Volume 6.44 | Oct 31

Volume 6.44, October 31, 2005
     In this issue: Science | Policy | Business | NIH | CBER | Regulatory
Cell Therapy News on Facebook  Cell Therapy News on Twitter

Top Stories

Stem Cells Turned into Organ Precursors: Scientists said Friday they have for the first time turned embryonic stem cells in the lab into a type of cell that can give rise to several internal organs, including the pancreas, liver and lungs.
Article

Tissue Implants in Canada May Have Come from Bodies Taken from Funeral Homes: Some Canadians who received transplants of bone, skin or tendons need to be tested for infectious diseases like HIV and hepatitis after it was discovered the U.S. supplier of the products may have illegally procured them from corpses at funeral homes.
Article

Science

Tissue Implants in Canada May Have Come from Bodies Taken from Funeral Homes
Some Canadians who received transplants of bone, skin or tendons need to be tested for infectious diseases like HIV and hepatitis after it was discovered the U.S. supplier of the products may have illegally procured them from corpses at funeral homes.
Article

Bone Marrow Stem Cells May Heal Hearts Even Years After Heart Attacks
Left ventricular function and exercise capacity increased, while the area of heart muscle damage shrank, in 18 patients given infusions of their own bone marrow stem cells up to eight years after a heart attack, according to a new study in the Nov. 1, 2005, issue of the Journal of the American College of Cardiology.
Article

Scientists Find Key Step in a Signaling Pathway that Helps Orchestrate Embryonic Development
University of California – San Francisco (UCSF) scientists have illuminated a key step in a signaling pathway that helps orchestrate embryonic development.
Article

New Understanding of How Neurogenesis Occurs
According to a study published in this week’s Nature, the decision to become a neuron is controlled by Wnt3 signaling molecules, which are secreted by neighboring astrocytes.
Article

Lineage Trees for Cells
Some fundamental outstanding questions in science – “Where do stem cells originate?” “How does cancer develop?” “When do cell types split off from each other in the embryo?” – might be answered if scientists had a way to map the history of the body’s cells going back to the fertilized egg. Now, a multidisciplinary team at the Weizmann Institute of Science has developed an analytical method that can trace the lineage trees of cells.
Article

Gene Therapy Reverses Genetic Mutation Responsible for Heart Failure in Muscular Dystrophy
University of Pittsburgh investigators have for the first time used gene therapy to successfully treat heart failure and other degenerative muscle problems in an animal model that is genetically susceptible to a human muscular dystrophy.
Article

Gene Therapy Operation Girl Recovering
Three-year-old Jasmine Harris, from Shooters Hill in south London, was one of 11 children picked for the controversial gene therapy from the 500 sufferers of Batten’s Disease worldwide.
Article

OPTN/UNOS Data Shows Significant Difference in Cancer Incidence Rates in Transplant Recipients Based Upon Immunosuppression Regimen
In the Oct. 15 edition of the journal Transplantation, a retrospective analysis of data from more than 33,000 renal transplant patients in the OPTN/UNOS (Organ Procurement and Transplant Network/United Network for Organ Sharing) database showed that the relative risk of developing any post-transplant skin or non-skin malignancy is substantially reduced in patients receiving maintenance immunosuppression with mTOR inhibitors as compared to patients receiving treatment with traditional calcineurin inhibitors.
Article

San Francisco Fertility Clinic To Recruit Women To Donate Eggs To Clone for Embryonic Stem Cell Research
The San Francisco-based Pacific Fertility Center plans to recruit women to donate eggs to be cloned for embryonic stem cell research conducted by the newly created World Stem Cell Foundation.
Article

ABSTRACT, REVIEWS, & SPECIAL REPORTS

Artificial and Engineered Chromosomes: Developments and Prospects for Gene Therapy
Among the topics discussed at the gene therapy session and the main focus of this review are requirements for de novo human artificial chromosome formation, assembly of chromatin on de novo human artificial chromosomes, advances in vector construction, and chromosome transfer to cells and animals.
Abstract

Combining Cytotoxic and Immune-mediated Gene Therapy to Treat Brain Tumors
We have therefore reviewed the most exciting non-invasive, in vivo imaging techniques which can be used in combination with gene therapy to monitor therapeutic efficacy over time.
Abstract

