Volume 7.23 | Jun 19

Volume 7.23, June 19, 2006
     In this issue: Science | Policy | Business | NIH | CBER | Regulatory
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Top Stories

Scientists Say Adult Cells Can Revert to Embryonic Stage: U.K. scientists have found a way to make adult cells revert to an embryonic stage, a discovery that could lead to disease treatments without the need to use embryonic stem cells or cloning.
Article

Science

First Embryonic Stem Cell Trial on the Cards
A US team hopes to be in clinical trials next year, using an ESC-derived product to help repair damaged spinal tissue.
Article

Study of Adult Stem Cells in the Treatment of Multiple Sclerosis Begins in Charleston
D-Finitive Technologies, Inc. has announced that a preliminary phase of animal testing of transfected adult stem cells is now underway that may lead to advances in the treatment of Multiple Sclerosis.
Article

Adult Stem Cell Research at University of Buffalo Targets Damaged Hearts
A specialist in stem cell biology at the University at Buffalo has received a $1.98 million grant from National Institutes of Health to investigate the potential of bone marrow-derived adult stem cells to treat the serious heart malfunction known as hibernating myocardium.
Article

University of California Researchers Develop ‘Smart Petri Dish’
Researchers at the University of California, San Diego have developed what they call a “Smart Petri Dish” that could be used to rapidly screen new drugs for toxic interactions or identify cells in the early stages of cancer circulating through a patient’s blood.
Article

Gene Therapy Injected into the Brains’ of Mice with Huntington’s Disease Protects Neurons, Stops Degeneration and Improves Behavioral Function
Researchers at Rush University Medical Center, Chicago, and Ceregene Inc., San Diego, have successfully used gene therapy to preserve motor function and stop the anatomic, cellular changes that occur in the brains of mice with Huntington’s disease (HD).
Article

Stem Cells Found In Adult Skin Can Be Transplanted And Function In Mouse Models Of Disease
Researchers at The Hospital for Sick Children (SickKids) and the University of Calgary have found that stem cells derived from adult skin can create neural cell types that can be transplanted into and function in mouse models of disease.
Article

Research at University of Washington May Hold Promise for Liver Damage
Scientists at the University of Washington are optimistic that they’ve made what they call meaningful progress toward learning how to repair damaged human livers with stem cells.
Article

Advanced Donor Age Reduces Quality of Islet Cells Used in Transplantation
Experiments in diabetic mice have demonstrated that the age of islet cell donors affects the efficacy of transplants, transplant surgeons at the University of Minnesota, Minneapolis, report.
Article

New Step Toward Treatment For Duchenne Muscular Dystrophy
After performing the first successful muscle cell transplant in young patients two years ago, professor Tremblay announced that eight out of the nine patients have shown promising results.
Article

Favrille Announces FDA Allowance of Investigational New Drug Application for FAV-201, a Patient-Specific Immunotherapy for T-Cell Lymphoma
Favrille, Inc. (Nasdaq: FVRL – News), a biopharmaceutical company developing patient-specific immunotherapies for the treatment of cancer, announced today that its electronic Investigational New Drug (IND) application for FAV-201, a patient-specific immunotherapy for the treatment of T-cell lymphoma, has been cleared by the U.S. Food & Drug Administration (FDA).
Article

Baylor College of Medicine and St. Luke’s Episcopal Hospital Study Uses Gene Therapy as Treatment for Pancreatic Cancer
The use of gene therapy alongside the standard treatment for pancreatic cancer is being studied by researchers at the Elkins Pancreas Center at Baylor College of Medicine and St. Luke’s Episcopal Hospital.
Article

Novocell Presents Phase I/II Data on Safety and Response to Encapsulated Islets at the American Diabetes Association’s 66th Annual Scientific Session
The poster entitled “Encapsulated Human Islet Allografts — Phase I/II Clinical Trial” described safety and efficacy results following subcutaneous implants of encapsulated human islet allografts into patients with Type I diabetes of long standing duration.
Article

Dendreon Announces Publication of Research Showing Promising Activity of PROVENGE in Combination with Avastin in Patients with Recurrent Early Stage Prostate Cancer
Dendreon Corporation has announced that the results from a National Cancer Institute (NCI)-sponsored Phase 2 study of its PROVENGE® (sipuleucel-T) active cellular immunotherapy for prostate cancer in combination with Avastin® (bevacizumab) have been published in the July issue of the American Cancer Society’s journal, Cancer.
Article

