impact. Factors to still be extensively tested include confirming the safety of the cells containing the magnetic particles and whether this process alters the cell's abilities" said Dr. Amit N. Patel, director of cardiovascular regenerative medicine at the University of Utah and section editor for Cell Transplantation.

More information: Chaudeurge, A.; Wilhelm, C.; Chen-Tournoux, A.; Farahmand, P.; Bellamy, V.; Autret, G.; Mnager, C.; Hagge, A.; Larghro, J.; Gazeau, F.; Clment, O.; Menasch, P. Can Magnetic Targeting of Magnetically Labeled Circulating Cells Optimize Intramyocardial Cell Retention? Cell Transplant. 21 (4):679-691; 2012.

Journal reference: Cell Transplantation

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Magnet helps target transplanted iron-loaded cells to key areas of heart

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COLORADO SPRINGS, Colo.--(BUSINESS WIRE)--

HemoGenix announced today that FDA CBER has given HemoGenix its first Master File Number for an in vitro blood stem cell potency, quality and release assay (HALO-96 PQR) (1)for cellular therapy products(2)used for stem cell transplantation purposes. HALO-96 PQR is the first commercially available stem cell potency assay for cellular therapy products. It incorporates the most sensitive readout available to measure changes in the cells energy source (ATP) as a function of the potential for stem cells to proliferate. Potency and quality of stem cell therapeutic products are required to be measured prior to use to help predict the engraftment of the cells in the patient. At the present time, tests such as cell number, viability and a stem cell marker called CD34 are routinely used. However, none of these tests specifically measure stem cells and none determine the stem cell biological activity required for a potency assay. The only cell functionality test presently used in this field, especially for umbilical cord blood transplantation, is the colony-forming unit (CFU) assay, which is subjective, non-validated and has been used since the early 1970s. HALO-96 PQR changes this paradigm. It is particularly needed in the umbilical cord blood stem cell transplantation field by providing an application-specific test incorporating all of the compliance characteristics required not only by regulatory agencies(3) and standards organizations, but also the cord blood community(4).

Stem cell potency is one of the most important parameters necessary for any therapeutic product, especially stem cells. Without it, the dose cannot be defined and the transplantation physician has no indication as to whether the product will engraft in the patient. The number of cord blood units collected and stored and the number of cord blood stem cell transplantations have increased exponentially over the last 12 years. During this time, significant advancements have been made in pre- and post stem cell transplantation procedures. Yet the tests used during the preparation and processing of the cells have remained unchanged and do not even measure the biological functionality of the stem cells being transplanted. Indeed, the standards organizations responsible for applying regulatory guidance to the community have so far failed to allow any new and alternative assays to be used during cord blood processing. HALO-96 PQR is the first test that actually quantitatively characterizes and defines the stem cells in cord blood, mobilized peripheral blood or bone marrow as high quality and potent active ingredients for release prior to transplantation. Presently, approximately 20% engraftment failure is encountered in cord blood transplantation. HALO-96 PQR could help reduce the risk of engraftment failure by providing valuable and time-sensitive information on the stem cells prior to use. HALO-96 PQR complies with the guidelines not only with the cord blood community, but also with regulatory agencies thereby providing a benefit to both the stem cell transplantation center and the patient, said Ivan Rich, Founder and CEO of HemoGenix (www.hemogenix.com).

About HemoGenix, Inc.

HemoGenix is a privately held Contract Research Service and Assay Development Laboratory based in Colorado Springs, Colorado. Specializing in predictive in vitro stem cell toxicity testing, HemoGenix provides its services to small, medium and many of the largest biopharmaceutical companies. HemoGenix has developed several assays for stem cell therapy and regenerative medicine applications. These and other patented and proprietary assays are manufactured and produced in Colorado Springs and sold worldwide. HemoGenix has been responsible for changing the paradigm and bringing in vitro stem cell hemotoxicity testing into the 21st century. With HALO-96 PQR the company is now also changing the paradigm to become a leader in stem cell therapy assays. To this end, HemoGenix is a member of the Alliance for Regenerative Medicine and working with other companies to decrease risk and improve safety for the patient.

Literature Cited

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HemoGenix® FDA Master File to Measure Blood Stem Cell Potency for Cellular Therapy Products:

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In just a few years, you might be able to grow your own replacement bones from stem cells.

Using pieces of human or animal bone as scaffolds, a Columbia University team has grown more than 50 healthy bones from stem cells -- the largest approximately 2.5 inches long. Among other specimens, the researchers produced a cheek bone, a small part of a femur bone, and a complex temporomandibular joint (TMJ), which is located in front of each ear and allows for chewing, speaking and smiling.

Using custom-built bioreactors housed at Columbia's Biomedical Engineering Lab, the process currently takes three to five weeks, and the team is working on a faster turnaround.

If we could grow this bone, we could do anything else, professor Gordana Vunjak-Novakovic, who heads up the team, told FoxNews.com. Stem cells are very smart. They can make anything as long as you place them in the right conditions and send them the right signals.

While building the new bone matrix, the cells also break down and decompose the old scaffold. The end result is a fully regenerated bone.

It looks like bone, feels like bone and responds like bone, said Sidney Eisig, a mouth, jaw and neck surgeon who collaborates with the lab to provide data necessary for growing anatomically shaped bones.

- Columbia University professor Gordana Vunjak-Novakovic

Cells that we use are the cells that make bones in our body normally, Vunjak-Novakovic said of the mesenchymal stem cells which reside in the bone marrow. Theyre constantly making and breaking bone. Similar to human skin, bone tissue is very metabolically active and regenerates quickly, which is why broken bones are able to heal. Bone tissue is actually easier to make than certain types of muscle, Vunjak-Novakovic explained. For example, the heart muscle is not designed to regenerate and is much harder to grow.

To prepare the scaffolds, Vunjak-Novakovics team thoroughly washed the animal bone pieces: first with water, which removed 99 percent of cellular material, then with special detergents to clean water resistant surfaces, and finally with enzymes to remove residual DNA from the cells nuclei. The result was a porous non-identifiable bone that could serve as a scaffold for any bone graft, including human.

They are also experimenting with synthetic silk scaffolds supplied by Tufts University.

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Need a Bone? Grow Your Own!

