Volume 7.06 | Feb 20

Volume 7.06, February 20, 2006
     In this issue: Science | Policy | Business | NIH | CBER | Regulatory
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Top Stories

Findings Advance Use of Adult Stem Cells for Replacement Bone: In a significant advance for regenerative medicine, researchers at Rice University have discovered a new way to culture adult stem cells from bone marrow such that the cells themselves produce a growth matrix that is rich in important biochemical growth factors.

Wisconsin Scientists Find A Way To Make Human Collagen In The Lab: “We can make collagen that duplicates nature exactly, but we can diverge from that when it is desirable,” says Ronald T. Raines, a UW-Madison professor of biochemistry who, with postdoctoral fellow Frank W. Kotch, authored the new PNAS study.


Johns Hopkins Scientists Map Brain Area that May Aid Hunt for Human Brain Stem Cells
A study led by a Johns Hopkins neurosurgeon has provided the first comprehensive map of a part of the adult human brain containing astrocytes, cells known to produce growth factors critical to the regeneration of damaged neural tissue and that potentially serve as brain stem cells.

UCI Researchers Discover Key Factor for Survival of Human Embryonic Stem Cells
Using neural growth factor could allow researchers to mass produce stem cells for treatment of disease.

ReNeuron Announces Initial Pre-clinical Data with Its ReN004 Human Stem Cell Lines for Parkinson’s Disease
ReNeuron Group plc (LSE: RENE) today announces that initial in vivo testing of its ReN004 candidate stem cell lines shows them to have attributes that may favour the reversal of the neurological deficits seen in Parkinson’s disease.

Researchers Find Better Way to Deliver Gene Therapy
Researchers used a laboratory technique called polymerase chain reaction (PCR) to alter genetic sequences of the outer coating, or capsid, of adeno-associated virus (AAV). AAV is a normally innocuous virus that is often used to deliver healthy genes to diseased tissues.

The Egg Hunt Is On
A shortage of human eggs is likely to be the biggest barrier for U.S. scientists who want to create cloned stem cells.

Healtheuniverse Develops Technology to Create Non-Embryonic Adult Stem Cells From Fat
Healtheuniverse Inc. (Other OTC:HLUN.PK), a diversified biotechnology development firm specializing in the development and commercialization of patented biopharmaceutical and biomedical products, announced today that its research has developed technology to create adult stem cells using fat.

Gene Therapy Cures Depressed Mice
Researchers in the U.S. say that deleting a specific gene in the brain of mice that have been conditioned to be depressed, has the same effect as antidepressants.


Long-Term Survival and Outgrowth of Mechanically Engineered Nervous Tissue Constructs Implanted Into Spinal Cord Lesions
In this study, we used a new tissue engineered technique to create long nervous tissue constructs spanned by living axon tracts to repair long SCI lesions.

General Safety Guidances in Stem Cell Bank Installations
The use of cell cultures in research and in regenerative medicine programs has increased in the past few years, and control of the risks inherent to these procedures should be increased.


Call to Allow Body Organ Selling
Two US doctors have suggested the sale of organs such as kidneys should be legalised to meet the rising demand.

Stem Cell Researchers Seek Equal Standards
Five nationally known scientists, including cloning expert Xiangzhong “Jerry” Yang of the University of Connecticut, today urged top scientific journals not to hold cloning and human embryonic stem cell research to higher standards than other medical research.


Geron Licenses MaxCyte Cell Loading Technology for Use in Closed-System Cancer Vaccine Manufacturing
MaxCyte, Inc. and Geron Corporation (Nasdaq:GERN) announced today a license, option, development, and supply agreement to utilize MaxCyte’s proprietary cell loading system in the manufacture of mRNA-loaded dendritic cell-based vaccines, including Geron’s GRNVAC1 telomerase vaccine.

Thermogenesis Gets Health Canada Regulatory License to Market AutoXpress System
The specific regulations allows GE Healthcare, the AXP system distributor, to begin its sales and marketing effort to cord blood banks and hospitals in Canada.

