ALBANY, N.Y. Almost halfway through a $600 million state program supporting stem cell research, eight medical schools around New York are reporting progress on projects such as replicating liver cells and eradicating leukemia cells.

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A new report from Associated Medical Schools of New York updates work at the institutions where hundreds of researchers are starting to unravel causes and potential treatments for conditions ranging from autism to heart disease and cancer. Stem cells are self-renewing and have the ability to develop into other types of cells.

The Mount Sinai School of Medicine reported finding a method to transform human skin cells into stem cells and turned differentiated human stem cells into heart cells. Those findings are expected to result in better understanding of how heart disease develops and allow initial testing of new treatments on stem cells before they are used on human subjects.

Dr. Ihor Lemischka, director of the Black Family Stem Cell Institute at Mount Sinai, said recreating heart cells in a dish from a patient with LEOPARD Syndrome, a disease caused by a genetic mutation, has opened ongoing avenues for researching the disease and screening potential drugs.

"It was a major achievement," Lemischka said. The initial work was reported in June 2010 in the journal Nature.

The shared research facility at Mount Sinai supports the work at 80 different labs, Lemischka said.

The Empire State Stem Cell Program was intended to fund projects in early stages, including those that initially have been unable to get federal or private funding. Grants have also been used for capital projects like renovating labs and establishing new stem cell centers.

The Albert Einstein College of Medicine reported replicating liver cells that could help reduce the need for liver transplants using live donors and cadavers.

Dr. Allen Spiegel said 12 new researchers have been hired with state funding at the Bronx school, which also lists anemia, brain disorders, heart disease and obesity among its stem cell research subjects.

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NY medical schools chart progress with stem cells

BOUDRY, Switzerland--(BUSINESS WIRE)--

Celgene International Srl, a subsidiary of Celgene Corporation (NASDAQ: CELG - News), today announced that results from three phase III studies evaluating the use of continuous REVLIMID (lenalidomide) treatment in newly diagnosed multiple myeloma (MM) patients or maintenance treatment with lenalidomide following autologous stem cell transplant were published online in the May 10, 2012 edition of the New England Journal of Medicine. All three publications highlight the expanding body of clinical evidence supporting lenalidomide treatment in these areas.

Continuous Lenalidomide Therapy (non-transplant eligible population):

The first article highlights a Celgene-sponsored study of continuous lenalidomide treatment in elderly patients newly diagnosed with multiple myeloma.

Continuous Lenalidomide Treatment for Newly Diagnosed Multiple Myeloma (MM-015)

This double-blind, phase III, multicenter, randomized study conducted by Celgene compared melphalanprednisonelenalidomide induction followed by lenalidomide maintenance (MPR-R), with melphalanprednisonelenalidomide (MPR), or melphalanprednisone (MP) followed by placebo in 459 patients aged 65 years with newly-diagnosed myeloma who were not eligible for autologous stem-cell transplant.

http://www.nejm.org/doi/full/10.1056/NEJMoa1112704

Post-transplant maintenance

The two additional articles published in the edition highlighted cooperative group studies that evaluated the use of lenalidomide maintenance following autologous stem cell transplant (ASCT).

In each of the studies, one funded by the National Cancer Institute and conducted by the Cancer and Leukemia Group B (CALGB) and one by the Intergroupe Francophone du Myelome (IFM), maintenance treatment with lenalidomide following ASCT resulted in delayed time to disease progression or death compared to placebo.

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New England Journal of Medicine Reports on Three Phase III REVLIMID® (lenalidomide) Trials in Patients with Newly ...

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

Contact: Paul Scotti scotti.paul@mayo.edu 904-953-2299 Mayo Clinic

JACKSONVILLE, Fla. A single gene that promotes initial development of the most common form of lung cancer and its lethal metastases has been identified by researchers at Mayo Clinic in Florida. Their study suggests other forms of cancer may also be driven by this gene, matrix metalloproteinase-10 (MMP-10).

The study, published in the journal PLoS ONE on April 24, shows that MMP-10 is a growth factor secreted and then used by cancer stem-like cells to keep themselves vital. These cells then drive lung cancer and its spread, and are notoriously immune to conventional treatment.

The findings raise hope for a possible treatment for non-small cell lung cancer, the leading cause of U.S. cancer deaths. Researchers discovered that by shutting down MMP-10, lung cancer stem cells lose their ability to develop tumors. When the gene is given back to the cells, they can form tumors again.

The power of this gene is extraordinary, says senior investigator Alan Fields, Ph.D., the Monica Flynn Jacoby Professor of Cancer Research within the Department of Cancer Biology at Mayo Clinic in Florida.

"Our data provides evidence that MMP-10 plays a dual role in cancer. It stimulates the growth of cancer stem cells and stimulates their metastatic potential,'' he says. "This helps explain an observation that has been seen in cancer stem cells from many tumor types, namely that cancer stem cells appear to be not only the cells that initiate tumors, but also the cells that give rise to metastases."

Dr. Fields says the findings were unexpected, for several reasons.

The first is that the cancer stem cells express MMP-10 themselves, and use it for their own growth. Most of the known members of the matrix metalloproteinase genes are expressed in the tumor's microenvironment, the cells and tissue that surround a tumor, he says. The enzymes produced by these genes are involved in breaking down the microenvironment that keeps a tumor in place, allowing cancer cells to spread, which is why other genes in this family have been linked to cancer metastasis.

"The fact that a gene like MMP-10, which codes for a matrix metalloproteinase that has been linked to metastasis, is actually required for the growth and maintenance of cancer stem cells is very surprising. One would not have predicted that such a gene would be involved in this process," Dr. Fields says.

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Mayo Clinic identifies gene critical to development and spread of lung cancer

Mike Ivey writes on all matters money in the spirit of Capital Times founder William T. Evjue, who believed that the concentration of wealth in the U.S. is not healthy for the Democracy.

When UW-Madison's James Thomson in 1998 became the first scientist to grow human embryonic stem cells in a lab, it generated tremendous excitement about the medical possibilities.

Thomson tried to downplay the breakthrough but talk spread about cures for Alzheimers or Parkinsons disease, growing livers for cirrhosis suffers or producing healthy heart cells for cardiac patients.

