Volume 11.40 | Oct 18

Cell Therapy News 11.40, October 18, 2010.
In this issue:  Science  |  Policy  |  Business  |  NIH  |  CBER  |  Regulatory  |  Events Subscribe  


Researcher Discovers Key Mechanism for Transforming Adult Cells 
Researchers have discovered that so-called “grim-reaper” caspase genes are the gatekeepers that can open the door to allow differentiated adult cells to regress to undifferentiated induced pluripotent stem cells. [Press release from the University of Colorado Denver discussing online prepublication in Cell Stem Cell]



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Stem Cell Model for Long-QT Syndrome May Spark New Avenues for Heart Research
Pluripotent stem cells, derived from skin fibroblasts of two relatives with familial long-QT syndrome and induced to differentiate into cardiac myocytes, exhibited the electrophysiologic traits of the disorder, showing for the first time that stem cell models “can recapitulate aspects of genetic cardiac diseases.” [Press release from Internal Medicine News discussing online prepublication in the New England Journal of Medicine]

Team Finds Protein That Sets the Stage for Exchanges of DNA Code in Eggs and Sperm
Scientists have discovered a regulatory protein that influences where genetic material gets swapped between maternal and paternal chromosomes during the process of creating eggs and sperm. [Press release from the University of Pittsburgh discussing online prepublication in Nature]
Stem Cells Repair Damaged Spinal Cord Tissue
Researchers have shown how stem cells, together with other cells, repair damaged tissue in the mouse spinal cord. [Press release from the Karolinska Institutet discussing online prepublication in Cell Stem Cell]
Research Team Developed New Stem Cell Therapy for Heart Repair
A research team has proved that by combining self-assembling peptide nanofiber hydrogel with autologous bone marrow stem cells, myocardial protection after acute myocardial infarction, vascular regeneration and heart functions can be improved. [Press release from National Cheng Kung University discussing online prepublication in Circulation]
Shifting Forms: Study Shows How Variations of Same Protein Affect Immune Response
Researchers have identified the steps that control how different forms of an immune cell protein called CD45 are controlled in the arc of a body’s immune response.  [Press release from the University of Pennsylvania School of Medicine discussing online prepublication in Molecular Cell]

Researcher Makes Breakthrough Discovery to Curb Heart Failure
A researcher has announced a breakthrough discovery to block a protein that can contribute to heart failure. They have discovered a novel method, using gene therapy, to block the actions of a gene-encoded protein. [Press release from Nova Southeastern University discussing online prepublication in the Journal of the American College of Cardiology]
Gene Identified That Prevents Stem Cells from Turning Cancerous
New research shows that having too many stem cells, or stem cells that live for too long, can increase the odds of developing cancer. By identifying a mechanism that regulates programmed cell death in precursor cells for hematopoietic stem cells, the work is the first to connect the death of such cells to a later susceptibility to tumors in mice. [Press release from Rockefeller University discussing online prepublication in Genes and Development]

Research Shows a Promising New Method to Reduce Graft-Versus-Host-Disease After Bone Marrow Transplantation
Researchers have discovered a new method to prevent the immune-system attacks that often occur following bone marrow transplants. [Press release from the University of Michigan discussing online prepublication in Blood]

Holding on to Cells with DNA
Researchers designed pieces of DNA that self-assemble into thick long strands four double helices across that structurally resemble the protein fibers of the natural extracellular matrix. [Press release from ScienceBlogs discussing online prepublication in the Journal of the American Chemical Society]
Mice with Human Body’s Defences
Scientists, with the help of human stem cells, generated mice with a human immune system, which were then vaccinated to produce human monoclonal antibodies. [Press release from the Helmholtz Centre for Infection Research discussing online prepublication in PLoS ONE]

Better Drug Delivery Eradicates Tumors
A new study demonstrates further promise for chitosan/interleukin-12 as an effective anti-tumor immunotherapy. Findings revealed that injections of chitosan/IL-12 eradicated aggressive colorectal and pancreatic tumors, as well as superficial bladder cancer. [Press release from the University of Arkansas discussing online prepublication in the Journal of Immunotherapy

CURRENT PUBLICATIONS (Ranked by Impact Factor of the Journal)

