Volume 8.45 | Nov 19

Volume 8.45, November 19, 2007
     In this issue: Science | Policy | Business | NIH | CBER | Regulatory
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Top Stories

Oregon Health & Science University Scientists First To Successfully Create Primate Embryonic Stem Cells: For the first time, scientists have successfully derived embryonic stem cells by reprogramming of genetic material from skin cells while studying rhesus macaque monkeys.
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Science

Transplantation of Pancreatic Islets into the Kidney Capsule of Diabetic Mice – VIDEO
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Creating Indestructible Insulin-producing Cells
Scientists at the Garvan Institute of Medical Research now have further support in their quest to create indestructible insulin-producing cells for transplant into people with Type 1 diabetes.
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Cells Discarded From Womb Lining During A Woman’s Period Are New Type Of Stem Cell
The cells which thicken the womb wall during a woman’s menstrual cycle contain a newly discovered type of stem cell, and could be used in the treatment of damaged and/or old tissue, according to new research.
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Journal of Neuroimmunology Publishes Study Results Showing That Geron’s Human Embryonic Stem Cell-Based Therapeutic for Spinal Cord Injury Evades Direct Attack by the Human Immune System
Geron Corporation has announced the publication of study results showing that GRNOPC1, the company’s human embryonic stem cell-based therapeutic for the treatment of spinal cord injury, evades direct attack by the human immune system in vitro.
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Study Assays Marrow Transplant Troubles
Bone marrow transplants are one of cancer care’s striking successes, but they have a dark side: The transplanted cells can turn on patients, attacking their skin and organs.
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The Next Generation of Artificial Kidneys
Nanotechnology – precision tooling at the micro-molecular level – is being used to create the next generation of artificial kidneys, ones that would be small enough to be implanted and engineered to more closely simulate the function of human kidneys than current equipment.
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Imaging Stem Cell Division Helps Identify Cancer Treatment Targets
Using a novel method for seeing the division of stem cells in real time, Duke University Medical Center researchers believe they have identified an unexpected way to interfere with the uncontrolled cell growth that is characteristic of cancer.
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Regenetech Initiates Preclinical Studies at Johns Hopkins University with Expanded Adult Stem Cells for Type 1 Diabetes Treatment
Regenetech(R), Inc. announces that it has signed a Sponsored Research Agreement with Johns Hopkins University in order to work toward a treatment for type 1 diabetes.
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Cell Transplants May Improve Severe Urinary Incontinence
Researchers have now discovered that when skeletal myoblasts – progenitor muscle cells with the potential to develop into muscle fiber – were transplanted into female rats suffering from urethral sphincter deficiency, the transplanted muscle cells helped increase urethral pressure, improving incontinence.
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Scientists Produce Cancer Vaccine from Tumour Cells
Scientists have found a way of producing a potent cancer vaccine which could be manufactured from a patient’s own cancer cells and used to treat their tumour.
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South Koreans Use Human Embryonic Stem Cells in Experiment
South Korean scientists have announced that they used human embryonic stem cells to treat mice suffering from a vascular disease, in an experiment that could lead to cures for strokes and other ailments.
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Ukraine Vets Pioneer Stem Cell Cure for Dogs
Veterinary scientists in Ukraine are claiming a medical breakthrough. For the first time ever, they’ve used stem cells extracted from canine liver to cure diseases in dogs.
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Treating Animals Without Steroids
The pioneering use of stem cells to treat injuries in horses will be extended so that camels and even falcons can benefit as well, experts have said. Dubai’s Central Veterinary Research Laboratory has teamed up with California-based company Vet-Stem to offer the technique in the Middle East.
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Researcher Says Targeted Genetics Drug Not to Blame in Death
Recent tests run by University of Chicago scientists points to the innocence of Targeted Genetics’ gene therapy for inflammatory arthritis in last summer’s death of an Illinois woman in a clinical trial, one of the university researchers said.
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Cord Blood Bank Could Solve Transplant Problems
A bone and marrow transplant specialist at a Toronto children’s hospital says for every three successful transplants performed, one patient on the waiting list dies for lack of an appropriate match — a problem that could be helped if Canada had a national cord blood bank.
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AMA Recommends Public Cord Blood Banks
The nation’s largest doctors’ group this week adopted new ethical guidelines for how physicians should talk to pregnant patients about donating their babies’ umbilical cord blood.
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Technology Strategy Board – Cell Therapy Autumn 2007 Competition for Funding
The Technology Strategy Board has allocated an indicative amount of £10 million to fund highly innovative collaborative research proposals in Cell Therapy.
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ABSTRACTS, REVIEWS AND SPECIAL REPORTS

Developmental Study of Fragile X Syndrome Using Human Embryonic Stem Cells Derived from Preimplantation Genetically Diagnosed Embryos
A human embryonic stem cell line has been isolated from a fragile X affected embryo, providing a unique source of adequate material for the study of the molecular processes underlying the syndrome. Analysis of early events in FMR1 inactivation reveals that silencing is differentiation dependent, in that the mutated FMR1 gene remains active in undifferentiated hESCs.
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JOB OPPORTUNITIES

Clinical Development Research Associate
Poway, California (VetStem)
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Islet Cell Associate Research Director
Irvine, CA (University of California, Irvine)
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Cell Therapeutics Supervisor
Philadelphia, PA (AppTec)
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Postdoc Fellow
Sweden (Wallenberg Neuro Center Neuronal Survival Unit)
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Manager, Manufacturing
Memphis, TN (Cognate Bioservices)
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Policy

