Volume 6.41 | Oct 10

Volume 6.41, October 10, 2005
     In this issue: Science | Policy | Business | NIH | CBER | Regulatory
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Top Stories

Austrianova and Miltenyi Biotec, Inc. Announce Strategic Partnership To Manufacture World’s First Allogeneic Product To Combat Pancreatic Cancer: The Viennese company Austrianova Biotechology has entered into a strategic alliance with the German biotechnological manufacturer Miltenyi Biotec (Bergisch Gladbach) to establish a manufacturing process for NovaCaps®.


Neural Stem Cells Are Long-lived
New studies in mice have shown that immature stem cells that proliferate to form brain tissues can function for at least a year — most of the life span of a mouse — and give rise to multiple types of neural cells, not just neurons.

Liver Failure Patients Get Own Stem Cells
Imperial College London physicians say they’ve successfully treated patients suffering liver failure by using the patients’ own bone marrow stem cells.

New Immune Cell Found to be a Key to Inflammatory Diseases
The molecular roots of inflammatory and autoimmune diseases such as asthma, arthritis, and multiple sclerosis (MS) have been discovered by a team of researchers led by The University of Texas M. D. Anderson Cancer Center.

Researchers Find Defects in Adult Stem Cell Niche May Cause Breast Cancer
Researchers at Georgetown’s Lombardi Comprehensive Cancer Center have found that the onset of breast cancer may be due to defects in somatic adult stem cell niches that exist long before tumors develop.

Increase in Stem Cell Subtype Indicates Better Survival Rate in Acute Lung Injury
According to the authors, the improved survival rate among 45 patients with ALI correlated with higher colony counts of a stem cell subtype called endothelial progenitor cells (EPCs).

Stem Cells as a Diagnotsic Tool for Atherosclerosis Risk
Undifferentiated cells circulating in the blood stream offer a tremendous potential for vascular tissue regeneration, as recent clinical trials proved.

Pioneering Gene Therapy Saves ‘Boy-in-a-bubble’
A former ‘boy in a bubble’ who once could have been killed by a common cold is now enjoying family life to the full, thanks to pioneering gene therapy.

Living Kidney ‘Paired Donation’ An Effective Strategy in Overcoming Donor-recipient Incompatibilities, Hopkins Study Shows
A Johns Hopkins study has affirmed the success of living kidney “paired donation” (KPD) as a means of efficiently finding more kidney donors who are a match for patients in need.

Red Blood Cells Fitted with Artificial Tails
They might look like sperm swimming backwards, but red blood cells have become the first living cells to be fitted with an artificial tail.

Hair-raising Stem Cells Identified: Swiss Study Shows That Hair Follicles Contain Bonafide Multipotent Stem Cells
Using an animal model, a research team led by Yann Barrandon at the EPFL (Ecole Polytechnique Federale de Lausanne) and the CHUV (Lausanne University Hospital) has discovered that certain cells inside the hair follicle are true multipotent stem cells, capable of developing into the many different cell types needed for hair growth and follicle replacement. In an article appearing in the Oct 3 advance online edition of the Proceedings of the National Academy of Sciences, they demonstrate that these holoclones can be used for long-term follicle renewal.

Wisconsin-based Group to Run Stem Cell Bank
A Wisconsin-based research group will run the nation’s first embryonic stem cell bank under a four-year, $16 million federal contract, officials announced Monday.

Researchers to Gain Wider Access to Knockout Mice
The National Institutes of Health (NIH) today announced contracts that will give researchers unprecedented access to two private collections of knockout mice, providing valuable models for the study of human disease and laying the groundwork for a public, genome-wide library of knockout mice.

American Society for Apheresis (ASFA) Call for Abstracts
The American Society for Apheresis (ASFA) invites apheresis professionals to submit abstracts for presentation at the ASFA 2006 Annual Meeting, to be held at the Venetian in Las Vegas from May 23-26, 2006.


ES Cell-derived Glial Precursors Contribute to Remyelination in Acutely Demyelinated Spinal Cord Lesions
These findings demonstrate that ESGPs transplanted into acutely demyelinated lesions can contribute to myelin repair.

Methods for Derivation of Human Embryonic Stem Cells
In this study, we introduce methods for the derivation of human embryonic stem cells (hESCs) depending on the quality of the blastocysts.

Motility and Growth of Human Bone-marrow Mesenchymal Stem Cells During Ex Vivo Expansion in Autologous Serum
Our results suggest that autologous human serum may provide sufficient ex vivo expansion of human bone-marrow mesenchymal stem cells possessing multidifferentiation potential and may be better than fetal bovine serum in preserving high motility.

