Volume 12.09 | Mar 7

     In this issue: Science | Policy | Business | NIH | CBER | Regulatory | Events
Scientists Discover Genetic Abnormalities Associated with the Creation of Stem Cells
Researchers showed that the reprogramming process for generating induced pluripotent stem cells is associated with inherent DNA damage. [Press release from the Samuel Lunenfeld Research Institute discussing online prepublication in Nature]


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Mutations Found in Human Induced Pluripotent Stem Cells
A new study finds that the genetic material of reprogrammed cells may in fact be compromised, and suggests that extensive genetic screening of human induced pluripotent stem cells become standard practice before these stem cells are used clinically. [Press release from the University of California, San Diego discussing online prepublication in Nature]

Researchers Discover How Cancer Cheats Immune System
Scientists have discovered that a single gene, CIITA, is implicated in almost 40 per cent of primary mediastinal B-cell lymphomas and 15 per cent of all Hodgkin lymphoma cases. [Press release from the British Columbia Cancer Agency discussing online prepublication in Nature]

Aging, Interrupted
Researchers report that they successfully generated induced pluripotent stem cells from skin cells obtained from patients with Hutchinson-Gilford progeria — who age eight to 10 times faster than the rest of us — and differentiated them into smooth muscle cells displaying the telltale signs of vascular aging. [Press release from the Salk Institute for Biological Studies discussing online prepublication in Nature]

Protein’s Elusive Role in Embryo and Disease Development Unravelled
Scientists have determined that a single protein called FADD controls multiple cell death pathways, a discovery that could lead to better, more targeted autoimmune disease and cancer drugs. [Press release from ScienceDaily discussing online prepublication in Nature]

New Clue to Controlling Skin Regeneration, as Well as Skin Cancer
Researchers in the Stem Cell Program at Children’s Hospital Boston have now found a regulator of gene activity that tells epidermal stem cells when it’s time to grow more skin, as well as a “crowd control” molecule that can sense cell crowding and turn the growth off. [Press release from ScienceDaily discussing online prepublication in Cell]

New Method Allows Human Embryonic Stem Cells to Avoid Immune System Rejection, Study Finds
A short-term treatment with three immune-dampening drugs allowed human embryonic stem cells to survive and thrive in mice, according to researchers. [Press release from Stanford School of Medicine discussing online prepublication in Cell Stem Cell]

Scientists Create Neurons with Symptoms of Parkinson’s Disease from Patient’s Skin Cells
Neurons have been derived from the skin of a woman with a genetic form of Parkinson’s disease and have been shown to replicate some key features of the condition in a dish. [Press release from Stanford School of Medicine discussing online prepublication in Cell Stem Cell]

Scientists Discover Genetic Switch That Increases Muscle Blood Supply
Scientists announced that they have identified a genetic switch that can increase the number of blood vessels in the skeletal muscle of non-exercising mice. [Press release from The University of Texas Health Science Center at Houston discussing online prepublication in Cell Metabolism]

Scientists Develop New Test for ‘Pluripotent’ Stem Cells
A team of Scripps Research Institute scientists has created a quality control diagnostic test that will make it much easier for researchers to determine whether their cell lines are normal pluripotent cells. [Press release from EurekAlert! discussing online prepublication in Nature Methods]

New Cell Therapy a Promising Atherosclerosis Treatment
Researchers have shown in a new study on mice that cell therapy can be used to reverse the effect of ‘bad’ LDL cholesterol and reduce the inflammation that leads to atherosclerosis. [Press release from the Karolinska Institutet discussing online prepublication in Circulation]

How Long Do Stem Cells Live?
To help determine how long a bone marrow (stem cell) graft will last, researchers have developed a mathematical model that predicts how long a stem cell will live and tested those predictions in a mouse model. [Press release from Sanford-Burnham Medical Research Institute discussing online prepublication in the Proceedings of the National Academy of Sciences USA]

