Volume 7.09 | Mar 13

Volume 7.09, March 13, 2006
     In this issue: Science | Policy | Business | NIH | CBER | Regulatory
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Top Stories

First Stem Cells Injected into Brains: The groundbreaking trial at Doernbecher Children’s Hospital at Oregon Health & Science University will test whether HuCNS-SC(TM), a proprietary human central nervous stem cell product is safe, and whether it can slow the progression of two forms of devastating illness known as Batten disease, according to StemCells, Inc. of Palo Alto, Calif.
Article

Baxter Commences Trial of Stem Cells in Coronary Artery Disease: Baxter Healthcare has initiated a first-of-its-kind phase II trial in the US to evaluate blood-derived selected CD34+ stem cells in the treatment of chronic myocardial ischemia, a severe form of coronary artery disease.
Article

Science

Manchester Scientists Create New Bio-gel for 3D Cell Culture
The gel is the first pH neutral material made from combinations of dipeptides (pairs of amino acids) to provide an environment in which cells can be cultured under physiological conditions.
Article

Double Transplants May Offer One Solution to Short Supply of Donated Kidneys
Transplanting a pair of kidneys with limited function into one patient can be just as successful as the standard procedure in which a patient receives a single kidney, according to new research at Wake Forest University Baptist Medical Center.
Article

San Diego Facility Collects Embryos For Stem Cell Research
Scientists in San Diego are operating Stem Cell Resource, which is believed to be the first public embryo bank in the U.S.
Article

Liquid Crystals Can Be Used To Report In Real Time On The Differentiation Of Embryonic Stem Cells
University of Wisconsin-Madison researchers at the NSF-funded Materials Research Science and Engineering Center (MRSEC) have shown that by straining mechanically the cells as they grow, it is possible to reduce significantly and almost eliminate the uncontrolled differentiation of stem cells.
Article

MS Vaccine Testing to Start in US
A US company is set to begin a trial of a vaccine which it claims halts the progress of multiple sclerosis.
Article

Cord Blood Growing Source for Transplants
“The stem cells from cord blood donations are easier to collect and less complicated than traditional bone marrow donations,” says Elizabeth Shpall, M.D., director of the new Cord Blood Bank at M. D. Anderson.
Article

ReNeuron Completes Banking of Stem Cell Therapy
The ReNeuron Group has announced it has completed the scale-up and cell banking of its lead stem cell product for stroke, which gives the Company the potential to progress this therapy without the need to re-derive the cells from source material in the future.
Article

Sanofi Gene Therapy Cuts Amputations
Injections of a Sanofi-Aventis experimental gene therapy treatment cut the risk of amputations in patients with severely decreased blood flow to the legs, according to results of a mid-stage trial reported
Article

Hwang Set to Strike Back With New Stem Cell Tests
Disgraced cloning scientist Hwang Woo-suk and his team are seeking to prove that they did clone human embryonic stem cells.
Article

Journal Publishes Proof First Cloned Dog Claim is True
His creator has been discredited and controversy has long surrounded him, but scientists have confirmed that an Afghan hound named Snuppy is the world’s first cloned dog.
Article

Xencor Data Shows Engineering the “Fc” Region of Antibodies Makes Them More Toxic to Cancer Cells
Engineering the “Fc” region of monoclonal antibodies (mAbs) increases their toxicity to cancer cells, potentially improving the utility of targeted cancer therapies, according to research conducted at Xencor, which will be published in the March 14 print issue of the Proceedings of the National Academy of Sciences (PNAS).
Article

ABSTRACTS, REVIEWS & SPECIAL REPORTS

The Effect of Three-Dimensional Co-Culture of Hepatocytes and Hepatic Stellate Cells on Key Hepatocyte Functions in vitro
This study shows that stellate cells facilitate spheroid formation, influence spheroid architecture, and are an effective method of preserving some aspects of hepatocyte function in the early stage of culture.
Abstract

Ideal Rather than Actual Body Weight Should be Used to Calculate Cell Dose in Allogeneic Hematopoietic Stem Cell Transplantation
We have shown that CD34+ cell doses based upon IBW are better predictive of engraftment after autologous and allogeneic HSCT.
Abstract

Policy

Spain to Authorise Umbilical Cord Stem Cell Banks
The Ministry for Health in Spain has announced that it will shortly be authorising the opening of private banks for umbilical cord stem cells.
Article

Business

LCT and The Bionic Ear Institute Announce Agreement to Improve Hearing Loss
Living Cell Technologies Limited (ASX: LCT) has entered into a collaborative agreement with The Bionic Ear Institute an internationally recognised not-for-profit biomedical research organisation, to improve the hearing outcomes for cochlear implant patients through rehabilitation of the auditory nerve.
Article

