Volume 9.22 | Jun 9

Cell Therapy News 9.22, June 9, 2008
     In this issue: Science | Policy | Business | NIH | CBER | Regulatory
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Top Stories

Human Stem Cells Show Promise Against Fatal Children’s Diseases: Scientists have used human stem cells to dramatically improve the condition of mice with a neurological condition similar to a set of diseases in children that are invariably fatal, according to an article in the June issue of the journal Cell Stem Cell.
Article

United States FDA Clears Phase 2 Trial for Congestive Heart Failure: Mesoblast Limited recently announced that the United States Food and Drug Administration had cleared an Investigational New Drug submission by its US-based sister company, Angioblast Systems Inc., to commence a Phase 2 trial of the stem cell platform technology for treating patients with congestive heart failure.
Article

Science

Cartilage Regeneration ‘20,000 Leagues Under the Sea’
Bioengineers at Rice University have discovered that intense pressure – similar to what someone would experience more than a half-mile beneath the ocean’s surface – stimulates cartilage cells to grow new tissue with nearly all of the properties of natural cartilage. The new method, which requires no stem cells, may eventually provide relief for thousands of arthritis sufferers.
Article

Enzyme Plays Key Role in Cell Fate
The road to death or differentiation follows a similar course in embryonic stem cells, said researchers at Baylor College of Medicine in Houston in a report that appeared online recently in the journal Cell Stem Cell.
Article

Scientists Develop “Cyborg Engineering” for Coronary Bypass Grafting
A team of London scientists have taken a major step in making the use of artificial veins and arteries in coronary bypass grafts a reality. In a study published in the June 2008 print issue of The FASEB Journal, researchers describe how they developed this artificial graft tissue by combining man-made materials with human cells to make it elastic and durable and so it can attach to host tissue.
Article

VIDEO: In Vitro and In Vivo Bioluminescence Reporter Gene Imaging of Human Embryonic Stem Cells
In this video, the specific materials and methods needed for tracking stem cell proliferation and teratoma formation with bioluminescence imaging will be described.
Video

Brain Stem Cells Can Be Awakened, Say Schepens Scientists
Scientists at Schepens Eye Research Institute have identified specific molecules in the brain that are responsible for awakening and putting to sleep brain stem cells, which, when activated, can transform into neurons and repair damaged brain tissue. Their findings are published online this week in the Proceedings of the National Academy of Science.
Article

Saving Teeth by Using Periodontal Ligament Regeneration
At the Academic Centre for Dentistry Amsterdam, Dutch researcher Agnes Berendsen has studied the regeneration of the periodontal ligament by use of tissue engineering. The 3D in vitro model she has developed appears to be promising for regenerating periodontal ligament and may also prove valuable for restoring tendons and ligaments elsewhere in the body.
Article

Gene Therapy Might Help Deaf Kids
Researchers from the Genetics Department of the Rappaport Faculty of Medicine, Technion, Haifa, Israel, tested the capacity of aminoglycosides to treat sight loss caused by type 1 Usher syndrome using gene therapy involving antibiotics.
Article

Finding Clues For Nerve Cell Repair
A new study at the Montreal Neurological Institute at McGill University identifies a key mechanism for the normal development of motor nerve cells – cells that control muscles. This finding is crucial to understanding and treating a range of conditions involving nerve cell loss or damage, from spinal cord injury to neurodegenerative diseases such as ALS, also known as Lou Gehrig’s disease.
Article

Mouse Model Developed at UT Southwestern Mimics Hyperglycemia, Aids in Diabetes Research
UT Southwestern Medical Center researchers have genetically engineered a laboratory mouse in which pancreatic beta cells can regenerate after being induced to die. The new animal model’s regenerative ability may provide future insights into improved treatments of diabetes, which affects millions of Americans.
Article

Novel Stem Cell Therapy Gives Hope to Boy with Rare Disease
For toddler Nate Liao, the slightest touch and every bite of food was painful. Nate was born with recessive dystrophic epidermolysis bullosa, a genetic disease that causes skin and the lining of the digestive tract to slough off. In young adulthood, it leads to an aggressive, inevitably fatal skin cancer.
Article

First Spine Surgery Using Adult Stem Cells Performed at The Medical Center of Aurora
Dr. Jeffrey Kleiner, spinal surgeon, performed the first diskectomy in the United States using adult stem cells to help repair the lower back. This milestone marks the beginning of how some types of back surgery will be performed in the future.
Article

