StemCell Therapy

SOUTH SAN FRANCISCO, CA--(Marketwire -03/21/12)- VistaGen Therapeutics, Inc. (OTC.BB: VSTA.OB - News) (OTCQB: VSTA.OB - News), a biotechnology company applying stem cell technology for drug rescue and cell therapy, and Vala Sciences, Inc., a biotechnology company developing and selling next-generation cell image-based instruments, reagents and analysis software tools, have entered into a strategic collaboration. Their goal is to advance drug safety screening methodologies in the most clinically relevant human in vitro bioassay systems available to researchers today.

Cardiomyocytes are the muscle cells of the heart that provide the force necessary to pump blood throughout the body, and as such are the targets of most of the drug toxicities that directly affect the heart. Many of these drug toxicities result in either arrhythmia (irregular, often fatal, beating of the heart) or reduced ability of the heart to pump the blood necessary to maintain normal health and vigor.

"Our collaboration with Vala directly supports the core drug rescue applications of our Human Clinical Trials in a Test Tube platform," said Shawn K. Singh, JD, VistaGen's Chief Executive Officer. "Our high quality human cardiomyocytes combined with Vala's high throughput electrophysiological assessment capabilities is yet another example of how we are applying our stem cell technology platform within a strategic ecosystem of complementary leading-edge companies and technologies. We seek to drive our drug rescue programs forward and generate a pipeline of new, cardiosafe drug candidates."

Through the collaboration, Vala will use its Kinetic Image Cytometer platform to demonstrate both the suitability and utility of VistaGen's human pluripotent stem cell derived-cardiomyocytes for screening new drug candidates for potential cardiotoxicity over conventional in vitro screening systems and animal models. VistaGen's validated human cardiomyocyte-based bioassay system, CardioSafe 3D, will permit Vala to demonstrate the quality, resolution, applicability and ease of use of its new instrumentation and analysis software to make information-rich, high throughput measurements and generate fundamentally new insights into heart cell drug responses. Accurate, sensitive and reproducible measurement of electrophysiological responses of stem cell-derived cardiomyocytes to new drug candidates is a key element of VistaGen's CardioSafe 3D drug rescue programs. VistaGen's strategic collaboration with Vala is directed towards this goal.

About VistaGen Therapeutics

VistaGen is a biotechnology company applying human pluripotent stem cell technology for drug rescue and cell therapy. VistaGen's drug rescue activities combine its human pluripotent stem cell technology platform, Human Clinical Trials in a Test Tube, with modern medicinal chemistry to generate new chemical variants (Drug Rescue Variants) of once-promising small-molecule drug candidates. These are drug candidates discontinued due to heart toxicity after substantial development by pharmaceutical companies, the U.S. National Institutes of Health (NIH) or university laboratories. VistaGen uses its pluripotent stem cell technology to generate early indications, or predictions, of how humans will ultimately respond to new drug candidates before they are ever tested in humans, bringing human biology to the front end of the drug development process.

Additionally, VistaGen's small molecule drug candidate, AV-101, is in Phase 1b development for treatment of neuropathic pain. Neuropathic pain, a serious and chronic condition causing pain after an injury or disease of the peripheral or central nervous system, affects approximately 1.8 million people in the U.S. alone. VistaGen is also exploring opportunities to leverage its current Phase 1 clinical program to enable additional Phase 2 clinical studies of AV-101 for epilepsy, Parkinson's disease and depression. To date, VistaGen has been awarded over $8.5 million from the NIH for development of AV-101.

About Vala Sciences

Vala Sciences is a San Diego-based biotechnology company that develops and sells cell-image-based instrumentation, reagents and analysis software tools to academic, pharmaceutical and biotechnology scientists. Vala's IC 200 class of instrumentation, and CyteSeer Automated Image Cytometry software convert labor-intensive qualitative observations of biological changes that can take from days to months, into accurate measurements delivered automatically in minutes.

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VistaGen Therapeutics Enters Strategic Drug Screening Collaboration With Vala Sciences

Context Antibody-based induction therapy plus calcineurin inhibitors (CNIs) reduce acute rejection rates in kidney recipients; however, opportunistic infections and toxic CNI effects remain challenging. Reportedly, mesenchymal stem cells (MSCs) have successfully treated graft-vs-host disease.

Objective To assess autologous MSCs as replacement of antibody induction for patients with end-stage renal disease who undergo ABO-compatible, cross-matchnegative kidney transplants from a living-related donor.

Design, Setting, and Patients One hundred fifty-nine patients were enrolled in this single-site, prospective, open-label, randomized study from February 2008-May 2009, when recruitment was completed.

Intervention Patients were inoculated with marrow-derived autologous MSC (12106/kg) at kidney reperfusion and two weeks later. Fifty-three patients received standard-dose and 52 patients received low-dose CNIs (80% of standard); 51 patients in the control group received antiIL-2 receptor antibodyplusstandard-dose CNIs.

Main Outcome Measures The primary measure was 1-year incidence of acute rejection and renal function (estimated glomerular filtration rate [eGFR]); the secondary measure was patient and graft survival and incidence of adverse events.

