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New gene therapy strategy boosts levels of deficient protein in Friedreich’s ataxia

Posted: July 25, 2012 at 7:18 pm

Public release date: 25-Jul-2012 [ | E-mail | Share ]

Contact: Vicki Cohn vcohn@liebertpub.com 914-740-2100 x2156 Mary Ann Liebert, Inc./Genetic Engineering News

New Rochelle, NY, July 25, 2012A novel approach to gene therapy that instructs a person's own cells to produce more of a natural disease-fighting protein could offer a solution to treating many genetic disorders. The method was used to achieve a 2- to 3-fold increase in production of a protein deficient in patients with Friedreich's ataxia, as described in an article published Instant Online in Human Gene Therapy, a peer-reviewed journal from Mary Ann Liebert, Inc. (http://www.liebertpub.com) The article is available free online at the Human Gene Therapy website (http://www.liebertpub.com/hum).

The innovative gene therapy method described by Jacques Tremblay, Pierre Chapdelaine, Zo Coulombe, and Joel Rousseau, Laval University, Quebec, and University of Quebec, Canada, takes advantage of the ability of a family of proteins called Tal effector (TALE) proteins to target specific DNA sequences. As a model of how this method could be used to treat genetic disease, the authors engineered TALE proteins to target the gene that codes for the frataxin protein, which is deficient in Friedreich's ataxia. The ability to induce cells to produce more frataxin could reduce symptoms of the disease and provide an effective, long-term therapeutic strategy, conclude the authors in the article "TALE Proteins Induce the Expression of the Frataxin Gene. (http://online.liebertpub.com/doi/full/10.1089/hum.2012.034)

"This is a very clever approach to treat a recessive disease caused by decreased quantity of an otherwise normal protein," says James M. Wilson, MD, PhD, Editor-in-Chief, and Director of the Gene Therapy Program, Department of Pathology and Laboratory Medicine, University of Pennsylvania Perelman School of Medicine, Philadelphia.

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About the Journal

Human Gene Therapy (http://www.liebertpub.com/hum), the Official Journal of the European Society of Gene and Cell Therapy, British Society for Gene and Cell Therapy, French Society of Cell and Gene Therapy, German Society of Gene Therapy, and five other gene therapy societies is an authoritative peer-reviewed journal published monthly in print and online that presents reports on the transfer and expression of genes in mammals, including humans. Related topics include improvements in vector development, delivery systems, and animal models, particularly in the areas of cancer, heart disease, viral disease, genetic disease, and neurological disease, as well as ethical, legal, and regulatory issues related to the gene transfer in humans. Tables of content and a free sample issue may be viewed online at the Human Gene Therapy website (http://www.liebertpub.com/hum).

About the Publisher

Mary Ann Liebert, Inc., publishers (http://www.liebertpub.com) is a privately held, fully integrated media company known for establishing authoritative peer-reviewed journals in many promising areas of science and biomedical research, including Tissue Engineering, Stem Cells and Development, and Cellular Reprogramming. Its biotechnology trade magazine, Genetic Engineering & Biotechnology News (GEN), was the first in its field and is today the industry's most widely read publication worldwide. A complete list of the firm's 70 journals, books, and newsmagazines is available at Mary Ann Liebert, Inc. (http://www.liebertpub.com)

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New gene therapy strategy boosts levels of deficient protein in Friedreich's ataxia

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Driver of breast cancer stem cell metastasis found

Posted: July 24, 2012 at 11:18 pm

ScienceDaily (July 24, 2012) Researchers at the University of Michigan Comprehensive Cancer Center have found that a cancer gene linked to aggressive spread of the disease promotes breast cancer stem cells. The finding implies a new way to target the behavior of these lethal cells.

The finding involves the cancer gene RhoC, which has previously been shown to promote metastasis of many types of cancer. RhoC levels increase as breast cancer progresses and high levels of RhoC are associated with worse patient survival.

