Volume 6.50 | Dec 12

Volume 6.50, December 12, 2005
     In this issue: Science | Policy | Business | NIH | CBER | Regulatory
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Top Stories

Computing Power Breaks New Boundaries in Understanding Stem Cells: Dr. Gary Wills and Dr Yee-Wai Sim at the School of Electronics and Computer Science at the University of Southampton are working on the Collaborative Orthopaedic Research Environment (CORE) project, funded by the Joint Information Systems Committee (JISC), to develop Virtual Research Environments (VRE) for orthopaedic surgeons.
Article

Science

Embryonic Stem Cells Could Treat Millions
British scientists say the stem cells taken from just 10 human embryos could supply suitable tissue to treat most of the U.K. population.
Article

How Many Stem Cell Lines Are Needed For A Functional Therapeutic Bank?
Scientists have estimated the number of human embryonic stem cell (hESC) lines that are needed to create a functional therapeutic hESC bank in the UK. They report their findings in this week’s issue of The Lancet.
Article

Stem Cells, Over Easy
The spectacle of the world’s top stem-cell scientist resigning from a major research center in disgrace over an ethical lapse offers an object lesson for those who worry this fledgling science is running out of control. But it’s not the lesson that opponents of stem-cell research believe.
Article

Iron Particles And MRI Could Replace Biopsies To Track Stem Cell Therapy And Deploy Stents
In a series of experiments in animals, researchers at Johns Hopkins have successfully used a technique that tracks mesenchymal stem cells via magnetic resonance imaging (MRI) to monitor the progress of the cells in repairing tissue scarred by heart attack.
Article

Spinal Cord Injury, Nerve Regeneration Possible, University Of California San Francisco
By stimulating nerve cells in laboratory rats at the time of the injury and then again one week later, the scientists were able to increase the growth capacity of nerve cells and to sustain that capacity.
Article

Liver Transplants May Not Be Indicated For Cystic Fibrosis Patients With Bleeding Complication
A new study on patients with cystic fibrosis (CF) who have had abnormal bleeding from ruptured blood vessels in the esophagus (variceal hemorrhage) as a result of liver disease found that transplant may not be indicated if there are no other indications of advanced liver disease.
Article

With Love at Christmas – A Set of Stem Cells
Christmas shopping for the unborn baby has never been easy. However, stem cell technology may have brought what is possibly this year’s most original gift. For a mere £1,250, it is possible to harvest stem cells from the umbilical cord at birth and store them frozen for up to 25 years.
Article

New Treatment Target Found for a Lethal Form of Leukemia
Through the use of a novel antibody, scientists may be able to target the specific cells that lead to a common form of leukemia, according to a study to be presented today during the 47th Annual Meeting of the American Society of Hematology (ASH).
Article

ABSTRACT, REVIEWS, & SPECIAL REPORTS

First Report of Donor Cell-derived Acute Leukemia as a Complication of Umbilical Cord Blood Transplantation
This represents the first reported case of donor cell leukemia following UCBT. This case illustrates that donor cell leukemia is a rare but real event after UCBT as with other stem cell sources and highlights the need for CBBs to maintain linkage data between donors and recipients.
Abstract

Images of Cloning and Stem Cell Research in Editorial Cartoons in the United States
Analyzing popular images can allow access to public understanding about genetic technology and evaluation of public beliefs, preconceptions, and expectations as the public is educated on the use and value of services.
Abstract

In Vitro Cartilage Formation of Composites of Synovium-derived Mesenchymal Stem Cells with Collagen Gel
The tissue engineering of autologous cartilage from the composites of synovium-derived MSCs with collagen gel in vitro for transplantation may be a future alternative to graft implantation for patients with cartilage defects.
Abstract

Policy

Genetic Doping will Soon be Detectable, Warns Rogge
Genetic doping is used by athletes trying to hide illegal use of performance-enhancing substances.
Article

Business

Osiris Cleared by FDA to Begin Phase II Stem Cell Trial for the Treatment of Crohn’s Disease
Osiris Therapeutics, Inc. announced today that it has received clearance from the U.S. Food and Drug Administration (FDA) to begin enrollment in a Phase II clinical trial to evaluate the safety and effectiveness of PROCHYMAL(TM) for the treatment of Crohn’s Disease.
Article

