Volume 12.30 | Aug 1

Cell Therapy News 12.30, August 1, 2011
     In this issue: Science | Policy | Business | NIH | CBER | Regulatory | Events
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TOP STORY
A Combined Cell Therapy and In-Situ Tissue-Engineering Approach for Myocardial Repair
Scientists tested the hypothesis that a combined delivery of cardiomyocytes with an in-situ polymerizable hydrogel into a post-MI rat heart will result in better functional outcomes than each intervention alone. [Biomaterials]

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SCIENCE NEWS

Scientist Converts Human Skin Cells into Functional Brain Cells
A scientist has discovered a novel way to convert human skin cells into brain cells, advancing medicine and human health by offering new hope for regenerative medicine and personalized drug discovery and development. [Press release from Gladstone Institute discussing online prepublication in Cell Stem Cell]

Insect Virus Holds the Key to Safer Stem Cell Therapy
Using an insect virus, a team of researchers successfully inserted a therapeutic gene into a safe site in the DNA of human embryonic stem cells without compromising the functionality of the engineered cells. [Press release from the Institute of Bioengineering and Nanotechnology discussing online prepublication in Nucleic Acids Research]

New Promising Data in the Phase I/II Clinical Trial in Lupus Patients: Data from the Last Cohort of Patients (240 mcg) Confirm the Safety, Immunogenicity and Pharmacodynamic of IFN-K
Neovacs® published the data of the last cohort of patients in a Phase I/II study with IFNα-Kinoid (IFN-K) in Lupus patients. [Neovacs® Press Release]

Scientists Design Nano-Sized Drug Transporter to Fight Disease
Scientists seeking to improve cancer treatments have created a tiny drug transporter that maximizes its ability to silence damaging genes by finding the equivalent of an expressway into a target cell. [The Ohio State University Press Release]

Cleveland Area Brain Cancer Patients Now Testing Revolutionary Personalized Immune Therapy For Cancer
A ground-breaking new treatment in late-stage clinical trials is giving Cleveland area patients new hope in their battle against one of the most lethal forms of cancer: glioblastoma multiforme brain cancer. [Medical News Today]

Cryo-Save Group NV: Girl with Cerebral Palsy Treated with Own Cord Blood Stem Cells
Cryo-Save Group N.V. released a cord blood sample of a six-year-old girl from Portugal. The girl will be treated with her own umbilical cord blood stem cells at Duke University for cerebral palsy. [Cryo-Save Group N.V. Press Release]

Stem Cell Treatment ‘Could Prevent MS Brain Damage’
A major new global clinical trial will test whether stem cells can be safely used to treat multiple sclerosis (MS), it was announced. It will investigate if cells can slow, stop and even reverse damage to the brain and spinal cord caused by active multiple sclerosis lesions. [The Telegraph]

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CURRENT PUBLICATIONS
(Ranked by Impact Factor of the Journal)

Autologous Non-Myeloablative Hematopoietic Stem-Cell Transplantation Compared with Pulse Cyclophosphamide Once Per Month for Systemic Sclerosis (ASSIST): An Open-Label, Randomized Phase II Trial
Scientists aimed to assess safety and efficacy of autologous non-myeloablative hematopoietic stem-cell transplantation in a Phase II trial compared with the standard of care, cyclophosphamide. [Lancet]

Direct Reprogramming of Adult Human Fibroblasts to Functional Neurons Under Defined Conditions
Here researchers show that a combination of a microRNA (miR-124) and two transcription factors (MYT1L and BRN2) is sufficient to directly reprogram postnatal and adult human primary dermal fibroblasts to functional neurons under precisely defined conditions. [Cell Stem Cell]

Redirected Tumor-Specific Allogeneic T Cells for Universal Treatment of Cancer
Investigators present a novel approach for adoptive immunotherapy using fully MHC-mismatched allogeneic T cells redirected with tumor-specific, non-MHC–restricted antibody-based chimeric antigen receptor in the absence of GVHD. [Blood]

Efficient Derivation of NPCs, Spinal Motor Neurons and Midbrain Dopaminergic Neurons from hESCs at 3% Oxygen
This protocol has been designed to generate neural precursor cells (NPCs) from human embryonic stem cells (hESCs) using a physiological oxygen level of 3% (previously termed hypoxia) and chemically defined conditions. [Nat Protoc]

Efficient Recombinase-Mediated Cassette Exchange at the AAVS1 Locus in Human Embryonic Stem Cells Using Baculoviral Vectors
Here, scientists employed homologous recombination in human embryonic stem cells to introduce heterospecific loxP sites into the AAVS1 locus, a site with an open chromatin structure that allows averting transgene silencing phenomena. [Nucleic Acids Res]

The Development of a Novel Cancer Immunotherapeutic Platform Using Tumor-Targeting Mesenchymal Stem Cells and a Protein Vaccine
Researchers established a platform, consisting of an antigen-delivering vehicle and a protein vaccine, for developing an immunotherapeutic approach with the potential for eliminating various cancer types. [Mol Ther]

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POLICY

Federal Judge Dismisses Stem Cell Suit Against NIH
In a surprise decision, a federal judge ruled in favor of the National Institutes of Health (NIH) in a court battle over the legality of human embryonic stem cell research. [U.S. District Court, United States]

