Volume 10.02 | Jan 26

Cell Therapy News 10.02, January 26, 2009
     In this issue: Science | Policy | Business | NIH | CBER | Regulatory
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Top Stories

Geron Receives FDA Clearance to Begin World’s First Human Clinical Trial of Embryonic Stem Cell-Based Therapy: Geron Corporation announced recently that the U.S. Food and Drug Administration has granted clearance of the company’s Investigational New Drug application for the clinical trial of GRNOPC1 in patients with acute spinal cord injury.
Article

Science

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Biologists at Tufts University Discover Link Between CGG Repeats and DNA Damage
Scientists at Tufts University have found that repetitive DNA sequences are associated with hereditary neurological disorders such as fragile X syndrome and FRAXE mental impairment.
Article

Special Nanotubes May Be Used as a Vehicle for Treating Neurodegenerative Disorders
Electrical engineering researchers at the University of Arkansas have demonstrated that magnetic nanotubes combined with nerve growth factor can enable specific cells to differentiate into neurons.
Article

Large DNA Stretches, Not Single Genes, Shut Off as Cells Mature
Experiments at Johns Hopkins have found that the gradual maturing of embryonic cells into cells as varied as brain, liver and immune system cells is apparently due to the shut off of several genes at once rather than in individual smatterings as previous studies have implied.
Article

Novel Cell Lines Propel the Search for Safer Stem Cell Induction
Whitehead Institute researchers have reliably produced mice and mouse cell lines with identical configurations of the specific factors needed to reprogram adult cells to an embryonic-stem-cell-like state.
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Mesoblast Stem Cells Approved for World First Osteoarthritis Clinical Trial
Mesoblast Limited recently announced that it had received Australian institutional ethics approval to begin the first human trial of adult stem cell treatment for prevention of knee osteoarthritis after an acute traumatic knee injury.
Article

Stem Cell Treatment Could Fight Aids
Results of a preliminary trial involving isolating genes which curb the spread of HIV inside the body, introducing the genes into human stem cells in a laboratory, then transplanting the stem cells into a patient’s bone marrow have raised hopes for people suffering from Aids.
Article

ReNeuron Gains UK Regulatory Approval to Start Ground-breaking Clinical Trial with Stem Cell Therapy for Stroke
ReNeuron Group plc recently announced that it has received approval from the UK Medicines and Healthcare Products Regulatory Agency to commence a first-in-man clinical trial for the treatment of patients who have been left disabled by an ischaemic stroke, the most common form of the condition.
Article

VIDEO: Embryonic Stem Cell-Derived Endothelial Cells for Treatment of Hindlimb Ischemia
The surgical procedure for delivery of embryonic stem cell-derived endothelial cells to the ischemic hindlimb is demonstrated, with non-invasive tracking by bioluminescence imaging.
Article

ABSTRACTS, REVIEWS AND SPECIAL REPORTS

Proteomic Characterisation of the Conditioned Media Produced by the Visceral Endoderm-like Cell Lines HepG2 and End2: Towards a Defined Medium for the Osteogenic/Chondrogenic Differentiation of Embryonic Stem Cells
This study utilized the conditioned media from the visceral endoderm-like cell lines, HepG2 and END2, to enhance lineage-specific differentiation of murine ESCs towards the osteogenic lineage.
Article

A Method for Isolating Pluripotent/Multi-potent Stem Cells from Blood by Using the Pluripotent and Germ-line DAZL Gene as a Marker
The researchers have shown for the first time that pluripotent/multi-potent stem cells can be isolated from blood in a relatively simple cell separation, which is fast and compatible with current standards.
Article

Reductive Isolation from Bone Marrow and Blood Implicates Common Lymphoid Progenitors as the Major Source of Thymopoiesis
Here the researchers took a comprehensive approach to prospectively identify the major source of thymocyte progenitors that reside within the BM and blood, and find that all thymocyte progenitor activity resides within a rare Flk2+CD27+ population.
Article

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Policy

VIDEO: Green Light for US Stem Cell Work
US regulators have cleared the way for the world’s first study on human embryonic stem cell therapy.
Article

Lifting Stem Cell Funding Restrictions by Executive Order is Inadequate According to the Genetics Policy Institute
Lifting the funding restrictions by presidential executive order is an inadequate remedy to fully realize the potential of embryonic stem cell research targeting cures.
Article

