Volume 9.05 | Feb 11

Cell Therapy News 9.05, February 11, 2008
     In this issue: Science | Policy | Business | NIH | CBER | Regulatory
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Top Stories

Scientists Develop Skin from Hair Cells: In a breakthrough for patients with serious burns and chronic wounds, German researchers have developed a method to artificially grow skin cells in a lab that are derived from a patient’s own stem cells found within hair roots.

Stem Cell Activity Follows Circadian Rhythyms: The effectiveness of stem cell therapies may rely not only on the nature of the cells involved, but the time of their application.


Cancer Biomarkers Development and Clinical Use
June 16, 2008 |  New York, New York

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Embryos with Three Parents Created in Lab
British scientists have created human embryos with three parents in a development they hope could lead to effective treatments for a range of serious hereditary diseases within five years.

Stem Cells May Help Trial Drugs
Drugs could be screened for potential harmful side-effects before they are trialled in patients using pioneering stem cell research.

Gene Therapy Shows Promise for HIV
For the first time, researchers have slowed and possibly stopped the AIDS virus from reproducing in patients by using a gene therapy that tricks it into self-destructing.

New Direction for Gene Therapy
Researchers have identified a new strategy for circumventing the safety problems that have plagued gene therapy according to a study published online in Cell.

Tattoos May Help Deliver Vaccine
Scientists in Germany say that tattoos could be the ideal way of delivering vaccines into the body.

See-through Fish is Created to Give a Clearer Idea of How Cancer Spreads
A transparent zebrafish has been engineered to allow scientists to watch how cancers develop and behave inside the body in real time.

Molecular Therapy Succeeds in Preventing Craniofacial Birth Defect in Mice
A new gene-based technique has successfully prevented a rare craniofacial birth defect in mice and holds promise to help children with the same disorder.

Alnylam Reports Pre-clinical Progress with RNAi Therapeutics in Neurological Disease
The new study, performed in collaboration with scientists Xandra Breakefield, Ph.D., Bakhos Tannous, Ph.D., and Jeffrey Hewett, Ph.D., from Massachusetts General Hospital, describes the silencing of a key gene implicated in early onset torsion dystonia, known as mutant torsinA.

New Victories for Adult Stem Cell Research Scientists Make Headway in Treating Damaged Hearts with Muscle, Fat and Bone Marrow Cells
Two studies show encouraging promise in using adult muscle stem cells derived from a patients own thigh tissue to treat advanced heart failure.

Cord Blood Registry Reports a Significant Increase in Number of Children Needing Access to Their Own Cord Blood Stem Cells for Treatment
Cord Blood Registry has announced that for the second year in a row, a record number of cord blood stem cell collections stored at CBR have been needed for medical use by the individual child from whom they were collected.

ACOG Revises Opinion On Cord Blood Banking
Physicians should give balanced information to their pregnant patients who are considering cord blood banking, presenting both the advantages and disadvantages of public vs. private cord blood banks, according to The American College of Obstetricians and Gynecologists in a revised Committee Opinion published today in the February issue of Obstetrics & Gynecology.


Human Embryonic Stem Cell Lines Generated without Embryo Destruction
The researchers report the derivation of five hESC lines without embryo destruction, including one without hESC coculture.

Transplants of Encapsulated Rat Choroid Plexus Cells Exert Neuroprotection in a Rodent Model of Huntington’s Disease
These data demonstrate that transplanted choroid plexus cells can be used to protect striatal neurons from excitotoxic damage and that the pattern of neuroprotection varies across specific neuronal populations.


Cell Therapy Business Development Leader
Portland, OR (Invitrogen)

Irvine, CA (Global Biopharmaceutical Company)

Biomedical Equipment Technician
Los Angeles, CA (Cedars-Sinai Medical Center)

Quality Manager
Singapore (Singapore Cord Blood Bank)


Bush Staff, Tech Titans Split Over Patent Bill
The Bush administration has said that it opposes a key provision of a patent reform bill that has passed the House of Representatives and is awaiting a floor vote in the Senate, taking sides in an intellectual war over how best to promote innovation.

