Volume 7.44 | Nov 13

Volume 7.44, November 13, 2006
     In this issue: Science | Policy | Business | NIH | CBER | Regulatory
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Top Stories

VIRxSYS Corporation Announces Publication of Phase I Study of Novel Gene Therapy for HIV: First clinical evaluation of a lentiviral vector promising for patients with HIV.
Article

Science

Osiris Therapeutics Reports Positive Phase II Results Using PROCHYMAL™ for the Treatment of Acute Graft vs. Host Disease
23 patients, or 74% achieved a complete response, meaning the patients had experienced total clinical resolution of the disease. Currently, PROCHYMAL is being evaluated in a Phase III trial for the treatment of steroid refractory GVHD.
Article

Dendreon Announces New Data Analysis Presented at Chemotherapy Foundation Symposium
Dendreon Corporation today announced the presentation of data from an exploratory analysis of Phase 3 Studies (D9901 and D9902A) that showed a prolonged survival benefit for patients initially treated with PROVENGE® (sipuleucel-T) who then went on to receive docetaxel chemotherapy after disease progression. PROVENGE is the Company’s lead investigational active cellular immunotherapy for the treatment of advanced prostate cancer.
Article

Cord Stem Cells Turned into Lung Cells
“In the future, we may be able to examine cord blood from babies who have lung diseases, such as cystic fibrosis, to do more research to understand how these diseases evolve, as well as to develop better medical treatments,” David McKenna, medical director of the Clinical Cell Therapy Lab at the University of Minnesota Medical Center in Minneapolis, said.
Article

U of M Receives $1.5 Million to Research Stem Cell Treatments for Heart Disease
The University of Minnesota is one of five institutions across the country chosen to receive $1.5 million from the National Institutes of Health (NIH) to research stem cell treatments for heart disease.
Article

Stem Cells Hold Promise For Diabetes Cure
A research team form the New Orleans’ Tulane University reveals that stem cells hold promise for diabetes cure. Researchers have used stem cells from human bone marrow to successfully treat diabetic mice.
Article

Transplanted Retinal Cells Let Blind Mice See Again
A team of British scientists using cellular implants has restored sight in adult mice — possibly paving the
Article

Uterus Transplant Could be Tomorrow
Last month Del Priore and colleagues at the University of Pittsburgh’s primate research laboratory performed the first successful uterus transplant in a non-human primate.
Article

Stretching Bone Marrow Stem Cells Pushes Them Towards Becoming Blood Vessel
When stretched, a type of adult stem cell taken from bone marrow can be nudged towards becoming the type of tissue found in blood vessels, according to a new study by bioengineers at the University of California, Berkeley.
Article

How To Grow Muscle Cells In A Dish
In a study that appears online on November 9, in advance of publication in the December print issue of the Journal of Clinical Investigation, Catherine Verfaille and colleagues at the University of Minnesota Medical School, Minneapolis, show that SMCs can be generated from multipotent adult progenitor cells (MAPCs) isolated from the bone marrow of rats, mice, pigs, and humans.
Article

Researchers Identify Cells that make Relapse Inevitable in Acute Lymphoblastic Leukemia
In “Dr Jekyll and Mr Hyde” Robert Louis Stevenson wrote about the good and evil sides of the same person; now scientists in Australia have discovered that in acute lymphoblastic leukaemia (ALL) there are Dr Jekyll and Mr Hyde cells – “good” and “evil” clones of the same type of ALL cell.  The “evil” cells are clones that have a pre-existing, rather than acquired, resistance to drugs used for treating ALL, and their presence in a patient means that person will inevitably relapse after chemotherapy, however well they respond initially.
Article

Doctors Now Back Face Transplants
Leading doctors have given cautious backing to face transplants.
Article

Mass Producing Engineered Organs
Bioartificial kidneys seem to work, but can we make enough for everyone who needs one?
Article

Gene Therapy Inhibits Epilepsy In Animals
For the first time, researchers have inhibited the development of epilepsy after a brain insult in animals.
Article

Scientists Find Problem & Possible Solution In Gene Therapy Delivery
“No one in protein or DNA therapeutics had considered cavitation as a problem,” notes Dr. Corinne Lengsfeld, “but cavitation occurs in every biotech processing system. We now know that if you can keep your turbulent eddy size bigger than the DNA, it will never fragment.”
Article

Plan to Create Human-cow Embryos
UK scientists have applied for permission to create embryos by fusing human DNA with cow eggs.
Article