Cancer stem cells are the small number of cells within a tumor that are believed to fuel the tumor's growth and spread. Researchers believe traditional chemotherapy and radiation treatments often become ineffective because they do not kill the cancer stem cells, and that the key to future treatments is to develop drugs that target and kill these cells.

This new study, which appears online in PLoS ONE, suggests a new way to get at the cancer stem cells.

"Targeting the specific molecular cogs driving the cancer stem cell machinery responsible for the cancer spreading has potential for future treatments. Eliminating cancer stem cells may ultimately be necessary to cure certain cancers, but in the meantime, we may be able to manage the cancer stem cell population and the invasive behaviors of these cells by disrupting the molecular machinery, using RhoC as a target," says senior study author Sofia D. Merajver, M.D., Ph.D., professor of internal medicine and epidemiology at the University of Michigan and scientific director of the breast oncology program at the U-M Comprehensive Cancer Center.

The researchers looked at breast cancer cell lines that were highly metastatic and cell lines from normal breast tissue. By inhibiting or overexpressing RhoC, they found that RhoC expression is necessary to cause metastasis in both cell lines, and that RhoC overexpression alone can cause metastasis. The researchers also tested this in mice and had similar results.

Merajver's lab, in conjunction with other U-M researchers, is studying a novel small molecule drug to inhibit RhoC, which has shown promising initial results in the laboratory. The researchers are continuing to develop this inhibitor, which will require several years of additional testing in the laboratory before potentially advancing to clinical trials.

Breast cancer statistics: 229,060 Americans will be diagnosed with breast cancer this year and 39,920 will die from the disease, according to the American Cancer Society

Additional authors: Devin T. Rosenthal, Jie Zhang, Liwei Bao, Lian Zhu, Zhifen Wu, Kathy Toy and Celina G. Kleer, all from U-M

Funding: Department of Defense Breast Cancer Research Program (BC083262); National Institutes of Health (T32-GM07315); Burroughs Wellcome Fund; Breast Cancer Research Foundation

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Driver of breast cancer stem cell metastasis found

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Novel pig model may be useful for human cancer studies

Posted: July 24, 2012 at 11:15 pm

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

Contact: Vicki Cohn vcohn@liebertpub.com 914-740-2100 x2156 Mary Ann Liebert, Inc./Genetic Engineering News

New Rochelle, NY, July 24, 2012A naturally occurring line of immunodeficient pigs can support the growth of human tumors injected under their skin, offering a promising new large animal model for studying human cancers and testing new drugs and treatment strategies. The ability of human melanoma cells and pancreatic carcinoma cells to grow in these pig models is described in an article in BioResearch Open Access, a new bimonthly peer-reviewed open access journal from Mary Ann Liebert, Inc. (http://www.liebertpub.com). The article is available free online at the BioResearch Open Access website (http://www.liebertpub.com/biores).

Mathew Basel and colleagues, Kansas State University (Manhattan, KS) and Iowa State University (Ames), highlight the advantages that pig disease models offer, as they are anatomically and physiologically more closely related to humans than traditional rodent animal models. As a result, findings from studies in large animal models such as pigs are more likely to translate into similar outcomes in humans. The authors present their findings in the article "Human Xenografts Are Not Rejected in a Naturally Occurring Immunodeficient Porcine Line: A Human Tumor Model in Pigs" (http://online.liebertpub.com/doi/full/10.1089/biores.2012.9902).

"This novel animal model has the potential to become a highly useful model in cancer research studies, in addition to providing significant opportunities for drug discovery and other translational applications," says Editor-in-Chief Jane Taylor, PhD, MRC Centre for Regenerative Medicine, University of Edinburgh, Scotland.

