Category Archives: Stem Cell Therapy

Lindsay Porter's kidneys weighed 16 pounds before her transplant.

STORY HIGHLIGHTS

(CNN) -- By the time Lindsay Porter had her kidneys removed two years ago, they were bulging -- covered in cysts -- and together weighed 16 pounds.

Her abdominal area was so distended, "I looked nine months pregnant, and people regularly asked when I was due," Porter said.

As she prepared for a transplant to address her polycystic kidney disease, Porter, 47, had mixed feelings -- relief to have found a donor, tinged with resignation. She was looking forward to both a new kidney, and a lifetime on immune system-suppressing drugs.

"You get this brand new shiny kidney, and then they give you drugs that eventually destroy it," said Porter.

But that scenario may eventually change, if results of a new pilot study are replicated in a larger group of patients. The study, published Wednesday in the journal Science Translational Medicine, describes eight kidney transplant patients, including Porter, who received a stem cell therapy that allowed donor and recipient immune cells to coexist in the same body.

The effect, in a handful of those patients, was to trick the recipient's immune system into recognizing the donated kidney as its own.

When it works, patients become a sort of medical rarity called a chimera.

"Chimerism is a condition wherein two different genetic cell populations are present in the body, and both cell types are tolerated," said Dr. Anthony Atala, director of the Institute for Regenerative Medicine at Wake Forest Baptist Medical Center, who was not involved in the study, via e-mail.

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Transplant without lifetime of drugs?

ROCKVILLE, Md., March 7, 2012 /PRNewswire/ -- Neuralstem, Inc. (NYSE Amex: CUR) announced that the second patient to receive stem cells in the cervical (upper back) region of the spine was dosed on February 29th in the ongoing Phase I trial of its spinal cord neural stem cells in amyotrophic lateral sclerosis (ALS or Lou Gehrig's disease). Patient 14 is also the first woman to be treated in the trial. Stem cell transplantation into the cervical region of the spinal cord couldsupport breathing, a key function that is lost as ALS progresses. The first twelve patients in the trial received stem cell transplants in the lumbar (lower back) region of the spinal cord only.

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

"This cohort of patients represents another first for our trial, as we transplant cells directly into the gray matter of the spinal cord in the cervical region," said Karl Johe, PhD, Neuralstem's Chairman and Chief Scientific Officer. "We are delighted that the surgeries are progressing in a region that could have a significant impact on the quality of life for ALS patients. With the safe transplantation of our 14th patient, we are well are on our way to demonstrating the safety of our novel procedure."

About the Trial The Phase I trial to assess the safety of Neuralstem's spinal cord neural stem cells and intraspinal transplantation method in ALS patients has been underway since January 2010. The trial is designed to enroll up to 18 patients. The first 12 patients were each transplanted in the lumbar (lower back) region of the spine, beginning with non-ambulatory and advancing to ambulatory cohorts. The trial has now progressed to the final six patients. Each is in the cervical (upper back) region of the spine. The entire 18-patient trial concludes six months after the final surgery.

About Neuralstem Neuralstem's patented technology enables the ability to produce neural stem cells of the human brain and spinal cord in commercial quantities, and the ability to control the differentiation of these cells constitutively into mature, physiologically relevant human neurons and glia. Neuralstem is in an FDA-approved Phase I safety clinical trial for amyotrophic lateral sclerosis (ALS), often referred to as Lou Gehrig's disease, and has been awarded orphan status designation by the FDA.

In addition to ALS, the company is also targeting major central nervous system conditions with its cell therapy platform, including spinal cord injury, ischemic spastic paraplegia and chronic stroke. The company has submitted an IND (Investigational New Drug) application to the FDA for a Phase I safety trial in chronic spinal cord injury.

Neuralstem also has the ability to generate stable human neural stem cell lines suitable for the systematic screening of large chemical libraries. Through this proprietary screening technology, Neuralstem has discovered and patented compounds that may stimulate the brain's capacity to generate new neurons, possibly reversing the pathologies of some central nervous system conditions. The company has received approval from the FDA to conduct a Phase Ib safety trial evaluating NSI-189, its first small molecule compound, for the treatment of major depressive disorder (MDD). Additional indications could include schizophrenia, Alzheimer's disease and bipolar disorder.

