Volume 8.25 | Jul 2

Volume 8.25, July 2, 2007
     In this issue: Science | Policy | Business | NIH | CBER | Regulatory
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Top Stories

Intercytex Artificial Skin Heals Wounds in Tests: A British biotechnology company has developed a long-lasting artificial skin that has produced promising results in healing wounds in early clinical trials.
Article

Cord Blood May Preserve Insulin Levels in Children with Type 1 Diabetes: University of Florida researchers sought to determine whether it is feasible to use a patient’s own cord blood stem cells to neutralize the body’s autoimmune attack on the pancreas and help restore the organ’s ability to make insulin.
Article

Science

Researchers Find ‘Missing Link’ Stem Cells
Two independent teams of researchers based at Cambridge University and Oxford University have discovered a new type of embryonic stem cell in mice and rats which is very similar to human embryonic stem cells.
Article

Scientists: Stem Cells Created From Unfertilized Eggs
Scientists say they’ve created embryonic stem cells by stimulating unfertilized eggs, a significant step toward producing transplant tissue that’s genetically matched to women.
Article

Stem Cells Could Treat Diabetes
Early-stage studies in mice have shown that adult blood could be a richer source of insulin-creating stem cells than fertilized eggs.
Article

Vitro Announces Key Advance in Stem Cell Research
Vitro Diagnostics, Inc. announced the development of a new method to derive human pancreatic beta islets from adult pancreatic stem cells.
Article

Can You Hear Me Now? Stem Cells Enhance Hearing Recovery
Researchers have shown that bone marrow stem cells injected into a damaged inner ear can speed hearing recovery after partial hearing loss.
Article

Clinical Trial Suggests Bone Marrow Stem Cells Are Useful for Spinal Cord Injury; PrimeCell Therapeutics Provided Pre-Clinical Study
PrimeCell(TM) Therapeutics LLC has announced that it provided research support and pre-clinical studies for a clinical trial to assess the safety, feasibility and efficacy of implanting autologous bone marrow stem cells into spinal cord injury (SCI) patients.
Article

Transplanting Angina Patients’ Stem Cells Shows Safety, Symptom Relief
The first U.S. study to transplant a potent form of purified adult stem cells into the heart muscle of patients with severe angina provided evidence that the procedure is safe and produced a reduction in angina pain as well as improved functioning in patients’ daily lives.
Article

Penn Researchers Report that Gene Therapy Awakens the Brain Despite Blindness from Birth
Researchers at the University of Pennsylvania have demonstrated that gene therapy used to restore retinal activity to the blind also restores function to the brain’s visual center, a critical component of seeing.
Article

First Patient Treated in Aastrom Adult Stem Cell Trial for Critical Limb Ischemia
Aastrom Biosciences, Inc. is evaluating its Vascular Repair Cell (VRC) product in a U.S. Phase IIb clinical trial to treat patients suffering from CLI, the most severe form of peripheral arterial disease (PAD).
Article

Disgraced Scientist Back in Lab
From the crack of dawn until late at night, stem cell researcher Hwang Woo-suk is at work in the lab, hoping to restore his credibility after a scandal that shocked the world.
Article

ABSTRACTS, REVIEWS AND SPECIAL REPORTS

Patient-Specific Stem Cell Lines Derived from Human Parthenogenetic Blastocysts
This research has resulted in a protocol for the production of human parthenogenetic embryos and the derivation of stem cell lines from them, which minimizes the presence of animal-derived components, making the derived phESC lines more suitable for potential clinical use.
Article

Integration and Persistence of an Investigational Human Living Skin Equivalent (ICX-SKN) in Human Surgical Wounds
This is the first report of preliminary evidence indicating the persistence of an autosynthesized, tissue-engineered, living human skin substitute in healed acute wounds in humans.
Article

Policy

Stem Cell Ban Lifted by New South Wales MPs
A ban on therapeutic stem cell research in NSW has been lifted after upper house MPs supported the controversial bill by 28 votes to 13.
Article

Animal-human Embryos Need Human Rights, Bishops Say
Hybrid animal-human embryos created for medical research should be viewed as human and permitted to develop into children, Roman Catholic bishops have urged the British parliament.
Article

Stem-cell Grant Compensation Bill Placed on Hold
A bill that would have required companies doing business with California’s $3 billion stem-cell research institute to pay the state more than the institute has proposed has been placed on hold until at least next year.
Article

Business

Stem Cell Innovations and High Q Foundation Collaborate to Develop Novel Models of Huntington’s Disease
The High Q Foundation Inc. and Stem Cell Innovations, Inc. announced today that they have entered into a two-year R&D alliance. The organizations will apply SCI’s PluriCells(TM) to develop Huntington’s disease specific human cell systems for the purpose of drug discovery.
Article

BioLife Solutions Announces HypoThermosol(R) Supply and License Agreement with Bioheart Inc.
The 10-year agreement includes volume based pricing and an intellectual property escrow provision which grants Bioheart access under certain conditions to BioLife’s HypoThermosol storage and preservation media when used in the production and therapeutic delivery of Bioheart’s MyoCell(R), a cellbased therapy for heart failure.
Article

Tarsus Group Forms New Company CapRegen to Invest in Anti-ageing Market
Media company Tarsus Group PLC said it formed a new company CapRegen PLC to make investments in the global anti-ageing and regenerative medicine marketplace.
Article

Invitrogen Launches GIBCO(R) AlgiMatrix(TM) 3D Culture System
Invitrogen Corporation has announced the launch of the GIBCO(R) AlgiMatrix(TM) 3D culture system, an animal-origin free bioscaffold that more closely mimics the conditions of a cell in the human body.
Article

Millipore Corporation and Burnham Institute of Medical Research to Conduct Human Stem Cell Training Workshops
Millipore Corporation has announced the development of training workshops in human stem cell research in conjunction with the Burnham Institute for Medical Research.
Article

World’s First Stem Cell ‘Library’ on Deck at McMaster
Mick Bhatia was handed $15 million to create the world’s first human embryonic stem cell “library” at McMaster University in Hamilton.
Article

Cytori Looks for Fat Profits
“Our goal is to be not only one of the first revenue-generating stem cell companies but also to be the first profitable one,” says Cytori CEO Christopher Calhoun.
Article

StemCells, Inc. Agrees to Stay Litigation against Neuralstem Pending Reexamination of Patents Involved in Lawsuit
StemCells, Inc. has announced it has consented to a stay, on mutually acceptable terms, of its patent infringement lawsuit against Neuralstem, Inc., pending reexamination by the U.S. Patent and Trademark Office (PTO) of the four patents that are the subject of the litigation.
Article

NIH

Change in Budgetary Guidelines for Initiative for Maximizing Student Development Awards (PAR-06-553)(NOT-GM-07-110)
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Change in Budgetary Guidelines for Research Initiative for Scientific Enhancement Awards (PAR-06-548) (NOT-GM-07-111)
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Neurotechnology Research, Development, and Enhancement (SBIR [R43/R44]) (PA-07-389).
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Neurotechnology Research, Development, and Enhancement (STTR [R41/R42]) (PA-07-390)
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CBER

CBER Organizational Information – Update
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Regulatory

FOOD AND DRUG ADMINISTRATION (Untited States of America)

Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; General Licensing Provisions:  Biologics License Application, Changes to an Approved Application,  Labeling, Revocation and Suspension, Postmarketing Studies Status  Reports, and Forms FDA 356h and 2567
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ISCT

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