Volume 8.31 | Aug 13

Volume 8.31, August 13, 2007
     In this issue: Science | Policy | Business | NIH | CBER | Regulatory
Cell Therapy News on Facebook  Cell Therapy News on Twitter

Top Stories

Successful Clinical Outcomes in Stem Cell Heart Trial: Mesoblast Limited has announced the successful conclusion of the Australian Cardiac Pilot Trial it had been conducting together with its United States-based sister company Angioblast Systems Inc. at John Hunter Hospital in New South Wales.
Article

Science

Scientists Move Closer To Bio-engineered Bladders
Researchers at the University of York are using an understanding of the special cells that line the bladder to develop ways of restoring continence to patients with serious bladder conditions, including cancer.
Article

Not All Embryonic Stem Cell Lines Are Created Equal
When it comes to generating neurons, researchers have found that not all embryonic stem cell lines are equal.
Article

UCLA Scientists Produce Functioning Neurons from Human Embryonic Stem Cells
Scientists with the Institute of Stem Cell Biology and Medicine at UCLA were able to produce from human embryonic stem cells a highly pure, large quantity of functioning neurons that will allow them to create models of and study diseases such as Alzheimer’s, Parkinson’s, prefrontal dementia and schizophrenia.
Article

Mechanism Discovered In Adult Stem Cell Regulation
Forsyth Institute scientists have discovered an important mechanism for controlling the behavior of adult stem cells.
Article

Proteins Linked To Stem Cells Could Lead To Alzheimer’s Treatment
Researchers combined a technique for transplanting stem cells into rats and a newly discovered compound, phenserine.
Article

GammaCan Receives FDA Orphan Drug Designation for Lead Product VitiGam(TM) for Stage IIB to Stage IV Melanoma
GammaCan anticipates filing an IND with the FDA for a Phase I/II clinical trial by year-end, and initiate clinical testing of VitiGam(TM) in early 2008.
Article

Treatment Permission Granted for Cancer Therapy in India
The Berlin-based biotechnology company MOLOGEN AG has been informed by its license partner ONCO Life Sciences Pvt. Ltd., India, that the respective authorities have granted treatment permission for MOLOGEN’S cell-based gene therapy.
Article

Stem Cell Transplantation Procedure Results In Long-term Survival For Amyloidosis Patients
Researchers from the Stem Cell Transplant Program and the Amyloid Treatment and Research Program at Boston University Medical Center have found that high-dose chemotherapy and blood stem cell transplantation can result in long-term survival for patients diagnosed with primary systemic light chain Amyloidosis.
Article

Death Points to Risks in Research
One woman’s experience in a gene therapy trial highlights weaknesses in the patient safety net.
Article

Targeted Genetics Defends Handling of Fatal Test Case
As more details emerged about the recent death of a patient during a clinical trial conducted by Targeted Genetics of Seattle, the company defended its handling of the case.
Article

Scientists Seek Test To Detect Gene Doping In Athletes
Research under way at the University of Florida could help level the playing field by detecting the first cases of gene doping in professional athletes before the practice enters the mainstream.
Article

Large-animal Clones Reach Fourth Generation
A Japanese geneticist has said his research team created the world’s first fourth-generation cloned pig, an achievement that could help scientists in medical and other research.
Article

ABSTRACTS, REVIEWS AND SPECIAL REPORTS

Directed Differentiation and Transplantation of Human Embryonic Stem Cell-Derived Motoneurons
The researchers present a novel in vitro protocol of the directed differentiation of human embryonic stem cells into engraftable motoneurons.
Abstract

Complete Spinal Cord Injury Treatment Using Autologous Bone Marrow Cell Transplantation and Bone Marrow Stimulation with Granulocyte Macrophage-Colony Stimulating Factor: Phase I/II Clinical Trial
To assess the safety and therapeutic efficacy of autologous human bone marrow cell transplantation and the administration of granulocyte macrophage-colony stimulating factor, a phase I/II open-label and nonrandomized study was conducted on 35 complete spinal cord injury patients.
Abstract

Stimulation of Peri-Implant Vascularization with Bone Marrow-Derived Progenitor Cells: Monitoring by In Vivo EPR Oximetry
The researchers developed a cell therapy-type strategy to maintain vascularization around implanted devices using co-administration of bone marrow–derived progenitor cells and demonstrated a novel O2-sensing method to functionally monitor neovascularization in vivo.
Abstract

Policy

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.