Breakthrough Results of Neurologix’s Gene Therapy Approach to Epilepsy Presented at American Epilepsy Society Meeting in Washington, D.C.
Neurologix, Inc. (OTCBB: NRGX) today announced results from preclinical studies, which showed that Neuropeptide Y (NPY) gene transfer reduces spontaneous seizures in an in vivo model of epilepsy as well as positively influences the fundamental biological process which leads to a chronically epileptic state.
Article

Stem Cell Therapeutics (SSS) And Medicon A/S Complete Dosing Of Patients In Phase I Study Of NTx(TM)-265
Stem Cell Therapeutics Corp. (“SCT”) is pleased to announce completion of patient dosing in the Phase I Clinical Study of SCT’s NTx(TM)-265 stroke program.
Article

Genitope Corporation Files Patents For Personalized, Therapeutic Monoclonal Antibodies To Treat Non-Hodgkin’s Lymphoma
Genitope Corporation (Nasdaq: GTOP) today announced the filing of two patents for the composition and use of a panel of monoclonal antibodies directed against specific epitopes in the variable regions of the B-cell receptor (BCR).
Article

Cytori Therapeutics Completes Collaboration with Olympus Corporation; Receives Initial $11.0 Million Payment from Olympus-Cytori Joint Venture
Cytori Therapeutics, Inc. (Frankfurt:XMPA) announced today it has formally completed its formation of the recently announced regenerative medicine collaboration it entered into with Olympus Corporation.
Article

Crucell to License PER.C6 Cell Line Technology to Vakzine Projekt Management
Crucell NV said it has agreed to license its PER.C6 human cell-line technology to German vaccine development company Vakzine Projekt Management (VPM) GmbH for use in the development of a vaccine to prevent a specific but undisclosed infectious disease, and to develop diagnostics.
Article

Cryo-Cell International (CCEL) Restructures U-Cord(R) Service To Significantly Enhance Client Value
CRYO-CELL International, Inc. (“CRYO-CELL” or the “Company”), the world’s largest U-Cord(R) stem cell bank, announced today that effective December 6, 2005, the Company has strategically restructured its U-Cord Service to improve clients’ value, increase the Company’s revenues and expand market share.
Article

HIS SpinTrap™ Columns Enable Fast and Efficient, Small-scale Isolation of Histidine-tagged Proteins
GE Healthcare has announced the availability of the His SpinTrap™, a single-use spin column designed for efficient purification of histidine-tagged proteins using a standard microcentrifuge. His SpinTrap allows direct loading of unclarified homogenized cell lysates, without the need for centrifugation or filtration of the sample.
Article

Immunology Transplantation Tolerance Study Commences
Norwood Abbey Ltd (ASX:NAL) announces that its subsidiary Norwood Immunology Ltd (AIM:NIM) has advised the commencement of the pre-clinical trial at Massachusetts General Hospital, in Boston, to determine whether tolerance to donated organ and tissue transplants can be established without the need for prolonged immuno-suppressants.
Article

California Legislators Visit BrainStorm Research Facility
The delegation visited BrainStorm’s research facility at the Felsenstein Medical Research Center of Tel-Aviv University. The visit came in the wake of a recent stem cell symposium, in which BrainStorm participated, that was hosted by the Cedars-Sinai Stem Cell Initiative in Los Angeles and that was aimed at promoting cooperation among California and Israeli stem cell companies.
Article

Invitrogen Announces Realignment to Move Closer to Customers; John ‘Kip’ Miller Signs on to Lead One of Several New Focus Areas
Effective January 1, 2006, the company will create three new divisions under the traditional BioDiscovery and BioProduction business segments: Life Sciences, Bio-Production Systems and Services, and Enabling Technologies. Each of the divisions will have dedicated manufacturing, research and development, and marketing functions.
Article

Xcyte Receives Notice of Non-compliance with Nasdaq Continued Listing Standard
On December 6, 2005 Xcyte Therapies, Inc. (Xcyte, the “Company”) (Nasdaq XCYT, XCYTP) received notice from The Nasdaq Stock Market indicating that the Company is not in compliance with Nasdaq Marketplace Rule 4450(a)(5) (the “Minimum Bid Price Rule”), and as a result the Company’s common stock will be delisted at the opening of business on December 15, 2005 unless the Company’s requests a hearing in accordance with the Nasdaq Marketplace Rules.
Article


