Volume 9.40 | Oct 13

Cell Therapy News 9.40, October 13, 2008
     In this issue: Science | Policy | Business | NIH | CBER | Regulatory
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Top Stories

Testicle Stem Cells Become Bone, Muscle in German Experiments: Stem cells were isolated from the testicles of adult men and turned into bone, muscle, neural and other kinds of cells, German researchers said.
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Science

New Method Generates Stem Cells Safely from Mice
Shinya Yamanaka of Kyoto University in Japan and colleagues invented a new way to transform ordinary cells into embryonic-like stem cells called iPS cells, using a ring of genetic material called a plasmid.
Article

Newly Identified Cells Make Fat
Scientists at the Howard Hughes Medical Institute and Rockefeller University have discovered an important fat precursor cell that may in time explain how changes in the numbers of fat cells might increase and lead to obesity.
Article

Study Unlocks Stem Cell, DNA Secrets to Speed Therapies
Florida State University researchers have discovered that as embryonic stem cells turn into different cell types, there are dramatic corresponding changes to the order in which DNA is replicated and reorganized.
Article

Reversible 3D Cell Culture Gel Invented by IBN Published in Nature Nanotechnology
Singapore’s Institute of Bioengineering and Nanotechnology latest invention, a unique user-friendly gel that can liquefy on demand, has the potential to revolutionize three-dimensional cell culture for medical research.
Article

Digital Zebrafish Embryo Provides the First Complete Developmental Blueprint of a Vertebrate
A new high-powered microscope has allowed scientists to watch a zebrafish develop from a single cell into an embryo with a beating heart, the first time this has been possible in vertebrates.
Article

Can Stem Cells Heal Damaged Hearts? No Easy Answers, but some Signs of Hope
In a recent systematic review, Cochrane Researchers concluded that more clinical trials are needed to assess the effectiveness of stem cell therapies for heart patients.
Article

Argos Therapeutics Publishes Approach to Improving Dendritic Cell-Based Immunotherapy
Argos Therapeutics recently announced the publication of a paper in the October 2008 issue of the Journal of Immunotherapy demonstrating that the Company’s process of maturing dendritic cells electroporated with antigen-encoded messenger RNA is capable of driving long-term, stable expansion of cytolytic antigen-specific T cells that express effector/memory phenotype.
Article

Amsterdam Molecular Therapeutics Intends to Incorporate Additional Data to its Marketing Authorization Dossier for Glybera(R)
In consultation with the Rapporteur countries, Germany and the United Kingdom, of the European Medicines Agency and Health Canada, AMT has decided to expand the clinical experience and to augment the Marketing Authorization Application with an additional 16-patient study that will investigate the broader impact of this gene therapy on additional aspects of lipid metabolism.
Article

Roger Tsien Wins 2008 Nobel Prize in Chemistry
The Royal Swedish Academy of Sciences announced recently that the 2008 Nobel Prize in Chemistry was awarded to Roger Y. Tsien, Osamu Shimomura, and Martin Chalfie for “the discovery and development of the green fluorescent protein, GFP.”
Article

ABSTRACTS, REVIEWS AND SPECIAL REPORTS

Cells Derived from Human Umbilical Cord Blood Support the Long-Term Growth of Undifferentiated Human Embryonic Stem Cells
This study reports the successful culture of two hESC lines (H1 and H9) on human umbilical cord blood-derived fibroblast-like cells.
Article

Unaltered Repopulation Properties of Mouse Hematopoietic Stem Cells Transduced with Lentiviral Vectors
The results of this study show unaltered repopulation properties of HSCs transduced with LVs, and confirm early studies suggesting the natural capacity of a few HSC clones to generate a monoclonal or oligoclonal hematopoiesis in transplant recipients.
Article

Hepatic Microenvironment Programs Hematopoietic Progenitor Differentiation into Regulatory Dendritic Cells, Maintaining Liver Tolerance
The researchers demonstrate that the liver microenvironment is highly important to program progenitors to differentiate into regulatory dendritic cells in situ, which contributes to the maintenance of liver tolerance.
Article

Hematopoietic Stem Cell Quiescence Is Maintained by Compound Contributions of the Retinoblastoma Gene Family
This study shows that Rb family members collectively maintain HSC quiescence and the balance between lymphoid and myeloid cell fates in the hematopoietic system.
Article

Donating Embryos for Research may be Easier Said than Done
Obstacles to donating embryos include piles of paperwork, choosing the type of medical research, getting the consent of egg and sperm donors or simply finding an organization that will accept the donation.
Article

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Policy

Bill Clinton to Support Stem Cell Ballot Issue in Michigan
A. Alfred Taubman said President Bill Clinton has accepted his invitation to come to Michigan on Friday and raise money for CureMichigan, the group supporting Proposal 2 on the state’s November ballot.
Article

Business

Pluristem Announces its Appointment to the Advisory Board of The Stem Cell Partnering Series
Pluristem Therapeutics Inc. announced recently it had been appointed to the Advisory Board of The Stem Cell Partnering Series.
Article

