Volume 8.20 | May 28

Volume 8.20, May 28, 2007
     In this issue: Science | Policy | Business | NIH | CBER | Regulatory
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Top Stories

University of Florida Researchers Awaken Vision Cells in Blind Mice: University of Florida researchers used gene therapy to restore sight in mice with a form of hereditary blindness, a finding that has bearing on many of the most common blinding diseases.


Stem Cells Provide Clues To Cancer Spread
The University of Manchester study used embryonic stem cells to investigate how some tumours are able to migrate to other parts of the body, which makes the treatment of cancer much more difficult.

Bone Marrow Stem Cells Mimic Cancer but Do Not Initiate It
Researchers found that bone marrow stem cells attracted to the site of a cancerous growth frequently take on the outward appearance of the malignant cells but don’t actually seed cancer. 

Cord Blood Stem Cells Produce Insulin
Stem cells taken from the umbilical cords of newborns can be engineered to produce insulin and may someday be used to treat diabetes.

Gene Therapy Helps Arthritis Pain, Damage in Mice
A gene therapy treatment that helped make cells more sensitive to the body’s own painkillers not only helped ease arthritis pain in mice but also reduced other symptoms.

Genzyme’s Gene Therapy Shows Promise
Genzyme has announced that its gene-therapy technique helped preserve brain function and extend lifespan in mice with the equivalent of Niemann-Pick disease, a metabolic illness that in some forms can be fatal in infancy.

Jefferson Scientists Use Gene Therapy to Reverse Heart Failure in Animals
Heart researchers at the Center for Translational Medicine at Jefferson Medical College have used gene therapy to reverse heart failure in animals.

Muscle Stem Cells Effectively Treat Urinary Incontinence Long Term
Women with stress urinary incontinence treated using muscle-derived stem cell injections to strengthen their sphincter muscles experience long-term improvements in their condition. The study, which followed patients for more than one year, suggests that the approach is safe, improves patients’ quality of life and may be an effective treatment for SUI.

Mayo Researchers Study Islet Cell Autotransplantation to Improve Diabetes after Partial Pancreas Removal
Mayo Clinic’s initial experience with pancreatic islet autotransplantation in select patients undergoing partial pancreas removal has found that the procedure shows promise for reducing the effects of pancreatogenic diabetes.

Genitope Corporation Initiates Phase 2 Clinical Trial to Evaluate Use of MyVax Personalized Immunotherapy Following Treatment With Rituximab and Chemotherapy for Follicular Non-Hodgkin’s Lymphoma
MyVax(R) personalized immunotherapy is based on the unique genetic makeup of a patient’s own tumor and is designed to activate the patient’s immune system to fight cancer.

Oncophage(R) Cancer Vaccine Significantly Prolongs Recurrence-Free Survival by 45 Percent in Patients With Intermediate-Risk Kidney Cancer
The end-of-study results showed that in a substantial subset of patients at intermediate risk for disease recurrence, Oncophage demonstrated a clinically significant improvement in recurrence-free survival of approximately 45 percent.

Patient’s Own Platelets May Speed Up Skin Wound Healing
Researchers have looked at how quickly skin wounds treated with a gel of their own platelets compared with a control antibiotic ointment.

Number of China’s Stem Cell Donors Doubles in a Year
The number of stem cell donors in China has nearly doubled over the past year after a promotion campaign by the Red Cross Society of China.

Prostate Cancer Advocates Unite to Fight for Immediate FDA Approval of First-of-Its-Kind Cancer Vaccine
Patients, survivors, physicians and caregivers have formed a coalition called ProvengeNow to fight the recent decision by the U.S. Food and Drug Administration to delay the approval of a new and safe immunotherapy vaccine treatment, until more data becomes available in 2010.


Restoration of Cone Vision in a Mouse Model of Achromatopsia
Using adeno-associated virus (AAV) gene therapy, the researchers show that it is possible to target cones and rescue both the cone-mediated electroretinogram response and visual acuity in the Gnat2 cpfl3 mouse model of achromatopsia.

Directed Engineering of Umbilical Cord Blood Stem Cells to Produce C-peptide and Insulin
The researchers demonstrate that human umbilical cord blood-derived stem cells can be engineered to engage in de novo synthesis of insulin.


Stem Cell Sticker Shock: Bush Fund Restrictions Rachet Up Biotech Costs
Local researchers say they’re wasting millions of dollars buying duplicative lab equipment – from expensive microscopes to pens and pencils – in order to comply with President Bush’s funding restrictions on human embryonic stem cell research.

UC Davis, UC Merced and Buck Institute Cooperate to Meet Stem Cell Oversight Requirements
Taking a cue from the state’s stem cell agency, which has galvanized stem cell research and opened up lines of communication among researchers in California, scientists at the University of California, Merced and the Buck Institute for Age Research in Marin County have established a cooperative agreement with UC Davis to meet the oversight requirements of the California Institute for Regenerative Medicine for stem cell research.


