StemCell Therapy

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

Advanced Cell Technology, Inc. (ACT; OTCBB: ACTC), a leader in the field of regenerative medicine, announced today that the Data and Safety Monitoring Board (DSMB), an independent group of medical experts closely monitoring the companys three ongoing clinical trials, has authorized the company to move forward with enrollment and treatment of additional patients in its clinical trial for dry age-related macular degeneration (dry AMD). ACT will proceed with patient screening and enrollment for the second cohort, who, in keeping with trial protocol, will be injected with 100,000 retinal pigment epithelial (RPE) cells derived from human embryonic stem cells (hESCs), as compared with the 50,000-cell dose used in the first cohort.

DSMB authorization to move to the higher dosage of cells in our clinical trial for dry AMD represents a significant milestone for our clinical programs, commented Gary Rabin, chairman and CEO of ACT. Our RPE program is now advancing rapidly, as we are now screening at multiple ophthalmological centers for the fourth surgery in both our dry AMD trial and our U.S. SMD trial, with our E.U. SMD trial, which was initiated much later, not far behind.

The trial is a prospective, open-label study, designed to determine the safety and tolerability of hESC-derived RPE cells following sub-retinal transplantation into patients with dry AMD at 12 months, the studys primary endpoint. The three procedures comprising the first cohort of patients were all conducted at University of California at Los Angeles (UCLA), by Steven Schwartz, M.D., Ahmanson Professor of Ophthalmology at the David Geffen School of Medicine at UCLA and retina division chief at UCLA's Jules Stein Eye Institute. It was announced in May that Mass Eye and Ear is an additional site for the trial.

Mr. Rabin added, Dry AMD represents one of the largest unmet ophthalmological needs in the world, with a potential market of $25 billion in the U.S. and Europe, alone, and this DSMB approval is a big step toward being able to potentially address that massive medical need.

ACT is conducting a total of three clinical trials in the U.S. and Europe using hESC-derived RPE cells to treat forms of macular degeneration. Each trial will enroll a total of 12 patients, with cohorts of three patients each in an ascending dosage format. Treatment of the final patient of the first cohort in the companys dry AMD trial was announced on April 20. On June 29, the second SMD patient enrolled in the Companys E.U. clinical trial was treated at Moorfields Eye Hospital in London, U.K., and on April 24 the company announced DSMB approval to treat the second patient cohort in its U.S. SMD trial.

Further information about patient eligibility for ACTs dry AMD study and the companys concurrent SMD studies in the U.S. and E.U. is available at http://www.clinicaltrials.gov, with the following Identifiers: NCT01344993 (dry AMD), NCT01345006 (U.S. SMD), and NCT01469832 (E.U. SMD).

About Advanced Cell Technology, Inc.

Advanced Cell Technology, Inc., is a biotechnology company applying cellular technology in the field of regenerative medicine. For more information, visit http://www.advancedcell.com.

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ACT Secures Approval to Proceed with Increased RPE Dosage for Patients in Clinical Trial for Dry AMD

DUBLIN--(BUSINESS WIRE)--

Research and Markets (http://www.researchandmarkets.com/research/kxltqj/gene_therapy_marke) has announced the addition of the "Gene Therapy Market to 2018 - Product Development Slowed by Clinical Failures, Close Regulatory Surveillance and High Compliance Standards" report to their offering.

Gene Therapy: the Next Big Step in Cancer Treatments.

The fight against cancer is leading a new movement in gene therapy, as the failure of conventional cancer therapies is fuelling demand for new treatments, according to a new report by healthcare experts GBI Research.

The new report* states that gene therapy technology is still in its nascent stage, and high levels of regulatory surveillance in clinical development is affecting progress. However, the increasing potential of upcoming treatments and shortcomings in traditional therapies is gradually leading to broader acceptance of gene therapy in medicine.

Therapies such as chemotherapy and hormone therapy control the progression of diseases, but are often associated with severe side effects, such as nausea, hair loss and abnormal blood cell counts. Once administered, the drugs induce systemic action throughout the body, and patients often die due to the side effects of treatment rather than the cancer itself. The inability of these conventional therapies to cure diseases has created a significant unmet need in the treatment of cancer, as well as Human Immunodeficiency Virus (HIV), autoimmune diseases, and viral infections.

Targeted therapies such as monoclonal antibodies, stem cell therapies, Ribonucliec Acid (RNA) therapies and gene therapies have initially shown better efficacy and safety profiles compared to chemotherapies.

Gene therapy has several promising drug candidates, which are likely to drive the growth of the gene therapy market if clinical trials are successful. Collategene by AnGes MG, Cardium Therapeutics' Generx, and Vical Incorporation's Allovectin-7 are in development for a wide range of cancer indications, and are expected to compete in the oncology therapeutics market as the market acceptance of gene therapy improves over time.

Companies Mentioned

- ReGenX Biosciences

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Research and Markets: Gene Therapy Market to 2018 - Product Development Slowed by Clinical Failures, Close Regulatory ...

(HealthDay News) -- Needle-sharing among drug abusers may play as big a role as risky sexual behavior in the transmission of syphilis, a new study suggests.

American and Mexican researchers interviewed more than 900 female sex workers in the Mexican border towns of Tijuana and Ciudad Juarez, which are adjacent to San Diego and El Paso, Texas, respectively. The sex workers, who were also tested for HIV and sexually transmitted diseases (STDs), operate legally in the two Mexican towns, which are located on major drug trafficking routes.