The miracle cures have been slow in coming, however. Scientists can replicate healthy nerve cells in a Petri dish but havent found a way to replace defective spinal cells in ALS victims, for example.

In many ways, were still at the first steps,Anita Bhattacharyya, a senior scientist in the stem cell program at the UW's Waisman Center, told a business group Tuesday.

Butproducing stem cells for others to use is proving one of Madisons more promising new business ventures. Pharmaceutical companies in particular are using stem cells to test drugs before launching into expensive further testing.

Were making these cells available to the masses, says Chris Parker, chief technology officer at Cellular Dynamics International.

Launched by Thomson -- and backed with $100 million from a local investor group -- Cellular Dynamics International was lauded recently by MIT as one of the 50 most important companies in the world

Since its founding in 2005, the company now counts 107 employees at it offices in University Research Park and is continuing to grow.

Im hiring right now, Parker joked toa lunch crowd of the Wisconsin Technology Council Tuesday.

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Biz Beat: Making stem cells "available to the masses"

SOUTH SAN FRANCISCO, CA--(Marketwire -04/25/12)- VistaGen Therapeutics, Inc. (VSTA.OB - News) (VSTA.OB - News), a biotechnology company applying stem cell technology for drug rescue, has secured a new United States patent covering the company's proprietary methods used to measure and type the toxic effects produced by drug compounds in liver stem cells.

Test methods included in this new patent, (U.S. Patent 11/445,733), titled "Toxicity Typing Using Liver Stem Cells," cover all mammalian liver stem cells -- rat and mouse cells, for example, in addition to human cells. Liver stem cells used in drug testing can be derived from in vivo tissue or produced from embryonic stem cells (ES) or induced pluripotent stem cells (iPS).

H. Ralph Snodgrass, Ph.D., VistaGen's President and Chief Scientific Officer, said, "This patent covers the monitoring of changes in gene expression as an assay for predicting drug toxicities. It is well known that drugs activate and suppress specific genes, and that the changes in gene expression reflect the mechanism of drug toxicities. The specific sets of genes that are affected become a profile of that drug."

VistaGen's new patent also covers techniques used to develop a database of gene expression profiles of drugs that have the same type of liver toxicity. Using sophisticated "pattern matching" database tools, drug developers can analyze these related profiles to determine "gene expression signatures" that are common and predictive of drugs that produce specific types of toxicity.

"Without this database capability, a drug's single gene expression profile could not be interpreted," Dr. Snodgrass added. "The ability to use liver stem cells to differentiate drug-dependent gene expression profiles, and to compare those profiles of drugs known to induce toxic liver effects, provides a powerful tool for predicting liver toxicity of new drug candidates, including drug rescue variants."

Shawn K. Singh, VistaGen's Chief Executive Officer, stated, "Strong and enforceable intellectual property rights are critical components of our plan to optimize the commercial potential of our Human Clinical Trials in a Test Tube platform. This new liver toxicity typing patent further solidifies our growing IP portfolio, and supports the continuing development of LiverSafe 3D, our human liver cell-based bioassay system, which complements our CardioSafe 3D human heart cell-based bioassay system for heart toxicity."

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.

Visit VistaGen at http://www.VistaGen.com, follow VistaGen at http://www.twitter.com/VistaGen or view VistaGen's Facebook page at http://www.facebook.com/VistaGen

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VistaGen Secures Key U.S. Patent Covering Stem Cell Technology Methods Used to Test Drug Candidates for Liver Toxicity

April 20, 2012 18:19 PM

IBN Discovers Human Neural Stem Cells, Promising Discovery For Breast Cancer Therapy

By Tengku Noor Shamsiah Tengku Abdullah

SINGAPORE, April 20 (Bernama) -- Could engineered human stem cells hold the key to cancer survival?

Scientists at the Institute of Bioengineering and Nanotechnology (IBN), the world's first bioengineering and nanotechnology research institute, have discovered that neural stem cells possess the innate ability to target tumor cells outside the central nervous system.

This finding, which was demonstrated successfully on breast cancer cells, was recently published in leading peer reviewed journal, Stem Cells.

Despite decades of cancer research, cancer remains a leading cause of death worldwide, accounting for 7.6 million deaths in 2008, and breast cancer is one of the most common causes of cancer deaths each year.

In Singapore, more than 1,400 women are diagnosed with breast cancer and more than 300 die as a result of breast cancer annually.

A team of researchers led by IBN group leader Dr Shu Wang, has made a landmark discovery that neural stem cells (NSCs) derived from human induced pluripotent stem (iPS) cells could be used to treat breast cancer.

The effectiveness of using NSCs, which originate from the central nervous system, to treat brain tumors has been investigated in previous studies.

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IBN Discovers Human Neural Stem Cells, Promising Discovery For Breast Cancer Therapy

MEDIA RELEASE

IBN Discovers Human Neural Stem Cells with Tumor Targeting Ability A Promising Discovery for Breast Cancer Therapy

Singapore, April 20, 2012 Could engineered human stem cells hold the key to cancer survival? Scientists at the Institute of Bioengineering and Nanotechnology (IBN), the worlds first bioengineering and nanotechnology research institute, have discovered that neural stem cells possess the innate ability to target tumor cells outside the central nervous system. This finding, which was demonstrated successfully on breast cancer cells, was recently published in leading peer reviewed journal, Stem Cells.

A team of researchers led by IBN Group Leader, Dr Shu Wang, has made a landmark discovery that neural stem cells (NSCs) derived from human induced pluripotent stem (iPS) cells could be used to treat breast cancer. The effectiveness of using NSCs, which originate from the central nervous system, to treat brain tumors has been investigated in previous studies. This is the first study that demonstrates that iPS cell-derived NSCs could also target tumors outside the central nervous system, to treat both primary and secondary tumors.

To test the efficiency of NSCs in targeting and treating breast cancer, the researchers injected NSCs loaded with a suicide gene (herpes simplex virus thymidine) into mice bearing breast tumors. They did this using baculoviral vectors or gene carriers engineered from an insect virus (baculovirus), which does not replicate in human cells, making the carriers less harmful for clinical use. A prodrug (ganciclovir), which would activate the suicide gene to kill the cancerous cells upon contact, was subsequently injected into the mice. A dual-colored whole body imaging technology was then used to track the distribution and migration of the iPS-NSCs.