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About the Journal

BioResearch Open Access (http://www.liebertpub.com/biores) is a bimonthly peer-reviewed open access journal that provides a new rapid-publication forum for a broad range of scientific topics including molecular and cellular biology, tissue engineering and biomaterials, bioengineering, regenerative medicine, stem cells, gene therapy, systems biology, genetics, biochemistry, virology, microbiology, and neuroscience. All articles are published within 4 weeks of acceptance and are fully open access and posted on PubMedCentral. All journal content is available online at the BioResearch Open Access website (http://www.liebertpub.com/biores).

About the Publisher

Mary Ann Liebert, Inc., publishers (http://www.liebertpub.com) is a privately held, fully integrated media company known for establishing authoritative peer-reviewed journals in many promising areas of science and biomedical research, including Tissue Engineering, Stem Cells and Development, Human Gene Therapy and HGT Methods, and AIDS Research and Human Retroviruses. Its biotechnology trade magazine, Genetic Engineering & Biotechnology News (GEN), was the first in its field and is today the industry's most widely read publication worldwide. A complete list of the firm's 70 journals, books, and newsmagazines is available on the Mary Ann Liebert, Inc. website (http://www.liebertpub.com).

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StemCells and Keryx Biopharmaceuticals Showing Strong Gains as Biotechnology Industry Soars in 2012

Posted: July 24, 2012 at 11:15 pm

NEW YORK, NY--(Marketwire -07/24/12)- The Biotechnology Industry has been soaring in 2012 as companies -- both large and small -- have shown impressive growth. The SPDR S&P Biotech ETF (XBI) and the First Trust NYSE Arca Biotech Index ETF (FBT) year-to-date are up 38 percent and 37 percent, respectively, outperforming the broader market by a wide margin. The Paragon Report examines investing opportunities in the Biotechnology Industry and provides equity research on StemCells, Inc. (STEM) and Keryx Biopharmaceuticals (KERX).

Access to the full company reports can be found at:

http://www.ParagonReport.com/STEM http://www.ParagonReport.com/KERX

Despite having to negotiate a more challenging regulation process biotech companies have continued to show investors strong gains in 2012. The FDA Amendments Act of 2007 forced regulators to increase standards for approvals of new drugs, introducing mandatory risk evaluation and mitigation strategies. According to a Pharmaceuticals & Biotechnology report from IMAP, several pharmaceutical firms have altered their drug portfolios from primary care driven blockbusters towards specialties such as oncology, immunology and inflammation, where the medical need is "so high that prices are more easily accepted by the regulators."

Paragon Report 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.ParagonReport.com and get exclusive access to our numerous stock reports and industry newsletters.

StemCells is engaged in the research, development, and commercialization of cell-based therapeutics and tools for use in stem cell-based research and drug discovery. The company recently announced preclinical data demonstrating that its proprietary human neural stem cells restored memory and enhanced synaptic function in two animal models relevant to Alzheimer's disease. Shares of the company have soared nearly 90 percent this year.

Keryx Biopharmaceuticals is focused on the acquisition, development and commercialization of medically important pharmaceutical products for the treatment of renal disease. Keryx is developing Zerenex (ferric citrate), an oral, ferric iron-based compound that has the capacity to bind to phosphate and form non-absorbable complexes. Shares of the company have rebounded nearly 50 percent over the last three months.

The Paragon Report has not been compensated by any of the above-mentioned publicly traded companies. Paragon Report is compensated by other third party organizations for advertising services. We act as an independent research portal and are aware that all investment entails inherent risks. Please view the full disclaimer at: http://www.paragonreport.com/disclaimer

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Biostem U.S., Corporation Enters Into Medical Affiliate Agreement With Pizarro Hair Restoration Clinics

Posted: July 24, 2012 at 12:12 pm

CLEARWATER, FL--(Marketwire -07/23/12)- Biostem U.S., Corporation, (HAIR) (HAIR) (Biostem, the Company), a fully reporting public company in the stem cell regenerative medicine sciences sector, enters into an agreement with Pizarro Hair Restoration Clinics to offer The Biostem Method of stem cell hair re-growth treatments.

