Volume 12.10 | Mar 14

Cell Therapy News 12.10, March 14, 2011.
     In this issue: Science | Policy | Business | NIH | CBER | Regulatory | Events
A New Stem Cell Enters the Mix: Induced Conditional Self-Renewing Progenitor (ICSP) Cells
Researchers outline a method to obtain a new kind of stem cell they call “induced conditional self-renewing progenitor cells.” [Press release from the Sanford-Burnham Medical Research Institute discussing online prepublication in the Proceedings of the National Academy of Sciences USA]


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Researchers Identify Mechanism for Repairing Bladder Infection Damage; Also Find Possible Bladder Stem Cell
Scientists have identified the key molecular pathways that form a control circuit involved in kick-starting cell division in the bladder to repair the damage. They’ve also pinpointed what appear to be bladder stem cells critical to the repair. [Press release from the Stanford University School of Medicine discussing online prepublication in Nature]

Genetic Studies Expose Instigators of Aggressive Breast Tumors
Researchers have just discovered an important molecular cop on the cancer beat: take the cop off the job, they have found, and a gang of cancer-promoting troublemakers run amok. [Press release from Howard Hughes Medical Institute discussing online prepublication in Cell]

Laboratory-Grown Urethras Implanted in Patients, Scientists Report
Researchers reported on a new advance in tissue engineering. The team is the first in the world to use patients’ own cells to build tailor-made urinary tubes and successfully replace damaged tissue. [Press release from Wake Forest University Baptist Medical Center discussing online prepublication in The Lancet]

Protein Engineered by Researchers Has Potential for New Anti-Inflammatory Treatment
Researchers created a new protein molecule derived from the growth factor progranulin that may provide the basis for new therapies in inflammatory diseases, such as rheumatoid arthritis. [Press release from NYU Langone Medical Center discussing online prepublication in Science]

Finding of Long-Sought Drug Target Structure May Expedite Drug Discovery
Researchers have solved the three-dimensional structure of a key biological receptor. The finding has the potential to speed drug discovery in many areas, from arthritis to respiratory disorders to wound healing, because it enables chemists to better examine and design molecules for use in experimental drugs. [Press release from the National Institutes of Health discussing online prepublication in Science]

Protein and MicroRNA Block Cellular Transition Vital to Metastasis
Like a bounty hunter returning escapees to custody, a cancer-fighting gene converts organ cells that change into highly mobile stem cells back to their original, stationary state, researchers report. [Press release from The University of Texas MD Anderson Cancer Center discussing online prepublication in Nature Cell Biology]

Journal of Clinical Investigation Publishes Data Demonstrating Enhanced Antitumor Efficacy of Second Generation DeCIDe™ Technology
Bellicum Pharmaceuticals, Inc. announced the publication of studies comparing AP1903-activated iMyD88/CD40-transduced dendritic cells (DCs) to conventionally matured DCs. [Press release from Bellicum Pharmaceuticals, Inc. discussing online prepublication in the Journal of Clinical Investigation]

New Method Powerfully Boosts Efficiency of RNA Interference (RNAi) in Shutting Down Genes
A research team has developed a powerful method that allows them to sift through thousands of candidate hairpin-shaped RNA molecules at a time and pull out only those RNAs that potently shut down the activity of a target gene. [Press release from Cold Spring Harbor Laboratory discussing online prepublication in Molecular Cell]

Researchers Use ‘Nano-Velcro’ Technology to Improve Capture of Circulating Cancer Cells
A research team has developed an innovative device based on Velcro-like nanoscale technology to efficiently identify and “grab” circulating tumor cells in the blood. [Press release from the University of California, Los Angeles discussing online prepublication in Angewandte Chemie International Edition]

Earliest Cardiovascular Progenitors That Arise During the Differentiation of Pluripotent Stem Cells Isolated
Researchers from the Université libre de Bruxelles have isolated the earliest cardiovascular progenitors that arise during the differentiation of pluripotent stem cells. [Press release from ScienceDaily discussing online prepublication in the Journal of Cell Biology]