The imaging results revealed that the iPS-NSCs homed in on the breast tumors in the mice, and also accumulated in various organs infiltrated by the cancer cells such as the lung, stomach and bone. The survival of the tumor-bearing mice was prolonged from 34 days to 39 days. This data supports and explains how engineered iPS-NSCs are able to effectively seek out and inhibit tumor growth and proliferation.

Dr Shu Wang shared, We have demonstrated that tumor-targeting neural stem cells may be derived from human iPS cells, and that these cells may be used in combination with a therapeutic gene to cripple tumor growth. This is a significant finding for stem cell-based cancer therapy, and we will continue to improve and optimize our neural stem cell system by preventing any unwanted activation of the therapeutic gene in non-tumor regions and minimizing possible side effects.

IBNs expertise in generating human stem cells from iPS cells and our novel use of insect virus carriers for gene delivery have paved the way for the development of innovative stem cell-based therapies. With their two-pronged attack on tumors using genetically engineered neural stem cells, our researchers have discovered a promising alternative to conventional cancer treatment, added Professor Jackie. Y. Ying, IBN Executive Director.

Compared to collecting and expanding primary cells from individual patients, IBNs approach of using iPS cells to derive NSCs is less laborious and suitable for large-scale manufacture of uniform batches of cellular products for repeated patient treatments. Importantly, this approach will help eliminate variability in the quality of the cellular products, thus facilitating reliable comparative analysis of clinical outcomes.

Additionally, these iPS cell-derived NSCs are derived from adult cells, which bypass the sensitive ethical issue surrounding the use of human embryos, and since iPS cells are developed from a patients own cells, the likelihood of immune rejection would be reduced.

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:: 20, Apr 2012 :: IBN DISCOVERS HUMAN NEURAL STEM CELLS WITH TUMOR TARGETING ABILITY – A PROMISING DISCOVERY FOR ...

IRVINE, Calif.--(BUSINESS WIRE)--

California Stem Cell, Inc. (CSC)s Hans S. Keirstead, Ph.D. will speak at todays Global Emerging Leaders Forum in New York City, participating in a panel of the worlds leading innovators, philanthropists, and business thought-leaders who have gathered to discuss global issues. This symposium is the latest in a series of thought leadership and panel discussion appearances by CSC team members in recent months.

The NYC-based Global Emerging Leadership Forum was founded in 2011 to support emerging professionals through the discussion of the top social and economic issues of today, as well as emerging trends of the future. Dr. Keirstead will speak at 1pm in New York Citys Kaufmann Concert Hall, joining a diverse panel of influential and forward-thinking leaders in their respective fields. Attendees will gain valuable insight into the future of global society, global citizenship, corporate responsibility, and the politics of being an emerging global leader.

In February of this year, Dr. Keirstead presented at Singularity Universitys FutureMed event Exploring the Future of Healthcare. He delivered a presentation highlighting the powerful potential uses of stem cells for spinal cord injury and beyond. More recently, California Stem Cells Gabriel Nistor, M.D. participated in an Institute of Medicine (IOM) hosted review of the California Institute of Regenerative Medicine (CIRM)s programs, operations, strategies, and performance.

Details of California Stem Cell pubic speaking appearances are at: http://californiastemcell.com/press_cal

More information about the Global Emerging Leadership Forum: http://www.emergingleadersnyc.com/

More information about FutureMed: http://futuremed2020.com/

About California Stem Cell

California Stem Cell Inc. (CSC) is an Irvine, CA based company with proprietary methods to generate human stem cell lines, expand them to clinically and commercially useful numbers, and differentiate them at extremely high purity using fully-defined, proprietary media and GMP processes. CSC is able to supply its human cell populations to companies and institutions worldwide for use in the development of therapies, efficacy screening or the creation of toxicity profiles for candidate drugs, and experimental research tools.

CSC is currently focused on the development of stem cell based therapies for spinal muscular atrophy (SMA), amyotrophic lateral sclerosis (ALS, or Lou Gehrigs Disease), and metastatic cancers.

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California Stem Cell Chairman Hans Keirstead Speaks at Prominent Global Emerging Leadership Forum

Trial Provides Proof-of-Concept for Cell-Based Therapy in a Myelination Disorder

Company to Host Conference Call Today to Discuss Summary Results

NEWARK, Calif., April 2, 2012 (GLOBE NEWSWIRE) -- StemCells, Inc. (Nasdaq:STEM - News) today announced preliminary evidence of progressive and durable donor-cell derived myelination in all four patients who underwent transplantation with the Company's proprietary HuCNS-SC(R) cells (purified human neural stem cells) in its clinical trial for Pelizaeus-Merzbacher disease (PMD), a rare hypo-myelination disorder in children. In addition, clinical assessment revealed small but measureable gains in motor and/or cognitive function in three of the four patients; the fourth patient remained clinically stable. The study was conducted by researchers at the University of California, San Francisco (UCSF).

A summary of the trial results were presented Saturday, March 31, at the 2012 European Leukodystrophy Association (ELA) Families/Scientists Meeting in Paris. The findings are being submitted for publication in a peer-reviewed scientific journal.

"The results from this Phase I study are meaningful and important," said study investigator Nalin Gupta, MD, PhD, UCSF associate professor of neurological surgery and pediatrics and chief of pediatric neurological surgery at UCSF Benioff Children's Hospital. "The safety and clinical outcomes a year after transplantation in this Phase I study, combined with durable radiological signals of myelin formation, provide objective evidence of a biological effect of HuCNS-SC transplantation that addresses the fundamental basis of the pathology in the brain of PMD patients. We also wish to recognize the families' contribution to this study. These advances would not be possible without their willingness to participate in this clinical research."

Patients with PMD have a defective gene, which leads to insufficient myelin in the brain. The disease occurs only in males, and those with the most severe form of the disease, connatal PMD, are significantly disabled from birth and usually die, within the first decade of life. The study was the first to test transplantation of neural stem cells as a potential treatment for a myelination disorder. Myelin is the substance that surrounds and insulates nerve cells' communications fibers (also known as axons). Without sufficient myelination, these fibers are unable to properly transmit nerve impulses, leading to a progressive loss of neurological function, and death.