Introgen Therapeutics, Inc. (INGN) Awarded Patent For Gene-Based Therapies Combined With Conventional Therapies
Introgen Therapeutics, Inc. announced today that a patent has been awarded by the U.S. Patent and Trademark Office which covers, for example, administration of chemotherapeutic drugs, radiation therapies, or other agents that have a damaging effect on the DNA of cancer cells, to a cancer patient, followed by administration of a desired therapeutic gene, such as one or more of Introgen’s molecular therapies.

Genentech Submits Supplemental Biologics License Application for Adjuvant Herceptin in Early-Stage HER2-Positive Breast Cancer
Genentech, Inc. (NYSE: DNA) announced today that the company completed the submission of a supplemental Biologics License Application (sBLA) with the U.S. Food and Drug Administration (FDA) for use of Herceptin® (Trastuzumab) to treat early-stage, HER2-positive breast cancer.

India’s Reliance Life to Launch Stem Cell Therapies Soon
Reliance Life Sciences (RLS), the pioneer of embryonic stem cell research in the country, is likely to launch its first stem cell-based therapies for neuro-degenerated diseases, including Parkinson’s and ocular diseases and spinal cord injury soon.

LCT Reports Positive Meetings with FDA and MedSafe – Preparing for Cell Therapy Trials
Living Cell Technologies Limited (ASX:LCT) today reported it has held positive meetings with the US Food and Drug Administration (FDA) and New Zealand’s MedSafe, regarding its NeurotrophinCell and DiabeCell products.

Stem Cell Innovations Formerly Interferon Sciences (IFSC.PK) And Amphioxus Cell Technologies Announce Merger And Related Events
Stem Cell Innovations, Inc. (IFSC.OB), formerly known as Interferon Sciences, Inc., and Amphioxus Cell Technologies, Inc., a privately held company, today announced the merger of the two companies, a new management team, the completion of an approximately $3.8 million private placement, and certain debt exchanges.

GenVec Names Russell Wesdyk Vice President of Business Development and Strategic Planning
GenVec, Inc.(Nasdaq:GNVC) announced today that Russell P. Wesdyk has joined the company as vice president of business development and strategic planning, a new position reporting to company president and chief executive officer Paul Fischer, Ph.D.



NIH Guide for Grants and Contracts – Week Of February 17, 2006

NIH Director Welcomes Five New Members to the Advisory Committee to the Director
The National Institutes of Health (NIH) has selected five individuals to serve as members of the Advisory Committee to the Director (ACD). Since 1966, the ACD has advised the NIH Director on policy and planning issues.

Genome-Wide Association Studies to Identify Genetic Components that Relate to Heart, Lung, and Blood Disorders (R01)(RFA-HL-06-012)


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

Guidance for Industry: Considerations for Developmental Toxicity Studies for Preventive and Therapeutic Vaccines for Infectious Disease Indications

Workshop on Behavior-Based Blood Donor Deferrals in the Era of Nucleic Acid Testing (NAT) Agenda

Workshop on Behavior-Based Blood Donor Deferrals in the Era of Nucleic Acid Testing (NAT) Issue Paper

2006 Biological Approvals – Update

Guidance for Industry: Reports on the Status of Postmarketing Study Commitments – Implementation of Section 130 of the Food and Drug Administration Modernization Act of 1997

2nd Annual FDA and the Changing Paradigm for Tissue Regulation – Slide Presentation

Guidance for Industry: Considerations for Developmental Toxicity Studies for Preventive and Therapeutic Vaccines for Infectious Disease Indications

The Ninth US-Japan Cellular and Gene Therapy Conference on Genomics and Proteomics Technology in Biomarker Discovery


Food and Drug Administration (United States of America)

Guidance for Industry on Reports on the Status of Postmarketing Study Commitments–Implementation of Section 130 of the Food and Drug Administration Modernization Act of 1997; Availability

The Medicines and Healthcare products Regulatory Agency (United Kingdom)

Quality Control in Laboratories


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

AABB-ISCT Cellular Therapy Audioconference Series

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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