Biostem U.S., Corporation announced today that it has entered into a contractual affiliate agreement with Dr. Marina Pizarro and her multi-location practice, Pizarro Hair Restoration Clinics http://www.DrPizarro.com. Additionally, Dr. Pizarro will serve as the Medical Director for the company.

Dr. Pizarro's Orlando, Florida office will serve as the national training center for future Biostem U.S. affiliates.

Dwight Brunoehler, Chief Executive Officer for Biostem, stated, "We have been seeking the right partner to become our first affiliate. We have also been seeking a qualified Medical Director as well as a first rate training facility to accommodate the many requests for affiliation that we have received nationwide from physicians wanting to offer our services to their clientele. The Company is extremely fortunate to have filled these multiple needs in one place. Dr. Pizarro's impeccable credentials and extensive experience rank her among the best in her field. We look forward to a long and prosperous relationship."

According to Dr. Pizarro, "I have been following the discovery and development of hair re-growth technology on the cellular level for some time. Biostem's unique approach using Platelet Rich Plasma along with other proven treatments has shown to be highly effective for many qualified male and female patients. I am excited to be able to offer this service to my patients, and to be on the ground floor of this growing industry."

Dr. Marina Pizarro holds the distinction of being the first female hair transplant physician in the industry and belongs to the elite group of surgeons who have performed over 30,000 hair transplant procedures in their careers. She received her Medical Degree from Ponce School of Medicine in Puerto Rico in 1985. After completing her residency in Orlando, Dr. Pizarro worked with world renowned hair transplant surgeon Dr. Constantine Chambers building one of the largest hair restoration practices in history. After five years, and performing thousands of procedures around the world while lecturing at hair restoration conventions, Dr. Pizarro opened her first two facilities in Orlando and Jacksonville, Florida in 1994 specializing in hair transplantation for both men and women. She currently has three facilities in Florida with the addition of her clinic in Tampa. Dr. Pizarro is a member of The International Society of Hair Restoration Surgery and the European Society of Hair Restoration Surgery.

About Biostem U.S., Corporation:

Biostem U.S., Corporation (HAIR) is a fully reporting Nevada corporation with offices in Clearwater, Florida. Biostem U.S. is a technology licensing company with proprietary technology centered on providing hair re-growth using human stem cells. The company also intends to train and license selected physicians to provide Regenerative Cellular Therapy treatments to assist the body's natural approach to healing tendons, ligaments, joints and muscle injuries by using the patient's own stem cells. Biostem U.S. is seeking to expand its operations worldwide through licensing of its proprietary technology and acquisition of existing stem cell related facilities. The company's goal is to operate in the international biotech market, focusing on the rapidly growing regenerative medicine field, using ethically sourced adult stem cells to improve the quality and longevity of life for all mankind.

The company's Board of Directors is headed by Chairman, Scott Crutchfield, who also acts as Senior Vice President of World Wide Operations for Crocs, Inc. (CROX) and includes Crocs, Inc. original member, Steve Beck.

For further information on Biostem U.S., Corporation can be obtained through http://www.biostemus.com or by contacting Fox Communications Group at 310-974-6821.

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Biostem U.S., Corporation Enters Into Medical Affiliate Agreement With Pizarro Hair Restoration Clinics

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Histogenics Closes $49 Million Series A Fundraising to Support Commercial Development of Transformational Cartilage …

