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Single cell triggers fibroid uterine tumor

By Uncategorized

CHICAGO, May 5 (UPI) -- U.S. researchers say they've identified the molecular trigger of fibroid uterine tumors -- a single stem cell develops a mutation and grows uncontrollably.

Dr. Serdar Bulun, the chairman of obstetrics and gynecology at Northwestern University Feinberg School of Medicine and Northwestern Memorial Hospital, said the single cell activates other cells to join its frenzied expansion.

"It loses its way and goes wild," Bulun said in a statement. "No one knew how these came about before. The stem cells make up only 1.5 percent of the cells in the tumor, yet they are the essential drivers of its growth."

Dr. Masanori Ono, a post-doctoral student in Bulun's laboratory who was the study's lead author, said the stem cell that initiated the tumor carries a mutation called MED12.

Recently, mutations in the MED12 gene have been reported in the majority of uterine fibroid tissues. Once the mutation kicks off the abnormal expansion, the tumors grow in response to steroid hormones, particularly progesterone, Bulun said.

"Understanding how this mutation directs the tumor growth gives us a new direction to develop therapies," Bulun said in a statement.

The paper is published in the journal PLoS ONE.

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Single cell triggers fibroid uterine tumor

A single stem cell mutation triggers fibroid tumors: Mutated stem cell 'goes wild' in frenzied tumor expansion

By Stem Cell Treatment

ScienceDaily (May 4, 2012) Fibroid uterine tumors affect an estimated 15 million women in the United States, causing irregular bleeding, anemia, pain and infertility. Despite the high prevalence of the tumors, which occur in 60 percent of women by age 45, the molecular cause has been unknown.

New Northwestern Medicine preclinical research has for the first time identified the molecular trigger of the tumor -- a single stem cell that develops a mutation, starts to grow uncontrollably and activates other cells to join its frenzied expansion.

"It loses its way and goes wild," said Serdar Bulun, M.D., the chair of obstetrics and gynecology at Northwestern University Feinberg School of Medicine and Northwestern Memorial Hospital. "No one knew how these came about before. The stem cells make up only 1 percent of the cells in the tumor, yet they are the essential drivers of its growth."

The paper is published in the journal PLoS ONE. Masanori Ono, M.D., a post-doctoral student in Bulun's lab, is the lead author.

The stem cell initiating the tumor carries a mutation called MED12. Recently, mutations in the MED12 gene have been reported in the majority of uterine fibroid tissues. Once the mutation kicks off the abnormal expansion, the tumors grow in response to steroid hormones, particularly progesterone.

For the study, researchers examined the behavior of human fibroid stem cells when grafted into a mouse, a novel model initiated by Northwestern scientist Takeshi Kurita, a research associate professor of obstetrics and gynecology. The most important characteristic of fibroid stem cells is their ability to generate tumors. Tumors originating from the fibroid stem cell population grew 10 times larger compared to tumors initiated with the main cell population, suggesting a key role of these tumor stem cells is to initiate and sustain tumor growth.

"Understanding how this mutation directs the tumor growth gives us a new direction to develop therapies," said Bulun, also the George H. Gardner Professor of Clinical Gynecology.

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A single stem cell mutation triggers fibroid tumors: Mutated stem cell 'goes wild' in frenzied tumor expansion

Stem cell therapy to battle HIV?

By Stem Cell Treatment

(SACRAMENTO, Calif.) -- UC Davis Health System researchers are a step closer to launching human clinical trials involving the use of an innovative stem cell therapy to fight the virus that causes AIDS.

In a paper published in the May issue of the Journal of Virology, the UC Davis HIV team demonstrated both the safety and efficacy of transplanting anti-HIV stem cells into mice that represent models of infected patients. The technique, which involves replacing the immune system with stem cells engineered with a triple combination of HIV-resistant genes, proved capable of replicating a normally functioning human immune system by protecting and expanding HIV-resistant immune cells. The cells thrived and self-renewed even when challenged with an HIV viral load.

"We envision this as a potential functional cure for patients infected with HIV, giving them the ability to maintain a normal immune system through genetic resistance," said lead author Joseph Anderson, an assistant adjunct professor of internal medicine and a stem cell researcher at the UC Davis Institute for Regenerative Cures. "Ideally, it would be a one-time treatment through which stem cells express HIV-resistant genes, which in turn generate an entire HIV-resistant immune system."

