Volume 8.38 | Oct 1

Volume 8.38, October 1, 2007
     In this issue: Science | Policy | Business | NIH | CBER | Regulatory
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Top Stories

New Use for Stem Cells Found in War on Terrorism: For more than a decade, Steve Stice has dedicated his research using embryonic stem cells to improving the lives of people with degenerative diseases and debilitating injuries. His most recent discovery, which produces billions of neural cells from a few stem cells, could now aid in national security.


Equine Umbilical Cord Stem Cells Isolated; Suitable for Variety of Uses
Stem cells have been isolated successfully from the equine umbilical cord. Once collected, these cells (referred to as umbilical cord matrix cells) can then be preserved frozen, cultured, and differentiated into a host of cell lines, including bone, cartilage, fat, and those of the nervous system.

Scientists Criticize Adult Stem Cell Claim
German stem cell researchers say a colleague’s claims about an adult stem cell heart therapy are scientifically flawed and politically motivated

Brown Scientists Take the Petri Dish to New Dimensions
Brown University biomedical engineers have created a new method for growing cells in three dimensions rather than the traditional two.

‘Jumping Genes’ Could Make for Safer Gene Delivery System
the advent of new nonviral gene delivery systems using transposons, or “jumping genes,” provides a safer alternative than viruses and more efficient delivery than plasmids, according to a publication by a University of Wisconsin-Madison molecular biologist and biological safety expert.

HepaLife(TM) Releases Positive New Research Results For First-of-its-Kind Bioartificial Liver
HepaLife’s patented PICM-19 liver cells show increased liver-specific activity inside Company’s bioartificial liver – a significant milestone in development of liver device.

Therapy to Slow Down Liver Damage 
Scientists have developed a new way to treat liver failure by dampening the immune response using stem cells taken from the bone marrow.

Stem Cells Show Promise For Treating Huntington’s Disease
Paying close attention to how a canary learns a new song has helped scientists open a new avenue of research against Huntington’s disease – a fatal disorder for which there is currently no cure or even a treatment to slow the disease.

Promising Genetic Therapy Uses RNA Interference
Researchers from MIT, Alnylam Pharmaceuticals and other institutions have demonstrated the safety of a promising type of genetic therapy that could lead to treatments for a wide range of diseases such as cancer.

Angioblast Featured at US Global Life Sciences Conference in New York. Company Unveils Major New Program in Eye Disease.
Professor Itescu will present exciting new results showing that Angioblast’s proprietary stem cells are highly effective in preclinical trials for the treatment of leaky blood vessels in the eye, the major cause of vision loss in patients with wet age-related macular degeneration and macular oedema complicating diabetic retinopathy.

Transplants Using Adult Bone Marrow Stem Cells Restore Functions for Spinal Cord Injury Patients; PrimeCell Therapeutics Provides Research Support
PrimeCell(TM) Therapeutics LLC has announced that it provided research support and pre-clinical studies for a clinical trial that involved the implantation of autologous adult bone marrow stem cells into spinal cord injury patients – resulting in some restored function for patients who have been paralyzed for an average of four years, some up to 22 years.

South Florida Studies Aim to Mend Hearts with Patients’ Stem Cells
Two studies starting in South Florida will test the long-dreamed vision that the body’s own stem cells can be deployed to reverse the damage from heart disease.

Stem Cells Trial for MS Patients
Six patients at Frenchay Hospital are being injected with their own stem cells in the hope that they will repair damage to the brain.

Stem Cell Therapy ‘Will be Commonplace’
Professor Ian Wilmut, director of the Scottish Centre for Regenerative Medicine at Edinburgh University, said the first of these revolutionary therapies is expected to be available in around a decade and will develop rapidly over the coming years.

Man Sues Over Stolen Bone Placed in Neck
A man who found out the bone implanted in his neck to relieve back pain was stolen from a corpse is suing a medical technology company and several tissue processing businesses, including two in Tennessee.


Second Malignancies after Allogeneic Hematopoietic Cell Transplantation
Allogeneic hematopoietic cell transplantation (allo-HCT) may prolong life and cure patients suffering from otherwise fatal diseases. However, the growing population of long-term survivors has led to the realization of multiple long-term complications, including the risk of second malignancies. Guidelines should be developed in regard to screening and prevention of second malignancies, so that physicians can provide state-of-the-art counsel and care for the benefit of our patients.