Patient-Specific Induced Pluripotent Stem-Cell Models for Long-QT Syndrome
Researchers generated patient-specific pluripotent stem cells from members of a family affected by long-QT syndrome type 1 and induced them to differentiate into functional cardiac myocytes. The patient-derived cells recapitulated the electrophysiological features of the disorder. [N Engl J Med]
xnd-1 Regulates the Global Recombination Landscape in Caenorhabditis elegans
Researchers show that xnd-1 functions independently of genes required for X chromosome-specific gene silencing, revealing a novel pathway that distinguishes the X from autosomes in the germ line, and further show that xnd-1 exerts its effects on meiotic crossovers, at least in part, by modulating levels of H2A lysine 5 acetylation. [Nature]
Apoptotic Caspases Regulate Induction of iPSCs from Human Fibroblasts
Researchers report that caspases 3 and 8, two proteases associated with apoptotic cell death, play critical roles in induction of induced pluripotent stem cells (iPSCs) from human fibroblasts. [Cell Stem Cell]
Origin of New Glial Cells in Intact and Injured Adult Spinal Cord
Several distinct cell types in the adult central nervous system have been suggested to act as stem or progenitor cells generating new cells under physiological or pathological conditions. Researchers have assessed the origin of new cells in the adult mouse spinal cord by genetic fate mapping. [Cell Stem Cell]
Intramyocardial Peptide Nanofiber Injection Improves Postinfarction Ventricular Remodeling and Efficacy of Bone Marrow Cell Therapy in Pigs
Researchers demonstrated that nanofiber (NF) injection alone prevents ventricular remodeling, whereas cell implantation with NFs improves cell retention and cardiac functions after myocardial infarction in pigs. [Circulation]

Phosphorylation-Dependent Regulation of PSF by GSK3 Controls CD45 Alternative Splicing
Data place two players, GSK3 and TRAP150, in the complex network that regulates CD45 alternative splicing and demonstrate a paradigm for signal transduction from the cell surface to the RNA processing machinery through the multifunctional protein PSF. [Mol Cell]
Sept4/ARTS Is Required for Stem Cell Apoptosis and Tumor Suppression
Researchers show that deletion of the mouse Sept4 gene, which encodes the Inhibitor of Apoptosis Protein antagonist ARTS, promotes tumor development. [Genes Dev]
Notch Signaling Is a Critical Regulator of Allogeneic CD4+ T Cell Responses Mediating Graft-Versus-Host Disease
Results identify Notch as a novel essential regulator of pathogenic CD4+ T cell responses during acute graft-versus-host disease and suggest that Notch signaling in T cells should be investigated as a therapeutic target following allogeneic hematopoietic stem cell transplantation. [Blood]

A Structurally Tunable DNA-Based Extracellular Matrix
The principles of DNA nanotechnology and protein engineering have been combined to generate a new class of artificial extracellular matrices. The potential of this material for ex vivo cellular scaffolding was demonstrated using experiments in which human cervical cancer cells were found to adhere strongly, stay alive, and grow with high migration rates. [J Am Chem Soc]
Generation of Human Antigen-Specific Monoclonal IgM Antibodies Using Vaccinated “Human Immune System” Mice
Researchers describe a novel approach to generate fully human monoclonal antibodies by combining a humanized mouse model with a new B cell immortalization technique. [PLoS ONE]

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European Medicines Agency Strengthens Rules on Conflicts of Interests of Its Scientific Experts
The European Medicines Agency has published new rules on how the Agency will be handling potential conflicts of interests of its scientific experts, following endorsement by its Management Board. [European Medicines Agency, European Union]

IQWiG: Law Must Prescribe Obligation to Publish All Clinical Trials
If the currently discussed draft on the “Law on the Reorganization of the Pharmaceutical Market” (AMNOG) is implemented, drug manufacturers will in future have to register their clinical trials at inception and publish results after completion. [Institute for Quality and Efficiency in Health Care (IQWiG), Germany]

Loss of UK Genetics Public Bodies Confirmed
The official announcement from the UK Government on the future of non-departmental public bodies has confirmed the rumored abolition of a total of 192 public bodies, with a further 118 to be merged. [Foundation for Genomics and Population Health, United Kingdom]

More Legal Jousting in Stem Cell Case
The two sides in the ongoing court battle over stem cell research filed another batch of legal documents in response to court-ordered deadlines [Court of Appeals, United States] 

