Volume 7.26 | Jul 10

Volume 7.26, July 10, 2006
     In this issue: Science | Policy | Business | NIH | CBER | Regulatory
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Top Stories

University of California AIDS and Stem Cell Researchers Discover Way to Develop T-cells From Human Embryonic Stem Cells: The study found that it is possible to convert human embryonic stem cells into blood forming stem cells that in turn can differentiate into the helper T-cells that HIV specifically targets.


Novel Gene Therapy May Lead to Cure in Hemophilia A Patients
A discovery by Medical College of Wisconsin and BloodCenter of Wisconsin researchers in Milwaukee may be a key to a permanent genetic cure for hemophilia A patients, including a subset who do not respond to conventional blood transfusions.

Healing The Heart With Bone Marrow Cells
Researchers at the McEwen Centre for Regenerative Medicine at Toronto General Hospital have discovered the ‘SOS’ distress signal that mobilizes specific heart repair cells from the bone marrow to the injured heart after a heart attack.

Geron Presents New Data That Document Progress in Development of Therapeutic Products from Human Embryonic Stem Cells
Geron Corporation has announced the presentation of new data that document the company’s progress in the development of first-in-class therapeutic products from human embryonic stem cells (hESCs) for the treatment of degenerative diseases.

Tissue Engineering Breakthrough Could Aid Human Fertility
A supportive gel capsule has allowed researchers to mature mouse eggs in the lab, which then went on to produce offspring for the first time.

Stem Cell Transplants Tested as Innovative Therapy for Scleroderma
In a bold attempt to control a disabling and often fatal immune disease called scleroderma, physicians at Duke University Medical Center are leading a national study to test whether stem cell transplants can reconstruct defective immune systems.

Cell Genesys Announces Publication of Encouraging Phase 1/2 Clinical Results For GVAX(R) Immunotherapy for Prostate Cancer in Early Stage Patients Before Receiving Hormone Therapy
Cell Genesys has completed five Phase 1 and Phase 2 clinical trials of GVAX immunotherapy for prostate cancer in approximately 200 patients with various stages of recurrent prostate cancer, and each trial has demonstrated a favorable safety profile.

Epeius Biotechnologies Corporation Initiates Tri-REX Vaccination Protocols For Breast Cancer
Epeius Biotechnologies has announced the opening of a Vaccine-assisted Phase I/II clinical trial for metastatic breast cancer that is refractory to conventional chemotherapy.

Special Protocol Assessment Granted for TroVax
The U.S. Food and Drug Administration (FDA) has granted Oxford BioMedica a special protocol assessment (SPA) agreement for their immunotherapy agent Trovax in the treatment of clear cell renal adenocarcinoma.

Lab Grown Cartilage Fixes Damaged Knees
Knee cartilage injuries can be effectively repaired by tissue engineering and osteoarthritis does not stop the regeneration process.

Stem Cells Contain Immortal DNA
Researchers show for the first time the mechanism that adult muscle stem cells use to protect their DNA from mutations.

Research Shows Stem Cell’s Fate Affected by Surroundings
U.S. scientists found that even when embryonic stem cells are outside the body and in a laboratory dish, the proteins surrounding the developing cells play a major role in what organ the stem cells become.

Researchers Aim to Cut Future Need for Liver Transplants
University of Edinburgh scientists have identified primitive liver cells – possibly dormant from the earliest developmental stage of a human being – which have the potential to mature into different cells types and help repair a failing liver.

Face Transplant Deemed a Success
The patient’s recovery of sensation four months after the surgery has been “excellent” and her psychological progress is good.


Using Therapeutic Cloning to Fight Human Disease: A Conundrum or Reality?
This article discusses the biological, legislative, and moral restraints that must be overcome to maximize the potential of this therapeutic strategy and to alleviate human disease.

Stem Cells for the Treatment of Neurological Disorders
This article discusses the application of stem cell therapy to the treatment of neurological disorders.

Gene Therapy Progress and Prospects: Cystic Fibrosis
This review summarizes the progress made in cystic fibrosis (CF) gene therapy since October 2002 and comments on the prospects for CF gene therapy over the coming years.


Australia Federal Government in Stem Cell Law Dispute with Victoria
The Bracks Government has signalled it is prepared to go it alone and allow therapeutic cloning in Victoria despite suggestions from Canberra that it is opposed to the research.

UK Fights Over National Stem Cell Network
UK scientists are struggling to create a national network for stem cell science, as a lack of consensus about how such a network should operate is significantly limiting progress.


Another Stem Cell First For University Of Toronto And Canada
Harvesting and storing stem cells found in the umbilical cord will soon be available to the public with the launch of Tissue Regeneration Therapeutics (TRT), in collaboration with Create Cord Blood Bank (CCBB).

Stem Cell Research Centre at Armed Forces Medical College
Close on the heels of guidelines prepared by Indian Council of Medical Research (ICMR) and the Department of Biotechnology involving research projects in embryonic stem cells in the country, Asia’s largest stem cell research centre is set to come up at the Armed Forces Medical College (AFMC).

Regulators Probe Yale Accounting
Yale University officials said that they have received three subpoenas as federal regulators have launched a probe into the Ivy League school’s accounting practices surrounding its government research grants.

Private Donation of $10 Million Given to California Stem Cell Center
Prominent bond fund manager Bill Gross is donating $10 million to the University of California, Irvine to support stem cell research.

Living Cell Technologies Granted Diabetes Patent in the US
Living Cell Technologies has received a Notice of Allowance for a US patent relating to methods of preparing transplantable neo-natal porcine islets, for the treatment of diabetes.

Medistem Announces Appointment of Chief Financial Officer
Steven M. Rivers, CPA, a veteran financial professional with extensive experience has been named to oversee financial operations of this adult stem cell technology company.


NIH Official Says Legislation Not Needed For Agency To Research Means Of Deriving Embryonic Stem Cells Without Destroying Embryos
Such research proposals would undergo the same review process regardless of if a bill (S 2754) is passed, NIH Stem Cell Task Force Chair James Battey has said.

Notice of NCI Participation on PAR-06-091, NCCAM Exploratory/Developmental Grant for Clinical Studies (R21) (NOT-CA-06-033)

Notice of Change in Submission Dates for NIDDK NRSA Institutional Research Training Grant (T32) Applications (NOT-DK-06-011)

Diabetes Research Centers (P30, P60) (RFA-DK-06-014)

Career Development Program in the Genetics and Genomics of Lung Diseases (K12) (RFA-HL-07-004)


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

Licensed Products and Establishments List Update

Approved Biological NDA and ANDA Applications Update


Australia New Zealand Therapeutic Products Authority (Australia and New Zealand)

Presentations from the June Australia New Zealand Therapeutic Products Authority Stakeholder Information Meetings


AABB-ISCT Cellular Therapy Audioconference Series

For more information on the Somatic Cell Therapy Symposium, see www.celltherapysociety.org.

European branch of the International Society for Cellular Therapy (ISCT-Europe) and German Society for Transfusion Medicine and Immunohematology (DGTI) Joint meeting: “Regulatory Framework for Advanced Medicinal Products in Europe”

Profiled Journal

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.

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