Pluristem Strengthens Business Strategy, Company to Focus on Commercializing Cell Therapy Products
Pluristem Life Systems, Inc. (OTC BB:PLRS), a biotechnology company dedicated to the commercialization of cell therapy products, today announced that the Company is changing its business strategy. Instead of working towards the goal of licensing out the use of its proprietary bioreactor-enabling technology, the company plans to develop cell therapy products that can be marketed on a for-sale basis.
Article

Former StemCo Executive Launches BioTechnology Transfer
Cynthia Pritchard, Ph.D., today announced the launch of BioTechnology Transfer, a Triangle-based company that provides outsourced strategic product development and regulatory submissions for early-stage life science and medical device companies.
Article

Baxter International, Inc. (BAX) Chief Hints At Blood Unit Sale
Speculation has swirled recently that Deerfield-based Baxter is shopping its blood-transfusion therapies, a unit with static sales within Baxter’s larger bioscience business.
Article

GenVec Completes Enrollment in AdPEDF Clinical Study for Macular Degeneration
GenVec, Inc.(Nasdaq:GNVC) announced today the completion of enrollment in the company’s follow-on Phase I study of its AdPEDF gene therapy in patients diagnosed recently with wet age-related macular degeneration (AMD).
Article

Vesta Therapeutics Names Scientific Advisory Board
Vesta Therapeutics, which is developing treatments for liver disease, has named a four-member scientific advisory board.
Article

Dendreon Names Ernest Bognar General Manager of Hanover, NJ Manufacturing Facility
Dendreon is currently developing this facility to meet the anticipated clinical and commercial manufacturing needs for PROVENGE® (sipuleucel-T) and its other active immunotherapy product candidates in development.
Article

NIH


NATIONAL INSTITUTES OF HEALTH

Request for Information (RFI): Genetics of Multiple Autoimmune Diseases (NOT-AI-06-019)
Link

National Mesothelioma Virtual Registry and Tissue Bank (U19) (RFA-OH-06-005)
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Testing Stem Cell Therapy in Mouse Models of Premature Aging (R21) (PA-06-137)
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Pilot and Feasibility Program in Hematologic Diseases (R21) (PA-06-150)
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Intestinal Failure, Short Gut Syndrome and Small Bowel Transplantation (R21) (PA-06-229)
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Intestinal Failure, Short Gut Syndrome and Small Bowel Transplantation (R01) (PA-06-230)
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Developmental Biology and Regeneration of the Liver (R01) (PA-06-231)
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Developmental Biology and Regeneration of the Liver (R21) (PA-06-232)
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Interactions Between Stem and Progenitor Cells and the Microenvironment (R03)(PAS-06-207)
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Interactions Between Stem and Progenitor Cells and the Microenvironment (R21) (PAS-06-208)
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CBER

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

CPG 7345.848: Inspection of Biological Drug Products
Link

Report on the Performance of Drug and Biologics Firms in Conducting Postmarketing Commitment Studies, 2006
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Cell Product Reporting Workshop – Slide Presentation
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Testing Donors of Human Cells and Tissues
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Devices and CBER: 2006 Update
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Licensed Products and Establishments List – Update
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Substantially Equivalent 510(k) Device – GranType – GTI, Inc
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Approved Biological NDA and ANDA Applications – Update
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Cleared Biological 510(k) Device Applications – Update
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Approved Biological Premarket Approval (PMA) Device Applications – Update
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Regulatory

Food & Drug Administration (United States of America)

Industry Exchange Workshop on Food and Drug Administration Clinical Trial Requirements; Public Workshop
Link

ISCT

ISCT2006. May 4-7. Berlin.
Click here for the preliminary program or registration information.

AABB-ISCT Cellular Therapy Audioconference Series
Link

Somatic Cell Therapy Symposium Survey
Representatives from FDA, ISCT, and AABB are once again working on developing an outstanding program for the Annual Somatic Cell Therapy Meeting. The 6th Annual Somatic Cell Therapy Symposium, which ISCT expects will be co-sponsored again by the FDA and AABB, is the premier forum for discussing current issues around cell therapy regulations. The meeting is an interactive, panel-based meeting meant to educate and foster dialogue between the industry and those in the Agency. As representatives in the cell therapy liaison meeting stakeholder group, we ask your assistance in completing a very brief survey and circulating the survey to your various organizations and constituencies as a way of assisting the organizing committee in ensuring the meeting addresses the topics of most interest and priority.
For the survey, click here.
For more information about the meeting, click here.

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.
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