World at a Cloning Crossroads, U.N. Study Says
The world faces a stark choice between banning cloning of humans or preparing ways to protect them from potential abuse or discrimination, a U.N. study has said.
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Vietnam Ready to Research Stem Cells
The government has approved an initial US$2.48 million budget to build the country’s top lab for stem cell research under the HCMC University of Natural Sciences.
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Nebraska Lawmakers to Tackle Stem Cell Research Controversy
The Nebraska Legislature’s Judiciary Committee is holding a hearing today in Lincoln on stem cell research and human cloning.
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New Jersey Panel Delays Vote on Two Stem Cell Labs
The drive to build a statewide stem cell research network stumbled again when the state Economic Development Authority postponed a vote on funding for proposed labs in Newark and Camden yesterday.
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Business

Invitrogen and CytRx Subsidiary RXi Pharmaceuticals Collaborate to Enhance RNAi Technologies for Therapeutic Applications
Invitrogen Corporation and CytRx Corporation’s majority-owned subsidiary RXi Pharmaceuticals Corporation have announced that they have entered into an agreement whereby RXi will exclusively license second generation RNA interference technology from Invitrogen for designated target genes in all human therapeutic categories.
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Regeneration Technologies, Tutogen Medical Announce Agreement to Merge
Regeneration Technologies, Inc. and Tutogen Medical, Inc. have announced that the boards of directors of both companies have unanimously approved a definitive agreement to combine the two companies in a tax-free, stock-for-stock exchange.
Article

Nastech Pharmaceutical Company to Establish Subsidiary, MDRNA, as an Independent Company to Focus on the Development of RNA-Based Therapeutics
Nastech Pharmaceutical Company Inc. has announced that the Board of Directors has approved the recommendation of its Special Committee to move forward with the process of establishing Nastech’s wholly-owned subsidiary, MDRNA, Inc., as an independent company. Nastech is transferring its intellectual property and agreements related to RNA interference into MDRNA.
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Pluristem Completes Construction of Its New GMP Facilities to Support Production for Clinical Trials
Pluristem Life Systems, Inc. has announced that it has completed the construction of its new state-of-the-art GMP facilities which are designed to support the manufacturing process of the Company’s PLX-I cells for the upcoming Phase I clinical trials, in which PLX-I will be used with cord blood as an alternative to bone marrow transplantation. Additionally, these facilities will be sufficient to enable large-scale commercial production of PLX cells.
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Concern Over Menstrual Blood Bank
Experts have expressed concern over the launch by a US company of a service for women to store their own menstrual blood.
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Patent on Technology for the Delivery of Stem Cells to the Human Heart Issued to CellCyte Genetics Corp. of Washington
CellCyte Genetics Corporation has announced that is has received notice of the issuance of a U.S. patent (U.S. Patent No. 7,282,222) for its unique methods and compositions approach to deliver and direct stem cells to target organs in the body.
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Stem Cell Leader Beike Biotech And China’s Tsinghua University Receive USD $4 Million For Stem Cell Reprogramming Laboratory
Beike Biotechnology has announced that it has formally established a world-class laboratory facility for the research of cell reprogramming and gene engineering, through a joint agreement with the Shenzhen Graduate School of China’s renowned Tsinghua University.
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ImmunoCellular Therapeutics Names Interim President, Files Key Patent Applications
ImmunoCellular Therapeutics, Ltd. has announced that it has named C. Kirk Peacock to serve as its Interim President. Mr. Peacock, who has served on a part-time basis as IMUC’s Chief Financial Officer since January 2006, will also now serve as IMUC’s Interim President on a part-time basis.
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NIH

NIH Director’s Pioneer and New Innovator Award Programs Launch 2008 Application Cycles
The National Institutes of Health (NIH) is calling for applications for 2008 NIH Director’s Pioneer and New Innovator Awards. Both programs support exceptionally creative scientists who take highly innovative – and often unconventional – approaches to major challenges in biomedical or behavioral research.
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Guidance on New Law (Public Law 110-85) Enacted to Expand the Scope of ClinicalTrials.gov: Registration (NOT-OD-08-014)
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Change of NIGMS MBRS Support of Competitive Research (SCORE) Program to Electronic Submission and Standard Receipt Dates (NOT-OD-08-115)
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NIGMS Will Discontinue Support of SCORE Institutional Development Award (S06) (NOT-GM-08-114)
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Availability of Administrative Supplements to NIGMS MBRS-Research Initiative for Scientific Enhancement (RISE) and MBRS-Initiative for Maximizing Student Diversity (IMSD) Programs (NOT-GM-08-116)
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Technology Development for Biomedical Applications (R21) (RFA-RR-08-001)
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Support of Competitive Research (SCORE) Research Advancement Award (SC1) (PAR-08-026)
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Support of Competitive Research (SCORE) Pilot Project Award (SC2) (PAR-08-027)
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CBER

Electronic Human Cell and Tissue Establishment Registration (eHCTERS) Instructions – Updated
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Draft Guidance for FDA Advisory Committee Members and FDA Staff: Voting Procedures for Advisory Committee Meetings
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Regulatory

FOOD AND DRUG ADMINISTRATION (United States of America)

FDA Announces Steps to Improve Advisory Committee Processes
The Food and Drug Administration is announcing several steps to strengthen its advisory committee processes in ways consistent with recommendations of the Institute of Medicine.
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MEDICINES AND HEALTHCARE PRODUCTS REGULATORY AGENCY (United Kingdom)

Department of Health and MHRA Register of Licensed Manufacturing Sites (Human Veterinary and Combined Sites) 2007
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ISCT

WEBINAR

ISCT is proud to present: “Overview of GCP for Cell Therapy”

Date: Wednesday November 28th, 2007
Time: 12pm ET – 1pm ET

Registration Rates (Nov 17th – Nov 26th)
ISCT Member     $90        
Non-Member      $105       

Please visit www.celltherapysociety.org for more information



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