The researchers found that female sex workers who didn't have HIV, but tested positive for active syphilis infection, were more likely than those without active syphilis infection to inject drugs, to use illegal drugs before or during sex in the past month, and to have U.S. clients who had higher rates of drug use, including the use of injection drugs. Read more…

Source:
http://feeds.feedburner.com/integratedmedicine

(HealthDay News) -- Needle-sharing among drug abusers may play as big a role as risky sexual behavior in the transmission of syphilis, a new study suggests.

American and Mexican researchers interviewed more than 900 female sex workers in the Mexican border towns of Tijuana and Ciudad Juarez, which are adjacent to San Diego and El Paso, Texas, respectively. The sex workers, who were also tested for HIV and sexually transmitted diseases (STDs), operate legally in the two Mexican towns, which are located on major drug trafficking routes.

The researchers found that female sex workers who didn't have HIV, but tested positive for active syphilis infection, were more likely than those without active syphilis infection to inject drugs, to use illegal drugs before or during sex in the past month, and to have U.S. clients who had higher rates of drug use, including the use of injection drugs. Read more…

Source:
http://feeds.feedburner.com/integratedmedicine

Antibodies taken from rabbits can improve the survival rates of leukemia and myelodysplasia patients who are receiving stem cell transplant from an unrelated donor.

Researchers from Virginia Commonwealth University (VCU) have found that rabbits' antibodies trick the body immune system into accepting the stem cell from an unrelated donor. They claim that this discovery will improve the survival rates of leukemia and myelodysplasia patients.

Researchers had conducted a study on groups of patients who were going to receive stem cells.

Scientists injected rabbits' anti-thymocyte globulin (ATG) into one group of patients who were going to receive stem cells from an unrelated donor whereas the other group received the stem cells from a related donor.

After the transplantation, scientists studied the outcomes of patients who received a transplant of stem cells from an unrelated donor and compared the result with people who had received stem cells from a related donor.

Scientists were stunned to find that the outcomes after implanting the cells were very similar in terms of mortality, relapse and development of graft-versus-host disease (GVHD), a common complication that can occur after a stem cell or bone marrow transplant in which the newly transplanted material attacks the transplant recipient's body.

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"Unfortunately, we can't always find a related (genetically similar) donor for patients in need of stem cell transplantation," said Amir Toor, hematologist-oncologist at VCU School of Medicine, in a statement. "Obtaining better outcomes with unrelated donor stem cell transplants could represent a significant advancement in extending the lives of more patients with blood cancers."

Usually, when an unrelated donor stem is implanted into the body, the body immune system immediately rejects it. However, scientists found that rabbits' antibodies trick the immune system into accepting it.

Rabbit anti-thymocyte globulin ATG works by reducing T-lymphocytes, a key component of the immune system.

Read more from the original source:
Hope for Leukemia and Myelodysplasia Patients from Rabbits' Antibodies

Public release date: 6-Jul-2012 [ | E-mail | Share ]

Contact: Phyllis Edelman pedelman@genetics-gsa.org 301-634-7302 Genetics Society of America

BETHESDA, MD July 6, 2012 Yona Goldshmit, Ph.D., is a former physical therapist who worked in rehabilitation centers with spinal cord injury patients for many years before deciding to switch her focus to the underlying science.

"After a few years in the clinic, I realized that we don't really know what's going on," she said.

Now a scientist working with Peter Currie, Ph.D., at Monash University in Australia, Dr. Goldshmit is studying the mechanisms of spinal cord repair in zebrafish, which, unlike humans and other mammals, can regenerate their spinal cord following injury. On June 23 at the 2012 International Zebrafish Development and Genetics Conference in Madison, Wisconsin, she described a protein that may be a key difference between regeneration in fish and mammals.

One of the major barriers to spinal regeneration in mammals is a natural protective mechanism, which incongruously results in an unfortunate side effect. After a spinal injury, nervous system cells called glia are activated and flood the area to seal the wound to protect the brain and spinal cord. In doing so, however, the glia create scar tissue that acts as a physical and chemical barrier, which prevents new nerves from growing through the injury site.

One striking difference between the glial cells in mammals and fish is the resulting shape: mammalian glia take on highly branched, star-like arrangements that appear to intertwine into dense tissue. Fish glia cells, by contrast, adopt a simple elongated shape called bipolar morphology that bridges the injury site and appears to help new nerve cells grow through the damaged area to heal the spinal cord.

"Zebrafish don't have so much inflammation and the injury is not so severe as in mammals, so we can actually see the pro-regenerative effects that can happen," Dr. Goldshmit explained.

Studies in mice have found that mammalian glia can take up the same elongated shape, but in response to the environment around the injury they instead mature into scar tissue that does not allow nerve regrowth.

Dr. Goldshmit and her colleagues have focused on a family of molecules called fibroblast growth factors (Fgf), which have shown some evidence of improving recovery in mice and humans with spinal cord damage. The Monash University group found that Fgf activity around the damage site promotes the bipolar glial shape and encourages nerve regeneration in zebrafish.

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Zebrafish reveal promising mechanism for healing spinal cord injury

MANILA, Philippines Stem cell therapy, aside from being a potential cure for a wide range of illnesses, can also make a patient look and feel younger, a stem cell therapist said.

Dr. Ricardo Quiones, a cosmetic surgeon and dermatologist, has trained to conduct stem cell therapy, which he describes as the future of medicine.

Quiones said stem cell therapy has become popular for its ability to regenerate and heal properties of adult stem cells.

As we grow old, our stem cells dramatically decline. When we were children, we had 80 million stem cells. As we reach the age of 40, our stem cells decline to 35 million, he told Mornings@ANC on Friday.

