Volume 9.11 | Mar 24

Cell Therapy News 9.11, March 24, 2008
     In this issue: Science | Policy | Business | NIH | CBER | Regulatory
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Top Stories

Work With Power Grids Leads to Cell Biology Discovery: Gene therapy is a promising experimental technique for the prevention and treatment of disease. Now a research team led by a Northwestern University physicist reports that a counterintuitive approach also holds promise. The targeted removal of genes – the exact opposite of what a gene therapist would do – can restore cellular function in cells with genetic defects, such as mutations.
Article

Science

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UConn Researchers Take First Step Toward Arthritis Treatment
The research team has been able to turn embryonic stem cells into the cells that make up cartilage, which is the tissue at the surface of joints that allows movement.
Article

Scientists Successfully Awaken Sleeping Stem Cells
Scientists at Schepens Eye Research Institute have discovered what chemical in the eye triggers the dormant capacity of certain non-neuronal cells to transform into progenitor cells, a stem-like cell that can generate new retinal cells.
Article

Texas Tech Researchers Discover Two Proteins that Regulate Potassium in Stem Cells
Researchers at Texas Tech University and the University of Wisconsin have discovered two proteins that control potassium regulation in stem cells found in the embryonic brain of rats.
Article

Way to Target Genes Devised for Gene Therapy
Sir Aaron Klug, a Nobel laureate working at the Medical Research Council’s Laboratory of Molecular Biology in Cambridge, has developed a more efficient way to target genes, so gene therapy can be done with surgical precision.
Article

Novel Approach May Spell Safer Gene Therapy
A novel strategy for circumventing safety problems that have plagued gene therapy has been offered by a complex multicenter group of researchers.
Article

Tobacco Plants Get Gene Therapy
Knocking out a specific gene in burley tobacco plants significantly reduces harmful carcinogens in cured tobacco leaves, scientists at N.C. State University have shown.
Article

Stem Cell Firm in Limbo as Tests Delayed
British stem cell pioneer ReNeuron Group Plc is looking elsewhere to test its experimental stroke treatment ReN001, following a series of delays in the United States.
Article

Targeted Genetics Announces Completion of Dosing for the Phase 1/2 Clinical Trial of tgAAC94 for Inflammatory Arthritis
Targeted Genetics Corporation has announced that dosing has been completed for the Phase 1/2 clinical trial of tgAAC94 for the treatment of inflammatory arthritis.
Article

ProNAi Therapeutics, Inc. Cleared to Begin Phase I Clinical Trials for the First DNA Interference (DNAi(R)) Therapeutic
ProNAi Therapeutics, Inc. has announced that it has received clearance from the U.S. Food and Drug Administration to proceed into Phase I clinical trials with its first drug candidate, PNT2258.
Article

Isolagen, Inc. Completes Enrollment in Isolagen Therapy(TM) Phase II/III Acne Scar Study
Isolagen(TM), Inc. has announced the completion of enrollment of approximately 120 patients in its Phase II/III Study IT-A-008 investigating the Isolagen Therapy(TM) for the treatment of moderate to severe acne scars.
Article

Body Snatching Ring Boss ‘Guilty’
The head of a US body-snatching ring accused of stealing the parts of around 1,000 people has pleaded guilty, after striking a deal with prosecutors.
Article

Are Dual Cord Blood Banks the Answer to Increasing Stem Cell Demand?
Virgin recently introduced the concept of dual public-private banking. Virgin Health Bank stores 20% of the sample for private use and 80% for public use and uses some of the proceeds to support stem cell research.
Article

‘A Race to the Starting Line’: Diagnosing What’s Holding Biotechnology Back
New strategies will be necessary for biotechnology companies to thrive in the new era of personalized medicine, but the healthcare system itself will also have to change, according a panel of six biotechnology company representatives who participated in a discussion titled, "Emerging Technologies and the Innovation of Competitive Advantage," at the 2008 Wharton Health Care Business Conference.
Article

Post-ISCF Clinical Grade Stem Cell Banking Meeting
April 19-23, 2008 | Institute of Zoology, Chinese Academy of Sciences, Beijing
Link

ABSTRACTS, REVIEWS AND SPECIAL REPORTS

Market for Adult Stem Cells Multiplies
While the research community remains interested in embryonic stem cells, these days the focus is on the potential uses of adult stem cells, where it turns out that significant progress is being made away from the political spotlight.
Article

Regrowing Limbs: Can People Regenerate Body Parts?
Progress on the road to regenerating major body parts, salamander-style, could transform the treatment of amputations and major wounds.
Article

Cardiac Stem Cells in the Real World
These data raise a cautionary note on the therapeutic exploitation of cardiac stem cells in patients with ischemic cardiomyopathy, who may be the elective candidates for regenerative therapy.
Abstract

Policy

Unproven Stem Cell Treatments Spur Research Group Guidelines
An international group of scientists is establishing guidelines for stem-cell therapies because clinics in China, Costa Rica and Barbados are using unproven treatments on sick patients.
Article