Results Patient and graft survival at 13 to 30 months was similar in all groups. After 6 months, 4 of 53 patients (7.5%) in the autologous MSC plus standard-dose CNI group (95% CI, 0.4%-14.7%; P=.04) and 4 of 52 patients (7.7%) in the low-dose group (95% CI, 0.5%-14.9%; P=.046) compared with 11 of 51 controls (21.6%; 95% CI, 10.5%-32.6%) had biopsy-confirmed acute rejection. None of the patients in either autologous MSC group had glucorticoid-resistant rejection, whereas 4 patients (7.8%) in the control showing increased eGFR levels during the first month postsurgery group did (95% CI, 0.6%-15.1%; overall P=.02). Renal function recovered faster among both MSC groups showing increased eGFR levels during the first month after surgery than the control group. Patients receiving standard-dose CNI had a mean difference of 6.2 mL/min per 1.73 m2 (95% CI, 0.4-11.9; P=.04) and those in the low-dose CNI of 10.0 mL/min per 1.73 m2 (95% CI, 3.8-16.2; P=.002). Also, during the 1-year follow-up, combined analysis of MSC-treated groups revealed significantly decreased risk of opportunistic infections than the control group (hazard ratio, 0.42; 95% CI, 0.20-0.85, P=.02)

Conclusion Among patients undergoing renal transplant, the use of autologous MSCs compared with anti-IL-2 receptor antibody induction therapy resulted in lower incidence of acute rejection, decreased risk of opportunistic infection, and better estimated renal function at 1 year.

Trial Registration clinicaltrials.gov Identifier: NCT00658073

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Induction Therapy With Autologous Mesenchymal Stem Cells in Living-Related Kidney Transplants: A Randomized Controlled ...

Newswise CHICAGO Among patients with end-stage renal disease undergoing living-related kidney transplants, the use of bone-marrow derived mesenchymal (cells that can differentiate into a variety of cell types) stem cells instead of antibody induction therapy resulted in a lower incidence of acute rejection, decreased risk of opportunistic infection, and better estimated kidney function at 1 year, according to a study in the March 21 issue of JAMA.

Induction therapy, routinely implemented in organ transplant procedures, consists of use of biologic agents to block early immune activation. New induction immunosuppressive protocols with increased efficacy and minimal adverse effects are desirable. "Antibody-based induction therapy plus calcineurin inhibitors (CNIs) reduce acute rejection rates in kidney recipients; however, opportunistic infections and toxic CNI effects remain challenging. Reportedly, mesenchymal stem cells (MSCs) have successfully treated graft-vs.-host disease," according to background information in the article.

Jianming Tan, M.D., Ph.D., of Xiamen University, Fuzhou, China and colleagues examined the effect of autologous (derived from the same individual) MSC infusion as an alternative to anti-IL-2 receptor antibody for induction therapy in adults undergoing living-related donor kidney transplants. The randomized study included 159 patients. Patients were inoculated with marrow-derived autologous MSC at kidney reperfusion and two weeks later. Fifty-three patients received standard-dose and 52 patients received low-dose CNIs (80 percent of standard); 51 patients in the control group received anti-IL-2 receptor antibody plus standard-dose CNIs.

Patient and graft survival at 13 to 30 months was similar in all groups. The researchers found that after 6 months, 4 of 53 patients (7.5 percent) in the autologous MSC plus standard-dose CNI group and 4 of 52 patients (7.7 percent) in the low-dose group compared with 11 of 51 controls (21.6 percent) had biopsy-confirmed acute rejection. Renal function recovered faster among both MSC groups showing increased estimated glomerular filtration rate (eGFR; a measure of kidney function) levels during the first month after surgery than the control group.

The authors also found that during the 1-year follow-up, combined analysis of MSC-treated groups revealed significantly decreased risk of opportunistic infections than the control group.

"In our prospective randomized trial on a large patient population, autologous MSCs could replace anti-IL-2 receptor-induction therapy in living-related donor kidney transplants. Recipients of autologous MSCs showed lower frequency of biopsy-confirmed acute rejection in the first 6 months than the control group," the researchers write.

"Extended monitoring of study participants will allow assessment of the long-term effects of autologous MSCs on renal allograft function, survival, and safety."

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(JAMA. 2012;307[11]:1169-1177. Available pre-embargo to the media at http://www.jamamedia.org)

Editor's Note: This study was supported in part by grants from the Key Science Research Project and the Key Laboratory, both of Fujian Province, China. All authors have completed and submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest and none were reported.

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Use of Stem Cells for Adults Receiving Related Donor Kidney Transplants Appears to Improve Outcomes

SILVER SPRING, MD.--(BUSINESS WIRE)--

Nuvilex, Inc. (OTCQB:NVLX), an emerging biotechnology provider of cell and gene therapy solutions through its acquisition of the SG Austria assets, today discussed the value of encapsulation, freezing, storage, survivability and localization of human stem cells once implanted using the proprietary Cell-in-a-Box technology.

The encapsulation of human stem cells is enabled by the Cell-in-a-Box technology, which can then be frozen, stored and later implanted into target tissues. The benefits of encapsulation are several: first, the process allows for freezing of stem cells for long-term storage without appreciably affecting viability. Second, encapsulation protects the stem cells from stress factors caused by direct aeration and sheer forces associated with bioreactors. Third, Cell-in-a-Boxencapsulated stem cells are held in place at the site of implantation, maximizing their potential efficacy as they have the potential to stimulate growth of surrounding new, healthy tissue. Finally, encapsulated cells may prevent any potential side effects associated with direct injection since they remain localized to the area of treatment when encapsulated.

Dr. Robert Ryan, Chief Executive Officer of Nuvilex, commented, "For many years it was assumed stem cells existed only to replace cells that had died or were damaged. Recent studies suggest factors stem cells secrete provide signals to surrounding tissue that can stimulate regeneration. The potential therefore, is that if stem cells can be maintained at a particular site where damaged, removed or non-functional tissue was through some sort of holding mechanism, this may aid in a positive growth response in that tissue. In addition, the stem cells themselves have the potential to undergo development into the appropriate cell type at that location, potentially creating miniature organs. The Cell-in-a-Boxtechnology is designed specifically for those purposes. Thus, encapsulated stem cells would be implanted and remain in place, ultimately being able to serve a broad number of medical applications entirely dependent on where in the body they are placed."

