Volume 7.08 | Mar 6

Volume 7.08, March 6, 2006
     In this issue: Science | Policy | Business | NIH | CBER | Regulatory
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Top Stories

Stem Cells Stabilize Huntington’s Disease: Transplanting embryonic neuronal tissue into the brains of patients with Huntington’s chorea has resulted in six years of stable disease, as well as motor and cognitive improvement, say French researchers in this week’s online issue of The Lancet Neurology.

Marrow-derived Stem Cells Deliver New Cytokine To Kill Brain Tumor Cells, Offer Protection: Attaching a recently discovered cytokine to neural stem cells derived from bone marrow, researchers at Cedars-Sinai Medical Center’s Maxine Dunitz Neurosurgical Institute have developed a tool to track and kill malignant brain tumor cells and provide long-term protection against their return.


Gene Therapy Shield for Cancer Treatment
Gene therapy could be used to shield important healthy stem cells of cancer patients during radiotherapy, enabling stronger doses to be administered safely, according to a report published today in the Journal of Gene Medicine*.

Bone Marrow Cells Can Become Functional Gut Lining Cells
Researchers report the discovery that cells used in bone marrow transplantation can develop into new cells lining the gut, according to a study by Yale School of Medicine in the Proceedings of the National Academy of Sciences.

Tissue Engineering Technique Does Not Cause Tumor Growth
A gene therapy approach used in creating new arteries for older patients does not appear to cause cancer, according to a pilot study by Yale School of Medicine researchers reported in the Proceedings of the National Academy of Sciences.

Stem Cell Mobilization Therapy Ineffective in Repairing Heart Attack Damage
Therapy that involved bone marrow stem cells did not improve cardiac function in patients following a heart attack, according to a study in the March 1 issue of JAMA.

FDA Approves Rituxan(R) – The First Targeted B-Cell Therapy for Treatment of Moderate-to-Severe Rheumatoid Arthritis
Genentech, Inc. (NYSE: DNA – News) and Biogen Idec, Inc. (Nasdaq: BIIB – News) announced today that the U.S. Food and Drug Administration (FDA) has approved, following Priority Review, the therapeutic antibody Rituxan® (Rituximab) in combination with methotrexate (MTX) to reduce signs and symptoms in adult patients with moderately-to-severely active rheumatoid arthritis (RA) who have had an inadequate response to one or more tumor necrosis factor (TNF) antagonist therapies.

Bioengineers Create Stable Networks Of Blood Vessels
Yale biomedical engineers have created an implantable system that can form and stabilize a functional network of fine blood vessels critical for supporting tissues in the body, according to a report in the Proceedings of the National Academy of Sciences.


Human Embryonic Stem Cells and Their Differentiated Derivatives Are Less Susceptible to Immune Rejection Than Adult Cells
Thus, immunosuppressive regimens for hESC-based therapeutics could be highly reduced compared with conventional organ transplantation because direct allorejection processes of hESCs and their derivatives are considerably weaker.

Innovation in Biomedicine: Can Stem Cell Research Lead the Way to Affordability?
In 2004, California voters approved a US$3 billion stem cell research program. Goozner outlines his innovative suggestions for ensuring that any treatments resulting from the program will be made affordable for state residents.


Trial Over California’s Stem Cell Institute Concludes
A trial that could determine the fate of the state’s $3-billion stem cell research initiative concluded Thursday in Alameda County Superior Court, but the judge will not issue a ruling until later this month at the earliest.

Hospital Is Rebuked in Organ Case
The national organization that regulates organ transplantation handed its harshest rebuke Thursday to St. Vincent Medical Center in Los Angeles — the first time it has publicly sanctioned one of its members.

Pope Benedict XVI Declares Embryos Developed For In Vitro Fertilization Have Right To Life
Pope Benedict XVI during a conference on Monday said embryos developed for in vitro fertilization have a right to life even before they are implanted in a woman’s uterus.


Sangamo BioSciences Licenses MaxCyte Cell Loading Technology for ZFP Therapeutic Program for HIV/Aids
MaxCyte, Inc. and Sangamo BioSciences, Inc. (Nasdaq: SGMO – News) announced today a license, option, development, and supply agreement to utilize MaxCyte’s proprietary cell loading system for use in Sangamo’s HIV/CCR5 ZFP Therapeutic(TM) program.

Osteotech (OSTE) And Community Tissue Services Enter Into Tissue Supply Agreement
Osteotech, Inc. announced today that it successfully completed the first milestone of its recently announced tissue diversification strategy by entering into a tissue supply agreement with Community Blood Center/Community Tissue Services (“CTS”).

Chemicon International and Stem Cell Sciences Announce Launch of ESGRO Complete(TM) Product Line
Serologicals Corporation (NASDAQ: SERO) announced today that Chemicon International, Inc., its wholly-owned subsidiary, and Stem Cell Sciences plc (LSE:STEM, SCS) are launching the ESGRO Complete(TM) product line for murine embryonic stem (ES) cell culture, following the establishment of an exclusive agreement on November 3, 2005.

Diosynth Biotechnology Enters Long-Term Commercial Supply Agreement With Dendreon Corporation
Diosynth Biotechnology has entered into a long-term commercial supply agreement with Dendreon Corporation for the manufacture of the recombinant antigen component of PROVENGE(R) (sipuleucel-T), Dendreon’s investigational active cellular immunotherapy for prostate cancer.



Updates to NIH’s Electronic Application Submission Program Available Through Listserv Subscription (NOT-OD-06-047)

Novel HIV Therapies: Integrated Preclinical/Clinical Program (U19) (RFA-AI-06-009)

Characterization, Behavior and Plasticity of Pluripotent Stem Cells (R21) (PA-06-198)


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

FDA Public Health Notification: Update of Information about BioMedical Tissue Services

Device Correction: Operator’s Manual for Baxter Fenwal Amicus Separator – Baxter Healthcare Corp

Exceptions and Alternative Procedures Approved Under 21 CFR 640.120 – Update


Health Canada (Canada)

Expert Advisory Committee on Cells, Tissues and Organs- Update Membership List


ISCT2006. May 4-7. Berlin.
Click here for the preliminary program or registration information.

AABB-ISCT Cellular Therapy Audioconference Series

Profiled Journal

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

Current Volume: Volume 8 Number 1/February 2006

This issue contains:

Can we use monoclonal antibodies to help T cells fight tumors?

CTLA-4 blockade by a human MAb enhances the capacity of AML-derived DC to induce T-cell responses against AML cells in an autologous culture system

The apoptotic and proliferative fate of cytokine-induced killer cells after redirection to tumor cells with bispecific Ab

Expression of aberrantly glycosylated tumor mucin-1 on human DC after transduction with a fiber-modified adenoviral vector

Transduction with a fiber-modified adenoviral vector is superior to non-viral nucleofection for expressing tumor-associated Ag mucin-1 in human DC

General safety guidances in stem cell bank installations

Novel cryoprotectant significantly improves the post-thaw recovery and quality of HSC from CB

Introduction of a validation concept for a PCR-based Mycoplasma detection assay

SCF modulates organ distribution and hematopoietic engraftment of CB-derived pluripotent HPC transplanted in NOD/SCID mice

Quality assessment of autografting by probability evaluation: model estimation by clinical end-points in newly diagnosed multiple myeloma patients

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.