Volume 8.19 | May 21

Volume 8.19, May 21, 2007
     In this issue: Science | Policy | Business | NIH | CBER | Regulatory
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Top Stories

Geron Scientists and Collaborators Differentiate Human Embryonic Stem Cells Into Insulin-Producing Islet-Like Clusters: Geron Corporation has reported that its scientists and collaborators at the University of Alberta have differentiated human embryonic stem cells (hESCs) into islet-like clusters (ILCs) that secrete insulin in response to elevated glucose levels.


Growing Nerve Cells in 3-D Dramatically Affects Gene Expression
Nerve cells grown in three-dimensional environments deploy hundreds of different genes compared with cells grown in standard two-dimensional petri dishes.

Effort To Develop Patient-specific Stem Cell Lines Launched
UC Irvine neurobiologist Hans Keirstead and his research team recently launched a project to develop stem cell lines that genetically match human patients.

Gene Therapy Holds Out Hope for Baldness Cure
Skin cells have been primed to regrow hair follicles for the first time and leading scientists claim it is a breakthrough in the quest for a cure for baldness.

Bone Marrow Stem Cells May Cure Eye Disease
Scientists have completed a study using mice which showed that bone marrow stem cells can switch roles and produce keratocan, a natural protein involved in the growth of the cornea – the transparent, outer layer of the eyeball.

New Gene Therapy Targets Cholesterol
The latest technology promising to regulate gene expression has been used therapeutically for the first time – if only in mice – to cut cholesterol levels.

Celladon and Targeted Genetics Initiate Phase I Clinical Trial of MYDICAR(TM) in Patients With Heart Failure
MYDICAR(TM) utilizes an adeno-associated virus (AAV) vector to deliver the SERCA2a gene to heart muscle tissue.

Opexa Therapeutics Completes Patient Enrollment in Phase IIb Trial of Tovaxin(TM) for Treatment of Multiple Sclerosis
Opexa Therapeutics, Inc. has announced the completion of patient enrollment in a 150-patient Phase IIb safety and efficacy study. The trial design is a U.S. multicenter, randomized, double-blind, placebo-controlled study of subcutaneous Tovaxin(TM) in subjects with Clinically Isolated Syndrome (CIS) or Relapsing/Remitting Multiple Sclerosis (RRMS).

For Sale: Stem Cell Enhancers
A California company is marketing the latest in dietary supplements, an extract from algae they claim will boost the number of circulating stem cells, easing disease and discomfort.


Generation of Insulin-producing Islet-like Clusters from Human Embryonic Stem Cells
The researchers report here the development of a novel serum-free protocol to generate insulin-producing islet-like clusters (ILCs) from hESCs grown under feeder-free conditions.

Directed Sibling Cord Blood Banking for Transplantation: The Ten Year Experience in the National Blood Service in England
This paper summarises the experience in collection, testing, storage and transplantation of DCB units by the National Blood Service for England and North Wales over ten years.


California High Court Clears the Way for Stem Cell Grants
The state’s high court declined to review a lower court ruling that upheld the constitutionality of the California Institute for Regenerative Medicine. The litigation had prevented the agency from doling out $3 billion in research grants.

Stanford Experts Outline Possible Criteria for Assessing Economic Benefits of State Stem Cell Funding
Three researchers at the Stanford University School of Medicine think there’s no time like the present to start putting a dollar value to possible future therapies.

Split Emerges on California Stem Cell Investment
Legislators concerned state will not receive fair share of revenues; regulatory agency insists plan is fair.

Governor Patrick Increases State Stem Cell Funds
Governor Deval L. Patrick has announced a $1.25 billion funding initiative for life science research in Massachusetts that will focus in part on embryonic stem cells.

Maryland Stem Cell Commission Awards Grants
In it’s first year of funding, the Maryland Stem Cell Commission has awarded 24 grants to researchers at local universities and companies in the life sciences industry.

Animal-human Embryos U-turn Expected
A UK Government U-turn is expected on controversial plans to ban the creation of hybrid animal-human embryos.


Bio-Matrix Scientific Enters into Contract with Validation Systems to Finalize FDA cGMP Quality Systems for First Adult Stem Cell Bank Focused on Fat Tissue
Bio-Matrix Scientific Group Inc. has announced it has entered into a contract with Validation Systems, Inc. to complete and finalize its FDA Good Manufacturing Practices Quality Systems documentation.

ReNeuron Announces Collaboration to Enhance its Stem Cell Expansion Technology
ReNeuron Group plc has announced that it has signed a Research Collaboration Agreement with Kings College London to further develop the Company’s c-mycERstem cell expansion technology.

Millipore’s MEL Cell Lines Advance Human Embryonic Stem Cell Research
Millipore Corporation has announced the availability of their MEL cell lines – licensed, low passage, human embryonic stem cells used in research for the treatment and potential cure of disabling and terminal diseases and conditions.

State Offers $1M Financial Package To New Stem Cell Company
A new stem cell company in Madison developing ways to test drugs for side effects will receive $1 million from the state to help get started.

Polyplus-transfection Obtains an AFM Grant for the Development of its Gene/Drug Delivery Tool for Clinical Applications
Polyplus-transfection has announced that it has obtained a EUR 80,000 grant from AFM (Association Française contre les Myopathies), France’s Muscular Dystrophy Association. The grant will finance the cGMP (current good manufacturing practices) compliant production process of its in vivo-jetPEI(TM) reagent, thus enabling its use in gene therapy.

University of Wisconsin-Madison Stem Cell and Regenerative Medicine Center to Aid Education and Commerce
The coordination of the companion disciplines of stem cell research and regenerative medicine will be the focus of a new interdisciplinary center being established at the University of Wisconsin-Madison, but it is also being developed with the biotechnology industry in mind.


Investigator Initiated Multi-Site Clinical Trials (R01) (PAR-07-373)


Guidance for Industry: Clinical Trial Endpoints for the Approval of Cancer Drugs and Biologics

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


FOOD AND DRUG ADMINISTRATION (Untited States of America)

Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Administrative Procedures for the Clinical Laboratory Improvement Amendments of 1988 Categorization

Science Board to the Food and Drug Administration; Notice of Meeting


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