Volume 12.33 | Aug 22

Cell Therapy News 12.33, August 22, 2011
     In this issue: Science | Policy | Business | NIH | CBER | Regulatory | Events
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Immunogene Therapy Combined with Standard Treatment Is Safe for Patients with Brain Tumors
A clinical trial has shown that a form of gene therapy is safe for treating a deadly form of brain cancer, even when combined with radiation therapy. [Press release from The Ohio State University Comprehensive Cancer Center discussing online prepublication in the Journal of Clinical Oncology]


Scientists Offer New Insight into the Regulation of Stem Cells and Cancer Cells
Scientists have gained new insight into the delicate relationship between two proteins that, when out of balance, can prevent the normal development of stem cells in the heart and may also be important in some types of cancer. [Press release from The Gladstone Institute discussing online prepublication in Nature Cell Biology]

Molecular Delivery Truck Serves Gene Therapy Cocktail
Scientists have devised a gene therapy cocktail that has the potential to treat some inherited diseases associated with “misfolded” proteins. [Press release from the University of North Carolina Health Care System discussing online prepublication in the Proceedings of the National Academy of Sciences, United States]

Cells Derived from Pluripotent Stem Cells May Pose Challenges for Clinical Use, Research
Researchers have found that three types of cells derived from human embryonic stem cells and from induced pluripotent stem cells are similar to each other, but they are far more developmentally immature than those same cell types taken directly from human tissue. [Press release from the University of California, Los Angeles discussing online prepublication in Cell Research]

Chained Muscle Tissue Culture Develops Blood Vessels and Aligned Structure
Researchers have found a simple way to grow muscle tissue with a real muscle structure in the laboratory. [Press release from Eindhoven University of Technology discussing online prepublication in Tissue Engineering Part A]

Penn-Designed Triple Therapy Regime Puts Patients with Leukemic Form of Cutaneous Lymphoma in Remission
A three-pronged immunotherapy approach nearly doubles five-year survival among patients with a rare leukemic form of cutaneous T-cell lymphoma, reports a new study by dermatologists. [Press release from Penn Medicine Abramson Cancer Center discussing online prepublication in the Archives of Dermatology]

Researchers Combine Stem Cell with Artificial Chromosome to Treat Duchenne Muscular Dystrophy in Mice
Researchers report on the use of genetically modified stem cells to generate new muscle fibers and improve disease-associated muscle function and phenotype in a mouse model of Duchenne muscular dystrophy. [Press release from Genetic Engineering & Biotechnology News discussing online prepublication in Science Translational Medicine]

Targeting a Cure: Research Looks at Developing a Bull’s-Eye Therapy to Combat Lung Cancer
Masaaki Tamura and his research team are working on several projects that use nanoparticles to treat and directly target the “bull’s-eye”: cancer cells. [Kansas State University Press Release]

Stem Cell Team Aims for Spare Heart Parts in Five Years
Stem cell researchers in Hong Kong and the United States are trying to grow spare parts for the human heart that may be ready for tests on people within five years, they said. [Reuters]


(Ranked by Impact Factor of the Journal)

Notch Post-Translationally Regulates β-Catenin Protein in Stem and Progenitor Cells
Here, scientists show that membrane-bound Notch physically associates with unphosphorylated (active) β-catenin in stem and colon cancer cells and negatively regulates post-translational accumulation of active β-catenin protein. [Nat Cell Biol]

Phase IB Study of Gene-Mediated Cytotoxic Immunotherapy Adjuvant to Up-Front Surgery and Intensive Timing Radiation for Malignant Glioma
Patients with newly diagnosed malignant glioma received AdV-tk at 3 × 1010, 1 × 1011, or 3 × 1011 vector particles via tumor bed injection at time of surgery followed by 14 days of valacyclovir. [J Clin Oncol]

Combination Therapy Utilizing shRNA Knockdown and an Optimized Resistant Transgene for Rescue of Diseases Caused by Misfolded Proteins
In this study researchers used alpha-1 antitrypsin (AAT) deficiency with the piZZ mutant phenotype as a model system to evaluate the efficiency of gene-delivery approaches that both silence the piZZ transcript and restore circulating wild-type AAT expression from resistant codon-optimized AAT transgene cassette using adeno-associated virus vector delivery. [Proc Natl Acad Sci U S A]

Defining the Nature of Human Pluripotent Stem Cell Progeny
To determine whether human embryonic stem cells and human-induced pluripotent stem cells (hiPSCs) make equivalent progeny, and whether either makes cells that are analogous to tissue-derived cells, investigators performed comprehensive transcriptome profiling of purified PSC derivatives and their tissue-derived counterparts. [Cell Res]

High Clinical Response Rate of Sézary Syndrome to Immunomodulatory Therapies
The objective of this study is to quantify response rates of Sézary syndrome to multimodality immunomodulatory therapy and to identify the important prognostic parameters that affect overall response to treatment. [Arch Dermatol]

Stem Cell–Mediated Transfer of a Human Artificial Chromosome Ameliorates Muscular Dystrophy
Here, scientists report the amelioration of the dystrophic phenotype in the mdx mouse model of Duchenne muscular dystrophy using a combination of human artificial chromosome-mediated gene replacement and transplantation with blood vessel–associated stem cells. [Sci Transl Med]



Lawsuit Dismissal Removes Cloud Over Alzheimer’s Research
In a move that researchers called a victory for science, a lawsuit that threatened scientists who use mouse models in Alzheimer’s research has been dismissed. [Alzheimer’s Institute of America, United States]