Cell Therapeutics Supervisor
Philadelphia, PA (AppTec)

Postdoc Fellow
Sweden (Wallenberg Neuro Center Neuronal Survival Unit)

Manager, Manufacturing
Memphis, TN (Cognate Bioservices)


State Readies for First Stem Cell Bond Sale
California Treasurer Bill Lockyer is preparing for the sale of $250 million worth of bonds – the first tranche of $3 billion sold as a result of Prop. 71, the 2004 voter-approved initiative to fund embryonic stem cell research.

New Jersey Judge Clears Stem Cell Vote
A judge has rejected a bid by abortion opponents to halt New Jersey’s plans to ask voters whether the state should borrow $450 million to fund stem cell research for 10 years.

Stem Cell Funding Stalled by Contract
Saying it was more suited for corporations than for educational institutions, University of Maryland officials have refused to sign the agreement that would release their portion of $15 million in grant money awarded from the Maryland Stem Cell Research Fund.

Warning for UK Stem Cell Research if US Relaxes Rules
The UK is in danger of losing its leading position in stem cell research if the next US president relaxes restrictions imposed by George Bush, according to the new head of the Medical Research Council.

Main Hospitals Veto Lifesaving Cord-blood Bank
Ireland’s three leading maternity hospitals will not provide standard cord-blood collection facilities for parents who want to save their newborn’s stem cells for future medical use.


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Advanced Cell Technology Completes Acquisition of Mytogen, Inc.
Advanced Cell Technology, Inc. has announced that it has completed the acquisition of all of the outstanding capital stock of Mytogen, Inc.

StemCells, Inc. Announces Research Collaboration Focused On Cell-Based Liver Therapy
StemCells, Inc. has announced that it has entered into a research collaboration with Belgium’s Université Catholique de Louvain and the UCL-affiliated Cliniques Universitaires Saint Luc to further the development of the Company’s proprietary human liver engrafting cells as a potential cell-based liver therapy.

Plasticell and Hamilton Company Announce Agreement to Automate High Throughput Stem Cell Differentiation Technology
Plasticell has entered into an agreement with Hamilton Company to automate Plasticell’s Combinatorial Cell Culture(TM) technology for the determination of optimal protocols to direct stem cell differentiation.

China Marrow Donor Program Expands Stem Cell Databank Sharing
The Chinese Marrow Donor Program signed an agreement on Tuesday with the Beijing Cord Blood Stem Cell Bank to share its bank of 10,000 stem cell data reserves.

SCS Wins EU Funding to Use Stem Cells for Drug Discovery
Stem Cell Sciences plc announces that it is to lead an EU funded, multinational novel drug screening collaboration using stem cells.  The project, named "NEUROscreen", will use Stem Cell Sciences’ proprietary neural stem cell technology and has received a contribution from the EU’s 6th Framework Programme for Research and Technical Development.

Non-Profit Founded to Advance Orphan Drug Research
Asklepios BioPharmaceutical, Inc. announced the creation of the Chapel Hill Project, a non-profit organization created to advance the development of cell and gene therapies for orphan diseases through increased scientific collaboration.

NeoStem Announces Launch of "Stem for Life" Foundation to Promote Public Awareness of Adult Stem Cell Promise and Accelerate Groundbreaking Science
NeoStem, Inc. has announced the launch of the "Stem for Life" Foundation dedicated to heightening public awareness and knowledge of the benefits and the promise of utilizing adult stem cells to treat serious medical conditions in the burgeoning regenerative medicine industry.

Cardiac Stem Cell Therapy Company, Cardio3 BioSciences, Appoints Former New Jersey Medical School Assistant Professor, Dr. Vinciane Gaussin, as its Chief Scientific Officer
“The addition of Dr. Gaussin to our management team represents an important milestone in our mission to position Cardio3 BioSciences as a global leader in the field of regenerative therapies for heart failure,” said Christian Homsy, M.D., CEO of Cardio3 BioSciences.


NIH to Hold Symposium on Cardiovascular Regenerative Medicine
To accelerate the advancement of stem cell biology from bench to bedside for treatment of cardiovascular disease, the National Institutes of Health (NIH) will host the scientific symposium Cardiovascular Regenerative Medicine at the NIH Natcher Conference Center in Bethesda, Maryland.

Sally Lee Appointed NIGMS Executive Officer
Jeremy M. Berg, Ph.D., director of the National Institute of General Medical Sciences (NIGMS), has appointed Sally Lee as the institute’s new executive officer.