Tumor Immunology, Immunomics and Targeted Immunotherapy for Central Nervous System Malignancies
The current state of immune-based treatment paradigms and future directions will be discussed, paying particular attention to targeted antibody strategies, adoptive cellular immunotherapy, and tumor vaccine approaches that have been studied in clinical trials for CNS neoplasms.


Catholic Church Funds Research on Adult Stem Cells
The Catholic Archdiocese of Seoul said yesterday it will donate millions of dollars for research into adult stem cells.

Australian Minister Warns on Stem Cells
Australia’s reputation as a global player in biotechnology could be undermined if conservative forces succeed in banning groundbreaking embryonic stem-cell research, a senior cabinet minister has warned.


LifeCell Corporation (LIFC) Voluntarily Recalls Product From One Tissue Recovery Organization
LifeCell Corporation initiated a voluntary recall of certain AlloDerm(R), Repliform(R) and GraftJacket(R) product from the marketplace on September 30, 2005.

Chromos Molecular Systems Inc. Enters Into License Agreement With Becton, Dickinson And Company For T-cell Expansion Patents
Chromos Molecular Systems Inc. announced today that a patent license has been granted to BD (Becton, Dickinson and Company) , a global medical technology company, under Chromos’ U.S. Patent Number 6,316,257 and 6,890,753 and their foreign counterparts relating to expansion of antigen-specific T- cells.

Baxter Bolsters Biotech Base for Clotting Drugs
The Deerfield-based medical products giant said it signed late last month “collaborative research agreements” with Nektar Therapeutics Inc. of San Carlos, Calif., and Lipoxen Technologies of London to develop longer acting blood-clotting drugs.

Chemicon Announces Agreement with Stem Cell Sciences for Exclusive Manufacturing and Marketing of Novel, Serum-free, Embryonic Stem Cell Tissue Culture Media
Under the terms of this agreement, SCS will transfer the patented technology and expertise to Chemicon to allow it to manufacture a fully formulated cell culture media that Chemicon will exclusively market worldwide.

LCT and MultiCell Announce Joint Venture – Opening Pathway for Stem Cell Delivery
Living Cell Technologies Limited (ASX: LCT) has entered into a joint venture with US-based adult stem cell company, MultiCell Technologies, Inc. (OTCBB: MCET), to develop therapeutic liver cell applications.

Invitrogen Acquires Quantum Dot and BioPixels(R), Adding Nanotechnology Portfolio to Its Molecular Probes Franchise; Company Also Closes Acquisition of Biosource International, Inc.
The acquisition of Quantum Dots and BioPixels(R) bolster Invitrogen’s Molecular Probes business as the leader in advanced labeling and detection technologies.

Pluristem Obtains Issuance from U.S. Patent Office for Coverage of Proprietary Stem Cell Expansion Technology
Pluristem Life Systems, Inc. (OTC BB: PLRS), a biotechnology company dedicated to the expansion of stem cells from umbilical cord blood to address a myriad of fatal illnesses, today announced that it received an Issuance from the U.S. Patent Office for “Method of Producing Undifferentiated Hematopoietic Stem Cells Using a Stationary Phase Plug Flow Bioreactor” – U.S. Patent Number 6911201.


Amendments and Corrections to RFA-HG-05-007 “Completion of a Comprehensive Mouse Knockout Resource”

NIH Support for Conferences and Scientific Meetings (R13/U13): Transition to the SF424 (R&R) Form and Electronic Submission through Grants.gov


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

Draft Guidance for Industry and FDA Staff: Compliance with Section 301 of the Medical Device User Fee and Modernization Act of 2002, as amended – Prominent and Conspicuous Mark of Manufacturers on Single-Use Devices


Food & Drug Administration (USA)

Draft Guidance for Industry and FDA Review Staff on Collection of Platelets by Automated Methods; Availability

Establishing a Docket for the Biological Products for Treatment of Rare Plasma Protein Disorders Public Workshop; Availability


Regulatory Consultants
Medsafe has been informed that the following people provide independent regulatory, clinical and other consultancy services to the pharmaceutical sector in New Zealand (as of July 2003).


2005 Cell Therapy Audioconference Series

Profiled Journal

Join ISCT($130) and receive the journal as a benefit of membership.

Cytotherapy now incorporates “Cytokines, Cellular & Molecular Theory”.

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Current Volume:
Volume 7, Number 4 / September 2005

Cytotherapy publishes original research, reviews, meeting reports, special focus issues and letters in the general field of cell therapy. The scope of the journal includes basic and applied research with hematopoietic and non-hematopoietic stem cells, immune cells, and antigen-presenting cells. Therapeutic topics within the scope of Cytotherapy include ex-vivo and in-vivo aspects of gene therapy, immunotherapy, stem cell transplantation and tissue regeneration. Cytotherapy particularly welcomes contributions from researchers, clinicians, technicians and individuals involved in regulatory aspects of cell therapy.