Volume 9.35 | Sep 8

Cell Therapy News 9.35, September 8, 2008
     In this issue: Science | Policy | Business | NIH | CBER | Regulatory
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Top Stories

Engineers Create Bone that Blends into Tendons: Engineers at Georgia Tech have used skin cells to create artificial bones that mimic the ability of natural bone to blend into other tissues such as tendons or ligaments.



iPS Scientist Create Mouse Pancreases
A group of researchers have succeeded in creating mouse pancreases with the use of induced pluripotent stem cells, opening the door for a significant advance in regenerative medicine.

Battling Diabetes with Beta Cells
Professor Shimon Efrat from Tel Aviv University’s Sackler Faculty of Medicine, has developed a way to cultivate cells derived from insulin-producing beta cells from human tissue in the laboratory.

New Stem Cell Tools to Aid Drug Development
A collaborative team of scientists from Durham University and the North East England Stem Cell Institute have developed two synthetic molecules which can be used to coax stem cells to differentiate into other forms of tissue.

Stem Cell Sciences Announces the Creation of the World’s First Authentic Rat Embryonic Stem Cells from its Exclusively Licensed Technology
Stem Cell Sciences plc announced that two independent laboratories in the UK and USA have achieved germ-line transmission from embryonic stem cells in rats using technologies exclusively licensed to the company by Edinburgh University.

Researchers Devise Means to Create Blood by Identifying Earliest Stem Cells
Johns Hopkins researchers have discovered the earliest form of human blood stem cells and deciphered the mechanism by which these embryonic stem cells replicate and grow.

Stem Cell Research Puts Interstate Rivalry on Hold
Scientists from the Monash Institute of Medical Research and colleagues from New South Wales will compare two different methods of creating patient-specific stem cells: somatic cell nuclear transfer and induced pluripotent stem cells.

Cardiac Cell Transplant Studies Show Promise in Cardiac Tissue Repair
Two studies published in the current issue of CELL TRANSPLANTATION (17:6) found that cardiomyocytes and bone marrow cells can assist and compliment each other when transplanting bone marrow cells for the repair of heart tissue.

Introgen Receives Notice ADVEXIN(R) U.S. BLA Not Sufficiently Complete to File
Introgen Therapeutics, Inc. recently announced that the United States Food and Drug Administration notified the Company that its Biologics License Application for ADVEXIN(R) (p53 gene tumor suppressor therapy) for the treatment of recurrent, refractory squamous cell carcinoma of the head and neck, submitted on June 30, 2008, was not sufficiently complete and would not be filed at this time.

Stem Cell Therapeutics Corp. Receives Positive Review from Data Safety & Monitoring Board
The REGENESIS Phase IIb clinical trial designed to demonstrate that the NTxTM-265 therapy is both a safe and effective therapy capable of improving recovery after acute ischemic stroke, has completed a safety analysis and has recommended the trial continue as per the protocol.

VIDEO: In vitro Labeling of Human Embryonic Stem Cells for Magnetic Resonance Imaging
In this video, the researchers show how to label hESC with MnCl2 and how those cells can be clearly seen by using MRI in vitro.


Neural Stem Cell Transplantation can Ameliorate the Phenotype of a Mouse Model of Spinal Muscular Atrophy
Researchers at the University of Milan have generated data using a mouse model of spinal muscular atrophy to suggest that spinal cord neural stem cells might be a possible treatment for individuals with spinal muscular atrophy.

Hepatic Progenitor Cells from Adult Human Livers for Cell Transplantation
Bipotential progenitor cells from human adult livers can be isolated using Thy-1 and might be a potential candidate for cell treatment in liver diseases.

Previous Claims of SiRNA Therapeutic Effects Called into Question by Report in Human Gene Therapy
The many recent reports documenting the therapeutic efficacy of short interfering RNAs (siRNAs) in animal models of human disease may actually be describing non-specific therapeutic effects related to the ability of siRNA to activate an immune response, according to a new paper.

Culturing Human Embryonic Stem Cells with Mouse Embryonic Fibroblast Feeder Cells
Here the researchers describe an efficient method for culturing and passaging hESCs by enzyme (collagenase) for culture on irradiated mouse embryonic fibroblasts.


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Biotech Group Not Endorsing for Prez, but Seeks More in FDA Budget
When that next U.S. leader is elected, the Biotechnology Industry Organization’s members will call on him to significantly increase the federal Food and Drug Administration’s budget.

