Volume 7.13 | Apr 10

Volume 7.13, April 10, 2006
     In this issue: Science | Policy | Business | NIH | CBER | Regulatory
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Top Stories

Gene Therapy Fights Immune Disorder: Two men, diagnosed with a genetic immune disorder, were able to overcome life-threatening fungal infections after receiving gene therapy, according to the study in Nature Medicine, a biomedical research journal.


Michigan Team Singles Out Cancer Stem Cells for Attack
Close on the heels of the discovery that cancer has its own rejuvenating stem cells, a University of Michigan research team has found a way to distinguish these bad-actors from the normal stem cells that they so closely resemble, and to kill the cancer stem cells without harming the normal stem cells in the same tissue.

Lab Grows Bladders From Cells of Patients
It is the first time a complex human organ like the bladder has been mostly replaced with tissue grown from a patient’s own cells.

Broken Bone Treatment First
A Melbourne hospital is using cultured adult stem cells to heal broken bones in a clinical trial.

Bone Loss Seen in Children After Stem Cell Therapy
A type of stem cell therapy called hematopoietic cell transplantation (HCT) often leads to a reduction in bone formation in children, according to Minneapolis-based researchers.

New Applications for Cord Lining Stem Cells – Diabetes and Wound Healing
Cord Lining Stem Cells discovered by CellResearch Corporation makes headway in areas with exciting potential therapeutic applications

Gene Therapy Helps Blind Mice See the Light
A protein normally found in green algae can make retinal cells in blind mice sensitive to light, researchers report, adding that advances with the technique could one day help restore sight in people with inherited eye problems.
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Umbilical Cord Blood: The Future of Stem Cell Research?
Researchers at the University of Minnesota recently announced that they were able to largely reverse the effects of stroke in lab rats using stem cells found in human umbilical cord blood.

Results In For First Gene Therapy For Alzheimer’s Disease
Researchers say they see promising results from the first gene therapy trial for Alzheimer’s disease. And one of the trial’s patients believes the experimental treatment slowed down her disease.

Researchers Explore New Technique to Treat High Blood Pressure, Kidney Damage
Using a corrective gene, scientists were able to block a protein in the kidneys that triggers high blood pressure and kidney damage.

Stem Cell Transplants Improve Recovery In Animal Models For Stroke, Cerebral Palsy
A single dose of adult donor stem cells given to animals that have neurological damage similar to that experienced by adults with a stroke or newborns with cerebral palsy can significantly enhance recovery from these types of injuries, researchers say.

Factor Stimulates Cartilage Growth from Stem Cells
A novel growth factor significantly improves the ability of specialized stem cells derived from human fat to be transformed into cartilage cells, according to Duke University Medical Center and Pratt School of Engineering researchers.

Israeli Researchers Regenerate Torn Ligaments and Tendons with Adult Stem Cells
In studies conducted on rats, the researchers at the Skeletal Biotechnology Laboratory at the university’s Faculty of Dental Medicine have successfully used adult stem cells to form new tendon or ligament tissue.

Virginia Commonwealth University’s Medical CenterTeam Implants Total Artificial Heart
The cardiac surgery team at Virginia Commonwealth University’s Pauley Heart Center has performed the first artificial heart implant on the East Coast.

AVEO Presents a Novel System for the Generation of Fully Human Breast Tumors in Mice
AVEO Pharmaceuticals, Inc., a biopharmaceutical company focused on the discovery and development of novel cancer medicines, announced today that is has developed the first system which allows for the generation of fully human breast tumors in mice.

Mutation in Blood Stem Cells Provides Clues to Cancer Development
A mutation in blood stem cells occurs in patients with a blood disorder called polycythemia vera (PV), scientists at the Moores Cancer Center at the University of California, San Diego (UCSD) and the Institute for Stem Cell Biology and Regenerative Medicine and Comprehensive Cancer Center at Stanford University School of Medicine have confirmed.