Effect of Neurotrophic Factors on Neuronal Stem Cell Death
Promotion of the long term-survival and differentiation of the transplanted neural precursors by PDGF may facilitate regeneration in the aging adult brain and probably in the injury sites of the brain.
Abstract

Use of Cytokines in Cancer Vaccines/immunotherapy: Recent Developments Improve Survival Rates for Patients with Metastatic Malignancy
This new knowledge offers support for further enhancing patient survival by combining previous therapies such as use of cytokines in biochemotherapy together with immunization using cytokine activated whole cell cancer vaccines in the future.
Abstract

Policy

Czech Deputies Support Bill on Stem Cells Research
Czech scientists might be able to work with human embryonal stem cells from redundant or damaged eggs as the Chamber of Deputies supported the relevant government bill in the first reading today.
Article

Specter Drops Plan To Attach Embryonic Stem Cell Bill to Budget Measure, Says Frist Agreed to Vote Next Year, USA
Sen. Arlen Specter (R-Pa.) on Friday said he will not attempt to attach language from a bill (HR 810/S 471) that would expand federal funding for human embryonic stem cell research to the fiscal year 2006 Labor-HHS-Education (HR 3010) appropriations measure, the New York Times reports.
Article

Business

Stem Cell Therapy International Announces the Successful Treatment of Stroke Victim Who Received Stem Cell Transplantation Therapy
Stem Cell Therapy International, Inc. (OTC: SCII), a leading company in the field of research and development of stem cell transplantation (SCT) therapy and regenerative medicine, announced today the successful results of a case of stem cell transplantation recently concluded in Kiev, Ukraine, on Ian McBride, 49, a stroke victim from Belfast, Ireland.
Article

ReNeuron Group plc Demonstrates Key Characteristics with its Hepatocyte (liver) Cell Lines for Drug Discovery Applications
ReNeuron Group plc (LSE: RENE.L) today announced that it has developed human hepatocyte (liver) cell lines using its proprietary c-mycERTAM platform technology.
Article

European Commission Approves Kepivance(TM) (Palifermin) for Oral Mucositis in Cancer Patients Undergoing Blood and Bone Marrow Transplant
Amgen (Nasdaq:AMGN), the world’s largest biotechnology company, today announced that Kepivance(TM) (palifermin) has received regulatory approval in the European Union (EU).
Article

Sigma-Aldrich Corporation (SIAL) Strengthens Position In RNAi Through Licensing And Equity Positions In Benitec Limited (BLT.AX) And Oxford BioMedica PLC (OXB.L)
Sigma-Aldrich, a leading $1.4 billion Life Science company announced today that it has signed a series of agreements that expand its position in the area of RNA Interference (RNAi).
Article

BioWa and OncoTherapy Science Announce Collaboration to Develop Anticancer Monoclonal Antibodies With Enhanced ADCC
BioWa, Inc. and OncoTherapy Science, Inc. today announced that the two companies have entered into a collaboration to identify and develop cancer- focused monoclonal antibodies (Mabs).
Article

Chromos Molecular Systems Inc. (CHR.TO) Enters Definitive Agreement To Acquire Targeted Molecules Corporation; Secures Financing Commitments
Chromos Molecular Systems Inc. (“Chromos”) (TSX:CHR) announced today that it has entered into a definitive agreement under which it will acquire Targeted Molecules Corporation (“TMC”), a privately held San Diego based biotechnology company focused on the research and development of two antibody product candidates for treatment of multiple sclerosis (MS) and acute thrombosis.
Article

ChondroGene Inc. (CDG.V) Enters Into Agreement With Kaiser Permanente
ChondroGene Limited announced today that it has entered into an agreement with the Division of Research of the Permanente Medical Group of Northern California, to jointly develop a research database infrastructure that will be used for genomic research.
Article

GE Healthcare Introduces ÄKTAprocess – A Flexible Chromatography System for Fast and Efficient Purification at Process Scale
GE Healthcare, a unit of General Electric Company (NYSE: GE), introduced today the ÄKTAprocess low pressure liquid chromatography system for accurate, and reproducible purification in downstream processing. ÄKTAprocess is a configurable manufacturing system that promotes process efficiency and reliability, and complies with regulatory requirements.
Article