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COLORADO SPRINGS, Colo.--(BUSINESS WIRE)--

HemoGenix announced today that FDA CBER has given HemoGenix its first Master File Number for an in vitro blood stem cell potency, quality and release assay (HALO-96 PQR) (1)for cellular therapy products(2)used for stem cell transplantation purposes. HALO-96 PQR is the first commercially available stem cell potency assay for cellular therapy products. It incorporates the most sensitive readout available to measure changes in the cells energy source (ATP) as a function of the potential for stem cells to proliferate. Potency and quality of stem cell therapeutic products are required to be measured prior to use to help predict the engraftment of the cells in the patient. At the present time, tests such as cell number, viability and a stem cell marker called CD34 are routinely used. However, none of these tests specifically measure stem cells and none determine the stem cell biological activity required for a potency assay. The only cell functionality test presently used in this field, especially for umbilical cord blood transplantation, is the colony-forming unit (CFU) assay, which is subjective, non-validated and has been used since the early 1970s. HALO-96 PQR changes this paradigm. It is particularly needed in the umbilical cord blood stem cell transplantation field by providing an application-specific test incorporating all of the compliance characteristics required not only by regulatory agencies(3) and standards organizations, but also the cord blood community(4).

Stem cell potency is one of the most important parameters necessary for any therapeutic product, especially stem cells. Without it, the dose cannot be defined and the transplantation physician has no indication as to whether the product will engraft in the patient. The number of cord blood units collected and stored and the number of cord blood stem cell transplantations have increased exponentially over the last 12 years. During this time, significant advancements have been made in pre- and post stem cell transplantation procedures. Yet the tests used during the preparation and processing of the cells have remained unchanged and do not even measure the biological functionality of the stem cells being transplanted. Indeed, the standards organizations responsible for applying regulatory guidance to the community have so far failed to allow any new and alternative assays to be used during cord blood processing. HALO-96 PQR is the first test that actually quantitatively characterizes and defines the stem cells in cord blood, mobilized peripheral blood or bone marrow as high quality and potent active ingredients for release prior to transplantation. Presently, approximately 20% engraftment failure is encountered in cord blood transplantation. HALO-96 PQR could help reduce the risk of engraftment failure by providing valuable and time-sensitive information on the stem cells prior to use. HALO-96 PQR complies with the guidelines not only with the cord blood community, but also with regulatory agencies thereby providing a benefit to both the stem cell transplantation center and the patient, said Ivan Rich, Founder and CEO of HemoGenix (www.hemogenix.com).

About HemoGenix, Inc.

HemoGenix is a privately held Contract Research Service and Assay Development Laboratory based in Colorado Springs, Colorado. Specializing in predictive in vitro stem cell toxicity testing, HemoGenix provides its services to small, medium and many of the largest biopharmaceutical companies. HemoGenix has developed several assays for stem cell therapy and regenerative medicine applications. These and other patented and proprietary assays are manufactured and produced in Colorado Springs and sold worldwide. HemoGenix has been responsible for changing the paradigm and bringing in vitro stem cell hemotoxicity testing into the 21st century. With HALO-96 PQR the company is now also changing the paradigm to become a leader in stem cell therapy assays. To this end, HemoGenix is a member of the Alliance for Regenerative Medicine and working with other companies to decrease risk and improve safety for the patient.

Literature Cited

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HemoGenix® FDA Master File to Measure Blood Stem Cell Potency for Cellular Therapy Products:

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Capt. Gene Flipse, president of Conscious Breath Adventures, presents Into the Wild with Dolphins & Whales from 6 to 7 p.m. on Wednesday, June 27 at the Rookery Bay Environmental Learning Center, 300 Tower Road in Naples. Doors open at 5:30 p.m. for a wine and cheese reception with the speaker. The cost is $8 for Friends of Rookery Bay members and $10 for non-members. Registration is suggested at rookerybay.org/upcoming-events. For more information, call 417-6310 x401.

Flipse will introduce guests to some of the most iconic marine species of our sub-tropical corner of the North Atlantic. Join him on a magical and visually stunning journey into their watery realm to learn how to meet them for yourself and the actions we can take to ensure these ocean sentinels are protected for years to come.

Flipse was born in Miami and grew up on the waters of Biscayne Bay, the Keys, the Ten Thousand Islands and the Bahamas. A United States Coast Guard licensed captain for 27 years, Flipse worked for more than 15 years captaining liveaboard dive boats operating between Florida, the Bahamas and the Dominican Republic. During these years, he had his first interactions with wild dolphins and whales in their natural environment. Over the course of his career, he has had the honor to work with world-class explorers, researchers, environmentalists, conservationists, photographers and documentary and feature film makers, guiding them to experience the thrill of swimming with dolphins and whales themselves. His work has also taken him to California, Japan, Australia and Tonga.

The series continues on July 11 with Denise Boyd, research associate for the Florida Fish and Wildlife Conservation Commission Marine Mammal Program, discussing Helping Stranded Marine Mammals.

On July 25, Wayne Hasson, president of Oceans for Youth Foundation and co-founder of Aggressor Fleet, presents Fascinating Humpback Whale Facts. The series concludes on Aug. 15 when Kati Therriault, a manatee research biologist for the Florida Fish and Wildlife Conservation Commission, presents Manatee Response, Recovery and Research.

This story is contributed by a member of the Naples community and is neither endorsed nor affiliated with Naples Daily News

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Gene Flipse is next lecturer in Rookery Bay’s summer series

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MAYNARD, Mass.--(BUSINESS WIRE)--

Allegro Diagnostics today announced the formation of its Clinical and Scientific Advisory Board. Allegro has developed a molecular testing platform that utilizes gene expression of normal epithelial cells in the respiratory tract to detect early signs of lung cancer.

Our advisory board is comprised of some of the most respected and prolific clinicians, researchers and pioneers in the fields of pulmonary medicine, lung cancer and cancer diagnostics, said Michael D. Webb, President and Chief Executive Officer of Allegro Diagnostics. These individuals will play a central role in advising Allegro on its research and development efforts, as well as on the product development strategy for the BronchoGen genomic test, which is approaching commercialization.

The members of the advisory board are:

About the Allegro Platform

Allegro Diagnostics molecular testing platform utilizes gene expression of normal epithelial cells in the respiratory tract to detect early signs of lung cancer. The field of injury principle on which the platform is based refers to the common molecular response that occurs throughout the respiratory tract in current and former smokers with lung cancer. These changes can be detected in a gene expression signature from non-malignant airway cells and indicate the presence of malignancy remotely in the lung. Allegro has applied this platform to generate multiple product candidates.

