Volume 15.14 | Apr 14

Issue 15.14 April 14, 2014
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Publications | Reviews | Science | Policy | Business | NIH | CBER | Regulatory | Events | Jobs
 
TOP STORY
Laboratory-Grown Vaginas Implanted in Patients, Scientists Report
Researchers describe long-term success in four teenage girls who received vaginal organs that were engineered with their own cells. The girls in the study were born with Mayer-Rokitansky-Küster-Hauser syndrome, a rare genetic condition in which the vagina and uterus are underdeveloped or absent. [Press release from Wake Forest Baptist Medical Center discussing online prepublication in The Lancet] Press Release | Abstract
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PUBLICATIONS (Ranked by impact factor of the journal)
Engineered Autologous Cartilage Tissue for Nasal Reconstruction after Tumor Resection: An Observational First-in-Human Trial
Autologous native cartilage from the nasal septum, ear, or rib is the standard material for surgical reconstruction of the nasal alar lobule after two-layer excision of non-melanoma skin cancer. Investigators assessed whether engineered autologous cartilage grafts allow safe and functional alar lobule restoration. [Lancet]
Abstract | Press Release

Wnt7a Stimulates Myogenic Stem Cell Motility and Engraftment Resulting in Improved Muscle Strength
Investigators observed that a short Wnt7a treatment markedly stimulated tissue dispersal and engraftment, leading to significantly improved muscle function. Moreover, myofibers at distal sites that fused with Wnt7a-treated cells were hypertrophic, suggesting that the transplanted cells deliver activated Wnt7a/Fzd7 signaling complexes to recipient myofibers. [J Cell Biol] Abstract

Utility of an Immunotherapy Trial in Evaluating Patients with Presumed Autoimmune Epilepsy
Investigators evaluated a trial of immunotherapy as an aid to diagnosis in suspected autoimmune epilepsy. Eighteen patients responded, of whom 10 became seizure-free; 52% improved with the first agent. [Neurology]
Abstract | Press Release

In Vivo Osteogenic Differentiation of Human Turbinate Mesenchymal Stem Cells in an Injectable In Situ-Forming Hydrogel
To examine osteogenic differentiation of human turbinate mesenchymal stromal cells (hTMSCs) in vivo in an injectable hydrogel, cells were incorporated into a methoxy polyethylene glycol-polycaprolactone block copolymer (MP) solution simply by mixing. hTMSC-loaded MP solutions formed a hydrogel almost immediately upon injection into animals and the cells remained viable, even after 12 weeks. [Biomaterials] Abstract

Regeneration of the Aged Thymus by a Single Transcription Factor
Scientists showed that forced, thymic epithelial cell-specific upregulation of Forkhead box N1 in the fully involuted thymus of aged mice results in robust thymus regeneration characterized by increased thymopoiesis and increased naive T cell output. [Development] Full Article | Press Release

Amniotic Mesenchymal Stem Cells Display Neurovascular Tropism and Aid in the Recovery of Injured Peripheral Nerves
Researchers determined whether local injection of amniotic membrane-derived mesenchymal stem cells (AMMs) ameliorates peripheral neuropathy. AMMs were transplanted into injured sciatic nerves. AMM injection promoted significant recovery of motor nerve conduction velocity and voltage amplitude compared to human adipose-derived mesenchymal stem cells. [J Cell Mol Med] Full Article

Adipose-Derived Regenerative Cells in Patients with Ischemic Cardiomyopathy: The PRECISE Trial
Researchers performed the first randomized, placebo-controlled, double-blind trial to examine the safety and feasibility of the transendocardial injections of adipose-derived regenerative cells in no-option patients with ischemic cardiomyopathy. [Am Heart J] Abstract | Press Release

Endothelial Cells Enhance the In Vivo Bone-Forming Ability of Osteogenic Cell Sheets
Monoculture osteogenic cell sheets (CSs) were stacked on top of homotypic or heterotypic CSs, and subcutaneously implanted in the dorsal flap of nude mice for seven days. The implants showed mineralized tissue formation under both conditions. [Lab Invest] Abstract

Impact of Cotransplantation of Mesenchymal Stem Cells on Lung Function after Unrelated Allogeneic Hematopoietic Stem Cell Transplantation Following Non-Myeloablative Conditioning
Investigators prospectively followed 30 patients who underwent unrelated hematopoietic stem cell transplantation (HSCT) with mesenchymal stem cell co-infusion after non-myeloablative conditioning. Each patient underwent detailed lung function testing and measurement of exhaled nitric oxide before HSCT and 3, 6, and 12 months posttransplant. [Transplantation] Abstract

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REVIEWS
Growing Tissues in Real and Simulated Microgravity: New Methods for Tissue Engineering
This review highlights the advances and accomplishments in the field of tissue engineering that could be achieved by culturing cells in space or by devices created to simulate microgravity on Earth. Understanding the biology of three-dimensional multicellular structures is very important for a more complete appreciation of in vivo tissue function and advancing in vitro tissue engineering efforts. [Tissue Eng Part B Rev] Abstract

Visit our reviews page to see a complete list of reviews in the cell, gene and immunotherapy research field.