Researchers Question NSF’s Changes to Merit Review Criteria
At a congressional hearing, a university leader added to concerns from the scientific community that the draft changes proposed in June by the National Science Board (NSB) confuse further, rather than clarify, the National Science Foundation’s (NSF’s) so-called Criterion Two. [National Science Board, United States]

Report on Regenerative Medicine by the Office for Life Sciences/Department of Health Published
The Office for Life Sciences and the Department of Health published a report into the regenerative medicine field on 18 July 2011. [Office for Life Sciences, United Kingdom]

U.K. Panel: Primate Research Is Justified, But Don’t Overstate Its Benefits
Most research using monkeys, baboons, and other nonhuman primates in the United Kingdom produces results that justify the animal welfare costs, according to a comprehensive review made public. [Medical Research Council, United Kingdom]

U.K. Parliament Panel Reviews Peer Review
Following an inquiry into peer review in scientific research, U.K. parliamentarians have concluded that, despite many criticisms and little evidence of its effectiveness, the traditional practice of having research articles evaluated by anonymous colleagues before publication is valued by the community and shouldn’t be completely abandoned. [U.K. Parliament Panel, United Kingdom]


BUSINESS

Caltech, Zcube Collaboration Will Bring Painless Transdermal Drug Delivery to Patients
Zcube Srl and the California Institute of Technology (Caltech) have signed an exclusive research and option agreement to develop and commercialize skin patches that contain embedded carbon nanotubes for delivering drugs. [California Institute of Technology Press Release]

Penn Receives $10 Million to Create Center for Orphan Disease Research and Therapy
The Raymond and Ruth Perelman School of Medicine at the University of Pennsylvania announces the launching of a first-of-its-kind interdisciplinary center focused on discovering novel treatments for orphan diseases. [Penn Medicine Press Release]

NSERC Invests $42 Million in U of T Research
The Government of Canada and the Natural Sciences and Engineering Council of Canada gave the University of Toronto (U of T) research a huge boost July 27 when it announced $42 million in investment to 158 U of T faculty members, as well as graduate, postgraduate and postdoctoral students. [University of Toronto Press Release]

West Penn Allegheny Health System Scientists Explore Novel Approach to Gene Therapy for Sjögren’s Syndrome
Scientists at West Penn Allegheny Health System’s Allegheny Singer Research Institute have been awarded a grant from the Sjögren’s Syndrome Foundation to investigate an innovative technique for delivering gene drugs to the salivary glands to potentially block the development and progression of Sjögren’s syndrome. [West Penn Allegheny Health System Press Release]

Adaptimmune Announces Opening of Pilot Clinical Trial in Synovial Sarcoma
Adaptimmune announced that it has opened a pilot, open‐label clinical trial in synovial sarcoma at the National Cancer Institute testing its enhanced T cell receptor T cell therapy. [Adaptimmune Ltd. Press Release]

Histogenics Reports Positive Phase II Data for NeoCart Autologous Cartilage Tissue Implant for the Treatment of Knee Cartilage Injury
Histogenics Corporation announced the presentation of positive Phase II data for the NeoCart Autologous Cartilage Tissue Implant. [BusinessWire]


NIH

Center for Scientific Review; Notice of Closed Meetings (FR Doc No: 2011-18894)

National Institute of General Medical Sciences; Notice of Closed Meeting (FR Doc No: 2011-18898)

National Institute of General Medical Sciences; Notice of Closed Meeting (FR Doc No: 2011-18901)

Request for Comments Under the Paperwork Reduction Act, Section 3506 (FR Doc No: 2011-18970)

Agency Information Collection Activities: Proposed Collection; Comment Request; Generic Clearance for the Collection of Qualitative Feedback on Agency Service Delivery: National Cancer Center (NCI) (FR Doc No: 2011-19027)


CBER

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

August 2-3, 2011 Blood Products Advisory Committee Meeting Draft Agenda

August 2-3, 2011 Blood Products Advisory Committee Meeting Issue Summary


REGULATORY

FOOD AND DRUG ADMINISTRATION (United States)

Human Subjects Research Protections: Enhancing Protections for Research Subjects and Reducing Burden, Delay, and Ambiguity for Investigators [FR Doc No: 2011-18792]


Agency Information Collection Activities; Proposed Collection; Comment Request; Current Good Manufacturing Practices and Related Regulations for Blood and Blood Components; and Requirements for Donor Testing, Donor Notification, and “Lookback” [FR Doc No: 2011-19040]

EUROPEAN MEDICINES AGENCY (European Union)

Expressions of Interest Invited for Workshop on Ethics of Clinical Trials in Children

MEDICINES AND HEALTHCARE REGULATORY AGENCY (United Kingdom)

Medicines Act 1968 Advisory Bodies Annual Report 2010

THERAPEUTIC GOODS ADMINISTRATION (Australia)

Proposed Standards for Human Blood and Blood Components, Human Tissues and Human Cellular Therapy Products


EVENTS

NEW 4th Annual Biorepositories Event
September 19-21, 2011
Boston, United States

NEW Clinical Business Expo
September 19-21, 2011
Boston, United States

NEW 7th Annual Cell Based Assays and Bioanalytical Method Development
October 3-5, 2011
Berkeley, United States

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


JOB OPPORTUNITIES

Lab Technologist – Tissue Culture (STEMCELL Technologies)

Research and Development Technologist, hPSC Media (STEMCELL Technologies)

Scientist (iPSC) (STEMCELL Technologies)

Post-Doctoral Scientists (North Carolina Central University)

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)

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