Posted: July 24, 2012 at 12:12 pm

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

Regenerative medicine company Histogenics Corporation, announced today the completion of a $49 million round of financing. The syndicate was led by Sofinnova Ventures with participation from additional new investors Split Rock Partners, BioMed Ventures and FinTech GIMV Fund, L.P. Existing investors ProChon Holdings BV, Altima Partners, Foundation Medical Partners, Inflection Point Capital and Boston Millennia Partners also participated in the financing. Proceeds will be used to complete the ongoing Phase 3 clinical program for lead product candidate NeoCart, which is currently enrolling patients. NeoCart is an autologous neocartilage tissue implant that utilizes the patients own cells to regenerate cartilage in patients suffering from cartilage lesions in the knee. Funds will also support efforts to obtain regulatory clearance in the European Union for product candidate VeriCart, a single-step, cell-free collagen scaffold uniquely designed to be used in conjunction with the patients own stem cells, to repair small cartilage defects frequently observed in meniscal and anterior cruciate ligament repair procedures. Garheng Kong, MD, PhD of Sofinnova Ventures and Josh Baltzell of Split Rock Venture Partners will join Histogenics Board of Directors. Arnold Freedman of Boston Equity Advisors served as the exclusive placement agent.

Patrick ODonnell, President and Chief Executive Officer of Histogenics, commented, We believe the quality of the investors and the significant level of commitment demonstrated in this financing speak to the potential of our product candidates to transform the treatment of cartilage injury with the goal of returning patients to their pre-injury level of activity. Each year, 1.8 million active adults and elite athletes undergo arthroscopy for the diagnosis and treatment of painful cartilage defects in the knee. With continued positive clinical results, we believe our Phase 3 product candidate, NeoCart, has considerable potential as a much-needed treatment alternative for a significant portion of these patients. The successful completion of this financing fully funds the Company to reach key clinical and commercial milestones for NeoCart and VeriCart and allows us to focus our full attention on continued successful clinical and regulatory execution.

Garheng Kong, MD, PhD, General Partner of Sofinnova Ventures added, NeoCart has the potential to dramatically change the way knee cartilage injuries are treated. Current treatments for knee cartilage damage frequently do not produce the lasting effects that individuals need to avoid serious knee pain and improve functionpreventing them from getting back to their active, daily lives. Published data have shown that patients treated with NeoCart experienced a very durable response that is sustained throughout a period of four years or more. Sofinnova is pleased to support Histogenics efforts to receive approval for NeoCart and address this unmet clinical need.

About NeoCart NeoCartis an autologous bioengineered neocartilage grown outside the body using the patients own cells for the regeneration of cartilage lesions. NeoCart recently entered a Phase 3 clinical trial after reporting positive Phase 2 data, in which all primary endpoints were met, and NeoCart was found to be generally well tolerated.

About VeriCart VeriCart is a single step, off-the-shelf, cell-free collagen scaffold, specifically designed for cartilage applications, which when reconstituted with the patients own bone marrow or augmenting marrow stimulation procedures, is intended for the improved repair of cartilage tissue. VeriCart is currently in development.

About Histogenics Histogenics is a leading regenerative medicine company that combines cell therapy and tissue engineering technologies to develop highly innovative products for tissue repair and regeneration. In May of 2011, Histogenics acquired Israeli cell-therapy company ProChon BioTech. Histogenics flagship products focus on the treatment of active patients suffering from articular cartilage derived pain and immobility. The Company takes an interdisciplinary approach to engineering neocartilage that looks, acts and lasts like hyaline cartilage. It is developing new treatments for sports injuries and other orthopedic conditions, where demand is growing for long-term alternatives to joint replacement. Histogenics has successfully completed Phase 1 and Phase 2 clinical trials in which the NeoCart autologous tissue implants effectiveness is compared to that of standard microfracture surgery. Based in Waltham, Massachusetts, the company is privately held. For more information, visitwww.histogenics.com.

About Sofinnova Ventures Sofinnova Ventures has over 40 years of experience building start-ups and later stage companies into market leaders. With $1.4 billion under management, the firm applies capital and expertise to build companies from inception to exit. Sofinnova closed its life science-focused $440M, SVP VIII, in late 2011. The firms investment team of MDs and PhDs has significant scientific, operational and strategic experience, and specializes in financing later stage clinical products. The Sofinnova team partners with entrepreneurs to address patients unmet medical needsand has had a string of recent exits through companies, including Movetis, Preglem, Amarin, Vicept and Intellikine.

