Volume 8.14 | Apr 16

Volume 8.14, April 16, 2007
     In this issue: Science | Policy | Business | NIH | CBER | Regulatory
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Top Stories

Study Suggests New Avenue on Diabetes: Thirteen young diabetics in Brazil have been able to stop receiving insulin after being treated with stem cells taken from their own blood.

Sex Differences Found in Stem Cells: Stem cells taken from the muscles of female mice are better at regenerating tissue than those taken from male mice.


Sperm Made From Human Bone Marrow
Scientists say they have successfully made immature sperm cells from human bone marrow samples.

National Stem Cell Announces Publication of Sponsored Research Findings for Type I Diabetes
Scientists were able to, “show that cells derived from human embryonic germ (EG) cells express markers of definitive endoderm, pancreatic and B-cell development, glucose sensing, and production of mature insulin.”

Japan Develops Technology to Make Human Blood Vessels from Fish
A group of researchers on Japan’s northernmost island of Hokkaido have broken new medical ground by developing a way to make human blood vessels using fish as a raw material.

HepaLife’s Cells for Artificial Liver Device Significantly Outperform Most-Widely Used Human Liver Cell Line
HepaLife Technologies, Inc. announced that the Company’s patented ‘PICM-19’ cells, under development for use in artificial liver support and in-vitro toxicology testing, have significantly outperformed the world’s most widely used human liver cell line in important tests of liver-specific metabolic functions.

New Therapy Attacks Multiple Sclerosis on Two Fronts
Scientists have successfully treated an animal model of multiple sclerosis using modified bone marrow and the results could lead the way to a therapy suitable for humans.

Ceregene Enrolling Patients for Phase 2 Clinical Trial of Parkinson’s Disease
Ceregene, Inc. has confirmed that enrollment is well under way in its randomized, controlled, double-blind, Phase 2 clinical trial evaluating CERE-120, a gene therapy product in development for the treatment of Parkinson’s disease.

ALS (Lou Gehrig’s Disease) Patient Improves Significantly After Stem Cell Therapy
Stem Cell Pharma, Inc plans to submit an Investigational New Drug application to the Food and Drug Administration claiming Orphan Drug status for its amniotic stem cell implant in the treatment of ALS.

South Korea Wolf Clone Claims Probed
A claim by South Korean scientists to have created the first cloned wolves is being investigated by officials at the team’s university.


A Role for Cell Sex in Stem Cell–mediated Skeletal Muscle Regeneration: Female Cells Have Higher Muscle Regeneration Efficiency
The researchers show here that cell sex is a variable that considerably influences muscle-derived stem cells’ (MDSCs) regeneration abilities and that female MDSCs (F-MDSCs) regenerated skeletal muscle more efficiently.

Evidence for a Stem Cell Hierarchy in the Adult Human Breast
Cellular pathways that contribute to adult human mammary gland architecture and lineages have not been previously described. In this study, the researchers identify a candidate stem cell niche in ducts and zones containing progenitor cells in lobules.


The Student Society for Stem Cell Research (SSSCR)
SSSCR is an international network dedicated to advancing scientific research for cures. Our network spans over 15 countries, 100 institutions, and 35 U.S. states. Our network includes students, professionals, and patient advocates. We are a special project of the Genetics Policy Institute and a member of the Coalition for the Advancement of Medical Research. Get plugged-in and be a part of the future of stem cell research. Join today, http://www.ssscr.org/main/join_now.

Senate Passes Stem Cell Funding Bill
The Senate approved a measure that would roll back President Bush’s 2001 limits on embryonic stem-cell research Wednesday afternoon, but the margin was short of the two-thirds needed to override a promised veto.

Stem Cell Battle Now in High Court
The state Supreme Court has been asked to decide a legal challenge to California’s stem cell bond measure.

Actions Taken On Stem Cell Legislation In Florida, Missouri
This article highlights the recent news in stem cell legislation.

Minnesota Lawmakers Grapple With Stem Cell Bill
Minnesota lawmakers are nearing final votes on legislation that would permit state spending on embryonic stem cell research.

Grant Recipients Would Have to Offer Products to Uninsured at Set Prices
The board of California’s stem cell institute voted unanimously yesterday to oppose legislation before the Senate Health Committee that would set price limits on any stem cell therapies that result from state taxpayer funding.


Affitech Contracts With ProBioGen For Producer Cell Line Generation for Oncology Antibody Candidate
ProBioGen AG, and Affitech AS, jointly announced that they have entered into an agreement for a biopharmaceutical cell line to be developed by ProBioGen for high-level production of one of the lead candidates in Affitech’s oncology therapeutic antibody pipeline.

LCT to Establish Level 1 American Depository Receipt Program
Living Cell Technologies Limited announced that it will establish a Level 1 American Depositary Receipt Program (ADR), appointing The Bank of New York as its depository bank. The establishment of an ADR program in the United States is intended to facilitate trading in LCT shares by US investors.

Cord Blood America Gets $200,000 in Capital for Potential Acquisition
The debt will be serviced primarily with cash flow from the acquisition, for which a letter of intent has been issued, Cord Blood America said. The company being acquired was not named.

Stem Cell Innovations Patents on Pluripotent Cells Cited by the U.S. Patent and Trademark Office as Prior Art, Pre-Dating the WARF and Thomson Core Embryonic Stem Cell Patents
Stem Cell Innovations announced its issued patents to pluripotent stem cells were used by the U.S. Patent and Trademark Office in rejecting the core ES cell patents issued to the Wisconsin Alumni Research Association (WARF) invented by James Thomson.

GTC Biotherapeutics Obtains License to Nuclear Transfer Patents
GTC Biotherapeutics, Inc. announced that it has been granted a non-exclusive worldwide license from Start Licensing, Inc., a joint venture between Geron Corporation and Exeter Life Sciences, Inc., for the patents and patent applications developed by the Roslin Institute to apply nuclear transfer to the production of therapeutic proteins in the milk of transgenic animals.

Amatokin(R), the Controversial ‘Stem Cell’ Mystery Wrinkle Cream Comes to America
Ever since the rumor about a stem cell-based mystery skin cream first raised its head in early 2005, Amatokin quickly became the most controversial and most sought-after anti-aging cream in the world. U.S. retailers were clamoring to be the first to bring Amatokin to America.


Integrating Developmental Biology with Tissue Engineering and Regenerative Medicine in Musculoskeletal Tissues and Skin: NIAMS Areas of Interest in Bioengineering Research Partnerships [R01] (NOT-AR-07-002)

Bioengineering and Obesity (R01) (PA-07-354)

Improving Heart Failure Disease Management (R01) (PA-07-355)


Draft Guidance for Industry: Dosage and Administration Section of Labeling for Human Prescription Drug and Biological Products – Content and Format

2007 Biological Approvals – Update

Fast Track Designation Request Performance Report – Update

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)

Vaccines and Related Biological Products Advisory Committee; Notice of Meeting


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