Quiones explained that the procedure is similar to turning back the clock because it can increase a persons stem cells to 100 million.

Ive done two patients from Zamboanga City. I called them up after the procedure and they told me they look younger. They have the stamina, the vigor and they have felt an increase in short-term memory, powers of attention and concentration, he said.

Quiones also said the procedure has the potential to cure diabetes, heart damage, brain damage such as Parkinsons and Alzheimers, osteoarthritis, stroke, baldness and even sports injuries.

3-hour procedure

Quiones said any patient, except those diagnosed with cancer, can undergo the procedure, which he said will only last for about 3 to 4 hours.

After receiving clearance from a physician and passing medical and laboratory tests, anesthesia will be administered to a patient before stem cells are harvested.

Excerpt from:
Stem cell therapy 'turns back clock'

MANILA, Philippines Stem cell therapy, aside from being a potential cure for a wide range of illnesses, can also make a patient look and feel younger, a stem cell therapist said.

Dr. Ricardo Quiones, a cosmetic surgeon and dermatologist, has trained to conduct stem cell therapy, which he describes as the future of medicine.

Quiones said stem cell therapy has become popular for its ability to regenerate and heal properties of adult stem cells.

As we grow old, our stem cells dramatically decline. When we were children, we had 80 million stem cells. As we reach the age of 40, our stem cells decline to 35 million, he told Mornings@ANC on Friday.

Quiones explained that the procedure is similar to turning back the clock because it can increase a persons stem cells to 100 million.

Ive done two patients from Zamboanga City. I called them up after the procedure and they told me they look younger. They have the stamina, the vigor and they have felt an increase in short-term memory, powers of attention and concentration, he said.

Quiones also said the procedure has the potential to cure diabetes, heart damage, brain damage such as Parkinsons and Alzheimers, osteoarthritis, stroke, baldness and even sports injuries.

3-hour procedure

Quiones said any patient, except those diagnosed with cancer, can undergo the procedure, which he said will only last for about 3 to 4 hours.

After receiving clearance from a physician and passing medical and laboratory tests, anesthesia will be administered to a patient before stem cells are harvested.

See the article here:
Stem cell therapy 'turns back clock'

TORONTO -- A drug commonly used to control Type 2 diabetes can help trigger stem cells to produce new brain cells, providing hope of a potential means to treat brain injuries and even neurodegenerative diseases like Alzheimer's, researchers say.

A study by scientists at Toronto's Hospital for Sick Children found the drug metformin helps activate the mechanism that signals stem cells to generate neurons and other brain cells.

If you could take stem cells that normally reside in our brains and somehow use drugs to recruit them into becoming appropriate neural cell types, then you may be able to promote repair and recovery in at least some of the many brain disorders and injuries for which we currently have no treatment, said principal investigator Freda Miller.

This work is happening against a background of a lot of excitement in the stem cell field about the idea that since we now know that we have stem cells in many of our adult tissues, then perhaps if we could figure out how to pharmacologically tweak those stem cells, then perhaps we could help to promote tissue repair, added Miller, a senior scientist at SickKids.

The research, published online Thursday in the journal Cell Stem Cell, involved lab-dish experiments using both mouse and human brain stem cells, as well as learning and memory tests performed on live mice given the drug.

Researchers started by adding metformin to stem cells from the brains of mice, then repeated the experiment with human brain stem cells generated in the lab. In both cases, the stem cells gave rise to new brain cells.

They then tested the drug in lab mice and found that those given daily doses of metformin for two or three weeks had increased brain cell growth and outperformed rodents not given the drug in learning and memory tasks.

One standard test involves a water maze in which the mice must swim around until they locate a hidden platform.

And the remarkable thing is the mice that got the metformin, what they showed was increased flexibility in terms of the way they learned the location of things, said Miller, explaining that the drug-treated mice had a greater ability to learn and remember.

If you then, for example, moved the platform some place completely different, the metformin-treated animals were remarkably good at just saying, OK, things have changed and learning the new thing and (were) much better than the controls (untreated mice).

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Diabetes drug triggers neuron growth, potential to regenerate brain cells: study

Public release date: 6-Jul-2012 [ | E-mail | Share ]

Contact: Dr. Changfa Guo guo.changfa@zs-hospital.sh.cn Society for Experimental Biology and Medicine

Dr Changfa Guo, Professor Chunsheng Wang and their co-investigators from Zhongshan hospital Fudan University, Shanghai, China have established a novel hyperbranched poly(amidoamine) (hPAMAM) nanoparticle based hypoxia regulated vascular endothelial growth factor (HRE-VEGF) gene therapy strategy which is an excellent substitute for the current expensive and uncontrollable VEGF gene delivery system. This discovery, reported in the June 2012 issue of Experimental Biology and Medicine, provides an economical, feasible and biocompatible gene therapy strategy for cardiac repair.

Transplantation of VEGF gene manipulated mesenchymal stem cells (MSCs) has been proposed as a promising therapeutic method for cardiac repair after myocardium infarction. However, the gene delivery system, including the VEGF gene and delivery vehicle, needs to be optimized. On one hand, long-term and uncontrollable VEGF over-expression in vivo has been observed to lead to hemangioma formation instead of functional vessels in animal models. On the other hand, though non-viral gene vector can circumvent the limitations of virus, drawbacks of the current non-viral vectors, such as complex synthesis procedure, limited transfection efficiency and high cytotoxicity, still needs to be overcome.