Webinar: Modeling Human Neurological Disease with iPS Cells
 
SCIENCE NEWS
Transplantation Cell Therapy Offers Hope to Stroke Patients
In the first North American trial of its kind, researchers conducted intraparenchymal transplantation of bone marrow-derived cell therapy in chronic stroke patients. The study tested the feasibility of administering escalated doses of stromal cells. [Press release from Newswise, Inc. discussing research presented at the 82nd Annual Scientific Meeting of the American Association of Neurological Surgeons (AANS), San Francisco] Press Release | Abstract

New Immunotherapy IMCgp100 Shows Early Promise in Advanced Melanoma Patients
A new type of immunotherapy that directs patients’ immune responses toward tumor cell killing, IMCgp100, was well tolerated and showed efficacy in some patients with advanced melanoma in a Phase I clinical trial. [Press release from the American Association for Cancer Research (AACR) discussing research presented at the AACR Annual Meeting 2014, San Diego] Press Release

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POLICY
White House Budget Director to Lead Health and Human Services
President Barack Obama nominated Sylvia Mathews Burwell, director of the White House budget office, to replace Kathleen Sebelius as secretary of the Department of Health and Human Services. [ScienceInsider] Editorial

Former NIH Stem-Cell Chief Joins New York Foundation
Stem-cell biologist Mahendra Rao, who resigned last week as director of the Center for Regenerative Medicine at the US National Institutes of Health (NIH), has a new job. He was appointed vice-president for regenerative medicine at the New York Stem Cell Foundation, a non-profit organization that funds embryonic stem-cell research. [Nature News] Editorial

Acid-Bath Stem Cell Scientist Apologizes and Appeals
Haruko Obokata, the Japanese scientist at the center of a controversy over studies purporting to turn mature cells to stem cells simply by bathing them in acid or subjecting them to mechanical stress, apologized for her errors in the work. [Nature News] Editorial

Pro-Life Citizens’ Initiative Worries E.U. Scientists
A group of European pro-life organizations are mobilizing against embryonic stem cell research in a way that the European Commission cannot ignore. One of Us, a so-called European citizens’ initiative, has collected 1.7 million signatures from all 28 E.U. member states for a proposal that would block funding for research in which embryos are destroyed; under E.U. rules, the European Commission must now consider turning the proposal into legislation. [ScienceInsider] Editorial

London Mayor Seeks to Form Biomedical ‘Golden Triangle’
London’s mayor, Boris Johnson, unveiled an initiative that aims to attract commercial investment to the bioscience research powerhouses of London, Oxford, and Cambridge. Johnson hopes that his plan – dubbed MedCity – will forge a “golden triangle” of research collaborations between the three cities, bring in venture capital financing for spinout companies, and encourage major pharmaceutical companies to establish bases in the region. [ScienceInsider] Editorial
 
BUSINESS
MD Anderson Announces Immunotherapy Collaboration with GSK
The University of Texas MD Anderson Cancer Center announced it formed a research alliance with GlaxoSmithKline (GSK) to strengthen its efforts in advancing therapies that train the body’s immune system to combat cancer. [The University of Texas MD Anderson Cancer Center] Press Release

Regeneus Partners with US Specialist Manufacturer for Its Canine Cancer Immunotherapy
Regeneus announced that it has partnered with US specialist veterinary vaccine manufacturer, Hennessy Research, for the production of Regeneus’ new autologous canine cancer immunotherapy, Kvax. [Regeneus Ltd] Press Release

Bezos Family Donates $20 Million to Fred Hutch to Develop Therapies that ‘Melt’ Cancer
Fred Hutchinson Cancer Research Center scientists striving for new cancer cures – and the patients who stand to benefit from them – got an enormous boost when the Bezos family committed $20 million to support the development of novel cancer immunotherapies. It is the largest single contribution in Fred Hutch’s history. [Fred Hutchinson Cancer Research Center] Press Release

Clinical Trial Uses Gene Therapy to Target Mutations in Mitochondrial Genes
Researchers have pioneered a gene therapy approach for Leber Hereditary Optic Neuropathy, an inherited genetic disorder that causes rapid, permanent, and bilateral loss of vision in people of all ages, but primarily men ages 20-40. This preclinical research has been funded since 2007 by National Institutes of Health and National Eye Institute grants totaling $6.1 million. A similar amount will fund a new five-year clinical trial. [University of Miami Miller School of Medicine] Press Release