Obama Lifts Ban on Abortion Funds
President Obama signed an executive order Friday striking down a rule that prohibits U.S. money from funding international family-planning clinics that promote abortion or provide counseling or referrals about abortion services.
Article

Business

PerkinElmer ViaCord Research Institute to Support Diabetes Research Efforts at University of Massachusetts Medical School
PerkinElmer, Inc. recently announced that its ViaCord Research Institute will support the University of Massachusetts Medical School in its research efforts into the potential use of umbilical cord blood-derived stem cells in treating type 1 diabetes.
Article

ALS TDI and Asklepios to Develop New Therapeutic Delivery Options for Treating Lou Gehrig’s Disease
ALS Therapy Development Institute and Asklepios BioPharmaceutical, Inc. announced recently their collaboration aimed at developing a panel of viral vectors that could be used to deliver therapeutics based on targets identified by ALS TDI that slow or stop amyotrophic lateral sclerosis.
Article

PerkinElmer ViaCord Research Institute and M. D. Anderson Cancer Center Extend Collaboration to Study Cord Blood Stem Expansion System in Adult Transplantation
PerkinElmer, Inc. recently announced the extension of a research collaboration between its ViaCord Research Institute and The University of Texas M.D. Anderson Cancer Center.
Article

HHS Awards $487 Million Contract to Build First U.S. Manufacturing Facility for Cell-Based Influenza Vaccine
The U.S. Department of Health and Human Services recently announced a $487 million multiple year contract with Novartis Vaccines and Diagnostics, Inc., to build the first U.S. facility to manufacture cell-based vaccine for seasonal and pandemic flu.
Article

BioE Receives FDA 510(K) Clearance for Cord Blood Processing System
BioE Inc. announced recently it received 510(k) clearance from the U.S. Food and Drug Administration for its PrepaCyte-CB Processing System for umbilical cord blood.
Article

TAP Launches Automated Stem Cell Picker at Stem Cells World Congress
The Automation Partnership recently announced CellCelector, the first commercial automated stem cell picker.
Article

Lucky Fellows
Joann O’Connor faced a problem seen by many new graduates – she was looking for a job, but no one would hire her without industry experience…
Article

Stem Cell Innovations, Inc., Files New Patent Application
Stem Cell Innovations, Inc. announced recently that it has filed a new patent application for the production of pluripotent stem cells from primordial germ cells.
Article

NIH

CHI Submits Letter to Congress Urging Increased Funding for NIH
In a letter to Speaker of the House Nancy Pelosi, signed by business and academic leaders in California, the California Healthcare Institute supported the inclusion of increased funding for the National Institutes of Health in the economic stimulus package currently under discussion.
Article

NIH Policy Concerning Career Development (K) Awards: Leave, Temporary Adjustments to Percent Effort, and Part-Time Institutional Appointments
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Independent Scientist Award (K02)
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Mentored Research Scientist Research Career Development Award (K01)
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CBER

Animal Models – Essential Elements to Address Efficacy Under the Animal Rule
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Guidance for Clinical Investigators, Sponsors, and IRBs Adverse Event Reporting to IRBs Improving Human Subject Protection
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Draft Guidance for Industry: Current Good Tissue Practice (CGTP) and Additional Requirements for Manufacturers of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)
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FEDERAL REGISTER: Draft Guidance for Industry: Current Good Tissue Practice (CGTP) and Additional Requirements for Manufacturers of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps); Availability
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SOPP 8006: Resolution of Differences in Scientific Judgment in the Review Process – Update
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Regulatory

FOOD AND DRUG ADMINISTRATION (United States)

Viewpoint: A Message from the Acting FDA Commissioner
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The FDA this Week: Andy’s Take — Farewell
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Draft Guidance for Industry on Animal Models: Essential Elements to Address Efficacy Under the Animal Rule , 3610–3611 [E9–936]
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Final Guidance for Sponsors, Industry, Researchers, Investigators, and Food and Drug Administration Staff: Certifications to Accompany Drug, Biological Product, and Device Applications/Submissions; Compliance, etc. , 3614–3615 [E9–1183]
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MEDICINES AND HEALTHCARE PRODUCTS REGULATORY AGENCY (United Kingdom)

Alert: Impersonation of MHRA staff
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What’s New in GLP
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THERAPEUTICS GOODS ADMINISTRATION (Australia)

Conformity Assessment Bodies (CABs) Approved to Undertake Assessments to Australian Requirements (Updated)
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Consultation on European Union Guidelines in Australia (6 for Adoption, 2 for Non-adoption)
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