The open-label Phase I trial, conducted between February 2010 and February 2012, enrolled four patients with the connatal form of PMD, between the ages of 14 months and 5 years, and was designed to assess safety and preliminary efficacy of the intervention. The study used magnetic resonance (MR) imaging, commonly employed in other neurological diseases, to explore signs of myelination related to the transplanted neural stem cells. The HuCNS-SC transplants were surgically delivered to multiple sites within the frontal lobes of the brain. Patients also received immunosuppression for nine months following transplantation and underwent intensive follow-up neurological assessments and MR imaging for twelve months following transplantation. A separate four-year observational study will continue to monitor and report the future progress for all four patients.

At the one-year interval, MR imaging showed changes compatible with increased myelination in the region of the transplantation. The MR signs of myelination persisted after the withdrawal of immunosuppression at nine months and were also found to progress over time. The development of new myelin signals is unprecedented in patients with connatal PMD and is consistent with HuCNS-SC engraftment.

"The finding of myelin formation in this first exploratory study is indeed very encouraging," said Stephen Huhn, MD, FACS, FAAP, Vice President and Head of the CNS Program at StemCells, Inc. "We believe that the results of this trial provide proof-of-concept and a compelling rationale for the Company to begin planning for a controlled Phase II study in PMD. These results may also have implications for other leukodystrophies, as well as more common myelin disorders including transverse myelitis, multiple sclerosis and periventricular white matter injury seen in Cerebral Palsy. We are very pleased to be working with investigators at UCSF and deeply appreciate the critical research expertise they have dedicated to the trial."

Conference Call

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StemCells, Inc's Milestone Clinical Trial in Pelizaeus-Merzbacher Disease Shows Evidence of Myelination Following ...

Early in March 2012, 77-year-old Richard Poling entered a clinic in Bonita Springs, Fla., for a stem cell treatment to help with age-related heart and lung conditions.

Poling, an avid golfer and family man from Indiana, had sought several conventional therapies to alleviate his suffering with unsatisfactory results and was desperate for a treatment that would allow him to enjoy the pleasures of life again. Shortly after receiving his alleged treatment, however, Poling went into cardiac arrest at the clinic and died. According to investigators, the alleged stem cell treatment Poling received was not approved by the FDA.

According to multiple reports, the local cardiologist who conducted the treatment removed fat cells from Poling's abdomen and sent them to a lab that claimed to process and isolate adult stem cells from a patient's own fat. A few hours later, a second procedure was allegedly performed at the same clinic in which Poling had the stem cells injected back into his bloodstream for their regenerative properties. The entire process took one day, and during the hours between the procedures, Poling enjoyed lunch out with his family.

Poling was the second patient to die under the same doctor's care in the last two years after receiving the supposed stem cell therapy. The physician was already under order by the state of Florida to cease performing any further stem cell treatments pending further review, but the doctor allegedly continued performing various stem cell procedures -- until his license was revoked and suspended after Poling's death.

With all the marvels of modern medicine, there are still medical needs that remain unmet by our conventional health care system. When that happens, desperate people like Poling search for alternatives anywhere they can find them. One of these alternatives is stem cell therapy, a science that is no stranger to controversy.

The problem lies in that most stem cell therapies are not FDA-approved, and thus the market is under-regulated and consists of products that lack standardization and legitimacy. The lack of approved products has generated a gray market for stem cell therapeutics -- one that is dangerous and can be deadly.

Even though the United States has taken a passive approach to stem cell therapy as compared to its European and Asian counterparts, there are several U.S. companies vying for FDA approval as they develop stem cell therapies for indications such as heart disease, neurologic disorders and ophthalmologic diseases. While these companies spend hundreds of millions of dollars individually -- billions collectively -- to conduct groundbreaking research and development, rigorous safety studies, and extensive human trials to establish meaningful uses of their medical technologies, the majority of their studies occur overseas where they are sure to receive swifter review and eventual approvals.

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Patient Beware: When Stem Cells Harm

California's $3 billion stem cell agency, now more than 7 years old, has joined research partnerships with science and health agencies in eight foreign countries, the San Francisco institute announced.

The agreements call for collaboration in efforts aimed at speeding stem cell research from the laboratory to the hospital, where researchers hope that basic human cells will be programmed to treat scores of human degenerative diseases.

Research partnerships between American and foreign stem cell scientists are encouraged, but the California institute's funds would only be spent within the state, institute officials said.

Alan Trounson, president of the California Institute for Regenerative Medicine, signed agreements with stem cell funding agencies in Brazil and Argentina last week, he said Thursday.

"Both Brazil and Argentina have strong and robust stem cell research communities in basic science and transitional clinical science, which should create exciting synergies with many scientists in California," Trounson said in a statement.

He has signed similar pacts with stem cell agencies in Canada, Britain, France, Spain, Australia, Japan, China and Indiana.

The California institute was created in 2004 after Proposition 71, a $3 billion bond issue, was approved by California voters at a time when use of federal funds was barred for research into the promising field of embryonic stem cells.

So far the state agency has committed $1.2 billion to scientists and training centers at 56 California institutions, and the rest of the bond money should last until 2020, a spokesman said.

This article appeared on page C - 9 of the SanFranciscoChronicle

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Stem cell institute to work with foreign agencies

ROCKVILLE, Md., March 28, 2012 /PRNewswire/ --Neuralstem, Inc. (NYSE Amex: CUR) announced that safety results from the first 12 patients with amyotrophic lateral sclerosis (ALS or Lou Gehrig's disease) to receive its stem cells were reported online in the peer-reviewed publication, STEM CELLS, on March 13th. "Lumbar Intraspinal Injection of Neural Stem Cells in Patients with ALS: Results of a Phase I Trial in 12 Patients" (http://www.ncbi.nlm.nih.gov/pubmed/22415942.1) reports that one patient has shown improvement in his clinical status, even though researchers caution that the study was not designed to show efficacy. Additionally, there was no evidence of accelerated disease progression due to the intervention in any of the 12 patients, who were followed from 6-18 months after they were transplanted with the cells. All of the patients, who received transplants in the lumbar (lower back) region, tolerated the treatment without any long-term complications related to either the surgery or the cells.

