Volume 6.39 | Sep 26

Volume 6.39, September 26, 2005
     In this issue: Science | Policy | Business | NIH | CBER | Regulatory
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Top Stories

Story: US Doctors Prepare for First Human Face Transplant
Article

Story: Adult Human Neural Stem Cell Therapy Successful In Treating Spinal Cord Injury
Article

Science

Supercharging Blood-Forming Stem Cells
Researchers studying the colorfully named zebrafish mutant, mind bomb, have discovered a way to replenish blood cells more quickly after exposure to radiation.
Article

Silencing Alzheimer’s: Targeting a Key Enzyme with Gene Therapy Reversed Course of Disease in Mouse Models
In mice, that had been genetically engineered to develop Alzheimer’s disease, scientists were able to reverse the rodents’ memory loss by reducing the amount of an enzyme that is crucial for the development of Alzheimer’s disease.
Article

“Hitchhiking” Viruses as Cancer Drug Delivery System
A Mayo Clinic research team has devised a new virus-based gene therapy delivery system to help fight cancer. Researchers say their findings will help overcome hurdles that have hindered gene therapy cancer treatments.
Article

Chatting Up Cells: Nano Reservoirs on a Chip Tell Stem Cells What To Do 
Stanford materials scientist Nicholas A. Melosh and his colleagues are developing a microscopic lab on a silicon chip that surrounds a stem cell with as many as 1,000 cavities, each 500 nanometers wide.
Article

Canadian Discoverers of Stem Cells to be Honoured
Two Canadian researchers have been awarded the prestigious “Lasker” prize for their discovery of stem cells. Ernest McCulloch and James Till, respectively a cellular biologist and a biophysicist, discovered the existence of stem cells in the early 1960’s in experiments with mice and bone marrow.
Article

Parents Gamble on Unproven Gene Therapy to Give Daughter a Normal Life
Since 1995, neuroscientist Paola Leone, director of the Cell and Gene Therapy Center there, has been developing a gene-therapy treatment for Canavan.
Article

Researchers Create Functioning Artificial Proteins Using Nature’s Rules
By examining how proteins have evolved, UT Southwestern Medical Center researchers have discovered a set of simple “rules” that nature appears to use to design proteins, rules the scientists have now employed to create artificial proteins that look and function just like their natural counterparts.
Article

Stem Cell Therapy Centre in Chennai, Japan
The Nichi-In Centre for Regenerative Medicine (NCRM) a unit of Nichi-In Bio Sciences (P) Ltd, an organisation for research, training and clinical application – protocol development in cell therapeutics with emphasis on stem cells, was inaugurated here Saturday by the consul general of Japan at Chennai, Yoshiaki Kodaki.
Article

Stem Cell Databank Launched
Shanghai opened its fourth haematopoietic stem cell donor databank yesterday.
Founded by the Shanghai Red Cross Society, the facility will be open to the public all year around to offer donors more convenience, said Zhang Jin, who is in charge of haematopoietic stem cell donations at the society.
Article

ABSTRACT, REVIEWS, & SPECIAL REPORTS

A 37-year-old Spinal Cord-injured Female Patient, Transplanted of Multipotent Stem Cells from Human UC Blood, with Improved Sensory Perception and Mobility, Both Functionally and Morphologically: A Case Study
Abstract

Green Tea Catechin Enhances Osteogenesis in a Bone Marrow Mesenchymal Stem Cell Line
Abstract

Molecular Dissection of Mesenchymal–Epithelial Interactions in the Hair Follicle
Abstract

Osteogenic Differentiation of Mesenchymal Progenitor Cells in Computer Designed Fibrin-polymer-ceramic Scaffolds Manufactured by Fused Deposition Modeling
Abstract

Policy

Stem Cell Ethical Guidelines Must Be Strengthened, UCSF Team Says
The possibility of using embryonic stem cells to treat disease, a strategy known as regenerative medicine, is not yet being explored in clinical trials, and may not be for many years. However, current ethical practices need to be strengthened -now- in preparation for this possibility, according to a UCSF team.
Article

Business

BUSINESS NEWS

Adult Stem Cell Trial Approved By Royal Melbourne Hospital For Orthopaedic Use
Australian adult stem cell company, Mesoblast Limited , announced today approval to commence the first human orthopaedic trial of Mesoblast’s specialist adult stem cell technology.
Article