For more information, please visit http://www.neuralstem.com and connect with us on Twitter and Facebook.

Cautionary Statement Regarding Forward Looking Information This news release may contain forward-looking statements made pursuant to the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995. Investors are cautioned that such forward-looking statements in this press release regarding potential applications of Neuralstem's technologies constitute forward-looking statements that involve risks and uncertainties, including, without limitation, risks inherent in the development and commercialization of potential products, uncertainty of clinical trial results or regulatory approvals or clearances, need for future capital, dependence upon collaborators and maintenance of our intellectual property rights. Actual results may differ materially from the results anticipated in these forward-looking statements. Additional information on potential factors that could affect our results and other risks and uncertainties are detailed from time to time in Neuralstem's periodic reports, including the annual report on Form 10-K for the year ended December 31, 2010 and the quarterly report on Form 10-Q for the period ended September 30, 2011.

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Fourteenth Patient Dosed in Neuralstem ALS Stem Cell Trial

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

Nuvilex, Inc. (OTCQB:NVLX), an emerging biotechnology provider of cell and gene therapy solutions, today pointed out the potential for substantial partnership and licensing opportunities using the companys cell encapsulation technology for applications in stem cell research and medicine. Migration of implanted cells away from the target site and host rejection have been recognized as fundamental challenges faced by the stem cell community regarding their use in therapy, which the companys technology overcomes.

The technology being acquired from associate SG Austria is used to place live stem cells into strong, flexible and permeable capsules. These capsules can then be implanted into animals or humans for specific therapies. Stem cells can then exist at the desired location inside the capsules, prevented from migrating and protected from the immune system that aims to eliminate such foreign cells from the body.

Stem cell therapy is being used by clinicians throughout the world for treating such diverse diseases as spinal cord injury, amyotrophic lateral sclerosis, burns, glioma, multiple myeloma, arthritis, heart disease, stroke, Stargardt's Macular Dystrophy, and age-related macular degeneration, among others, most of which can be found at ClinicalTrials.gov.

Historically, researchers have faced numerous difficulties in succeeding with certain stem cell treatments, because of the problems associated with keeping stem cells alive for significant periods of time, stopping rejection and destruction by the recipients immune system, and keeping stem cells from migrating away from the desired sites. Cells encapsulated in SG Austrias porous beads have been shown to remain alive for long periods of time in humans, surviving intact for at least two years. Once encapsulated, cells are protected from the bodys immune system. Furthermore, encapsulated cells remain within the beads and are unable to migrate to other sites in the body.

In the February 29, 2012 research report, Goldman Small Cap Research stated, The Cell-in-a-Box approach could significantly advance the implementation and utilization of stem cells for a host of debilitating diseases and conditions, making it a uniquely valuable commodity. We believe that by partnering with leading players in the field, Nuvilex could find that companies with deep pockets would be happy to collaborate or license the delivery system and engage in further research which could result in meaningful development and licensing revenue.

Dr. Robert Ryan, Chief Executive Officer of Nuvilex, discussed the value for licensing the companys stem cell therapy, adding, By overcoming traditional barriers to effective stem cell therapy, namely viability, migration, and host rejection, we believe these new advances in medical science utilizing stem cells and encapsulation will enable us to take quantum leaps forward now and in the future. As a result of challenges SG Austria has overcome, new advances will be surprisingly close at hand and are part of the driving force behind our desire to work with a number of companies in this endeavor. Our primary goal has been and remains to use our technology to bring life changing treatments to patients on an expedited basis.

About Nuvilex

Nuvilex, Inc. (OTCQB:NVLX) is an emerging international biotechnology provider of clinically useful therapeutic live encapsulated cells and services for encapsulating live cells for the research and medical communities. Through our effort, all aspects of our corporate activities alone, and especially in concert with SG Austria, are rapidly moving toward completion, including closing our agreement. One of our planned offerings will include cancer treatments using the companys industry-leading live-cell encapsulation technology.

