Volume 8.21 | Jun 4

Volume 8.21, June 4, 2007
     In this issue: Science | Policy | Business | NIH | CBER | Regulatory
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Top Stories

Dendreon Announces FDA Confirms Data Required for Provenge(R) Licensure: Dendreon Corporation has announced that the Company has received confirmation that the U.S. Food and Drug Administration (FDA) will accept either a positive interim or final analysis of survival from its ongoing IMPACT study to amend the Biologics License Application (BLA) for PROVENGE (sipuleucel-T).


New Beta Cells Without Stem Cells?
Two studies find adult pancreatic cells maintain islet population, contradicting a hypothesis that regeneration relies on stem cells.

Muscle Repair Depends on Multiple Cell Types
Researchers have identified a new population of stem cells that act to repair muscle after damage.

Vidacare(R) Announces Release of Novel Bone Marrow Aspiration System for Hematology/Oncology
With its lithium-powered EZ-IO(R) driver, Vidacare’s system represents the first effort in decades to improve the speed, control and patient comfort of the bone marrow aspiration procedure.

Human Stem Cell Treatment Restores Motor Function in Paralyzed Rats
Rats paralyzed due to loss of blood flow to the spine returned to near normal ambulatory function six weeks after receiving grafts of human spinal stem cells, researchers from the University of California, San Diego School of Medicine report.

Immunization Against Type 1 Diabetes: Mice Successfully Treated
Researchers in France and Germany have successfully treated type 1 diabetic mice with a vaccination. The vaccine they designed in this model included structures that the immune system mistakenly attacks in type 1 diabetes.

Study Helps Gene Therapy Work in Obesity
Gene therapy that could treat obesity may also have benefits for bone growth, according to a new study by scientists at Oregon State University and the University of Florida.

Gene Therapy Offers New Hope for Treatment of Peripheral Neuropathy
Researchers from the University of Pittsburgh School of Medicine report that they have successfully used gene therapy to block the pain response in an animal model of neuropathic pain, a type of chronic pain in people for which there are few effective treatments.

ReNeuron Announces New Data Concerning its ReNcell(R) Neural Stem Cell Lines
ReNeuron Group plc announces new data concerning its ReNcell(R)CX and ReNcell(R)VM neural cell lines. These cell lines are marketed through Millipore Corporation as drug discovery tools for academic and commercial research.

Italian Doctor Builds New, More Natural Female Anatomy
An Italian doctor has reconstructed vaginas for two women born with a rare congenital deformation, using their own cells to build vaginal tissue in the lab for the first time.

Significant Scientific Breakthrough in Stem Cell Banking
Scientists from the Research Department of Cryo-Save Group NV together with the University of Cologne have developed a new scientifically validated method to collect adult mesenchymal stem cells from the lining of umbilical cord tissue.


All Beta Cells Contribute Equally to Islet Growth and Maintenance
The results of this research support the conclusion that the Beta cell pool is homogeneous with respect to replicative capacity and suggest that all beta cells are candidates for in vitro expansion.

Differential Development of Neuronal Physiological Responsiveness in Two Human Neural Stem Cell Lines
These data demonstrate that overexpression of myc in NSCs can be used to generate electrophysiologically active neurons in culture. Development of a functional neuronal phenotype may be dependent on parameters of isolation and differentiation of the cell lines, indicating that not all human NSCs are functionally equivalent.


Conscience Vote on New South Wales Stem Cell Bill
Premier Morris Iemma has announced that legislation to overturn the current ban on stem cell research will be tabled in parliament this week.

Congress Plans to Send Bush Measure Easing Restrictions on Stem Cell Research
Congress intends to send President Bush legislation next week to ease restrictions on federally funded embryonic stem cell research, inviting his second veto in as many years on the subject.

Schwarzenegger, Ontario Premier in Stem Cell Deal
Ontario and California will work together to develop new stem cell therapies to help conquer cancer.

Illinois Lawmakers Approve Stem Cell Research
Illinois is on the verge of officially supporting research on embryonic stem cells, a practice that offers hope of medical breakthroughs but also raises ethical questions.

Conflicting Stem Cell Amendments Could End Up On Florida Ballot
One constitutional amendment would force the state to spend $200 million for embryonic stem-cell research. The other would ban any state money for such research.


Dendreon Sued After Provenge’s OK Put Off
A shareholder lawsuit has been filed against Seattle-based Dendreon, alleging the company misrepresented its clinical trial results and didn’t provide clear information about when the U.S. Food and Drug Administration would rule on its prostate cancer drug.

StemLifeLine Introduces First Service Allowing IVF Patients to Develop Personal Stem Cell Lines
StemLifeLine has announced that it received approval from the California Department of Health Services to engage in the operation of a tissue bank. With this Tissue Bank license, individuals who have undergone in vitro fertilization may now use StemLifeLine’s service to develop personal stem cell lines from their remaining stored embryos.

Advanced Cell Technology Enters Into Letter of Intent to Acquire Mytogen, Inc. and Proceed with the Human Clinical Trials Utilizing Myoblasts for the Treatment of Heart Failure
The company plans to commence Phase II human clinical trials to treat heart failure utilizing autologous myoblast stem cell therapy following successful Phase I human clinical trials which have already been completed.