HHS to Let Secretary's Genetics Committee Expire
The Secretary's Advisory Committee on Genetics, Health, and Society will disband next month, eight years after its founding. The committee had completed its original task, advising the Department of Health and Human Services (HHS) on a number of issues related to genomics. [Department of Health and Human Services, Untied States]

Advisory Council on Blood Stem Cell Transplantation; Notice of Meeting (FR Doc. 2010-25646) [Department of Health and Human Services, United States]
Screening Framework Guidance for Providers of Synthetic Double-Stranded DNA (FR Doc. 2010-25728) [Department of Health and Human Services, United States]

Proposed Collection; Comment Request; National Evaluation of the Clinical and Translational Science Awards (CTSA) Initiative (FR Doc. 2010-25589) [Department of Health and Human Services, United States]
Agency Information Collection Request. 30-Day Public Comment Request (FR Doc. 2010-25587) [Department of Health and Human Services, United States]
Partnerships To Advance the National Occupational Research Agenda (NORA) (FR Doc. 2010-25973) [Centers for Disease Control and Prevention, States]



Cell Cure Neurosciences Ltd., a Subsidiary of BioTime, Inc. and Hadasit Bio Holdings Ltd., Enters into an Exclusive License Option Agreement with Teva Pharmaceutical Industries Ltd. to Develop and Market OpRegen™ for the Treatment of Age-Related Macular Degeneration
BioTime, Inc., Cell Cure Neurosciences Ltd., and Hadasit Bio-Holdings Ltd. jointly announced that Cell Cure and Teva Pharmaceutical Industries Ltd. have entered into an exclusive license option agreement to develop and commercialize Cell Cure's OpRegen™ product for the treatment of age-related macular degeneration. OpRegen™ is a proprietary formulation of embryonic stem cell-derived retinal pigment epithelial cells designed by Cell Cure. [BioTime, Inc. Press Release]

Breakthrough Regenerative Therapy for Newborns with Metabolic Disorders in Qatar
Hamad Medical Corporation has partnered with the University Children’s Hospital in Heidelberg and German biotech company Cytonet GmbH & Co. KG to establish an agreement to conduct the clinical trial SELICA (Safety and Efficacy of Liver Cell Application). [Hamad Medical Corporation Press Release]

BioFocus Extends Collaboration with Chiesi
BioFocus, a leading provider of integrated gene-to-clinical candidate drug discovery services, announced that it has expanded a collaboration with Chiesi Farmaceutici, a privately held Italian pharmaceutical company.  [BioFocus Press Release]

KINAXO Enters Agreement with Bristol-Myers Squibb Company
KINAXO Biotechnologies GmbH announced that Bristol-Myers Squibb Company has chosen KINAXO to support several of its drug discovery programs. [KINAXO Biotechnologies GmbH Press Release]
ImmunoGen, Inc. Announces Collaboration for Rights to Use ImmunoGen's Targeted Antibody Payload Technology
ImmunoGen, Inc. announced that it has entered into a collaboration agreement with Novartis to discover and develop targeted anticancer therapeutics using antibodies to several antigen targets to be named by Novartis. [ImmunoGen, Inc. Press Release]
Genmab Announces Antibody Development Collaboration with Lundbeck
Genmab A/S announced an agreement to create and develop human antibody therapeutics for disorders of the central nervous system with H. Lundbeck A/S. [Genmab Press Release]
American Cancer Society Awards New Research and Training Grants
The American Cancer Society has awarded 94 national research and training grants totaling $46,633,000 to 70 institutions nationwide in the first of two grants cycles for 2011. [American Cancer Society Press Release]

Cytomedix Secures $13 Million in Committed Funding
Cytomedix, Inc., a leading developer of biologically active regenerative therapies for wound care, inflammation and angiogenesis, announced that the Company has secured approximately $13 million in current and future funding via a registered direct offering and commitments under two separate equity purchase agreements. [Cytomedix, Inc. Press Release]

