Cell Therapy News Volume 14.19 | May 20 2013

Zwitterionic Hydrogels Implanted in Mice Resist the Foreign-Body Reaction
The performance of implantable biomedical devices is impeded by the foreign-body reaction, which results in formation of a dense collagenous capsule that blocks mass transport and/or electric communication between the implant and the body. Researchers demonstrated that ultra-low-fouling zwitterionic hydrogels can resist the formation of a capsule for at least three months after subcutaneous implantation in mice. Zwitterionic hydrogels also promote angiogenesis in surrounding tissue, perhaps owing to the presence of macrophages exhibiting phenotypes associated with anti-inflammatory, pro-healing functions. [Nat Biotechnol] Abstract | Press Release

Enhanced-Affinity Murine TCRs for Tumor/Self-Antigens Can Be Safe in Gene Therapy Despite Surpassing the Threshold for Thymic Selection
Investigators showed that two variants of a high affinity WT1-specific TCR with enhanced affinity for WT1 are safe, and do not mediate autoimmune tissue infiltration or damage when transduced into peripheral CD8 T cells and transferred in vivo. [Blood] Abstract

Very Small Embryonic-Like Stem Cells from the Murine Bone Marrow Differentiate into Epithelial Cells of the Lung
Previously, researchers demonstrated that non-hematopoietic bone marrow cells are the primary source of bone marrow (BM) derived lung epithelial cells. Here they tested the hypothesis that very small embryonic like cells (VSELs) are responsible for this engraftment. They directly compared the level of BM derived epithelial cells after transplantation of VSELs, hematopoietic stem/progenitor cells, or other nonhematopoietic cells. [Stem Cells] Abstract

Generation of Engraftable Hematopoietic Stem Cells from Induced Pluripotent Stem Cells by Way of Teratoma Formation
Researchers demonstrated a unique in vivo differentiation system yielding engraftable hematopoietic stem cells (HSCs) from mouse and human induced pluripotent stem cells (iPSCs) in teratoma-bearing animals in combination with a maneuver to facilitate hematopoiesis. In mice, they found that iPSC-derived HSCs migrate from teratomas into the bone marrow and their intravenous injection into irradiated recipients resulted in multilineage and long-term reconstitution of the hematolymphopoietic system in serial transfers. [Mol Ther] Abstract | Press Release

Reversal of Hyperglycemia by Insulin-Secreting Rat Bone Marrow- and Blastocyst-Derived Hypoblast Stem Cell-Like Cells
To generate insulin-secreting cells scientists used two cell sources: rat multipotent adult progenitor cells (rMAPC) and the highly similar rat extra-embryonic endoderm precursor cells isolated under rMAPC conditions from blastocysts (rHypoSC). When rMAPC or rHypoSC differentiated d21 progeny were grafted under the kidney capsule of streptozotocin-induced diabetic nude mice, hyperglycemia reversed after four weeks in 6/10 rMAPC- and 5/10 rHypoSC-transplanted mice. [PLoS One] Full Article

Hypoxic Preconditioning with Cobalt of Bone Marrow Mesenchymal Stem Cells Improves Cell Migration and Enhances Therapy for Treatment of Ischemic Acute Kidney Injury
Scientists tested the potential of hypoxic-preconditioned-mesenchymal stem cell (MSC) transplantation to enhance the efficacy of cell therapy on acute kidney injury by improving MSC migration to the injured kidney. [PLoS One] Full Article

In Vitro Development and Characterization of a Tissue Engineered Conduit Resembling Esophageal Wall Using Human and Pig Skeletal Myoblast, Oral Epithelial Cells and Biologic Scaffolds
In order to create the components necessary to reconstruct an esophageal wall, researchers analyzed the feasibility and the optimal conditions of human and pig skeletal myoblast and porcine oral epithelial cell culture on biologic scaffolds. [Tissue Eng Part A] Abstract

Bone Morphogenetic Protein-5 and Early Endothelial Outgrowth Cells (eEOCs) in Acute Ischemic Kidney Injury (AKI) and 5/6-Chronic Kidney Disease
Investigators analyzed the effects of bone morphogenetic protein-5 treatment in an eEOC-based therapy of murine ischemic AKI and 5/6-neprectomy. [Am J Physiol Renal Physiol] Abstract

