Volume 8.03 | Jan 29

Volume 8.03, January 29, 2007
     In this issue: Science | Policy | Business | NIH | CBER | Regulatory
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Top Stories

Cells Passed From Mother to Child May be First Step in Developing New Treatments for Type 1 Diabetes and Similar Diseases: For the first time, scientists have discovered that cells passed from mother to child during pregnancy can differentiate into functioning islet beta cells that produce insulin in the child.

Stem Cells Cultured From Human Bone Marrow Behave Like Those Derived From Brain Tissue: Stem cells taken from adult human bone marrow have been manipulated by scientists at the Maxine Dunitz Neurosurgical Institute at Cedars-Sinai Medical Center to generate aggregates of cells called spheres that are similar to those derived from neural stem cells of the brain.


Cancer Stem Cell Development is Documented
U.S. scientists have clarified how normal stem cells become cancer stem cells, as well as how cancer stem cells can cause the formation of tumors.

Brain Tumor Researchers Find Their “Niche”
Brain tumors appear to arise from cancer stem cells (CSCs) that live within microscopic protective “niches” formed by blood vessels in the brain; and disrupting these niches is a promising strategy for eliminating the tumors and preventing them from re-growing, according to results of a study by investigators at St. Jude Children’s Research Hospital.

Researchers Make Diabetes and Stem Cell Breakthrough
A team of South Korean scientists has grown pancreatic beta cells, which can help treat diabetes, from stem cells taken from the umbilical cord blood of new born babies.

Turning a Cellular Sentinel into a Cancer Killer
Howard Hughes Medical Institute researchers have developed two strategies to reactivate the p53 gene in mice, causing blood, bone and liver tumors to self destruct.

Alzheimer’s Vaccine in a Patch
A patch which delivers a vaccine against Alzheimer’s disease through the skin has been shown to be safe and effective, a study has found.

GenVec Announces First Patient Treated with TNFerade(TM) for Head and Neck Cancer at University of Chicago
GenVec, Inc. has announced that the first patient has been dosed in a Phase I/II trial with TNFerade(TM) for head and neck cancer at the University of Chicago Medical Center. GenVec is sponsoring two separate Phase I/II studies at the University of Chicago to explore the use of TNFerade as a second-line treatment for unresectable, recurrent tumors, and as a first-line treatment for elderly or frail patients.

Cell Genesys Announces Encouraging Follow-Up Survival Data From Phase 2 Clinical Trial of GVAX(R) Immunotherapy for Pancreatic Cancer
Cell Genesys, Inc. has announced follow-up data from a Phase 2 clinical trial of GVAX(R) immunotherapy for pancreatic cancer in 60 patients with operable pancreatic cancer who received the immunotherapy after surgical resection of their tumor and adjuvant radiation and chemotherapy.

Introgen Reports that INGN 241 in Combination with Avastin(R) Results in Complete Tumor Regression
Introgen Therapeutics, Inc. has today the publication of data in Molecular Therapy, the journal of the American Society of Gene Therapy, highlighting the results of a preclinical study with INGN 241 in combination with Avastin(R) (Bevacizumab). Synergistic activity resulting in a curative therapeutic effect was seen in the treatment of lung cancer following the combination of the two agents.

Millipore’s HEScGRO(TM) Medium Advances Human Embryonic Stem Cell Research
Millipore Corporation today announced the availability of HEScGRO animal component-free medium for human embryonic stem cell research.

Cytori Receives U.S. 510(K) Regulatory Clearance for its Adipose Tissue Processing System with Related Celase(TM) Reagent
Cytori Therapeutics received U.S. 510(K) regulatory clearance from the Food and Drug Administration’s Center for Devices and Radiological Health (CDRH) for its adipose (fat) tissue processing system with related Celase(TM) tissue processing reagent.

Seoul Lab Clones Poodle
A source familiar with the cloning has reported that scientists at the College of Veterinary Medicine of Seoul National University (SNU) cloned a female Poodle midway through last year.


Maternal Microchimerism in Peripheral Blood in Type 1 Diabetes and Pancreatic Islet Cell Microchimerism
This paper describes experiments showing that cells passed from mother to child during pregnancy can differentiate into functioning islet beta cells that produce insulin in the child.


