Volume 8.29 | Jul 30

Volume 8.29, July 30, 2007
     In this issue: Science | Policy | Business | NIH | CBER | Regulatory
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Top Stories

FDA Suspends Gene Therapy Study: The government has suspended a Seattle company’s gene therapy study – and is reviewing the safety of 28 others around the country – after learning that a patient died this week.
Article

Science

Study Identifies New Gene Therapy Tools for Inherited Blindness
Researchers have taken initial steps toward filling a gap in the toolkit for treating blindness by identifying DNA elements that control when and where genes linked to blindness are turned on.
Article

New Method Of Adult Stem Cell Growth Treats Cornea Disorders
A new method of adult stem cell growth has demonstrated its efficacy for its capacity to grow cornea stem cells.
Article

Pluristem’s PLX Cells Show Promise in Treating Limb Ischemia
Pluristem Life Systems, Inc. has announced that favorable results have been obtained in pre-clinical testing using the Company’s proprietary PLX cells to treat limb ischemia.
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Mesoblast Commences Vertebral Disc Cartilage Program to Target Early Disease
Mesoblast Limited has announced that it has commenced preclinical trials of its patented adult stem cell technology for repair and regeneration of vertebral disc cartilage.
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Gene Therapy For Parkinson’s Hitches Ride On Virus
A new clinical trial at Oregon Health & Science University is examining whether therapeutic genes that hitch a ride with a harmless virus attracted to nerve cells can reduce Parkinson’s disease symptoms.
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Theregen Launches Second Phase One Study of Anginera Cell-Based Patch in Heart Patients
Theregen, Inc. has announced a second Phase I trial to examine the role of its Anginera(TM) cell-based cardiovascular heart patch on adult patients suffering from heart disease.
Article

Acquisitive Ways Paying Off for Genzyme
Last week biotech powerhouse Genzyme announced that a first phase 3 study of stem cell-stimulating drug Mozobil was successful on the primary and secondary efficacy endpoints.
Article

Oxford Biomedica Cleared to Continue Phase III TroVax Cancer Drug Trial
Oxford Biomedica PLC said the independent Data Safety Monitoring Board has concluded that the Phase III trial of its TroVax drug for renal cancer should continue as planned without modification.
Article

Pig To Human Transplantation Getting Closer
Experiments using pigs genetically engineered for compatibility with the human immune system have raised hopes that cross-species transplantation could soon become an option for patients with diabetes and other currently incurable diseases.
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China Claims a First with Cloned Rabbit
China has produced the world’s first cloned rabbit using a biological process that takes cells from a fetus.
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Back Fractures Common After Stem Cell Transplant
More than one third of children and adolescents who undergo allogenic stem cell transplantation have thinning of their bones, and one in five had crushed vertebrae in their backs, Finnish researchers report.
Article

Authors Retract Science Paper
A lead author is found guilty of misconduct in embryonic cell lineage paper called into question over a year ago.
Article

ABSTRACTS, REVIEWS AND SPECIAL REPORTS

Hematopoietic Stem Cell Transplantation in Multiple Myeloma
Newer and better induction regimens, rigorous analysis of results with autologous and allogeneic transplantation, and the development of risk-adapted stratification provide the impetus for this critical evaluation of the role of hematopoietic stem cell transplantation in multiple myeloma.
Abstract

Aging Hematopoietic Stem Cells Decline in Function and Exhibit Epigenetic Dysregulation
In highly purified hematopoietic stem cells from mice aged 2 to 21 months, gene expression analysis indicates a deficit in function yet an increase in stem cell number with advancing age.
Abstract

Policy

Corzine Signs $450 Million Stem Cell Bill
New Jersey voters will decide this November whether to approve borrowing $450 million to pay for stem cell research in the state for 10 years under legislation signed Thursday by Gov. Jon S. Corzine.
Article

Stem Cell Movement Faces Setbacks in Missouri
Eight months ago, Missouri seemed well on its way to becoming a national leader in stem cell research. Now the spotlight is all but gone after a research institute and lawmakers withdrew financial support.
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North Carolina House Panel Narrowly Passes Embryonic Stem Cell Research
The largest committee in the state House backed legislation Thursday setting rules for how research can be performed on human embryonic stem cells, even though the bill eliminated funding to encourage research.
Article

Business

ReNeuron Acquires Business Assets of AmCyte Inc. for $4 Million
ReNeuron Group plc has announced that it has entered into arrangements pursuant to which ReNeuron will acquire the business assets of AmCyte Inc., a development stage cell therapy company based in Santa Monica, California.
Article

Osiris and Genzyme Partner to Develop Medical Countermeasures for Nuclear and Radiological Threats
The initial focus of the partnership will be to develop Prochymal(TM), a formulation of adult stem cells derived from bone marrow, to treat the potentially lethal complications of acute radiation syndrome (ARS).
Article

Lonza Hikes Guidance for New Bioscience Unit, Unveils Business Strategy
Lonza Group AG said it has hiked the targets for its new Bioscience unit with current business strength allowing the group to invest through 2007 and 2008 without impacting current margin levels.
Article

MicroIslet Implements Staffing Changes to Further the Company’s New Corporate Strategy
As previously announced, MicroIslet, Inc. has refocused its efforts to accelerate the clinical testing of the Company’s “MicroIslet-P(TM)” encapsulated islet preparation in persons suffering from Type 1 diabetes.
Article

California Stem Cell Company Transplanting Headquarters to Philadelphia or New Jersey
StemCyte Inc. of Arcadia, California, operates as both an international umbilical stem cell storage bank and a therapeutics company.
Article

Premier and His Wife to Run Stem Cell Clinic
Dr. Ewart Brown, Bermuda’s premier, has entered into a partnership with a Californian firm called Stemedica Cell Technologies.
Article

Embryonic Stem Cell Firm Abandons Efforts
Investors reportedly have lost interest in an embryonic stem cell research lab’s failed efforts to create clinical therapies, according to the company’s former chief executive.
Article

Abraxis Licenses Rights To Biosimilar From Indian Firm Biocon
Abraxis BioScience and Biocon have signed a licensing agreement that gives the Los Angeles firm the right to develop a biosimilar of granulocyte-colony stimulating factor in North America and the European Union.
Article

Stem Cell Patent Skeptics Also Filed
Two of the scientists questioning the Wisconsin Alumni Research Foundation’s key embryonic stem cell patents tried to patent similar discoveries themselves, the foundation said Wednesday.
Article

NIH

NIH Requiring Mandatory Use of the Electronic Financial Status Report System in the eRA Commons Beginning October 1, 2007 (NOT-OD-07-078)
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NCI-Supported Ruth L. Kirchstein Institutional (T32) National Research Service Award Programs for Transdisciplinary Training in the Chemical Biology of Cancer  (NOT-CA-07-020)
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Frequently Asked Questions about PAR-06-243, “New Approaches to Non-Viral Systems for Gene Transfer Applications for Heart, Lung, and Blood Diseases (R21/R33)” (NOT-HL-07-114)
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Lymphatic Biology in Health and Disease (R01) (PAR-07-420)
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CBER

Draft Guidance for Industry: Cell Selection Devices for Point of Care Production of Minimally Manipulated Autologous Peripheral Blood Stem Cells (PBSCs)
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Public Workshop: Processing of Orthopedic, Cardiovascular, and Skin Allografts – Agenda
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Regulatory

FOOD AND DRUG ADMINISTRATION (United States of America)

FDA Statement on Gene Therapy Clinical Trial
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Guidance for Industry: Exports Under the FDA Export Reform and Enhancement Act of 1996
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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.
Link



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