Obama Answers Science Policy Questionnaire
Senator Obama answers Scientists and Engineers for America’s questions on topics including biosecurity, embryonic stem cell research, and national security, as well as the more common questions on research and education.

Running Mate Differs on Drilling, Stem Cell Research
John McCain and his handpicked vice presidential nominee Sarah Palin, differ on global warming, drilling for oil in the Arctic National Wildlife Refuge and stem cell research.

Maryland Stem Cell Research Commission: Public Meeting Notice

Czech City Bids to be Global Biotech Hub
Just a few steps from the monastery where Gregor Mendel pioneered the field of genetics some 150 years ago, Czech officials hope to nurture their own biotech revolution.


Regenetech and Biogenea-CellGenea, Ltd. Jointly Announce an Extensive Technology and Patent Licensing Agreement
Regenetech, Inc. and Biogenea-CellGenea, Ltd. jointly announced that they have entered into an extensive technology and patent licensing agreement for Biogenea-CellGenea to utilize Regenetech’s technology for the expansion of adult stem cells in Biogenea-CellGenea’s research and therapeutic applications for use in Greece, Egypt ,Romania ,Bulgaria, Cyprus, Albania, and F.Y.RO.M..

Neurologix Licenses Exclusive Rights to Key Gene from Aegera Therapeutics for Use as a Potential Gene Therapy for Huntington’s Disease
Pursuant to the agreement, Neurologix has exclusively licensed the worldwide rights, excluding China, for the use of the XIAP gene (x-linked inhibitor of apoptosis protein) for therapeutic or prophylactic purposes in the treatment of Huntington’s disease.

Histogenics Secures $9 Million in Second Round of Financing
Histogenics Corporation has closed a $9 million Series B round of equity financing led by Boston Millennia Partners.

Vitrolife: New Unique Product Approved in Europe
Vitrolife has received European approval, a so-called CE mark, for its new needle for the collection of human oocytes.

John Gearhart: Penn Integrates Knowledge Professor
The University of Pennsylvania announced the appointment of John Gearhart, a pioneer in stem cell research, as the eighth Penn Integrates Knowledge University Professor.

Australian Stem Cell Board Resigns Amid Power Fight
Australia’s bid to become a world leader in stem cell science has been plunged into turmoil by the mass resignation yesterday of the seven-strong board of the country’s premier research organization in the field.


NIH Funds Nine Centers to Speed Application of Powerful New Research Approach
The funding of a network of nine centers across the country that will use high tech screening methods to identify small molecules for use as probes to investigate the diverse functions of cells was announced recently by the National Institutes of Health.

Exceptional, Unconventional Research Enabling Knowledge Acceleration (EUREKA) Grants
The National Institutes of Health has awarded $42.2 million to fund 38 exceptionally innovative research projects that could have an extraordinarily significant impact on many areas of science.

Clarification of NIH Policy on Late Submission of Grant Applications

Revision Award Mechanism for Support of Animal and Biological Materials Resources (ABMR) to Develop Translational Pilot Projects with Investigators at Clinical and Translational Research Institutions (P40, P51, U42)


Guidance for Industry: Integrated Summary of Effectiveness

Approval Information: Blood Grouping Reagent Anti-Fya (Monoclonal) (Seraclone) – Summary Basis for Regulatory Action

Approval Information: Blood Grouping Reagent Anti-s (Monoclonal)

Approval Information: Blood Grouping Reagent Anti-S (Monoclonal)

Sunquest Laboratory Blood Bank and Blood Donor Modules

Current Licensed Establishments and Products



FDA Seeks to Establish Branch Office in China
This October the FDA plans to open an office at the U.S. embassy in Beijing in an effort to implement a cost-effective, prevention-based approach to risk management.

Vaccines and Related Biological Products Advisory Committee


What’s New in Good Laboratory Practices


Adoption of European Union Guidelines in Australia


8th Annual Somatic Cell Therapy Symposium
Register now!
September 22-24, 2008
Bethesda, Maryland

The Somatic Cell Therapy Symposium is a forum designed to engage FDA, academia,
and industry in an open dialogue regarding regulatory issues pertaining to the
translation of basic laboratory research findings into therapeutic procedures suitable
for human clinical trial evaluation.

Visit this Link

to learn more.

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