To establish immunity in mice whose immune systems paralleled those of patients with HIV, Anderson and his team genetically modified human blood stem cells, which are responsible for producing the various types of immune cells in the body.

Building on work that members of the team have pursued over the last decade, they developed several anti-HIV genes that were inserted into blood stem cells using standard gene-therapy techniques and viral vectors (viruses that efficiently insert the genes they carry into host cells). The resulting combination vector contained:

These engineered blood stem cells, which could be differentiated into normal and functional human immune cells, were introduced into the mice. The goal was to validate whether this experimental treatment would result in an immune system that remained functional, even in the face of an HIV infection, and would halt or slow the progression toward AIDS.

The results were successful on all counts.

"After we challenged transplanted mice with live HIV, we demonstrated that the cells with HIV-resistant genes were protected from infection and survived in the face of a viral challenge, maintaining normal human CD4 levels," said Anderson. CD4+ T-cells are a type of specialized immune cell that HIV attacks and uses to make more copies of HIV.

"We actually saw an expansion of resistant cells after the viral challenge, because other cells which were not resistant were being killed off, and only the resistant cells remained, which took over the immune system and maintained normal CD4 levels," added Anderson.

The data provided from the study confirm the safety and efficacy of this combination anti-HIV lentiviral vector in a hematopoietic stem cell gene therapy setting for HIV and validated its potential application in future human clinical trials. The team has submitted a grant application for human clinical trials and is currently seeking regulatory approval, which is necessary to move on to clinical trials.

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Stem cell therapy to battle HIV?

South Korea Steps Up Stem-Cell Work

By Uncategorized

Nature | Health

Regenerative medicine gets a cash boost from the nation's health ministry, but stricter regulations are needed to ensure safety

May 1, 2012

By Soo Bin Park of Nature magazine

Seoul, South Korea

The South Korean health ministry announced last month that research into stem cells and regenerative medicine will receive a funding boost of 33 billion won (US$29 million) in 2012, four times that given in 2011. Overall, six different ministries will invest 100 billion won in stem-cell research this year.

Until last year, public investment in stem cells in South Korea was relatively low and targeted mainly at basic research. But the country's Ministry of Health and Welfare is now expanding its support for clinical research on stem cells, with the money being used to link basic research to intermediate or clinical studies. The aim is to commercialize the research at an early stage.

"From the current research atmosphere and infrastructure, the government has judged that stem-cell studies are now maturing," says Hyung Min Chung, president of Seoul-based biotechnology firm Cha Bio and Diostech and an adviser on the budget plan. He adds that his company is particularly pleased that government investment decisions on developing stem-cell therapies will be made more quickly.

Target market

The government money will be allocated to two areas: rare or incurable diseases for which there is little incentive for private investment, such as spinal cord damage; and common chronic conditions, such as arthritis, for which the aim is to help South Korean companies to capture part of the large potential market for treatments.

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South Korea Steps Up Stem-Cell Work

Nuvilex, Inc. Retains Dawson James Financial Services and Moves to Finalize SG Austria Asset Acquisition

By Uncategorized

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

Nuvilex, Inc. (OTCQB:NVLX), an emerging biotechnology provider of cell and gene therapy solutions, today announced that it has executed a consulting agreement with Dawson James Financial Services, Inc. The agreement is seen as a key step as the company moves forward with closing the SG Austria asset acquisition.

Chief Executive Officer Dr. Robert Ryan commented, Weve been working closely with SG Austria over the past several months to develop the cell encapsulation technology and to focus on preparing that technology for market for stem cell therapy, for treating diabetes and pancreatic cancer. With the recent consolidation of the patent rights under the SG Austria roof, we are now finally in a position to move forward with the previously executed asset purchase agreement.

Dr. Ryan added, We are dedicated to completing development of the encapsulation technology for stem cell therapy and diabetes, all at the same time while gearing up for Phase 2 and 3 clinical trials for the pancreatic cancer treatment which is paramount to our immediate business goals. Thus, completing the SG Austria asset acquisition, bringing clinical trial preparations to fruition, and initiating the clinical trials are our top priorities.