About Allegro Diagnostics

Allegro Diagnostics is a molecular diagnostics company focused on the development and commercialization of innovative genomic tests for the diagnosis, staging and informed treatment of lung cancer and other lung diseases. Allegro has developed a molecular testing platform that utilizes a genomic biomarker to detect early signs of lung cancer in current and former smokers. The companys lead product is the BronchoGen genomic test for use in combination with standard bronchoscopy for the diagnosis of lung cancer. http://www.allegrodx.com

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Allegro Diagnostics Appoints Clinical and Scientific Advisory Board Comprised of Experts in Pulmonology, Lung Cancer ...

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I have argued that natural genetic engineering is the real creative process in evolutionary innovation. A central but undocumented feature of my argument is that cells can coordinate separate DNA-change events to produce functional new genome structures. How can experimentalists test this argument?

The experiments will probably involve microorganisms, such as bacteria or yeast. A standard procedure for measuring microbial DNA change (mutation) is to place the microbes in a petri dish where they cannot grow into colonies, count the number of cells deposited, incubate them for a period of time, and count the number of colonies that appear. Each colony arose from a mutational event that overcame whatever prevented growth (e.g., inability to utilize the nutrients provided or to synthesize a needed biochemical). The ratio of colonies to cells placed on the growth medium is the mutant frequency. We can measure how various treatments, such as UV irradiation, change this frequency.

Mutation experiments generally look for changes at a single location in the genome. With modern DNA-sequencing technology, the precise changes are easy to identify. Colonies typically appear two to three days after the appropriate DNA change has occurred. In most cases studied, suitable mutations occur in the population prior to plating. Examining the petri dishes after two or three days indicates the frequency of preexisting mutations.

Longer incubation of the selection plates often produces a large increase in the number of colonies. This indicates that mutations continue to occur under selection conditions. By counting these colonies and analyzing the population dynamics of the selected bacteria, we can determine whether selection affects the process of genome change.

When selection significantly stimulates mutations above prior levels, the process is called "adaptive mutation." Molecular geneticists agree that adaptive mutation (observed in different microorganisms) occurs when selective stress triggers natural genetic engineering activities that carry out DNA changes allowing mutated cells to form colonies.

In some cases, we know the consensus interpretation is correct. Together with my colleague Genevieve Maenhaut-Michel, I confirmed this. We studied an experimental situation where the required DNA change (a special type of coding sequence fusion) was never detected during normal growth but increased at least 100,000-fold after selection.

Other groups confirmed selection stress triggering natural genetic engineering by detecting evidence of "induced hypermutation" at various locations throughout the genome and by direct measurement of mutator function.

It is likely that more complex changes can be triggered by selection conditions. My colleague Bernhard Hauer worked for many years at the large German chemical company BASF. In order to produce certain specialty biochemicals, BASF used microbes. But often the good producer organisms would only grow on expensive nutrients. So Bernhard simply plated them on medium containing economic nutrients, waited for a month or so, and harvested the late-appearing colonies. Unfortunately, this was before the days of rapid sequencing, and we do not know what kinds of DNA changes occurred in the long time before the colonies finally appeared.

In order to look for coordinated natural genetic engineering at multiple locations, one approach is to repeat what Bernhard did but start with well-defined strains. We know that coding sequences that lack transcription signals can be activated by the upstream insertion of mobile elements in bacteria and yeast.

The strategy is to engineer strains that could only grow when multiple mobile element insertions activated several different coding sequences. For example, these sequences might encode proteins needed at various steps of a metabolic pathway (for nutrient utilization or for biosynthesis). Selection for activation of all the sequences together simply involves placing the microbes on a medium where the whole pathway is essential for growth, and then waiting for colonies to appear.

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James A. Shapiro: Experimental Evolution: How Can We Watch Natural Genetic Engineering in Real Time?

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Prenatal exposure to bisphenol A -- a compound bearing similarities to the hormone estrogen, which is found in a lot of plastics -- meant lasting genetic changes for female mice when they reached puberty, according to new research that reinforces concerns about the link between BPA and female reproductive disorders.

Yale University School of Medicine researchers presented the data Tuesday at a meeting of The Endocrine Society in Houston, Texas. The research has not yet appeared in a peer-reviewed journal.

Before the mice reached puberty, the Yale team didn't see much difference in the gene expression patterns of BPA-exposed mice and control mice.

But after the mice reached puberty, BPA-exposed mice showed alterations in how much of a gene's product was produced for 365 separate genes. In 208 of those genes, the researchers saw unusual patterns of DNA methylation - a chemical process that regulates how the gene is expressed. Of those 208 genes, at least 14 are known to play roles in the mouse's response to estrogen.

Other studies have linked BPA's estrogen-like characteristic to breast cancer and other disorders with roots in abnormal sensitivity to estrogen, according to the researchers.

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Many major manufacturers have already stopped using BPA in the production of baby bottles and other products, and the U.S. Food and Drug Administration says it is working to develop BPA alternatives for the linings of infant formula cans.

"BPA exposure in utero appears to program uterine estrogen responsiveness in adulthood," lead author Hugh Taylor said in a statement. "Pregnant women should minimize BPA exposure."

Link:
BPA Exposure Alters Genetic Patterns In Pubescent Mice: Study

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ALISO VIEJO, Calif.--(BUSINESS WIRE)--

Ambry Genetics, a global leader in genetics with a focus on clinical diagnostics and genomic services, is sponsoring the Clinical Diagnostics Conference 2012, September 27-29 at the St. Regis Monarch Beach Resort. The event will feature a keynote speech by Kevin Davies, Ph.D., Editor-in-Chief of Bio-IT World and author of The $1,000 Genome: The Revolution in DNA Sequencing and the New Era of Personalized Medicine (Free Press, 2010), as well as a number of industry leaders and surprise guests.

As the name implies, this conference will take a close look at cutting-edge developments in clinical diagnostics and related fields, as well as insights on what comes next, from some of the leaders in the field, commented Charles Dunlop, chief executive officer of Ambry Genetics. This is the first of what we hope will become an annual event, and the speaker roster is growing fast with boldface names from around the world. We invite clinicians and anyone else with an interest in clinical diagnostics, genomics and genetics to join us at the beautiful St. Regis Monarch Beach for two days of enrichment, networking and socializing.

Conference highlights:

About Ambry Genetics

Ambry Genetics is a College of American Pathologists (CAP)-accredited and Clinical Laboratory Improvement Amendments (CLIA)-certified commercial clinical laboratory with headquarters in Aliso Viejo, Orange County, Calif. Since its founding in 1999, it has become a leader in providing genetic services focused on clinical diagnostics and genomic services, particularly in sequencing and array services. Ambry has established a reputation for unparalleled service and has been at the forefront of applying new technologies to the clinical molecular diagnostics market and to the advancement of disease research. To learn more about testing and services available through Ambry Genetics, visit http://www.ambrygen.com.