Co-investigators, Drs. Kai Zhu and Hao Lai, said "Hypoxia response elements were inserted into the promoter region of VEGF gene to form HRE-VEGF, which provided a safer alternative to the conventionally available VEGF gene". "The HRE-VEGF up-regulates gene expression under hypoxic conditions caused by ischemic myocardium and turns it off under normoxia condition when the regional oxygen supply is adequate."

The hPAMAM nanoparticles, which exhibit high gene transfection efficiency and low cytotoxicity during the gene delivery process, can be synthesized by a simpler and more economical one-step/pot polymerization technique. Drs. Zhu and Lai, said "Using the hPAMAM based gene delivery approach, our published and unpublished results explicitly demonstrated that it was an economical, effective and biocompatible gene delivery vehicle".

Dr Guo concluded that "Treatment with hPAMAM-HRE-VEGF transfected MSCs after myocardium infarction improved the myocardial VEGF level, which improved graft MSC survival, increased neovascularization and ultimately improved heart function. And this novel VEGF gene delivery system may have clinical relevance for tissue repair in other ischemic diseases".

Dr. Steve Goodman, Editor-in-Chief of Experimental Biology and Medicine said "Guo and colleagues have provided an exciting new nanoparticle based gene therapy for cardiac repair. This novel approach has great promise for repair of the heart after myocardial infarction."

###

Experimental Biology and Medicine is the journal of the Society of Experimental Biology and Medicine. To learn about the benefits of society membership visit http://www.sebm.org. If you are interested in publishing in the journal please visit http://ebm.rsmjournals.com/

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An economical, effective and biocompatible gene therapy strategy promotes cardiac repair

SACRAMENTO, CA. - A drug used to treat diabetes encourages the brain to grow and repair itself, afinding with far-reaching implications for the treatment of Alzheimers and brain injury, a new study published in Cell: Stem Cell reports.

The widely used diabetes drug metformin comes with the unexpected side effect of causing the growth of new neurons in the brain and makes mice smarter, the July 6th issue of Cell Stem Cell, a Cell Press publication, said. The study has potentially wide-reaching implications for the treatment of Alzheimers in humans and brain related injury.

The discovery has important implications for brain repair because it works not by introducing new stem cells but rather by spurring those that are already present into action, said the study's lead author Freda Miller of the University of Toronto-affiliated Hospital for Sick Children. And since the drug is already so widely used and so safe it means doctors could quickly begin using the drug for brain therapy treatment.

Earlier work by Miller's team highlighted a pathway known as aPKC-CBP for its essential role in telling neural stem cells where and when to differentiate into mature neurons, the report said. Other researchers had found before them that the same pathway is important for the metabolic effects of the drug metformin, but in liver cells.

"We put two and two together," Miller says. If metformin activates the CBP pathway in the liver, they thought, maybe it could also do that in neural stem cells of the brain to encourage brain repairm, he said.

Mice taking metformin not only showed an increase in the birth of new neurons, but they proved to become smarter by being better able to learn the location of a hidden platform in a standard maze test of spatial learning. The new evidence lends support to that promising idea in both mouse brains and human cells.

While it remains to be seen whether the very popular diabetes drug might already be serving as a brain booster for those who are now taking it, there are early hints the drug may have cognitive benefits for people with Alzheimer's disease. Scientists had speculated those improvements were the result of better diabetes control, Miller says, but it now appears that metformin may improve Alzheimer's symptoms by enhancing brain repair.

Miller says they now hope to test whether metformin might help repair the brains of those who have suffered brain injury due to trauma or radiation therapies for cancer.

Original post:
Diabetes drug helps brain growth, makes mice smarter

ScienceDaily (July 5, 2012) The widely used diabetes drug metformin comes with a rather unexpected and alluring side effect: it encourages the growth of new neurons in the brain. The study reported in the July 6th issue of Cell Stem Cell, a Cell Press publication, also finds that those neural effects of the drug also make mice smarter.

The discovery is an important step toward therapies that aim to repair the brain not by introducing new stem cells but rather by spurring those that are already present into action, says the study's lead author Freda Miller of the University of Toronto-affiliated Hospital for Sick Children. The fact that it's a drug that is so widely used and so safe makes the news all that much better.

Earlier work by Miller's team highlighted a pathway known as aPKC-CBP for its essential role in telling neural stem cells where and when to differentiate into mature neurons. As it happened, others had found before them that the same pathway is important for the metabolic effects of the drug metformin, but in liver cells.

"We put two and two together," Miller says. If metformin activates the CBP pathway in the liver, they thought, maybe it could also do that in neural stem cells of the brain to encourage brain repair.

The new evidence lends support to that promising idea in both mouse brains and human cells. Mice taking metformin not only showed an increase in the birth of new neurons, but they were also better able to learn the location of a hidden platform in a standard maze test of spatial learning.

While it remains to be seen whether the very popular diabetes drug might already be serving as a brain booster for those who are now taking it, there are already some early hints that it may have cognitive benefits for people with Alzheimer's disease. It had been thought those improvements were the result of better diabetes control, Miller says, but it now appears that metformin may improve Alzheimer's symptoms by enhancing brain repair.

Miller says they now hope to test whether metformin might help repair the brains of those who have suffered brain injury due to trauma or radiation therapies for cancer.

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Diabetes drug makes brain cells grow

(PRWEB) July 05, 2012

Researchers at Adelaide University have developed a potential therapy for stroke victims utilizing dental stem cells to regenerate damaged brain cells.