U.S. BioDefense, Inc. (UBDF.OB) Option Agreement With The University of Minnesota Ended
U.S. BioDefense, Inc. announced today that its Option Agreement to license United States Patent Application No. 6,485,722 B1 entitled “Method for Selective Engraftment of Drug-Resistant Hematopoietic Stem Cells” and related applications was unilaterally terminated by University of Minnesota.
Article

ViaCell, Inc. Announces Settlement Of Litigation With Cord Blood Registry
ViaCell, Inc. announced today that it has entered into an agreement to settle pending litigation with CBR Systems, Inc.
Article

Hemosol (HMSL) Cuts Two-Thirds Of Staff To Conserve Cash
Hemosol Corp. (NASDAQ: HMSL, TSX: HML) today announced that it has served approximately two thirds of its employees with layoff notices.
Article

ViRexx Appoints Dr. Lorne Tyrrell Chief Executive Officer
ViRexx Medical Corp. (TSX:VIR), a company focused on immunotherapy treatments for cancer, chronic hepatitis B & C and embolotherapy treatments for tumors today announced that Dr. Lorne Tyrrell has been named the Company’s Chief Executive Officer by the Board of Directors effective November 1, 2005.
Article

PharmaFrontiers Corp. Elects Interim Chairman
PharmaFrontiers Corp. (OTCBB:PFTR), a company involved in the development and commercialization of cell therapies, announced today that Brooks Boveroux, a director of the Company, has been unanimously elected interim chairman of the board, effective immediately.
Article

NIH

NIH Rolls Out Electronic Grant Submission
Stacks and stacks of grant application packages on paper will soon be a thing of the past at the National Institutes of Health (NIH) as it readies to receive grant applications electronically through the federal portal of Grants.gov, marking a major change in the way it has traditionally conducted its grants submission business.
Link

NIH Guide for Grants and Contracts – Week Of October 28, 2005
Link

Electronic Submission of Small Business Innovation Research Program (SBIR) and Small Business Technology Transfer (STTR) Program Electronic Grant Applications through Grants.gov (NOT-OD-06-008)
Link

Delays in Grant Application Submission due to Hurricane Wilma (NOT-OD-06-006)
Link

Notice of the NHLBI Clinical Hematology Research Career Development Program (NOT-HL-06-110)
Link

CBER

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

Vaccines and Related Biological Products Advisory Committee Meeting
Link

Blood Products Advisory Committee Meeting
Link

510(k) Summary – COBE Angel Whole Blood Separation System – COBE Cardiovascular, Inc
Link

Substantially Equivalent 510(k) Device – BloodTrack SafeTx Version 2.0 – Neoteric Technology Ltd
Link

Exceptions and Alternative Procedures Approved Under 21 CFR 640.120 – Update
Link

Substantially Equivalent 510(k) Device – SoftDonor 4.3 with SoftScape 1.2.0 – SCC Soft Computer
Link

510(k) Summary – Monitor Blood Administration Module Release 24.0- Healthcare Management Systems, Inc
Link

510(k) Summary – Dynal RELI SSO HLA-DRB1 Typing Kit – Dynal Biotech Ltd
Link

510(k) Summary – Pall Acrodose PL System, Platelet Pool and Store Set with eBDS – Medsep Corp
Link

510(k) Summary – Leucolab LCG2 Leukoreduction System for Red Blood Cells – MacoProductions S.A.S
Link

Vaccines and Related Biological Products Advisory Committee Meeting
Link

Regulatory

Food & Drug Administration (USA)

FDA Provides Information on Investigation into Human Tissue for Transplantation
The Food and Drug Administration (FDA) is notifying the public of its investigation of human tissue recovered by Biomedical Tissue Services, Ltd. (BTS) of Ft. Lee, NJ, and sent to tissue processors.
Link

Vaccines and Related Biological Products Advisory Committee; Notice of Meeting
November 17, 2005
Link

Medical Devices; Immunology and Microbiology Devices; Classification of Cystic Fibrosis Transmembrane Conductance Regulator Gene Mutation Detection System
Link

ISCT

2005 Cell Therapy Audioconference Series
Link



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.

Here’s how the deal works:

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

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.
http://journalsonline.tandf.co.uk/link.asp?id=107693



 Learn more about Cell Therapy News:  Archives  |  Events  |  Update Profile  |  Contact Us