About Nuvilex

Nuvilex, Inc. (OTCQB:NVLX) is an emerging international biotechnology provider of live clinically useful, therapeutically valuable, encapsulated cells, as well as services for encapsulating live cells for the research and medical communities. Through substantial effort, the aspects of our corporate activities alone and in concert with SG Austria continue to move toward agreement completion and ultimately a strong future together. Our company's ultimate clinical offerings will include cancer, diabetes and other treatments using the company's industry-leading cell and gene therapy expertise and cutting edge, live-cell encapsulation technology.

Safe Harbor Statement

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 involving risks and uncertainties, including product demand, market competition, and Nuvilex's ability to meet current or future plans which may cause actual results, events, and performances, expressed or implied, to vary and/or differ from those contemplated or predicted. Investors should study and understand all risks before making an investment decision. Readers are recommended not to place undue reliance on forward-looking statements or information. Nuvilex is not obliged to publicly release revisions to any forward-looking statement, to reflect events or circumstances afterward, or to disclose unanticipated occurrences, except as required under applicable laws.

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Cell-In-A-Box Encapsulation Technology Creates Extensive Applications Within The Stem Cell Arena

FORT WASHINGTON, Pa.--(BUSINESS WIRE)--

The National Comprehensive Cancer Network (NCCN) has issued its first ever NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines) for Acute Lymphoblastic Leukemia (ALL). The new guidelines were presented by the co-chairs of the NCCN ALL Panel, Joseph C. Alvarnas, MD, Director of Medical Quality and Associate Director in the Division of Hematology and Hemapoietic Cell Transplantation at the City of Hope Comprehensive Cancer Center and Patrick A. Brown, MD, Associate Professor of Oncology and Pediatrics/Director of the Pediatric Leukemia Program, at The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins.

We felt that it was very important to develop a clear standard of treatment for adult acute lymphoblastic leukemia (ALL), said Dr. Brown. We now have consistent data demonstrating that young adults - those between the ages of 15 and 39 - with ALL benefit significantly from treatments inspired by those used for children with ALL. The main reason for this is that younger adult patients can tolerate the intensive therapies that we use for our pediatric patients, and this translates into better outcomes. We hope that these new NCCN Guidelines will give oncologists the information they need to ensure that young adult ALL patients receive these intensive therapies.

Dr. Brown noted that there had been considerable cross-over and discussion between his group and the panel which just released the new NCCN Guidelines for Adolescent and Young Adult (AYA) Oncology headed by Peter F. Coccia, MD, of the UNMC Eppley Cancer Center at The Nebraska Medical Center. Both the NCCN ALL and AYA Guidelines emphasize the importance of providing expert, comprehensive supportive care and the importance of increasing the enrollment of young adult patients into clinical trials.

The NCCN Guidelines also address treatment for older ALL patients, a group that Dr. Brown said is often more difficult to treat successfully than the younger patients. This is in large part due to the higher frequency of poor-risk cytogenetic abnormalities observed among older adults with ALL. One such abnormality is a translocation that results in the Philadelphia chromosome (Ph), which leads to the formation of the BCR-ABL fusion gene. Given the poor prognosis associated with Ph-positive ALL, the NCCN Guidelines initially stratify patients (both in AYA and adults) based on the presence of this abnormality. Regardless of age group, patients with Ph-positive ALL benefit from treatment regimens that incorporate BCR-ABL-targeting tyrosine kinase inhibitors.

The role of allogeneic stem cell transplantation (SCT) in treating ALL was also discussed. The NCCN Guidelines recommend allogeneic SCT as a consolidation option in patients with Ph-positive ALL, although the optimal role of SCT in this setting is yet to be defined. In addition, consolidation with allogeneic SCT is strongly recommended in patients with Ph-negative ALL with high-risk features. Evaluation of minimal residual disease can provide further risk stratification following initial induction therapy, and may help to identify patients who could potentially benefit from allogeneic SCT. Older adult patients, however, may not be appropriate candidates for SCT or intensive therapy options. Dr. Alvarnas discussed that in older adults, presence of comorbid factors such as organ dysfunction, limits the use of intensive regimens, which significantly impacts on the outcomes for this population. Dr. Brown pointed to the emergence of novel immune based therapies as new hope for increased remission rates and longer disease-free survival in older ALL patients.

Both Dr. Brown and Dr. Alvarnas emphasized the need for adequate central nervous system (CNS)-directed treatment to prevent CNS relapse for all patients with ALL, and the importance of comprehensive supportive care measures tailored to the needs of each patient.

ALL is the rarest form of leukemia in adults, Dr. Brown said. Its treatment poses many challenges and requires expertise and experience in a number of medical disciplines and supportive care areas. We recommend that ALL patients be referred to specialized treatment centers, and if possible, enrolled on clinical trials.

About the National Comprehensive Cancer Network

The National Comprehensive Cancer Network (NCCN), a not-for-profit alliance of 21 of the worlds leading cancer centers, is dedicated to improving the quality and effectiveness of care provided to patients with cancer. Through the leadership and expertise of clinical professionals at NCCN Member Institutions, NCCN develops resources that present valuable information to the numerous stakeholders in the health care delivery system. As the arbiter of high-quality cancer care, NCCN promotes the importance of continuous quality improvement and recognizes the significance of creating clinical practice guidelines appropriate for use by patients, clinicians, and other health care decision-makers. The primary goal of all NCCN initiatives is to improve the quality, effectiveness, and efficiency of oncology practice so patients can live better lives.

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NCCN Presents New Guidelines for Acute Lymphoblastic Leukemia

Four-year-old Angela Irizarry was born with a single pumping chamber in her heart, a potentially lethal defect. To fix the problem, Angela is growing a new blood vessel in her body in an experimental treatment that could advance the burgeoning field of regenerative medicine.

Doctors at Yale University here implanted in Angela's chest in August a bioabsorbable tube that is designed to dissolve over time. The tube was seeded with cells, including stem cells, that had been harvested from Angela's bone marrow. Since then, the doctors say, the tube has disappeared, leaving in its place a conduit produced by Angela's cells that functions like a normal blood vessel.