The study involved the use of human dental pulp stem cells in rats suffering from post- stroke symptoms. The stem cells were transplanted into the damaged brains of the rats with the rats showing significant improvement in brain function, motor skills and cognitive abilities within several weeks. The therapy poses a new possibility for patients who have suffered a stroke. Patients will be able to use stem cells extracted from their own teeth to regenerate damaged brain tissue. The use of autologous stem cells eliminates the risk of rejection and the need for immune-suppression drugs and results in a more positive outcome. The research is so promising that the researchers hope to begin clinical trials within three to four years.

The research is another example of the inherent plasticity of dental stem cells, i.e. their ability to differentiate into a wide range of tissue types that may be utilized to treat a broad array of disease, trauma and injury. Banking your own valuable dental stem cells for use in emerging regenerative therapies is both convenient and affordable and as easy as a trip to the dentists.

To learn more about how you can bank your valuable dental stem cells , visit http://www.StemSave.com or call 877-783-6728 (877-StemSave) today.

Link:
StemSave - Researchers Utilize Dental Stem Cells for Stroke Treatment

July 5, 2012

Connie K. Ho for redOrbit.com Your Universe Online

Stem cell research is gaining headway, but is still controversial. Scientists hope that a new discovery regarding stem cells from amniotic fluid will pave the way to an alternative option. A collaborative group of researchers recently discovered that stem cells in amniotic fluid can be changed into a more flexible state, which could possibly open another option to embryonic stem cells.

The study was recently published in the journal Molecular Therapy and it described how a team of investigators from Imperial College London and the UCL Institute of Child Health were successful in reprogramming amniotic fluids without introducing extra genes. Based on the findings, the researchers believe that stem cells from amniotic fluid could be held in banks for therapy or research purposes. Amniotic fluid, which surrounds and feeds the fetus, can be taken from the mothers abdomen with a needle during amniocentesis and has stem cells from the fetus. These stem cells have more limitations in developing into other cells as compared to embryonic stem cells.

These cells have a wide range of potential applications in treatments and in research. We are particularly interested in exploring their use in genetic diseases diagnosed early in life or other diseases such as cerebral palsy, noted Dr. Pascale Guillot, a representative of the Department of Surgery and Cancer at Imperial College London, in a prepared statement.

In the project, the scientists utilized stem cells that were donated from mothers who were undergoing amniocentesis; amniocentesis has been used in the past in testing for genetic diseases. The cells were then grown on a gelatinous protein mixture in a lab and reprogrammed into a lower state by adding the drug valproic acid to the culture medium. The results showed that the reprogrammed cells had traits like those found in embryonic stem cells; embryonic stem cells have pluripotency, which means they have the ability to develop into any cell type found in the body. In particular, the reprogrammed cells from the amniotic fluid were able to develop into functioning cells like bone, liver, and nerve cells. The cells were also able to stay pluripotent after they were frozen and rethawed.

Amniotic fluid stem cells are intermediate between embryonic stem cells and adult stem cells. They have some potential to develop into different cell types but they are not pluripotent. Weve shown that they can revert to being pluripotent just by adding a chemical reagent that modifies the configuration of the DNA so that genes that are expressed in the embryo get switched back on, explained Guillot in the statement.

The findings from the project showed that stem cells from amniotic fluid can possibly be used in treatments for a number of diseases, disease research, and drug screenings. Researchers are positive about the alternative to embryonic stem cells, as it there is a limited number of donor embryos available. The study by Guillot and his colleagues shows that it is possible to have pluripotency in human cells without introducing foreign genetic material into the cells.

This study confirms that amniotic fluid is a good source of stem cells. The advantages of generating pluripotent cells without any genetic manipulation make them more likely to be used for therapy, remarked Dr. Paolo De Coppi, a member of the UCL Institute of Child Health who led the research with Guillot, in the statement. At GOSH we have focused on building organs and tissues for the repair of congenital malformations, which are usually diagnosed during pregnancy. Finding the way of generating pluripotent cells from the fluid that surround the fetus in the womb move us one step further in the this direction.

The study is funded by the Genesis Research Trust, the Henry Smith Charity, and the Action Medical Research.

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Stem Cells Extracted From Amniotic Fluid

REDWOOD CITY, Calif.--(BUSINESS WIRE)--

OncoMed Pharmaceuticals, Inc., a clinical-stage company developing novel therapeutics that target cancer stem cells (CSCs), or tumor-initiating cells, today announced that Proceedings of the National Academy of Sciences of the United States of America (PNAS) July 2, 2012 PNAS Early Edition has published online OncoMed data demonstrating the potent anti-cancer activity of OMP-18R5, the companys first Wnt pathway product candidate, in multiple preclinical human tumor models. OMP-18R5 is currently in Phase 1 clinical testing.

OMP-18R5 is, we believe, the first therapeutic antibody to enter clinical trials that specifically inhibits the Wnt pathway, an important pathway in cancer. Our research published in PNAS suggests that inhibiting the Wnt pathway within tumors has the potential to improve treatment for multiple cancers, said Austin Gurney, Ph.D., Senior Vice President, Molecular and Cellular Biology of OncoMed Pharmaceuticals and a co-author of the paper. OMP-18R5 has demonstrated the remarkable ability to drive the differentiation of tumor cells in preclinical models. Tumors become less tumorigenic.