‘Cross-Talk’ Research May Pave the Way to Understanding and Controlling Chronic Pain
Researchers at the University of California, Davis have discovered a “cross-talk” between two major biological pathways that involve pain — research that may pave the way to new approaches to understanding and controlling chronic pain. [Press release from ScienceDaily discussing online prepublication in the Proceedings of the National Academy of Sciences USA]

An Alzheimer’s Vaccine in a Nasal Spray?
Researchers are working on a nasally-delivered 2-in-1 vaccine that promises to protect against both Alzheimer’s and stroke. The new vaccine repairs vascular damage in the brain by rounding up “troops” from the body’s own immune system. [Press release from ScienceDaily discussing online prepublication in Neurobiology of Aging]

Stem Cells May Provide Treatment for Brain Injuries
Stem cells derived from a patient’s own bone marrow were safely used in pediatric patients with traumatic brain injury, according to results of a Phase I clinical trial. [Press release from The University of Texas Health Science Center at Houston discussing online prepublication in Neurosurgery]

Tiny Gems Take Big Step in Battling Cancer
In studies of liver and breast cancer models in vivo, a multidisciplinary team of scientists, engineers and clinicians found that a normally lethal amount of a chemotherapy drug when bound to nanodiamonds significantly reduced the size of tumors in mice. [Press release from Northwestern University discussing online prepublication in Science Translational Medicine]

Making Viruses Pass for ‘Safe’
Researchers have created a lentiviral vector that expresses CD47, the “marker of self” protein, on its surface. The protein gives cells a free license from macrophages. [Press release from ScienceDaily discussing research presented at the 55th Annual Biophysical Society Meeting]

UC Davis Launches Stem Cell Study to Reduce Amputations from Vascular Disease and Diabetes
The University of California (UC), Davis Vascular Center researchers have embarked on a highly anticipated study that involves using a patient’s own stem cells to increase blood circulation to the lower leg with the hope of preventing amputation due to severe arterial disease or diabetes. [University of California, Davis Health System Press Release]

CURRENT PUBLICATIONS (Ranked by Impact Factor of the Journal)

Hedgehog/Wnt Feedback Supports Regenerative Proliferation of Epithelial Stem Cells in Bladder
Findings provide a conceptual framework for injury-induced epithelial regeneration in endodermal organs, and may provide a basis for understanding the roles of signaling pathways in cancer growth and metastasis. [Nature]

Activation of Multiple Proto-Oncogenic Tyrosine Kinases in Breast Cancer via Loss of the PTPN12 Phosphatase
Data identify PTPN12 as a commonly inactivated tumor suppressor and provide a rationale for combinatorially targeting proto-oncogenic tyrosine kinases in triple-negative breast cancer and other cancers based on their profile of tyrosine-phosphatase activity. [Cell]

Tissue-Engineered Autologous Urethras for Patients Who Need Reconstruction: An Observational Study
Researchers aimed to assess the effectiveness of tissue-engineered urethras using patients’ own cells in patients who needed urethral reconstruction. [Lancet]

The Growth Factor Progranulin Binds to TNF Receptors and Is Therapeutic Against Inflammatory Arthritis in Mice
Findings demonstrate that progranulin is a ligand of tumor necrosis factor receptors (TNFR), an antagonist of TNFα signaling and plays a critical role in the pathogenesis of inflammatory arthritis in mice. They also suggest new potential therapeutic interventions for various TNFα-mediated pathologies and conditions, including rheumatoid arthritis. [Science]

Structure of an Agonist-Bound Human A2A Adenosine Receptor
Researchers report the crystal structure of the A2A adenosine receptor bound to an agonist UK-432097 at 2.7 angstrom resolution. [Science]

p53 Regulates Epithelial-Mesenchymal Transition and Stem Cell Properties Through Modulating miRNAs
Using genomic approaches, researchers show that tumor suppressor p53 has a role in regulating both epithelial-mesenchymal transition (EMT) and EMT-associated stem cell properties through transcriptional activation of the microRNA miR-200c. [Nat Cell Biol]

