Volume 6.43 | Oct 24

Volume 6.43, October 24, 2005
     In this issue: Science | Policy | Business | NIH | CBER | Regulatory
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Top Stories

Clarification of the Nomenclature for MSC: The International Society for Cellular Therapy Position Statement: To address this inconsistency between nomenclature and biologic properties, and to clarify the terminology, we suggest that the fibroblast-like plastic-adherent cells, regardless of the tissue from which they are isolated, be termed multipotent mesenchymal stromal cells, while the term mesenchymal stem cells is used only for cells that meet specified stem cell criteria.

International Stem Cell Bank Opens: A bank that will create and supply new lines of embryonic stem cells for research around the world has been opened in Seoul, South Korea.


BWH Researchers Generate New T Cells from Adult Skin Tissue and Bone Marrow Stem Cells
Boston – Researchers at Brigham and Women’s Hospital (BWH), for the first time, have discovered that adult skin tissue and bone marrow stem cells can be used to create T cells-cells that are largely responsible for fighting disease in the human body.

New Tissue ‘Grown within Minutes’
The lengthy process can be accelerated by simply removing the water present in the starting material, the University College London team discovered.

Development of Gametes from Embryonic Stem Cells
Researchers at Cornell reported the ability to generate new pluripotent stem cell lines from embryos which began not as a union of sperm and egg, but rather of an egg and an embryonic stem cell.

First Korean Clinical Trial of Stem Cell Therapy Due This Year
The first clinical application of embryonic stem cell therapy by Korean researchers could be made this year at the earliest or next year, experts forecast in a report released yesterday.

New U of T Strategy Will Boost Cord Blood Stem Cells
A team of bioengineers led by the University of Toronto has discovered a way to increase the yield of stem cells from umbilical cord blood, to an extent which could broaden therapeutic use of these cells.

New Stem Cell Transplantation Technique May Match Donor For Every Patient
By using novel graft engineering technologies, a stem cell donor may be matched for almost every patient that needs one.

Gene Therapy May Protect Normal Tissues During Radiation Retreatment for Lung Cancer
Gene therapy could be used as an agent to protect normal tissues, including the esophagus and lung, from damage during a second administration of radiation therapy for non-small cell lung cancer, according to an animal study presented today by University of Pittsburgh researchers at the 47th Annual Meeting of the American Society for Therapeutic Radiology and Oncology (ASTRO) in Denver.

New Antifreeze Protein May Allow Longer Storage Of Transplant Organs
A new antifreeze protein discovered in tiny snow fleas by Queen’s University researchers may lengthen the shelf life of human organs for transplantation.

Subtypes of Ependymomas Arise from Rare Stem Cells in the Nervous System
Brain tumors called ependymomas that occur in different parts of the central nervous system appear to arise from subpopulations of stem cells called radial glia cells (RGCs), according to investigators at St. Jude Children’s Research Hospital.

Gene Therapy for Kidney Failure
A new technique delivers gene therapy directly to blood vessels in patients with kidney failure who undergo dialysis.

Using T-Cell-Based Vaccines, Penn Researchers Achieve Rapid Restoration of Immunity in Immune-Suppressed Cancer Patients
“We found that we can rapidly rebuild the patients’ immunity after chemotherapy and stem-cell transplant,” said Carl June, MD, Director of Translational Research at Penn’s Abramson Cancer Center.

Immunotherapy Provides Responses in Refractory Nasopharyngeal Cancer
According to an early on-line publication in the Journal of Clinical Oncology, a type of immunotherapy targeted against cancer cells appears to provide some anticancer responses in patients with advanced nasopharyngeal cancer that has stopped responding to radiation and chemotherapy.

Discovery Could Help make Cellular Immunotherapy Safer
Researchers at the University of Michigan’s Comprehensive Cancer Center have discovered the secret weapon behind the most powerful form of cancer immunotherapy known to medicine.

Chineses Doctors and Nurses Donate Stem Cells to Cut Shortage
More than 800 doctors and nurses from Zhongshan Hospital registered with the Shanghai Stem Cell Donor Bank yesterday, to help solve the shortage of samples at the bank and encourage more people to register and donate stem cells.


Clinical Proteomics: from Biomarker Discovery and Cell Signaling Profiles to Individualized Personal Therapy
The successful transition of these groundbreaking proteomic technologies from research tools to integrated clinical diagnostic platforms will require ongoing continued development, and optimization with rigorous standardization development and quality control procedures.

Development of a Gene Therapy Based Bone Marrow Purging System for Leukemias
These proof of principle experiments demonstrate that gene therapy technology could be utilized to successfully purge leukemia cells from HPC.

Ex Vivo Regeneration of the Murine Kidney from Human Mesenchymal Stem Cells
These findings, which show that mesenchymal cells can differentiate into each type of resident cell and organize into a renal structure, suggest a potential for therapeutic renal regeneration.

