Volume 10.03 | Feb 2

Cell Therapy News 10.03, February 2, 2009
     In this issue: Science | Policy | Business | NIH | CBER | Regulatory
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Top Stories

Gene Therapy Demonstrates Benefit in Patients with Rheumatoid Arthritis: Researchers have reported the first clinical evidence that gene therapy reduces symptoms in patients with rheumatoid arthritis.
Article

Science

Visit our events page to stay up to date with the latest events in the cell, gene and immunotherapy community.

Governor Rell, Hogan, Williams Announce Connecticut’s First Two Human Embryonic Stem Cell Lines Created for Research Use
The University of Connecticut recently announced that UConn researchers have created two new human embryonic stem cell lines and are making the lines available to academic researchers to study the therapeutic potential of the cells.
Article

Biologists ID Gene, Pathway for Nerve Regeneration in Worms
University of Utah scientists identified a worm gene that is essential for damaged nerve cells to regenerate, and showed they could speed nerve regeneration by over-activating the gene.
Article

Scientists Reprogram Induced Pluripotent Cells into Precursors of Eggs, Sperm
For the first time, UCLA researchers have reprogrammed human induced pluripotent stem cells into the cells that eventually become eggs and sperm, possibly opening the door for new treatments for infertility using patient-specific cells.
Article

Biologists Find Stem Cell-like Functions in Other Types of Plant Cells
Ordinary cells have the ability to replace lost organs in plants, a function previously thought to be limited to stem cells, researchers have found.
Article

Stem Cells and ABC Transporters Essential in Kidney Regeneration
Researchers have found that stem cells and ABC transporter proteins are indispensable for tubular regeneration after acute kidney injury.
Article

Scientists Find a New Class of Small RNAs and Define its Function
Researchers at Cold Spring Harbor Laboratory announced recently the discovery of a new class of small RNAs and suggest the presence of a strikingly novel biochemical pathway for RNA processing in which these and possibly other small RNAs are produced.
Article

Spinal Fluid Proteins Signal Lou Gehrig’s Disease
High levels of certain proteins in the spinal fluid could signal the onset of Lou Gehrig’s disease, which may lead to diagnostic kits for early diagnosis, accurately measuring the progression of the disease and monitoring the effects of treatment.
Article

Engineered Virus Targets and Kills Apparent Cancer Stem Cells in Neuroblastoma
After identifying an apparent population of cancer stem cells for neuroblastoma, researchers successfully used a reprogrammed herpes virus to block tumor formation in mice by targeting and killing the cells.
Article

Gene Therapy Cures Form of ‘Bubble Boy Disease’
Gene therapy seems to have cured eight of 10 children who had potentially fatal “bubble boy disease” or severe combined immunodeficiency, according to a study that followed their progress for about four years after treatment.
Article

Stem Cell Transplants Show Promise for Multiple Sclerosis
U.S. researchers have reversed multiple sclerosis symptoms in early stage patients by using bone marrow stem cell transplants to reset the immune system, they said on Thursday.
Article

ABSTRACTS, REVIEWS AND SPECIAL REPORTS

Human Embryos Derived by Somatic Cell Nuclear Transfer Using an Alternative Enucleation Approach
This study performed somatic cell nuclear transfer to generate patient-specific embryonic stem cells from blastocysts cloned by nuclear transfer.
Article

Generation of Transplantable, Functional Satellite-like Cells from Mouse Embryonic Stem Cells
In this study, the researchers report the successful in vitro induction of Pax7-positive satellite-like cells from mouse embryonic stem cells.
Article

Human Fetal Pancreatic Insulin-producing Cells Proliferate in Vitro
Considering the inherent differences in mouse and human pancreatic islets, this study assesses the potential of human fetal pancreatic insulin-producing cells to proliferate in vitro.
Article

Identification of a Bone Marrow–derived Epithelial-like Population Capable of Repopulating Injured Mouse Airway Epithelium
This study reports what is believed to be a newly discovered population of cells in mouse and human bone marrow that express Clara cell secretory protein, a marker of airway progenitor and stem cells.
Article

Can I Serve You Now?
American attitudes to stem cell therapies are changing fast.
Article

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Policy

Life Sciences CEOs Line Up Questions for Obama
Days before the inauguration of President Barack Obama, Mass High Tech asked a handful of CEOs from life sciences companies for their thoughts on what impact on their industry sectors they expect from the new administration, the economic crisis and the Massachusetts Life Sciences Bill.
Article

Politics Enters State’s Stem Cell Research Program
On the cusp of a new era in stem cell science, Democratic heavyweights are pushing to install the outgoing California Democratic Party chief in a leadership post at the state’s $3-billion research program.
Article