About Split Rock Partners Split Rock Partners, with offices in Minneapolis and Menlo Park, seeks emerging opportunities in healthcare as well as software and internet services. Since 2005, Split Rock has raised $575 million over two funds. Representative companies backed by Split Rock's team include Ardian, Atritech, DFine, Entellus, eBureau, Evalve, Guardian Analytics, HireRight, Intacct, LowerMyBills, MyNewPlace, QuinStreet (QNST), SPS Commerce (SPSC) and Tornier (TRNX). Additional information about the firm can be found atwww.splitrock.com.

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Histogenics Closes $49 Million Series A Fundraising to Support Commercial Development of Transformational Cartilage ...

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Israel ALS stem cell trials hopeful

Posted: July 24, 2012 at 12:11 pm

2012-07-23 19:43

Tel Aviv - A clinical trial of ALS patients conducted by BrainStorm Cell Therapeutics shows its adult stem cell therapy is well-tolerated, appears to be safe and does not present undue risk, according to an interim safety review.

Moreover, in some patients signs of stabilisation of the disease were detected.

Israel-based BrainStorm is developing NurOwn for the treatment of amyotrophic lateral sclerosis (ALS), also known as Lou Gehrig's Disease, a progressive neurodegenerative disease that affects nerve cells in the brain and spinal cord.

"It's very uncommon to give at such an early point in a clinical study efficacy data, but we cannot ignore the fact on an individual basis we could see improvement in many of the patients involved, each one in different areas," Moshe Neuman, CEO of Biomedical Research Design, which serves as a contract research organisation for the trial, said.

In some patients breathing improved, in others it was muscle strength and in others it was speech, he told Reuters.

Neuman said a final report was expected by the end of the year after each patient has been observed for nine months.

BrainStorm President Chaim Lebovits said the preliminary results demonstrate that the stem cells have the potential not only to stop deterioration but perhaps even cure ALS.

"The coming phases in the trial will have to prove this, but these results also reaffirm our belief that we have an enormous potential of being successful with less severe indications such as multiple sclerosis and Parkinson's," he said.

Patients in the trial were transplanted with stem cells derived from their own bone marrow and treated with the NurOwn stem cell technology.

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Breakthrough on damaged heart cells

Posted: July 24, 2012 at 9:20 am

Scientists have turned back the hands of a biological clock to rejuvenate ageing and damaged human heart cells.

Using stem cells, they reset a molecular mechanism that determines the rate at which cells age.

Although the work on human cells was confined to the laboratory, the same technique has been successfully tested in mice and pigs.

Researchers in the US managed to get new heart tissue to grow in the animals in just four weeks.

They hope the advance will lead to new treatments for heart failure, which often follows a heart attack.

'Modifying aged human cardiac cells from elderly patients adds to the cell's ability to regenerate damaged heart muscle, making stem cell engineering a viable option,' said lead scientist Dr Sadia Mohsin, from San Diego State University in California.

During heart failure the damaged heart is not strong enough to pump blood around the body efficiently, leading to rapid exhaustion.

In the laboratory studies, Dr Mohsin's team worked on heart tissue surgically removed from elderly patients.

Stem cells from the samples were treated with a growth protein called PIM-1.

The effect was to boost activity of an enzyme called telomerase, which has a direct impact on ageing.

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Heart rejuvenated with modified stem cells

Posted: July 24, 2012 at 9:20 am

NEW ORLEANS, July 23 (UPI) -- U.S. scientists said they modified stem cells that rejuvenated damaged and aged heart tissue in older heart failure patients.

Sadia Mohsin, a postdoctoral research scholar at San Diego State University's Heart Institute, said the finding could one day lead to new treatments for heart failure patients.

