Volume 12.27 | Jul 11

Cell Therapy News 12.27, July 11, 2011
     In this issue: Science | Policy | Business | NIH | CBER | Regulatory | Events
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First Successful Transplantation of a Synthetic Tissue Engineered Windpipe
For the first time in history, a patient has been given a new trachea made from a synthetic scaffold seeded with his own stem cells. [Karolinska University Hospital Press Release]


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Gene Therapy Stimulates Protein that Blocks Immune Attack and Prevents Type 1 Diabetes in Mice
Increasing a specific protein in areas of the pancreas that produce insulin blocks the immune attack that causes type 1 diabetes, researchers reported. [Press release from Child & Family Research Institute discussing online prepublication in the Journal of Clinical Investigation]

Stem Cell Therapy for Heart Disease Reduces Chest Pain, Increases Exercise Tolerance
New research found that injections of adult patients’ own CD34+ stem cells reduced reports of angina episodes and improved exercise tolerance time in patients with chronic, severe refractory angina. [Press release from Northwestern Memorial Hospital discussing online prepublication in Circulation Research]

A Change of Heart: Researchers Reprogram Brain Cells to Become Heart Cells
Researchers demonstrate the direct conversion of a non-heart cell type into a heart cell by RNA transfer. [Press release from Penn Medicine discussing online prepublication in the Proceedings of the National Academy of Sciences, United States]
New RA B-Cell Drug Flops in Early Studies
The investigational B-cell inhibitor atacicept failed to show clinical efficacy for rheumatoid arthritis (RA) in a pair of international phase II trials, researchers reported. [Press release from MedPage Today discussing online prepublication in Arthritis & Rheumatism]

Researchers Engineer Functioning Small Intestine in Laboratory Experiments
Researchers have successfully created a tissue-engineered small intestine in mice that replicates the intestinal structures of natural intestine. [Press release from Children’s Hospital Los Angeles discussing online prepublication in Tissue Engineering Part A]

One-Pot Shot: Unique Gel Capsule Structure Enables Co-Delivery of Different Types of Drugs
Researchers have designed a multiple-compartment gel capsule that could be used to simultaneously deliver drugs of different types. [Press release from Georgia Tech discussing online prepublication in Macromolecular Rapid Communications]

Inovio Pharmaceuticals Synthetic DNA Vaccine Protects Against HIV in Non-Human Primates
Inovio Pharmaceuticals, Inc. announced that novel data from a preclinical study of its SynCon™ DNA vaccine against HIV were published in two separate scientific journals. [Press release from Inovio Pharmaceuticals, Inc. discussing online prepublications in Vaccine and PLoS One]


(Ranked by Impact Factor of the Journal)
Prevention of Murine Autoimmune Diabetes by CCL22-Mediated Treg Recruitment to the Pancreatic Islets
Researchers demonstrate that production of CCL22 in islets after intrapancreatic duct injection of double-stranded adeno-associated virus encoding CCL22 recruits endogenous Tregs to the islets and confers long-term protection from autoimmune diabetes in NOD mice. [J Clin Invest]

Intramyocardial, Autologous CD34+ Cell Therapy for Refractory Angina
The objective of this study is to evaluate the safety and bioactivity of intramyocardial injections of autologous CD34+ cells in patients with refractory angina who have exhausted all other treatment options. [Circ Res]

Transcriptome Transfer Provides a Model for Understanding the Phenotype of Cardiomyocytes
Investigators show that the transfer of the adult ventricular myocyte transcriptome into either a fibroblast or an astrocyte converts the host cell into a cardiomyocyte. [Proc Natl Acad Sci U S A]

A Novel Nested Liposome Drug Delivery Vehicle Capable of Ultrasound Triggered Release of Its Payload
Scientists demonstrate a unique ultrasound triggered vehicle design and fabrication method where the payload and a perfluorocarbon gas microbubble are both encapsulated within the internal aqueous space of a liposome. [J Control Release]

A Multicellular Approach Forms a Significant Amount of Tissue-Engineered Small Intestine in the Mouse
Tissue-engineered small intestine (TESI) has successfully been used to rescue Lewis rats after massive small bowel resection. In this study, researchers transitioned the technique to a mouse model, allowing investigation of the processes involved during TESI formation through the transgenic tools available in this species. [Tissue Eng Part A]

One-Pot Synthesis of Microcapsules with Nanoscale Inclusions
This one-pot synthetic approach resulted in core/shell microgels at high temperature wherein only the shell component contained stable, covalent cross-links between chains. [Macromol Rapid Commun]



Wolf Says No-Growth Budget Is Good News for NSF—and Lobbyists Agree
Instead of gnashing their teeth over the panel’s failure to back President Barack Obama’s request for a $907-million increase (13%), science lobbyists say they’re thrilled that legislators had “spared” the National Science Foundation (NSF) from the cuts made to other agencies in the $50-billion bill that funds NASA and science programs within the Department of Commerce as well as other federal agencies. [National Science Foundation, United States]