T-Cell Immunotherapy: Researchers Predict Age of T Cells to Improve Cancer Treatment
Manipulation of cells by a new microfluidic device may help clinicians improve a promising cancer therapy that harnesses the body’s own immune cells to fight such diseases as metastatic melanoma, non-Hodgkin’s lymphoma, chronic lymphocytic leukemia and neuroblastoma. [Press release from the Georgia Institute of Technology discussing online prepublication in Molecular and Cellular Proteomics]

Human Stem Cells Transformed into Neurons Lost in Alzheimer’s
Researchers for the first time have transformed a human embryonic stem cell into a critical type of neuron that dies early in Alzheimer’s disease and is a major cause of memory loss. [Press release from Northwestern University Feinberg School of Medicine discussing online prepublication in Stem Cells]

Two-Pronged Approach Brings Hope for Bowel Cancer Treatment
Scientists have discovered that blocking two cell DNA repair routes at once could provide a completely new way to treat bowel cancer and potentially other cancers. [Press release from Cancer Research UK discussing online prepublication in Cancer Research]

Boosting Protein Garbage Disposal in Brain Cells Protects Mice from Alzheimer’s Disease
Gene therapy that boosts the ability of brain cells to gobble up toxic proteins prevents development of Alzheimer’s disease in mice that are predestined to develop it, report researchers at Georgetown University Medical Center. [Press release from ScienceDaily discussing online prepublication in Human Molecular Genetics]

Researchers Focus on Human Cells for Spinal Cord Injury Repair
For the first time, scientists discovered that a specific type of human cell, generated from stem cells and transplanted into spinal cord injured rats, provide tremendous benefit, not only repairing damage to the nervous system but helping the animals regain locomotor function as well. [Press release from the University of Rochester Medical Center discussing online prepublication in PLoS One]

Stem Cell Study Could Aid Motor Neuron Disease Research
Scientists have discovered a new way to generate human motor nerve cells in a development that will help research into motor neuron disease. A team has created a range of motor neurons from human embryonic stem cells in the laboratory. [Press release from the University of Cambridge discussing online prepublication in Nature Communications]

Scientists Target Aggressive Prostate Cancer
Researchers have identified a potential target to treat an aggressive type of prostate cancer. [Press release from the University of Michigan Health System discussing online prepublication in Science Translational Medicine]

CURRENT PUBLICATIONS (Ranked by Impact Factor of the Journal)

Copy Number Variation and Selection During Reprogramming to Pluripotency
Researchers show that significantly more copy number variations are present in early-passage human induced pluripotent stem (iPS) cells than intermediate passage human iPS cells, fibroblasts or human embryonic stem cells. [Nature]

Somatic Coding Mutations in Human Induced Pluripotent Stem Cells
Researchers show that 22 human induced pluripotent stem cell lines reprogrammed using five different methods each contained an average of five protein-coding point mutations in the regions sampled (an estimated six protein-coding point mutations per exome). [Nature]

Major Histocompatibility Complex Class II Transactivator CIITA Is a Recurrent Gene Fusion Partner in Lymphoid Cancers
Findings suggest that recurrent rearrangements of CIITA may represent a novel genetic mechanism underlying tumor-microenvironment interactions across a spectrum of lymphoid cancers. [Nature]

Recapitulation of Premature Aging with iPSCs from Hutchinson-Gilford Progeria Syndrome
Researchers report the generation of induced pluripotent stem cells (iPSCs) from fibroblasts obtained from patients with Hutchinson-Gilford progeria syndrome. [Nature]

Functional Complementation Between FADD and RIP1 in Embryos and Lymphocytes
Data demonstrate an unexpected cell-type-specific interplay between FADD and RIP1, which is critical for the regulation of apoptosis and necrosis during embryogenesis and lymphocyte function. [Nature]