VIRxSYS Presents New VRX496 Phase II HIV Gene Therapy Trial Data
VIRxSYS Corporation will present additional results from its Phase II trial of VRX496, an investigational gene therapy for the treatment of AIDS, at the 2008 American Society of Gene Therapy Annual Meeting in Boston, Massachusetts.
Article

ABSTRACTS, REVIEWS AND SPECIAL REPORTS

A Decrease of Cell Proliferation by Hypothermia in the Hippocampus of the Neonatal Rat
Hypothermia is a potential therapy for cerebral hypoxic ischemic injury of not only adults but also neonates. However, the side effects of hypothermia in the developing brain, where a massive amount of neurogenesis occurs, remain unclear. The researchers determine that the severe hypothermic environment induced a decrease of neurogenesis in the neonatal rat.
Article

A Combined Chemical and Genetic Approach for the Generation of Induced Pluripotent Stem Cells
Here, the researchers have explored two approaches toward identifying conditions that can replace viral transduction of oncogenic transcription factors and enhance reprogramming efficiency. In one, they have found that neural progenitor cells can be reprogrammed with fewer genetic manipulations than previously reported somatic cells, and in the other they have found that small molecules may be able to replace viral integration of certain transcription factors and promote the reprogramming process.
Article

PUMA Regulates Intestinal Progenitor Cell Radiosensitivity and Gastrointestinal Syndrome
The loss of crypt stem cells or villus endothelial cells has been suggested to be responsible for radiation-induced intestinal damage. The researchers report here a critical role of the BH3-only protein p53 upregulated modulator of apoptosis in the radiosensitivity of intestinal epithelium and pathogenesis of GI syndrome.
Article

Q&A: The Man Behind Embryonic Stem Cells
Ten years ago in a small, closet-like laboratory, James “Jamie” Thomson, an embryologist at the University of Wisconsin, Madison, changed the world by creating the first human embryonic stem cells. Few research experiments have generated as much hype or controversy. More recently, he played a key role in creating induced pluripotent stem cells, which might someday provide the benefits of embryonic stem cells without destroying embryos.
Article

JOB OPPORTUNITIES

Product Manager

Lead Clinical Laboratory Scientist

Adult Stem Cell Biology Researcher

Operations Manager

Market Development Manager – Americas

Field Applications Specialist

Product Development Associate

Human Application Laboratory Opportunities

Cellular Therapy Laboratory Manager

Cellular Therapy Laboratory Manager

Stem Cell Laboratory Medical Technologist

Stem Cell Laboratory Supervisor

Quality Management Supervisor

Policy

High School Gets an Edge on Biotech
Dover-Sherborn High School is just one of 50 public schools across Massachusetts to receive a BioTeach grant of up to $24,000 from the Massachusetts Biotechnology Education Foundation, a nonprofit organization established in 2001 to work with the state’s leading biotechnology, life sciences, and pharmaceutical companies.
Article

On Long Island, a Push to Nurture Biotech Work
As dozens of states and municipalities across the country pass initiatives to develop office space for biotechnology businesses, Long Island has, in fits and starts, been working to attract start-up life sciences companies.
Article

An American Puzzle: Funding Embryonic Stem Cell Research
The two-room laboratory on the 13th floor of Northwestern’s Feinberg School of Medicine is about the size of a dorm room. It houses drawers full of slides and pipettes, a collection of microscopes and the progeny of four human embryonic stem cell lines. According to the original design, the rooms were to be separated by a border not all researchers could cross. Federally approved stem cell lines – created before Aug. 9, 2001 – would live and grow on one side. Newer, privately funded stem cell lines would stay on the other, and never the twain would meet.
Article


Business

Connexon Creative and Advanced Cell & Gene Therapy Launch Directory for the Cell and Gene Therapy Community
Connexon Creative Inc., a company specializing in scientific and medical communications, and Advanced Cell & Gene Therapy, a consulting firm serving biotechnology companies and clinical laboratories, are pleased to announce the launch of The Cell Therapy Pages, a comprehensive directory of the cell and gene therapy community.
Article

