Volume 9.00 | Jan 7

Cell Therapy News 9.0, January 7, 2008
     In this issue: Science | Policy | Business | NIH | CBER | Regulatory
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Top Stories

Osiris Therapeutics Awarded Department of Defense Contract for Prochymal(TM) Fully Valued at $224.7 Million: Osiris Therapeutics has announced that it has been awarded a $224.7 million contract, including purchase options, from the United States Department of Defense (DoD) to develop and stockpile Prochymal, an adult stem cell therapy, for the repair of gastrointestinal injury resulting from radiation exposure.
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Science

Personalized Medicine through Genomic Analysis and Molecular Diagnostics
March 31, 2008
Boston, Massachusetts

Enter “CONNEXON” at checkout and receive 10% off registration.
Click here to register today.

UC Irvine Scientists Find New Way to Sort Stem Cells
UC Irvine scientists have found a new way to sort stem cells that should be quicker, easier and more cost-effective than current methods. The technique could in the future expedite therapies for people with conditions ranging from brain and spinal cord damage to Alzheimer’s and Parkinson’s diseases.
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“Virgin” Birth Stem Cells May Offer Tissue Bank
Human egg cells can be tweaked to give rise to valued stem cells that match the tissue types of many different groups of people, U.S. and Russian researchers have reported. They said the stem cells they have created from unfertilized human eggs look and act like embryonic stem cells.
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Researchers Get Embryonic Stem Cells from Skin
A third team of researchers has found a way to convert an ordinary skin cell into valued embryonic-like stem cells, with the potential to grow batches of cells that can be directed to form any kind of tissue.
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Growing Artificial Skin From Hair Roots
There is new hope for patients with chronic wounds: euroderm GmbH and the Fraunhofer Institute for Cell Therapy and Immunology IZI in Leipzig have been granted approval to produce artificial skin from patients’ own cells.
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Artificial Blood Vessels Closer
Scientists are a step nearer the creation of tiny artificial blood vessels after growing minuscule tubes out of stem cells in the laboratory.
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South Koreans Claim to Create Cloned Pigs Through Stem Cells
The scientists said they had used stem cells extracted from pigs’ bone marrow to obtain cloned embryos, much improving the success rate.
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Gene Therapy Can Reduce Long-term Drinking Among Rodents
A proof-of-principle study has found that administering an anti-Aldh2 antisense gene in rodents can curtail their urge to drink.
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RNA Therapy Heals Growth Deficiency Disorder in a Live Animal
A team of Vanderbilt researchers has demonstrated for the first time that RNA interference can heal a genetic disorder in a live animal.
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Reneuron Says IND Application for Stem Cell Therapy Still on Hold
The company said that while it has addressed most of the substantive issues raised by the US Food and Drug Administration in the original hold letter on its ReN001 therapy, there are a small number of issues that are not yet resolved.
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University Hospitals Researchers Initiate Gene Therapy Trial in Patients with Advanced Skin Cancer
Researchers at the Ireland Cancer Center of University Hospitals Case Medical Center are the first in the region to have joined a nationwide clinical trial to evaluate the effectiveness of a gene therapy in patients with advanced melanoma which is aimed to help a patient’s own immune system fight their cancer.
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Northwest Biotherapeutics Conducting Ovarian Cancer Clinical Trial With DCVax(R)-L at University of Pennsylvania
Northwest Biotherapeutics, Inc. has announced that a Phase I/II clinical trial in at least 30 patients, using DCVax(R)-L for recurrent ovarian cancer, has begun at The University of Pennsylvania Center for Research on Early Detection and Cure of Ovarian Cancer and the Abramson Cancer Center.
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Boy Develops Leukemia After Gene Therapy in UK
A three-year-old “bubble boy” undergoing pioneering gene therapy in London has developed leukemia, marking another setback for the experimental treatment.
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Tengion Launches Third Phase 2 Clinical Trial of Regenerated Human Bladder
Tengion, Inc. has announced it is initiating its third Phase 2 multi-center clinical trial of its Neo-Bladder Augment derived from a patient’s own (autologous) cells.
Article

Disgraced South Korean Stem Cell Scientist Seeking to Resume Research
Hwang Woo-suk is part of a team that requested the Health Ministry last week for permission to carry out research on embryonic stem cells using human eggs.
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ABSTRACTS, REVIEWS AND SPECIAL REPORTS

HLA Homozygous Stem Cell Lines Derived from Human Parthenogenetic Blastocysts
The researchers report the successful derivation of four stable hpSC-Hhom lines from both HLA homozygous and HLA heterozygous donors.
Abstract

