Volume 9.37 | Sep 22

Cell Therapy News 9.37, September 22, 2008
     In this issue: Science | Policy | Business | NIH | CBER | Regulatory
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Top Stories

Can Stem Cells Block Stroke Damage? Yes, But in a Surprising Way: Injecting stem cells into the brains of mice that recently suffered a stroke can reduce nerve cell (neuron) damage by up to 60 percent, according to new research.


Scientists Identify Genes Capable of Regulating Stem Cell Function
Scientists from The Forsyth Institute, Boston, MA, and the Howard Hughes Medical Institute at the University of Utah School of Medicine have developed a new system in which to study known mammalian adult stem cell disorders.

University of North Carolina Scientists Turn Human Skin Cells into Insulin-Producing Cells
Researchers at the University of North Carolina at Chapel Hill School of Medicine have transformed cells from human skin into cells that produce insulin, the hormone used to treat diabetes.

The Derivation of Human Embryonic Stem Cells Without Deleting the Embryo
Scientists at UZ Brussel have for the first time succeeded in deriving human embryonic stem cells from one single cell of a four-cell embryo on day 2 of its pre-implantation development.

Researchers Disclose Key Advance in Treating Spinal Cord Injuries
Researchers in Rochester, NY and Colorado have shown that manipulating stem cells prior to transplantation may hold the key to overcoming a critical obstacle to using stem cell technology to repair spinal cord injuries.

Seeing the Shape of Gene Silencing
Researchers have devised clever new techniques to mimic the chemical marks on tightly wound DNA-protein complexes that silence gene expression.

Children’s Hospital of Pittsburgh of UPMC Researchers Identify Genetic Mutation That May Predict Organ Rejection
Using a novel combination of cutting-edge technologies to scan the human genome, researchers at Children’s Hospital of Pittsburgh of UPMC have identified a genetic mutation that identifies transplant recipients who experience rejection.

Singapore Scientists’ Discovery on Stem Cell Factors Proves a Significant Step for Stem Cell Technology and Clinical Research
Singapore scientists have recently made a significant discovery in understanding the behaviour of a class of gene regulators, known as transcriptional factors, paving the way for important advancements in stem cell technology and clinical research.

Muscle Stem Cell Identity Confirmed by Stanford Researchers
A single cell can repopulate damaged skeletal muscle in mice, say scientists at the Stanford University School of Medicine, who devised a way to track the cell’s fate in living animals.

‘Baby’ Fat Cells May be Key to Treating Obesity
Immature, or “baby,” fat cells lurk in the walls of the blood vessels that nourish fatty tissue, just waiting for excess calories to help them grow into the adult monsters responsible for packing on the extra pounds, researchers at UT Southwestern Medical Center have found in mice.

Pluristem Presents Final PLX-PAD Efficacy Data Supporting Upcoming IND Submission to the U.S. FDA
Pluristem Therapeutics Inc. announced recently the successful conclusion of its pre-clinical efficacy studies utilizing PLX-PAD prior to the initiation of human clinical trials.

Inovio Biomedical Achieves 75% Complete Response Rate in Preclinical Testing of DNA-Based Cancer Vaccine Using Its Electroporation DNA Delivery System
Inovio Biomedical Corporation announced recently that it achieved positive results from its proprietary research and development program for DNA-based cancer vaccines delivered using the company’s electroporation-based DNA delivery technology.

Engineered Stem Cells Carry Promising Amyotrophic Lateral Sclerosis Therapy
Using adult stem cells from bone marrow as “Trojan horses” to deliver a nurturing growth factor to atrophied muscles, Wisconsin scientists have successfully slowed the progression of ALS in rats.


ES-Cell Derived Hematopoietic Cells Induce Transplantation Tolerance
The researcher’s data show, for the first time, the efficacy of ES-derived CD45+ HPCs to engraft in allogenic recipients without the use of immunosuppressive agents, there by protecting cardiac allografts from rejection.

Stem/Progenitor Cells from Bone Marrow Decrease Neuronal Death in Global Ischemia by Modulation of Inflammatory/Immune Responses
The human mesenchymal stromal cells injected into the hippocampus both improved neurologic function and markedly decreased neuronal cell death of the hippocampus.

Stem Cells for Kidney Repair: Useful Tool for Acute Renal Failure?
Chen et al. report that local mesenchymal stem cells derived from adult mouse kidneys are another source of cells that can differentiate into mature kidney cells that may participate in renal repair after systemic administration.


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Australia Issues First License to Clone Human Embryos
The Australian government has issued its first license allowing scientists to create cloned human embryos to try and obtain embryonic stem cells.

