Volume 9.49 | Dec 15

Cell Therapy News 9.49, December 15, 2008
     In this issue: Science | Policy | Business | NIH | CBER | Regulatory
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Top Stories

Osiris Completes Enrollment in First Worldwide Phase III Stem Cell Trial: Osiris Therapeutics, Inc. announced recently that it has completed patient enrollment in its Phase III pivotal trial evaluating Prochymal for the treatment of steroid-refractory acute Graft versus Host Disease.
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Science

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Some Blood-System Stem Cells Reproduce More Slowly Than Expected
A research collaboration lead by Harvard Stem Cell Institute researchers at Massachusetts General Hospital has found a subpopulation of hematopoietic stem cells, which generate all blood and immune system cells, which reproduce much more slowly than previously anticipated.
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Researchers Provide Definitive Proof of Where, How Blood Stem Cells are Created
Stem cell researchers at UCLA have proven definitively that blood stem cells are made during mid-gestational embryonic development by endothelial cells, the cells that line the inside of blood vessels.
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First Functional Stem Cell Niche Model Created by Stanford Scientists
Scientists at the Stanford University School of Medicine have taken a significant step forward by devising a way to recreate a niche-in an adult animal.
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Researchers Make Key Discovery for Body to Accept Gene Therapy
Researchers at Columbia University Medical Center and the State University of New York at Stony Brook have developed a groundbreaking technique to sneak therapeutic genes past the body’s defenses, possibly clearing one of the largest hurdles to realizing the potentials of medically altering a patient’s DNA.
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Heart Regenerates after Infarction – First Trials with Mice
Researchers were able to show that the body’s own heart muscle stem cells do generate new tissue and improve the pumping function of the heart considerably in an adult organism, when they suppress the activity of a gene regulator known as beta-catenin in the nucleus of the heart cells.
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Gene Therapy Effective Treatment Against Gum Disease
Scientists at the University of Michigan have shown that gene therapy can be used to successfully stop the development of periodontal disease, the leading cause of tooth loss in adults.
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Cytori Demonstrates Benefit of Adipose-Derived Stem and Regenerative Cells in Spinal Disc Repair in Preclinical Study
Cytori Therapeutics, Inc. reported preclinical study results, which demonstrate the potential benefit of adipose-derived stem and regenerative cells for the treatment of damaged intervertebral discs, evidenced by significantly increased disc tissue density and disc-specific extracellular matrix components at 12-months post treatment in a large animal model.
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Alternative Splicing Proteins Prompt Heart Development
Researchers have identified two proteins (CUGBP and ETR-3-like factors called CELF and muscleblind-like protein called MBNL1) that reprogram alternative splicing in the developing hearts of mice, affecting how the heart grows during the pre-birth and immediate post-birth periods.
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Stem Cells Deliver Gene Therapy to Bone Tumors in Preclinical Test
Researchers from The University of Texas M. D. Anderson Cancer Center have potentially found a way to use stem cells to deliver a gene therapy that fights pediatric bone tumors.
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Company Eyes Brain Implant of Pig Cells for Parkinson’s
Living Cell Technologies claimed recently that rat studies show brain cells taken from pigs and wrapped in seaweed gel may be useful to combat Parkinson’s disease.
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Clinical Trial Demonstrates Safety of Pre-Transplant Expansion of Umbilical Cord Blood Stem Cells
Taking blood stem cells collected from an umbilical cord into the lab and expanding their number before transplanting them to replace a patient’s blood supply is as safe as a standard cord blood transplant, researchers suggest.
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Osiris Receives Approval for Prochymal Expanded Access Program in Canada
Osiris Therapeutics, Inc. recently announced it has received approval from Health Canada to initiate a pediatric expanded access treatment program for Prochymal, making the investigational stem cell product more readily available to children with life-threatening Graft vs. Host Disease.
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ABSTRACTS, REVIEWS AND SPECIAL REPORTS

Biphasic Induction of Pdx1 in Mouse and Human Embryonic Stem Cells can Mimic Development of Pancreatic Beta Cells
Here the researchers describe a genetic approach that enables fine control of Pdx1 transcriptional activity during endoderm differentiation of mouse and human ES cell for a basis in inducing and studying ES cell differentiation into insulin-secreting cells.
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Detection of Pre-Transplant Clonal Cytogenetic Abnormalities in Stem Cells Used for Autologous Stem Cell Transplant in Relapsed Non-Hodgkin Lymphoma is a Predictor of Relapse
The researchers in this study performed a retrospective analysis of their center’s transplant data and reviewed pre-transplant cytogenetic analysis on the patient’s collected stem cells to look for evidence of MDS or characteristics of their lymphoma.
Article

A Functional Screen to Identify Novel Effectors of Hematopoietic Stem Cell Activity
This study reports the results of a novel in vitro to in vivo functional screen, which identified a series of nuclear factors that induced high levels of HSC activity similar to that previously achieved with Hoxb4.
Article

Mature Adipocyte-Derived Cells, Dedifferentiated Fat Cells, Promoted Functional Recovery from Spinal Cord Injury-Induced Motor Dysfunction in Rats
Transplantation of mature adipocyte-derived cells (dedifferentiated fat cells) led to marked functional recovery from spinal cord injury-induced motor dysfunction in rats.
Article

In Vivo Proliferation Advantage of Genetically Corrected Hematopoietic Stem Cells in a Mouse Model of Fanconi Anemia FA-D1
Studies in mosaic fanconi anemia patients have shown that reversion of one inherited germ-line mutation resulting in a functional allele in one or a few hematopoietic stem cells can lead to the proliferation advantage of corrected cells but it is still unclear whether ex vivo genetic correction of FA HSCs also provides a similar proliferation advantage to FA HSCs.
Article

