Volume 10.00 | Jan 12

Cell Therapy News 10.00, January 12, 2009
     In this issue: Science | Policy | Business | NIH | CBER | Regulatory
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Top Stories

Embryonic Stem Cells from Rats Derived: University of Southern California researchers, for the first time, have derived authentic embryonic stem cells from rats. This breakthrough finding will enable scientists to create far more effective animal models for the study of a range of human diseases.
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Biomedical Researchers Create Artificial Human Bone Marrow in a Test Tube: Artificial bone marrow that can continuously make red and white blood cells has been created in a University of Michigan lab.
Article

Science

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Scientists Identify New Kind of Stem Cell Found in Testes
Scientists at the Stanford School of Medicine and at the University of California San Francisco have succeeded in isolating stem cells from human testes, which bear a striking resemblance to embryonic stem cells.
Article

Single Virus Used to Convert Adult Cells to Embryonic Stem Cell-like Cells
Whitehead Institute researchers have greatly simplified the creation of so-called induced pluripotent stem cells, cutting the number of viruses used in the reprogramming process from four to one.
Article

Patient-Derived Induced Stem Cells Retain Disease Traits
Svendsen and colleagues at UW-Madison and the University of Missouri-Columbia created disease-specific stem cells by genetically reprogramming skin cells from a patient with spinal muscular atrophy.
Article

Hebrew University of Jerusalem-Hadassah Medical Scientists Reveal Mechanism that Triggers Differentiation of Embryo Cells
The mechanism whereby embryonic cells stop being flexible and turn into more mature cells has been discovered by scientists at the Hebrew University of Jerusalem.
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Columbia University Scientist Devises New Way to More Rapidly Generate Bone Tissue
Using stem cell lines not typically combined, researchers at Columbia University Medical Center have designed a new way to “grow” bone and other tissues.
Article

Bioreactors Might Solve Blood Blood-Platelet Supply Problems
It might be possible to grow human blood platelets in the laboratory for transfusion, according to a new study at The Ohio State University Medical Center.
Article

Functional Vasculature Generated from Advanced Cell Technology’s Human Embryonic Stem Cells 
Advanced Cell Technology, Inc. reported that it is feasible to differentiate human embryonic stem cells into functional human vasculature and that they have the potential for both endothelial cell and vascular smooth muscle cell lineage differentiation.
Article

“Scrawny” Gene Keeps Stem Cells Healthy
Scientists at the Carnegie Institution have identified a gene, named scrawny, that appears to be a key factor in keeping a variety of stem cells in their undifferentiated state.
Article

Molecular Marker Identifies Normal Stem Cells as Intestinal Tumor Source
Scientists at St. Jude Children’s Research Hospital have answered a central question in cancer biology: whether normal stem cells can give rise to tumors.
Article

Stem Cells and Leukemia Battle for Marrow Microenvironment
Learning how leukemia takes over privileged “niches” within the bone marrow is helping researchers develop treatment strategies that could protect healthy blood-forming stem cells and improve the outcomes of bone marrow transplantation for leukemia and other types of cancer.
Article

VIDEO: Fusing Embryonic Stem Cells with Adult Cells Using Highly Efficient New Fusing System
MIT engineers have developed a new, highly efficient way to pair up cells so they can be fused together into a hybrid cell, for example, fusing an adult cell and an embryonic stem cell allows researchers to study the genetic reprogramming that occurs in such hybrids.
Article

Scientists Call Up Stem Cell Troops to Repair the Body Using New Drug Treatments
Scientists have tricked bone marrow into releasing extra adult stem cells into the bloodstream, a technique that they hope could one day be used to repair heart damage or mend a broken bone.
Article

Newly Discovered Esophagus Stem Cells Grow Into Transplantable Tissue
Researchers at the University of Pennsylvania, School of Medicine have discovered stem cells in the esophagus of mice that were able to grow into tissue-like structures and when placed into immune-deficient mice were able to form parts of an esophagus lining.
Article

Scientists Develop Method for Generating Novel Types of Stem Cells
A team led by Scripps Research Institute scientists has for the first time developed a technique for generating novel types of rat and human stem cells with characteristics similar to mouse embryonic stem cells.
Article