Reminder of NIH Policy for Enhancing the Science, Safety, and Ethics of Recombinant DNA Research (NOT-OD-07-096)

Notice of Availability of Funds to Support Clinical trials on the Safety and Effectiveness of Products for Rare Diseases (NOT-FD-08-001)

Paul B. Beeson Career Development Awards in Aging (K08 & K23) (RFA-AG-08-006)

Research on Research Integrity (R03) (RFA-RR-07-004)


Revisions to the Requirements Applicable to Blood, Blood Components and Source Plasma; Correction

Revisions to the Requirements Applicable to Blood, Blood Components, and Source Plasma; Companion Document to Direct Final Rule; Correction

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



FDA Considers Reforming Use, Selection of Advisory Panels
Federal advisers who met last week to consider whether to restrict doses of popular antianemia drugs were themselves under scrutiny during the hearing. The Food and Drug Administration is considering a top-to-bottom reshaping of how it picks and uses the outside scientists who serve on the agency’s advisory panels.


Therapeutic Goods Order No. 75 Standards for Haematopoietic Progenitor Cells Derived from Cord Blood

Quarterly Report of the Therapeutic Goods Administration Against the 2006-2007 Business Plan, April – June 2007


ISCT Membership
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Profiled Journal

Current Issue: Volume 16, No 5


Original Contributions

Nitric Oxide-Containing Neurons in Long-Term Grafts in a Rat Model of Parkinson’s Disease
B. Rajakumar, B. A. Flumerfelt, A. W. Hrycyshyn, and N. Rajakumar

The Effect of Truncated Human ?-Synuclein (1–20) on Dopaminergic Cells in a Transgenic Mouse Model of Parkinson’s Disease
A. W. Michell, G. K. Tofaris, H. Gossage, P. Tyers, M. G. Spillantini, and R. A. Barker

Combined Treatment of Neurotrophin-3 Gene and Neural Stem Cells Is Propitious to Functional Recovery After Spinal Cord Injury
Luyi Zhang, Shuting Gu, Cuiping Zhao, and Tieqiao Wen

An Immortalized Rat Ventral Mesencephalic Cell Line, RTC4, Is Protective in a Rodent Model of Stroke
B. K. Harvey, G. J. Chen, C. J. Schoen, C. T. Lee, D. B. Howard, O. Dillon-Carter, M. Coggiano, W. J. Freed, Y. Wang, B. J. Hoffer, and J. F. Sanchez

Chondroitinase ABC Treatment Enhances Synaptogenesis Between Transplant and Host Neurons in Model of Retinal Degeneration
Takuya Suzuki, Masayuki Akimoto, Hiroo Imai, Yoshiki Ueda, Michiko Mandai, Nagahisa Yoshimura, Anand Swaroop, and Masayo Takahashi

Time Course and Quantification of Pancreatic Islet Revascularization Following Intraportal Transplantation
Gareth L. Jones, Maciej T. Juszczak, Stephen J. Hughes, Paul Kooner, Stephen H. Powis, and Martin Press

Role of Blood Glucose in Cytokine Gene Expression in Early Syngeneic Islet Transplantation
Marta Montolio, Noèlia Téllez, Joan Soler, and Eduard Montanya

Cell Loss During Pseudoislet Formation Hampers Profound Improvements in Islet Lentiviral Transduction Efficacy for Transplantation Purposes
H. Callewaert, C. Gysemans, A. K. Cardozo, M. Elsner, M. Tiedge, D. L. Eizirik, and C. Mathieu

Improved Quality and In Vivo Function of Islets Isolated by Reduced Pressure-Controlled Injection of Collagenase in a Rat Model
Shiri Li, Tetsuya Sakai, Yasuyuki Suzuki, Tadahiro Goto, Tomohiro Tanaka, Takuro Yoshikawa, Keitaro Kakinoki, Yasuki Tanioka, Ippei Matsumoto, Yasuhiro Fujino, and Yoshikazu Kuroda

Intrasplenic Hepatocyte Transplantation Prolonged the Survival in Nagase Analbuminemic Rats With Liver Failure Induced by Common Bile Duct Ligation
Masahiro Ito, Hideo Nagata, Toshiyuki Yamamoto, Daisuke Yoshihara, Ira J. Fox, and Shuichi Miyakawa

Comparison of Mesenchymal Stem Cells From Different Tissues to Suppress T-Cell Activation
Kirsten A. Keyser, Karen E. Beagles, and Hans-Peter Kiem

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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