IDM Pharma Receives Special Protocol Assessment from FDA for Phase 2/3 Trial of Bexidem for Superficial Bladder Cancer
IDM Pharma Inc. announced today that it has received a Special Protocol Assessment (SPA) from the U.S. Food and Drug Administration (FDA) for the planned Phase 2/3 clinical trial in the U.S. of Bexidem for the treatment of superficial bladder cancer.
Article

Genitope Cancer Treatment on Fast Track
Genitope Corp. said Tuesday the Food and Drug Administration gave its cancer treatment candidate, MyVax, Fast Track status.
Article

Amgen Cancer Drug Panitumumab Gets FDA Priority Review
Amgen, the world’s largest biotechnology company, today announced that the U.S. Food and Drug Administration (FDA) has accepted the Biologic License Application (BLA) for panitumumab, an investigational fully human monoclonal antibody that targets the epidermal growth factor receptor (EGFr) and has granted Priority Review.
Article

Genes Governing Embryonic Stem Cell “Immortality” Discovered
New research has uncovered some of the genes that allow embryonic stem cells to renew themselves.
Article

New Stem-cell Findings Can Help The Body To Cure Itself
Researchers at Karolinska Institutet have identified an important mechanism that regulates how many new cells are produced by each intestinal stem cell.
Article

Scientists Tie Several Cancers to Common “Oncogene Engine”
Researchers at Dana-Farber Cancer Institute report that a common “oncogene engine” – a small family of malfunctioning cell growth switches – drives several seemingly unrelated, lethal forms of cancer, including malignant melanoma.
Article

Software Tracks Proteins Inside Living Cells
A computer system that automatically tracks the movements of proteins within a living cell has been developed by a team of biologists and computer vision experts.
Article

Joslin Diabetes Center Study Refutes Recent Report that Bone Marrow Can Replenish Female Oocytes
Study shows that circulating bone-marrow derived cells do not contribute to egg formation.
Article

ABSTRACTS, REVIEWS & SPECIAL REPORTS

Nanog Promotes Transfer of Pluripotency After Cell Fusion
The researchers conclude that Nanog can orchestrate ES cell machinery to instate pluripotency with an efficiency of up to 100% depending on the differentiation status of the somatic cell.
Abstract

Dissecting Self-Renewal in Stem Cells with RNA Interference
The researchers use short hairpin RNA (shRNA) loss-of-function techniques to downregulate a set of gene products whose expression patterns suggest self-renewal regulatory functions. Their studies suggest specific biological roles for these molecules and reveal the complexity of cell fate regulation in embryonic stem cells.
Abstract

Policy

EU Lawmakers Maintain Limits on Stem Cell Research
The European Union parliament, while boosting funding for scientific research, voted to maintain the status quo on stem cell work. The lawmakers said funds could be provided for research into human stem cells, both adult and embryonic, but strict conditions should apply for work with embryonic cells.
Article

Consumer Group Proposes Plan for Fair Pricing in Stem Cell Ownership Rules; Urges Strengthened Regulations with Role for Attorney General
Regulations governing the ownership of discoveries resulting from Proposition 71-funded stem cell research must be strengthened to allow the California Attorney General to intervene if the drugs or cures are unreasonably priced, the Foundation for Taxpayer and Consumer Rights (FTCR) said today.
Article

Lawyers for Stem-Cell Research Institute Ask Appeals Court for Speedy Review
Lawyers for California’s $3 billion stem-cell research institute have asked an appeals court for an expedited review of two lawsuits challenging the institute’s constitutionality.
Article

Row Flares Over Stem Cell Research
The Italian government has no immediate plans to change controversial legislation on stem cell research, a ministerial panel said on Tuesday amid polemics over recent Italian moves on the European stage .
Article

Business

Amorcyte Closes $4.2 million Series A Financing
Amorcyte Inc (Amorcyte), a privately funded biotechnology company developing cell therapy products to treat cardiovascular disease, announced today the conclusion of a $4.2 million first round of financing to fund its initial phase I clinical trial.
Article