Norway Considers Easing Stem Cell Research Ban
Current Norwegian law, from 2003, bars the use of fertilized eggs or stem cells taken from them in research and requires eggs left over after assisted pregnancies to be destroyed. The proposed law would allow research on such eggs under strict legal and ethical limits.

Korea Mulls Allowing Research Using Cloned Embryos
The government is looking into permitting research with cloned human embryos, something that has been practically prohibited after the scandal involving the nation’s disgraced stem cell scientist Hwang Woo-suk.

Stem Cell Study a Priority for Florida
The state would pay for stem-cell research, including studies using cells harvested from embryos, under a bill filed Tuesday in the Florida Legislature that might have new hope because of backing from Gov. Charlie Crist.

U.S. Praises Potential of Stem Cell Research
Many adults in the United States express hope in a specific type of scientific investigation, according to a poll by Rasmussen Reports. 66 per cent of respondents think it is very or somewhat likely that embryonic stem cell research has the potential to lead to cures to previously incurable diseases.

Greater Transparency Urged About Use Of Aborted Foetuses In Stem Cell Research
Women in the UK should be provided with detailed information about how aborted foetuses might be used in stem cell research, say leading social scientists.

StemCore is First Independent Review Board Specializing in Stem Cell Research Protocols
In response to the rapidly evolving field of stem cell research, this month’s launch of StemCore marks the establishment of the first independent ethical review board focusing exclusively on stem cell research.


MaxCyte Technology Licensed For Use In Geron’s Cancer Vaccines
MaxCyte, Inc. has announced that Geron Corporation has exercised an option for a clinical and commercial license to use MaxCyte’s proprietary cell loading system in the manufacture of mRNA-loaded autologous dendritic cell-based vaccines, including Geron’s GRNVAC1 telomerase vaccine.

Lentigen Corporation and Wave Biotech Announce Formation of Collaboration
Lentigen Corporation and Wave Biotech, LLC have announced that they have entered into a collaboration under which Wave Biotech will provide process and equipment expertise for Lentigen’s manufacturing platform based on its proprietary lentiviral vector technology.

Stem Cell Storage Firm Takes Branson Into Biotech Sector
Sir Richard Branson will launch his most controversial business to date as he moves into stem-cell storage and the biotech sector.

Biomed Firm Commercializes Stem Cell Sales
A U.S. biomedical company said Thursday it reached an agreement to commercialize the distribution of neural stem cells by the billions.

Advanced Cell Technology Engages Burrill & Company to Act as Financial Advisor to Accelerate Formation of New Strategic Partnerships
Advanced Cell Technology, Inc. has announced that it has retained Burrill & Company to act as its financial advisor with regard to the formation of strategic partnerships designed to accelerate development of stem cell based cures and treatments.

National Stem Cell Explores Ventures in China
A National Stem Cell senior leadership team traveled to China to cultivate scientific and business relationships with the intent of launching National Stem Cell’s operations in the region.

University of Massachusetts Memorial Revives Cord Blood Program for Stem Cell Transplants
UMass Memorial was contacted by Cryobanks International Inc. of Altamonte Springs, Florida, to explore setting up a new voluntary donation site.

£1.1 Million for Stem Cell Robotics
The DTI has granted £1.1m for British scientists to develop robotics to automate stem cell research, meaning thousands of experiments could be conducted simultaneously.

Foundation Awards $4.6 Million to 10 Industry Teams for Parkinson’s Drug Development Research
The Michael J. Fox Foundation for Parkinson’s Research today announced $4.6 million in total funding to 10 industry research teams under its Therapeutics Development Initiative.

WARF to Waive Some Fees to Encourage More Industry-sponsored Research
The changes come in response to criticism from scientists who said the Wisconsin Alumni Research Foundation’s fees and licensing system was impeding research and driving some investment overseas.

Medistem Laboratories Announces Plan for Angiostem(TM) to Be First Pipeline Product for U.S. Commercialization
Medistem Laboratories, Inc. announced today it has filed a patent application covering its Angiostem(TM) platform, a technology with potential to benefit cardiac and limb ischemic diseases. Angiostem(TM) is planned to be the company’s first pipeline product intended for U.S. commercialization.