Organogenesis Presents Data Demonstrating Apligraf® Speed and Incidence of Wound Closure in Real-World Analysis of Venous Leg Ulcer Patients
Organogenesis Inc. announced key findings demonstrating the speed and incidence of wound closure for venous leg ulcer (VLU) patients who were treated with Apligraf®. Apligraf is a living-cell-based product for the treatment of chronic wounds, and is the only product with FDA approval to treat both VLUs and diabetic foot ulcers. [Press release from PR Newswire Association LLC discussing research presented at the Symposium of Advanced Wound Care Meeting, Denver] Press Release

Sangamo BioSciences Presents Clinical Data Demonstrating HIV Reservoir Reduction in HIV-Infected Subjects Treated with ZFP Therapeutic^®, SB-728-T
Sangamo BioSciences, Inc. announced the presentation of new clinical data from its program to develop a ZFP Therapeutic^® for HIV/AIDS. The data demonstrate that SB-728-T treatment results in a reduction in the HIV reservoir in HIV-infected subjects. [Press release from Sangamo BioSciences, Inc. discussing research presented at the 16^th Annual Meeting of the American Society of Gene and Cell Therapy, Salt Lake City]
Press Release

Presentation of Promising Nonclinical and Phase I Study Results of Ad-RTS-IL-12 in Advanced Melanoma
Researchers announced promising results from nonclinical and Phase I studies in advanced melanoma using Ad-RTS-IL-12, a novel DNA-based therapeutic candidate. [Press release from ZIOPHARM Oncology, Inc. discussing research presented at the 16^th Annual Meeting of the American Society of Gene and Cell Therapy, Salt Lake City] Press Release

Key Pre-Clinical Proof-of-Concept Data for ALN-AS1, an RNAi Therapeutic Targeting Aminolevulinate Synthase-1 (ALAS-1) for the Treatment of Porphyria
Alnylam Pharmaceuticals, Inc. announced that it has presented key pre-clinical proof-of-concept data from its RNAi therapeutic program targeting ALAS-1 for the treatment of porphyria including acute intermittent porphyria. [Press release from Alnylam Pharmaceuticals, Inc. discussing research presented at the International Congress of Porphyrins and Porphyrias, Lucerne] Press Release

Italy May Rein in Rogue Stem-Cell Therapy
A controversial decree allowing severely ill patients to continue treatment with an unproven, and possibly unsafe, stem-cell therapy may be amended, if the Italian parliament’s Chamber of Deputies has its way. The Chamber’s social affairs committee unanimously passed amendments to the decree that would allow the Brescia-based Stamina Foundation, which developed the therapy, to continue administering it. [Chamber of Deputies, Italy] Press Release

Japan to Offer Fast-Track Approval Path for Stem Cell Therapies
A retooling of Japan’s drug authorization framework, on its way to becoming law, could produce the world’s fastest approval process specifically designed for regenerative medicine. [Pharmaceutical and Medical Devices Agency, Japan] Press Release

Australian Budget Spares Research from Further Blow
After deep funding cuts for science announced earlier this year, the Australian research community was relieved to dodge further reductions in the federal budget. [Australian Government, Australia] Press Release

South Africa’s Research Spending Slows Down
A fall in spending on research and development (R&D) in South Africa has raised doubts about the country’s future science performance and its ambitions to move from a resource-based to a knowledge-based economy. A survey published shows that the country spent just under 21 billion rand (US$2.2 billion) on R&D in the 2009-10 fiscal year. That is 86-million rand less than the previous year – the first drop in more than a decade. [Science Minister, South Africa] Press Release

NSF Says No to Congressman’s Request for Reviewer Comments
The National Science Foundation (NSF) rebuffed a request from the chairman of the House of Representatives science committee to obtain reviewer comments on five social science research projects it is funding. The refusal is the latest twist in an increasingly edgy battle between the agency and Republicans in Congress over the agency’s grants-making process and, in particular, its support for the social and behavioral sciences. [National Science Foundation, United States] Press Release

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American CryoStem to Collaborate with Rutgers University on Adipose-Derived Stem Cell Research
American CryoStem Corporation announced that it has entered into Material Transfer Agreements with three leading research scientists at Rutgers, The State University of New Jersey, distinguished as one of the world’s premier universities for stem cell research and training. [American CryoStem Corporation] Press Release

BioRestorative Therapies Signs Agreement with Dexterity, Inc. to Advance Production of the Company’s Novel brtxDISC™ Stem Cell Therapy Device
BioRestorative Therapies, Inc. announced the signing of a consulting agreement with Dexterity, Inc. Dexterity is a product design and bioengineering firm that will provide services to further the development and production of BRT’s proprietary therapeutic delivery device for its intervertebral disc stem cell therapy program, brtxDISC™. [BioRestorative Therapies, Inc.] Press Release