Business

Pluristem Therapeutics Collaborates with the Charite – Universitatsmedizin Berlin and Franziskus-Krankenhaus Hospital for its Clinical Trials in Germany
Pluristem Therapeutics Inc. announced recently that the Company signed an agreement with Charite – Universitatsmedizin Berlin and Franziskus-Krankenhaus Hospital for the upcoming Critical Limb Ischemia clinical trials in Germany utilizing Pluristem’s placental-derived adherent stromal cell product, PLX-PAD.
Article

Medical Research Council Technology License Rights to Develop Potential Novel Immunotherapy
The Medical Research Council and MRC Technology have signed exclusive License and Research Collaboration agreements with Centocor, Inc., which is now known as Centocor Ortho Biotech Inc., for the development of a novel immunotherapy targeting respiratory disease.
Article

Roche Intends to Commence Tender Offer to Acquire All Shares of Genentech for US $86.50 Per Share in Cash
Roche announced recently that it intends to commence a cash tender offer replacing the public proposal made by Roche on July 21, 2008 to acquire all of the publicly-held shares of Genentech at a price of US $89 per share in cash by means of a negotiated merger.
Article

Massachusetts Life Sciences Center Board Approves $7.4 Million Investment in Expansion of Organogenesis
The Massachusetts Life Sciences Center announced recently that the Center’s Board of Directors has approved a $7.4 million grant to Organogenesis, Inc. to facilitate a major expansion.
Article

Venture Capital Investments Fall 33 Percent in 4Q
Venture capital investments plunged 33 percent in the fourth quarter, falling to the lowest level in nearly four years as the financiers of new business ideas became more reluctant to take on new risks during a recession that has shown no signs of easing.
Article

BioTime Launches New Stem Cell Lines in Anticipation of President Obama’s Removal of Restrictions on Federal Funding of Embryonic Stem Cell Research
BioTime will launch new cell lines that show markers of neural, muscle, vascular, and cartilage progenitors, as well as other properties of interest to the medical research community.
Article

Geron Announces John Walker Resigns as Director
Geron Corporation recently announced that John P. Walker has resigned from the Board of Directors. Mr. Walker served as a Director of the company since 1997 and was Chair of the Audit Committee.
Article

Neuralstem Receives Final Notice of Allowance for New Stem Cell Immortalization Technology Patent
Neuralstem, Inc. recently announced that it has received Official Notice of Allowance for its patent application, number 10/047,352, covering the technology to immortalize any human neural stem cell, rendering its growth robust and long-lasting.
Article

Vitro Diagnostics, Inc. Receives Notice of Allowance for Adult Stem Cell Patent from the United States Patent and Trademark Office
Vitro Diagnostics, Inc. recently announced notification from the United States Patent Office indicating the successful examination of its patent application entitled, “Generation and Differentiation of Adult Stem Cells.”
Article

NIH

Three New Informatics Pilot Projects to Aid Clinical and Translational Scientists Nationwide
The National Institutes of Health (NIH) has awarded three contracts for pilot projects to improve informatics support for researchers conducting small- to medium-sized clinical studies.
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Adobe-Based Grant Application Forms Now Available for All NIH Funding Opportunity Announcements Requiring Electronic Submission (NOT-OD-09-043)
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Error-Correction Window Extended for All Electronic Applications with Submission Deadlines through the End of February, 2009 (NOT-OD-09-045)
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2009 NIH Regional Seminar on Program Funding & Grants Administration: Register now for Atlanta, Ga (NOT-OD-09-046)
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NHLBI Progenitor Cell Biology Consortium Research Hubs (U01) (RFA-HL-09-004)
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NHLBI Progenitor Cell Biology Consortium Administrative Coordinating Center (U01) (RFA-HL-09-005)
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CBER

Substantially Equivalent 510(k) Device Applications – Leucolab LCG2 Leukoreduction System for AS-1, AS-3, and AS-5 Red Blood Cells
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Substantially Equivalent 510(k) Device Applications – Clotalyst and GPS III Platelet Concentrate Separation Kit with ACD-A, Clotalyst and GPS III Mini Platelet Concentrate Separation Kit with ACD-A
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Exceptions and Alternative Procedures Approved Under 21 CFR 640.120 – Update Regarding Blood, Blood Components or Blood Products
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Variances for Collection of Blood and Blood Products from Patients with Hemochromatosis – Update
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Vaccines and Related Biological Products Advisory Committee Roster – Update
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Regulatory

FOOD AND DRUG ADMINISTRATION (United States)

Dissidents at F.D.A. Complain of Inquiry
Nine dissident scientists at the Food and Drug Administration who say they were forced to approve high-risk medical devices sent a letter to President Obama on Monday stating that agency officials might have made them the targets of a criminal investigation into their complaints.
Article

Request for Nominations for Voting Members on Public Advisory Committees , 5166–5167 [E9–1821]
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