Yap1 Acts Downstream of α-Catenin to Control Epidermal Proliferation
Data identify Yap1 as a determinant of the proliferative capacity of epidermal stem cells and as an important effector of a “crowd control” molecular circuitry in mammalian skin. [Cell]

Short-Term Immunosuppression Promotes Engraftment of Embryonic and Induced Pluripotent Stem Cells
This report describes a short-term immunosuppressive approach capable of inducing engraftment of transplanted embryonic stem cells and induced pluripotent stem cells, providing a significant improvement in our mechanistic understanding of the critical role costimulatory molecules play in leukocyte activation. [Cell Stem Cell]

LRRK2 Mutant iPSC-Derived DA Neurons Demonstrate Increased Susceptibility to Oxidative Stress
Researchers report generation of induced pluripotent stem cells that carry the p.G2019S mutation (G2019S-iPSCs) in the Leucine-Rich Repeat Kinase-2 (LRRK2) gene, the most common Parkinson’s disease-related mutation, and their differentiation into dopaminergic (DA) neurons. [Cell Stem Cell]

Exercise and PGC-1α-Independent Synchronization of Type I Muscle Metabolism and Vasculature by ERRγ
Researchers show that nuclear receptor ERRγ is highly expressed in type I muscle and, when transgenically expressed in anaerobic type II muscles, dually induces metabolic and vascular transformation in the absence of exercise. [Cell Metab]

A Bioinformatic Assay for Pluripotency in Human Cells
Researchers report PluriTest, a robust open-access bioinformatic assay of pluripotency in human cells based on their gene expression profiles. [Nat Methods]



U.S. Bioethics Panel to Review Clinical Trials Around the World
Prompted by concerns about an unethical U.S.-sponsored study in the 1940s, bioethics advisers to President Barack Obama formed an international panel that will examine whether current rules adequately protect volunteers in global clinical trials. [Presidential Commission for the Study of Bioethical Issues, United States]

HHS Funds New Vaccine Technology
With the aim of enhancing the country’s ability to react quickly to another influenza pandemic, the Department of Health and Human Services (HHS) has awarded two contracts for the development of next-generation recombinant influenza vaccines that do not require egg-based technology. [Department of Health and Human Services, United States]

New Panel to Clear Clinical Trials
In a bid to tighten the regulatory control over cell-based therapies taking place in the country, the office of the Drugs Controller General of India has set up a new committee of experts to clear the clinical trial programs related to cell research. [Drugs Controller General, India]

New President for Chinese Science Academy
The Chinese State Council appointed chemist Bai Chunli the next president of the Chinese Academy of Sciences. [Chinese State Council, China]

Australian Stem Cell Researchers Call for Less Regulatory Red Tape
The licensing system for creating stem cells is preventing potentially lifesaving research and should be streamlined, say Australian stem cell researchers. [National Health and Medical Research Council, Australia]

Request for Comments on Human Subjects Protections in Scientific Studies (FR Doc. 2011-4658) [Department of Health and Human Services, United States]



Lycera Announces Research Collaboration with Merck to Discover, Develop and Commercialize Drugs for Autoimmune Diseases
Lycera Corporation announced that it has entered into an exclusive research collaboration with Merck to discover, develop and commercialize small molecules that target T-helper 17 cells, key mediators of inflammation. [Lycera Corporation Press Release]

Daiichi Sankyo to Acquire Plexxikon
Plexxikon Inc. announced it has entered into a merger agreement with Daiichi Sankyo Company, Limited, a Japan-based global pharmaceutical company. [Plexxikon Inc. Press Release]

Pfizer Completes Acquisition of King Pharmaceuticals, Inc.
Pfizer Inc. announced that it has combined operations with King Pharmaceuticals, Inc. On February 28, 2011, Pfizer completed its acquisition of King through the merger of its wholly owned subsidiary, Parker Tennessee Corp., with and into King. [Pfizer Inc. Press Release]

