Volume 8.08 | Mar 5

Volume 8.08, March 5, 2007
     In this issue: Science | Policy | Business | NIH | CBER | Regulatory
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Top Stories

New Stem Cell Procedure Is Developed: U.S. scientists have created the first transplantable source of lung epithelial cells by developing a new way to differentiate human embryonic stem cells.

Mayo Clinic Researchers Safely Regenerate Failing Mouse Hearts with Programmed Embryonic Stem Cells: Mayo Clinic researchers have safely transplanted cardiac preprogrammed embryonic stem cells into diseased hearts of mice successfully regenerating infarcted heart muscle without precipitating the growth of a cancerous tumor – which, so far, has impeded successful translation into practice of embryonic stem cell research.


MIT Bioengineer Advances Survival, Promise of Adult Stem Cells
MIT researchers have developed a technique to encourage the survival and growth of adult stem cells, a step that could help realize the therapeutic potential of such cells.

Major Discovery in Advancing of Regenerative Medicine
Scientists at Forsyth may have moved one step closer to regenerating human spinal cord tissue by artificially inducing a frog tadpole to re-grow its tail at a stage in its development when it is normally impossible. Using a variety of methods including a kind of gene therapy, the scientists altered the electrical properties of cells thus inducing regeneration.

Inter-Species Stem Cells to Be Created
A team of Korean scientists has come close to creating interspecies stem cells by combining monkey cells with cow ova for the first time in history.

Gene Required For Steps From Embryonic To Heart Muscle Cell
An important choreographer of the complicated dance of signals, enzymes and proteins that takes embryonic stem cells through the steps to becoming a beating heart muscle cell is the gene Sox17.

New Imaging Technique Tracks Traffic Patterns Of White Blood Cells
Researchers at Mount Sinai School of Medicine have just developed an advanced imaging technique to capture the movement of the microdomains of leukocytes or white blood cells.

Healtheuniverse Announces Non-Embryonic Adult Stem Cell Technology Approaching Clinical Trials
Healtheuniverse Inc. announced today that the Company’s non-embryonic stem cell technology is being prepared for clinical trials.

Liposuctioned Fat Stem Cells To Repair Bodies
A team led by Philippe Collas at the University of Oslo in Norway has identified certain chemical marks that allow him to predict which, among the hundreds of millions of stem cells in liposuctioned fat, are best at regenerating tissue.

Athersys, Inc. Completes GMP Manufacturing of Multistem(R) for Clinical Trials
Athersys, Inc. has announced that it has successfully produced a clinical grade master cell bank and initial product doses intended to support its clinical trial activity in 2007 and 2008.

TVAX Gets OK for Human Trial of Brain-cancer Therapy
TVAX Biomedical has received authorization from the Food and Drug Administration to begin a large-scale human trial to test a new immunotherapy for brain cancer.

Gene Therapy Shows Promise as Treatment for Diseased Limbs
New research led by an Ohio State University Medical Center vascular medicine specialist suggests that gene therapy is a safe treatment method to explore in patients whose lower limbs are at risk for amputation because of poor circulation caused by blocked blood vessels.

Dendreon Announces FDA’s Cellular, Tissue and Gene Therapies Advisory Committee to Review Provenge(R) for the Treatment of Asymptomatic, Metastatic, Androgen-Independent Prostate Cancer
Dendreon Corporation has announced that the U.S. Food and Drug Administration’s Office of Cellular, Tissue and Gene Therapies Advisory Committee will review the Biologics License Application (BLA) for PROVENGE (sipuleucel-T), the Company’s investigational active cellular immunotherapy (ACI) for the treatment of asymptomatic, metastatic, androgen-independent (also known as hormone refractory) prostate cancer on March 29, 2007.

Milestone In Finding Diabetes Cure: Pigs Arrive In Biosecure Facility
Spring Point Project, a non-profit organization created to expedite the widespread availability of islet tissue for diabetes care, has now conducted the first animal population of its biosecure animal facility in Western Wisconsin to breed and maintain high-health, pathogen-free pigs.


Concise Review: Stem Cells, Myocardial Regeneration, and Methodological Artifacts
This review discusses the current controversy about the role that endogenous and exogenous progenitor cells have in cardiac homeostasis and myocardial regeneration following injury.

A Pure Population of Lung Alveolar Epithelial Type II Cells Derived from Human Embryonic Stem Cells
The data presented in this study document the successful generation of a pure population of Alveolar epithelial type II (ATII) cells derived from hES cells, providing a practical source of ATII cells to explore in disease models their potential in the regeneration and repair of the injured alveolus and in the therapeutic treatment of genetic diseases affecting the lung.


California Stem Cell Research Is Upheld by Appeals Court
California’s stem cell research program is legal, a state appeals court ruled Monday in a decision that could hasten the day when the state’s $3 billion research effort can get fully under way.

Auditors Criticize Stem Cell Institute’s Spending
A study has found that vague policies led to pricey meals and airfare.

Illinois House Passes Stem Cell Legislation
The Illinois House says state money should be used to support research using embryonic stem cells.

Cloning Ban Built into Stem Cell Research Bill
Legislation giving the University of Minnesota permission to use state money on all varieties of stem cell research was revised to explicitly bar human cloning.