Ninth Annual NIH SBIR/STTR Conference, February 26 & 27, 2007 (NOT-OD-07-042)

Extension of Several NRSA Training (T), NRSA Fellowship (F), and Career Development (K) Funding Opportunity Announcements (NOT-OD-07-043)

NIH Policy on Allowable Costs for Grant Activities Involving Animals when Terms and Conditions are not Upheld (NOT-OD-07-044)

Notice of Institutes Participating in the Support of Competitive Research (SCORE) SC1 (PAR-06-491) and SC2 (PAR-06-492) Awards and Guidance on PI Eligibility to Apply for SCORE Individual Awards (NOT-GM-07-100)

Notice of Summer Institute Program to Increase Diversity in Health-Related Research (NOT-HL-06-138)

Notice of Change of Contact and Receipt Date for the Jointly Sponsored Ruth L. Kirschstein National Research Service Award Institutional Predoctoral Training Program in the Neurosciences (PAR-05-055) (NOT-NS-07-006)

NHLBI Career Transition Award (K22) (PAR-07-317)

NIH Center for Scientific Review to Host Open House Workshops to Improve the Review of NIH Grant Applications
Starting in March 2007, the Center for Scientific Review (CSR) at the National Institutes of Health (NIH) will convene the first of six one-day Open House Workshops in 2007 to solicit input from leaders of the scientific community and other stakeholders. This input will be critical to realigning and reinventing CSR’s application review groups so the $20+ billion NIH invests in biomedical research grants each year advances the most promising research.


Guidance for Industry: Certain Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) Recovered From Donors Who Were Tested For Communicable Diseases Using Pooled Specimens or Diagnostic Tests

Agency Information Collection Activities; Proposed Collection; Comment Request; Human Cells, Tissues, and Cellular and Tissue-Based Products: Establishment Registration and Listing; Form Food and Drug Administration 3356; Eligibility Determination for Donors; and Current Good Tissue Practice

Electronic Biological Product Deviation Reporting (eBPDR) – Latest System Changes – Update

Electronic Biological Product Deviation Reporting (eBPDR) Instructions – Update

Stem Cells and Multiple Sclerosis: Prospects and Strategies – Slide Presentation

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



John Dyer is New Chief Operations Officer at FDA
John Dyer, chief operating officer of the Centers for Medicare and Medicaid Services, is moving to the Food and Drug Administration, where he becomes deputy commissioner for operations as well as chief operations officer.


The Boards of AABB, ASBMT, ASFA, EBMT, FACT, ICCBBA Inc, ISBT, ISCT, ISCT Europe, JACIE, NMDP and WMDA agreed to develop standards for the use of ISBT 128 for coding and labeling of CT products, and established an international advisory group to take forward the development and management of terminology and label design. The International Cellular Therapy Coding and Labeling Advisory Group has been working on this project since October 2005 and a workshop was held at the ISCT meeting in Berlin in 2006.
Two draft standards have been prepared covering the aspects of terminology and labeling, together with a guidance document on implementation. These documents are now available for public comment and we value your feedback.  They may be accessed by clicking here:  http://www.iccbba.org/ctcomments.html

The International Cellular Therapy Coding and Labeling Advisory Group would like to know your current labeling practice. Are you completely automated, completely manual or somewhere in between? Please complete the brief survey accessed at http://www.surveymonkey.com/s.asp?u=959303138614. The information gathered will be valuable as we move toward global standardization for labeling of cellular therapy products. Your participation is greatly appreciated. For more information about this project, please visit: http://www.iccbba.org/cellulartherapy_home.html

Call for Abstracts
On-line abstract submission for the 2007 ISCT Annual Meeting is now available through the ISCT Website. 
Submission deadline: February 16, 2007

ISCT Membership
Renew your ISCT Membership for 2007 now!
Not a member?  Visit the ISCT website to learn about the benefits of membership.

AABB-ISCT Cellular Therapy Audioconference Series

Profiled Journal

Robert Weinstein, MD
Chief, Division of Transfusion Medicine, UMass Memorial Medical Center, Worcester, MA.

The Journal of Clinical Apheresis provides the world’s premier source of current information in the field of apheresis. The Journal presents work in all aspects of basic and clinical research, practical applications, emerging technologies and regulation in apheresis and related fields including hematology, nephrology, neurology, rheumatology, transplantation, cellular therapies, blood banking, transfusion medicine, and others.

A subscription to the journal is a key benefit of ASFA membership, which ranges from $120-145 annually. To become a member please contact:

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