MediGene Completes the Transfer of Eligard® Rights for EU Countries to Astellas
The biotech company MediGene AG announced that exclusive European rights to the cancer drug Eligard® have been transferred to Astellas Pharma Europe Ltd. with effect from March 1, 2011. [MediGene AG Press Release]

AMT Receives Grant from Dutch Parents Organization for Duchenne Muscular Dystrophy Gene Therapy
Amsterdam Molecular Therapeutics (AMT) announced that the Duchenne Parent Project, based in the Netherlands, has awarded AMT a grant of EUR 145,000 to support the development of AMT-080, AMT’s gene therapy for Duchenne Muscular Dystrophy. [Amsterdam Molecular Therapeutics Press Release]

Tengion Announces Pricing of $31.4 Million Private Placement
Tengion, Inc., a leader in regenerative medicine, announced that it has entered into definitive agreements with certain investors in connection with a PIPE financing transaction pursuant to registration exemptions under the Securities Act of 1933, as amended. [Tengion, Inc. Press Release]

LCT’s World-Leading Encapsulating Technology Granted Vital Australian Patent
Living Cell Technologies (LCT) Limited a global company pioneering the development of a cell implant therapy to treat diabetes and neurodegenerative diseases, has been granted a patent by the Australian Patent Office for IMMUPEL™, LCT’s industry-leading technology for encapsulating living cells prior to transplantation. [Living Cell Technologies Limited Press Release]

Seattle Genetics Submits BLA to FDA for Brentuximab Vedotin in Relapsed or Refractory Hodgkin Lymphoma and Systemic ALCL
Seattle Genetics, Inc. announced that it has submitted a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for the use of brentuximab vedotin in relapsed or refractory Hodgkin lymphoma and relapsed or refractory systemic anaplastic large cell lymphoma (ALCL). [Seattle Genetics, Inc. Press Release]

Positive Pre-Clinical Data from Muscle Injury Study Moves Pluristem Toward Second Multi-Billion Dollar Clinical Indication
Pluristem Therapeutics, Inc. and the Berlin-Brandenburg Center for Regenerative Therapies, in cooperation with the Charité – University of Medicine in Berlin, announced the results of a pre-clinical study demonstrating that the local administration of PLX cells following muscle injury resulted in significant improvement in the recovery of muscle function when compared with the control group. [Pluristem Therapeutics, Inc. Press Release]

New Breast Reconstruction Procedure Demonstrates Long Term Success in European Trial; Data Reported from Cytori’s Restore-2 Study of the Celution® System
Results from a European breast reconstruction trial using a new minimally invasive procedure to repair lumpectomy defects resulted in a sustained and substantial rate of physician and patient satisfaction at 12 months. The study utilized the regenerative cells in the patient’s own fat tissue, extracted at the time of the procedure using the Celution® 800/CRS System. [Cytori Therapeutics, Inc. Press Release]

ReNeuron Gives Update on Stroke Clinical Trial
ReNeuron Group plc provides an update on progress with the PISCES clinical trial of its ReN001 stem cell therapy for disabled stroke patients. [ReNeuron Group plc Press Release]

Osiris Therapeutics Completes Enrollment of Stem Cell Trial for the Treatment of Heart Attacks
Osiris Therapeutics, Inc. announced that it has successfully completed enrollment in a Phase II clinical trial evaluating Prochymal (remestemcel‐L), an adult mesenchymal stem cell therapy, in patients experiencing their first heart attack. [Osiris Therapeutics, Inc. Press Release]

Traditional Drug-Discovery Model Ripe for Reform
With drug pipelines running dry and a slew of blockbuster medicines about to lose patent protection, the voices arguing that the traditional drug-development process is too expensive and inefficient to survive are getting louder. [NatureNews]


NIAMS Announces Participation in the NIH Parent Program Announcement PA-11-113, Ruth L. Kirschstein National Research Service Awards (NRSA) for Individual Postdoctoral Fellows (Parent F32) (NOT-AR-11-016)

