Volume 7.12 | Apr 3

Volume 7.12, April 3, 2006
     In this issue: Science | Policy | Business | NIH | CBER | Regulatory
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Top Stories

Groundbreaking Human Clinical Trial For Type 1 Diabetes To Start This Spring: Children’s Hospital of Pittsburgh researchers Massimo Trucco, MD, and Nick Giannoukakis, PhD, observed marked amelioration of diabetes in a mouse model by a novel treatment strategy involving specific modification of the animal’s own dendritic cells, thereby reversing diabetes in animal studies. The U.S. Food and Drug Administration (FDA) approved the start of a clinical trial to evaluate the safety and feasibility of the treatment (Phase 1 trial).
Article

PrimeGen Biotech Successfully Derives Human Heart, Brain, Bone and Cartilage Cells from Stem Cells Found in Adult Male Testes: In a breakthrough for stem cell research and cellular replacement therapies, PrimeGen Biotech today announced that its researchers have successfully developed the first human adult therapeutic germ stem cell.
Article

Science

Minimal Cocktail for Growing Human Embryonic Stem Cells Established
Researchers at Yale have established the minimal nutritional requirements for growing and maintaining human embryonic stem cells, a recipe that is critical for clinical application and for developmental studies, according to an early online report this week in Proceedings of the National Academy of Sciences.
Article

Engineered Stem Cells Show Promise for Sneaking Drugs Into The Brain
Scientists have found a new way to sneak drugs past the blood-brain barrier by engineering and implanting progenitor brain cells derived from stem cells to produce and deliver a critical growth factor that has already shown clinical promise for treating Parkinson’s disease.
Article

Getting ACL Tears to Heal Themselves
In the April Journal of Orthopaedic Research, orthopedic surgeon Martha Murray, MD reports that a collagen gel, enriched with blood platelets, can stimulate natural healing of a partial ACL tear, encouraging the body’s cells to fill in the defect and restore mechanical strength to the ligament.
Article

Transplanted Mice Cells Ease Rat Paralysis
Scientists eased the paralysis of rats with spinal cord injury by transplanting cells taken from the brains of adult mice, an encouraging sign for developing a human treatment.
Article

Generating Egg-like Cells from Pig Fetal Skin
Julang Li and colleagues show that even post-embryonic somatic stem cells (derived from later stages of foetal development) can give rise to egg-like cells in vitro.
Article

Periosteal Cells Grow Cartilage, Bone, and Skeletal Muscle
Cultured adult human periosteal stem cells demonstrate mesenchymal multipotency, suggesting that they may be used to repair tissue and joint damage associated with arthritis.
Article

Rice University Bioengineers Pioneer Techniques for Knee Repair
A breakthrough self-assembly technique for growing replacement cartilage offers the first hope of replacing the entire articular surface of knees damaged by arthritis.
Article

First Clinical Trial of Gene Therapy for Muscular Dystrophy Now Under Way
The clinical trial for Duchenne muscular dystrophy (DMD) tests the safety and effectiveness of a therapy that was developed over two decades by scientists at the University of North Carolina at Chapel Hill’s School of Medicine and the University of Pittsburgh.
Article

Brain Cells Fused with Computer Chips
European researchers have created an interface between mammalian neurons and silicon chips.
Article

DNA Gene Vaccine Protects Against Harmful Protein of Alzheimer’s Disease
Doses of DNA-gene-coated gold particles protect mice against a protein implicated in Alzheimer’s disease.
Article

Doctor is Charged with Therapy Scam
The Atlantic County physician allegedly bilked patients by offering a bogus stem-cell treatment.
Article

Researchers Create Pigs That Produce Heart-Healthy Omega-3 Fatty Acids
Researchers report they have created pigs that produce omega-3 fatty acids, which are known to improve heart function and help reduce the risks for heart disease, representing the first cloned transgenic livestock in the world that can make the beneficial compound.
Article

Stem cells, Gene Therapy and Allograft Applications Show Promise for Treating Orthopaedic Conditions
Recent advances in gene therapy, stem cells and other promising applications are offering new hope for patients and helping orthopaedic surgeons provide state-of-the-art treatment for various frame-related conditions.
Article