The Immune Response Corporation’s MS vaccine Spurs T-cell Response
The Immune Response Corporation announced that its T-cell receptor peptide vaccine candidate, NeuroVax(TM), induces increased FOXP3 expression resulting in re-establishment of normal levels of the FOXP3+ regulatory T-cells believed to be important in controlling the development of multiple sclerosis (MS).

Co-Researcher of Hwang Faked Stem Cells Alone
Prosecutors have tentatively concluded that Kim Sun-jong, co-researcher of disgraced cloning expert Hwang Woo-suk, fabricated samples of stem cell lines without Hwang’s knowledge.

Pair Indicted For Fake Stem Cell Therapy
A federal grand jury in Atlanta has returned an 51-count indictment against Laura Brown, 35, of Miami Beach, Florida, and Stephen Van Rooyen, 44, of Cape Town, South Africa, on charges of wire fraud and distributing unapproved and misbranded drugs relating to fraudulent claims of stem cell treatment and therapy.


The Long Journey from Stem Cells to Medical Product
There is much interest in developing stem cells and the cells derived from them as therapies for treating human disease and injury, but many biological, technological and regulatory hurdles have to be overcome before these cell therapies can be brought to commercial fruition.

Correction of X-linked Chronic Granulomatous Disease by Gene Therapy, Augmented by Insertional Activation of MDS1-EVI1, PRDM16 or SETBP1
The results suggest that gene therapy in combination with bone marrow conditioning can be successfully used to treat inherited diseases affecting the myeloid compartment such as Chronic Granulomatous Disease.

Pten Dependence Distinguishes Haematopoietic Stem Cells from Leukaemia-Initiating Cells
Mechanistic differences between normal stem cells and cancer stem cells can be targeted to deplete cancer stem cells without damaging normal stem cells.


Health and Technology Leaders Release the Connecting for Health Common Framework for Initiating Private and Secure Health Information Sharing
The Common Framework provides the initial elements of a comprehensive approach for secure, authorized, and private health information sharing, so that patients and their authorized providers can have access to vital clinical data when and where they are needed.

U.S. Trails Other Countries in Publishing Embryonic Stem Cell Studies, Stanford Researcher Finds
A study by a researcher at the Stanford University School of Medicine for the first time documents that stem cell researchers in other countries are out-publishing U.S. scientists.


ReNeuron Announces Initial Pre-clinical Data with its ReN003 Retinal Stem Cell Programme and Signs Collaboration Agreement with Schepens Eye Research Institute
ReNeuron Group today announces initial survival efficacy data with its ReN003 stem cell therapy programme for diseases of the retina.

Advanced Cell Technology Announces Exclusive License of Key Intellectual Property Portfolio on Somatic Cell Reprogramming Technology
Advanced Cell Technology, Inc. announced today that it has exclusively licensed a key intellectual property portfolio in regard to somatic cell reprogramming from TranXenoGen, Inc., Shrewsbury, Massachusetts.

California Stem Cell Agency to be Loaned $14M
Six philanthropic organizations have agreed to loan California’s stem cell agency $14 million until it can raise money on its own, state Treasurer Phil Angelides said Tuesday.

ProBioGen Signed Agreement on Testing of Neuronal Cell Lines with Serono
ProBioGen announced today that Serono, Switzerland has signed an Agreement to evaluate ProBioGen’s novel human neuronal cell line for the production of recombinant proteins.

Osiris Completes Enrollment in Stem Cell Trial to Treat Cardiac Disease
Osiris Therapeutics, Inc. announced today that it has completed enrollment in a human clinical trial designed to evaluate the safety and preliminary effectiveness of its universal adult stem cell drug candidate Provacel(TM), being developed to treat patients suffering from heart attacks.

Brain Power Combined to Form New $125M Institute
In an effort to discover better treatments for brain disorders and create one of the world’s top 10 neuroscience research institutes, the Howard Florey Institute, Brain Research Institute and the National Stroke Research Institute will amalgamate to form a new neuroscience institute in Melbourne.