(Logo: http://photos.prnewswire.com/prnh/20061221/DCTH007LOGO )

The 12 patients, part of the ongoing Phase I trial to evaluate the safety of Neuralstem's stem cells and transplantation procedure in patients with ALS, were the first in the world to receive intraspinal stem cell injections. Results from these patients were also were reported at the American Academy of Neurology Annual Meeting last September.

Based on a positive safety assessment, the trial has now been approved by the FDA to progress to transplanting ALS patients in the cervical (upper back) region of the spine, where the goal is to protect the motor neurons which affect respiratory function, and possibly prolong life. The fourteenth patient was transplanted earlier this month. All patients were treated at Emory University Hospital in Atlanta, Georgia.

"For these first 12 patients, we have met the objective of the Phase I trial, demonstrating safety for both the procedure of intraspinal injection and the presence of the neural stem cells in the spinal cords of ALS patients," said Jonathan Glass, MD, lead author of the publication. "We are encouraged by these results and have now advanced our trial to injections into the cervical spinal cord, targeting the motor neurons that control respiratory function." Dr. Glass is Professor of Neurology and Pathology at Emory University School of Medicine, as well as the Director of the Emory ALS Center.

"This important peer-reviewed publication reinforces our belief that we have demonstrated a safe, reproducible and robust route of administration into the spine for these spinal cord neural stem cells," said Eva Feldman, MD, PhD, Director of the A. Alfred Taubman Medical Research Institute and Director of Research of the ALS Clinic at the University of Michigan Health System. "The publication covers data up to 18 months out from the original surgery. However, we must be cautious in interpreting this data, as this trial was neither designed nor statistically powered to study efficacy." Dr. Feldman is senior author on the study, principal investigator (PI) of the ALS trial and serves as a consultant to Neuralstem as part of her University of Michigan activities.

"As this article points out, our experience in the lumbar spinal cord has been overwhelmingly positive," commented Karl Johe, PhD, study author and Neuralstem Chairman and Chief Scientific Officer. "We have already transplanted two patients in the cervical spinal cord, where we believe we can affect patients' lives the most by improving their breathing. We are in active discussions with the FDA to increase the number of cells and the number of injections as well."

"We wish to thank the teams at Michigan and Emory for the tireless efforts required to refine this breakthrough method of administration of our neural stem cells. We'd also like to thank the patients and families involved in the trial," said Richard Garr, Neuralstem CEO and President. "The progress we have made to date is both substantial, and a true team effort."

About the Study

Safety results were reported on the first 12 patients in an ongoing Phase I study to evaluate the safety of Neuralstem's spinal cord stem cells (HSSC's), as well as the transplantation technique, in the treatment of ALS (amyotrophic lateral sclerosis, or Lou Gehrig's disease).

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Neuralstem ALS Stem Cell Trial Interim Results Reported in the Journal, STEM CELLS

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

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

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

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

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

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

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

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

Bone marrow was aspirated from the patients and processed to obtain just the mononuclear fraction of the marrow. In patients randomly selected to receive stem cell therapy, doctors inserted a catheter into the heart's left ventricle to inject a total of 3 ccs comprising 100 million stem cells into an average of 15 sites that showed damage on the electromechanical mapping image of the heart. Dr. Perin said the procedure is relatively quick and painless, involving only an overnight stay at the hospital.

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

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Stem cell therapy possibly helpful in heart failure patients

SACRAMENTO, Calif. (KGO) -- Stem cells are the focus of debate in Sacramento where an effort is underway to use more than $1 billion in voter-approved bonds to continue experiments that may one day cure disease.

Major medical breakthroughs take time, but as public money for stem cell research is spent down, the pressure to cure something is going up.

The California Institute for Regenerative Medicine (CIRM) is about to enter a crucial stage in stem cell research, going to clinical trials. The most promising experiments could cure diabetes, HIV, sickle cell anemia, and blindness in the elderly. "You don't really get to find out whether the potential of the treatment is really going to be effective until you start to treat the patients," Alan Trounson explained.

CIRM's board is discussing how much to allocate for that trial phase. Through the 2004 voter-approved bonds under Proposition 71, it has already given out or spent half of the $3 billion, but despite the medical promise, there's little to show for it beyond basic research and several high-tech labs. Still, the agency says the breakthroughs will come over the next few years, way ahead of the rest of the world. "This would all be happening in California, all driven by this Proposition 71 money," Trounson said.

The bond money is expected to last only several more years. One option is to ask voters to approve more bonds, something taxpayer groups oppose. "When people think about bond financing, they think about a bridge, a school, a canal. But, stem cell research is just kind of out there," said Jon Coupal with the Howard Jarvis Taxpayers Association.

Rancher Diana Souza says it would be a shame to stop public funding of stem cell research. Through clinical trials at UC Davis Medical Center not financed by Prop 71 money, she says stem cells helped restore full use of her severely fractured arm. "I hope they can continue doing this because it is a miracle. It does work. And, I have a good arm to prove it," she said.

CIRM's transition plan, already submitted to Gov. Brown and lawmakers, assumes no more taxpayer support after the bond money runs out. The agency is also thinking about becoming a non-profit and letting others carry on the work.

(Copyright 2012 KGO-TV/DT. All Rights Reserved.)

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Researchers: Stem cell cures are on the way

Newswise MANHATTAN, KAN. -- Research from a Kansas State University professor may make it easier to recover after spinal cord injury or to study neurological disorders.

Mark Weiss, professor of anatomy and physiology, is researching genetic models for spinal cord injury or diseases such as Parkinson's disease. He is developing technology that can advance cellular therapy and regenerative medicine -- a type of research that can greatly improve animal and human health.

"We're trying to build tools, trying to build models that will have broad applications," Weiss said. "So if you're interested in neural differentiation or if you're interested in response after an injury, we're trying to come up with cell lines that will teach us, help us to solve a medical mystery."

Weiss' research team has perfected a technique to use stem cells to study targeted genetic modifications. They are among a handful of laboratories in the world using these types of models for disease. The research is an important step in the field of functional genomics, which focuses on understanding the functions and roles of these genes in disease.

