Volume 8.44 | Nov 12

Volume 8.44, November 12, 2007
     In this issue: Science | Policy | Business | NIH | CBER | Regulatory
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Top Stories

First Patient Undergoes Expanded Cord Blood Transplant in the ExCell Registration Study of StemEx(R) for Leukemia and Lymphoma: The Gamida Cell-Teva Joint Venture have announced that the first patient in the international, pivotal registration ExCell study has undergone a StemEx(R) transplant at the Ireland Cancer Center of University Hospitals Case Medical Center.
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Imaging Neural Progenitor Cells in the Living Human Brain: For the first time, investigators have identified a way to detect neural progenitor cells, which can develop into neurons and other nervous system cells, in the living human brain using a type of imaging called magnetic resonance spectroscopy.
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Science

Seaweed Transformed Into Stem Cell Technology
Engineers at Rensselaer Polytechnic Institute have transformed a polymer found in common brown seaweed into a device that can support the growth and release of stem cells at the sight of a bodily injury or at the source of a disease.
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Crops That Shut Down Pests’ Genes
Monsanto is developing genetically modified plants that use RNA interference to kill the insects that eat them.
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New Territory Mapped in Stem Cell Transplantation
Transplant research has taken another step forward at The Hospital for Sick Children where scientists have discovered a gene with properties that allow for the successful engraftment of stem cells from human bone marrow into mice.
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Novel Human-Derived "Blood Vessels" Durable in Vivo and Off-the-Shelf
In the studies, scientists began by seeding smooth muscle cells on a tubular biodegradable scaffold, which produced extracellular matrix proteins in the shape of blood vessels. Following a two month growth period, researchers removed the smooth muscle cells, leaving behind the intact ECM, thereby making them universally compatible.
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Advanced Cell Technology and the Casey Eye Institute at Oregon Health & Science University Present Results of Functional Studies for RPE Program at Neuroscience 2007
The results of the study showed that the RPE cells demonstrated a statistically significant therapeutic effect compared to controls with a maximum efficacious effect at a medium dose level.
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Data Show Geron’s Cell-Based Therapeutic for Spinal Cord Injury Survives and Exhibits Remyelination for at Least Nine Months Following Injection
Geron Corporation has announced that data show GRNOPC1, the company’s human embryonic stem cell-based therapeutic for spinal cord injury, survives and exhibits durable and robust human remyelination in spinal cord-injured rats for at least nine months following a single injection.
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Injecting Stem Cells Sparks Progress in Repairing Heart
Researchers reported small successes in using stem cells to patch ailing hearts, an effort that has generated more debate than breakthroughs.
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Advanced Cell Technology Announces 12-Month Results of Myoblast Therapy Trial
Advanced Cell Technology, Inc. has announced that a controlled, randomized clinical trial using ACT’s myoblast therapy demonstrated marked improvement in heart failure symptoms after both six and twelve months.
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Mini Cell Treatment Hope for Cancer Sufferers
Doctors have pioneered a radical new cancer treatment using mini cell transplants.
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Cytori’s Celution(TM) System Under Evaluation for Breast Augmentation as Part of Investigator Initiated Study
A new study underway in Japan will examine the effect of adult stem and regenerative cells derived from adipose tissue in breast augmentation. In this investigational procedure, a patient’s breast is augmented with her own liposuctioned fat, which has been combined and enhanced with her own adipose-derived stem and regenerative cells.
Article

Stem Cells Used for Severe Skin Disease
University of Minnesota Children’s Hospital physicians reported performing the first bone marrow and cord blood transplant to treat recessive dystrophic epidermolysis bullosa.
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FDA Grants Kiadis Pharma Lead Product ATIR Orphan Drug Designation
Kiadis Pharma has announced that its lead product ATIR has been granted orphan drug designation by the US Food and Drug Administration as a therapy for immune reconstitution and prevention of Graft versus Host Disease following allogeneic bone marrow transplantation.
Article

Gum Tissue May Help Cure Ills
Scientists, doctors and dentists are pinning hopes on dental-pulp stem cells because the research is promising, the need for stem cells is out there and these stem cells carry no controversy, unlike embryonic stem cells.
Article

Clinical Research Cord Blood Bank Opens in Montreal
The new comprehensive tool will be used to collect and store umbilical cord blood which does not meet the collection standards of the bank managed by Hema-Quebec. The cord blood samples will be used exclusively for research projects on stem cells.
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Stem Cell and Marrow Network Trying to Spread Message to Ethnic Communities
The stem cell and marrow network program, which is part of Canadian Blood Services, had persistently been looking for ways to reach ethnic communities, in hopes of encouraging them to be donors.
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Cheek Swabs Could Help Find Marrow Donors
B.C. residents are the focus of a pilot project by Canadian Blood Services to test whether cheek swabs – which are quick and easy to do – can help attract more volunteer bone-marrow donors.
Article

Blood-incompatible Baby Heart Transplant Seen Safe
Babies waiting desperately to receive a heart transplant can receive a heart from a donor even if the blood type is incompatible – good news for infants who might otherwise die.
Article

ABSTRACTS, REVIEWS AND SPECIAL REPORTS

Progress and Prospects: Gene Therapy Clinical Trials (Part 2)
This is the second part of a review summarizing progress and prospects in gene therapy clinical research.
Abstract