About Nuvilex

Nuvilex, Inc. (OTCQB:NVLX) is an emerging international biotechnology provider of live therapeutically valuable, encapsulated cells and services for research and medicine. Substantial effort for our corporate activities in concert with SG Austria is near completion and will drive our strong future together. Our Companys 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 described within the Private Securities Litigation Reform Act of 1995 involving risks and uncertainties including product demand, market competition, and meeting 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, reflect events or circumstances afterward, or disclose unanticipated occurrences, except as required under applicable laws.

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Nuvilex, Inc. Retains Dawson James Financial Services and Moves to Finalize SG Austria Asset Acquisition

VistaGen Licenses Breakthrough Stem Cell Culture Technology To Speed Development Of Drug Screening And Cell Therapy …

By Stem Cell Treatment

South San Francisco, CA (Marketwire) - VistaGen Therapeutics, Inc. (OTCBB:VSTA) (OTCQB:VSTA), a biotechnology company applying stem cell technology for drug rescue and cell therapy, has licensed breakthrough stem cell culture technology from the McEwen Centre for Regenerative Medicine located at the University Health Network (UHN) in Toronto, Canada.

VistaGen will be utilizing the licensed technology to develop hematopoietic precursor stem cells from human pluripotent stem cells, with the goal of developing drug screening and cell therapy applications for human blood system disorders. The breakthrough technology is included in a new United States patent application.

Hematopoietic precursor stem cells give rise to all red and white blood cells and platelets in the body. VistaGen will use the UHN invention to improve the cell culture methods used to efficiently produce hematopoietic stem cell populations.

"This technology dramatically advances our ability to produce and purify this important blood stem cell precursor for both in vitro drug screening and in vivo cell therapy applications," said H. Ralph Snodgrass, PhD, VistaGen's President and Chief Scientific Officer.

"In addition to defining new cell culture methods for our use, the technology describes the surface characteristics of stem cell-derived adult hematopoietic stem cells. Most groups study embryonic blood development from stem cells, but, for the first time, we are able to not only purify the stem cell-derived precursor of all adult hematopoietic cells, but also pinpoint the precise timing when adult blood cell differentiation takes place in these cultures," Snodgrass added. "It is our belief that these early cells will be the precursors of the ultimate adult, bone marrow-repopulating hematopoietic stem cells."

Bone marrow-derived hematopoietic stem cells are able to repopulate the blood and immune system when transplanted into patients prepared for bone marrow transplantation. These cells have important potential therapeutic applications for the restoration of healthy blood and immune systems in individuals undergoing transplantation therapies for cancer, organ grafts, HIV infections or for acquired or genetic blood and immune deficiencies.

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 athttp://www.VistaGen.com, follow VistaGen athttp://www.twitter.com/VistaGenor view VistaGen's Facebook page athttp://www.facebook.com/VistaGen

Cautionary Statement Regarding Forward Looking Statements The statements in this press release that are not historical facts may constitute forward-looking statements that are based on current expectations and are subject to risks and uncertainties that could cause actual future results to differ materially from those expressed or implied by such statements. Those risks and uncertainties include, but are not limited to, risks related to regulatory approvals, the issuance and protection of patents and other intellectual property, the success of VistaGen's ongoing clinical studies, including the safety and efficacy of its drug candidate, AV-101, the failure of future drug rescue and pilot preclinical cell therapy programs related to VistaGen's stem cell technology-based Human Clinical Trial in a Test Tube platform, its ability to enter into drug rescue collaborations, risks and uncertainties relating to the availability of substantial additional capital to support VistaGen's research, development and commercialization activities, and the success of its research, development, regulatory approval, marketing and distribution plans and strategies, including those plans and strategies related to AV-101 and any drug rescue variants identified and developed by VistaGen. These and other risks and uncertainties are identified and described in more detail in VistaGen's filings with the Securities and Exchange Commission (SEC). These filings are available on the SEC's website at http://www.sec.gov. VistaGen undertakes no obligation to publicly update or revise any forward-looking statements.

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VistaGen Licenses Breakthrough Stem Cell Culture Technology To Speed Development Of Drug Screening And Cell Therapy ...

Duke Team Turns Scar Tissue into Heart Muscle Without Using Stem Cells

By Stem Cell Medical Center

By Duke Medicine News and Communications

Scientists at Duke University Medical Center have shown the ability to turn scar tissue that forms after a heart attack into heart muscle cells using a new process that eliminates the need for stem cell transplant.