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Ambry Genetics to Sponsor The Clinical Diagnostics Conference 2012: What’s Next & What’s Now

Recommendation and review posted by Bethany Smith

ScienceDaily (June 26, 2012) In the brains of humans and non-human primates, over 100 billion nerve cells build up complicated neural circuits and produce higher brain functions. When an attempt is made to perform gene therapy for neurological diseases like Parkinson's disease, it is necessary to specify a responsible neural circuit out of many complicated circuits.Until now, however, it was difficult to introduce a target gene into this particular circuit selectively.

The collaborative research group consisting of Professor Masahiko Takada from Primate Research Institute, Kyoto University, Professor Atsushi Nambu from National Institute for Physiological Sciences, National Institutes of Natural Sciences, and Professor Kazuto KOBAYASHI from Fukushima Medical University School of Medicine have now developed a gene transfer technique that can "eliminate"a specific neural circuit in non-human primates for the first time.

They applied this technique to the basal ganglia, the brain region that is affected in movement disorders such as Parkinson's disease, and successfully eliminated a particular circuit selectively to elucidate its functional role. This technique can be applied to gene therapy for various neurological diseases in humans. This research achievement was supported by the Strategic Research Program of Brain Sciences by MEXT of Japan.

The research group developed a special viral vector, NeuRet-IL-2R alpha-GFP viral vector, expressing human interleukin type 2 alpha receptor, which the cell death inducer immunotoxin binds. Nerve cells transfected with this viral vector cause cell death by immunotoxin. First, the research group injected the viral vector into the subthalamic nucleus that is a component of the basal ganglia. Then, they injected immunotoxin into the motor cortex, an area of the cerebral cortex that controls movement, and succeed in selective elimination of the "hyperdirect pathway" that is one of the major circuits connecting the motor cortex to the basal ganglia. As a result, they have discovered that neuronal excitation observed at the early stage occurs through this hyperdirect pathway when motor information derived from the cortex enters the basal ganglia.

Professors Takada and Nambu expect that this gene transfer technique enables us to elucidate higher brain functions in primates and to develop primate models of various psychiatric/neurological disorders and their potential treatments including gene therapy. They think that this should provide novel advances in the field of neuroscience research that originate from Japan.

This research was supported by the Strategic Research Program of Brain Sciences by MEXT of Japan.

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The above story is reprinted from materials provided by National Institute for Physiological Sciences.

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Transgenic technique 'eliminates' a specific neural circuit in brain of primates

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The Sugar Land company involved in Gov. Rick Perry's unlicensed adult stem-cell procedure is rife with basic manufacturing problems, according to the U.S. Food and Drug Administration.

In a report one expert called a blow to the entire adult stem-cell industry, the FDA found that Celltex Therapeutics Corp. cannot guarantee the sterility, uniformity and integrity of stem cells it takes from people and then stores and grows for eventual therapeutic reinjection.

"You have not performed a validation of your banking and thawing process to assure viability" of the stem cells, reads the April 27 report, meaning that the company cannot verify the cells are alive.

The FDA report, which followed an April 16-27 inspection of Celltex, was released under the Freedom of Information Act Monday to the Houston Chronicle and a University of Minnesota bioethicist who complained in February that Celltex is a potential danger to patients and not in compliance with federal law.

The report, partially redacted, was not accompanied by a warning letter.

A former FDA official who read it, however, said the deficiencies - 79 in all, from incorrectly labeled products to failed sterility tests - are so serious that Celltex risks being shut down if it does not remedy the problems quickly. The former official asked not to be identified.

Adult stem cells are cells in the body that multiply to replenish dying cells. Long used to treat leukemia and other cancers, they have shown promise for tissue repair in many other diseases in the last decade, although most scientists in the field consider them not ready for mainstream use.

Rules take effect Friday

Celltex has been in the public eye since it was revealed that Perry's Houston doctor treated him with his own stem cells during back surgery last July and in follow-up appointments. His stem cells were stored and grown at Celltex.

Perry subsequently called for Texas to become the nation's leader of adult stem cell medicine, which he touts as an ethical alternative to embryonic stem cells. Perry worked with his Houston doctor and a state representative to write legislation intended to commercialize the therapy in Texas.

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Stem-cell company used by Perry troubles feds

Recommendation and review posted by simmons

SUNRISE, Fla., June 25, 2012 (GLOBE NEWSWIRE) -- Bioheart, Inc. (BHRT.OB) announced today that Kristin Comella, the company's Chief Science Officer presented at the 10th Annual Meeting of the International Society for Stem Cell Research (ISSCR) in Yokohama, Japan June 13 - 16, 2012. One of the world's premier stem cell research events, the ISSCR format includes international research and poster presentations from invited speakers, exceptional peer-to-peer learning and unparalleled networking opportunities.

Comella presented a poster on clinical applications of adipose or fat derived stem cells (ADSCs).

The ISSCR annual meeting serves as the largest forum for stem cell and regenerative medicine professionals from around the world. Through lectures, symposia, workshops, and events attendees experience innovative stem cell and regenerative medicine research, advances and what's on the horizon. The meeting features more than 1,000 abstracts, nearly 150 speakers and provides numerous networking and professional development opportunities and social events. For additional information, visit http://www.isscr.org.

Kristin Comella has over 14 years experience in corporate entities with expertise in regenerative medicine, training and education, research, product development and senior management including more than 10 years of cell culturing experience. She has made a significant contribution to Bioheart's product development, manufacturing and quality systems since she joined the company in September 2004.

About Bioheart, Inc.

Bioheart is committed to maintaining its leading position within the cardiovascular sector of the cell technology industry delivering cell therapies and biologics that help address congestive heart failure, lower limb ischemia, chronic heart ischemia, acute myocardial infarctions and other issues. Bioheart's goals are to cause damaged tissue to be regenerated, when possible, and to improve a patient's quality of life and reduce health care costs and hospitalizations.

Specific to biotechnology, Bioheart is focused on the discovery, development and, subject to regulatory approval, commercialization of autologous cell therapies for the treatment of chronic and acute heart damage and peripheral vascular disease. Its leading product, MyoCell, is a clinical muscle-derived cell therapy designed to populate regions of scar tissue within a patient's heart with new living cells for the purpose of improving cardiac function in chronic heart failure patients. For more information on Bioheart, visit http://www.bioheartinc.com, or visit us on Facebook: Bioheart and Twitter @BioheartInc.