NIAMS Announces Participation in the NIH Parent Program Announcement PA-11-114, Ruth L. Kirschstein National Research Service Awards (NRSA) for Individual Senior Fellows (Parent F33) (NOT-AR-11-017)

Notice of Changes in Key Dates for RFA-AR-11-002, Centers of Research Translation (P50) (NOT-AR-11-015)

National Cancer Institute; Notice of Closed Meetings (FR Doc. 2011-4777)

National Center for Research Resources; Notice of Closed Meetings (FR Doc. 2011-4825)

National Heart, Lung, and Blood Institute; Notice of Closed Meetings (FR Doc. 2011-4548)

Center for Scientific Review; Notice of Closed Meetings (FR Doc. 2011-4634)

Center for Scientific Review; Notice of Closed Meetings (FR Doc. 2011-4945)

Center for Scientific Review; Notice of Closed Meetings (FR Doc. 2011-5040)

Roster of the Blood Products Advisory Committee (Updated)

February 24, 2011 Approval Letter – Rotarix

Annual Summary for Fiscal Year 2010 – Biological Product and HCT/P Deviation Report

Animal Models Essential Elements to Address Efficacy Under the Animal Rule and Reopening of Comment Period Transcript

List of Establishments Granted Approval for a Variance to 21CFR640.3(d) and 21CFR640.3(f)


FDA Prompts Removal of Unapproved Drugs from Market
The U.S. Food and Drug Administration took action against companies that manufacture, distribute, or market certain unapproved prescription oral cough, cold, and allergy products.

Obama Describes FDA as Agency in Need of Overhaul
President Obama said his administration would focus on modernizing the U.S. Food and Drug Administration, an agency not prepared to handle emerging 21st century challenges in regulating food and drugs.

Oncologic Drugs Advisory Committee; Notice of Meeting [FR Doc. 2011-4614]


Information Sent to Healthcare Professionals in February About the Safety of Medicines


April 6-7, 2011
Birmingham, United Kingdom

NEW Stem Cells for Drug Developers 2011
April 26-29, 2011
Boston, United States

NEW 6th Annual European Biomarkers Summit
May 18-19, 2011
London, United Kingdom

NEW Immunology: A Pathway Through the Maze Short Course
May 25-26, 2011
Oxford, United Kingdom

NEW 6th Protein Kinases in Drug Discovery
May 26-27, 2011
Boston, United States

NEW 7th Stem Cell Research & Therapeutics
May 26-27, 2011
Boston, United States

NEW 2nd North American Veterinary Regenerative Medicine Association (NAVRMA) Conference
June 2-4, 2011
Lexington, United States

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


Lab Technologist – Human Embryonic and Induced Pluripotent Stem Cells (STEMCELL Technologies)

Implementation Coordinator – Maternity Leave Contract (STEMSOFT Software Inc.)

Postdoctoral Position (Johns Hopkins University School of Medicine)

Manager Clinical Affairs (Bioheart, Inc.)

Quality Assurance Specialist – Gene Transfer & Somatic Cell Engineering Facility (Memorial Sloan-Kettering Cancer Center)

Postdoctoral Position – Germline Stem Cells (R. L. Brinster, School of Veterinary Medicine, University of Pennsylvania)

Scientific Director (Adipose Derived Stem Cell Bank)

Process Technical Development Scientist (StemCells, Inc.)

Field Applications Specialist – Cell Therapy (Medical) (Pall Corporation)
Postdoctoral Positions – Stem Cell Biology (Joslin Diabetes Center/Harvard Stem Cell Institute)
Cell Therapy Manufacturing Manager (Opexa Therapeutics)

Assistant Professor (University of Pittsburgh School of Medicine, Center for Cellular and Molecular Engineering)
Post-Doctoral Positions (University of Texas MD Anderson Cancer Center)

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