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

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


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.

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.

“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.

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.

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.

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.

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.

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.

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.


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

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

Molecular Dissection of Mesenchymal–Epithelial Interactions in the Hair Follicle

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


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.



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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.


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
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“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



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


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

Code of Federal Regulations – Biologics Related

Approved Biological NDA and ANDA Applications – Update

Cleared Biological 510(k) Device Applications – Update

Approved Biological Premarket Approval (PMA) Device Applications- Update

10th Annual GMP by the Sea Conference – Slides

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




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

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


Regulatory Consultants Update

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 



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

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


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

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

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

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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)

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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)

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San Diego, California (California Institute of Regenerative Medicine)

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Dallas, Texas (ODC Therapy Inc.)


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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.

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