Tekmira and Collaborators Awarded $2.4 Million NIH Grant for Development of RNAi Therapeutics to Treat Ebola and Marburg Viral Infections
Tekmira Pharmaceuticals Corporation announced that, together with collaborators at The University of Texas Medical Branch, it has been awarded a new United States National Institutes of Health (NIH) grant to support research to develop RNAi therapeutics to treat Ebola and Marburg hemorrhagic fever viral infections using Tekmira’s lipid nanoparticle delivery technology.  [Tekmira Pharmaceuticals Corporation Press Release]
Geron Initiates Clinical Trial of Human Embryonic Stem Cell-Based Therapy
Geron Corporation announced the enrollment of the first patient in the company's clinical trial of human embryonic stem cell-derived oligodendrocyte progenitor cells, GRNOPC1. [Geron Corporation Press Release]
BrainStorm Receives Approval to Begin Clinical Trial of Adult Stem Cell Therapy in Patients with ALS
BrainStorm Cell Therapeutics Inc. announced that the Israeli Ministry of Health has granted clearance for a Phase I/II clinical trial using the company’s autologous NurOwn™ stem cell therapy in patients with amyotrophic lateral sclerosis (ALS). [BrainStorm Cell Therapeutics Inc. Press Release]
CEL-SCI Corporation Receives Approval from First Taiwanese Institutional Review Board to Commence Phase III Clinical Trial of Multikine in Head and Neck Cancer
CEL-SCI Corporation announced it has received approval from the first Taiwanese Institutional Review Board to begin enrollment of subjects for a Phase III clinical trial of Multikine®, the Company's flagship immunotherapy developed as a first-line standard of care in treating head and neck cancer. [CEL-SCI Corporation Press Release]
Immunomedics Awarded Additional U.S. Patent for Antibody Therapy of Autoimmune Diseases
Immunomedics, Inc. announced that additional claims for the patent family “Method and kit for imaging and treating organs and tissue,” were issued as U.S. Patent No. 7,811,570. [Immunomedics, Inc. Press Release]
The New York Stem Cell Foundation Announces 2010 NYSCF-Investigators in Conjunction with Fifth Annual Translational Stem Cell Conference
In an expansion of its ongoing effort to promote the next generation of stem cell scientists, The New York Stem Cell Foundation (NYSCF) named the first six NYSCF Investigators. Each of the NYSCF-Robertson and NYSCF-Helmsley Investigators will receive up to $1.5 million over the next five years to expand their own laboratories, train other scientists and foster innovative high-risk/high reward research to explore the therapeutic potential of stem cells derived from humans and model organisms. [The New York Stem Cell Foundation Press Release]
Personal Genetic Secrets Made Public by Experts
The Genomes Unzipped project is releasing personal genetic data from contributors — researchers and other genomics experts and commentators, who have had their genome scanned by personal genomics companies. [Foundation for Genomics and Population Health Press Release]


Cancer Chief Varmus Draws Up a List of Unsolved Mysteries
Harold Varmus has made a start on one of his first priorities as chief of the U.S. National Cancer Institute (NCI): coming up with a set of key unanswered questions.

Office of the Director, National Institutes of Health; Notice of Meeting (FR Doc. 2010-26036)

National Human Genome Research Institute; Notice of Closed Meeting (FR Doc. 2010-25634)

Center for Scientific Review; Notice of Closed Meetings (FR Doc. 2010-25595)

Center for Scientific Review; Notice of Closed Meetings (FR Doc. 2010-25597)

Center for Scientific Review; Amended Notice of Meeting (FR Doc. 2010-25598)

Center for Scientific Review; Amended Notice of Meeting (FR Doc. 2010-25601)

Center for Scientific Review; Notice of Closed Meetings (FR Doc. 2010-26028)

Center for Scientific Review; Notice of Closed Meetings (FR Doc. 2010-26033)

National Cancer Institute; Notice of Closed Meeting (FR Doc. 2010-25636)
National Cancer Institute; Notice of Closed Meeting (FR Doc. 2010-25640)

National Cancer Institute; Notice of Meeting (FR Doc. 2010-26032)

National Cancer Institute; Notice of Closed Meetings (FR Doc. 2010-26035) 

National Institute of General Medical Sciences; Notice of Closed Meeting (FR Doc. 2010-26037) 

National Institute of General Medical Sciences; Notice of Closed Meeting (FR Doc. 2010-26075)



Draft Guidance for Industry: Early Clinical Trials with Live Biotherapeutic Products: Chemistry, Manufacturing, and Control Information
Clinical Investigator Status (Biologics)



