Cell Therapy News Volume 8.12 | Apr 2 2007

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    Volume 8.12, April 2, 2007
         In this issue: Science | Policy | Business | NIH | CBER | Regulatory
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    Top Stories

    Dendreon Announces FDA Advisory Committee Reviewed Provenge(R) for Hormone Refractory Prostate Cancer: Dendreon Corporation has announced that the U.S. Food and Drug Administration’s (FDA) Office of Cellular, Tissue and Gene Therapies Advisory Committee recommended to the FDA that there is substantial evidence of efficacy and safety of PROVENGE (sipuleucel-T) for the treatment of patients with asymptomatic, metastatic, androgen-independent (also known as hormone refractory) prostate cancer.
    Article

    Osiris Therapeutics Announces Positive Results in Groundbreaking Stem Cell Trial to Treat Heart Disease: Intravenous therapy resulted in statistically significant improvement over placebo in multiple safety and efficacy endpoints.
    Article

    Science

    Dental Enamel Grown From Cultured Cells
    A Japanese team say’s they’ve used cultured cells to grow new tooth enamel.
    Article

    Engineering the Heart Piece by Piece
    University of Michigan scientists see great promise in cardiac tissue engineering, but hurdles remain before lab-grown muscle is ready for patients
    Article

    Ultrathin Films Deliver DNA as Possible Gene Therapy Tool
    Researchers have created ultrathin, nanoscale films composed of DNA and water-soluble polymers that allow controlled release of DNA from surfaces.
    Article

    DNA Layer Reduces Risk Of Reserve Parts Being Rejected
    Dutch researchers have given body implants a DNA layer that ensures a better attachment, more rapid recovery of the surrounding tissue and less immune responses.
    Article

    Immune Response to Cancer Stem Cells May Dictate Cancer’s Course
    A new study by Rockefeller University scientists shows that immunity to cancer stem cells may help protect people with a precancerous condition from developing the full-blown disease, and that these cells could be an important target for cancer vaccines.
    Article

    Hopkins Researchers Develop Novel X-Ray System for Tracking the Delivery and Distribution of Stem Cells
    In a first of its kind study, researchers at Johns Hopkins Medicine have developed a new technique that transports therapeutic stem cells in a multilayer microcapsule that not only protects the cells from being attacked by the body’s immune system but also enables them to be seen on X-ray.
    Article

    Stem Cell Therapy Shows Promise for Rescuing Deteriorating Vision
    In a study in rats, neural progenitor cells derived from human fetal stem cells have been shown to protect the vision of animals with degenerative eye disease similar to the kinds of diseases that afflict humans.
    Article

    FDA Submission Filed for Clinical Trial of Stem Cells in Heart Attack Patients
    Australia’s adult stem cell company, Mesoblast Limited has announced that its US-based sister company, Angioblast Systems Inc., had filed an Investigational New Drug (IND) submission to the US Food and Drug Administration (FDA) to commence a Phase 2 clinical trial of its allogeneic, or ‘off-the- shelf’, adult stem cells in patients with heart attacks.
    Article

    University of Alabama at Birmingham to Lead Pioneering Cancer Trial
    Ovarian cancer patients in the study to be treated with a tumor-killing virus.
    Article

    Stem Cell Technique Speeds Liver Regeneration
    Using adult bone marrow stem cells, scientists say they have been able to regenerate human liver tissue.
    Article

    Muscle Stem Cells May Offer A New Treatment Option For Congestive Heart Failure
    Scientists have performed the first U.S. controlled, randomized Phase I clinical trial using a three-dimensional guided catheter system to deliver muscular stem cells to the heart.
    Article

    Dolly Cloner Offers Sad Tale
    Ian Wilmut, in Hartford for the StemCONN 07 international stem cell conference, talked about why over the last 10 years he and other scientists have not been able to accomplish the same feat with human cells.
    Article

    Korean Team Claims to Have Cloned Wolves
    A Seoul National University team has said that it successfully cloned two female wolves in October 2005 for the first time in the world.
    Article

    Thinking Outside the Egg, Scientists Propose Interspecies Cloning
    At least three respected teams of British scientists have reignited the moral debate over inserting human genes into animal eggs by proposing similar experiments to Cibelli’s.
    Article

    University of Florida Launches Project to Bridge ‘Regeneration’ Gap
    Researchers at the McKnight Brain Institute of the University of Florida have initiated a project to treat human brain and other diseases by plundering the secrets of regeneration from creatures with remarkable powers of self-renewal, such as salamanders, newts, starfish and flatworms.
    Article

    ABSTRACTS, REVIEWS AND SPECIAL REPORTS

    Clinical Xenotransplantation of Organs: Why Aren’t We There Yet?
    This article discusses the history, current status, and challenges of xenotransplanation.
    Abstract

    Policy

    More Institutions Developing Stem Cell Research Ethics Oversight, Survey Shows
    In the first attempt to track ethical oversight activity among U.S. research institutions engaged in human embryonic stem cell research, a survey done by UConn’s Office of Embryonic Stem Cell Research Oversight (ESCRO) finds that a majority have, or plan to establish, special ethics review panels for this research.
    Article