Forward-Looking Statements: Except for historical matters contained herein, statements made in this press release are forward-looking statements. Without limiting the generality of the foregoing, words such as "may," "will," "to," "plan," "expect," "believe," "anticipate," "intend," "could," "would," "estimate," or "continue" or the negative other variations thereof or comparable terminology are intended to identify forward-looking statements.

Forward-looking statements involve known and unknown risks, uncertainties and other factors which may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. Also, forward-looking statements represent our management's beliefs and assumptions only as of the date hereof. Except as required by law, we assume no obligation to update these forward-looking statements publicly, or to update the reasons actual results could differ materially from those anticipated in these forward-looking statements, even if new information becomes available in the future.

The Company is subject to the risks and uncertainties described in its filings with the Securities and Exchange Commission, including the section entitled "Risk Factors" in its Annual Report on Form 10-K for the year ended December 31, 2011, and its Quarterly Report on Form 10-Q for the quarter ended March 30, 2012.

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Bioheart's Chief Science Officer Kristin Comella Presents at 10th Annual Meeting of International Society for Stem ...

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ScienceDaily (June 25, 2012) If you break a bone, you know you'll end up in a cast for weeks. But what if the time it took to heal a break could be cut in half? Or cut to just a tenth of the time it takes now? Qian Wang, a chemistry professor at the University of South Carolina, has made tantalizing progress toward that goal.

Wang, Andrew Lee and co-workers just reported in Molecular Pharmaceutics that surfaces coated with bionanoparticles could greatly accelerate the early phases of bone growth. Their coatings, based in part on genetically modified Tobacco mosaic virus, reduced the amount of time it took to convert stem cells into bone nodules -- from two weeks to just two days.

The key to hastening bone healing or growth is to coax a perfectly natural process to pick up the pace.

"If you break a rib, or a finger, the healing is automatic," said Wang. "You need to get the bones aligned to be sure it works as well as possible, but then nature takes over."

Healing is indeed very natural. The human body continuously generates and circulates cells that are undifferentiated; that is, they can be converted into the components of a range of tissues, such as skin or muscle or bone, depending on what the body needs.

The conversion of these cells -- called stem cells -- is set into motion by external cues. In bone healing, the body senses the break at the cellular level and begins converting stem cells into new bone cells at the location of the break, bonding the fracture back into a single unit. The process is very slow, which is helpful in allowing a fracture to be properly set, but after that point the wait is at least an inconvenience, and in some cases highly detrimental.

"With a broken femur, a leg, you can be really incapacitated for a long time," said Wang. "In cases like that, they sometimes inject a protein-based drug, BMP-2, which is very effective in speeding up the healing process. Unfortunately, it's very expensive and can also have some side effects."

In a search for alternatives four years ago, Wang and colleagues uncovered some unexpected accelerants of bone growth: plant viruses. They originally meant for these viruses, which are harmless to humans, to work as controls. They coated glass surfaces with uniform coverings of the Turnip yellow mosaic virus and Tobacco mosaic virus, originally intending to use them as starting points for examining other potential variations.

But they were surprised to find that the coatings alone could reduce the amount of time to grow bone nodules from stem cells. Since then, Wang and co-workers have refined their approach to better define just what it is that accelerates bone growth.

Over the course of the past four years, they've demonstrated that it's a combination of the chemistry as well as the topography of the surface that determines how long it takes a stem cell to form bone nodules. The stem cells are nestled into a nanotopgraphy defined by the plant virus, and within that nanotopography the cells make contact with the variety of chemical groups on the viral surface.

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Speeding up bone growth by manipulating stem cells

Recommendation and review posted by Bethany Smith

25-06-2012 00:49 ProGenaCell physicians provide advanced cellular therapy to patients suffering from all known degenerative diseases. For over 70 years cell therapy has been used safely and effectively in such diverse regions as the European Union, former USSR, Republic of China, Middle East, Pacific Rim, Central and South America, Baja California and more recently the United States under select clinical trials. ProGenaCell provides patients with autologous stem cells (patient's own cells), adult progenitor xenocells, and organ extracts & growth factors. These "cellular products" are delivered to physicians who have been approved to prescribe and administer cellular therapies to patients in need. All cellular products are lawfully manufactured, and regulated under strict European Union guidelines. Visit us:

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Dr. Ulrich Friedrichson, MD,PHD - Cell Therapy Introduction - Video

Recommendation and review posted by Bethany Smith

NEW YORK, June 25, 2012 (GLOBE NEWSWIRE) -- NeoStem, Inc. (NYSE MKT:NBS) ("NeoStem" or the "Company"), a cell therapy company, today announced that it has been awarded a two year grant totaling $595,252 for the "Development of Human, Autologous, Pluripotent Very Small Embryonic Like (VSELs) Stem Cells as a Countermeasure to Radiation Threat" from the National Institute of Allergy and Infectious Diseases (NIAID), a division of the National Institutes of Health (NIH). This peer reviewed grant was awarded to support research to be headed by Denis O. Rodgerson, Ph.D., Director of Stem Cell Science for NeoStem and Mariusz Ratajczak, M.D., Ph.D., who is the head of the Stem Cell Biology Program at the James Graham Brown Cancer Center at the University of Louisville and co-inventor of VSELTM Technology.

This award will fund studies to investigate the potential of very small embryonic-like stem cells as a countermeasure to radiological and nuclear threat. The product candidate, which is an autologous stem cell therapy derived from the patient's own stem cells, will be developed to rescue patients who have been exposed to radiation due to nuclear accident or terrorist threat and to treat cancer patients who have undergone radiation therapy and who consequently have compromised immune systems. The award includes $295,252 for the first year and $300,000 for the second year of the project.

Dr. Denis O. Rodgerson, Director of Stem Cell Science for NeoStem, said, "We are very excited to add radiation treatment to the growing list of indications for which our VSELTM Technology is being evaluated. Those exposed to acute high-dose radiation have compromised immune systems such that the virulence and infectivity of biological agents is dramatically increased. Death can occur within 1-6 weeks following radiation exposure. Currently there is only one intervention that saves a fatally irradiated person -- a rescue through stem cell transplantation. VSELs might be an ideal cell therapy to regenerate the body's immune system and repair other tissues damaged by radiation exposure. Most importantly, early studies show VSELs are resistant to lethal radiation which destroys other immune system restoring stem cells in the body, making autologous treatment post-exposure possible."

Dr. Robin L. Smith, Chairman and CEO of NeoStem, added, "NeoStem is pleased that the NIAID is funding this cutting edge technology that we hope will reinvent the treatment landscape for acute radiation syndrome. We plan to continue to pursue NIH SBIR grants to fund our VSEL technology platform development with non-dilutive capital."

