Volume 8.33 | Aug 27

Volume 8.33, August 27, 2007
     In this issue: Science | Policy | Business | NIH | CBER | Regulatory
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Study Finds Virus Contributes to Obesity
New research has found that when human stem cells were exposed to a common virus they turned into fat cells. They didn’t just change, they stored fat, too.

Milestone In The Regeneration Of Brain Cells
The research group of Prof. Dr. Magdalena Götz at the Institute of Stem Cell Research of the GSF – National Research Centre for Environment and Health, and the Ludwig Maximilians University, Munich, has achieved an additional step for the potential replacement of damaged brain cells after injury or disease: functional nerve cells can be generated from astroglia, a type of supportive cells in the brain by means of special regulator proteins.

Mesoblast’s Stem Cells Protect Knee Cartilage in Osteoarthritis
Mesoblast Limited has announced that preclinical trials of its patented adult stem cells had shown that the therapy significantly protected knee cartilage against damage in osteoarthritis.

One Step Closer To Transplanting Stem Cells In The Brain
Stem cells transplanted into the brains of mice generate more numerous and more mature nerve cells if the brain cells called astrocytes are not activated.

ViaCell Expands Study Sites in ViaCyte Pivotal Trial
ViaCell, Inc. has announced that it expects to expand the number of U.S. clinical sites participating in its ViaCyteSM pivotal trial from three to eight. ViaCyte is an investigational product intended to broaden reproductive options for women through the freezing and thawing of human oocytes.

Dendreon Announces Publication of Phase 1 Study Highlighting Immunologic and Clinical Activity of Lapuleucel-T (Neuvenge(R)) in Advanced Breast Cancer Patients
The article highlights the safety profile, immune response and clinical activity of NEUVENGE in women with HER2/neu-positive breast cancer who have failed standard therapy.

Stem Cell Therapy For Patients Was A Success
The Regea Institute for Regenerative Medicine, which operates under the University of Tampere, administered the first clinical stem cell therapy to two patients in cooperation with the Tampere University Hospital. The therapy was a success.

Stem Cell Therapy: Cure or Hoax in China?
Some get miracles, while others are skeptical.


Hematopoietic Stem Cells and Tissue Stem Cells: Current Concepts and Unanswered Questions
This review questions several dogmas regarding the selfgenerative capacity of various hematopoietic cells, the single episodic origin of hematopoietic cells and the irreversible nature of progressive mature cell formation in individual hematopoietic lineages.

Human-Animal Chimeras in Biomedical Research
The biological consequences of human-animal chimeras have become an issue of ethical debate. Ironically, human-animal chimeras with human blood, neurons, germ cells, and other tissues have been generated for decades. This has facilitated human biological studies and therapeutic strategies for disease.


Queensland MPs to Debate Stem Cell Research
Queensland MPs are this week expected to have a conscience vote on new laws allowing embryonic stem cell research within tight restrictions.

State’s Stem Cell Policy Begins To Pay Off
Last year, a state committee allocated the first $20 million for research in Connecticut, almost all of the money going to projects using human embryonic cells. And with $2.5 million in funding, UConn was named a “stem cell core” to distribute and create cells used by the researchers.

Granholm Yanks Online Petition Supporting Stem Cell Research
An online petition supporting embryonic stem cell research in Michigan has been pulled from Governor Jennifer Granholm’s official government Web site.

Missouri Group Wants to Outlaw Form of Stem Cell Research
A coalition opposed to a form of embryonic stem cell research called somatic cell nuclear transplantation filed proposed ballot language Wednesday with the Missouri Secretary of State’s office aimed at outlawing the research.

CIRM’s Science Officer to Step Down
Dr. Arlene Chiu, interim chief scientific officer with the California Institute for Regenerative Medicine, will step down from her permanent position at the end of October and return to her home in Los Angeles.