The researchers are creating several tools to study functional genomics. One such tool involves developing new ways to use fluorescent transporters, which make it easier to study proteins and their functions. These fluorescent transporters can be especially helpful when studying neurological disorders such as Parkinson's disease, stroke and spinal cord injury.

"People who have spinal cord injury do not experience a lot of regeneration," Weiss said. "It is one of the problems of the nervous system -- it is not great at regenerating itself like other tissues."

The researchers want to discover a way to help this regenerative process kick in. By studying signals from fluorescing cells, they can understand how neural stem cells are reactivated.

"We want to try and make these genetic markers, and then we can test different kinds of treatment to see how they assist in the regenerative process," Weiss said.

Weiss' stem cell research has appeared in two recent journals: Stem Cells and Development and the Journal of Assisted Reproduction and Genetics. His research has been funded by the National Institutes of Health and university funds, including the Johnson Cancer Research Center.

Weiss' seven-member research team includes a visiting professor, two full-time researchers, a graduate student and three undergraduates. He has also been collaborating with researchers from the University of Kansas Medical Center.

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Anatomy of Success: Genetic Research Develops Tools for Studying Diseases, Improving Regenerative Treatment

CARLSBAD, Calif.--(BUSINESS WIRE)--

International Stem Cell Corporation (OTCBB: ISCO.OB - News) (www.internationalstemcell.com) today announced year-end financial results for the year ended December 31, 2011. ISCO is a California-based development-stage biotechnology company that is focused on therapeutic, biomedical and cosmeceutical product development and commercialization with multiple long-term therapeutic opportunities and two revenue-generating businesses offering potential for increased future revenue.

ISCO reported revenue of $1.1 million for the fourth quarter ended December 31, 2011, reflecting a 110% increase from the same period of the prior year. For the twelve months ended December 31, 2011, the Company reported revenue of $4.5 million, reflecting a year-over-year increase of 189%. The increases in revenues in both periods were primarily driven by strong sales at ISCOs wholly-owned subsidiary Lifeline Skin Care (LSC). In addition, steady growth in sales from ISCOs other wholly-owned subsidiary, Lifeline Cell Technology (LCT), contributed to the increases in revenues for both periods.

While the Company continued to invest in therapeutic projects, development of new technologies, and expansion of products and channels of distribution, to date we have generated limited revenue to support our core therapeutic research and development efforts. For the three months ended December 31, 2011, development expenses, excluding cost of sales, increased $507,000 or 17% compared with the same period of 2010, a reflection of increased G&A expenses resulting from higher stock-based compensation expenses.

For the twelve months ended December 31, 2011, development expenses, excluding costs of sales, increased approximately $3.0 million or 26% when compared with the prior year period.The majority of the increase was primarily due to increases in general and administrative and research and development activities. General and administrative expenses increased largely due to increased non-cash stock-based compensation, higher headcount, and increased expenses related business development activity and general corporate expenses. Research & Development expenses increased mainly due to increased number and complexity of experiments associated with our scientific projects. The increase in development expenses was also related to increased research activities on therapeutic products and product research activities for LSC and LCT coupled with increased sales and marketing expenses related to our skin care products.

Some of the 2011 Highlights:

-- A number of donors willing to provide oocytes for research purposed were enrolled in ISCO's program to establish a bank of clinical grade hpSC capable of being immune-matched to millions of patients.

-- The Research and Development team successfully completed the first series of preclinical studies that supports the therapeutic use of hepatocytes (liver cells) and neuronal cells derived from human parthenogenetic stem cells (hpSC). These in vivo experiments demonstrated that the derived cells are able to survive in targeted locations in mice without causing tumors.

-- We became Sarbanes-Oxley compliant and maintained, in all material respects, effective internal controls over financial reporting as of December 31, 2011.

-- We strengthened our Management Team through the appointments of well-known industry executives: Kurt May as President & Chief Operating Officer, Linh Nguyen as Chief Financial Officer, Donna Queen as Vice President of Marketing and Business Development for LSC.

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International Stem Cell Corporation Announces 2011 Financial Results

NEW YORK, March 20, 2012 (GLOBE NEWSWIRE) -- NeoStem, Inc. (NYSE Amex:NBS) ("NeoStem" or "the Company") is a leader in the cell therapy industry, developing cell based therapeutics supported by the Company's expertise in contract manufacturing. This strategic combination and depth of experience in cell therapy development and manufacturing provide NeoStem with unique capabilities to develop its own cell therapies and that sets the Company apart from others in the cell therapy landscape. 2011 represented a major year of strategic transition for NeoStem, and the Company plans to build upon that in 2012 and in the years ahead.

NeoStem reported its audited results for 2011. Consolidated revenues for the year ended December 31, 2011 were $73.7 million compared to $69.8 million for 2010. The Company's consolidated net loss for 2011 was $56.6 million, which included $10.3 million of non-cash equity-based compensation expense, $19.4 million of goodwill impairment charges and $9.0 million of depreciation and amortization. Overall, the Company's consolidated cash loss for 2011 was $15.5 million (see reconciliation below). Net loss attributable to NeoStem common shareholder interests for 2011 was $47.8 million, or $0.54 per share.

As of December 31, 2011, the Company had consolidated cash and cash equivalents of $12.7 million, and an additional $2.5 million in cash held in escrow (classified in Other Assets).

NeoStem believes that the opportunities that exist today in cell therapy are robust and growing despite a persistently difficult financial environment, making this an opportunistic time to pursue the monetization of the Company's 51% ownership of Suzhou Erye Pharmaceutical Co., Ltd. and bolster its cell therapy business. In June 2011, the Company engaged a financial advisor to lead the effort to pursue the possible divestiture of the Company's interest in Erye. Marketing efforts are underway and have generated interest from both financial and strategic buyers.