"We're making a blood vessel where there wasn't one," said Dr. Christopher Breuer, the Yale pediatric surgeon who led the 12-hour procedure to implant the device. "We're inducing regeneration."

Angela, who had little stamina before the operation, now has the energy of a regular kid. She is on several medications, but Breuer and her parents think she'll be able to start school in the fall.

Scientists have long been captivated by the ability of animals such as salamanders and starfish to regrow body parts lost to injury. It was long assumed that developmental forces that create a human being in the womb are lost at birth. But recent advances in stem-cell research and tissue engineering suggest that regenerative forces can be reawakened with strategically implanted stem cells and other tissue.

This notion is fueling research at many academic laboratories and dozens of start-up companies where scientists are hoping to identify effective ways to treat maladies including heart muscle damaged from heart attacks, paralysis due to spinal cord injuries and poor-functioning kidneys and bladders.

Angela's condition, known as hypoplastic left heart syndrome, affects some 3,000 newborns in the U.S. each year. With just one pumping chamber, or ventricle, instead of the usual two, the babies can't deliver sufficient levels of oxygen to their organs and extremities, compromising their development and causing them to turn blue and suffer from a lack of energy. Without a surgical repair, says Breuer, 70 percent of them die before their first birthday.

Pediatric surgeons typically treat the condition with a series of operations called the Fontan procedure, designed to enable the heart to function without the missing ventricle. The last operation involves implanting a synthetic blood vessel made of Gore-Tex to reroute blood from the lower extremities directly to the lungs instead of through the heart. The device works, but it is prone to clotting, infection and in some cases, the need for additional surgery later in life as the child grows. The idea behind Breuer's project is that a natural conduit with the biology of a normal blood vessel would grow with the child and avoid or significantly reduce complications associated with a synthetic tube.

Angela's case "is a real milestone and broadly important for the field of tissue engineering," said Robert Langer, a researcher at Massachusetts Institute of Technology and a regenerative-medicine pioneer who isn't involved in the Yale initiative. "It gives you hope that when you combine cells with a scaffold and [put] them in the body, they will do the right thing."

Angela's heart defect was diagnosed in utero, when her mother Claudia was five months pregnant. She had her first operation when she was 5 days old, and another at 8 months. But her heart defect was taking a toll. She was shy, small for her age and lacked the stamina of a normal 3-year-old.

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To fix a heart, doctors train girl's body to grow new part

MCKINNEY (CBSDFW.COM) - If you have ever dealt with back pain, then you know how quickly it can take over your life. But some North Texans are discovering that tiny cells in their own bodies could be key to long-lasting relief.

A simple walk on a beautiful day is not something that Kim Ferracioli takes for granted, as the McKinney resident has been dealing with debilitating back pain for years due to a bad disk in her lower spine. It was so painful, she said. Everytime I would stand up or sit too long, it was just a horrible pinching feeling.

When steroid injections, physical therapy and a minimally-invasive surgery actually made the pain worse, Ferracioli decided to try a new therapy that is revolutionizing the way that doctors treat spinal injuries.

Were using your stem cells, which decreases the rate for complications, explained Dr. Rob Dickerman, a neurosurgeon and one of a few doctors in the country using a patients own stem cells to actually grow new bones from scratch. We can remove a disk and put them between the bones of the spine, and itll stimulate a fusion.

Dickerman removes stem cells from a patients hip and places them in a disk-like carrier. Once implanted into the patients spine, within three months, the stem cells begin to grow into new bone where the damaged disk was removed.

There was an automatic difference, said Ferracioli about the procedure. I could get up out of chairs. I didnt need the cane anymore.

Dickerman said that the success of these procedures are just the first steps for stem cell use in the spine. He hopes that they will soon be able to treat more serious injuries. If we can tweak these cells, Dickerman explained, to make it beneficial to these patients that for the most part have irreparable injuries, that would just be a huge advance in science.

Research is already underway in several labs around the world, transplanting a patients own stem cells to repair spinal cord injuries and even traumatic brain injuries. Dickerman hopes to see these treatments hit the mainstream within the next few years.

In the meantime, Ferracioli said that this new procedure is the only thing that gave her life back. I had to literally pull this back leg up the stairs, Ferracioli recalled. Now, I can just go no pain!

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Stem Cells Could Be Key To Back Pain Relief

Public release date: 21-Mar-2012 [ | E-mail | Share ]

Contact: Stephen Rouse RouseS@cardiff.ac.uk 44-292-087-5596 Cardiff University

Powerful new cells created by Cardiff University scientists from cheek lining tissue could offer the answer to disorders of the immune system.

While the body's immune system protects against many diseases, it can also be harmful. Using white blood cells (lymphocytes), the system can attack insulin-producing cells, causing diabetes, or cause the body to reject transplanted organs.

A team from Cardiff's School of Dentistry led by Professor Phil Stephens, with colleagues from Stockholm's Karolinska Institute, have found a new group of cells with a powerful ability to suppress the immune system's action.

The team took oral lining cells from the insides of patients' cheeks and cloned them. Laboratory tests showed that even small doses of the cells could completely inhibit the lymphocytes.

The breakthrough suggests that the cheek cells have wide-ranging potential for future therapies for immune system-related diseases. Existing immune system research has focussed on adult stem cells, particularly those derived from bone marrow. The cheek tissue cells are much stronger in their action.

Dr Lindsay Davies, a member of the Cardiff team, said: "At this stage, these are only laboratory results. We have yet to recreate the effect outside the laboratory and any treatments will be many years away. However, these cells are extremely powerful and offer promise for combating a number of diseases. They are also easy to collect bone marrow stem cells require an invasive biopsy, whereas we just harvest a small biopsy from inside the mouth."