About VSELTM Technology

NeoStem has a worldwide exclusive license to VSELTM Technology. Research by Dr. Mariusz Ratajczak, M.D., Ph.D., and others at the University of Louisville provides compelling evidence that bone marrow contains a heterogeneous population of stem cells that have properties similar to those of an embryonic stem cell. These cells are referred to as very small embryonic-like stem cells. This finding opens the possibility of capturing some of the key advantages associated with embryonic stem cells without the ethical or moral dilemmas and without some of the potential negative biological effects associated with stem cells of embryonic derivation. The possibility of autologous VSEL treatments is yet another important potential benefit to this unique population of adult stem cells. VSELTM Technology offers the potential to go beyond the paracrine effect, yielding cells that actually differentiate into the target tissue creating true cellular regeneration.

About NeoStem, Inc.

NeoStem, Inc. ("we," "NeoStem" or the "Company") continues to develop and build on its core capabilities in cell therapy to capitalize on the paradigm shift that we see occurring in medicine. In particular, we anticipate that cell therapy will have a large role in the fight against chronic disease and in lessening the economic burden that these diseases pose to modern society. Our January 2011 acquisition of Progenitor Cell Therapy, LLC ("PCT") provides NeoStem with a foundation in both manufacturing and regulatory affairs expertise. We believe this expertise, coupled with our existing research capabilities and collaborations, will allow us to achieve our mission of becoming a premier cell therapy company. Our PCT subsidiary's manufacturing base is one of the few current Good Manufacturing Practices ("cGMP") facilities available for contracting in the burgeoning cell therapy industry. Amorcyte, LLC ("Amorcyte"), which we acquired in October 2011, is developing a cell therapy for the treatment of cardiovascular disease. Amorcyte's lead compound, AMR-001, represents NeoStem's most clinically advanced therapeutic and Amorcyte is enrolling patients for a Phase 2 trial to investigate AMR-001's efficacy in preserving heart function after a heart attack. We also expect to begin a Phase 1 clinical trial by 2012/2013 to investigate AMR-001's utility in arresting the progression of congestive heart failure and the associated comorbidities of that disease. Athelos Corporation ("Athelos"), which is approximately 80%-owned by our subsidiary, PCT, is engaged in collaboration with Becton-Dickinson that is exploring the earlier stage clinical development of a T-cell therapy for autoimmune conditions. In addition, our pre-clinical assets include our VSELTM Technology platform as well as our MSC (mesenchymal stem cells) product candidate for regenerative medicine.

For more information on NeoStem, please visit http://www.neostem.com.

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NeoStem Awarded NIAID Research Grant for the Development of VSEL Technology for Radiation Exposure

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

Contact: Kim Menard kim.menard@uphs.upenn.edu 215-662-6183 University of Pennsylvania School of Medicine

PHILADELPHIA - A new test can be used to identify low-risk thyroid nodules, reducing unnecessary surgeries for people with thyroid nodules that have indeterminate results after biopsy. The results of the multi-center trial, which includes researchers from the Perelman School of Medicine at the University of Pennsylvania, appear online in the New England Journal of Medicine.

Ultrasound-guided fine-needle aspiration biopsies (FNA) accurately identify 62-85 percent of thyroid nodules as benign. For those deemed malignant or unclassifiable, surgery is currently required. However, about 20-35 percent of nodules have inconclusive results after FNA. This novel test classifies genes from the thyroid nodule tissue obtained through FNA.

"This test, currently available at Penn Medicine, can help us determine whether these nodules with indeterminate biopsy results are likely to be benign," said Susan Mandel, MD, MPH, professor of Medicine in Endocrinology, Diabetes and Metabolism in the Perelman School of Medicine at Penn."If so, patients may be able to avoid unnecessary surgeries and lifelong thyroid hormone replacement treatment."

In an accompanying NEJM editorial, J. Larry Jameson, MD, PhD, Dean of the Perelman School of Medicine and Executive Vice President for the Health System at the University of Pennsylvania, notes that the gene expression test is able to identify nodules at low risk of malignancy, making it possible to avoid approximately 25,000 thyroid surgeries per year. "In this era of focusing on high-quality outcomes at lower cost, this new gene expression classifier test is a welcome addition to the tools available for informed decision making about the management of thyroid nodules," writes Jameson.

The gene expression classifier was tested on 265 indeterminate thyroid nodules, and was able to correctly identify 92 percent of cases as suspicious. The test demonstrated a 85 - 95 percent negative predictive value, effectively ruling out a malignancy.

The Penn research team included Dr. Mandel, Zubair Baloch, MD, PhD, and Virginia A. LiVolsi, MD, both professors of Pathology and Laboratory Medicine. The investigation was funded by a research grant provided by Veracyte, Inc., the maker of the gene expression classifier.

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Penn Medicine is one of the world's leading academic medical centers, dedicated to the related missions of medical education, biomedical research, and excellence in patient care. Penn Medicine consists of the Raymond and Ruth Perelman School of Medicine at the University of Pennsylvania (founded in 1765 as the nation's first medical school) and the University of Pennsylvania Health System, which together form a $4.3 billion enterprise.

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Gene expression test identifies low-risk thyroid nodules

Recommendation and review posted by Bethany Smith

SAN DIEGO--(BUSINESS WIRE)--

Pathway Genomics Corporation, a San Diego-based genetic testing laboratory, has partnered with Diagnsticos da Amrica (DASA), the largest private medical diagnostics company in Latin America and the fourth largest provider of diagnostic services in the world. Based in Brazil, DASAs clinical analysis division collects samples from more than 500 patient service centers and has 11 central laboratories. DASAs brands include Alta Excelncia Diagnstica, Delboni Auriemo, Lavoisier, CDPI, Srgio Franco, Pasteur, Exame and others. Through this partnership, physicians have access to Pathways valuable genetic testing services, bringing additional personalized care to more than 180 million people in Brazil.

Pathways vision is to responsibly reveal personalized and actionable genetic information in order to globally educate, inform and improve health and well-being, said Dr. Michael Nova, Pathways chief medical officer. Our alignment with DASA is a major part of this vision, and we are excited to help bring this scientifically-advanced technology to the people of Brazil.