Concise Review: The Potential of Stem Cells for Auditory Neuron Generation and Replacement
This review examines the potential of embryonic stem cells to generate new neurons for the deafened mammalian cochlea, including the directed differentiation of stem cells toward a sensory neural lineage and the engraftment of exogenous stem cells into the deafened auditory system.
Abstract

JOB OPPORTUNITIES

Islet Cell Associate Research Director
Irvine, CA (University of California, Irvine)
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Cell Therapeutics Supervisor
Philadelphia, PA (AppTec)
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Postdoc Fellow
Sweden (Wallenberg Neuro Center Neuronal Survival Unit)
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Manager, Manufacturing
Memphis, TN (Cognate Bioservices)
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Policy

New Jersey Democrats Grapple With Rebuke of Stem Cell Initiative
Stung and puzzled by the defeat of a ballot initiative to borrow $450 million for stem cell research, leading Democrats in New Jersey struggled on Wednesday to explain why they were repudiated by voters and how they planned to finance the biomedical research for a center already under construction.
Article

Stem Cell Research Could Face Michigan House Committee Vote Soon
Legislation that would lift restrictions on embryonic stem cell research in Michigan soon could come up for a vote in a state House committee.
Article

Stem Cell Funds In Demand
A new technique being developed by a group of scientists at the University of Connecticut has the potential to create customized human embryonic stem cells in a way that may make cloning unnecessary and end the ethical objections that have long hamstrung this type of research.
Article

Vatican Conference to Study Embryo Origin, Development
The Vatican is organizing a conference on the origin and development of the human embryo, saying current bioethical debates regarding stem cells, cloning and assisted fertility often overlook what it considers the crucial origin of organisms.
Article

What Price, A Woman’s Eggs?
How much should a woman be paid for donating her eggs for research? This is one of the big questions the Bioethics Advisory Committee is grappling with, as it starts its latest public consultation exercise.
Article

Business

Arteriocyte Medical Systems Forms Strategic Partnership with Medtronic including Acquisition of the Magellan Platelet Rich Plasma Business
Arteriocyte Medical Systems has announced that the company has struck a Strategic Partnership with Medtronic that includes the acquisition of the Magellan Platelet Business, a worldwide exclusive distribution agreement in the Cardiac Surgery Market for the next five years, and a manufacturing services agreement for the Magellan products.
Article

SpineSmith Acquires Rights to Tissue Genesis’ Stem Cell Isolating Technology for Diagnosis and Treatment of the Human Spine
SpineSmith Partners, LP acquired rights in spine for Tissue Genesis, Inc.’s adipose tissue derived cell technology.
Article

Regenetech Signs an Exclusive License to Commercialize its cellXpansion(TM) Technology in Mexico
Regenetech, Inc. announces that it has signed a Mexican, country-exclusive license for its cellXpansion(TM) technology with Regenevita, a new Mexican company.
Article

HepaLife(TM) Announces Exclusive License Agreement with U.S. Government Agency for Liver Cell Lines
HepaLife Technologies, Inc. has announced that the Company has entered into an exclusive license agreement with the U.S. Department of Agriculture, Agricultural Research Service for the use of patented liver cell lines in artificial liver devices and in-vitro toxicological testing platforms.
Article

Bio-Matrix Scientific Group Inc. Receives Biologics License to Accept Cord Blood and Other Specimens
Bio-Matrix Scientific Group Inc. has announced that on November 1, 2007, the Company was granted a Biologics license from the Department of Health Services of the State of California. This License permits the Company’s current facility to accept and store cord blood, whole blood, and various blood related specimens for cryogenic short and long term storage.
Article

CellGenix Introduces CellGro(R) Interleukin 15 in GMP Quality
CellGenix announces the launch of its newest, standard-setting product: CellGro(R) rec. hum. GMP Interleukin 15.
Article

Stem Cell Sciences Regains All Outstanding Rights to Commercialise its NS Cell Technology Platform Globally
The recovery of these rights from SCS KK completes a series of transactions through which SCS plc and SCS KK have become fully independent companies.
Article

India to Have First Clinical Research Facility for Stem Cells and Regenerative Medicine at Hyderabad
The Nation’s first Clinical Research Facility for Stem Cells and Regenerative Medicine will open in Hyderabad by the Centre for Cellular and Molecular Biology along with Nizam’s Institute of Medical Sciences.
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NIH

2008 NIH Director’s New Innovator Award Program (DP2) (RFA-RM-08-014)
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Predictive Multiscale Models of the Physiome in Health and Disease (R01) (PAR-08-023)
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Assay Development for High Throughput Molecular Screening (R21) (PAR-08-024)
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CBER

Background Information Regarding the ISBT Label
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Compliance Program: Chapter 41 – Inspection of Tissue Establishments – Updated
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Approved Biological NDA and ANDA Applications – Update
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Tissue Reference Group Annual Reports – FY 2007 Update
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FDA Public Workshop: Processing of Orthopedic, Cardiovascular, and Skin Allografts – October 11 Transcripts
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FDA Public Workshop: Processing of Orthopedic, Cardiovascular, and Skin Allografts – October 12 Transcripts
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Regulatory

FOOD AND DRUG ADMINISTRATION (United States of America)

Requirements for Human Blood and Blood Components Intended for Transfusion or for Further Manufacturing Use; Proposed Rule
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ISCT

ISCT Membership
Renew your ISCT Membership for 2007 now!
Not a member?  Visit the ISCT website to learn about the benefits of membership.
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