The findings have just been published online in Stem Cells and Development. The team has now been funded by the Medical Research Council to investigate the cloned cells further.

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Key to immune system disease could lie inside the cheek

Public release date: 21-Mar-2012 [ | E-mail | Share ]

Contact: Ingrid L. Thomas ithomas@aadronline.org 703-299-8084 International & American Associations for Dental Research

Tampa, Fla., USA On March 23, during the 41st Annual Meeting & Exhibition of the American Association for Dental Research (AADR), held in conjunction with the 36th Annual Meeting of the Canadian Association for Dental Research, a symposium titled "TMJ: Stem Cell Biology and Engineering toward Clinical Translation" will provide a rare forum for multidisciplinary discussion of the biology, engineering and clinical translation of fundamental discoveries towards novel clinical therapy. The symposium is co-sponsored by the Craniofacial Biology, Mineralized Tissue and Neuroscience Scientific Research Groups of the International Association for Dental Research. The presentations in this multidisciplinary symposium will represent broad and yet comprehensive approaches toward the understanding of the origin, homeostasis, differentiation, hormonal regulation and bioengineering of temporomandibular joint (TMJ) tissues.

TMJ disorders are a poorly understood cluster of diseases, ranging from neuromuscular pain to severe forms of arthritis. Recently, stem/progenitor cells have been identified in TMJ disc and condyle, with potential origin from neural crest cells in development. Putative TMJ stem/progenitor cells are subjected to local, hormonal and other systemic factors in homeostasis in multiple processes that warrant better elucidation. In parallel, there is an acute demand in the clinical community for the regeneration of various TMJ components, including the disc, condyle, synovium and the mandible.

This symposium will not only provide new aspects of a timely and under-studied subject of TMJ biology and therapeutics, but also use TMJ as a model for the study of other dental and craniofacial structures and diseases.

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This is a summary of sequence #87 titled "TMJ: Stem Cell Biology and Engineering toward Clinical Translation" which will feature abstracts to be presented by M. Embree, M. Detamore, A. Le and S. Kapila at the Annual Meeting of the American Association for Dental Research. This symposium will take place at 8 a.m. on Friday, March 23, 2012, in room 10 of the Tampa Convention Center.

About the American Association for Dental Research

The American Association for Dental Research (AADR), headquartered in Alexandria, Va., is a nonprofit organization with nearly 4,000 members in the United States. Its mission is: (1) to advance research and increase knowledge for the improvement of oral health; (2) to support and represent the oral health research community; and (3) to facilitate the communication and application of research findings. AADR is the largest Division of the International Association for Dental Research (IADR).

To learn more about the AADR, visit http://www.aadronline.org.

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TMJ: Stem cell biology and engineering toward clinical translation

March 21, 2012|8:48 am

Case in point: StemCells, Inc. just put out a news release for investors in which they announced their latest money-making opportunity using the brains from aborted babies for research.

Of course they don't call the brains "brains," nor do they mention that the organs were part of a baby once residing safely in a mother's womb. Rather, they label the material proprietary HuCNS-SC, or "purified human neural stem cells." (Both of which sound far more appealing than "the brain we just removed from the child the doctor killed and threw away.")

And since StemCells, Inc. has already received the approval of President Obama's Food and Drug Administration for this research, it's off to the races.

According to StemCells, Inc. CEO Martin McGlynn:

With the approval of this trial, we have accomplished something truly unique in the stem cell field, which is the extension of clinical testing of our proprietary human neural stem cell platform to all three elements of the central nervous system: the brain, spinal cord and eye. The preclinical data supporting our IND is particularly compelling and we look forward to getting this trial underway.

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And Stephen Huhn, MD, vice president of the program at StemCells, Inc., was elated: "We have published the preclinical evidence demonstrating that our human neural stem cells might offer a safe, effective and simple approach to treating AMD and other retinal diseases."

In other words, taking the brains out of one person and injecting them into another may actually help the second to see better. Of course, the side effects for the person forced to donate the brain are horrific, but there's money to be made.

As Scott Fischbach, the director of Minnesota Citizens Concerned for Life points out, the babies being sacrificed for this purpose are 10 to 20 weeks old, "with visible fingers, toes and ears." This means "developing human beings in the womb are treated simply as raw material for laboratory experimentation by StemCells Inc. and other companies seeking to monetize aborted unborn children."

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Post-Abortion Baby Parts Now a Booming Business

SILVER SPRING, Md.--(BUSINESS WIRE)--

Nuvilex, Inc. (OTCQB:NVLX), an emerging biotechnology provider of cell and gene therapy solutions through its acquisition of the SG Austria assets, today discussed the value of encapsulation, freezing, storage, survivability and localization of human stem cells once implanted using the proprietary Cell-in-a-Box technology.

The encapsulation of human stem cells is enabled by the Cell-in-a-Box technology, which can then be frozen, stored and later implanted into target tissues. The benefits of encapsulation are several: first, the process allows for freezing of stem cells for long-term storage without appreciably affecting viability. Second, encapsulation protects the stem cells from stress factors caused by direct aeration and sheer forces associated with bioreactors. Third, Cell-in-a-Box encapsulated stem cells are held in place at the site of implantation, maximizing their potential efficacy as they have the potential to stimulate growth of surrounding new, healthy tissue. Finally, encapsulated cells may prevent any potential side effects associated with direct injection since they remain localized to the area of treatment when encapsulated.

Dr. Robert Ryan, Chief Executive Officer of Nuvilex, commented, For many years it was assumed stem cells existed only to replace cells that had died or were damaged. Recent studies suggest factors stem cells secrete provide signals to surrounding tissue that can stimulate regeneration. The potential therefore, is that if stem cells can be maintained at a particular site where damaged, removed or non-functional tissue was through some sort of holding mechanism, this may aid in a positive growth response in that tissue. In addition, the stem cells themselves have the potential to undergo development into the appropriate cell type at that location, potentially creating miniature organs. The Cell-in-a-Box technology is designed specifically for those purposes. Thus, encapsulated stem cells would be implanted and remain in place, ultimately being able to serve a broad number of medical applications entirely dependent on where in the body they are placed.

