Volume 8.36 | Sep 17

Volume 8.36, September 17, 2007
     In this issue: Science | Policy | Business | NIH | CBER | Regulatory
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Top Stories

Embryonic Stem Cells Thrive When Shaken: Embryos spend much of their time in the womb bobbing along with a mother’s movement, and, surprisingly enough, new research from the Georgia Institute of Technology and Emory University suggests that embryonic stem cells may develop much better under similarly shaky conditions.
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LCT Receives Approval for DiabeCell Clinical Trial in NZ: Living Cell Technologies Ltd is pleased to announce that it has obtained all the regulatory and ethics approvals required by the NZ Minister of Health before proceeding with its type 1 diabetes phase I/IIa clinical trial in New Zealand.
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Science

Point of Care Testing Conference
October 22, 2007
New York
Enter “CONNEXON” at checkout and receive 10% off registration. Click here to register today.

Scientists Identify Stem Cells in Tendons
U.S. scientists have discovered stem cells in adult tendons can regenerate tissue – a finding that promises new treatments for tendon injury and disease.
Article

How To Isolate Stem Cells In Womb Tissue
Scientists in Australia have found a way of identifying probable stem cells in the lining of women’s wombs. The finding opens up the possibility of using the stem cells for tissue engineering applications such as building up natural tissue to repair prolapsed pelvic floors.
Article

Embryonic Stem Cell Strategy Advanced with UCSF Finding
UCSF scientists are reporting what they say is a significant improvement in the technique for genetically reprogramming mouse cells to their embryonic state, a process that transforms the cells, in essence, into embryonic stem cells.
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A Step Toward Tissue-engineered Heart Structures for Children
Researchers at Children’s Hospital Boston have now described making pulmonary valves through tissue engineering.
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Putting Stem Cell Research on the Fast Track
Engineers at Rensselaer Polytechnic Institute have developed tools to help solve two of the main problems slowing the progress of stem cell research – how to quickly test stem cell response to different drugs or genes, and how to create a large supply of healthy, viable stem cells to study from only a few available cells.
Article

Delivering Gene Therapy
A team of Italian Researchers is opening a route for delivering nucleic acid-based therapies into cells without using potentially problematic viruses as carriers.
Article

BrainStorm Cell Therapeutics Takes Initial Steps Toward FDA Submission
BrainStorm Cell Therapeutics Inc. has announced that the Company has completed a preliminary meeting with representatives of the FDA Office of Cellular, Tissues and Gene Therapies, to discuss BrainStorm’s preclinical research program in Parkinson’s Disease.
Article

Breakthrough Research Identifies How Cells from Pigs May Cure Diabetes
Within three years, insulin-producing islet cells from pigs may be used in clinical trials on a path to finally cure insulin dependant diabetes.
Article

Stem Cell Therapy Disappoints Against Rare Kidney Ailment
In a disheartening result that confounds existing research, a team in France says a new stem cell therapy for a rare kidney disease is no better than the usual chemotherapy-only approach.
Article

Allogeneic T-Cell Therapy Effective Against Post-Transplant EBV-Related Tumors
Partially HLA-matched allogeneic cytotoxic T-cell therapy shows promise in treatment of Epstein-Barr virus-positive post-transplantation lymphoproliferative disease, according to British and Australian researchers.
Article

Opexa Therapeutics Gives Update on Phase IIb Trial of Tovaxin(R) for Treatment of Multiple Sclerosis
Opexa Therapeutics, Inc. has provided an update on its 150-patient Phase IIb safety and efficacy study of Tovaxin(R) in multiple sclerosis. The trial design is a U.S. multicenter, randomized, double-blind, placebo-controlled study of subcutaneous Tovaxin in subjects with Clinically Isolated Syndrome or Relapsing/Remitting Multiple Sclerosis.
Article

Stem Cell Use is Blood Bank’s Gain
Of the thousands of stem cell transplants performed annually worldwide on cancer patients, just 1 to 2 percent use samples taken from umbilical cord blood and placentas donated by the mothers of newborns. But that figure is expected to rise dramatically in the next decade – to as high as 50 percent, if stem cell researchers and advocates are correct in their projections.
Article

Help for Hounds
While many promising stem cell therapies are still awaiting approval for use in humans, vets are already using the technology to treat arthritis and tendon ailments in dogs and horses.
Article

Most Science Studies Appear to Be Tainted By Sloppy Analysis
We all make mistakes and, if you believe medical scholar John Ioannidis, scientists make more than their fair share. By his calculations, most published research findings are wrong.
Article

ABSTRACTS, REVIEWS AND SPECIAL REPORTS

A Tissue Engineering Approach to Progenitor Cell Delivery Results in Significant Cell Engraftment and Improved Myocardial Remodeling
This study found that pluripotent hMSCs can be efficiently delivered to a site of myocardial injury using an epicardial cardiac patch, and such delivery results in improved myocardial remodeling after infarction.
Abstract

Co-expression of Two Perivascular Cell Markers Isolates Mesenchymal Stem-like Cells from Human Endometrium
This study shows that human endometrium contains a small population of MSC-like cells that may be responsible for its cyclical growth, and may provide a readily available source of MSC for tissue engineering applications.
Abstract