Federal Court Raises the Bar for Overturning Patents
A US federal appeals court ruling will make it harder for patent holders to lose their intellectual property protection because of charges that they engaged in misconduct by misleading or deceiving the patent office. [U.S. Federal Appeals Court, United States]

Europe Lines Up Hefty Science-Funding Hike
Under a proposal released by the European Commission, spending on research and innovation would rise by about 45%, from €55 billion (US$80 billion) over the current 2007–13 period to €80 billion in 2014–20. [European Commission, European Union]

Greek Crisis Spurs Research Reforms
The Greek government agreed to implement further austerity measures in order to get another international bail-out for its crippled economy. [Greek Government, Greece]

South Korea Back in Stem Cell Spotlight with New Treatment
More than five years after South Korea’s scientific reputation was shattered by a cloning research scandal, the country has approved stem cell medication in the form of a treatment for heart attack victims for the world’s first clinical use. [Korea Food and Drug Administration, Korea]

Independent Committee Recommendations – No Change for Australian Stem Cell Science
The Australian Government tabled the Report of the Independent Review by the committee which reviewed the legislation governing the use of human embryos in Australian research. [Australian Parliament, Australia]

Sudan Splits and Science Community Divides
As South Sudan prepares to become Africa’s newest nation, plans to build an independent higher education system are in disarray. [South Sudan Ministry of Higher Education, Science and Technology, Sudan]



Ulster Joins International Alliance on Tissue Engineering Research
Scientists at the University of Ulster have joined a new international scientific alliance, working on the regeneration of human tissue and the growth of vital organs. [University of Ulster Press Release]

Medical College of Wisconsin and Cellular Dynamics Awarded NHLBI Grant Using Human Induced Pluripotent Stem Cells
The Medical College of Wisconsin and Cellular Dynamics International announced receipt of a research grant award from the National Heart, Lung, and Blood Institute (NHLBI) to investigate the mechanisms underlying Left Ventricular Hypertrophy. [Cellular Dynamics International Press Release]

Researchers Receive Grants from NCCN Oncology Research Program Funded Through Pfizer
The National Comprehensive Cancer Network (NCCN) Oncology Research Program received $2.1 million in research funding from Pfizer, Inc. to support research at NCCN Member Institutions in order to gain further insight into the use of axitinib in various tumor types. [National Comprehensive Cancer Network Press Release]

Preventing the Spread of HIV
Professor Vincent has been awarded almost a million dollars by the Bill & Melinda Gates Foundation to examine how key immune cells in the skin can be targeted to cause the immune system to produce antibodies against infection. [Cardiff University Press Release]

Supercharging Research Towards Effective Cancer Treatment
Australian researchers aim to use a newly-funded collaboration to develop a new generation of cancer treatment, “supercharging” antibodies with a drug delivery vehicle for targeting tumors. [The University of Queensland Press Release]

NIH Funds New Research Toward an HIV Cure
Three research teams focused on developing strategies that could help to rid the body of HIV are receiving grants totaling more than $14 million a year, for up to five years, the National Institute of Allergy and Infectious Diseases of the National Institutes of Health (NIH) announced. [National Institute of Allergy and Infectious Diseases Press Release]

Mesoblast Receives FDA Clearance for Phase III Bone Marrow Transplant Trial
Mesoblast Limited announced that it has received clearance from the United States Food and Drug Administration (FDA) to begin a Phase III clinical trial for bone marrow regeneration in patients with blood cancers. [Mesoblast Limited Press Release]

SpinalCyte, LLC Receives U.S. Patent for Spinal Disc Tissue Engineering
SpinalCyte, LLC announced the U.S. Patent Office issued Patent #7,850,983 “Methods and Compositions for Repair of Cartilage Using An In Vivo Bioreactor” to regrow the spinal disc, using human dermal fibroblasts. [Business Wire]

Scancell Develops New Vaccine for the Treatment of Lung Cancer
Scancell Holdings Plc, announced that a treatment utilizing a DNA vaccine based on its ImmunoBody® technology, in combination with Homspera®, an adjuvant developed by ImmuneRegen BioSciences, Inc.® has produced encouraging anti-tumor results in animal models. [Scancell Holdings Plc Press Release]

RegenoCELL Announces That Patients Can Be Treated with Its Autologous Stem Cell Therapy in Greece
RegenoCELL Therapeutics, Inc. announced the opening of another state of the art facility in Greece for patients to be treated for congestive heart failure and peripheral artery disease with its autologous stem cell therapy. [RegenoCELL Therapeutics, Inc. Press Release]