Stem Cell Institute Names Interim President
The governing board of the California Institute for Regenerative Medicine named Richard A. Murphy, Ph.D. as its interim president.
Article

New York Promotes Stem Cell Education
According to an August 7th, 2007, press release, Governor Spitzer of New York signed into law a bill sponsored by Lentol that requires the New York Health Department to develop a program for making expectant parents and others aware of the value of storing umbilical cord blood and the potential uses for such banked cord blood.
Article

For Missouri, Stem Cell Amendment Changes Little
The expected expansion of stem cell research in Missouri has since run into political and financial roadblocks, putting the future of the research in doubt.
Article

Bill Calls for FDA to End All Conflicts of Interest
The Food and Drug Administration could face a tough new assignment from Congress: Eliminate all conflicts of interest on outside advisory panels whose votes heavily guide the agency’s decision-making.
Article

New South Wales Offers $500,000 for Stem Cell Breakthrough
Sydney could become the first city in the world to produce stem cells from cloned human embryos with a $500,000 grant being offered by Premier Morris Iemma to the first scientist to do it.
Article

Business

Invitrogen Introduces Disposable Stem Cell Passaging Tool
Invitrogen has launched a new disposable device to simplify manual passaging, the process of dividing human embryonic stem cell (hESC) colonies.
Article

Lonza Announces the Availability of Poietics(R) Human Adipose-Derived Stem Cells for Use in Adult Stem Cell Research
The Adipose-Derived Stem Cells system provides research laboratories with ready to use cells and media for research in areas such as tissue repair, wound healing, cell differentiation, osteoporosis, insulin resistance or obesity.
Article

Integra LifeSciences and IsoTis to Combine Creating a Global Leader in Orthobiologics
Integra LifeSciences Holdings Corporation and IsoTis, Inc. have announced a definitive agreement whereby Integra would acquire IsoTis in an all cash transaction.
Article

Alnylam Awarded $38.6 Million U.S. Government Contract to Develop RNAi Therapeutics for Biological Threats
Alnylam Pharmaceuticals, Inc. has announced that it has been awarded a $38.6 million contract over 33 months from the United States Defense Threat Reduction Agency to develop a broad spectrum RNAi anti-viral therapeutic for the treatment of viral hemorrhagic fever.
Article

Proposed Joint Program Would Train Research Staffers
The California State University and Community College systems will appear before the state stem cell institute, hoping to wrangle $31 million from the state’s $3 billion stem cell initiative.
Article

Opexa Therapeutics Receives European Patent Notification for T-Cell Vaccine
Opexa Therapeutics, Inc. has announced that it has received notification under Rule 51(4) from the Examining Division of the European Patent Office (EPO) that the EPO intends to issue a patent for “Autologous T Cell Vaccine Materials and Method.”
Article

NeoStem Announces Approval for Listing on American Stock Exchange Under Ticker Symbols NBS and NBS.U Starting Thursday August 9, 2007
NeoStem, Inc. announces its common stock and units have been approved to be listed on the American Stock Exchange under the ticker symbols – NBS and NBS.U – and will start trading August 9, 2007.
Article

NIH

Full Implementation to Shorten the Review Cycle for New Investigator R01 Applications Reviewed in Center for Scientific Review (CSR) Recurring Study Sections (NOT-OD-07-083)
Link

Extended Comment Period for the Request for Information on the NIH System to Support Biomedical and Behavioral Research and Peer Review (NOT-OD-07-084)
Link

Revision: Streamlined Review Process to be used for Ruth L. Kirschstein National Research Service Awards (NRSA) Postdoctoral Fellowship Applications (F32) (NOT-OD-07-085)
Link

Genome-wide Association Studies in the Genes, Environment, and Health Initiative – Study Investigators (U01) (RFA-HG-07-012)
Link

CBER

Guidance for Industry: Eligibility Determination for Donors of Human Cells,Tissues, and Cellular and Tissue-Based Products (HCT/Ps)
Link

Guidance for Industry: Adequate and Appropriate Donor Screening Tests for Hepatitis B; Hepatitis B Surface Antigen (HBsAg) Assays Used to Test Donors of Whole Blood and Blood Components, Including Source Plasma and Source Leukocytes
Link

Approved Biological NDA and ANDA Applications – Update
Link

Licensed Products and Establishments List – Update
Link

Regulatory

FOOD AND DRUG ADMINISTRATION (United States of America)

Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Requirements for Submission of Labeling for Human Prescription Drugs and Biologics in Electronic Format
Link

Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Submitting and Reviewing Complete Responses to Clinical Holds
Link

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



 Learn more about Cell Therapy News:  Archives  |  Events  |  Update Profile  |  Contact Us