The study, published online April 26 in the journal Circulation Research, used molecules called microRNAs to trigger the cardiac tissue conversion in a lab dish and, for the first time, in a living mouse, demonstrating the potential of a simpler process for tissue regeneration.

If additional studies confirm the approach in human cells, it could lead to a new way for treating many of the 23 million people worldwide who suffer heart failure, which is often caused by scar tissue that develops after a heart attack. The approach could also have benefit beyond heart disease.

"This is a significant finding with many therapeutic implications," said Victor J. Dzau, MD, a senior author on the study who is James B. Duke professor of medicine and chancellor of health affairs at Duke University. "If you can do this in the heart, you can do it in the brain, the kidneys, and other tissues. This is a whole new way of regenerating tissue."

To initiate the regeneration, Dzau's team at Duke used microRNAs, which are molecules that serve as master regulators controlling the activity of multiple genes. Tailored in a specific combination, the microRNAs were delivered into scar tissue cells called fibroblasts, which develop after a heart attack and impair the organ's ability to pump blood.

Once deployed, the microRNAs reprogrammed fibroblasts to become cells resembling the cardiomyocytes that make up heart muscle. The Duke team not only proved this concept in the laboratory, but also demonstrated that the cell conversion could occur inside the body of a mouse -- a major requirement for regenerative medicine to become a potential therapy.

"This is one of the exciting things about our study," said Maria Mirotsou, PhD, assistant professor of cardiology at Duke and a senior author of the study. "We were able to achieve this tissue conversion in the heart with these microRNAs, which may be more practical for direct delivery into cells and allow for possible development of therapies without using genetic methods or transplantation of stem cells."

The researchers said using microRNA for tissue regeneration has several potential advantages over genetic methods or transplantation of stem cells, which have been difficult to manage inside the body. Notably, the microRNA process eliminates technical problems such as genetic alterations, while also avoiding the ethical dilemmas posed by stem cells.

"It's an exciting stage for reprogramming science," said Tilanthi M. Jayawardena, PhD, first author of the study. "It's a very young field, and we're all learning what it means to switch a cell's fate. We believe we've uncovered a way for it to be done, and that it has a lot of potential."

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Duke Team Turns Scar Tissue into Heart Muscle Without Using Stem Cells

Improved adult-derived human stem cells have fewer genetic changes than expected

By Uncategorized

A team of researchers from Johns Hopkins University and the National Human Genome Research Institute has evaluated the whole genomic sequence of stem cells derived from human bone marrow cellsso-called induced pluripotent stem (iPS) cellsand found that relatively few genetic changes occur during stem cell conversion by an improved method. The findings, reported in the March issue of Cell Stem Cell, the official journal of the International Society for Stem Cell Research (ISSCR), will be presented at the annual ISSCR meeting in June.

Our results show that human iPS cells accrue genetic changes at about the same rate as any replicating cells, which we dont feel is a cause for concern, says Linzhao Cheng, Ph.D., a professor of medicine and oncology, and a member of the Johns Hopkins Institute for Cell Engineering.

Each time a cell divides, it has the chance to make errors and incorporate new genetic changes in its DNA, Cheng explains. Some genetic changes can be harmless, but others can lead to changes in cell behavior that may lead to disease and, in the worst case, to cancer.

In the new study, the researchers showed that iPS cells derived from adult bone marrow cells contain random genetic changes that do not specifically predispose the cells to form cancer.

Little research was done previously to determine the number of DNA changes in stem cells, but because whole genome sequencing is getting faster and cheaper, we can now more easily assess the genetic stability of these cells derived by various methods and from different tissues, Cheng says. Last year, a study published in Nature suggested higher than expected cancer gene mutation rates in iPS cells created from skin samples, which, according to Cheng, raised great concerns to many in the field pertaining to usefulness and safety of the cells. This study analyzed both viral and the improved, nonviral methods to turn on stem cell genes making the iPS cells

To more thoroughly evaluate the number of genetic changes in iPS cells created by the improved, non-viral method, Chengs team first converted human blood-forming cells or their support cells, so-called marrow stromal cells (MSCs) in adult bone marrow into iPS cells by turning on specific genes and giving them special nutrients. The researchers isolated DNA from--and sequenced--the genome of each type of iPS cells, in comparison with the original cells from which the iPS cells were derived.