Dendreon Shares Rise on Layoffs
Shares of Biotechnology company Dendreon Corp. jumped Monday after the company said it laid off 40 people, or 18 percent of its work force, last week following a negative letter from the Food and Drug Administration.

CytRx to Cut Jobs in Massachusetts Facility
Biopharmaceutical company CytRx Corp. said in a regulatory filing that it will cut almost all of the laboratory jobs in its Massachusetts facility and take a related charge of $260,000.

BioE and Phillips Plastics to Develop and Commercialize Stem Cell Therapeutics
BioE(R), Inc. and Phillips Plastics Corp.(R) have announced that they entered into a collaborative agreement to develop and commercialize stem cell therapeutics for orthopedic applications.

Neuronascent, Inc. Announces License of Its Patented Animal Cells to Lifeline Cell Technology, LLC
The worldwide exclusive license covers the marketing, sale and distribution of adult Arctic ground squirrel (AGS) neural stem cells for research use and provides Neuronascent with license fees and royalty income.

Pluristem Acquires Patents and Technology for the Three Dimensional Expansion of Human Cells
Pluristem Life Systems, Inc. has announced that it has purchased patents for its innovative stem cell production technology from the Technion-Israel Institute of Technology and the Weizmann Institute of Science for approximately $2 million.

Stem Cell Labs Set to Deliver Medicines of the Future
New state-of-the-art laboratories that will allow scientists to make stem cells and turn them into tissue suitable for human transplantation officially opened at The University of Manchester on Wednesday.

Stem Cell Network Receives $995,000 Federal Grant
Stem Cell Network, which focuses on the use of stem cell therapy for disease treatment, will receive $995,000 from the Networks of Centres of Excellence to establish ties with similar research organizations in Australia, Israel, the United States, Germany, the United Kingdom, Japan and India.

CytRx Names Shi Chung Ng, Ph.D., Senior Vice President of Research and Development
Dr. Ng will be based in CytRx’s new San Diego-based research and development facility, scheduled to open in the third quarter of 2007.


Summer Institute Program to Increase Diversity in Health-Related Research (SIPID) (R25) (RFA-HL-07-012)


Guidance for Industry: Clinical Trial Endpoints for the Approval of Cancer Drugs and Biologics

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



Questions & answers about the Regulation of Human Cellular and Tissue Therapies (HCTs) under ANZTPA.

Presentation – Proposed Regulation of Human Cellular and Tissue Therapies (HCTs) under ANZTPA


ISCT 2007-Register Now!
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Sydney, Australia

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Profiled Journal

Current Issue: Volume 16, No. 2



9th International Conference on Neural Transplantation and Repair
Shinn-Zong Lin, Guest Editor

Making Stem Cell Lines Suitable for Transplantation
Helen Hodges, Kenneth Pollock, Paul Stroemer, Sara Patel, Lara Stevanato, Iris Reuter, and John Sinden

Derivation of Functional Dopamine Neurons From Embryonic Stem Cells
Dae-Sung Kim, Ji Young Kim, Minkyung Kang, Myung Soo Cho, and Dong-Wook Kim

Intracerebral Transplantation of Genetically Engineered Cells for Parkinson’s Disease: Toward Clinical Application
Takao Yasuhara and Isao Date

Neural Stem Cells, Neural Progenitors, and Neurotrophic Factors
Yi-Chao Hsu, Don-Ching Lee, and Ing-Ming Chiu

Umbilical Cord Blood Research: Current and Future Perspectives
Jennifer D. Newcomb, Paul R. Sanberg, Stephen K. Klasko, and Alison E. Willing

Transplantation of Bone Marrow-Derived Stem Cells: A Promising Therapy for Stroke
Yamei Tang, Takao Yasuhara, Koichi Hara, Noriyuki Matsukawa, Mina Maki, Guolong Yu, Lin Xu, David C. Hess, and Cesario V. Borlongan

Regenerative Therapy for Stroke
Ying-Chao Chang, Woei-Cherng Shyu, Shinn-Zong Lin, and Hung Li


Cell Transplantation publishes original, peer-reviewed research and review articles on the subject of cell transplantation and its application to human diseases. To ensure high-quality contributions from all areas of transplantation, separate section editors and editorial boards have been established. Articles deal with a wide range of topics including physiological, medical, preclinical, tissue engineering, and device-oriented aspects of transplantation of nervous system, endocrine, growth factor-secreting, bone marrow, epithelial, endothelial, and genetically engineered cells, among others. Basic clinical studies and immunological research papers are also featured. To provide complete coverage of this revolutionary field, Cell Transplantation will report on relevant technological advances, and ethical and regulatory considerations of cell transplants.

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