Policy

Germany Boosts Non-embryonic Stem Cell Research
The German government said it would allocate 5 million euros ($6.9 million) over three years for non-embryonic stem cell research. 
Article


 
Pioneering Transplant Research is ‘Driven Away by Red Tape’
One of Britain’s leading scientists has been forced to move groundbreaking organ transplant research to the United States, after he was blocked by red tape from conducting a key experiment in Britain.
Article

Eggs Can be Used in Stem Cell Research
Women in the north of England are being offered half-price fertility treatment if they donate some of their eggs to medical research.
Article

Business

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Ahead Of Elections, Cautious Optimism Over Stem Cells
No matter who wins the 2008 elections, companies with embryonic stem cell technologies are champing at the bit.
Article

California Firms Vie for Stem Cell Research Funds
Southern California’s stem cell companies, eager to get a piece of the state’s $3 billion funding for stem cell research, seem willing to do whatever they must to qualify for state grants.
Article

Sanofi-aventis Initiates Research Collaboration in China in the Cancer Stem Cell Field
Sanofi-aventis has announced that it has signed a collaboration agreement with the Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences, Tianjin, China, recommended by the Central Chinese Authorities, in order to capitalize on the increasing evidence of the role of cancer stem cells.
Article

Cytori Therapeutics Expands Asia Pacific Celution(TM) System Distribution Network
Cytori Therapeutics expanded its Asia Pacific distribution network for the Celution(TM) System in reconstructive surgery. Two additional distributors will cover Korea, through Olympus Digital Networks Korea, and China, through Shanghai Cosmo Medical Products Co., Ltd.
Article

Golden Hour Technology Validated for Transporting Human Tissue
Minnesota Thermal Science, LLC announced it has begun production of a new thermal container designed for shipping human tissue through standard shipping services. The container is designed to hold the human tissue within its safe temperature range of between 0º and 10ºC for up to 48 hours of transit time in either summer or winter conditions.
Article

Medtronic Seeks Gene Therapy for Heart Ailment
Medtronic Inc. invested $3.75 million in NanoCor Therapeutics Inc. to develop a gene therapy for congestive heart failure.
Article

£6m For Cancer Drug Trial
Gene therapy company Oxford BioMedica is to receive a £6m payment after hitting a research milestone.
Article

CytRx Subsidiary RXi Pharmaceuticals Licenses RNA Chemistry Technologies from TriLink Biotechnologies
CytRx Corporation’s majority-owned subsidiary RXi Pharmaceuticals Corporation has announced that it has entered into an agreement with privately-held TriLink Biotechnologies, Inc. to exclusively license three RNA interference chemistry technologies for all therapeutic RNAi applications.
Article

Aldagen Raises Additional $9 Million, Increasing Series C Financing to $23 Million
New investors include Tullis-Dickerson and CNF Investments LLC. Existing investors Harbert Venture Partners, LLC and Intersouth Partners also participated in the additional financing.
Article

US Moves to Reform Patent Laws
Big US technology companies won an important patent reform victory on Friday when the House of Representatives passed a bipartisan bill that would bring sweeping changes to the way America rewards innovation.
Article

CytRx Names Mitchell K. Fogelman Chief Financial Officer
CytRx Corporation has announced the appointment of Mitchell K. Fogelman as Chief Financial Officer, effective immediately, replacing Matthew Natalizio, who plans to pursue other opportunities.
Article

NIH

Translational Application of Gene Silencing Strategies to Oral and Craniofacial Disorders (R21) (RFA-DE-08-005)
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Near-Term Technology Development for Genome Sequencing (R01) (RFA-HG-07-016)
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Near-Term Technology Development for Genome Sequencing (R21) (RFA-HG-07-017)
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Near-Term Technology Development for Genome Sequencing (SBIR [R43/R44]) (RFA-HG-07-018)
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Near-Term Technology Development for Genome Sequencing (STTR [R41/R42]) (RFA-HG-07-019)
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Revolutionary Genome Sequencing Technologies – The $1000 Genome (R01) (RFA-HG-07-020)
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Revolutionary Genome Sequencing Technologies – The $1000 Genome (R21) (RFA-HG-07-021)
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Revolutionary Genome Sequencing Technologies – The $1000 Genome (SBIR [R43/R44]) (RFA-HG-07-022)
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Revolutionary Genome Sequencing Technologies – The $1000 Genome (STTR [R41/R42]) (RFA-HG-07-023)
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New Technology for Proteomics and Glycomics (SBIR [R43/R44]) (PA-07-451)
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New Technology for Proteomics and Glycomics (STTR [R41/R42]) (PA-07-452)
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CBER

FDA Workshop – Licensure of Apheresis Blood Products – Slide Presentation
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12th Annual GMP by the Sea – Slide Presentation
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SOPP 8795: Posting and Announcement of Premarket Approval Application Approvals and Denials
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Regulatory

FOOD AND DRUG ADMINISTRATION (United States of America)

FDA Licenses 15 New Blood Typing Tests
The U.S. Food and Drug Administration today licensed 15 new blood typing tests that were previously unavailable in the United States.
Article

MEDICINES AND HEALTHCARE PRODUCTS REGULATORY AGENCY (United Kingdom)

Conference Information: Good Clinical Practice (GCP) in Today’s Changing Environment
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ISCT

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

Registration now open!  Click here to register.

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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