ViaCell, Inc. Says FDA Formalizes Halting Of Study By Issuing Clinical Hold
ViaCell, Inc. today announced that the U.S. Food and Drug Administration (FDA) has placed a clinical hold on the Company’s Phase I clinical trial evaluating CB001, an investigational cord blood stem cell product for hematopoietic stem cell transplantation in patients affected by a variety of cancers.
Article

StemCells, Inc. Announces Filing of IND Amendment for Human Neural Stem Cell Transplant Treatment for Batten Disease
StemCells, Inc. today announced the filing with the U.S. Food and Drug Administration (FDA) of an amendment to its initial IND (Investigational New Drug) application to begin a clinical trial of its human neural stem cells (HuCNS-SC) as a treatment for Batten disease.
Article

Stem Cell Therapy International Signs Exclusive License Agreement for the Supply of Stem Cells and Use of 26 Related Patents from the Institute of Cell Therapy In Kiev, Ukraine
Stem Cell Therapy International, Inc. today announced that it has signed an exclusive global Licensing Agreement with the Institute of Cell Therapy (ICT) a biotechnology company incorporated and organized in Kiev, Ukraine, for the supply of stem cells and use of 26 related patents.
Article

ReNeuron Group PLC Holds Key Meeting with the FDA Regarding Its ReN001 Stem Cell Therapy for Stroke
ReNeuron Group PLC today announced that it has held a formal pre-IND1 meeting with the CBER2 component of the US Food & Drug Administration (FDA) regarding its lead ReN001 stem cell therapy to treat chronic disability after stroke.
Article

Cellerant Therapeutics Adds $9 Million to Series B Round for a Total of $25 Million
The first closing was led by Novel Bioventures, with the participation of Series A stockholders MPM Capital, Allen & Company LLC, and BD Ventures, and new investors CX Venture Group and Amgen founder George Rathmann.
Article

Genzyme Expands Global Infrastructure for Manufacturing, R&D
Genzyme Corporation announced today that it has substantially strengthened its global infrastructure for manufacturing and product development through four major expansion projects in Belgium, Ireland, and the United Kingdom.
Article

Alnylam Grants QIAGEN License to Kreutzer-Limmer Patents in the Research Products Market
Alnylam Pharmaceuticals, Inc., a leading RNAi therapeutics company, announced today that it has granted QIAGEN N.V. (Nasdaq: QGEN; Frankfurt, Prime Standard: QIA), a leading provider of innovative enabling technologies and products for the separation, purification and handling of nucleic acids and proteins, a non-exclusive license to provide research products and services in RNA interference (RNAi) under the Kreutzer-Limmer patent family.
Article

Dendreon Corporation Announces Modulation Of Trp-p8 Significantly Inhibits Tumor Growth In Vivo
Dendreon Corporation today announced new data was presented showing that modulation of the Trp-p8 tumor target with small molecules may represent a new approach to cancer therapy.
Article

Kensey Nash Announces Expanded Indications for Its BioBlanket(TM) Soft Tissue Repair Patch 
The expanded indications specifically allow the product to be used for the repair of hernias and reinforcement of soft tissue in rotator cuff repair surgery, two of the important target markets for the technology.
Article

Life Therapeutics Acquires Pyramid Biological Corporation; Acquisition Expands Company’s Plasma Collection Capacity, Increases Share of Global Hyperimmune and Normal Plasma Markets
Life Therapeutics announced today the signing of a binding agreement to acquire privately-held Pyramid Biological Corporation, for US$13 million plus assumption of US$7 million debt. An additional US$5 million is subject to milestones.
Article

Osiris Launches the Osteocel(R) Product Line; Bone repair product provides a much needed option for orthopedic surgery
Osiris Therapeutics, Inc. announced today that it has begun distribution of Osteocel(R) a product indicated for the repair, replacement and/or reconstruction of bone defects. Osteocel is an allogeneic bone matrix containing viable stem cells.
Article

Vernalis PLC Signs Agreement With Diosynth Biotechnology (Research Triangle Park) For Phase III Manufacture Of V10153
Vernalis Plc has signed a contract with Diosynth Biotechnology for process development, scale-up and manufacturing of V10153 for Phase III clinical trials.
Article

MARKET REPORTS

Malachite Management has joined forces with established and reputable authors and publishers to bring you the following market reports outlining the very latest in Cell Therapy, Gene Therapy, and Immunotherapeutic approaches to Cancer. 