Safe Harbor Statement

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Nuvilex Forecasts Vast Partnership Opportunities Using Breakthrough Stem Cell Technology

SOUTH SAN FRANCISCO, CA--(Marketwire -03/05/12)- VistaGen Therapeutics, Inc. (OTC.BB: VSTA.OB - News) (OTCQB: VSTA.OB - News), a biotechnology company applying stem cell technology for drug rescue, and Duke University, one of the country's premier academic research institutions, have entered into a strategic research collaboration aimed at combining their complementary expertise at the forefront of cardiac stem cell technology, electrophysiology and tissue engineering. The initial goal of the collaboration is to explore potential development of novel, engineered, stem cell-derived cardiac tissues to expand the scope of VistaGen's drug rescue capabilities focused on heart toxicity. The research will be led at Duke, by Dr. Nenad Bursac, Associate Professor in the Departments of Cardiology and Biomedical Engineering, and at VistaGen, by Dr. Ralph Snodgrass, President and Chief Scientific Officer.

"We are pleased to be collaborating with Dr. Bursac and his team at Duke," said Dr. Snodgrass. "Our human stem cell-derived heart cells combined with Dr. Bursac's cutting-edge technology relating to cardiac electrophysiology and cardiac tissue engineering will permit us to use micro-patterned cardiac tissue to significantly expand the approaches we use in our Drug Rescue Programs to quantify drug effects on functional human cardiac tissue -- in effect, synthetic human heart muscle."

Dr. Bursac is a leader in the field of cardiac tissue engineering and cell-based therapies in which different cells, either alone or in combination with therapeutic molecules or biomaterials, can be transplanted into the human body to restore function of damaged or diseased organs. Dr. Bursac's research has additional applications in the fields of cardiac electrophysiology, in vitro drug screening, and the generation of novel bioengineered model systems for studies of heart development, function, and disease.

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 by pharmaceutical companies, the U.S. National Institutes of Health (NIH) or university laboratories after substantial development due to heart toxicity. 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.

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 the success of VistaGen's stem cell technology-based drug rescue activities, ongoing AV-101 clinical studies, its ability to enter into drug rescue collaborations and/or licensing arrangements with respect to one or more drug rescue variants, risks and uncertainties relating to the availability of substantial additional capital to support VistaGen's research, drug rescue, development and commercialization activities, and the success of its research and development plans and strategies, including those plans and strategies related to AV-101 and any drug rescue variant 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 Therapeutics and Duke University Enter Into Strategic Research Collaboration

NEW YORK, NY--(Marketwire -03/05/12)- February was a challenging month for stem cell stocks. TickerSpy's Stem Cell Stocks Index (RXSTM) has slipped nearly 13 percent over the last month -- underperforming the S&P 500 by close to 17 percent over that time frame. Despite the drop in investor optimism, new and promising research continues to propel the industry forward. Five Star Equities examines the outlook for companies in the Biotechnology industry and provides equity research on BioTime, Inc. (AMEX: BTX - News) and Aastrom Biosciences, Inc. (NASDAQ: ASTM - News). Access to the full company reports can be found at:

http://www.fivestarequities.com/BTX

http://www.fivestarequities.com/ASTM

A new study at Johns Hopkins University has shown that stem cells from patients' own cardiac tissue can be used to heal scarred tissue after a heart attack. "This has never been accomplished before, despite a decade of cell therapy trials for patients with heart attacks. Now we have done it," Eduardo Marban, director of the Cedars-Sinai Heart Institute and one of the study's co-authors, said in a statement. "The effects are substantial."

In another study, researchers led by Jonathan Tilly, director of the Vincent Center for Reproductive Biology at Massachusetts General Hospital, argue they've discovered the ovaries of young women harbor very rare stem cells capable of producing new eggs.