Cordis Corporation To Develop Global Cardiac And Vascular Institute
Cordis Corporation announced today plans to develop a world-class global cardiac and vascular institute that will provide physicians and other health care providers with educational and clinical resources designed to help advance the understanding and treatment of a broad range of cardiac and vascular conditions, including coronary artery disease and stroke.

Amgen Slates Major Growth for Seattle Research Campus
Amgen plans a major expansion of its Helix research campus on Elliott Bay, a company spokeswoman said today.

Amgen Cuts 98 Fremont Workers
Abgenix employed about 440 workers companywide, and 98 workers were given notices, according to the Alameda County Workforce Investment Board. Klem said the company retained all the employees at its other site in Burnaby, British Columbia.

Nabi Biopharmaceuticals Acquires Exclusive North American Commercialization Rights To Phase III Antibody Product For Prevention And Treatment Of Rejection Following Organ Transplantation
Nabi Biopharmaceuticals today announced that it has signed an agreement with Fresenius Biotech to advance the development of ATG-Fresenius S in the U.S. and Canada.

Sartorius and ProMetic Announce Two Agreements
Sartorius AG and ProMetic Life Sciences Inc. announced today the signing of a collaboration agreement utilizing bioseparation systems to recover proteins from human blood plasma, between Sartorius and ProMetic’s subsidiary ProMetic BioTherapeutics, Inc.

GE Healthcare Unveils New Life Sciences Business
GE Healthcare has today announced the creation of GE Healthcare Life Sciences – a new business, involving the combination of two existing businesses – Protein Separations and Discovery Systems and is effective immediately.

CancerVax Announces FDA Approval of IND for Novel Anti-Angiogenic Antibody D93
CancerVax Corporation, a biotechnology company focused on the research, development and commercialization of biological products for the treatment of cancer, announced today that the United States Food and Drug Administration (FDA) has approved the Company’s Investigational New Drug (IND) application for D93, an investigational, humanized, monoclonal antibody with a novel anti-angiogenic and tumor inhibitory mechanism of action.



NIH Announces Change in Business Process: Replacing Principal Investigator Signature on Grant Applications, Progress Reports, and Prior Approval Requests with an Institutional Compliance Requirement

NIH/AHRQ Announce Change in Business Process Concerning eRA Commons Verifications of Electronically Submitted Applications

NIH Announces Interim Changes to the PHS398 Application and Instructions

NIH Announces Changes to the SF424 (R&R) Instructions

NIH Announces Interim Changes to the PHS2590 Noncompeting Progress Report Forms and Instructions

Findings Of Scientific Misconduct

Notice of Availability of Administrative Supplements for Training in Techniques in the Establishment and Manipulation of Organotypic Model Systems

Extension of Expiration Date for PAR-02-076 –Mentored Clinical Scientists Development Award (K12)

Reduction in Percent Effort for NHLBI Mentored Career Development K Awards

Clinical Trial Methods In Neurology


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

Frequently Asked Questions – Bar Code Label Requirements for Blood and Blood Components

FDLI 49th Annual Conference CBER Update 2006 – Slide Presentation

Licensed Products and Establishments List – Update

Import Alert #57-19 “Importation of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)”

Approved Biological NDA and ANDA Applications – Update


Food and Drug Administration (United States of America)

Acting U.S. FDA Head Says He’s Giving up Cancer Job
Andrew von Eschenbach, the director of the National Cancer Institute, who last week took on the added duties of acting Food and Drug Administration commissioner after the abrupt resignation of Commissioner Lester M. Crawford, said yesterday that he will temporarily step down from his day-to-day leadership of the cancer institute.

Cooperative Agreement to Support a Single-Source Application–The Critical Path Institute: Collaborative Cardiovascular Drug Safety and Biomarker Research Program

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

Second meeting of the Joint Interim Expert Advisory Committee on Standards

Medsafe (New Zealand)

Details of the consultation process being undertaken as part of the establishment of the joint Australia New Zealand Therapeutics Products Authority


ISCT2006. May 4-7. Berlin, Germany.
Visit http://www.celltherapysociety.org.

AABB-ISCT Cellular Therapy Audioconference Series

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

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

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