Unique Dielectric Properties Distinguish Stem Cells and Their Differentiated Progeny
These findings provide evidence for a whole cell property that reflects stem cell fate bias, and establish dielectrophoresis (DEP) as a tool with unique capabilities for interrogating, characterizing, and sorting stem cells.
Abstract

JOB OPPORTUNITIES

Cell Therapy Business Development Leader
Portland, OR (Invitrogen)
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Scientist
Irvine, CA (Global Biopharmaceutical Company)
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Biomedical Equipment Technician
Los Angeles, CA (Cedars-Sinai Medical Center)
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Quality Manager
Singapore (Singapore Cord Blood Bank)
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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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Policy

Senators Likely to Take Up Cloning Ban
Scientific breakthroughs suggest some types of adult stem cells may be as useful in research as embryonic ones, but lawmakers in Nebraska and elsewhere continue to debate whether laws are needed to prevent scientists from using human embryos.
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Bishops: Limit Stem Cell Research to Skin Cells
The four Catholic bishops of Massachusetts have called upon the state Legislature and Gov. Deval L. Patrick to revise biotechnology and stem cell research plans for the state by using recently announced scientific advances that can allow human skin cells to be turned into cells that are very similar, but not identical to embryonic stem cells.
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New Law Provides Permanent State Funding For Stem Cell Research
The Stem Cell Research and Human Cloning Prohibition Act, which prohibits cloning or the attempt to clone humans, authorizes the Illinois Department of Public Health to administer the Illinois Regenerative Medicine Institute Program to provide grants to Illinois medical research institutions for stem cell research, according to a release from Gov. Rod R. Blagojevich’s office.
Article

Bill Aims to Boost Organ Donations
With 4,200 New Jerseyans await ing potentially life-saving organ transplants, Senate President Richard Codey said yesterday he has introduced a bill to require drivers to decide whether they want to become donors before they can obtain or renew their license.
Article

CIRM Announces Extensive Interest In Disease Team Planning Awards
CIRM has received and accepted 66 letters of intent for the Disease Team Planning Awards. Fifty six applications were received from non-profit organizations and 10 have been submitted by for-profit companies. The Disease Team Planning Awards will support multi-disciplinary teams of scientists in pursuit of therapies for specific diseases by providing up to 20 planning grants of up to $55,000.
Article

Recommendations To Independent Citizens Oversight Committee In First Round Of Major Facilities Grant Program Announced
The CIRM today announced that 12 California institutions have been recommended for the second round of consideration for its Major Facilities Grant Program. The program will fund the establishment of CIRM facilities in support of stem cell research programs that encompass a broad spectrum of research and development of therapies, diagnostics and technologies for the treatment of injury or disease.
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Business

Thermo Fisher Scientific Launches New Stem Cell Solutions Program
Thermo Fisher Scientific Inc. has introduced its Thermo Scientific Stem Cell Excellence program, a new initiative that brings together nearly 100 essential laboratory products and services, spanning instruments, consumables, reagents, and informatics as well as service and automation, to address the needs of stem cell researchers.
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BioMimetic Therapeutics to Sell Remaining Dental Business for Additional $40 Million Cash plus Continuation of Royalties; Company to Focus on Orthopedics, Spine and Sports Medicine
BioMimetic Therapeutics, Inc. has announced the Company has entered into a definitive agreement with Luitpold Pharmaceuticals Inc., under which it will sell its remaining dental business, including the downstream formulation, fill and finish manufacturing rights of GEM 21S(R), to Luitpold.
Article

Neuralstem Biopharmaceuticals Enters Into Clinical Trial Research Agreement with University of Pennsylvania
Stem cell company, Neuralstem, Inc. has announced that it has entered into a Clinical Trial Research Agreement aimed at treating patients suffering from Ischemic Spastic Paraplegia, a form of spinal cord paralysis, with the Trustees of the University of Pennsylvania through its Department of Anesthesiology and Critical Care.
Article

DomaniCell Cord Blood Banking Program Launched at Saint Peter’s University Hospital
DomaniCell, LLC has announced that Saint Peter’s University Hospital has recently partnered with DomaniCell to provide a hospital-based cord blood banking program.
Article

CentraState Medical Center Launches DomaniCell Cord Blood Banking Program
DomaniCell, LLC has announced that CentraState Healthcare System has partnered with DomaniCell to provide a hospital-based cord blood banking program at CentraState Medical Center.
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Progenitor Cell Therapy Achieves Compliance Program Milestone
Progenitor Cell Therapy, LLC has announced that it has obtained a renewal of FACT accreditation for its Hackensack, New Jersey facility, in addition to gaining first-time accreditation of its facility in Mountain View, California.
Article