BioLife Solutions Announces Exclusive CryoStor(TM) Supply Agreement With the New England Cryogenic Center, Inc.
The five year agreement includes volume based pricing and an exclusive commitment from NECC to purchase all of its demand for cord blood preservation media from BioLife.

International Stem Cell Corporation Contracts to Manufacture Adipose-Derived Stem Cells for Cytori Therapeutics
International Stem Cell Corporation has announced that its wholly-owned subsidiary Lifeline Cell Technology has entered into an agreement to manufacture adipose (fat)-derived stem cell research products for Cytori Therapeutics.

Stem Cell Sciences plc Consolidates Business Through Technology Buy-back
Stem Cell Sciences plc has announced the completion of a technology buy-back and rights exchange with Stem Cell Sciences KK to enable each company to pursue their core business focus on a global basis.

Vivalis Scores Another Cell Culture Technology
French biopharmaceutical company Vivalis has added another cell culture technology to its stronghold as it moves to dominate the avian stem cell market.

New Patent Rules Hurt Biotech?
Changes to streamline patenting process could add to cost and time, experts say.

Aastrom Paid Lobbying Group $60,000
Aastrom Biosciences Inc. paid Alpine Group Inc. $60,000 in the first half of 2007 to lobby the federal government, according to a disclosure form.

Osiris Therapeutics Hires Lobbyist
Osiris Therapeutics Inc. hired McKenna Long & Aldridge LLP to lobby the federal government, according to a disclosure form.

Andra E. Miller of Biologics Consulting Joins BrainStorm Cell Therapeutics as FDA Consultant
BrainStorm Cell Therapeutics Inc. has announced that in preparation of a scheduled pre-pre-IND meeting discussion with the FDA, the company has retained the services of the Director of Cell and Gene Therapies of the Biologics Consulting Group, Inc., Dr. Andra E. Miller, as consultant to handle the company’s FDA interactions.

NeoStem Hires Industry Veteran Renee Cohen as Vice President of Operations & Corporate Strategy
NeoStem, Inc. has announced further strides in its program to commercialize the Company’s proprietary processes and first-to-market competitive advantage to a nationwide consumer base with the hiring of Renee Cohen as Vice President of Operations and Corporate Strategy.

Indo-Japanese Institute Plans Regenerative Medicine Training Programme
The Nichi-in Centre for Regenerative Medicine (NCRM), an Indo-Japanese institute working on research and application of stem cells, is planning to collaborate with Yamanashi University, Japan, for a training programme in regenerative medicine.


Bioengineering Approaches to Energy Balance and Obesity (SBIR [R43/R44]) (PA-07-435)

Bioengineering Approaches to Energy Balance and Obesity (STTR [R41/R42]) (PA-07-436)


Guidance for Industry: Regulation of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) – Small Entity Compliance Guide

Medical Devices Regulated by the Center for Biologics Evaluation and Research; Availability of Summaries of Safety and Effectiveness Data for Premarket Approval Applications

Current Good Manufacturing Practice for Blood and Blood Components; Notification of Consignees and Transfusion Recipients Receiving Blood and Blood Components at Increased Risk of Transmitting Hepatitis C Virus Infection (“Lookback”); Final Rule

“Guidance for Industry: ‘Lookback’ for Hepatitis C Virus (HCV): Product Quarantine, Consignee Notification, Further Testing, Product Disposition, and Notification of Transfusion Recipients Based on Donor Test Results Indicating Infection with HCV;” Availability



FDA Considers Outsourcing 300 Jobs
The government’s chief health regulatory agency is reviewing more than 300 positions in more than 20 cities to determine whether they could be performed cheaper and better by the private sector.

Changes To Practice for Continued Examination Filings, Patent Applications Containing Patentably Indistinct Claims, and Examination of Claims in Patent Applications; Final Rule


7th Annual Somatic Cell Therapy Symposium
September 26-28, 2007
Hyatt Regency Bethesda, Maryland

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