A Composite MyD88/CD40 Switch Synergistically Activates Mouse and Human Dendritic Cells for Enhanced Antitumor Efficacy
Researchers engineered a drug-inducible, composite activation receptor for dendritic cells comprising the TLR adaptor MyD88, the CD40 cytoplasmic region, and 2 ligand-binding FKBP12 domains. [J Clin Invest]

Functional Identification of Optimized RNAi Triggers Using a Massively Parallel Sensor Assay
The study establishes a powerful tool for large-scale identification of highly potent short hairpin RNAs and provides insights into sequence requirements of effective RNAi. [Mol Cell]

Highly Efficient Capture of Circulating Tumor Cells by Using Nanostructured Silicon Substrates with Integrated Chaotic Micromixers
A new technology is demonstrated to enrich circulating tumor cells with high efficiency by integrating an antibody-coated silicon nanopillar substrate with an overlaid polydimethylsiloxane microfluidic chaotic mixer. [Angew Chem Int Ed]

Defining the Earliest Step of Cardiovascular Progenitor Specification During Embryonic Stem Cell Differentiation
The study identifies the early multipotent cardiovascular progenitors residing at the top of the cellular hierarchy of cardiovascular lineages during embryonic stem cell differentiation. [J Cell Biol]

Self-Renewal Induced Efficiently, Safely, and Effective Therapeutically with One Regulatable Gene in a Human Somatic Progenitor Cell
Precursor/progenitor cells from the organ of therapeutic concern typically lack only one critical attribute – the capacity for sustained self-renewal. Researchers speculated that this could be induced in a regulatable manner such that cells proliferate only in vitro and differentiate in vivo without the need for promoting pluripotence or specifying lineage identity. [Proc Natl Acad Sci U S A]



Senate Approves Patent Reform to End Backlog
The U.S. Senate voted overwhelmingly to overhaul U.S. patent laws, approving a measure aimed at chipping away at a huge backlog of patent applications and offering alternatives to expensive litigation. [Senate, United States]

China Bets Big on Small Grants, Large Facilities
The National Natural Sciences Foundation of China, the country’s main agency for funding competitive, peer-reviewed research grants, will get 12 billion yuan ($1.83 billion) in 2011—a 17% increase over 2010 and twice its budget just 2 years ago. [National Natural Sciences Foundation, China]

Irish Election Raises Questions for Stem Cell Research
Irish scientists have to worry about whether progress will be maintained under Fine Gael, the party that swept to victory and is likely to form a coalition government with the Labour party. But stem cell researchers have most to worry about, since Fine Gael is opposed to research using human embryonic stem cells. [Science Foundation Ireland and Health Research Board, Ireland]



Fibrocell Science, Inc. Accesses Patents from Stanford University on Fibroblast Research to Advance Cell Therapy
Fibrocell Science, Inc. announced that it has entered into a scientific collaboration with University of California, Los Angeles  to research the conversion of dermal fibroblasts into pure functional human cell types that may have greater regenerative capacity. In addition, Fibrocell announces they have accessed key patents from Stanford University to enable the process. [Fibrocell Science, Inc. Press Release]

Epizyme Enters Worldwide Strategic Partnership with Eisai for Cancer Therapeutics Targeting EZH2 Epigenetic Enzyme
Epizyme, Inc. announced a worldwide partnership with Eisai Co., Ltd., Tokyo, Japan to discover, develop and commercialize therapeutics targeting EZH2, an epigenetic enzyme, for the treatment of lymphoma and other cancers in genetically-defined patients. [Epizyme, Inc. Press Release]

Généthon and Wake Forest University School of Medicine (North Carolina) Announce Their Collaboration for a Preclinical Gene Therapy Trial
Généthon and Wake Forest University School of Medicine announced that they are to collaborate on the preclinical development of a gene therapy for myotubular myopathy. [Généthon Press Release]