Alnylam Earns $20 Million Payment from Takeda
Alnylam Pharmaceuticals, Inc. recently announced that it has earned a $20 million technology transfer milestone payment from Takeda Pharmaceutical Company Limited as part of the strategic alliance the companies formed in May 2008.
Article

Advanced Cell Technology, Inc. Receives $500,000 Funding Commitment
Advanced Cell Technology, Inc. announced recently that it has entered into a definitive agreement with Transition Holdings Ltd, an Irish institutional investor, under which it will sell $500,000 of one-year 7% convertible debentures over the next 90 days.
Article

University of North Carolina at Chapel Hill gets $7M Grant for Muscular Dystrophy Research
The five-year, $7 million grant from the National Institutes of Health will establish the Senator Paul D. Wellstone Muscular Dystrophy Cooperative Research Center at the university.
Article

University of Georgia Receives $8.3 Million NIH Grant to Study Stem Cells, Cancer
The National Institutes of Health has awarded the University of Georgia a five-year, $8.3 million grant to further its research into the role cell-surface sugars known as glycans play in the development of stem cells and cancer cells.
Article

Lokey Gives $75 Million to Create Nation’s Largest Stem Cell Research Center at Stanford
Lorry I. Lokey, the Business Wire founder and philanthropist, is giving $75 million to the Stanford University School of Medicine to help build what is expected to be the nation’s largest center for stem cell research.
Article

Nonprofit foundation raises $400,000 for Texas Cord Blood Bank
The South Texas Blood and Tissue Center Foundation raised more than $400,000 for the Texas Cord Blood Bank over the weekend during its 5th annual Red & White Ball.
Article

Charter Medical Receives 510(k) Clearance for CELL-FREEZE(R) Cryogenic Storage Containers for Peripheral Blood Stem Cells
Lydall, Inc. Charter Medical, Ltd is pleased to announce 510(k) clearance for CELL-FREEZE(R) cryogenic storage containers. CELL-FREEZE(R) cryogenic storage containers were designed for peripherally derived stem cell applications.
Article

Cytori Receives Two Patent Allowances Related to Uses of the Celution(R) System Output
These patent allowances add specific commercial applications to U.S. Patent No. 7,390,484, issued in June 2008, which covers the Celution System technology that processes adipose-derived stem and regenerative cells at a patient’s bedside.
Article

Composition of Matter Patent Allowance Covers Adipose-Derived Stem and Progenitor Cells
A Notice of Allowance was issued to the University of California by the United States Patent & Trademark Office for composition of matter claims pending in a patent application licensed by Cytori Therapeutics.
Article

University of Minnesota says 2001 Stem Cell Study Drew on Falsified Data
The University of Minnesota has concluded that falsified data were used in a 2001 article published by one of its pioneering researchers on adult stem cells.
Article

NIH

Elias A. Zerhouni, M.D., NIH Director, Announces New NIH CIO
Director of the National Institutes of Health, U.S. Department of Health and Human Services, is pleased to announce the appointment of John F. “Jack” Jones, Ph.D., as NIH Chief Information Officer, effective June 22, 2008.
Article

NIH Administrative Supplements for Induced Pluripotent Stem Cell Research
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New NIH Policy on Resubmission (Amended) Applications
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Extension of Interim NIH Reimbursement Process for New Peer Reviewers and Peer Reviewers Up for CCR Renewal
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Updates and Reminders on NIH Policy Pertaining to Grants to Foreign Institutions, International Organizations and Domestic Grants with Foreign Components
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Circadian-Coupled Cellular Function in Heart, Lung, and Blood Tissue (R01)
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Understanding the Effects of Emerging Cellular, Molecular, and Genomic Technologies on Cancer Health Care Delivery (R21)
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CBER

Human Cell, Tissues and Cellular and Tissue-Based Products (HCT/P) Alphabetical List of Registered Establishments
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New Contrast Imaging Indication Considerations for Devices and Approved Drug and Biological Products; Draft Guidance for Industry, 58604 [E8–23712]
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Medical Device Notification (PSN-08-09) – Sunquest Laboratory Blood Bank and Blood Donor Modules – Sunquest Information Systems, Inc.
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Regulatory

FOOD AND DRUG ADMINISTRATION (United States)

Agency Information Collection Activities; Proposals, Submissions, and Approvals, 58970–58972 [E8–23833]
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Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Guidance for Industry: Cooperative Manufacturing Arrangements for Licensed Biologics
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Science Board to the Food and Drug Administration; Notice of Meeting
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Draft Guidance for Industry: Potency Tests for Cellular and Gene Therapy Products; Availability
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MEDICINES AND HEALTHCARE PRODUCTS REGULATORY AGENCY (United Kingdom)

Laboratories that are Members of the UK GLP Compliance Monitoring Programme Revised as of October 6, 2008
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Call for Papers for Next Ministerial Industry Strategy Group (MISG) New Technologies Advisory Panel Meeting
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Alert: Impersonation of MHRA staff
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