Charité Establishes NanoTherm® Therapy for the Treatment of Recurrent Brain Tumors
Charité – Universitätsmedizin Berlin has established a new treatment at the Clinic for Radiooncology, Campus Virchow, which offers selected patients a nanomedicine approach for the treatment of recurrent brain tumors. [Charité – Universitätsmedizin Berlin Press Release]

Celldex Expands Senior Management Team with Appointment of Dr. Ronald A. Pepin, Senior Vice President and Chief Business Officer
Celldex Therapeutics, Inc. announced the appointment of Ronald A. Pepin, Ph.D. to Senior Vice President and Chief Business Officer, effective immediately. [Celldex Therapeutics, Inc. Press Release]


Center For Scientific Review; Notice of Closed Meeting (FR Doc No: 2011-17367)

Center For Scientific Review; Notice of Closed Meetings (FR Doc No: 2011-17371)

Government-Owned Inventions; Availability for Licensing (FR Doc No: 2011-17227)

Government-Owned Inventions; Availability for Licensing (FR Doc No: 2011-17228)

National Cancer Institute Notice of Meeting (FR Doc No: 2011-17075)

National Center for Research Resources; Notice of Closed Meetings (FR Doc No: 2011-17214)

Request for Nominations for Members To Serve on National Institute of Standards and Technology Federal Advisory Committees (FR Doc No: 2011-16925)


August 2-3, 2011: Blood Products Advisory Committee Meeting Announcement

August 2-3, 2011: Blood Products Advisory Committee Meeting Waivers for Conflicts of Interest



FDA Proposes New Policy for Some Diagnostic and Radiology Devices
The U.S. Food and Drug Administration issued a draft guidance describing its intent to exercise enforcement discretion with respect to the premarket notification requirements for certain in vitro diagnostic and radiology devices with well-established safety and effectiveness profiles.

Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Applications for Food and Drug Administration Approval to Market a New Drug; Postmarketing Reports; Reporting Information About Authorized Generic Drugs [Docket No. FDA-2011-N-0237]

Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Exports: Notification and Recordkeeping Requirements [Docket No. FDA-2010-N-0595]

Joint Meeting of the Advisory Committee for Reproductive Health Drugs and the Drug Safety and Risk Management Advisory Committee; Notice of Meeting [FR Doc No: 2011-17271]


European Medicines Agency Plans Public Access to Information On Side Effects
The European Medicines Agency has published its plans for granting public access to the information held in its databases of the potential side effects of human and veterinary medicines.


Information Sent to Healthcare Professionals in June About the Safety of Medicines
Copies of letters sent to healthcare professionals in June 2011 to inform of new safety information and advice.

Drug Safety Update: July 2011 (Volume 4, Issue 12)


The TGA and the USA FDA Agree About Problems at CSL Biotherapies
The TGA wishes to clarify some aspects of this action and what it means for public safety.

Low Value Turnover Application Forms
Updated forms to apply for an exemption from payment of annual charges on the basis that the turnover for an existing or new product is less than the applicable threshold

Scheduling News
Updates and news about scheduling medicines and poisons

Overview of the Regulatory framework for In-Vitro Diagnostic Medical Devices
Provides an overview of how in vitro diagnostic medical devices are regulated in Australia

Orphan Drugs
Added ovine anti-colchicine polyclonal antibody fragments to the list of designated orphan drugs


NEW Advanced Cre-lox and Other Recombination/Conditional Systems
July 21, 2011

Visit 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)

Postdoctoral Position (Nanyang Technological University)

Medical Officer (California Institute for Regenerative Medicine)

Postdoctoral Position (University of California, Davis)

Director, Cell Processing Operations (Hospira Industry)

PhD Scholarship (Tasmania University)

Postdoctoral Fellow (Roswell Park Cancer Institute)

Industrial Postdoctoral Research Fellow (Regenerative Medicine Cell Therapy) (Tissue Regeneration Therapeutics Inc.)

Research Laboratory Technician (Cambridge Centre for Brain Repair)

Postdoctoral Research Fellow (Tshwane University of Technology)

Senior Research Fellowship (Masaryk University)

Junior Research Fellowship (Masaryk University)

Reintegrating/Czech Nationality/ Research Fellowship (Masaryk University)

Microscopy and Image Analysis Specialist (Masaryk University)

PhD Positions in Stem Cell Research (Masaryk University)

PhD Positions in Medical Biology (Masaryk University)

Postdoctoral Fellow – Stem Cell Biology and Immunology (NIH Center for Biomedical Research Excellence)

Graduate Student – Laboratory for Equine and Comparative Orthopedic Research (Louisiana State University)

Postdoctoral Fellow (University of California, Los Angeles)

Postdoctoral Positions in Immune Cell Activation (Institut de Recherches Cliniques de Montréal)

Postdoctoral Position in Developmental Neurobiology (Institut de Recherches Cliniques de Montréal)

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