BioTime’s Subsidiary Cell Cure Neurosciences Ltd. Awarded $1.5 Million Grant from Israel’s Office of the Chief Scientist
BioTime, Inc. and its subsidiary Cell Cure Neurosciences Ltd. announced that Cell Cure Neurosciences has been awarded a grant of 5.34 million Shekels, approximately $1.5 million, for 2013 from Israel’s Office of the Chief Scientist to help finance the development of OpRegen^®, a cell-based therapeutic product in development by Cell Cure Neurosciences for the treatment of age-related macular degeneration. [BioTime, Inc.] Press Release

Cardio3 BioSciences Raises €19 Million Through a Private Placement
Cardio3 BioSciences announced that it has increased its equity by €19 million through a private placement with existing investors. The new funds will be used to finance the on-going clinical development of the Company’s lead product, C-Cure^®, currently tested in Europe in a Phase III trial (CHART-1 – Congestive Heart failure Cardiopoietic Regenerative Therapy) and the preclinical development of other product candidates. CHART-1 is the world’s first phase III trial using pre-programmed cardiac progenitor cells and targeting heart failure. [Cardio3 BioSciences] Press Release

BioTime and Subsidiary LifeMap Sciences Announce Release of Enhanced LifeMap BioReagents™ Portal Offering Additional PureStem™ Human Progenitor Cells Including Those for Diabetes Research
BioTime, Inc. and subsidiary, LifeMap Sciences, announced the release of the enhanced LifeMap BioReagents™ portal featuring an improved user interface, product descriptions, and customer support options, as well as the addition of new PureStem™ progenitor cells to the site. [BioTime, Inc.] Press Release

ImmunoCellular Therapeutics Announces Issuance of Key Patent Covering ICT-107 Cancer Vaccine Target
ImmunoCellular Therapeutics, Ltd. announced that the US Patent and Trademark Office has issued a patent covering methods of use of interleukin 13-receptor alpha 2 protein (IL-13Ra2) in cancer immunotherapy. IL-13Ra2 is an important target of ImmunoCellular’s lead product candidate, ICT-107, a dendritic cell vaccine directed against glioblastoma antigens and cancer stem cells, as well as ICT-140, a dendritic cell vaccine to treat ovarian cancer. [ImmunoCellular Therapeutics, Ltd.] Press Release

TAL-Effector Nuclease: Issuance by the USPTO of Two New Patents
Cellectis announced the issuance by the USPTO of two new US patents directed to TAL-effector nucleases. The technology provides to researchers tools and comprehensive solutions to edit genes efficiently in all cell types. [Cellectis] Press Release

NeoStem Announces Geographic Expansion of Intellectual Property Coverage of Cardiovascular Asset AMR-001
NeoStem, Inc. announced the geographic expansion of intellectual property protection around its lead product candidate, AMR-001, with the notice of patent grant in Malaysia and notice of recommendation for patent allowance in the Philippines. These patents are in the family of U.S. patent number 7,794,705 titled “Compositions and Methods of Vascular Injury Repair” and protect a chemotactic stem cell product enriched for CD34+ cells that treats injury from acute myocardial infarction. [NeoStem, Inc.] Press Release

Dr. Patrick Stiff Named Chair of SWOG Bone Marrow and Stem Cell Transplantation Committee
Dr. Patrick Stiff of Loyola University Medical Center has been named chairman of a nationwide committee of cancer researchers who design and conduct clinical trials involving bone marrow and stem cell transplants. The committee includes 86 investigators from many of the nation’s top cancer centers. [Loyola University Chicago Health Sciences Division] Press Release

Summary of Significant Changes to the Standards for Cellular Therapy Services, 6th Edition
A summary of changes to the Standards for Cellular Therapy Services, 6th edition is now available.  The summary details the edits made to the 6th edition. [AABB] Press Release

Fact Sheet: Impact of Sequestration on the National Institutes of Health
On March 1, 2013, as required by statute, President Obama signed an order initiating sequestration. The sequestration requires the National Institutes of Health (NIH) to cut 5 percent or $1.55 billion of its fiscal year 2013 budget. NIH must apply the cut evenly across all programs, projects, and activities, which are primarily NIH institutes and centers. This means every area of medical research will be affected. Press Release

National Cancer Institute; Notice of Closed Meetings (FR Doc No: 2013-13371)

Center for Scientific Review; Notice of Closed Meetings (FR Doc No: 2013-13618)

Food and Drug Administration (United States)

Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Bar Code Label Requirement for Human Drug and Biological Products (FR Doc No: 2013-11630)

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