On the therapeutics side of the business NeoStem now has a pipeline of assets that includes Amorcyte (Phase 2 trial for preservation of heart function after a heart attack), Athelos (physician sponsored Phase 1 trials for a range of auto-immune conditions) and pre-clinical development work on its VSEL(TM) technology. The Company's most advanced asset is AMR-001 for the treatment of acute myocardial infarction for which enrollment for a Phase 2 study in the United States commenced in January. The study is a multicenter, randomized, double-blind, placebo-controlled clinical trial to evaluate the safety and efficacy of infarct-related artery infusion of AMR-001, an autologous bone marrow derived cell therapy enriched for CD34+ cells. AMR-001 is administered 5 to 11 days post-stent placement in patients diagnosed with an ST segment elevation myocardial infarction ("STEMI") with ejection fraction less than or equal to 48%. The study will include 160 subjects, age 18 and older, randomized 1:1 between treatment and control. The manufacturing, product supply, and logistics for the trial will be supported by Progenitor Cell Therapy, LLC, NeoStem's contract manufacturing company.

Amorcyte currently has ten activated clinical trial sites for its Phase 2 AMI clinical trial with the initial patients enrolled. Trial enrollment is expected to be completed in approximately one year with data read out six months following the last treated patient. The Amorcyte franchise is supported by a strong patent portfolio which includes both composition of matter and methods of treatment around use of these hematopoietic stem cells for treatment of cardiac ischemia and other ischemic tissue that result from vascular insufficiency. The Company sees Amorcyte as a pipeline of therapeutics with potential in multiple indications from STEMI to congestive heart failure and other related vascular insufficiencies. The Amorcyte product addresses both an unmet medical need and a large potential market.

"One of the most important attributes of AMR-001 is that it's 'natural.' We are enhancing the body's normal and natural response to ischemic injury," said Dr. Robin Smith, CEO of NeoStem. "Ample historical evidence, published literature and our own compelling Phase 1 data give us confidence that this product will ultimately make it to the marketplace. Our next most advanced asset is held by Athelos Corporation, (a NeoStem company, partnered with Becton, Dickinson and Company) which is developing a novel T-cell platform for immunological disorders. The Athelos T-cell technology represents an innovative approach to restoring immune balance with potential applications in graft vs. host disease (GvHD), solid organ transplant (SOT) and autoimmune diseases, such as asthma and diabetes. Multiple physician sponsored phase 1 studies are expected to report results that will be used to determine the direction of clinical development.

"NeoStem is also developing pre-clinical assets, including its VSEL(TM) Technology platform for regenerative medicine, which NeoStem believes is an endogenous pluripotent non-embryonic cell that has the potential to change the paradigm of cell therapy as we know it today. These activities have received awards in excess of $2.5 million which funds support the work of prestigious researchers who are pioneering this science with NeoStem.

"Behind the development of these therapeutic assets is the NeoStem cell therapy contract manufacturing business (PCT) which itself continues to grow. New clients have engaged PCT to assist them in the development of their products, including a global, diversified healthcare company who recently selected PCT to provide stem cell processing in our two GMP manufacturing facilities in the United States (California and New Jersey). PCT's prominence in the marketplace continues to grow and that is reflected by both client satisfaction and the revenues the company generates.

"As we look to the year ahead, we are excited on multiple fronts. Our capital preservation efforts are now bearing fruit as our cash burn rate is in-line with our peers. We expect to continue to carefully invest our capital in projects that meet our internal rate of return hurdle and risk parameters. We believe the PCT and Amorcyte acquisitions have created true value for our shareholders and we look forward to demonstrating that as these assets reach their respective value inflection points. We see the unmet medical need in cardiology and the treatment burden associated with chronic diseases as representing a significant challenge to modern society. We believe that cell therapy holds many of the solutions to the health crisis that societies face and have the potential to create real pharmacoeconomic benefit as well as shareholder value for our company.

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NeoStem Provides Updates and Reports Year End Results

Among the primary causes of adult-onset blindness are degenerative diseases of the retina, such as macular degeneration and retinitis pigmentosa. While some treatments have been developed that slow down the rate of degeneration, the clinical situation is still generally unsatisfactory. But if you could grow a new retina, transplant might be a possible cure. Now new hope is springing up from a research project at the University of Wisconsin-Madison in which scientists have succeeded in growing human retinal tissue from stem cells.

Pluripotent stem cells are capable of forming nearly any tissue in the body including retinal tissue. There has been great controversy about using pluripotent stem cells for human research or treatment, as historically the only source was to harvest them from early stage human embryos. Instead, for this work the researchers were able to regress mature body cells back into the pluripotent stem cells from which they originally grew. The process is called reprogramming, and is accomplished by inserting a set of proteins into the cell.

To produce the pluripotent stem cells, a white blood cell was taken from a simple blood sample. Genes which code for the reprogramming proteins are inserted into a plasmid, a nonliving ring of DNA. The cell is then infected with the plasmid, rather as a virus infects a cell, with the difference that the plasmid's genes do not become part of the cell's genetic structure. As the reprogramming proteins are formed within the cell by the plasmid DNA, the cell has a good chance of being reprogrammed into a pluripotent stem cell. This stem cell can then be encouraged to grow and differentiate into retinal tissue rather than make more blood cells.

Laboratory-grown human retinal tissue will certainly be used in testing drugs and to study degenerative diseases of the retina, and may eventually make available a new transplantable retina, or a new retina that is grown in place within the eye.

The figure above compares a schematic of the human retina with a photomicrograph of laboratory-grown retinal tissue. The new tissue has separated into at least three layers of cells, with rudimentary photosensitive rods or cones (red) at the top of the picture, and nerve ganglia (blue-green) at the bottom. The blue cells in the middle layer are likely bipolar retinal cells. The structure of the lab-grown retinal tissue is similar to that of a normal human eye, as can be seen by comparison with the retina schematic. The cells also formed synapses, which provide the channels through which optical information flows to the brain.

"We don't know how far this technology will take us, but the fact that we are able to grow a rudimentary retina structure from a patient's blood cells is encouraging, not only because it confirms our earlier work using human skin cells, but also because blood as a starting source is convenient to obtain," says Dr. David Gamm, pediatric ophthalmologist and senior author of the study. "This is a solid step forward." Further steps are eagerly awaited by those living in the dark.