ABSTRACTS, REVIEWS & SPECIAL REPORTS

Genospheres: Self-Assembling Nucleic Acid-Lipid Nanoparticles Suitable for Targeted Gene Delivery
This work describes a novel, readily scalable method for preparing highly stable immunotargeted nucleic acid delivery vehicles capable of achieving a high degree of specific transfection activity.
Abstract

Human Neural Progenitors Deliver Glial Cell Line-Derived Neurotrophic Factor to Parkinsonian Rodents and Aged Primates
hNPC can be genetically modified, and thereby represent a safe and powerful option for delivering growth factors to specific targets within the central nervous system for diseases such as Parkinson’s.
Abstract

Delayed Transplantation of Adult Neural Precursor Cells Promotes Remyelination and Functional Neurological Recovery after Spinal Cord Injury
The data provides strong evidence in support of the feasibility of adult NPCs for cell-based remyelination after SCI.
Abstract

In Vitro Germline Potential of Stem Cells Derived from Fetal Porcine Skin
We report that stem cells isolated from the skin of porcine fetuses have the intrinsic ability to differentiate into oocyte-like cells.
Abstract

Policy

EU Stem Cell Funding in Jeopardy?
Germany, Austria and other nations opposed to EU funding of human embryonic stem cell research proposed an EU funding ban this month in Brussels at a meeting of the EU’s 25 national science ministers, raising concerns that the minority group could force nations to remove this funding from the newest budget, even for scientists in countries where the research is legal.
Article

South Korea to Form Pan-National Stem Cell Research Network
The government seeks to boost stem cell research once again by establishing a broad-based network encompassing Korean experts both at home and abroad.
Article

China Bans Transplant Organ Sales
China has said it will ban the sale of human organs from July in an attempt to clean up its transplant industry.
Article

Stem Cell Institute May Sell Naming Rights to Wealthy Donors
Perhaps tens of millions of dollars worth of contributions to the California’s cash-strapped stem cell agency if its board adopts a proposal to swap naming rights to research programs and office space in exchange for sizable donations.
Article

Stem-cell Issue Headed for US Senate Floor
Americans who believe embryonic stem cells could one day cure their cancers, their parents’ degenerative diseases or their children’s diabetes may soon reach a crossroads: a final vote by Congress to lift President Bush’s ban on federal funding for research on new embryonic stem cell lines.
Article

Stem Cell Therapy – Harney Must Close All Legal Loopholes
Around 6,000 Irish people are afflicted with the chronically debilitating and incurable condition which attacks the nervous system. Seeking a remedy at any cost, some are turning to unproven stem cell treatment at a Cork clinic.
Article

Business

National Stem Cell, Inc. Intends to Merge with Azurel, Ltd.
National Stem Cell, Inc today announced that it has entered into a letter of intent to merge with Azurel, Ltd.
Article


Body, Heal Thyself
After false starts, cancer immunotherapies tiptoe toward commercialization
Article

Stem Cell Sciences to Open California Office
Stem Cell Sciences, the ambitious Edinburgh biotech company, is expanding into the United States as it moves to become a genuine global player.
Article

ViaGen, Inc. Gallops Into Horse Cloning
Livestock cloning company ViaGen, Inc. is partnering with equine marketing firm Encore Genetics to create the first commercial horse cloning operation in the country. Today the companies launched the new entity with announcements about the births of two famous horse clones and news of other pregnancies.
Article

A Bioscience Beginning
Buoyed by Georgia State’s $500 million University Science Park, a formal bioscience district could become a reality.
Article

Millenium Biologix Provides Update on Corporate Strategy, Progresses with Continued Business and Financial Restructuring and Appoints Brian Fielding as Interim CEO
Millenium Biologix Corporation, today provided an update on its corporate strategy, an update on its continuing business and financial restructuring, and announced the appointment of Brian Fielding, Millenium’s Executive Deputy Chairman as interim Chief Executive Officer.
Article

Immunicon and Pfizer Extend and Expand Clinical Research and Development Agreement
Immunicon Corporation (NASDAQ-NM:IMMC) announced today an extension of its Research and Development Agreement with Pfizer, Inc., under which the Company collaborates with Pfizer to develop new reagents designed to detect certain undisclosed antigens on circulating tumor cells (CTCs).
Article

Ono Pharmaceutical Company, Ltd. And Medarex, Inc. Enter Into Second Collaboration For The Development Of A Fully Human Antibody Therapeutic
Ono Pharmaceutical Co., Ltd. and Medarex, Inc. announced today that they have entered into a collaborative agreement to research and develop a fully human anti-SDF-1 antibody for the potential treatment of multiple indications.
Article