Notch-Mediated Expansion of Human Cord Blood Progenitor Cells Results in Rapid Myeloid Reconstitution in Vivo Following Myeloablative Cord Blood Transplantation
This study reports results of the initial 6 patients enrolled in a phase I study evaluating the safety and potential efficacy of cord blood progenitors cultured in the presence Delta1 and recombinant cytokines, with the goal of generating increased numbers of short term repopulating cells capable of providing rapid myeloid engraftment.
Article

Cells of Adult Brain Germinal Zone have Properties Akin to Hair Cells and can be Used to Replace Inner Ear Sensory Cells after Damage
Here, the researchers report that in the adult brain of both rodents and humans, the ependymal layer of the lateral ventricle contains cells with proliferative potential, which share morphological and functional characteristics with hair cells.
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Largest Study of Fertility Patients Shows Concerns about Embryo Disposition
Fertility patients who are done having children feel responsible for the stored, frozen embryos left over from their treatment, yet more than half are against implanting the embryos in anyone else, according to a new study.
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Policy

Daschle Will Oversee Health Reform Office
Former Senate Majority Leader Tom Daschle will pull double duty in the Obama administration, where he will serve not only as the Health and Human Services secretary but also oversee a new White House Office of Health Reform.
Article

Missouri Stem Cell Research Critics Refile Lawsuit
Missouri critics of embryonic stem cell research have resurrected a lawsuit that seeks to block $21 million from going to life sciences research.
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Klein Will Get Paid to Head California Institute for Regenerative Medicine
California’s stem cell agency has agreed to start paying a salary to Chairman Robert Klein, who has served unpaid since the institute began four years ago.
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Schwarzenegger Nominates San Diegan as Stem Cell Institute Vice Chair
Governor Arnold Schwarzenegger on Tuesday nominated Duane Roth, a San Diego biotechnology industry veteran and board member of the state stem cell institute, to serve as the institute’s vice chairman.
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ISSCR Releases New Guidelines for the Clinical Translation of Stem Cells
Today, the ISSCR released new guidelines that examine the scientific, clinical, regulatory, ethical and societal issues that must be addressed to ensure that basic stem cell research is responsibly transitioned into appropriate clinical applications.
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Business

Novocell Announces Collaboration with World-Renowned Stem Cell Researcher Shinya Yamanaka of Kyoto University
Novocell, Inc. recently announced a collaboration with renowned stem cell researcher Dr. Shinya Yamanaka of Kyoto University, Japan, to allow Novocell to explore the creation of human islet cells from induced pluripotent stem cells.
Article

Alnylam Forms Collaboration with University of California, San Francisco to Investigate Therapeutic Silencing of Key Gene Implicated in Uveal Melanoma
Alnylam Pharmaceuticals, Inc. announced recently that it has formed an exclusive collaboration with the University of California, San Francisco to evaluate the potential of an RNAi therapeutic targeting a heterotrimeric G protein alpha-subunit, known as G-alpha q or GNAQ, for the treatment of metastatic uveal melanoma.
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Pluristem Receives $1.6M Grant from the Office of Israel’s Chief Scientist
Pluristem Therapeutics Inc. recently announced it has received a $1.6M grant part of the Government’s Ministry of Trade and Industry Program to support innovative technologies in Israel.
Article

For Biotech, a Tax Break Spells Hope
Biotechnology industry executives plan to visit Congress on Wednesday to ask for a temporary change in the tax law that would let money-losing companies get cash from the government now, in exchange for tax credits they would pledge not to take if they eventually become profitable.
Article

Healionics Corporation Completes Series B Financing
Healionics Corporation recently announced that it has raised $2.6 million in a Series B financing from private investors.
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BioLife Solutions Granted European Biopreservation Patent
BioLife Solutions Inc. recently announced that it has been granted a European patent for an application that includes claims related to protecting cells from injury and death caused by cold temperatures used in biopreservation.
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Alnylam Strengthens Intellectual Property Estate through Acquisition of Nucleonics Patent Assets
Alnylam Pharmaceuticals, Inc. announced recently that it has acquired the intellectual property assets of Nucleonics, Inc which includes certain early patents and patent applications, notably the "Li & Kirby," "Pachuk I," and "Giordano" patent families, which cover broad structural features of RNAi therapeutics.
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Introgen Common Stock to be Delisted from the Nasdaq Stock Market
Introgen Therapeutics, Inc. announced recently that it has received a letter from the Nasdaq Listing Qualifications Panel stating that it has reached a decision to delist the shares of Introgen from the Nasdaq Stock Market and to suspend trading effective at the open of trading on Tuesday, December 9, 2008.
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NIH

Clarification of NOT-OD-08-014 and NOT-OD-08-023 Regarding Registration in ClinicalTrials.gov
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Transition of Individual Career Development (K) Applications to Electronic Submission (Grants.gov) New Business Processes and Other Information
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CBER

Current Licensed Establishments and Products – Alphabetical List of Licensed Establishments – Updated
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Current Licensed Establishments and Products – Listed by Product – Updated
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Blood Products Advisory Committee Meeting
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Regulatory

FOOD AND DRUG ADMINISTRATION (United States)

Critics Top Shortlist for FDA Head
A doctor who once denounced Pfizer Inc. for holding a marketing event in a pool hall is leading President-elect Barack Obama’s team formally assessing the troubled Food and Drug Administration, boosting his chances of becoming the next FDA commissioner.
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Guidance for Industry Process Validation: General Principles and Practices
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THERAPEUTIC GOODS ADMINISTRATION (Australia)

Guideline on Clinical Investigation of Medicinal Products in the Treatment of Parkinson’s Disease (Proposed for Adoption)
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