    EU to Register Human Embryonic Stem Cell Lines
    The European Commission has agreed on funding for the creation of a European registry for human embryonic stem cell lines.
    Article

    Ban on Private Cord Blood Centres in Dubai Likely
    “Two private cord blood centres were recently shut down by the Department of Health and Medical Services as part of the government’s plan to ban all such centres operating in the country,” said an official, adding that other such centres will also face the axe soon.
    Article

    New Australian Cloning Laws ‘Stem the Brain Drain’
    Australia’s new therapeutic cloning laws will help stem the brain drain of top scientists heading overseas, one of the nation’s top legal ethicists says.
    Article

    Missouri House Committee Advances Anti-stem Cell Measure
    Opponents of embryonic stem cell research Tuesday forced through a House committee a proposed constitutional change that would undo research protections, seizing an opportunity when a supporter of embryonic research was absent.
    Article

    Governor Wants End to Curb on Stem Cells in Boston
    Governor Deval Patrick will announce this morning that he wants the Department of Public Health to reverse restrictions on stem cell research imposed by his predecessor, according to an administration official with direct knowledge of the governor’s intentions.
    Article

    Competing Stem Cell Bills Get Committee Pass in Florida
    A Senate panel rushed for time passed two contradictory stem cell bills Tuesday that would alternately prohibit and allow $20 million in state funding to be used for embryonic stem cell research.
    Article

    Business

    Oxford BioMedica, Sanofi-Aventis Enter Development Agreement for Cancer Treatment
    Oxford BioMedica PLC, a developer of gene therapy treatments, and drugmaker Sanofi-Aventis SA have said they have agreed to jointly develop and market the cancer treatment TroVax.
    Article

    Stemagen, UPenn Partner to Advance Therapeutic Use of Stem Cells
    Stemagen has acquired the exclusive rights to a patent for a groundbreaking technique that allows the development of embryonic stem cells appearing to have a markedly enhanced potential for therapeutic use – uniparental embryonic stem cells.
    Article

    Alnylam Grants Bio-Rad License to Kreutzer-Limmer Patents for the RNA Interference (RNAi) Research Products Market
    Alnylam Pharmaceuticals, Inc. has announced that it has granted Bio-Rad a non-exclusive license to provide RNAi research products under the Kreutzer-Limmer patent family. This patent family, owned exclusively by Alnylam, covers small interfering RNAs (siRNAs) and their use to mediate RNAi in mammalian cells.
    Article

    Plureon Corporation Receives NIH Grant
    Plureon Corporation has announced it has been awarded a grant by the National Institute of Diabetes & Digestive & Kidney Diseases of the National Institutes of Health to advance the company’s platform stem cell technology in the field of diabetes. The grant provides $1 million in funding over a two-year period and may be extended after that for a total of up to $4 million.
    Article

    Pluristem Upgrading Its Manufacturing Facility to Support $200 Million in Production Capacity for PLX – I
    The additional 6,900 square foot will double in size the Company’s facilities and is expected to be ready this summer. This facility will manufacture PLX-I, the Company’s introductory product to address the bone marrow transplant market, for Phase I clinical trials and large scale commercial production.
    Article

    NIH

    Notice of Extension for Request for Information (RFI): Tools and Resources for Human Embryonic Stem Cell Research in the Nervous System (Neuroscience Blueprint) (NOT-DC-07-002)
    Link

    Notice of Clarification of Application Instructions for NIH Director’s New Innovator Award (DP2) (NOT-RM-07-007)
    Link

    Notice of NCRR’s intent to withdraw from Development of Nonmammalian Models and Related Biological Materials for Research (R21) (NOT-RR-07-008)
    Link

    Innovations in Biomedical Computational Science and Technology (R01) (PAR-07-344)
    Link

    CBER

    Biological Product and HCT/P Deviation Reports – Annual Summary for FY2006
    Link

    All new CBER information can be reached from the What’s New page at What’s New Page

    Regulatory

    FOOD AND DRUG ADMINISTRATION (Untited States of America)

    Agency Information Collection Activities; Proposed Collection; Comment Request; Focus Groups as Used by the Food and Drug Administration
    Link

    Industry Exchange Workshop on Food and Drug Administration Clinical Trial Requirements; Public Workshop
    Link

    AUSTRALIA NEW ZEALAND THERAPEUTIC PRODUCTS AUTHORITY (Australia and New Zealand)

    Consultation Paper on the Proposed Clinical Trial Regulatory Arrangements Under ANZTPA
    Link

    ISCT

    ISCT 2007-Register Now!
    13th ISCT Annual Meeting
    June 24-27, 2007
    Sydney, Australia

    Early Registration Deadline: April 4

    Register by clicking here.
    View the Program at a Glance by clicking here.

    ISCT Membership
    Renew your ISCT Membership for 2007 now!
    Not a member?  Visit the ISCT website to learn about the benefits of membership.
    Link


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