McCain vs Obama: Who Will End the War on Science?
With the 2008 election under way and a new occupant heading for the Oval Office, Solomon is one of a group of influential thinkers who see closing the gap between science and the presidency as a vital goal of the next four years.

Barrier to Bay State Biotech
With the prospects for new cures from breakthrough technologies like stem cells and RNAi stronger than ever, Governor Deval Patrick’s recent signing of the Massachusetts Life Sciences Initiative into law has provided $1 billion of hope for patients with life-threatening diseases.

Consumer Group Urges Governor Schwarzenegger to Sign Stem Cell Bill Into Law
In a letter to the governor, Consumer Watchdog said the bill would help ensure that the people paying $6 billion for stem cell research, the taxpayers of California, will have affordable access to the fruits of the research they are funding.

Payment to Overseas Bio-Research Costs Not Taxable in India
A tax tribunal recently said overseas firms providing research facilities for clinical and bio-analytical studies to Indian companies for developing of new drugs are not liable to pay tax here, if they do not have a permanent establishment in the country.


Cerus and German Red Cross to Collaborate on INTERCEPT Red Blood Cell System Development
Cerus Corporation announced recently that the German Red Cross in the Baden-Wurttemberg-Hessen region has agreed to collaborate in the development of the company’s INTERCEPT Blood System for red blood cells.

T. Denny Sanford Donates $30 Million to San Diego Consortium for Regenerative Medicine
The San Diego Consortium for Regenerative Medicine recently announced that it has received a generous $30 million donation from T. Denny Sanford of South Dakota.

ImmuneRegen BioSciences Looks to Test Adult Stem Cell Compound
The 13-employee Scottsdale company recently received a $5 million round of institutional financing from Brencourt Advisors LLC, which is expected to generate an additional $10 million in syndicated funding. The money will be used to move into human testing.

University of Massachusetts Medical School and Massachusetts Life Sciences Center Announce Launch of International Stem Cell Registry
As an initial component of Governor Deval Patrick’s 10-year, $1 billion Life Sciences Initiative, the ISCR received a $570,000 grant from the Massachusetts Life Sciences Center.

Celprogen Introduces Stem Cells in Syringes for In Vivo Applications
Celprogen Inc. recently announced that they have successfully validated shipment of embryonic and adult stem cells at room temperature within United States research facilities for in vivo applications.

Life Sciences Companies say Massachusetts Failing to Train Workforce
With 100,000 workers and growing, companies in the Massachusetts life sciences sector have urgent hiring needs. But according to a study paid for by the industry, meeting that demand is difficult because the state continues to face shortfalls in education and training.

New Stem Cell Centre Gives Hope for Stroke Damage
Researchers within the University of Adelaide’s new Centre for Stem Cell Research are aiming by the end of this year to show repair in stroke-damaged brains using stem cells taken from adult teeth.

Novocell Awarded Landmark U.S. Patents for Innovative Stem Cell Technologies
Novocell, Inc. recently announced that the U.S. Patent and Trademark Office has issued two patents related to its stem cell encapsulation technology  and granted Notice of Allowance for a patent relating to the Company’s technology for the isolation of clinical-grade human embryonic stem cell lines.

Examiner Made Two Legal Errors in Stem Cell Patent Decision, Consumer Advocates Say Appeal Brief Asks Wisconsin Alumni Research Foundation’s Patent Claims Be Rejected
Legal papers just filed with the U.S. Patent Office cite two legal errors made by a patent examiner in confirming a patent on human embryonic stem cells and ask its claims be rejected, two consumer groups said recently.


Extension of Expiration Date for PA-06-012 (STTR) and PA-06-013 (SBIR) — Manufacturing Processes of Medical, Dental, and Biological Technologies


Substantially Equivalent 510(k) Device Information: PLASMALINK

Substantially Equivalent 510(k) Device Information: Trima Accel Automated Blood Component Collection System, COBE Spectra Apheresis System

Manual of Standard Operating Procedures and Policies: Procedures for Developing Postmarketing Requirements and Commitments

Manual of Standard Operating Procedures and Policies: Handling of Regulatory Electronic Communications

Public Workshop: Structured Product Labeling Content of Labeling and Electronic Drug Establishment Registration and Drug Listing for the Biologics Industry

Presentation: GMP by the Sea



Current Good Manufacturing Practice and Investigational New Drugs Intended for Use in Clinical Trials: Final Rule

FDA Hires 1,300 New Doctors and Scientists
The Food and Drug Administration said Thursday it has hired more than 1,300 professional staffers in a move that officials hope will help the beleaguered agency better protect the public health amid rapid technological and scientific change.

FDA Issues Draft Guidance on Regulating Genetically Engineered Animals

Guidance for Industry: Regulation of Genetically Engineered Animals Containing Heritable rDNA Constructs; Availability


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