About Nuvilex

Nuvilex, Inc. (OTCQB:NVLX) is an emerging international biotechnology provider of live clinically useful, therapeutically valuable, encapsulated cells, as well as services for encapsulating live cells for the research and medical communities. Through substantial effort, the aspects of our corporate activities alone and in concert with SG Austria continue to move toward agreement completion and ultimately a strong future together. Our companys ultimate clinical offerings will include cancer, diabetes and other treatments using the companys industry-leading cell and gene therapy expertise and cutting edge, live-cell encapsulation technology.

Safe Harbor Statement

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 involving risks and uncertainties, including product demand, market competition, and Nuvilexs ability to meet current or future plans which may cause actual results, events, and performances, expressed or implied, to vary and/or differ from those contemplated or predicted. Investors should study and understand all risks before making an investment decision. Readers are recommended not to place undue reliance on forward-looking statements or information. Nuvilex is not obliged to publicly release revisions to any forward-looking statement, to reflect events or circumstances afterward, or to disclose unanticipated occurrences, except as required under applicable laws.

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Cell-in-a-Box® Encapsulation Technology Creates Extensive Applications within the Stem Cell Arena

TUESDAY, March 20 (HealthDay News) -- A novel technique that uses a kidney transplant recipient's own stem cells may someday replace or reduce the initial use of anti-rejection medications, new research suggests.

Six months after receiving a kidney transplant, only about 8 percent of people given their own mesenchymal stem cells experienced rejection compared with almost 22 percent of people on the standard anti-rejection drugs, according to the study.

"Mesenchymal stem cells are stem cells that can be differentiated into a variety of cells," explained Dr. Camillo Ricordi, study senior author and director of the Cell Transplant Center and Diabetes Research Institute at the University of Miami Miller School of Medicine.

"If you infuse mesenchymal stem cells at the time of the transplant, you could replace the use of powerful anti-rejection drugs, and maybe replace immunosuppressants altogether," he said. This technique could be used in the transplantation of islet cells (in the pancreas) for people with type 1 diabetes, and for other organ transplants, such as the liver, he added.

The people given their own stem cells also had improved kidney function earlier after transplant, Ricordi said.

Results of the study appear in the March 21 issue of the Journal of the American Medical Association.

One of the biggest remaining hurdles in organ transplantation remains the need for powerful anti-rejection and immune-suppressing medications after the transplant.

"Basically, the way we prevent kidney rejections is by putting you on very powerful anti-rejection drugs and immunosuppressive agents to prevent your cells from attacking the foreign organ," said Dr. Robert Provenzano, chair of the department of nephrology, hypertension and transplantation at St. John Providence Health System in Detroit. "But, the current standard has some problems, like an increased risk of infections and the possibility of creating a cancer."

The body's immune system sends out surveillance cells to protect the body against foreign invaders, such as a bacteria, virus or, in this case, a new organ, Provenzano said. The current method of preventing these cells from attacking the new organ is essentially to destroy the surveillance cells. But mesenchymal cells can naturally suppress those surveillance cells so they don't attack, he said.

To see if this suppression would be enough to prevent rejection, Ricordi and his colleagues, including researchers from Xiamen University in China, recruited 159 people with serious kidney disease who were on dialysis. They ranged in age from 18 to 61.

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Stem Cell Therapy Could Boost Kidney Transplant Success: Study

To: HEALTH, MEDICAL AND NATIONAL EDITORS

MIAMI, March 20, 2012 /PRNewswire-USNewswire/ -- New findings from a transplant study led by scientists from the Diabetes Research Institute (DRI) at the University of Miami Miller School of Medicine and a DRI Federation center at Xiamen University in China showed that mesenchymal stem cells may replace a powerful anti-rejection drug in transplant recipients. The results of this pioneering study involving kidney transplant patients is published in the March 21 issue of the Journal of the American Medical Association (JAMA) and may fundamentally transform the future of clinical transplantation.

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Patients undergoing a transplant routinely receive a regimen of immunosuppressive therapy to block the body's immune system from rejecting the donor organ or cells. While these drugs have been shown to improve graft function and minimize rejection episodes, they increase the risk of dangerous side effects, including infections and organ toxicity. To eliminate these adverse effects, scientists at the Diabetes Research Institute and collaborating centers worldwide have been investigating safer methods for preventing transplant rejection and have turned their attention to naturally-occurring cells in the body that have immuno-modulatory properties, like mesenchymal stem cells.

A mesenchymal stem cell (MSC) is a type of cell that can differentiate into bone, cartilage, fat and other body tissues. But MSCs have also been found to have a number of other beneficial therapeutic properties, including their ability to modulate the immune system by inhibiting T-cell proliferation, eliminating graft-vs.-host disease, limiting cytotoxic inflammation and stimulating vascularization, among other benefits.

"This study represents a first, important step towards the definition of cell-based strategies that will one day allow for transplantation without the need for life-long, anti-rejection drugs," said Camillo Ricordi, M.D., director of the University of Miami Diabetes Research Institute and Cell Transplant Center. "The worldwide collaborative strategy of the Diabetes Research Institute Federation and The Cure Alliance has resulted in yet another small step forward in our worldwide cure-focused efforts, indicating safety and efficacy of a stem cell-based strategy towards reducing and eventually eliminating anti-rejection drugs. This is particularly important to the DRI mission, as transplantation without immunosuppression is a major goal in any strategy for transplantation of insulin producing cells and a requirement for becoming a reality for all patients with Type 1 or Type 2 insulin dependent diabetes."