Public Stem Cell Bank for Chennai
City based Jeevan Blood Bank, a non profit company, will establish a Public Stem Cell Bank, which would provide high quality stem cells for treatment.
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University of Pennsylvania Investing $30 million for Regenerative Medicine
The University of Pennsylvania is investing $30 million over the next five years to establish the Penn Institute for Regenerative Medicine, which sets out to help position the university as a leader in stem cell research and therapies.
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Lonza Group Ltd. Withdraws Majority of Claims in Patent Lawsuit Against Northwest Biotherapeutics
Northwest Biotherapeutics, Inc. has announced that Lonza Group AG has withdrawn all claims of patent infringement involving NWBT’s DCVax(R)-Brain product and other NWBT DCVax(R) products other than DCVax(R)-Prostate.
Article

Cord Blood Bank Sued by Former Employee
The former lab director for a Newton company that stores newborns’ umbilical cord blood claims he was fired after blowing the whistle on problems with the company’s quality controls.
Article

Alnylam Announces Continued Progress on Development of its Intellectual Property Estate Covering RNAi Therapeutics
The Tuschl II patent has been granted in Europe and a new Kreutzer-Limmer patent has been granted in Germany.
Article

Aldagen, Inc. Appoints Laurence Keller, MD as Chief Medical Officer
Aldagen, Inc. has announced that Laurence Keller, MD has been appointed as Chief Medical Officer. Dr. Keller is a board-certified pediatric cardiologist and brings to Aldagen significant experience in leading product development efforts for a broad range of indications.
Article

MultiCell Technologies Inc. To Increase Focus on Therapeutic Candidates; CEO Resigns
MultiCell Technologies, Inc. has announced that Stephen M. Chang, Ph.D. has resigned as President and Chief Executive Officer to pursue other interests. W. Gerald Newmin, the Company’s Chairman, will be Interim President and Chief Executive Officer until the Company identifies a permanent replacement.
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Histogen Welcomes Robert Kellar as Vice President of Research and Development
Kellar’s knowledge in the field of tissue engineering, and experience in bringing products from concept through to commercial market, will be vital in enabling Histogen to meet the company’s product launch goals in the coming year.
Article

Dolly the Sheep Pioneer Knighted
Professor Ian Wilmut, who led the team which created Dolly the sheep through genetic cloning, has been knighted.
Article

NIH

Modified Application Submission, Referral and Review for Appointed NIH Study Section Members (NOT-OD-08-026)
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NIH Policy on Late Submission of Grant Applications (NOT-OD-08-027)
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Clinical Trials Registration in ClinicalTrials.gov (Public Law 110-85): Competing Applications and Non-Competing Progress Reports (NOT-OD-08-023)
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NIH Offers Manufacturing Assistance Program to SBIR Phase II Awardees (NOT-OD-08-025)
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Change of Biomedical Information Science and Technology Initiative (BISTI) FOAs to Regular Program Announcements (PA) (NOT-GM-08-117)
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Expansion of Scientific Scope of PAR-08-025, Quick-Trials for Novel Cancer Therapies and Prevention: Exploratory Grants (R21), to Include Symptom Management (NOT-CA-08-005)
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Adminstrative Supplements for High-Quality Low-Cost Monoclonal Antibodies for Studies of the Nervous System (NOT-NS-08-009)
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Development and Application of New Technologies to Targeted Genome-wide Resequencing in Well-Phenotyped Populations (R01) (RFA-HL-08-004)
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Institutional Clinical and Translational Science Award (U54) (RFA-RM-08-002)
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Nanoscience and Nanotechnology in Biology and Medicine (R01) (PA-08-052)
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Nanoscience and Nanotechnology in Biology and Medicine (R21) (PA-08-053)
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CBER

Cellular, Tissue and Gene Therapies Advisory Committee Meeting
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2008 Tentative Advisory Committee Meeting Schedule
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WilBio 2nd Annual Cell Banking Meeting – Slide Presentation
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All new CBER information can be reached from the What’s New page at What’s New Page

Regulatory

FOOD AND DRUG ADMINISTRATION (United States)

Exceptions or Alternatives to Labeling Requirements for Products Held by the Strategic National Stockpile; Interim Final Rule; Request for Comments
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Agency Emergency Processing Under the Office of Management and Budget Review; Certification to Accompany Drug, Biological Product, and Device Applications or Submissions; Correction
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Certification of Compliance, under 42 U.S.C., 282(j)(5)(B), with Requirements of ClinicalTrials.gov Data Bank (42 U.S.C., 282(j)) – Form
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ISCT

14th ISCT Annual Meeting

May 17-20, 2008
Downtown Miami, Florida

Abstract Submission and Early Registration Deadline: January 31, 2008

Full details at: http://www.celltherapysociety.org



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