Stem Cell Institute Wants to Make Loans
California’s taxpayer-funded stem cell institute wants to do something a lot of banks won’t: make loans to biotechnology companies with no cash flow, very little collateral and a high risk of failure.

California Stem Cell Institute Gets 50 Applications for Cell Line Funding
CIRM will give as many as 16 awards of up to $25 million for development of new lines of pluripotent human stem cells for research and clinical use to study, diagnose and treat serious injury and disease.

Stem Cells Nudge Closer to Ballot Spot
Campaigns to lift Michigan’s restrictions on embryonic stem-cell research and to scrap much of the state tax system got the go-ahead Monday to begin circulating petitions in an effort to put the issues before voters in November.

United Kingdom Ministers Back Down on Stem Cell Cloning Ban
The Government is to back down from introducing strict curbs on stem-cell experiments after a plea by scientists.

Stott-Despoja Ignites New Stem Cell Row
Australian senator Natasha Stott-Despoja has begun lobbying state MPs to support stem cell research legislation, sparking a political row with opponents of the move.


WaferGen Signs Exclusive Distribution Agreements for SmartSlide(TM) Micro-Incubation System in Australia, Singapore and the Benelux
WaferGen Biosystems, Inc. has announced the signing of exclusive distribution agreements for the company’s SmartSlide Micro-Incubation System with INBIO in Australia, ScienceWerke Pte. Ltd. in Singapore and Westburg B.V. in the Benelux countries.

South Korean Stem Cell Firm Enters Into an Agreement with Tiantan Puhua Hospital in China
RNL Bio entered into an agreement with Tiantan Puhua Hospital for stem cell treatments for complications including spinal cord injury, hair loss and osteoarthritis.

AssureImmune Launches Premier Services in South Florida
AssureImmune LLC, a company specializing in collecting and preserving adult stem cells, today announced its launch of premier banking services in South Florida.

GeneMole “Personal” Automated DNA Extraction System Launched in Europe
Mole Genetics has launched the new GeneMole(R) automated DNA extraction system in Europe following successful trials in the Nordic region.

Geron’s Second U.S. Patent for Production of Pancreatic Islets from Human Embryonic Stem Cells Strengthens Company’s Intellectual Property Position
Geron Corporation has announced that it has received U.S. Patent 7,326,572 with claims covering a widely used method for producing endoderm cells from human embryonic stem cells.

Cohen, Milstein, Hausfeld & Toll, P.L.L.C. Announces Class Action Lawsuit on Behalf of Investors of CellCyte Genetics Corporation
The law firm of Cohen, Milstein, Hausfeld & Toll, P.L.L.C. has announced that it has filed a class action complaint in the United States District Court for the Western District of Washington on behalf of purchasers of CellCyte Genetics Corporation common stock from April 6, 2007 through January 9, 2008, inclusive.

Juvenile Diabetes Foundation to Fund Plureon Research
The Juvenile Diabetes Research Foundation will provide $500,000 over two year to fund research at Plureon Corp. into new treatments for type 1 diabetes.


NIDDK Welcomes Four New Members to Advisory Council
Health and Human Services Secretary Mike Leavitt appointed four new members to the Advisory Council of the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), the institute announced today. NIDDK is part of the National Institutes of Health (NIH) of the U.S. Department of Health and Human Services.

Notice of Change in Receipt Date and NIBIB Contact Person on TPA-06-504, Enabling Technologies for Tissue Engineering and Regenerative Medicine (NOT-EB-08-001)

Rare Diseases Clinical Research Consortia (RDCRC) for the Rare Diseases Clinical Research Network (U54) (RFA-OD-08-001)


Licensed Products and Establishments List – Update

Approved Biological NDA and ANDA Applications – Update

Clinical Hold/Refusal to File Meetings – 2008 Schedule

Eligibility Determination for Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)

HCT/P Compliance Update



FDA Budget Seeks Biotech Generics and User Fees
New fees for the Food and Drug Administration to speed review of generic pharmaceuticals and new authority to approve copycat versions of some biotech drugs were proposed in President George W. Bush’s budget.


14th ISCT Annual Meeting

May 17-20, 2008
Downtown Miami, Florida

Full details at: http://www.celltherapysociety.org

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