Yissum and Hadasit License Regenerative Polymeric Membrane Implants to RegeneCure
Yissum Research Development Company Ltd. and Hadasit Medical Research Services & Development Ltd. announced that they have licensed innovative regenerative membrane implant technology to RegeneCure, which will further develop and commercialize the technology for bone tissue engineering for applications in trauma, spine, and reconstructive cranial and facial orthopedics. [BusinessWire]

Liquidia Technologies Receives Significant Equity Investment to Bolster Development of Next Generation Vaccines
Liquidia Technologies announced the Bill & Melinda Gates Foundation has made a $10 million program-related investment in the company to support the development and commercialization of safer and more effective vaccines and therapeutics. [Liquidia Technologies Press Release]

Kite Pharma Raises $15 Million in Initial Round of Financing and Appoints David Bonderman to Board of Directors
Kite Pharma, Inc. announced that it has raised $15 million in an initial round of financing through a private placement with a syndicate of venture and qualified investors. [Business Wire]

ACT Receives Positive Opinion for Orphan Drug Designation from European Medicines Agency for hESC-Derived RPE Cells for Treatment of Stargardt’s Disease
Advanced Cell Technology, Inc. (ACT) announced that the Committee for Orphan Medicinal Products of the European Medicines Agency has announced a positive opinion of ACT’s human embryonic stem cell (hESC)-derived retinal pigment epithelial (RPE) cells for designation as an orphan medicinal product for the treatment of Stargardt’s disease. [Advanced Cell Technology Inc. Press Release]

Biovest Is Awarded Orphan Drug Status for its Personalized Cancer Vaccine for the Treatment of Mantle Cell Lymphoma in European Union
Biovest International, Inc. announced that BiovaxID®, its personalized cancer vaccine, has been designated as an “Orphan Medicinal Product” by the European Medicines Agency for the treatment of mantle cell lymphoma, which is an aggressive form of non-Hodgkin’s lymphoma. [Biovest International Inc. Press Release]

Cytori Patents Method of Making Stem and Regenerative Cell-Enriched Fat Grafts
Cytori received U.S. Patent No. 7,901,672 from the United States Patent and Trademark Office for a method of enriching a patient’s own fat with their own adipose derived stem and regenerative cells to create a cell-enriched fat graft. [Cytori Therapeutics, Inc. Press Release]

co.don AG Is Awarded the U.S.-Patent – Process to Produce Cell Transplants Patented Successfully
The refined method by co.don AG for growing three-dimensional autologous cell transplants is now protected on the U.S. market. [co.don AG Press Release]

New Aid for AIDS – ICAP Ocean Tomo Announces Auction of a Keystone Patent for Cell Therapy Use of Modified Red Blood Cells for Treating Viral Diseases
Developed by inventor Lawrence F. Glaser and represented by ICAP Ocean Tomo, this technology will be auctioned off at ICAP Ocean Tomo’s Spring 2011 Live IP Auction on March 31, 2011 in New York City. [ICAP Ocean Tomo, LLC Press Release]

Athersys Announces Initiation of Patient Enrollment for Phase II Clinical Trial in Inflammatory Bowel Disease
Athersys, Inc. announced the initiation of patient enrollment, and dosing of the first patient for a Phase II clinical trial evaluating the safety and efficacy of administration of MultiStem®, Athersys’ allogeneic cell therapy product for the treatment of ulcerative colitis. [Athersys, Inc. Press Release]

Adaptimmune Announces Launch of U.S. Subsidiary
Adaptimmune Limited announced that it has launched a U.S. subsidiary, Adaptimmune LLC, located in Philadelphia, and appointed Dr Gwen Binder-Scholl as Vice President of Operations of the new company. [Adaptimmune Limited Press Release]

CIRM Extends Support to Shared Labs, Providing $22 Million to a Program That Leverages Grants and Enables Collaboration
The 17 California Institute for Regenerative Medicine (CIRM) Shared Laboratories will continue receiving support to train stem cell scientists and provide research assistance for an additional three years after the state stem cell agency Governing Board voted to extend funding. [California Institute for Regenerative Medicine Press Release]