Stem Cell Innovations and TNO to Collaborate on Generating PluriCell Derived Cartilage and Cardiomyocytes
Stem Cell Innovations, Inc. has announced that the Company and TNO will collaborate in a program sponsored by a Dutch government EZ-Co-financing grant. The Parties have developed and will explore new strategies to control human stem cell differentiation into cartilage and cardiomyocytes.

Stem Cell Therapy International, Inc. Announces That it Has Received Licensing Requests for Its New Medical Breakthrough “No Scars” Stem Cell Treatment for Burn Victims
Stem Cell Therapy International, Inc. has announced that it has been contacted by representatives for companies in India, Australia and Indonesia regarding acquiring the technology and license rights to SCII’s new “no scars” stem cell treatment for burn patients.

Thailand Biotech Company Gets BOI Seal of Approval for Adult Stem Cells
Thailand’s Board of Investment has announced its approval for TheraVitae, an Israeli-Thai company, thus paving the way for the company to expand its research and development and provide therapies using adult stem cells.

Scripps Researchers Get $17M Stem Cell Grant
Scientists at The Scripps Research Institute have received a $17 million federal grant to research using stem cells to treat common kinds of vision loss.

Pluristem Receives $830,000 Grant from Israeli Government for Development of the PLX-I Stem Cell Product
Pluristem Life Systems, Inc. has announced that its fully owned subsidiary Pluristem Ltd has received a competitive research and development grant of about $830,000 from Israel’s prestigious Chief Scientist Office.

University of Wisconsin-Madison Challenges Rejection of Patents
With its patents on the stem cell work of University of Wisconsin-Madison professor James Thomson preliminarily rejected, the foundation that helps shepherd the school’s research discoveries to market fired back, saying the rejection was wrong on multiple counts.

DomaniCell Supports National Children’s Health Fund
DomaniCell, LLC has announced its support of the Children’s Health Fund (CHF) by participating in the CHF 20th anniversary gala dinner.


Notice of Extension for Request for Information (RFI): Tools and Resources for Human Embryonic Stem Cell Research in the Nervous System (Neuroscience Blueprint) (NOT-DC-07-003)

A Data Resource for Analyzing Blood and Marrow Transplants (Limited Competition U24) (RFA-CA-07-506)

Program Projects for Basic Research on Human Embryonic Stem Cells (P01) (RFA-GM-08-003)

Biology of Breast Pre-Malignancies (R01) (RFA-CA-07-047)


Exceptions and Alternative Procedures Approved Under 21 CFR 640.120 – Update

Variances for Collection of Blood and Blood Products from Patients with Hemochromatosis – Update

FDA Workshop on Licensure of Apheresis Blood Products

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



New European Regulation on Tissue Engineering to Benefit Patients


Russian Officials Bar Export of Blood Samples, Courier Services Say
Customs officials have banned exports of blood samples and other biological materials from Russia, leading courier companies said Wednesday, a decision that experts said could lead to the deaths of patients in need of bone marrow transplants and other treatment.


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Profiled Journal

Current Issue: Volume 16, No. 3



Challenges in Neurorestoration: A Special Issue for the 14th Annual American Society for Neural Therapy and Repair (ASNTR) Meeting
Marina E. Emborg, Guest Editor

Original Contributions

Heparan Sulfate Mediates Neuroprotection From Degeneration in Experimental Glutaric Aciduria
Michelle C. Naylor, Mesfin Negia, Meredith Noetzel, Terry C. Burns, Zach L. Demorest, and Walter C. Low

Galantamine Effects on Memory, Spatial Cue Utilization, and Neurotrophic Factors in Aged Female Rats
K. L. French, H. A. Bimonte-Nelson, and A.-Ch. Granholm

Schwann Cell Transplantation Improved Reticulospinal Axon Growth and Forelimb Strength After Severe Cervical Spinal Cord Contusion
S. M. Schaal, B. M. Kitay, K. S. Cho, T. P. Lo, Jr., D. J. Barakat, A. E. Marcillo, A. R. Sanchez, C. M. Andrade, and D. D. Pearse

Differential Loss of Presynaptic Dopaminergic Markers in Parkinsonian Monkeys
Diane T. Stephenson, Mary Abigail Childs, Qiu Li, Santos Carvajal-Gonzalez, Alan Opsahl, Mark Tengowski, Martin D. Meglasson, Kalpana Merchant, and Marina E. Emborg


The Pivotal Role of RhoA GTPase in the Molecular Signaling of Axon Growth Inhibition After CNS Injury and Targeted Therapeutic Strategies
Robert E. Gross, Qi Mei, Claire-Anne Gutekunst, and Enrique Torre

Plasticity of the Central Nervous System and Formation of  "Auxiliary Niches” After Stem Cell Grafting: An Essay
Václav Ourednik and Jitka Ourednik

The Role of Endothelial Progenitor Cells in Ischemic Cerebral and Heart Diseases
Dah-Ching Ding, Woei-Cherng Shyu, Shinn-Zong Lin, and Hung Li

Blood–Brain Barrier Pathology in Alzheimer’s and Parkinson’s Disease: Implications for Drug Therapy
Brinda S. Desai, Angela J. Monahan, Paul M. Carvey, and Bill Hendey

Huntington’s Disease: Pathological Mechanisms and Therapeutic Strategies
Shilpa Ramaswamy, Kathleen M. Shannon, and Jeffrey H. Kordower

Abstracts for the 14th Annual Meeting of the American Society for Neural Therapy and Repair

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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