Modified human stem cells helped the signaling and structure of the heart cells, which were biopsied from elderly patients, Mohsin explained.

The researchers modified the stem cells in the laboratory with PIM-1 -- a protein that promotes cell survival and growth, Mohsin said.

Cells were rejuvenated when the modified stem cells enhanced activity of the enzyme telomerase, which elongates telomere length. Telomeres are "caps" on the ends of chromosomes that facilitate cell

replication. Aging and disease results when telomeres break off.

"There is no doubt that stem cells can be used to counter the aging process of cardiac cells caused by telomere degradation," Mohsin said in a statement.

The technique increased telomere length and activity, and increased cardiac stem cell proliferation, all vital steps in combating heart failure, Mohsin told the American Heart Association's Basic Cardiovascular Sciences scientific sessions.

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Human Stem Cells Found to Restore Memory

Posted: July 24, 2012 at 9:20 am

Human Stem Cells Found to Restore Memory

StemCells Inc. hopes a clinical trial of its proprietary stem cells in rodents will lead to a clinical trial with Alzheimer's patients.

Neurosphere: StemCells is testing neuronal stem cells, which form floating aggregates when grown in culture, as a treatment for Alzheimers disease, spinal cord injury, and other neurological conditions. StemCells Inc.

Last week, a California biotech company announced that its human stem cells restored memory in rodents bred to have an Alzheimer's-like conditionthe first evidence that human neural stem cells can improve memory.

The company, called StemCells, is betting that its proprietary preparation of stem cells from fetal brain tissue will take on many different roles in the central nervous system. The company and its collaborators have already shown that its stem-cell product has potential in protecting vision in diseased eyes, acting as brain support cells, or improving walking ability in rodents with spinal cord injury.

This metamorphic ability is not so surprisingthey are stem cells, after all. But experts say the quality of scientists involved in StemCells and the interesting properties of its cells sets the company apart. "They've really been steadfast in their work to get these cells into clinical trials. That is a tough road and they've done it," says Larry Goldstein, a neuronal stem-cell researcher and director of UC San Diego's stem-cell program.

The company discovered the technique to isolate these cells from brain tissue in 1999 and has since spent some $200 million improving the technology. "Now we are really in the exciting phase, because now we are looking at human clinical data, as opposed to just small animals," says StemCells CEO Martin McGlynn.

His company is not the only group bringing stem cells into the clinic. While much attention was paid to Geron's departure from the world's first embryonic stem cell trial (see "Geron Shuts Down Pioneering Stem-Cell Program"), many other groups have continued to push their non-embryonic stem-cell therapies forward for leukemia, colitis, stroke, and more. Meanwhile, Advanced Cell Technology continues its U.K.-based embryonic stem-cell therapy trials for blindness. Non-embryonic stem cells can come from a variety of sourcesbone marrow, blood, as well as donated aborted fetal tissue, as is the case with StemCells and Neuralstem, another company focused on neuronal stem cells. In recent years, scientists have also developed methods for turning normal adult cells into stem cells (so-called induced pluripotent stem cells), but their safety has yet to be tested in humans.

So while StemCells is not a lone wolf, it may well be a pack leader. One of StemCells' first human studies involved a small trial of young children with a rare and fatal neurodegenerative disease called Batten disease. In 2006, the company began the first U.S. Food and Drug Administration-authorized trial of human neural stem cells at Oregon Health and Science University. Through small boreholes in the skull, a neurosurgeon implanted as many as a billion neural stem cells into different locations of the brains of six Batten patients.

The trial has since suggested that the cells are safe and integrate into the brain. At first, the children received immune system-suppressing drugs to prevent their body from rejecting the cells. But after a year, that treatment was stopped. "A big question that we had, that science had, that the FDA had, was what happens to these cells when you withdraw immunosuppression?" says McGlynn.

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Human Stem Cells Found to Restore Memory

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