Battelle Ventures Broadens Life Sciences Portfolio; Creates NellOne Therapeutics, Inc., a Spinout from Oak Ridge National Laboratory
Battelle Ventures, LP, has spun out regenerative-medicine start-up NellOne Therapeutics, Inc., from the U.S. Department of Energy’s Oak Ridge National Laboratory, with an initial $1.5-million seed investment from the fund and its Tennessee affiliate, Innovation Valley Partners. The investment will be tranched based on key technical milestones.
Article

Cryobanks International Adopts BioE’s Cord Blood Processing System
Cryobanks’ U.S. operation has converted to BioE’s proprietary cord blood processing system to obtain greater cord blood stem cell yields and improve processing efficiency. Cryobanks previously employed a hetastarch method to process cord blood units.
Article

Leading U.S. Bioscience Pioneers Enter International Collaboration with Government of Luxembourg to Accelerate Biomedical Research
Three of the United States’ most prominent biomedical science leaders have been tapped by the government of Luxembourg for an unprecedented international collaboration to establish a bioscience center of excellence in the heart of the European Union.
Article

Penn Announces $50 Million Gift From Anne and Jerome Fisher for New Translational Medicine Research Center
A $50 million gift from philanthropists Jerome and Anne Fisher will support a new eight-story biomedical-research center at the University of Pennsylvania dedicated to the growing field of translational medicine, which emphasizes an accelerated pace for converting laboratory discoveries into medical therapies.
Article

Clemson Bioengineer Receives NSF CAREER Award for Stem Cell-Viability Research
Stem cell-viability research has gotten a boost with a $400,000 National Science Foundation CAREER Award to Clemson University bioengineering professor Xuejun Wen.
Article

Early Career Physician-Scientists Awarded $7.1 Million to Pursue Research
Scientists who bridge the gap between basic research and clinical medicine at 14 academic medical centers will get a boost at a vital time in their career, as part of a $7.1 million initiative from the Howard Hughes Medical Institute.
Article

National Stem Cell Holding Appoints Kenneth Steiner, MD, MBA, as Chief Operating Officer
National Stem Cell Holding, Inc. recently announced the appointment of Kenneth D. Steiner, MD, MBA, as its Chief Operating Officer. Dr. Steiner brings with him a vast array of proven management and business skills.
Article

Stem Cell Sciences Granted Second European ‘Nanog’ Patent Key Gene Enabling the Production of Disease Specific Assays
Stem Cell Sciences plc recently announced that the European Patent Office has granted it a second patent for ‘Nanog’, a key factor used to convert adult cells back into a pluripotent state. With this technology, adult cells can be reprogrammed to behave like embryonic stem cells, thus avoiding the controversy associated with using embryos. The granted patent, EP Patent 1698639, covers mouse Nanog, complementing the Company’s existing patent, EP Patent 1470155, which covers human Nanog.
Article

Living Cell Technologies Lists on International OTCQX
Living Cell Technologies Limited recently announced that it has listed its American Depositary Receipts on the International OTCQX and began trading Monday, June 2nd in the United States.  LCT’s ordinary shares are listed on the Australian Securities Exchange, which is one of the qualifying foreign exchanges for an OTCQX listing.  LCT is the first New Zealand-based company to list on the International OTCQX trading platform in the United States.
Article

NIH

Ohio State Receives $34 Million NIH Grant
Medical researchers at The Ohio State University, in partnership with Nationwide Children’s Hospital, have received a $34 million grant from the National Institutes of Health to create a center to develop clinical and translational protocols that help identify and advance treatments for patients. The grant is one of the largest ever received by Ohio State.
Article

NIH Director Announces Enhancements to Peer Review
NIH Will Commit $1 Billion over Next Five Years to Investigator-Initiated High Risk, High Impact Transformative Research
Article

CBER

Substantially Equivalent 510(k) Device Applications
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Approved Premarket Approval (PMA) Device Applications
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Society of Clinical Research Associates Presentation: Working with Center for Biologics Evaluation and Research and Suggestions for Successful Clinical Trials
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Guidance for Industry: Indexing Structured Product Labeling
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Regulatory

FOOD AND DRUG ADMINISTRATION (United States)

Substantially Equivalent 510(k) Device Information – PCS2 Plasma Collection System_Revision K software – Haemonetics Corp
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Society of Clinical Research Associates Presentation: The Inspection is Over – What Happens Next? Possible FDA Enforcement Actions
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