Gene Therapy Bio-safety: Scientific and Regulatory Issues
A European cooperation between professionals (researchers, physicians, industries, patients’ associations, investors, etc) will allow implementation of gene therapy regulation in Eastern European countries.


Irish Hospitals Ban Staff From Storing Stem Cells
The three public maternity hospitals in Dublin have formally signed off on an agreement preventing staff from helping parents store stem cells from babies after birth.

Bank for Umbilical Cord Blood
New Jersey will create a storage bank for umbilical cord blood to aid stem cell research, under an executive order signed Tuesday by acting Gov. Richard J. Codey. State officials say it will be the first such program in the nation.


StemCells, Inc. Receives FDA Clearance to Initiate Phase I Clinical Trial of Neural Stem Cells to Treat Batten Disease; First-Ever FDA-Approved Trial to Transplant Human Neural Stem Cells
StemCells, Inc. (NASDAQ: STEM) today announced that it has received clearance from the U.S. Food and Drug Administration (FDA) to begin a Phase I safety and preliminary efficacy trial of the Company’s proprietary human neural stem cell product -HuCNS-SC ™- to treat Batten disease. Batten disease is a rare, fatal genetic disorder that affects the central nervous system of children.

AnorMED to Seek Conditional Marketing Authorization in Europe for MOZOBIL(TM), a New Stem Cell Mobilizer
AnorMED Inc. (TSX:AOM) announced today that it will seek a Conditional Marketing Authorization (CMA) for MOZOBIL (AMD3100, Plerixafor) in Europe in early 2007.

Cytori Demonstrates Adipose Stem Cells Improve Cardiac Function In Preclinical Heart Attack Model
Cytori Therapeutics, Inc. (Frankfurt: XMP), today presented results demonstrating that adipose stem cells improved cardiac function following a severe heart attack in a porcine study.

GE Healthcare Introduces the First Sterile Media For Mononuclear Cell Preparation Compliant with ISO and EC Guide to GMP
GE Healthcare announced today the launch of Ficoll-Paque™ PREMIUM.

GenVec Announces Plan to Sell Myoblast Cell Therapy Program to a Newly Formed Company
GenVec, Inc.(Nasdaq:GNVC) announced today that it has entered into a non-binding letter of intent to sell to a third-party buyer the assets and technology related to its myoblast cell therapy program to treat congestive heart failure that was acquired through GenVec’s 2003 merger with Diacrin, Inc.

LCT files Pre-IND Request Letter with FDA for its NeurotrophinCell Product
Living Cell Technologies Limited (ASX: LCT) today announced that it has filed a request for a Pre-IND Meeting with the FDA to seek guidance and feedback on the development program for its NeurotrophinCell product.

New MultiCell/Thomas Jefferson University Research Collaboration to Evaluate Cell Lines for Hepatitis C Treatment
MultiCell Technologies, Inc. (OTCBB: MCET), announced today that the Company has entered into a research collaboration with Thomas Jefferson University, Philadelphia’s premier medical and health sciences university, to evaluate the Company’s immortalized human hepatocytes as model systems to identify new drugs to treat hepatitis C viral (HCV) infection.

Oxford Biomedica Plc Announces Oxford BioMedica Presents Encouraging Final Phase II Results with Trovax(R) in Colorectal Cancer at the International Colorectal Cancer Congress
Oxford BioMedica (LSE: OXB), the leading gene therapy company, today announced that further encouraging data were presented from the Phase II trials of TroVax, its cancer immunotherapy, in metastatic colorectal cancer (CRC) at the Fourth International Colorectal Cancer Congress in Aventura, Florida, USA, on Saturday 15 October 2005.

Pluristem Announces Joint Projects Product Development and Worldwide Distributorship Agreement with Biological Industries, Ltd.
Pluristem Life Systems, Inc. (OTC BB: PLRS) (the “Company”), a biotechnology company dedicated to the expansion of stem cells from umbilical cord blood to address a myriad of fatal illnesses, today announced that the Company has launched a collaboration with Biological Industries, Ltd., to globally distribute joint project products in the field of serum-free media specially designed for hematopoietic and mesenchymal stem cells utilizing Pluristem’s patented PluriX(TM) bioreactor.

Positive Results of Trinam® Gene Therapy Presented at American College of Surgeons Congress
Ark Therapeutics Group plc (“Ark”) today announces the publication of positive results from an ongoing Phase II trial of Trinam®, its novel gene therapy to prevent blood vessels blocking in kidney dialysis patients who have undergone vascular access graft surgery.