Specifically, through DASA, physicians in Brazil now have access to multiple genetic tests, including:

The partnership between DASA and Pathway represents a milestone in Brazilian medicine, ensuring access to predictive genetic tests through an advanced and innovative technology, said Dr. Octvio Fernandes, DASAs chief operating officer. DASA is a reference in Brazil due to our excellence, innovation and quality in medical diagnostic services. With 50 years of expertise, the company has one of the largest medical teams in Latin America, composed of nearly 2,000 world-renowned doctors, and offering more than 3,000 types of laboratory tests and imaging diagnostics provided by more than 18,000 professionals.

Pathways laboratory is accredited by the College of American Pathologists (CAP) and accredited in accordance with the U.S. Health and Human Services Clinical Laboratory Improvement Amendments (CLIA) of 1988. Pathway is also a member of the American Clinical Laboratory Association (ACLA). The company consists of more than 40 scientific and medical professionals, including medical doctors, molecular geneticists, and genetic counselors, as well as an expert scientific advisory board.

About Pathway Genomics Corporation

Pathway Genomics owns and operates an on-site genetic testing laboratory that is accredited by the College of American Pathologists (CAP), accredited in accordance with the U.S. Health and Human Services Clinical Laboratory Improvement Amendments (CLIA) of 1988, and licensed by the state of California. Using only a saliva sample, the company incorporates customized and scientifically validated technologies to generate personalized reports, which address a variety of medical issues, including an individuals carrier status for recessive genetic conditions, food metabolism and exercise response, prescription drug response, and propensity to develop certain diseases such as heart disease, type 2 diabetes and cancer. For more information about Pathway Genomics, visit http://www.pathway.com.

About DASA

DASA is the largest private medical diagnostics company in Latin America offering a portfolio of over 3,000 clinical analysis and imaging tests. In the clinical analysis segment, samples are collected in more than 500 patient service centers and analyzed in 11 central laboratories. In the diagnostic imaging segment, the images are submitted to physicians for analysis and reporting according to their medical specialty. For more information about DASA, visit http://www.dasa.com.br.

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Pathway Genomics Partners with DASA, the Largest Private Medical Diagnostics Company in Brazil

Recommendation and review posted by Bethany Smith

Brian Wellss job is to make big data and technology issues disappear for the researchers at the Perelman School of Medicine. He is building the technical infrastructure needed to achieve the goals of personalized medicine regarding biobanking and genetic sequencing. This associate chief information officer for Health Technology and Academic Computing at Penn Medicine recently spoke with MedCity News about some new developments at Penn including his thoughts on the challenge of sharing electronic medical records.

What have been some of the unforeseen consequences of the growth of information technology in healthcare?

There will be increasing desire to provide access to all that information the problem is we dont have unified standards for access. So the exchange of real data discretely is very difficult today.

What we call a white blood cell count at Penn is probably different than what Geisinger calls it and thats just one lab test. The exchange and utilization of data that can be acted on electronically is pretty constrained. We have many ways to record information, but not as many common ways to share information.

For example, there may be as many as 10 coding systems. LOINC is the industry standard for lab tests. In the world of drugs there are three to four different systems. For diagnoses, a 70-fold explosion in the world of codes is on the horizon. Were about to shift from ICD-09 to ICD-10 (the coding system tied to reimbursement).

What have been some of the biggest challenges faced in implementing EMR to meet Meaningful Use criteria?

We are in very good shape for stage 1. Stage 2 is a little more difficult. CMS will want us to be able to exchange data with other hospitals without the same software. And it must be a facility that has at least 10 percent of our patients. That may be daunting for a tertiary care facility like Penn.

What about personal health records?

The whole personal health record industry came and went and failed because patients are busy. Its a lot of work to constantly update a PHR. The concept of a tethered PHR in which records are linked and tethered to Penn (such as mypennmedicine.org) is having more success in the industry.

And the new standard the FCC has just announced, Medical Body Area Networks, or MBAN, will allow devices to transmit data without wires. Its a protected bandwidth the FCC will preserve and Im sure vendors are jumping on that technology and will make it easier and more reliable to transmit that data.

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Penn Medicine HIT expert: Patient expectations ahead of current EHR capabilities

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WESTMINSTER, Colo., June 25, 2012 /PRNewswire/ --GeneThera Inc. (OTCQB: GTHR) is pleased to announce that Applied Genetics, GeneThera's majority owned subsidiary, has initiated commercial operation of its molecular diagnostic laboratory based in Monterrey, Mexico. Applied Genetics molecular diagnostic laboratory is the first molecular laboratory in Mexico, to date, which is capable to detect Johne's disease at the molecular level in milk, blood, and feces from dairy cows, goats and sheep infected with the disease using state-of-the-art molecular technology. Applied Genetics utilizes GeneThera proprietary Johne's disease HerdCheck Field Collection System (FCS) Molecular Assay. Dr. Tony Milici, interim president of Applied Genetics and CEO of GeneThera, stated; "The starting of Applied Genetics commercial operation is a great success for GeneThera. I think it is pretty remarkable that we were able to accomplish our goal in less than 18 months. This achievement was made possible thanks to the commitment and dedication of the Company's management and the outstanding support of our loyal investors and collaborators. I have to thank deeply all the people who believed in the Company and its ability to achieve its goals; I am grateful."

Nutrition Avanzada, GeneThera's exclusive buyer and distributor of the proprietary Johne's disease molecular system in Mexico, has entered into an agreement with a large veterinary laboratory in Northern Mexico. This agreement will provide access to about 20,000 animals initially. These animals will be tested for the presence of mycobacterium paratuberculosis in milk, blood and feces. Positive animals will be tested every 3 months to monitor progress of the disease. The cost of the test will range from US $30.00 $32.00. In addition, Nutrition Avanzada is in the final negotiation stages with two of the largest dairy companies in Mexico.

As previously announced Nutricion Avanzada will purchase the Johne's disease Field Collection System kit from Applied Genetics and resell it directly to third parties. Samples will be then shipped to Applied Genetics laboratory for processing. The commercial operation will be implemented in Three (3) Phases: during the current initial Phase (Phase I), Applied Genetics target is to process a maximum of 100 samples/daily. Phase II, to be initiated in late fall of 2012, will increase Applied Genetics sample process throughput to 1500 samples/daily. Phase II will be implemented in the early part of 2013, which will further increase sample throughput to over 2000 samples daily.

Johne's disease is a global devastating and incurable disease of dairy cows, sheep and goats caused by a bacterium called Mycobacterium Paratuberculosis sub. Avium, (MAP). Dairy products, contaminated with MAP, are the vehicles by which the infection spreads in the human intestine triggering the onset of Crohn's disease. Applied Genetics employs the use of GeneThera HerdCheck to test and control the spread of Johne's disease in Mexico. HerdCheck is a proprietary molecular diagnostic system based on the use of high throughput robotics and Real time PCR.