Cambrex Corporation and Cytori Therapeutics Enter Into Collaboration to Provide Adipose Derived Stem Cell Research Products
Cambrex Bio Science Walkersville, Inc., a subsidiary of Cambrex Corporation, and Cytori Therapeutics has announced that they have entered into a strategic marketing agreement to provide adipose-derived stem cell products globally for use in basic and translational bioresearch.
Article

ViaCell Announces Cardiac Collaboration with Centocor Research and Development, Inc.
ViaCell, Inc. has announced the signing of a cardiac collaboration agreement with the Stem Cell Internal Venture of Centocor Research and Development, Inc. to evaluate ViaCell’s proprietary cord blood-derived multi-potent stem cells as a potential treatment for cardiac disease in preclinical testing.
Article

A&G and Celltrion Form Anticancer Alliance
A&G Pharmaceutical and South Korean biopharmaceutical company Celltrion have entered into an agreement for clinical production of A&G’s theranostic monoclonal antibody for the treatment of cancer.
Article

Reliance Life Will Commercially Introduce Stem Cell Therapies Soon
The Mukesh Ambani-owned Reliance Life Sciences, the life science and biotechnology arm of Reliance Industries Ltd, plans to commercially introduce India’s first stem cell-based therapy next year.
Article

Healthy £4m Boost to Help Capital Stem Cell Centre
A New centre for stem cell research being built at Edinburgh University has received a £4 million funding boost that will allow it to attract more researchers.
Article

Thalassemia Patients Given a Better Chance With Stem Cell Therapy
To offer people better health care, the Thailand Centre of Excellence for Life Science (Tcels) has teamed up with the Thai Red Cross to develop stem-cell therapy and personalised medicine to treat thalassemia patients.
Article

Warning Over Cord Blood Banking
Parents have been warned against the use of private companies to store blood from their babies’ umbilical cord.
Article

NIH

National Institutes of Health (NIH) Scientist Might Have Received Payments For Tissue Samples; Refuses To Answer Questions
Trey Sunderland, a senior scientist at NIH, might have accepted several hundred thousand dollars from Pfizer and provided the company with more than 3,000 samples of human spinal fluid and plasma since 1998.
Article

NIH Launches Effort to Place More Knockout Mice in Public Repositories
As part of its ongoing effort to build a public, genome-wide library of “knockout” mouse models for the study of human disease, the National Institutes of Health (NIH) today awarded $800,000 to two public mouse repositories to acquire genetically engineered mouse lines not yet widely accessible to researchers.
Article

Monoclonal Antibodies for Neuroscience Research: Request for Mammalian Nervous System Targets (NOT-NS-06-008)
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Ruth L. Kirschstein National Research Service Award (NRSA) Institutional Research Training Grants (T32) (PA-06-468)
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Bioengineering Research Partnerships (BRP) [R01] (PAR-06-459)
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NINDS Clinical Trial Planning Grant (R34) (PAR-06-460)
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CBER

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

SOPP 9151: Procedures for Handling Requests for Exemptions and Alternative Procedures for Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) Under 21 CFR Section 1271.155
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2006 Biological Approvals – Update
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Cellular, Tissue and Gene Therapies Advisory Committee Roster
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WHO Meeting Slide Presentations – FDA and Tissue Regulation
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WHO Meeting Slide Presentations – FDA Inspections Tissue/Cell Establishments
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WHO Meeting Slide Presentations – FDA Adverse Reaction Reporting System for Human Cells, Tissues and Cellular and Tissue-Based Products (HCT/Ps)
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Regulatory

Food and Drug Administration (United States of America)

Orphan Drug Act Enabled Treatments for 288 Diseases
The FDA’s Office of Orphan Products Development reports 288 drugs and biologics have been approved for marketing since the Orphan Drug Act took effect in 1983, compared with only 10 such therapies approved in the decade before the law was passed.
Article

Foley & Lardner Survey of Industry Insiders Reflects Desire for European Regulatory Approach to Follow-on Biologics
Forty-four percent of industry executives believe the United States should follow the European approach for adopting follow-on biologics according to a survey of biotechnology executives conducted during BIO 2006.
Article

Medicines and Healthcare Products Regulatory Agency (United Kingdom)

Guidance Note 1 – Guidance Notes for Manufacturers on Clinical Investigations to be carried out in the UK
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ISCT

AABB-ISCT Cellular Therapy Audioconference Series
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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 2 / May 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