Draft Guidance for Industry: Early Clinical Trials With Live Biotherapeutic Products: Chemistry, Manufacturing, and Control Information; Availability (FR Doc. 2010-25850)
Draft Guidance for Industry on Investigational New Drug Applications–Determining Whether Human Research Studies Can Be Conducted Without an Investigational New Drug Application; Availability (FR Doc. 2010-25851)


Review of Medicines Legislation: Informal Consultation on the Medicines Act 1968 Exemptions for Sale, Supply and Administration of Medicines
The MHRA is undertaking a review of medicines legislation.

Drug Safety Update: Volume 4, Issue 3, October 2010

EVENTS (Listed by Date)

6th Modern Drug Discovery & Development Summit (M3D)
October 20-22, 2010
San Francisco, United States

NEW Cancer Immunotherapy: A Long-Awaited Reality
October 21, 2010
New York, United States

NEW International Federation of Adipose Therapeutics & Science (IFATS) 2010 Conference
October 22-24, 2010
Dallas, United States

European Society of Gene and Cell Therapy (ESGCT) 18th Annual Congress
October 22-25, 2010
Milan, Italy

3rd Annual Dubai Congress on Anti-Aging and Aesthetic Medicine (DCAAAM)
October 26-27, 2010
Dubai, United Arab Emirates

International Consensus Conference: Risk-Based Decision Making for Blood Safety
October 26-28, 2010
Toronto, Canada

2nd Annual Stem Cells Asia and Regenerative Medicine Congress
October 26-28, 2010
Seoul, Korea

Select Biosciences 2nd Annual Lab-on-a-Chip World Congress
October 28-29, 2010
San Diego, United States

Select Biosciences 3rd Annual Molecular Diagnostics World Congress
October 28-29, 2010
San Diego, United States

Fraunhofer Life Science Symposium Leipzig 2010
October 29-30, 2010
Leipzig, Germany

FDA Public Workshop on Cell and Gene Therapy Clinical Trials in Pediatric Populations
November 2, 2010
North Bethesda, United States

NEW 5th UK Cancer Stem Cell Symposium
November 2, 2010
London, United Kingdom

BioMalaysia 2010
November 2-3, 2010
Kuala Lumpur, Malaysia

Stem Cell Society Singapore Symposium 2010: Translating Science to Therapy
November 2-3, 2010

NEW 2010 National GvHD Symposium
November 4, 2010
Cleveland, United States

World Cord Blood Congress
November 4-7, 2010
Marseille, France

9th Annual American Association for Cancer Research (AACR) International Conference: Frontiers in Cancer Prevention Research
November 7-10, 2010
Philadelphia, United States

NEW Cambridge Healthtech Institute's Inaugural Stem Cells in Drug Discovery and Development
November 8-9, 2010
San Diego, United States

NEW GTCbio 8th Annual Vaccines: “All Things Considered” Conference
November 8-9, 2010
Washington, DC, United States

5th Annual European Biomarkers Summit
November 9-10, 2010
Florence, Italy

Select Biosciences 2nd International Forum on Stem Cells (2010 IFSC)
November 12-13, 2010
Tianjin, China

Select Biosciences 2nd Annual RNAi Asia Conference and Exhibition
November 15-16, 2010

The 16th International Conference of the International Society of Differentiation: From Stem Cells to Organisms
November 15-18, 2010
Nara, Japan

3rd Annual Workshop on Genome Engineering
November 16, 2010
Seattle, United States

NEW 22nd European Organization for Research and Treatment of Cancer (EORTC)-National Cancer Institute (NCI)-American Association for Cancer Research (AACR) Symposium: Molecular Targets and Cancer Therapeutics
November 16-19, 2010
Berlin, Germany

9th Annual Gene Therapy Symposium for Heart, Lung, and Blood Diseases
November 17-19, 2010
Sonoma, United States

8th Annual Commercial Translation of Regenerative Medicine Conference
November 18-19, 2010
London, United Kingdom

NEW Translational Excellence in Regenerative Medicine (TeRM) – Biophysical Stimuli and Mass Transport for Tissue Development
November 18-19, 2010
Lattrop, The Netherlands