Cell Transfer for Heart Patient
A man who has had six heart attacks is one of the first UK patients to undergo an experimental cell transfer.
Article

Lung-Cancer Vaccine with Stem Cells Successful on Mice
Researchers at the University of Louisville have developed a lung-cancer vaccine using embryonic stem cells that has proven to be effective in mice.
Article

Diabetes Shouldn’t Keep Patients From Heart Transplant
Diabetes alone should not disqualify a person from being considered for a heart transplant, U.S. researchers conclude. They found that it is the severity of diabetes damage to the body, not the illness itself, that plays the critical role in heart transplant success.
Article

Researchers Map Protein Network that Regulates “Stemness”
Howard Hughes Medical Institute (HHMI) researchers have created a map that charts the largely unexplored protein landscape that regulates a stem cell’s ability to differentiate into multiple types of mature cells.
Article

ABSTRACT, REVIEWS & SPECIAL REPORTS

Cytokine-induced Differentiation of Multipotent Adult Progenitor Cells into Functional Smooth Muscle Cells
Multipotent adult progenitor cells (MAPCs) isolated from rat, murine, porcine, and human bone marrow demonstrate the potential to differentiate into cells with an SMC-like phenotype and function. TGF-1 alone or combined with PDGF-BB in serum-free medium induces a temporally correct expression of transcripts and proteins consistent with smooth muscle development.
Abstract

Policy

Stem Cells a Priority for New US Congress
Stem cell issues emerged as an important platform during the midterm elections, and despite some moral concerns the new Congressional leadership is poised to bring the issue to the table.
Article

Business

Proneuron Ceases All R&D Activity
Proneuron CEO Nir Nimrodi told “Globes” yesterday “It’s not accurate to say that the company is closed. The company did indeed cease all R&D activity, closed its labs and even though it still retains several clean rooms, they are inactive.
Article

Indian Firms Bank on Cells to Stem Attrition
Five-star cafe lunches, employee share options, lifetime medical insurance et al are passe. India Inc has found another way to woo staffers – stem cell banking, where the company pays for storage of stem cells of babies born to employees.
Article

StemCellPatents.com Launches First-Ever Free Comprehensive Index of Stem Cell Related IP
StemCellPatents.com announced today the launch of a Beta Site summarizing all issued US patents in the area of stem cells, as well as their clinical applications. 
Article

Umblical Cord Blood Banking: India Set to be Key Player
A two billion dollar market worldwide, cord blood banking is fast coming up in India, with many big players foraying into collection, isolation and storage technologies for cord blood stem cells.
Article

NIH

Notice of a Report on the Review of Responses to the National Institutes of Health Request for Information (RFI): Standards for the Care and Use of Laboratory Animals (NOT-OD-07-016)
Link

Stephen E. Straus, M.D., Becomes Senior Advisor to NIH Director
Stephen E. Straus, M.D., Director of the National Center for Complementary and Alternative Medicine (NCCAM), stepped down from his leadership of the Center for health reasons.  Straus will become Senior Advisor to National Institutes of Health (NIH) Director Elias A. Zerhouni, M.D.
Article

CBER

Compliance Program Guidance Manual: Imported Human Cells, Tissues, and Cellular and Tissue-based Products (HCT/Ps) 7342.007 Addendum
Link

Vaccines and Related Biological Products Advisory Committee Meeting
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Cellular, Tissue and Gene Therapies Advisory Committee Meeting
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Licensed Products and Establishments List – 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)

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

Cellular, Tissue and Gene Therapies Advisory Committee; Minutes for February 9-10, 2006 Meeting
Link

ISCT

International Society for Cellular Therapy – http://www.celltherapysociety.org

AABB-ISCT Cellular Therapy Audioconference Series
Link

Profiled Journal

Editor-in-Chief:
Robert Weinstein, MD
Chief, Hematology and Transfusion Medicine, Caritas St. Elizabeth’s Medical Center, Tufts University School of Medicine, Boston, 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.

A subscription to the journal is a key benefit of ASFA membership, which ranges from $120-145 annually. To become a member please contact:

ASFA Head Office
570 West 7th Ave, Suite 402
Vancouver, BC V5Z IB3, Canada
T 604-484-2851
F 604-874-4378
E [email protected]
www.apheresis.org

Please visit the website for all you need to know about publishing in or subscribing to the Journal of Clinical Apheresis:
http://www.interscience.wiley.com/journal/jca



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