About GeneThera, Inc.

GeneThera, Inc. is a molecular biotechnology company located in Westminster, Colorado. The Company's proprietary diagnostic solution is based on a genetic expression system, GES and Johne's disease management system, HERDCHECK designed to function on a highly automated Fluorogenic PCR platform. This platform enables GeneThera to offer tests that are presently not available from other technologies. The GES and HERDCHECK systems are designed for a host of individual diseases, the current priority being Johne's disease. For more information, contact Dr. Tony Milici at 720-439-3011. http://www.genethera.net

This press release contains forward-looking statements, which are made pursuant to the Safe-Harbor provisions of the Private Securities Litigation Reform Act of 1995. Words such as "intends," "believes," and similar expressions reflecting something other than historical fact are intended to identify forward-looking statements, but are not the exclusive means of identifying such statements. These forward-looking statements involve a number of risks and uncertainties, including the timely development and market acceptance of products and technologies, the ability to secure additional sources of finance, the ability to reduce operating expenses, and other factors described in the Company's filings with the Securities and Exchange Commission. The actual results that the Company achieves may differ materially from any forward-looking statement due to such risks and uncertainties. The Company undertakes no obligation to revise or update any forward-looking statements in order to reflect events or circumstances that may arise after the date of this release.

GeneThera, Inc

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Applied Genetics Initiates Commercial Operation

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

Contact: Vicki Cohn vcohn@liebertpub.com 914-740-2100 x2156 Mary Ann Liebert, Inc./Genetic Engineering News

New Rochelle, NY, June 25, 2012Gene therapy to replace the protein missing in Pompe disease can be effective if the patient's immune system does not react against the therapy. Targeted delivery of the gene to the liver, instead of throughout the body,suppresses the immune response, improving the therapeutic effect, according to an article published in Human Gene Therapy, a peer-reviewed journal from Mary Ann Liebert, Inc. The article is available free online at the Human Gene Therapy website.

"The current unmet medical need in Pompe disease is for prevention of immune responses against standard-of-care enzyme replacement therapy," says coauthor Dwight Koeberl, MD, PhD. "However, we foresee a future application of the dual vector strategy described in this paper, including a liver-expressing vector along with a ubiquitously expressing vector, which might achieve much higher efficacy than either vector alone."

In the article "Immunodominant Liver-Specific Expression Suppresses Transgene-Directed Immune Responses in Murine Pompe Disease," Ping Zhang and coauthors from Duke University Medical Center (Durham, NC), targeted a gene delivery vector carrying the therapeutic gene to the livers of mice with Pompe disease. Not only did the liver-specific expression of the protein induce immune tolerance, but when combined with non-targeted delivery of the therapeutic gene it also boosted the overall effectiveness of the treatment.

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About the Journal

Human Gene Therapy, the Official Journal of the European Society of Gene and Cell Therapy, British Society for Gene Therapy, French Society of Cell and Gene Therapy, German Society of Gene Therapy, and five other gene therapy societies is an authoritative peer-reviewed journal published monthly in print and online that presents reports on the transfer and expression of genes in mammals, including humans. Related topics include improvements in vector development, delivery systems, and animal models, particularly in the areas of cancer, heart disease, viral disease, genetic disease, and neurological disease, as well as ethical, legal, and regulatory issues related to the gene transfer in humans. Tables of content and a free sample issue may be viewed online at the Human Gene Therapy website.

About the Publisher

Mary Ann Liebert, Inc. is a privately held, fully integrated media company known for establishing authoritative peer-reviewed journals in many promising areas of science and biomedical research, including Tissue Engineering, Stem Cells and Development, and Cellular Reprogramming. Its biotechnology trade magazine, Genetic Engineering & Biotechnology News (GEN), was the first in its field and is today the industry's most widely read publication worldwide. A complete list of the firm's 70 journals, books, and newsmagazines is available at the Mary Ann Liebert, Inc. website.

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Targeted gene therapy enhances treatment for Pompe disease

Recommendation and review posted by Bethany Smith

By Elizabeth Lopatto - 2012-06-25T19:00:00Z

Chronic stress appears to block a gene that guards against brain atrophy associated with depression, according to a study in rats that may help guide new treatments for mood disorders.

The gene, called neuritin, appears to be responsible for keeping healthy neuron connections in certain parts of the brain, according to the study published in the Proceedings of the National Academy of Sciences. Rats whose genes were suppressed were more anxious and depressed than those whose genes werent, an experiment found. Further, activating the gene led to an antidepressant response.

The research adds evidence to the idea that depression may be caused by atrophy in the hippocampus, the part of the brain responsible for mood and memory. Scientists have previously shown that some antidepressants increase the growth of new connections, called synapses, between neurons.

This is based on findings that basically stress and depression have been shown to cause atrophy, said Ronald Duman, a study author and professor of psychiatry at Yale University in New Haven, Connecticut, in a telephone interview. Theres good evidence theres a loss of synaptic connections in depressed rodents and depressed patients. If you dont have the appropriate number of connections in synapses, your brain isnt going to function properly.

Researchers found that chronically stressed rats, those who had been deprived of food, forced to swim in cold water, exposed to frightening odors and other stressors, had lower levels of neuritin expression and exhibited depressed behavior. The researchers then dosed the stressed rats with neuritin-boosting therapy, which improved the animals ability to swim longer without giving up in a test.

In another experiment reported in the study, rats were dosed with gene therapy to boost neuritins availability in the brain. That led to new neuron growth. Researchers also used gene therapy to suppress neuritin. These animals were less likely to eat right away and were more likely to show despairing behaviors when they were subjected to stress.

An estimated 9 percent of American adults are depressed, according to the U.S. Centers for Disease Control and Prevention. Discovering new drugs to treat people who are depressed may decrease disability and suicide rates, according to background information in the paper.

Its not clear exactly how current antidepressants including selective serotonin reuptake inhibitors, or SSRIs, like Eli Lilly & Co. (LLY)s Prozac, work in the brain. SSRIs are designed to block the reabsorption of the brain chemical serotonin. Still, previous work attempting to show serotonin is solely responsible for depression has been unsuccessful. The alternative theory about the role of neurogenesis developed in response.

Todays study shows a causal link between neuritin and depression, at least in rats, Duman said. Human studies will be more complicated, in part because there isnt a known drug that acts directly on neuritin in humans.

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Stress Blocks Gene That Guards Brain Against Depression

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