Hebrew University of Jerusalem-Hadassah Medical Scientists Succeed Through Stem Cell Therapy in Reversing Brain Birth Defects
Scientists at the Hebrew University of Jerusalem have succeeded in reversing brain birth defects in animal models, using stem cells to replace defective brain cells.
Article

Gene Therapy Reversed Heart Damage in Heart Failure
Long-term gene therapy resulted in improved cardiac function and reversed deterioration of the heart in rats with heart failure, according to a recent study conducted by researchers at Thomas Jefferson University’s Center for Translational Medicine.
Article

Researchers Engineer Pancreatic Cell Transplants To Evade Immune Response
Researchers at Albert Einstein College of Medicine of Yeshiva University have developed a technique for transplanting insulin-producing pancreatic cells that causes only a minimal immune response in recipients.
Article

BioLife Solutions Completes Safety Studies on HypoThermosol(R) and CryoStor(TM)
BioLife Solutions Inc. recently announced that it has completed an initial series of small animal safety studies at the Seattle-based Fred Hutchinson Cancer Research Center on its bio-preservation media products, HypoThermosol and CryoStor.
Article

Neuralstem Files FDA Application for First ALS Stem Cell Trial
Neuralstem, Inc. announced recently that it has filed an Investigational New Drug application with the U.S. Food and Drug Administration to begin a clinical trial to treat amyotrophic lateral sclerosis.
Article

Pluristem Therapeutics Inc. Announces Filing an IMPD to Commence Clinical Trials Utilizing PLX-PAD for Critical Limb Ischemia in Europe
Pluristem Therapeutics Inc. announced recently that it has filed an Investigational Medicinal Product Dossier application with the Paul Ehrlich Institute to begin clinical trials with its placental-derived adherent stromal cell product, termed PLX-PAD, for the treatment of critical limb ischemia.
Article

Medistem Files IND for Endometrial Regenerative Cells in Treatment of Critical Limb Ischemia
Medistem Inc. announced recently it has filed an Investigational New Drug Application with the United States Food and Drug Administration to undertake clinical studies using its proprietary endometrial regenerative cells in patients with an advanced form of peripheral artery disease termed “critical limb ischemia.”
Article

Athersys Receives IND Authorization for Multistem in Treatment of Ischemic Stroke
Athersys, Inc. announced recently that it has received authorization from the U.S. Food and Drug Administration to begin a Phase I clinical trial evaluating the safety of administration of its “off-the-shelf” adult stem cell product, MultiStem(R), in the treatment of ischemic stroke.
Article

StemCells, Inc. Receives FDA Approval to Initiate Clinical Trial of HuCNS-SC Cells in a Myelin Disease
StemCells, Inc. recently announced that it has received approval from the U.S. Food and Drug Administration to initiate a clinical trial of the Company’s proprietary purified human neural stem cell product candidate to treat Pelizaeus-Merzbacher Disease, a fatal brain disorder that mainly affects young children.
Article

Clinical Trial at UC San Diego Medical Center Tests Treatment for Heart Failure with Adult Stem Cells
The University of California, San Diego Medical Center is the first hospital in California to enroll patients in a multi-center clinical trial, sponsored by Angioblast Systems Inc., to examine the safety and feasibility of administering adult stems cells to treat congestive heart failure.
Article

Adipose Stem and Regenerative Cell Clinical Study Underway for Treatment of Chronic Radiation Injury
Cytori announced that the first patient was enrolled in an investigator-initiated study using adipose-derived stem and regenerative cells to treat the chronic effects of radiation-induced local tissue injury.
Article

Drug Provides Enhanced Mobilization of Stem Cells for Autologous Transplantation in Non-Hodgkin’s Lymphoma and Multiple Myeloma Patients
Genzyme Corporation announced recently that the U.S. Food and Drug Administration has granted marketing approval for Mozobil, a drug intended to mobilize hematopoietic stem cells to the bloodstream for collection.
Article

ABSTRACTS, REVIEWS AND SPECIAL REPORTS

Characterization of Human Embryonic Stem Cells with Features of Neoplastic Progression
The researchers in this study characterize two variant hES cell lines that express pluripotency markers at high levels and do not harbor chromosomal abnormalities by standard cytogenetic measures.
Article