ProMetic: Results of Blood-Borne Infectivity Study Show Dramatic Reduction in TSE Prions Using PRDT Technology; Results Presented at American Association of Blood Banks Forum Have Positive Implications for Human Blood Supply
Pathogen Removal and Diagnostic Technologies Inc. (PRDT), a joint venture between ProMetic Life Sciences Inc. (TSX:PLI.SV) and the American Red Cross, today announced the results of a major study showing that its patented ligand technology removes all detectable blood-borne TSE (transmissible spongiform encephalopathy) infectivity from whole blood.

ThermoGenesis Corp. Provides Master File for the AutoXpress System to the FDA
ThermoGenesis Corp.(NASDAQ:KOOL) announced today that it has provided a Master File on the AutoXpress System to the FDA.


National Cancer Institute Announces $35 Million in Awards to 12 Cancer Nanotechnology Platform Partnerships
The National Cancer Institute (NCI), part of the National Institutes of Health (NIH), today announced funding for a major component of its $144.3 million, five-year initiative for nanotechnology in cancer research.

NHGRI’s Large-Scale Sequencing Research Network Sets Its Sights on Disease Targets: NHGRI Effort Expands to Include Medical Sequencing
In what promises to be a significant step forward in the genome era, the National Human Genome Research Institute (NHGRI), one of the National Institutes of Health (NIH), today announced plans to devote a portion of its large-scale sequencing capacity to efforts aimed at identifying the genetic roots of specific diseases that have long eluded gene hunters.

NIH Guide for Grants and Contracts – Week Of October 21, 2005

Small Business Innovation Research to Improve The Chemistry and Targeted Delivery of RNAi Molecules (SBIR [R43/R44]) (PA-06-003)

Small Business Technology Transfer to Improve The Chemistry and Targeted Delivery of RNAi Molecules (STTR [R41/R42]) (PA-06-004)

Manufacturing Processes of Medical, Dental, and Biological Technologies (SBIR [R43/R44]) (PA-06-013)


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

2005 Biological Approvals – Update

Draft Guidance for Industry: Recommendations for Implementing a Collection Program for Source Plasma Containing Disease-Associated and Other Immunoglobulin (IgG) Antibodies

Recall of Human Tissue Products – Regeneration Technologies, Inc

Guidance for Industry: Providing Regulatory Submissions in Electronic Format–Human Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications

Recall of Human Tissue – Biomedical Tissue Services, Ltd

Recall of Human Tissue Products – Tutogen Medical, Inc

Recall of Human Tissue Products – The Blood and Tissue Center of Central Texas

Withdrawal of Human Tissue Products – Lost Mountain Tissue Bank

RAPS Annual Conference and Exhibition – Slides

CBER Organizational Information – Update

Substantially Equivalent 510(k) Device – Leucolab LCG2 Leukoreduction System for Red Blood Cells – MacoProductions S.A.S.


Food & Drug Administration (USA)

Draft Guidance for Industry on Recommendations for Implementing a Collection Program for Source Plasma Containing Disease-Associated and Other Immunoglobulin Antibodies; Availability


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”.

Cytotherapy/Telegraft Advertising Offer
Cytotherapy- the official journal of the International Society for Cellular Therapy (6x annually) – and Telegraft –ISCT’s global cell therapy newsletter (4 x annually) – are offering an integrated advertisement rates package enabling even more effective coverage of your products, services and recruitment vacancies to the industry at large. The combined reach is impressive, comprising as it does your target audience core.

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Display advertising / print: book an advertisement, any size, in both publications and we will apply a full 30% discount off the combined ratecard price. Plus, we’ll allow any earned volume discount too!

Recruitment advertising / online: postings on the ISCT website are $1,000 for 2 months. But we’ll reduce that by 50% to $500 only if the posting is taken in addition to a print advertisement in Telegraft or Cytotherapy. ISCT web site receives over 125,000 hits per months, guaranteeing your posting industry wide exposure.

All we ask is that you make your first insertion before the end of 2005 but we’ll be pleased to extend this deal with full rate protection into 2006 on anything booked before December 31st 2005. For more information and advertising rates, click here.

Current Volume: Volume 7 Number 5/November 2005

This issue contains:

Persistence makes perfect: the benefits of IL-2 in adoptive immunotherapy

Clarification of the nomenclature for MSC: The International Society for Cellular Therapy position statement

Fate and function of anti-CD3/CD28-activated T cells following adoptive transfer: IL-2 promotes development of anti-tumor memory T cells in vivo

IL-2-activated cord blood mononuclear cells

Expression and recombination of the EGFP and EYFP genes in lentiviral vectors carrying two heterologous promoters

Selective and efficient culturing of retinal pigment epithelial cells using a feeder layer

Innovative strategies for PBPC mobilization

Anterior cruciate ligament constructs fabricated from human mesenchymal stem cells in a collagen type I hydrogel

Stem cell therapy still not here

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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