The Wnt/beta-catenin pathway, which signals through the Frizzled (Fzd) receptor family and several co-receptors, has long been implicated in cancer. OncoMed researchers identified a novel therapeutic approach to targeting the Wnt pathway with a monoclonal antibody. OMP-18R5, initially identified by binding to Frizzled 7, interacts with key Fzd receptors through a conserved epitope within the extracellular domain and thereby inhibits canonical Wnt signaling induced by multiple Wnt family members. In xenograft studies with minimally passaged human tumors, OMP-18R5 inhibits the growth of a range of tumor types and exhibits synergistic activity with standard-of-care chemotherapeutic agents. These data are published in current edition of PNAS in an article titled Wnt Pathway Inhibition via the Targeting of Frizzled Receptors Results in Decreased Growth and Tumorigenicity of Human Tumors.

Paul Hastings, President and Chief Executive Officer of OncoMed Pharmaceuticals, said, OMP-18R5 is among a rich pipeline of therapeutic candidates discovered by OncoMed that are now in clinical trials. We look forward to reporting results from our initial trials as this product advances through the clinic.

About OMP-18R5

OMP-18R5 is a monoclonal antibody optimized to block a key signaling pathway in cancer. Specifically, OMP-18R5 selectively targets Frizzled receptors, activators of Wnt signaling. OMP-18R5 treatment exhibits broad anti-tumor activity in preclinical models. OMP-18R5 is currently in a Phase 1 clinical trial in patients with advanced solid tumors. This trial will assess safety, pharmacokinetics, and provide initial indications of anti-tumor efficacy and the effects of OMP-18R5 on Wnt pathway biomarkers. OMP-18R5 is part of OncoMeds collaboration with Bayer Pharma AG.

About OncoMed Pharmaceuticals

OncoMed Pharmaceuticals is a clinical-stage company that discovers and develops novel therapeutics targeting cancer stem cells, the cells shown to be capable of driving tumor growth, recurrence and metastasis. OncoMed has advanced three anti-cancer therapeutics into the clinic, demcizumab (OMP-21M18), OMP-59R5, and OMP-18R5, which target key cancer stem cell signaling pathways including Notch and Wnt. In addition, OncoMeds pipeline includes several novel preclinical product candidates targeting multiple validated cancer stem cell pathways, including the RSPO-LGR pathway. OncoMed has formed strategic alliances with Bayer Pharma AG and GlaxoSmithKline. Privately held, OncoMeds investors include: US Venture Partners, Latterell Venture Partners, The Vertical Group, Morgenthaler Ventures, Phase4Ventures, Delphi Ventures, Adams Street Partners, De Novo Ventures, Bay Partners and GlaxoSmithKline. Additional information can be found at the companys website: http://www.oncomed.com.

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PNAS Publishes OncoMed Data Demonstrating Potent Anti-Cancer Activity for Novel Wnt Pathway Antibody OMP-18R5

ScienceDaily (July 3, 2012) Stem cells found in amniotic fluid can be transformed into a more versatile state similar to embryonic stem cells, according to a study published July 3 in the journal Molecular Therapy. Scientists from Imperial College London and the UCL Institute of Child Health succeeded in reprogramming amniotic fluid cells without having to introduce extra genes. The findings raise the possibility that stem cells derived from donated amniotic fluid could be stored in banks and used for therapies and in research, providing a viable alternative to the limited embryonic stem cells currently available.

Amniotic fluid surrounds and nourishes the fetus in the womb. It can be extracted through the mother's abdomen using a needle in a process called amniocentesis, which is sometimes used to test for genetic diseases. The fluid contains stem cells that come from the fetus. These cells have a more limited capacity to develop into different cell types than stem cells in the embryo.

The researchers used stem cells from amniotic fluid donated by mothers undergoing amniocentesis for other purposes during the first trimester of pregnancy. The cells were grown on a gelatinous protein mixture in the lab and reprogrammed into a more primitive state by adding a drug called valproic acid to the culture medium. An extensive set of tests found that these reprogrammed cells have characteristics very similar to embryonic stem cells, which are capable of developing into any cell type in the body -- a property known as pluripotency.

Even after growing in culture for some time, the reprogrammed cells were able to develop into functioning cells of many different types, including liver, bone and nerve cells. They also maintained their pluripotency even after being frozen and rethawed.

The results suggest that stem cells derived from amniotic fluid could be used in treatments for a wide range of diseases. Donated cells could be stored in banks and used in treatments, as well as in disease research and drug screening. A previous study estimated that cells from 150 donors would provide a match for 38% of the population.

Alternatives to embryonic stem cells are keenly sought because of ethical concerns and limited availability of donor embryos. Previous research has shown that it is possible to make adult cells become pluripotent by introducing extra genes into the cells, often using viruses. However, the efficiency of the reprogramming is very low and there is a risk of problems such as tumours caused by disrupting the DNA. The new study is the first to induce pluripotency in human cells without using foreign genetic material. The pluripotent cells derived from amniotic fluid also showed some traits associated with embryonic stem cells that have not been found in induced pluripotent stem cells from other sources.

Amniocentesis is associated with a small risk of causing a miscarriage, estimated to be about one in 100.

Dr Pascale Guillot, from the Department of Surgery and Cancer at Imperial, said: "Amniotic fluid stem cells are intermediate between embryonic stem cells and adult stem cells. They have some potential to develop into different cell types but they are not pluripotent. We've shown that they can revert to being pluripotent just by adding a chemical reagent that modifies the configuration of the DNA so that genes that are expressed in the embryo get switched back on.

"These cells have a wide range of potential applications in treatments and in research. We are particularly interested in exploring their use in genetic diseases diagnosed early in life or other diseases such as cerebral palsy."

Dr Paolo De Coppi, from the UCL Institute of Child Health, who jointly led the study with Dr Guillot, said: "This study confirms that amniotic fluid is a good source of stem cells. The advantages of generating pluripotent cells without any genetic manipulation make them more likely to be used for therapy.