Hematopoietic Stem Cells Reversibly Switch from Dormancy to Self-Renewal During Homeostasis and Repair
Bone marrow hematopoietic stem cells are crucial to maintain lifelong production of all blood cells. Although HSCs divide infrequently, it is thought that the entire HSC pool turns over every few weeks, suggesting that HSCs regularly enter and exit cell cycle.
Article

Crypt Stem Cells as the Cells-of-origin of Intestinal Cancer
This report shows that deletion of Apc in long-lived intestinal stem cells leads to their transformation within days.
Article

Largest Ever Stem Cell ‘Dialogue’ Provides Insight into Public Attitudes
Results of the largest ever public dialogue on stem cell research in the UK have revealed high levels of public support for stem cell science and technology, from basic research to development of treatments.
Article

A Forum for International Leaders
The STEM CELLS CONGRESS

Contributing to the Future of Regenerative Medicine
February 25- 27, 2009 | San Francisco, California

– Address the topics central to the theme of regenerative medicine
– Network with prominent researchers, clinicians, businessmen, and regulators at the cutting edge of their respective fields
– Develop strategies to enable the rapidly expanding therapeutic potential of regenerative medicine
Advance registration Discount Expires Friday, January 23!

Register now and save $200! http://www.TheStemCellsCongress.com

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Policy

President-Elect Obama’s Choices for Key Science Posts Hailed
President-Elect Barack Obama’s recent appointment of four scientific luminaries to major posts in his new administration marks an ambitious attempt to improve U.S. science policy and implementation.
Article

California Stem Cell Agency Faces Cash Freeze
The global financial crisis may do what opponents of California’s $3 billion state-sponsored stem cell research experiment could not: dry up funding.
Article

Democrats Debate Methods to End Stem Cell Ban
Thwarted by President Bush in their efforts to expand federal spending on embryonic stem cell research, Democrats are now debating whether to overturn federal restrictions through executive order or by legislation when they assume full control of the government this month.
Article

Missouri Group Refiles Initiative to Ban Using Taxes for Abortion, Human Cloning
Missouri Roundtable for Life seeks a November 2010 vote on a proposed state constitutional amendment saying “it shall be unlawful to expend, pay, or grant any public funds for abortion services, human cloning or prohibited human research.”
Article

Business

STEMCELL Technologies Launches Direct Distribution to Singapore
STEMCELL Technologies Inc is pleased to announce the opening of a new sales and distribution office in Singapore, effective January 12th, 2009.
Article

VistaGen and WARF Sign License Agreement for Human Embryonic Stem Cell Technology
VistaGen Therapeutics and the Wisconsin Alumni Research Foundation have signed a license for human embryonic stem cell patents for the development and commercialization of stem cell-based research tools.
Article

Novocell Announces Non-Exclusive Drug Discovery Collaboration with Pfizer Research to Utilize Novocell’s Stem Cell-derived Pancreatic Progenitor Cells
Novocell, Inc. recently announced it has entered into a non-exclusive drug discovery collaboration with Pfizer giving Pfizer access to Novocell’s proprietary pancreatic progenitor cells derived from human embryonic stem cells.
Article

Joint Venture Between CHA Biotech and Advanced Cell Technology to be called Stem Cell & Regenerative Medicine International
The joint venture between Advanced Cell Technology, Inc. and leading Korean-based biotechnology company CHA Biotech Co, Ltd., announced recently that the company would be named “Stem Cell & Regenerative Medicine International.”
Article

The Massachusetts Life Sciences Center to Start Taking Tax Break, Funding Apps on New Year’s Day
The Massachusetts Life Sciences Center, which has been tasked with handling the state’s $1 billion Life Sciences Initiative, reports it will start taking online applications for the Life Sciences Tax Incentive Program and the Center’s new Life Sciences Accelerator investment program on Jan. 1.
Article

Madison Stem Cell Researchers Get $50,000 State Grant
A Madison company that is developing a better way to grow stem cells has received a $50,000 grant from the state, the governor’s office confirmed late recently.
Article