“Cell Therapy – Technologies, Markets, and Companies” is over 400 pages of the basic technologies, clinical applications, market analysis, and company profiles related to the cell therapy industry worldwide.
For more information, including order forms, please see:

Cell Therapy Report Summary
Cell Therapy Sample Chapter
Cell Therapy Table of Contents Vol. 1  Vol. 2
Cell Therapy Order Form

“Gene Therapy – Technologies, Markets, and Companies” is over 500 pages of the basic technologies, clinical applications, market analysis, and company profiles related to the gene therapy industry worldwide.
For more information, including order forms, please see:

Gene Therapy Report Summary
Gene Therapy Table of Contents Vol. 1 Vol. 2
Gene Therapy Order Form

The Immunotherapy Reports cover the most recent developments in the immunotherapeutic approaches to cancer.

A Shift in Cancer Immunotherapy Strategies?
Immunotherapy Strategies Executive Summary
Immunotherapy Strategies Table of Contents

Future Perspectives in Cancer Immunotherapy
Future Perspectives Executive Summary
Future Perspectives Table of Contents

Immunotherapy Reports Order Form

NIH


NATIONAL INSTITUTES OF HEALTH

NIBIB-NSF Bioengineering and Bioinformatics Summer Institutes Program (BBSI): A Joint Program for  Multidisciplinary Research Training and Education (NOT-EB-05-008)
Link

CBER

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

Guidance for Industry: Collection of Race and Ethnicity Data in Clinical Trials
Link

Code of Federal Regulations – Biologics Related
Link

Approved Biological NDA and ANDA Applications – Update
Link

Cleared Biological 510(k) Device Applications – Update
Link

Approved Biological Premarket Approval (PMA) Device Applications- Update
Link

10th Annual GMP by the Sea Conference – Slides
Link

Recall of Albumin (Human) 25%, Albuminar – Update – ZLB Behring LLC
Link

Regulatory

UNITED STATES OF AMERICA

FDA

Industry Exchange Workshop on Food and Drug Administration Clinical Trial Requirements; Public Workshop
Link

Preparation for International Conference on Harmonization Meetings in Chicago, Illinois; Public Meeting
Link

NEW ZEALAND

Medsafe
Regulatory Consultants Update
Link

For Country-Specific & International Regulatory Resources, Including Regulatory Agencies Such As the FDA, EMEA, & More, Please Visit The Regulatory Page On The Cell Therapy News Website 

Meetings

NEW THIS WEEK


Short Course in Cord Blood Transplantation
(in conjunction with The Annual Meeting of the Singapore Society of Haematology)
March 31 – April 1 2006
The Nanos, Singapore
Link

To View an Up-to-Date List of Cell Therapy-Related Meetings, Please Visit The Meetings Page  On The Cell Therapy News Website

Journals

To View a List of Cell Therapy-Related Journals, Please Visit The Journals Page On The Cell Therapy News Website

Careers

JOB POSTINGS IN CELL THERAPY NEWS ARE FREE!
For information on posting an opportunity email: [email protected]

Director of Quality and Regulatory Affairs NEW!
Florida (Company Confidential)

Cell Processing Tech I
 
Houston, Texas (Baylor College of Medicine Center for Cell & Gene Therapy)

Hospital Scientist 

Sydney, Australia (Bone Marrow Stem Cell Laboratory of St. Vincent’s Hospital)

Scientist/Immunologist (Research and Development
 
Gaithersburg, Maryland (Maxcyte)

Clinical Consultant  
Deerfield, Illinois (Baxter Healthcare)

Cord Blood Director 
Minneapolis Minnesota (The National Marrow Donor Program™)

Cytotherapy Technologist Stem Cell 
New York, New York (Memorial Sloan-Kettering Cancer Center)

Director of Research Programs 
Toronto, Ontario (Ontario Genomics Institute) 

Laboratory Supervisor (Stem Cell Lab)
Charlottesville, Virginia (University of Virginia Health System)

Scientific Review & Program Officers 
San Diego, California (California Institute of Regenerative Medicine)

Scientific/Technical Officer,Stem Cell Transplant Laboratory/Haematology 
Sydney, Australia (SWAPS, Liverpool Hospital)

Senior Officer for Medical & Ethical Standards 
San Diego, California (California Institute of Regenerative Medicine)

Vice President of Manufacturing Operations 
Dallas, Texas (ODC Therapy Inc.)

ISCT

Upcoming Meetings & Conferences:

2005 Cell Therapy Audioconference Series

Profiled Journal

Cytotherapy now incorporates “Cytokines, Cellular & Molecular Theory”

Join ISCT ($130) and receive the journal as a benefit of membership
http://www.celltherapy.org/mem_app.htm


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.
www.cytotherapy.com



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