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Amniotic fluid yields alternatives to embryonic stem cells

ScienceDaily (July 3, 2012) searchers from the University of Maryland School of Maryland report promising results from using adult stem cells from bone marrow in mice to help create tissue cells of other organs, such as the heart, brain and pancreas -- a scientific step they hope may lead to potential new ways to replace cells lost in diseases such as diabetes, Parkinson's or Alzheimer's.

The research in collaboration with the University of Paris Descartes is published online in the June 29, 2012 edition of Comptes Rendus Biologies, a publication of the French Academy of Sciences.

"Finding stem cells capable of restoring function to different damaged organs would be the Holy Grail of tissue engineering," says lead author David Trisler, PhD, assistant professor of neurology at the University of Maryland School of Medicine.

He adds, "This research takes us another step in that process by identifying the potential of these adult bone marrow cells, or a subset of them known as CD34+ bone marrow cells, to be 'multipotent,' meaning they could transform and function as the normal cells in several different organs."

University of Maryland researchers previously developed a special culturing system to collect a select sample of these adult stem cells in bone marrow, which normally makes red and white blood cells and immune cells. In this project, the team followed a widely recognized study model, used to prove the multipotency of embryonic stem cells, to prove that these bone marrow stem cells could make more than just blood cells. The investigators also found that the CD34+ cells had a limited lifespan and did not produce teratomas, tumors that sometimes form with the use of embryonic stem cells and adult stem cells cultivated from other methods that require some genetic manipulation.

"When taken at an early stage, we found that the CD34+ cells exhibited similar multipotent capabilities as embryonic stem cells, which have been shown to be the most flexible and versatile. Because these CD34+ cells already exist in normal bone marrow, they offer a vast source for potential cell replacement therapy, particularly because they come from a person's own body, eliminating the need to suppress the immune system, which is sometimes required when using adults stem cells derived from other sources," explains Paul Fishman, MD, PhD, professor of neurology at the University of Maryland School of Medicine.

The researchers say that proving the potential of these adult bone marrow stem cells opens new possibilities for scientific exploration, but that more research will be needed to see how this science can be translated to humans.

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Adult stem cells from bone marrow: Cell replacement/tissue repair potential in adult bone marrow stem cells in animal ...

FOR IMMEDIATE RELEASE: July 3, 2012

UNIVERSITY OF MARYLAND SCHOOL OF MEDICINE INVESTIGATORS FIND CELL REPLACEMENT/ TISSUE REPAIR POTENTIAL IN ADULT BONE MARROW STEM CELLS IN ANIMAL MODEL

Scientists Looking for Potential Avenue to Grow Cells of Different Organs

Newswise Baltimore, MD July 3, 2012. Researchers from the University of Maryland School of Maryland report promising results from using adult stem cells from bone marrow in mice to help create tissue cells of other organs, such as the heart, brain and pancreas - a scientific step they hope may lead to potential new ways to replace cells lost in diseases such as diabetes, Parkinsons or Alzheimers. The research in collaboration with the University of Paris Descartes is published online in the June 29, 2012 edition of Comptes Rendus Biologies, a publication of the French Academy of Sciences.

Finding stem cells capable of restoring function to different damaged organs would be the Holy Grail of tissue engineering, says lead author David Trisler, PhD, assistant professor of neurology at the University of Maryland School of Medicine.

He adds, This research takes us another step in that process by identifying the potential of these adult bone marrow cells, or a subset of them known as CD34+ bone marrow cells, to be multipotent, meaning they could transform and function as the normal cells in several different organs.

University of Maryland researchers previously developed a special culturing system to collect a select sample of these adult stem cells in bone marrow, which normally makes red and white blood cells and immune cells. In this project, the team followed a widely recognized study model, used to prove the multipotency of embryonic stem cells, to prove that these bone marrow stem cells could make more than just blood cells. The investigators also found that the CD34+ cells had a limited lifespan and did not produce teratomas, tumors that sometimes form with the use of embryonic stem cells and adult stem cells cultivated from other methods that require some genetic manipulation.

When taken at an early stage, we found that the CD34+ cells exhibited similar multipotent capabilities as embryonic stem cells, which have been shown to be the most flexible and versatile. Because these CD34+ cells already exist in normal bone marrow, they offer a vast source for potential cell replacement therapy, particularly because they come from a persons own body, eliminating the need to suppress the immune system, which is sometimes required when using adults stem cells derived from other sources, explains Paul Fishman, MD, PhD, professor of neurology at the University of Maryland School of Medicine.

The researchers say that proving the potential of these adult bone marrow stem cells opens new possibilities for scientific exploration, but that more research will be needed to see how this science can be translated to humans.

The results of this international collaboration show the important role that University of Maryland School of Medicine researchers play in advancing scientific understanding, investigating new avenues for the development of potentially life-changing treatments, says E. Albert Reece, M.D., Ph.D., M.B.A., vice president for medical affairs at the University of Maryland and the John Z. and Akiko K. Bowers Distinguished Professor and dean of the University of Maryland School of Medicine.

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Study Results: Adult Stem Cells From Bone Marrow

BELGRADE, Mont., July 3, 2012 /PRNewswire/ -- Bacterin International Holdings, Inc. (NYSE MKT LLC: BONE), a leader in the development of revolutionary bone graft material and antimicrobial coatings for medical applications, received a letter from NYSE Regulation on July 2, 2012 advising that the Company did not comply with Sections 703 and 1009 of the NYSEMKT LLC Company Guide, which required the Company to provide the NYSEMKT LLC with ten days prior notice of the June 8, 2012 record date for its upcoming 2012 Annual Meeting of Stockholders. The Company will file a Form 8-K with the Securities and Exchange Commission related to this matter. The NYSE MKT LLC also notified the Company that according to Section 401(j) of the Company Guide it needed to issue a news release. This action will NOT result in the suspension or delisting of the Company's securities.