California Funds University of California Irvine Stem Cell Sorting, Tracking Research
Two UC Irvine scientists will receive grants totaling nearly $1.6 million to develop and advance stem cell sorting and tracking devices aimed at improving future therapies for people with brain and spinal cord damage, Alzheimer’s and Parkinson’s diseases, and other disorders.
Article

Life Technologies to Develop Human Stem Cell Models of Neurodegenerative Diseases to Advance Drug Development
Life Technologies Corporation announced it will use human embryonic stem cells to develop new models of Lou Gehrig’s Disease and other neurodegenerative diseases with a grant it received this week from the California Institute for Regenerative Medicine.
Article

Progenitor Cell Therapy, LLC Appoints Chief Financial Officer 
Progenitor Cell Therapy, LLC announced recently the appointment of John P. Gandolfo as Chief Financial Officer effective January 2, 2009.
Article

University of Maryland Recruits Curt Civin, MD, to Lead New Stem Cell Center
Civin will become a professor of pediatrics in the Division of Hematology/Oncology, as well as associate dean for research and the founding director of the new University of Maryland School of Medicine Center for Stem Cell Biology and Regenerative Medicine.
Article

Seoul National University Drops Bid for Stem Cell Patent
Seoul National University has decided to make no more efforts to obtain overseas patents for the controversial stem cell production technology of disgraced scientist Hwang Woo-suk.
Article

Cytori Expands Patent Protection for Celution(R) Stem & Regenerative Cell Processing System
Cytori recently received U.S. Patent No. 7,473,420 (the ‘420 patent), which protects important formulations of the Celution(R) System output.
Article

NIH

Massachusetts Life Sciences Collaborative Urges Congress to Include New Research Funding in Federal Stimulus Package
The Massachusetts Life Sciences Collaborative has recently called for the proposed federal stimulus package to include increased funding for the National Institutes of Health and other scientific research agencies such as the National Science Foundation and the Department of Energy.
Article

The NIH Implements New Registration Process for Reviewer Reimbursement for Participation in NIH Peer Review Meetings (NOT-OD-09-033)
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Guidance to IACUCs Regarding Use of Designated Member Review (DMR) for Animal Study Proposal Review Subsequent to Full Committee Review (FCR) (NOT-OD-09-035)
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Institutional Clinical and Translational Science Award (U54) (RFA-RM-09-004)
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CBER

Meeting of the Blood Products Advisory Committee
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Electronic Biological Product Deviation Reporting (eBPDR) – Instructions for Using the eBPDR System
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Electronic Biological Product Deviation Reporting (eBPDR) – Latest System Changes
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Regulatory

FOOD AND DRUG ADMINISTRATION (United States)

FDA Commissioner Eschenbach to Resign
Food and Drug Administration Commissioner Andrew von Eschenbach has told his staff that he plans to resign effective Jan. 20, 2009.
Article

HHS Officials Mark Opening of First U.S. Food and Drug Administration Office in Latin America
The office in Costa Rica is the first in a series in the Region, which will eventually include an HHS/FDA presence in South America and México later in 2009.
Article

FDA Scientists Ask Obama to Restructure Drug Agency
A group of scientists at the U.S. Food and Drug Administration on Wednesday sent a letter to President-elect Barack Obama’s transition team pleading with him to restructure the agency, saying managers have ordered, intimidated and coerced scientists to manipulate data in violation of the law.
Article

Meetings: Blood Products Advisory Committee; Amendment, 110 [E8–31187]
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Agency Information Collection Activities; Proposals, Submissions, and Approvals: Financial Disclosure by Clinical Investigators, 79493–79495 [E8–30837]
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Agency Information Collection Activities; Proposals, Submissions, and Approvals: Notice of Participation, 79495–79496 [E8–30839]
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Agency Information Collection Activities; Proposals, Submissions, and Approvals, 904–906 [E9–175]
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MEDICINES AND HEALTHCARE PRODUCTS REGULATORY AGENCY (United Kingdom)

Review of the MHRA – Terms of Reference
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Licensing of Medicines: Time-based Performance Measures
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Good Clinical Practice (GCP) – Frequently Asked Questions; Updated
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