Source: University of Wisconsin School of Medicine and Public Health

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Physicians grow retinas from human blood-derived stem cells

Public release date: 15-Mar-2012 [ | E-mail | Share ]

Contact: Diane Schrick diane.schrick@gladstone.ucsf.edu 415-734-2538 Gladstone Institutes

SAN FRANCISCO, CAMarch 15, 2012Gladstone Institutes Senior Investigator Deepak Srivastava, MD has won the prestigious 2012 Abraham White Scientific Achievement Award from The George Washington University. Dr. Srivastava, who directs cardiac and stem cell research at Gladstone will share the award with Dr. Luigina Romani, professor of microbiology at the University of Perugia.

Dr. Srivastava is being recognized for his findings concerning how the protein thymosin beta 4 is vital to protect and repair cells that become damaged in a heart attackpointing the way to its potential use in treating cardiac disease. His research has shown that thymosin beta 4 is not only critical to the development of a heart, but that it also prevents heart cells from dyingwhile stimulating new blood vessels to form.

"Dr. Srivastava's pioneering studies and scientific contributions have significantly advanced our understanding of the role of thymosin beta 4 in the development and function of the human heart," said Allan Goldstein, PhD, professor and emeritus chairman of The George Washington University. "His studies have provided the scientific foundation for the potential use of thymosin beta 4 to treat heart attacks and other heart diseases."

Dr. Srivastava, who joined Gladstone in 2005, uses modern genetic and stem cell technologies to identify the molecular events that instruct progenitor cells to become cardiac cellsand subsequently fashion a functioning heart. In addition to his research with thymosin beta 4, Dr. Srivastava and his lab have successfully reprogrammed connective tissue in the heart directly into beating heart cellsa process that may help regenerate damaged heart muscle.

"Heart disease is the leading cause of death in the United States and basic research in this field is vital to identifying and understanding the causes of human heart disease," said Dr. Srivastava, who is also a professor of pediatrics, biochemistry and biophysics at the University of California, San Francisco (UCSF), with which Gladstone is affiliated. "I am honored to receive this award and hope our efforts ultimately lead to important new treatments for patients with heart conditions."

George Washington University presents the Abraham White Scientific Achievement Award annually to honor individuals who have made unique contributions to science and medicine. Notable past recipients include Nobel laureates Bengt Samuelsson, MD, Julius Axelrod, MD, Michael Brown, MD, Joseph Goldstein, MD and Tim Hunt, PhD in addition to a number of other distinguished scientists. The award will be presented today at a special ceremony in Washington D.C.

"We are delighted that George Washington University has acknowledged Dr. Srivastava's exceptional achievements in the field of cardiovascular research," said Gladstone President R. Sanders Williams, MD. "He richly deserves this recognition due to the creativity and innovation evident in his workand because of its potential to benefit the millions of individuals suffering from cardiac disorders."

Before joining Gladstone, Dr. Srivastava was a professor in the department of pediatrics and molecular biology at the University of Texas Southwestern (UTSW) Medical Center in Dallas. He has received numerous honors and awards, including endowed chairs at UTSW and UCSF, as well as election to the American Society for Clinical Investigation, the Society for Pediatric Research, the American Academy of Arts and Sciences and the American Association for the Advancement of Science.

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Gladstone director receives 2012 Abraham White Scientific Achievement Award

ScienceDaily (Mar. 14, 2012) A research team has identified epigenetic signatures, markers on DNA that control transient changes in gene expression, within reprogrammed skin cells. These signatures can predict the expression of a wound-healing protein in reprogrammed skin cells or induced pluripotent stem cells (iPSCs), cells that take on embryonic stem cell properties. Understanding how the expression of the protein is controlled brings us one step closer to developing personalized tissue regeneration strategies using stem cells from a patient, instead of using human embryonic stem cells.

The study was published in the Journal of Cell Science.

When skin cells are reprogrammed, many of their cellular properties are recalibrated as they aquire stem cell properties and then are induced to become skin cells again. In order for these "induced" stem cells to be viable in treatment for humans (tissue regeneration, personalized wound healing therapies, etc.), researchers need to understand how they retain or even improve their characteristics after they are reprogrammed.

Since the initial discovery of reprogramming, scientists have struggled with the unpredictability of the cells due to the many changes that occur during the reprogramming process. Classifying specific epigenetic signatures, as this study did, allows researchers to anticipate ways to produce cell types with optimal properties for tissue repair while minimizing unintended cellular abnormalities.

The researchers used reprogrammed cells to generate three-dimensional connective tissue that mimics an in vivo wound repair environment. To verify the role of the protein (PDGFRbeta) in tissue regeneration and maintenance, the team blocked its cellular expression, which impaired the cells' ability to build tissue.

"We determined that successful tissue generation is associated with the expression of PDGFRbeta. Theoretically, by identifying the epigenetic signatures that indicate its expression, we can determine the reprogrammed cells' potential for maintaining normal cellular characteristics throughout development," said first author Kyle Hewitt, PhD, a graduate of the cell, molecular & developmental biology program at the Sackler School of Graduate Biomedical Sciences, and postdoctoral associate in the Garlick laboratory at Tufts University School of Dental Medicine (TUSDM).

"The ability to generate patient-specific cells from the reprogrammed skin cells may allow for improved, individualized, cell-based therapies for wound healing. Potentially, these reprogrammed cells could be used as a tool for drug development, modeling of disease, and transplantation medicine without the ethical issues associated with embryonic stem cells," said senior author Jonathan Garlick, DDS, PhD, a professor in the department of oral and maxillofacial pathology and director of the division of tissue engineering and cancer biology at TUSDM.

Jonathan Garlick is also a member of the cell, molecular & developmental biology program faculty at the Sackler School and the director of the Center for Integrated Tissue Engineering (CITE) at TUSDM.

Additional authors of the study are Yulia Shamis, MSc, a PhD candidate in the cell, molecular, and developmental biology program at the Sackler School; Elana Knight, BSc, and Avi Smith, BA, both research technicians in the Garlick laboratory; Anna Maione, a PhD student in the cell, molecular & developmental biology program at the Sackler School, and Addy Alt-Holland, PhD, MSc, assistant professor at TUSDM.

This work was supported by grant # DE017413 to Dr. Garlick from the National Institute for Dental and Craniofacial Research, part of the National Institutes of Health.

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Epigenetic signatures direct the repair potential of reprogrammed cells