In this recent study, "Induction Therapy with Autologous Mesenchymal Stem Cells in Living-Related Kidney Transplants," patients with end-stage renal disease received infusions of bone-marrow derived autologous mesenchymal stem cells together with either standard-dose or low-dose calcineurin inhibitors (CNI). The control group received an immunosuppression regimen consisting of anti-IL-2 receptor antibody plus standard-dose CNI.

After one year post-transplant, the results of the study indicate that among the patients undergoing a kidney transplant, the use of autologous MSCs compared with the standard immunosuppressive therapy resulted in lower incidence of acute organ rejection, decreased risk of infection and better kidney function.

"We reported on the first 12 months follow-up, which showed no adverse events associated with MSC therapy. We will continue monitoring the patients in the study to assess the long-term effects on kidney transplant function and survival, as well as the safety of MSCs transplantation in this setting. Should long-term safety of MSCs be confirmed, it may be valuable for improving transplantation outcomes while reducing the risks associated with anti-rejection drugs," said Antonello Pileggi, M.D., Ph.D., director of Preclinical Cell Processing and Translational Models Program at the Cell Transplant Center of the DRI.

"This collaboration was part of the ongoing global efforts of The Diabetes Research Institute Federation and of The Cure Focus Research Alliance. The opportunity to contribute these results obtained through the combined team efforts of Affiliated Fuzhou General Hospital of Xiamen University and DRI to a journal as high impact as JAMA represents an important achievement for the China-USA Collaborative Human Cell Transplant Program at the Cell Transplant Center of DRI," said Xiumin Xu, M.S., director of the China-US Collaborative Human Cell Transplant Program at the Diabetes Research Institute.

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Collaborative Study from the Diabetes Research Institute Federation and The Cure Alliance Shows that Stem Cells Can ...

2nd Lee Co. doctor's license restricted in stem cell case

FORT MYERS, Fla.- Another Lee County doctor is caught in the center of a stem cell controversy. The State Department of Health has issued an emergency license restriction to Dr. Konstantine Yankopolus, a general practitioner.

Dr. Yankopolus is still allowed to practice general medicine and is treating patients. The license restriction mandates he can't do anything involving stem cell treatment.

It's business as usual at his office on Colonial Blvd.

The doctor is still treating patients, but an emergency order issued from the Florida Department of Health, Monday prevents him from doing anything with stem cells.

The order says Dr. Yankopolus' license "is hereby immediately restricted from providing, collaborating, facilitating, procuring, referring or advising on any stem cell treatment."

The action comes after the state suspended the license of his colleague, Dr. Zannos Grekos' earlier this month.

The emergency order says Dr. Yankopolus helped Dr. Grekos perform stem cell therapy on the late Richard Polling despite knowing the Bonita Springs cardiologist was not allowed to do such a procedure.

The state Surgeon General alleges, Dr. Yankopolus falsified Polling's records.

He writes, "Subsequent to the death of patient R.P., Dr. Yankopolus entered a false medical progress note in R.P.'s chart falsely indicating that no stem cell preparation was infused."

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2nd Lee Co. doctor's license restricted in stem cell case

TUESDAY, March 20 (HealthDay News) -- A novel technique that uses a kidney transplant recipient's own stem cells may someday replace or reduce the initial use of anti-rejection medications, new research suggests.

Six months after receiving a kidney transplant, only about 8 percent of people given their own mesenchymal stem cells experienced rejection compared with almost 22 percent of people on the standard anti-rejection drugs, according to the study.

"Mesenchymal stem cells are stem cells that can be differentiated into a variety of cells," explained Dr. Camillo Ricordi, study senior author and director of the Cell Transplant Center and Diabetes Research Institute at the University of Miami Miller School of Medicine.

"If you infuse mesenchymal stem cells at the time of the transplant, you could replace the use of powerful anti-rejection drugs, and maybe replace immunosuppressants altogether," he said. This technique could be used in the transplantation of islet cells (in the pancreas) for people with type 1 diabetes, and for other organ transplants, such as the liver, he added.

The people given their own stem cells also had improved kidney function earlier after transplant, Ricordi said.

Results of the study appear in the March 21 issue of the Journal of the American Medical Association.

One of the biggest remaining hurdles in organ transplantation remains the need for powerful anti-rejection and immune-suppressing medications after the transplant.

"Basically, the way we prevent kidney rejections is by putting you on very powerful anti-rejection drugs and immunosuppressive agents to prevent your cells from attacking the foreign organ," said Dr. Robert Provenzano, chair of the department of nephrology, hypertension and transplantation at St. John Providence Health System in Detroit. "But, the current standard has some problems, like an increased risk of infections and the possibility of creating a cancer."

The body's immune system sends out surveillance cells to protect the body against foreign invaders, such as a bacteria, virus or, in this case, a new organ, Provenzano said. The current method of preventing these cells from attacking the new organ is essentially to destroy the surveillance cells. But mesenchymal cells can naturally suppress those surveillance cells so they don't attack, he said.

To see if this suppression would be enough to prevent rejection, Ricordi and his colleagues, including researchers from Xiamen University in China, recruited 159 people with serious kidney disease who were on dialysis. They ranged in age from 18 to 61.

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Stem Cell Therapy Could Boost Kidney Transplant Success: Study

17-11-2011 10:50 Future of health care, hospitals, medicine, doctors, physicians, nurses and medical training. How latest research into cancer, stroke, heart disease will change our lives, living longer and healthier. Future of pharmaceuticals and the pharmaceutical industry, role of adult stem cells in organ regeneration and repair of heart, spinal cord, brain, liver, eyes and other tissues. Wellbeing and wellness industry. Gene therapy and genetic prophecy. How genetic engineering will treat illness. Slowing down the aging process. Getting old. Diseases of old age and how they will be treated. Keynote conference speaker Dr Patrick Dixon keynote speaker: Patrick Dixon

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Health care for retired people, hospitals, medicine and wellbeing - by Dr Patrick Dixon - Video

SILVER SPRING, Md.--(BUSINESS WIRE)--

Nuvilex, Inc. (OTCQB:NVLX), an emerging biotechnology provider of cell and gene therapy solutions through its acquisition of the SG Austria assets, today discussed the value of encapsulation, freezing, storage, survivability and localization of human stem cells once implanted using the proprietary Cell-in-a-Box technology.