Catholic Official Asks Legislators Not to Fund Stem Cell Research
New York state’s Roman Catholic church Wednesday urged the state Legislature to reject Gov. Eliot Spitzer’s proposal to invest $2.1 billion in stem cell and other biomedical research over the next decade.

UK Scientists Triumph in Battle Over Ban on Hybrid Embryos
Plans to outlaw the creation of human-animal hybrid embryos for potentially life-saving stem cell research are to be dropped after a revolt by scientists.

British Government to Ask Public What They Think of Stem Cell Science
Britain’s Science and Innovation Minister Malcolm Wicks has announced that the UK’s two major public funders of stem cell research will run a national public discussion about this cutting-edge area of science. 


The Stem Cell Meeting
March 12 – 13 at San Francisco’s Mission Bay Conference Center at UCSF.
The only international business, policy and economic forum for science and business professionals working at the leading edge of stem cell and regenerative medicine development.  Cell Therapy News readers receive a special discount. To register, please go to www.thestemcellmeeting.com and click “Registration.”  Select “Special” from the Attendee Type drop down menu. Click “Register Now” and enter access code “2SCSPC”. If you have any questions, please contact registration at 800-549-1735; or [email protected].

Aldagen Signs Worldwide Distribution Deal for ALDECOUNT(R) With StemCell Technologies
Aldagen, Inc. today announced that it has signed a worldwide distribution agreement whereby StemCell Technologies will distribute Aldagen’s ALDECOUNT(R) product. StemCell Technologies is also the worldwide distributor for Aldagen’s ALDEFLUOR(R) product.

CalbaTech Begins Development of New Subsidiary to Enable It to Bring Its Stem Cell Microbank(TM) Service to the United Kingdom
CalbaTech, Inc. has announced that it is creating a new subsidiary under CalbaTech to enable it to take its stem cell service to the United Kingdom and also to seek listing on the London Stock Exchange.

Vaccinex and Teva Ink Antibody Development Alliance in MS and Oncology
Vaccinex entered into a collaboration with Teva Pharmaceutical Industries to develop and commercialize VX15, a human antibody discovered by Vaccinex. VX15 has the potential to improve efficacy in treating multiple sclerosis (MS) by both suppressing the body’s autoimmune response and blocking damage to the central nervous system, Vaccinex reports.

ReNeuron Gains Revenue-share on New Cell Line Patent
ReNeuron Group plc today announces that it has entered into a revenue-sharing agreement with the international Ludwig Institute of Cancer Research (LICR) and the Dana-Farber Cancer Institute, Boston, US, concerning newly-patented research conducted by these institutions on certain gene-based somatic cell expansion technology.

Bioheart, Inc. Provides Unrestricted Research Grant to the Ohio Cell-Based Therapy Consortium
Bioheart, Inc.has announced that it has provided an unrestricted research grant to the Ohio Cell-based Therapy Consortium in the amount of $100,000.

Sysmex-Funded Research Laboratory to Launch at the Foundation for Biomedical Research and Innovation
Sysmex Corporation has made a commitment to fund a cell therapy research laboratory at the Foundation for Biomedical Research and Innovation.

$33 Million Donation from Lorry Lokey Will Go toward Stem Cell Institute Building at Stanford
Lorry I. Lokey, the founder of Business Wire and a passionate supporter of education and science, will give a minimum of $33 million to help build a home for Stanford’s Institute for Stem Cell Biology and Regenerative Medicine.

HRA Pharma Invest an Additional 2.5 Million Euros In Cell Therapy Through Its Subsidiary Celogos
The funds will allow the French biotech company, a pioneer in the development of cell-based therapies for muscle disorders, to ramp up the on-going clinical development of its pipeline.

Amsterdam Molecular Therapeutics BV Receives Global Rights to Develop and Commercialize AMT-020 for Acute Intermittent Porphyria
Amsterdam Molecular Therapeutics BV announces that it has obtained exclusive worldwide rights to develop and commercialise AMT-020 as a therapeutic product from UTE CIMA, Proyecto de Biomedicina CIMA, S.L. and Digna Biotech.


Amendments to PAR-06-511, the National Cancer Institute (NCI) R25 Cancer Education and Career Development Award (NOT-CA-07-009)

NLM Grants for Scholarly Works in Biomedicine and Health (G13) (PAR-07-237)


CBER Organizational Information – Update

Guidance for Industry: Eligibility Determination for Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products

Draft Guidance for Industry: Advisory Committee Meetings – Preparation and Public Availability of Information Given to Advisory Committee Members


FOOD AND DRUG ADMINISTRATION (Untited States of America)

Cellular, Tissue, and Gene Therapies Advisory Committee; Notice of Meeting


Questions and Answers About the Proposed Regulation of Blood

Consultation Paper on the Proposed Clinical Trial Regulatory Arrangements Under ANZTPA


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

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Profiled Journal

Robert Weinstein, MD
Chief, Division of Transfusion Medicine, UMass Memorial Medical Center, Worcester, MA.

The Journal of Clinical Apheresis provides the world’s premier source of current information in the field of apheresis. The Journal presents work in all aspects of basic and clinical research, practical applications, emerging technologies and regulation in apheresis and related fields including hematology, nephrology, neurology, rheumatology, transplantation, cellular therapies, blood banking, transfusion medicine, and others.

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