Cheng says they then counted the number of small DNA differences in each cell line compared to the original bone marrow cells. A range of 1,000 to 1,800 changes in the nucleic acid letters A, C, T and G occurred across each genome, but only a few changes were found in actual genes--DNA sequences that act as blueprints for our bodys proteins. Such genes make up two percent of the genome.

The blood-derived iPS cells contained six and the MSC-derived iPS cells contained 12 DNA letter changes in genes, which led the researchers to conclude that DNA changes in iPS cells are far more likely to occur in the spaces between genes, not in the genes themselves.

Next, the investigators examined the severity of the DNA changes--how likely each one would disrupt the function of each gene. They found that about half of the DNA changes were silent, meaning these altered blueprints wouldnt change the nucleic acid building code for its corresponding protein or change its function.

For the remaining DNA changes, the researchers guessed these would, in fact, disrupt the function of the gene by either making the gene inactive or changing the way the gene works. Since each cell contains two copies of each gene, in many cases the other, normal copy of the gene could compensate for a disrupted gene, Cheng and the team reasoned.

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Improved adult-derived human stem cells have fewer genetic changes than expected

Bio-Matrix Scientific Group, Inc. Announces Newly Formed Stem Cell Subsidiary — Regen BioPharma Inc., Secures $20,000 …

By Uncategorized

SAN DIEGO, CA--(Marketwire -04/30/12)- Bio-Matrix Scientific Group, Inc. (BMSN.PK - News) (BMSN.PK - News) announced today it has formed a new subsidiary, Regen BioPharma, Inc. Regen BioPharma has developed a vertically-integrated structure for acquiring patents, performing accelerating preclinical and clinical development, and licensing or selling technology developed to large pharma companies in the area of stem cells.

To date, Regen BioPharma has reviewed more than 20,000 US issued patents covering stem cell related subject matter, created a shortlist of 30 promising technologies for rapid commercialization, and currently is in negotiations to license several of these. Once the technology is secured, the Company anticipates partnering with industry leading scientists, physicians, and service providers to complete the Investigational New Drug (IND)-enabling work and begin clinical trials.

"In biotechnology in general, and specifically in the area of regenerative medicine, the biggest value creation occurs for shareholders when a company files an IND and obtains human data that provides proof of safety and efficacy," said David R. Koos, Chairman and Chief Executive Officer of Bio-Matrix. "We are assembling the team and capabilities to in-license and evaluate technologies rapidly, then to develop the regulatory package and initiate clinical trials. Our business model and partnerships will allow us to take cell therapy products from discovery to FDA Phase II clinical trials in as short a period as 18 - 24 months."

The Company also announced that it has secured $20,000,000 in financing from Southridge Partners II, LP of Ridgefield, Connecticut.

This agreement grants the Company the option to sell and obligates Southridge to purchase up to $20,000,000 of common stock over its term. The per share price will be determined based on market prices in accordance with an agreed upon formula and the Company is not obligated to draw on the facility.

The Company has agreed to file a registration statement with the U.S. Securities and Exchange Commission to register the resale by Southridge of any shares issued to it under the agreement. Subject to the effectiveness of the registration statement and the satisfaction of other customary conditions, the Company may draw on the facility from time to time, as and when it determines appropriate, in accordance with the timing and volume provisions set forth in the agreement.

A spokesperson for the Company noted that Its investment banker, Christopher Schufeldt of Capital Path Securities was instrumental in arranging the funding agreement with Southridge Partners II LP.

About Bio-Matrix Scientific Group, Inc.:

Bio-Matrix Scientific Group, Inc. (BMSN.PK - News) (BMSN.PK - News) is a biotechnology company focused on the development of regenerative medicine therapies and tools. The Company is specifically focused on human therapies that address unmet medical needs. Specifically, Bio-Matrix Scientific Group Inc. is looking to increase the quality of life through therapies involving stem cell treatments. These treatments are focused in areas relating to lung, heart, circulatory system and other internal organs.

Through Its wholly owned subsidiary, Regen BioPharma, it is the Company's goal to develop translational medicine platforms for the rapid commercialization of stem cell therapies. The Company is looking to use these translational medicine platforms to advance intellectual property licensed from entities, institutions and universities that show promise towards fulfilling the Company's goal of increased quality of life.

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Bio-Matrix Scientific Group, Inc. Announces Newly Formed Stem Cell Subsidiary -- Regen BioPharma Inc., Secures $20,000 ...

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