4th Annual Conference of the Korea Society of Gene Therapy (KSGT)
November 19, 2010
Seoul, Korea

Stem Cell Network's 10th Annual Scientific Meeting
November 22-24, 2010
Calgary, Alberta

HealthTech and Medicines Knowledge Transfer Network 7th Annual BioProcessUK Conference
November 24-25, 2010
Manchester, United Kingdom

NEW Tumor Immunology: Basic and Clinical Advances
November 30-December 3, 2010
Miami, United Sates

2ND European Association for Cardio-Thoracic Surgery (EACTS) Meeting on Cardiac and Pulmonary Regeneration
December 3-4, 2010
Vienna, Austria

3rd Annual BioPartnering China
December 5-7, 2010
Shanghai, China

Tissue Engineering & Regenerative Medicine International Society – North America (TERMIS-NA) 2010 Annual Conference
December 5-8, 2010
Orlando, United States

5th Annual Stem Cell Meeting on the Mesa
December 7, 2010
La Jolla, United States

Genesis 2010
December 9, 2010
London, United Kingdom

The American Society for Cell Biology 50th Annual Meeting
December 11-15, 2010
Philadelphia, United States

Functional Consequences of Structural Variation in the Genome
January 8-13, 2011
Steamboat Springs, Colorado

NEW Nano in Cancer: Linking Chemistry, Biology, and Clinical Applications In Vivo
January 12-15, 2011
Miami, United Sates

COGEM Symposium: GM Viruses as Medicine: Panacea or Pandora's Box?
January 20, 2011
Amsterdam, The Netherlands

NEW Extracellular Matrix and Cardiovascular Remodeling
January 23-28, 2011
Tahoe City, United States

5th Annual Stem Cells and Regenerative Medicine World Congress
January 24-25, 2011
San Diego, United States

BIO Asia International Partnering Conference
January 24-25, 2011
Tokyo, Japan

Phacilitate 7th Annual Cell & Gene Therapy Forum 2011
January 24-26, 2011
Washington, DC, United States

Phacilitate 9th Annual North American Vaccine Forum
January 24-26, 2011
Washington, DC, United States

Keystone Symposia: Stem Cells in Development, Tissue Homeostasis and Disease
January 30-February 4, 2011
Santa Fe, United States

NEW CMC Workshop: Translating Science into Successful Regulatory Submissions
February 7-9, 2011
Washington, DC, United States

NEW 23rd Lorne Cancer Conference
February 10-12, 2011
Lorne, Australia

NEW BMT Tandem Meetings (ASBMT/CIBMTR)
February 17-21, 2011
Honolulu, Hawaii

NEW 18th International Molecular Medicine Tri-Conference (MMTC)
February 23-25, 2011
San Francisco, United States

NEW Molecular Medicine Tri-Conference: Stem Cells – Revolutionizing Regenerative Medicine and Personalized Therapy 2011
February 23-25, 2011
San Francisco, United States

NEW Molecular Medicine Tri-Conference: Inaugural Circulating Tumor Cells for Cancer Detection, Diagnosis, Prognosis and Treatment
February 23-25, 2011
San Francisco, United States

NEW Targeting PI3K/mTOR Signaling in Cancer
February 24-27, 2011
San Francisco, United Sates

NEW 9th Annual BioPartnering North America
February 27-March 1, 2011
Vancouver, Canada

NEW 18th Conference on Retroviruses and Opportunistic Infections (CROI 2011)
February 27-March 2, 2011
Boston, United States

NEW American Association for Cancer Research (AACR) Stem Cells, Development, and Cancer
March 3-6, 2011
Vancouver, Canada

NEW Stem Cells, Cancer and Metastasis (C4)
March 6-11, 2011
Dillon, United States

NEW Spring Meeting of the Dutch Society of Gene Therapy (NVGT)
March 10-11, 2010
Heeze, The Netherlands

NEW BIO-Europe Spring 2011
March 14-16, 2011
Milan, Italy

NEW The 6th International Conference on Oncolytic Viruses as Cancer Therapeutics
March 16-19, 2011
Las Vegas, United States

NEW HIV Evolution, Genomics and Pathogenesis
March 20-25, 2011
Whistler, British Columbia

Visit our events page to stay up to date with the latest events in the cell, gene and immunotherapy community.



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