The encapsulation of human stem cells is enabled by the Cell-in-a-Box technology, which can then be frozen, stored and later implanted into target tissues. The benefits of encapsulation are several: first, the process allows for freezing of stem cells for long-term storage without appreciably affecting viability. Second, encapsulation protects the stem cells from stress factors caused by direct aeration and sheer forces associated with bioreactors. Third, Cell-in-a-Box encapsulated stem cells are held in place at the site of implantation, maximizing their potential efficacy as they have the potential to stimulate growth of surrounding new, healthy tissue. Finally, encapsulated cells may prevent any potential side effects associated with direct injection since they remain localized to the area of treatment when encapsulated.

Dr. Robert Ryan, Chief Executive Officer of Nuvilex, commented, For many years it was assumed stem cells existed only to replace cells that had died or were damaged. Recent studies suggest factors stem cells secrete provide signals to surrounding tissue that can stimulate regeneration. The potential therefore, is that if stem cells can be maintained at a particular site where damaged, removed or non-functional tissue was through some sort of holding mechanism, this may aid in a positive growth response in that tissue. In addition, the stem cells themselves have the potential to undergo development into the appropriate cell type at that location, potentially creating miniature organs. The Cell-in-a-Box technology is designed specifically for those purposes. Thus, encapsulated stem cells would be implanted and remain in place, ultimately being able to serve a broad number of medical applications entirely dependent on where in the body they are placed.

About Nuvilex

Nuvilex, Inc. (OTCQB:NVLX) is an emerging international biotechnology provider of live clinically useful, therapeutically valuable, encapsulated cells, as well as services for encapsulating live cells for the research and medical communities. Through substantial effort, the aspects of our corporate activities alone and in concert with SG Austria continue to move toward agreement completion and ultimately a strong future together. Our companys ultimate clinical offerings will include cancer, diabetes and other treatments using the companys industry-leading cell and gene therapy expertise and cutting edge, live-cell encapsulation technology.

Safe Harbor Statement

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 involving risks and uncertainties, including product demand, market competition, and Nuvilexs ability to meet current or future plans which may cause actual results, events, and performances, expressed or implied, to vary and/or differ from those contemplated or predicted. Investors should study and understand all risks before making an investment decision. Readers are recommended not to place undue reliance on forward-looking statements or information. Nuvilex is not obliged to publicly release revisions to any forward-looking statement, to reflect events or circumstances afterward, or to disclose unanticipated occurrences, except as required under applicable laws.

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Cell-in-a-Box® Encapsulation Technology Creates Extensive Applications within the Stem Cell Arena

A special dog used to help people is getting some much-needed help of her own at a Virginia clinic.

Red, a 12-year-old black Labrador, is one of the last surviving search-and-rescue dogs deployed during the 9/11 attacks, Fox affiliate WTTG-TV reported.

Her handler, Heather Roche, told the station that Red was recently certified when the terror attacks of Sept. 11, 2001, occurred, saying the search-and-rescue operation that followed was her first big mission.

Red's job was to find DNA evidence at the Pentagon's north parking lot with 26 other dogs, according to Roche, who said she did a "fantastic job."

"I got her as a puppy ... You have to convince [her] everything that she does, whether it's climbing ladders or any kind of search, that it's her idea," Roche told WTTG. "No matter what I've asked her to do, she's done it and she's done it flawlessly."

But in her old age, Red developed crippling arthritis and underwent stem cell regenerative therapy Monday to help ease her pain so she can get back out on the job.

Dr. John Herrity of Burke Animal Clinic in Burke, Va., told the station that "Red has a back issue that, after a fall from a ladder, has not really been right, and has been living in pain, so we're going to give those stem cells IV [intravenously] and then also inject them along the back to try to help Red's comfort."

"She's had a great career and has made a difference to a lot of families by bringing their loved ones home," Roche said.

Click for more on this story from MyFoxDC.com

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A Chance to Ease the Pain Of a Rescue Hero of 9/11

15-03-2012 15:54 This screencast focuses on stem cells, their sources, and their potential applications in biomedical research.

Excerpt from:
Biotechnology Screencast Session 5.m4v - Video

A special dog used to help people is getting some much-needed help of her own at a Virginia clinic, myFOXdc.com reported.

Red, a 12-year-old black Labrador, is one of the last surviving search and rescue dogs deployed during the 9/11 attacks.

Her handler, Heather Roche, told WTTG-TV that Red was recently certified when Sept. 11, 2001, occurred, and the devastating terror attacks were her first big mission.

Red's job was to find DNA evidence at The Pentagon's north parking lot with 26 other dogs, and according to Roche, she did a "fantastic job."

"I got her as a puppy ... You have to convince [her] everything that she does, whether it's climbing ladders or any kind of search, that it's her idea," Roche told WTTG-TV. "No matter what I've asked her to do, she's done it and she's done it flawlessly."

But in her old age Red developed crippling arthritis, and underwent stem cell regenerative therapy Monday to help ease her pain so she can get back out on the job.

Dr. John Herrity of Burke Animal Clinic in Burke, Va., told WTTG-TV, "Red has a back issue that, after a fall from a ladder has not really been right, and has been living in pain, so we're going to give those stem cells IV [intravenously] and then also inject them along the back to try to help Red's comfort."

"She's had a great career and has made a difference to a lot of families by bringing their loved ones home," Roche said.

Click here to read more.

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9/11 search and rescue dog receives stem cell therapy