NIH

NATIONAL INSTITUTES OF HEALTH

NIH Guide for Grants and Contracts – Week Of December 9, 2005
Link

NCI and NHGRI Launch Comprehensive Effort to Explore Cancer Genomics
The National Cancer Institute and the National Human Genome Research Institute will host a press conference to launch a human cancer genome pilot project. The project will lay the foundation for exploring genomic changes involved in cancer, with the ultimate goal of developing new means of preventing, detecting and treating cancer.
Link

Speedier NIH Review of Research Applications Planned
The National Institutes of Health (NIH) today announced a pilot effort to significantly shorten its peer reviews of research grant applications — so scientists can get on with their research sooner, to the public’s benefit. This pilot rose from a growing concern that the current grant review process takes too long and is hindering the careers of promising researchers and the advancement of science and health.
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Notice of the Presubmission Conference Call for the NHLBI Clinical Hematology Research Career Development Program (NOT-HL-06-112)
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Clinical Hematology Research Career Development Program (K12) (RFA-HL-06-006)
Application Receipt Date(s): February 14, 2006
Link

CBER

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

Recall of Charter Medical Transfer Bags – Charter Medical, Ltd
Link

2005 Biological Approvals – Update
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Approved Biological NDA and ANDA Applications – Update
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Cleared Biological 510(k) Device Applications – Update
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Approved Biological Premarket Approval (PMA) Device Applications – Update
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Regulatory

Food & Drug Administration (United States of America)

Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; MedWatch: Food and Drug Administration Medical Products Reporting Program
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Industry Exchange Workshop on Food and Drug Administration Clinical Trial Requirements; Public Workshop; Amendment of Notice
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Risk Management, Corrective and Preventive Actions, and Training: An Educational Forum; Public Workshop
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Draft Guidance for Industry and Food and Drug Administration; Nucleic Acid Based In Vitro Diagnostic Devices for Detection of Microbial Pathogens; Availability
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ISCT


ISCT2006. May 4-7. Berlin.
Click here for the Call for Abstracts and preliminary program or registration information.

2005 Cell Therapy Audioconference Series
Link



Profiled Journal

Join ISCT($130) and receive the journal as a benefit of membership.

Cytotherapy now incorporates “Cytokines, Cellular & Molecular Theory”.

Cytotherapy/Telegraft Advertising Offer
Cytotherapy- the official journal of the International Society for Cellular Therapy (6x annually) – and Telegraft –ISCT’s global cell therapy newsletter (4 x annually) – are offering an integrated advertisement rates package enabling even more effective coverage of your products, services and recruitment vacancies to the industry at large. The combined reach is impressive, comprising as it does your target audience core.

Here’s how the deal works:

Display advertising / print: book an advertisement, any size, in both publications and we will apply a full 30% discount off the combined ratecard price. Plus, we’ll allow any earned volume discount too!

Recruitment advertising / online: postings on the ISCT website are $1,000 for 2 months. But we’ll reduce that by 50% to $500 only if the posting is taken in addition to a print advertisement in Telegraft or Cytotherapy. ISCT web site receives over 125,000 hits per months, guaranteeing your posting industry wide exposure.

All we ask is that you make your first insertion before the end of 2005 but we’ll be pleased to extend this deal with full rate protection into 2006 on anything booked before December 31st 2005. For more information and advertising rates, click here.

Current Volume: Volume 7, Number 6 / December 2005

Cytotherapy publishes original research, reviews, meeting reports, special focus issues and letters in the general field of cell therapy. The scope of the journal includes basic and applied research with hematopoietic and non-hematopoietic stem cells, immune cells, and antigen-presenting cells. Therapeutic topics within the scope of Cytotherapy include ex-vivo and in-vivo aspects of gene therapy, immunotherapy, stem cell transplantation and tissue regeneration. Cytotherapy particularly welcomes contributions from researchers, clinicians, technicians and individuals involved in regulatory aspects of cell therapy.
http://journalsonline.tandf.co.uk/link.asp?id=107693



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