Oncothyreon Announces Merck KGaA, Darmstadt, Germany, Initiation of Phase III START2 Study with Tecemotide in Stage III Non-Small Cell Lung Cancer
Oncothyreon Inc. announced that Merck KGaA, Darmstadt, Germany, has initiated the international Phase III START2 study, which is designed to assess the efficacy and safety of the investigational MUC1 antigen-specific cancer immunotherapy tecemotide (also known as L-BLP25) in patients with unresectable, locally advanced Stage III non-small cell lung cancer. [Oncothyreon Inc.] Press Release

Moffitt Cancer Center Begins Phase I Clinical Trial of New Immunotherapy
Moffitt Cancer Center has initiated a Phase I clinical trial for a new immunotherapy drug, ID-G305, made by Immune Design. Immunotherapy is a treatment option that uses a person’s own immune system to fight cancer. [Moffitt Cancer Center] Press Release

Celladon Receives Breakthrough Therapy Designation from FDA for MYDICAR®, Novel, First-in-Class Therapy in Development to Treat Heart Failure
Celladon Corporation announced that its lead product candidate, MYDICAR®, has been granted breakthrough therapy designation by the U.S. Food and Drug Administration (FDA) for reducing hospitalizations for heart failure in NYHA class III or IV chronic heart failure patients who are NAb negative. MYDICAR uses genetic enzyme replacement therapy to correct the deficiency in the enzyme SERCA2a, which is an enzyme that becomes deficient in heart failure patients and results in inadequate pumping of the heart. [Celladon Corporation]
Press Release

Regeneus Receives Ethics Approval for Collecting Stem Cells from Human Donors for First-in-Man Safety Trial of Its Off-the-Shelf Treatment for Osteoarthritis
Regeneus announced that it has received ethics approval to collect stem cells from human donors for use in production of its new allogeneic off-the-shelf stem cell product for osteoarthritis. [Regeneus Ltd] Press Release

Alnylam’s McSwiggen Patent Upheld in European Opposition Proceedings
Alnylam Pharmaceuticals, Inc. announced that the European Patent Office has upheld the McSwiggen EP 1423406 patent in oral opposition proceedings. The McSwiggen patent estate broadly describes chemical modifications of RNAi therapeutics that the company believes are critical for achieving “drug-like” properties in siRNA, the molecules that mediate RNAi. [Alnylam Pharmaceuticals, Inc.] Press Release
 
NIH
Center for Scientific Review; Notice of Closed Meetings (FR Doc No. 2014-07861)

Government-Owned Inventions; Availability for Licensing (FR Doc No. 2014-07871)
 
CBER
CBER Is Moving

User Fee Billable Biologic Products and Potencies Approved Under Section 351 of the PHS Act
 
REGULATORY
Food and Drug Administration (United States)

Agency Information Collection Activities; Proposed Collection; Comment Request; Adverse Experience Reporting for Licensed Biological Products; and General Records (FR Doc No. 2014-07711)
 
EVENTS
NEW Tissue Engineering & Regenerative Medicine International Society (TERMIS) – Europe 2014
June 10-13, 2014
Genoa, Italy


Visit our events page to see a complete list of events in the cell, gene and immunotherapy community.
 
JOB OPPORTUNITIES
NEW Business Development Executive (Research Instruments Ltd)

MSc & PhD Positions – Cell Biology, Neurobiology, Neuroimmunology, Cancer Biology, Computational Biology (Hanyang University)

Postdoctoral Fellow – Therapeutic Corneal Endothelial Cell Culture (Lions VisionGift)

Postdoctoral Research Fellow / Research Officer – Stem Cell Research (Bioprocessing Technology Institute)

Postdoctoral Position – Gene Therapy of Lysosomal Storage Diseases (Cincinnati Children’s Hospital Medical Center)

Stem Cell Research Technician (Van Andel Research Institute)

Postdoctoral Position – Human Stem Cell Biology and Hematopoiesis (Johns Hopkins University School of Medicine)

Director of GMP/GLP Quality Operations (University of Pennsylvania, Perelman School of Medicine)

Postdoctoral Position – Tissue Engineering and Regenerative Medicine (RUNMC)

Research Associate – Cell Separation (STEMCELL Technologies Inc.)

Research Technologist – Pluripotent Stem Cells (STEMCELL Technologies Inc.)

Research Technologist – Particle Chemistry (STEMCELL Technologies Inc.)

Research Technologist – PSC Biology and Bioengineering (STEMCELL Technologies Inc.)


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