Volume 9.30 | Aug 4

Cell Therapy News 9.30, August 4, 2008
     In this issue: Science | Policy | Business | NIH | CBER | Regulatory
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Top Stories

New Key to Understanding and Treating ALS, and a Step Toward Personalized Regenerative Medicine: Harvard and Columbia scientists have for the first time used a new technique to transform an amyotrophic lateral sclerosis, or Lou Gehrig’s disease patient’s skin cells into motor neurons, a process that may be used in the future to create tailor-made cells to treat the debilitating disease.
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Science

The TriMark Molecular Diagnostics Conference 2008
October 6, 2008  |  New York, New York
Enter “CONNEXON” at checkout and receive 10% off registration.
Click here to register today.

Mature Cells Regress to Stem Cells
Researchers have found that mature, specialized cells naturally regress to serve as a kind of de facto stem cell during the fruit-fly life cycle.
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Cranking Out Healthy Platelets
Japanese researchers have produced a plethora of platelets by picking perfect stem cell progenitors and preventing shearing of the platelets’ activating receptors.
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Silence Therapeutics to Receive $1.9m Milestone Payment as Pfizer and Quark Commence Phase II Trial
Silence Therapeutics plc recently announced that its partner, Quark Pharmaceuticals Inc together with Pfizer, has commenced a Phase II clinical trial with RTP-801i-14 (PF-4523655), a small interfering RNA therapeutic product based on Silence’s AtuRNAi technology.
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Mini-Microscope Could Lead to Cell-Sorting Implants
Researchers hope that a new kind of small portable microscope may give health workers the ability to quickly and cheaply scan blood for tumor cells and life-threatening parasites.
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Osteotech’s Plexur M(TM) Biocomposite Receives FDA Clearance in Spine
Osteotech, Inc. announced recently that the United States Food and Drug Administration has cleared its 510(k) submission for Plexur M(TM) Biocomposite for use in spinal applications.
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ABSTRACTS, REVIEWS AND SPECIAL REPORTS

Regulation of ES Cell Self Renewal and Pluripotency by Foxd3
In this study, researchers derive ES cell lines from blastocysts that carried two conditional Foxd3 alleles and a tamoxifen-inducible Cre transgene to aid in the understanding of the Foxd3 transcription factor in ES cell maintenance.
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Hepatic Microenvironment Programs Hematopoietic Progenitor Differentiation into Regulatory Dendritic Cells Maintaining Liver Tolerance
Here the researchers used liver fibroblastic stromal cells to mimic the liver microenvironment and found that liver stroma could induce Lin-CD117+ progenitors to differentiate into dendritic cells with low CD11c, MHC II but high CD11b expression, high IL-10 but low IL-12 secretion.
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JOB OPPORTUNITIES

Cellular Therapy Laboratory Manager
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GMP Facility Quality Assurance
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Policy

Stanford, California Institute for Regenerative Medicine May Stop Research On Some Fed-Approved Stem Cell Lines
Stanford University and the California Institute for Regenerative Medicine are considering stopping research on some of the 21 human stem cell lines approved to receive federal funding because of potential ethical problems about the line’s creation.
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Michigan Board Sets Hearing To Decide if Measure Loosening Stem Cell Research Restrictions Will Be on Ballot
Supporters of more embryonic stem cell research and sweeping changes to Michigan government will know next month whether they collected enough valid voter signatures for the November ballot.
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South Korea Rejects Disgraced Clone Scientist’s License
The South Korean government on Friday barred disgraced scientist Hwang Woo-suk from resuming his research into cloned human embryonic stem cells.
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Business

ALS Therapy Development Institute and California Stem Cell, Inc. Announce Long-Term Scientific Collaboration
ALS Therapy Development Institute and California Stem Cell, Inc announced recently a new collaboration aimed at advancing any potential application of stem cells in treating ALS – amyotrophic lateral sclerosis, commonly known as Lou Gehrig’s diseases.
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Genentech Forms Special Committee of Independent Directors to Review Roche Proposal
Genentech, Inc. announced recently that it has formed a special committee of its Board of Directors, composed of the company’s three independent directors, to assess the proposal from Roche to acquire all of the outstanding shares of Genentech stock not owned by Roche at a price of $89.00 in cash per share.
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Invitrogen Licenses Stem Cell Line from Buck Institute
Invitrogen Corporation has licensed an engineered stem cell line from the Buck Institute for Age Research. The stem cell line is used in the study of neural cells in neurodegenerative disease.
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WaferGen, Inc. Signs Exclusive Distribution Agreements for SmartSlide(TM) Micro-Incubation System in Switzerland, Taiwan and the Nordic Region
WaferGen Biosystems, Inc. recently announced the signing of exclusive distribution agreements for the company’s SmartSlide Micro-Incubation System with Bucher Biotec AG in Switzerland, Unimed Healthcare Inc. in Taiwan and AH diagnostics AS in the Nordic region.
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Nucleonics Inc. Seeks Buyers For RNAi Assets
Nucleonics is seeking a buyer for its assets after being unable to raise additional financing from private investors.
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Building the Bionic Body
UNSW’s Faculty of Engineering has launched a world-class research facility focused on the development of a new generation of implantable bionic devices for the human body.
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New Venture Capitalist Fund Aims for Dozen Stem Cell Firms
A $225 million venture fund – the first exclusively aimed at emerging stem cell companies – looks to line up its lead investors by the end of the year, possibly by the end of September.
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Osiris Therapeutics Appoints Chief Financial Officer
Osiris Therapeutics, Inc. announced recently the appointment of Richard W. Hunt as Chief Financial Officer effective July 23, 2008.
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CEO of The Australian Stem Cell Centre Replaced Over Conflicting Views
The Australian Stem Cell Centre recently announced the departure of the Chief Executive Officer, Professor Stephen Livesey.
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The Esteemed Dr. Brian Annex Accepts Pluristem’s Invitation to Join its Scientific Advisory Board
Pluristem Therapeutics Inc. announced recently that Brian H. Annex, MD has accepted an appointment to the Company’s Scientific Advisory Board.
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NIH

Limited Competition for the Biomedical Informatics Research Network Community Service Award (U24)
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Reminders Regarding Inclusion of Special Features in Grant Applications (NOT-OD-08-095)
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Announcing the Availability of the Application Guide for the Pilot Transition from PureEdge to Adobe-based SF424 (R&R) Grant Application Forms (RFA-AI-08-020, RFA-DE-09-001 and RFA-DE-09-002)(NOT-OD-08-098)
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Ruth L. Kirschstein National Research Service Award (NRSA) Institutional Research Training Grants (T32)(PA-08-226)
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Ruth L. Kirschstein National Research Service Award Short-Term Institutional Research Training Grants (T35)(PA-08-227)
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Fogarty International Research Collaboration – Basic Biomedical (FIRCA-BB) Research Award (R03)(PAR-08-222)
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CBER

Draft Guidance for Industry: Nucleic Acid Testing (NAT) to Reduce the Possible Risk of Parvovirus B19 Transmission by Plasma-Derived Products
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Impact of Severe Weather Conditions on Biological Products
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Regulatory

FOOD AND DRUG ADMINISTRATION (United States)

Blood Products Advisory Committee; Notice of Meeting
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Grassley, Dingell Lead Calls For Overhauling FDA
Powerful members of Congress want to remake the Food and Drug Administration by giving it broad powers to levy fines, order drug recalls and restrict drug-industry advertising.
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MEDICINES AND HEALTHCARE PRODUCTS REGULATORY AGENCY (United Kingdom)

Public Consultation (MLX 353): Consultation on Advanced Therapy Medicinal Products
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