RenaMed Biologics to Expand Operations to Westborough, MA
RenaMed Biologics, Inc. (RenaMedâ„¢) announced today that it hasleased a facility in Westborough, Massachusetts to serve as its commercial manufacturing facility for its Renal Bio-Replacement Therapy product for Acute Renal Failure.
Article

New Life Scientific and Telomolecular Announce Agreement to Conduct Clinical Studies
Telomolecular has agreed to conduct key clinical studies through New Life Scientifics’ wholly owned Contract Research Organizations (CRO) in the United States and Europe.
Article

NIH


NATIONAL INSTITUTES OF HEALTH

NIH Director Selects Dr. Roger I. Glass as Fogarty International Center Director
Elias A. Zerhouni, M.D., director of the National Institutes of Health (NIH), today announced that Roger I. Glass, M.D., Ph.D., will be the new director of the Fogarty International Center (FIC) and Associate Director of NIH for international programs.
Article

Clarification of Instructions Regarding Inclusion of Publications as Appendix Materials
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Understanding the Effects of Emerging Cellular, Molecular, and Genomic Technologies on Cancer Health Care Delivery (R01)
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Understanding the Effects of Emerging Cellular, Molecular, and Genomic Technologies on Cancer Health Care Delivery (R21)
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Stem Cells and Cancer (R21)
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Correlative Studies with Specimens from Multi-Site Trials (R21)
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Innovative Application of Nanotechnology to Heart, Lung, Blood, and Sleep Disorders (R21/R33)
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CBER

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

Variances for Collection of Blood and Blood Products from Patients with Hemochromatosis – Update
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Annual Comprehensive List of Guidance Documents at the FDA
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Guidance for Clinical Trial Sponsors: Establishment and Operation of Clinical Trial Data Monitoring Committees
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Exceptions and Alternative Procedures Approved Under 21 CFR 640.120
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Regulatory

Food and Drug Administration (United States of America)

FDA Workshop on Behavior-Based Donor Deferrals in the NAT Era Transcript
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Guidance for Clinical Trial Sponsors: Establishment and Operation of Clinical Trial Data Monitoring Committees; Availability
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Annual Comprehensive List of Guidance Documents at the Food and Drug Administration
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Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Guidance on Informed Consent for In Vitro Diagnostic Device Studies Using Leftover Human Specimens That are Not Individually Identifiable
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Medicines and Healthcare Regulatory Agency (United Kingdom)

Regulation Matters: An information day about the work of the MHRA
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Good Clinical Practice Inspections Symposium
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Australia New Zealand Therapeutic Products Authority (Australia and New Zealand)

Stakeholder consultation programme 2006/07
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Medsafe (New Zealand)

Regulatory Consultants
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ISCT

ISCT2006. May 4-7. Berlin, Germany.
Visit http://www.celltherapysociety.org.

AABB-ISCT Cellular Therapy Audioconference Series
Link

The organizing committee for the 6th Annual Somatic Cell Therapy Symposium is asking for your assistance with the program of this year’s meeting. The original survey that was posted experienced technical difficulties and did not capture all of the responses. Therefore, we are requesting you take a few moments to visit this link to take the survey again even if you have previously responded.

Please respond by March 29, 2006.

Here is a link to the survey:
http://www.surveymonkey.com/s.asp?A=101935365E8233

For more information on the Somatic Cell Therapy Symposium, see www.celltherapysociety.org.

Profiled Journal

Join ISCT($130) and receive the journal as a benefit of membership.

Current Volume: Volume 8 Number 1/February 2006


Cytotherapy publishes original research, reviews, meeting reports, special focus issues and letters in the general field of cell therapy. The scope of the journal includes basic and applied research with hematopoietic and non-hematopoietic stem cells, immune cells, and antigen-presenting cells. Therapeutic topics within the scope of Cytotherapy include ex-vivo and in-vivo aspects of gene therapy, immunotherapy, stem cell transplantation and tissue regeneration. Cytotherapy particularly welcomes contributions from researchers, clinicians, technicians and individuals involved in regulatory aspects of cell therapy.
http://journalsonline.tandf.co.uk/link.asp?id=107693



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