Agencies Unveil Plans to Safeguard Science
White House is reviewing 19 ‘scientific integrity’ policies submitted by US agencies. [US White House, United States]

Johns Hopkins Education Leaders Call for Radical Transformation in Graduate Biomedical Curriculum
Leaders in biomedical education at Johns Hopkins University School of Medicine are calling for a radical new approach to post-graduate training in the life sciences to address significant challenges. [Johns Hopkins University School of Medicine, United states]

Primate Death Spurs Citations
Citations issued by the US Department of Agriculture last year failed to prevent another animal death at the New England Primate Research Center, a facility of the Harvard Medical School. [US Department of Agriculture, United States]

Turin Reformer Promises Shake-Up of Italy’s National Research Council
On 13 August, Italy’s Minister of research and education, Mariastella Gelmini, appointed Francesco Profumo, the successful, reform-minded rector of the Polytechnic University of Turin as the Italian National Research Council’s new president. [Italian National Research Council, Italy]



Scientists’ £3.9 Million Project to Develop Gene Therapy to Prevent Heart Bypass Graft Failure
A team of scientists, cardiologists and heart surgeons from the University of Glasgow and the Golden Jubilee National Hospital has been awarded £3.9 million for a study into how to prevent the failure of heart bypass grafts. [University of Glasgow Press Release]

NeoStem Provides Update on Amorcyte Clinical Progress and Reports Results for Second Quarter
NeoStem, Inc. reported on important progress toward the commencement of a Phase II clinical trial for AMR-001, the lead product candidate of Amorcyte, Inc. for the treatment of acute myocardial infarction. [NeoStem, Inc. Press release]

Key European Patent Granted for MolMed’s TK Cell Therapy
MolMed S.p.A. announced that the European Patent Office granted a key patent covering the gene forming the basis of TK, MolMed’s investigational cell therapy product currently in Phase III for the treatment of high-risk leukemia. [MolMed S.p.A. Press Release]

First Minimally-Invasive Procedure Performed in Mesoblast’s Phase II Stem Cell Trial for Lumbar Disc Repair
Mesoblast Limited announced that the first minimally-invasive lumbar disc procedure had been successfully performed in the Phase II clinical trial of its proprietary adult Mesenchymal Precursor Cell product for the treatment of low back pain and degenerative disc disease. [Mesoblast Limited Press Release]

RXi Pharmaceuticals Provides Update and Reports Financial Results for Q2 2011
RXi Pharmaceuticals Corporation reported its financial results for the quarter ended June 30, 2011. [RXi Pharmaceuticals Corporation Press Release]


Rao Named First Director of New Center For Regenerative Medicine
Dr. Mahendra S. Rao was recently appointed director of the new NIH intramural Center for Regenerative Medicine.

Departing Director Reflects on NCRR Breakup
Barbara Alving, who heads the doomed National Center for Research Resources (NCRR), announced that she’s resigning at the end of September.

National Cancer Institute; Notice of Meeting (FR Doc No: 2011-20944)

IACUC 101 and 201 PLUS Workshops: September 14-15, 2011 in Houston, TX (NOT-OD-11-104)

SCAW IACUC Training Workshop: September 19, 2011 in Atlanta, GA (NOT-OD-11-105)

Notice of Application Submission Date Extension for PAR-11-279 Bridges to the Doctorate (R25) (NOT-GM-11-109)

Request for Information (RFI): Input into the Deliberations of the Advisory Committee to the NIH Director Working Group on the Future Biomedical Research Workforce (NOT-OD-11-106)



FDA: Regulatory Science Plan Positions Agency to Foster Innovation through Better Science
The U.S. Food and Drug Administration released its “Strategic Plan for Regulatory Science,” calling for a sweeping modernization of the science used in developing and evaluating products critical to the nation’s health, economy, and security.

Draft Guidance for Industry: Cell Selection Devices for Point of Care Production of Minimally Manipulated Autologous Peripheral Blood Stem Cells; Withdrawal of Draft Guidance [Docket No. FDA-2007-D-0068; formerly Docket No. 2007D-0290]

Food and Drug Administration Clinical Trial Requirements, Regulations, Compliance, and Good Clinical Practice; Public Workshop [Docket No. FDA-2011-N-0002]


Biologicals Regulatory Framework Information Sessions
The TGA will be conducting a number of information sessions on the new biologicals framework. These information sessions will be held in the following locations on the specified dates.


NEW The Jackson Laboratory: Mouse Colony Management and Breeding Strategies
August 25, 2011

International Society for Cell Therapy North American Regional Meeting
September 15-16, 2011
Charlottesville, United States

NEW Phacilitate Cell & Gene Therapy Forum 2012
January 30-February 1
Washington, United States

our events page to see a complete list of events in the cell, gene and immunotherapy community.


Lab Technologist – Tissue Culture (STEMCELL Technologies)

Research and Development Technologist, hPSC Media (STEMCELL Technologies)

Scientist (iPSC) (STEMCELL Technologies)

Contract Assay Service Technologist (STEMCELL Technologies)

Research and Development Technologist (STEMCELL Technologies)

Postdoctoral Researchers (University of Cambridge)

Postdoctoral Position (University of Leicester)

Postdoctoral Position (Michigan State University)

Postdoctoral Scientists (North Carolina Central University)

Postdoctoral Position (Nanyang Technological University)

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