Five Star Equities releases regular market updates on the biotechnology industry so investors can stay ahead of the crowd and make the best investment decisions to maximize their returns. Take a few minutes to register with us free at http://www.fivestarequities.com and get exclusive access to our numerous stock reports and industry newsletters.

Aastrom Biosciences, Inc., a regenerative medicine company, engages in developing autologous cell therapies for the treatment of severe and chronic cardiovascular diseases.

BioTime, Inc. primarily focuses on regenerative medicine, which refers to therapies based on human embryonic stem (hES) cell and induced pluripotent stem (iPS) cell technology designed to rebuild cell and tissue function lost due to degenerative disease or injury. The company recently elected to market progenitors of muscle stem cells bearing hereditary diseases. BioTime will produce the products from five human embryonic stem (hES) cell lines from Reproductive Genetics Institute (RGI) of Chicago, Illinois.

Five Star Equities provides Market Research focused on equities that offer growth opportunities, value, and strong potential return. We strive to provide the most up-to-date market activities. We constantly create research reports and newsletters for our members. Five Star Equities has not been compensated by any of the above-mentioned companies. We act as an independent research portal and are aware that all investment entails inherent risks. Please view the full disclaimer at: http://www.fivestarequities.com/disclaimer

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BioTime and Aastrom Biosciences -- Stem Cell Research Making Breakthroughs

NEW YORK, NY--(Marketwire -03/05/12)- February was a challenging month for stem cell stocks. TickerSpy's Stem Cell Stocks Index (RXSTM) has slipped nearly 13 percent over the last month -- underperforming the S&P 500 by close to 17 percent over that time frame. Despite the drop in investor optimism, new research continues to propel the industry forward. Five Star Equities examines the outlook for companies in the Biotechnology industry and provides equity research on Advanced Cell Technology, Inc. (OTC.BB: ACTC.OB - News) and NeoStem, Inc. (AMEX: NBS - News). Access to the full company reports can be found at:

http://www.fivestarequities.com/ACTC

http://www.fivestarequities.com/NBS

A new study at Johns Hopkins University has shown that stem cells from patients' own cardiac tissue can be used to heal scarred tissue after a heart attack. "This has never been accomplished before, despite a decade of cell therapy trials for patients with heart attacks. Now we have done it," Eduardo Marban, director of the Cedars-Sinai Heart Institute and one of the study's co-authors, said in a statement. "The effects are substantial."

In another study, researchers led by Jonathan Tilly, director of the Vincent Center for Reproductive Biology at Massachusetts General Hospital, argue they've discovered the ovaries of young women harbor very rare stem cells capable of producing new eggs.

Five Star Equities releases regular market updates on the biotechnology industry so investors can stay ahead of the crowd and make the best investment decisions to maximize their returns. Take a few minutes to register with us free at http://www.fivestarequities.com and get exclusive access to our numerous stock reports and industry newsletters.

Advanced Cell Technology, Inc., a biotechnology company, focuses on the development and commercialization of human embryonic and adult stem cell technology in the field of regenerative medicine. The Company recently issued a press release stating that it utilized $13.6 million in cash for operations during 2011, compared to $8.8 million in the year-earlier period. The increase in cash utilization resulted primarily from ACT's ongoing clinical activities in the US and Europe.

NeoStem, Inc., a biopharmaceutical company, engages in the development and manufacture of cellular therapies for oncology, immunology, and regenerative medicines in the United States and China. In January, Amorcyte, LLC, a NeoStem, Inc. company, announced the enrollment of the first patient in the Amorcyte PreSERVE Phase 2 trial for acute myocardial infarction.

Five Star Equities provides Market Research focused on equities that offer growth opportunities, value, and strong potential return. We strive to provide the most up-to-date market activities. We constantly create research reports and newsletters for our members. Five Star Equities has not been compensated by any of the above-mentioned companies. We act as an independent research portal and are aware that all investment entails inherent risks. Please view the full disclaimer at: http://www.fivestarequities.com/disclaimer

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New Stem Cell Research Shows Promising Results -- Advanced Cell Tech and NeoStem Poised to Benefit