About Bacterin International Holdings Bacterin International Holdings, Inc. (NYSE MKT LLC: BONE) develops, manufactures and markets biologics products to domestic and international markets. Bacterin's proprietary methods optimize the growth factors in human allografts to create the ideal stem cell scaffold to promote bone, subchondral repair and dermal growth. These products are used in a variety of applications including enhancing fusion in spine surgery, relief of back pain, promotion of bone growth in foot and ankle surgery, promotion of cranial healing following neurosurgery and subchondral repair in knee and other joint surgeries.

Bacterin's Medical Device division develops, employs, and licenses bioactive coatings for various medical device applications. Bacterin's strategic coating initiatives include antimicrobial coatings designed to inhibit biofilm formation and microbial contamination. For further information, please visit http://www.bacterin.com.

Important Cautions Regarding Forward-looking Statements

This news release contains certain disclosures that may be deemed forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that are subject to significant risks and uncertainties. Forward-looking statements include statements that are predictive in nature, that depend upon or refer to future events or conditions, or that include words such as "continue," "efforts," "expects," "anticipates," "intends," "plans," "believes," "estimates," "projects," "forecasts," "strategy," "will," "goal," "target," "prospects," "potential," "optimistic," "confident," "likely," "probable" or similar expressions or the negative thereof. Statements of historical fact also may be deemed to be forward-looking statements. We caution that these statements by their nature involve risks and uncertainties, and actual results may differ materially depending on a variety of important factors, including, among others: the Company's ability to launch beta and full product releases, the Company's ability to obtain FDA concurrence use for anti-microbial coatings in a timely manner; the Company's ability to meet its obligations under existing and anticipated contractual obligations; the Company's ability to develop, market, sell and distribute desirable applications, products and services and to protect its intellectual property; the ability of the Company's sales force to achieve expected results; the ability of the Company's customers to pay and the timeliness of such payments, particularly during recessionary periods; the Company's ability to obtain financing as and when needed; changes in consumer demands and preferences; the Company's ability to attract and retain management and employees with appropriate skills and expertise; the impact of changes in market, legal and regulatory conditions and in the applicable business environment, including actions of competitors; and other factors. Additional risk factors are listed in the Company's Annual Report on Form 10-K under the heading "Risk Factors." The Company undertakes no obligation to release publicly any revisions to any forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events, except as required by law.

Contact:

INVESTOR INQUIRIES: Hayden IR James Carbonara, Regional Vice President, 646-755-7412 james@haydenir.com

Brett Maas, 646-536-7331 brett@haydenir.com

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Bacterin Receives Letter From NYSE MKT LLC Regarding Timely Notice of Record Date for 2012 Annual Meeting of ...

Tuesday, July 03 16:25:12

Ireland has the capacity to be an international centre for commercialisation in the field of regenerative medicine, delegates at an international stem cell conference in NUI Galway heard today.

Reflecting this potential, new Irish company Orbsen Therapeutics is developing proprietary technologies designed to isolate stem cells. The NUI Galway spin-out is targeting the rapidly maturing and expanding regenerative medicine market, which is expected to grow to $118 billion next year.

Frank Barry is Professor of Cellular Therapy at NUI Galway, Director of Orbsen Therapeutics, and organiser of the Mesenchymal Stem Cell Conference, which opened yesterday.

Mesenchymal stem cells (MSCs) are a type of adult stem cell, and this event brings together the world's leading scientists in the field to discuss their latest ideas and findings. This is the first major stem cell conference to take place in Ireland, and is looking at all aspects of adult stem cells, from basic biology to manufacturing to clinical trials and therapeutics.

Stem cells hold great promise as an alternative to drugs and surgical procedures for treating a wide range of medical conditions including heart disease, arterial disease of the limbs, diabetes complications, arthritis and other inflammatory conditions. The treatment potential of stem cells is linked to their natural capacity to dampen inflammation and promote healing, repair and regeneration of damaged tissues.

According to Professor Barry: "Ireland has a strong research base in adult stem cell therapy and has the capcacity for advanced stem cell bioprocessing. There is huge potential in this market and we anticipate that there will be extraordinary growth over the next 5-10 years. There are currently over 400 regenerative medicine products on the market with many more in development." Orbsen Therapeutics has developed a clear pipeline of clinical indications which they hope, using their proprietary technologies, to bring through to clinical trial over the coming years. These include osteoarthritis, acute lung injury syndrome, diabetic foot ulcer, critical limb ischemia and others."

"Combining the utility, novelty and the value of its technologies, Orbsen is well placed to take advantage of the many opportunities in this fast moving and important emerging market", said Brian Molloy, CEO of Orbsen Theraepeutics."

Orbsen Therapeutics Limited was formed as a spin out company to develop and commercialise new intellectual property built up by researchers at the SFI-funded Regenerative Medicine Institute (REMEDI) at NUI Galway.

Scientists at NUI Galway are investigating how adult stems cells might be used to develop new treatments for vascular disease, osteoarthritis and lung injury. The University has become a leading centre of translational research in adult stem cells involving its National Centre for Biomedical Engineering Science (NCBES) and REMEDI.

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Ireland could be stem cell research hub