Scientists Predict a New Era for Stem Cells After Presidential Slection
The three presidential candidates all support expanded federal funding of human embryonic stem cell research. Their actions would lift a restriction imposed by President Bush in 2001 that limits federally funded research to fewer than two dozen embryonic stem cell lines.
Article

Maryland Senate Approves $31.2B FY 2009 Budget That Reduces Stem Cell Research Funding
The Maryland Senate yesterday approved a $31.2 billion budget for the coming fiscal year after scaling back several high-profile initiatives, including a two-year-old program that provides grants for stem cell research.
Article

Bill Could Make Colorado a National Leader in Adult Stem Cell Transplants
The measure by Rep. Dianne Primavera, D-Broomfield, would add a checkoff on the state income-tax form that would allow residents to donate to a new Colorado Stem Cells Cure Fund to promote the saving of umbilical cord blood.
Article

Embryo Research Bill Could Block Life-saving Stem Cell Treatments
Stem cell therapies for diseases such as Parkinson’s and diabetes could become illegal in the UK under embryo research laws planned by the Government.
Article

An Embryonic Disaster?
The UK government’s new fertility bill is under fire on religious, moral and even scientific grounds.
Article

Business

Biotech Firms Turn to Reverse Mergers in Slow IPO Market
With the initial public offering market slowing, many private biotech companies are going the reverse merger route, seeking to combine their operations with either public companies that have fallen on hard times or public shells to gain access to capital markets.
Article

Stem Cell Therapy to Merge with Korean Company
A Tampa company said it has a definitive agreement to merge with Histostem Co. Ltd.
Article

ProtoKinetix to Open Washington, D.C. Office
To accommodate growth and to take advantage of current opportunities, ProtoKinetix, Inc. is opening an office in Washington, D.C.
Article

Cross Disciplinary Academy Founded
The Graduate Academy for Tissue Engineering and Regenerative Medicine aims to allow PhD students to integrate their research and skills in life sciences with engineering and physical sciences.
Article

Starfish and Sea Worms to Help Develop Stem Cell Research
Marine biotechnology company GlycoMar Ltd has been awarded a 70,000 pound grant to develop new products for growing human stem cells. 
Article

Living Cell Technologies Receives Another $6 Million US and Is Issued a 4th US Patent
Living Cell Technologies has announced that it has received funds of US $6 million, in relation to the placement of 24,150,408 ordinary shares, at a price of A$0.29 per share, as approved by shareholders at a General Meeting held on March 7, 2008.
Article

Bioheart Awarded Patent for Method to Repair Heart Tissue by Combination of Cell-Based Therapy and Electrostimulation
Bioheart, Inc. has announced that it has been awarded U.S. Patent #:7341062 (J. Chachques and H. Leonhardt) for a method to repair damaged myocardium by a combination of cell transplantation and electrostimulation.
Article

Biotechnology Needs 21st Century Patent System, Expert Argues
Biotechnology discoveries are at risk of being unduly hindered or taken hostage by private corporations unless patent systems are brought into the 21st century, an expert from The Australian National University argues.
Article

Medistem’s Thomas Ichim Appointed CEO
The appointment is the result of Medistem’s on-going succession planning process and is effective immediately.
Article

Bioheart Founder, Howard J. Leonhardt, Becomes Chairman of the Board of Directors
Mr. Leonhardt also serves as the company’s Chief Technology Officer and he will continue in that role.
Article

Opexa Therapeutics Announces Retirement of CEO David McWilliams
Opexa Therapeutics, Inc. has announced that David B. McWilliams, President and Chief Executive Officer, has notified the Company of his intention to retire following the naming of his successor.
Article

Medical School Chooses Leader for Its New Gene Therapy Center
Guangping Gao, 50, a researcher from the University of Pennsylvania School of Medicine, will become founding director of the Gene Therapy Center at the state’s medical school.
Article

Organogenesis Names Regenerative Medicine Expert Dr. Damien Bates Vice President, Medical Affairs
Organogenesis, Inc. has announced that Damien Bates, MD, PhD, FRACS (Plast.), has joined the company as vice president of medical affairs.
Article

NIH

Notice of Cancellation of the Center of Biomedical Research Excellence Program Announcement (PAR-07-229) (NOT-RR-08-004)
Link

NINDS Institutional Center Core Grants to Support Neuroscience Research (P30) (PAR-08-116)
Link

CBER

Compliance Program Guidance Manual: 7342.007 – Imported CBER-Regulated Products
Link

FDA/NIST Sponsored Workshop: In Vitro Analyses of Cell/Scaffold Products – Transcripts
Link

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

Regulatory

FOOD AND DRUG ADMINISTRATION (United States)

Tainted Drugs Put Focus on the FDA
After a contaminated medicine from China was linked to as many as 17 deaths in the United States, members of Congress clamored for changes while regulators defended their actions.
Article

ISCT

14th ISCT Annual Meeting

May 17-20, 2008
Downtown Miami, Florida

Full details at: www.celltherapysociety.org



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