Case Western Reserve Positions Regenerative Medicine Center for Future Growth
In a move to streamline and accelerate the research and development of new stem cell and regenerative medicine technologies, the National Center for Regenerative Medicine and the Center for Stem Cell and Regenerative Medicine at Case Western Reserve University have been rolled into a single entity housed within the university’s School of Medicine. [Case Western Reserve University Press Release]

Fortis Healthcare Ties Up with TotipotentRX to Set Up Stem Cell Therapy Center
Fortis Healthcare Ltd. and TotipotentRX Cell Therapy Pvt. Ltd. announced a collaboration to set up centers of excellence offering cellular therapies and stem cell clinical trials across select Fortis hospitals. [Fortis Healthcare Limited Press Release]

Scottish Stem Cell Network Launch New Community Website to Help Grow Life Science Industry
The Scottish Stem Cell Network have launched a new member focused website to assist in the networks role of facilitating communication, learning and collaboration amongst the stem cell and regenerative medicine community – one which is anticipated to be worth £40.2 billion worldwide by 2015, tripling its current value. [PR Web]


National Library of Medicine Celebrates 175 Years of Information Innovation
2011 marks the 175th anniversary of the National Library of Medicine (NLM), part of the National Institutes of Health. The world’s largest medical library and the producer of electronic information resources used by millions of people every day, NLM has changed the way scientific and medical information is organized, stored, accessed, and disseminated.

Centers for Education and Research on Therapeutics (CERTs) Scientific Forum (U19) (RFA-HS-11-003)

Centers for Education and Research on Therapeutics (CERTs) ( U19) (RFA-HS-11-004)

The Infant Immune System: Implications for Vaccines and Response to Infections (R01) (RFA-AI-11-010)

Nanoscience and Nanotechnology in Biology and Medicine (R01) (PA-11-148)

Nanoscience and Nanotechnology in Biology and Medicine (R21) (PA-11-149)

Proposed Collection; Comment Request; Process Evaluation of the NIH Roadmap Epigenomics Program (FR Doc. 2011-5786)

Cancer Therapy Evaluation Program Intellectual Property Option to Collaborator (FR Doc. 2011-5609)

Center for Scientific Review; Notice of Closed Meetings (FR Doc. 2011-5354)

Center for Scientific Review; Notice of Closed Meetings (FR Doc. 2011-5509)

Center for Scientific Review; Notice of Closed Meetings (FR Doc. 2011-5607)


April 6-7, 2011: Vaccines and Related Biological Products Advisory Committee Meeting Announcement

April 6-7, 2011: Vaccines and Related Biological Products Advisory Committee Meeting Waivers

Important Safety Information: Risk of Thrombotic Adverse Events with Subcutaneous or Inappropriate Intravenous Use of Vivaglobin (Immune Globulin Subcutaneous)

February 25, 2011: Vaccines and Related Biological Products Advisory Committee Meeting Presentations

March 7, 2011 Approval Letter – DECAVAC



Coalition Briefs Policymakers on FDA’s Role as Republicans Weigh Cuts
A coalition of drug makers and consumer advocates is spreading the word about the Food and Drug Administration’s (FDA) role in the national economy as Republicans weigh sharp cuts to the agency.

Oncologic Drugs Advisory Committee; Notice of Meeting [Docket No. FDA-2011-N-0002]


NEW Cancer Immunotherapy Consortium’s 2011 Scientific Colloquium
March 17-19, 2011
National Harbor, United States

NEW 9th Association for Cancer Immunotherapy (CIMT) Annual Meeting – Targeting Cancer: Road-Maps for Success
May 25-27, 2011
Mainz, Germany

NEW International Society for Hematology and Stem Cells (ISEH) 40th Annual Scientific Meeting
August 25-28, 2011
Vancouver, Canada

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)

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