Volume 11.07 | Mar 1

Cell Therapy News 11.07, March 1, 2010.
In this issue:  Science  |  Policy  |  Business  |  NIH  |  CBER  |  Regulatory  |  Events Unsubscribe


TOP STORY


Gene-Based Stem Cell Therapy Specifically Removes Cell Receptor that Attracts HIV
University of California, Los Angeles AIDS Institute researchers successfully removed CCR5 — a cell receptor to which HIV-1 binds for infection but which the human body does not need — from human cells. [Press release from the University of California, Los Angeles discussing the online prepublication in Blood]

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SCIENCE NEWS

Unpacking Condensins' Function in Embryonic Stem Cells
Regulatory proteins common to all eukaryotic cells can have additional, unique functions in embryonic stem cells, according to a study. [Press release from ScienceDaily discussing the online prepublication in Journal of Cell Biology]

University of Texas Health Science Center Research Shows Modified Adult Stem Cells May Be Helpful in Spinal Cord Injury
Researchers at the University of Texas Health Science Center have demonstrated in rats that transplanting genetically modified adult stem cells into an injured spinal cord can help restore the electrical pathways associated with movement. [Press release from the University of Texas Health Science Center discussing the online prepublication in the Journal of Neuroscience]

The Mouse with a Human Liver: a New Model for the Treatment of Liver Disease
How do you study – and try to cure in the laboratory – an infection that only humans can get? A team led by Salk Institute researchers does it by generating a mouse with an almost completely human liver. [Press release from the Salk Institute discussing the online prepublication in the Journal of Clinical Investigation]

Stem Cells Restore Sight in Mouse Model of Retinitis Pigmentosa
An international research team successfully used mouse embryonic stem cells to replace diseased retinal cells and restore sight in a mouse model of retinitis pigmentosa. [Press release from Columbia University Medical Center discussing the online prepublication in Transplantation]

Histostem Participates in Clinical Trials Demonstrating the Effective Use of Its Proprietary Stem Cells in the Treatment of Cirrhosis of the Liver
AmStem Corporation announced that Histostem Ltd. of South Korea has participated in a successful preclinical study of the use of its proprietary human umbilical cord blood-derived mesenchymal stem cells in the treatment of cirrhosis of the liver. [CNN Money]

Adult Stem Cell Therapy Shows Promise for Heart Attack Patients
Wake Forest University Baptist Medical Center is participating in a national research study testing the restorative effect that adult bone marrow stem cells have on damaged heart muscle in heart attack patients. [Wake Forest University Baptist Medical Center Press Release]

New Study Demonstrates Effectiveness of Prochymal as a Rescue Therapy for Pediatric Patients with Severe Graft vs. Host Disease
Osiris Therapeutics, Inc. reported that a new study shows Prochymal achieved an overall response rate of 63% when used as a rescue therapy in children suffering from severe treatment resistant graft vs. host disease. [Osiris Therapeutics, Inc. Press Release]

Investigators Present Phase III Data for Prochymal in Steroid-Refractory Graft vs. Host Disease
Osiris Therapeutics, Inc. announced that results from the Phase III trial evaluating Prochymal for the treatment of steroid-refractory acute graft vs. host disease will be presented by Paul Martin, M.D., of the Fred Hutchinson Cancer Research Center and Paul Szabolcs, M.D., of Duke University Medical Center at the 2010 Blood and Marrow Transplant Tandem Meeting. [Osiris Therapeutics, Inc. Press Release]

Aastrom Reports Interim Results from Critical Limb Ischemia Trial
Aastrom Biosciences, Inc. reported results from a planned interim analysis of the company's multi-center, randomized, double-blind, placebo-controlled U.S. Phase IIb clinical trial designated RESTORE-CLI. [Aastrom Biosciences, Inc. Press Release]

CURRENT PUBLICATIONS

Regenerative Medicine: Cell Reprogramming Gets Direct
Researchers describe a potential innovation for generating disease-specific and patient-specific tissues of the central nervous system that does not rely on stem cells. [Nature]

Location of Corneal Epithelial Stem Cells
Investigators point out that previous suggestions concerning the location of corneal epithelial stem cells are inconsistent with many known growth, differentiation and cell migration properties of the anterior ocular epithelia. [Nature]

Dicer-Independent Primal RNAs Trigger RNAi and Heterochromatin Formation
Results suggest that a transcriptome surveillance mechanism based on random association of RNA degradation products with Argonaute triggers siRNA amplification and heterochromatin assembly within DNA repeats. [Cell]

Cortical Plasticity Induced by Inhibitory Neuron Transplantation
Findings suggest that ocular dominance plasticity is regulated by the execution of a maturational program intrinsic to inhibitory neurons. [Science]

Human Liver Chimeric Mice Provide a Model for Hepatitis B and C Virus Infection and Treatment
Researchers have shown that a high transplantation dose (3 × 106 to 5 × 106 human hepatocytes/mouse) generates a higher rate of liver chimerism than was previously obtained in these mice, up to 95% human hepatocyte chimerism. [J Clin Invest]

A Highly Efficient Short Hairpin RNA Potently Down-Regulates CCR5 Expression in Systemic Lymphoid Organs in the Human Bone Marrow/Liver/Thymus Mouse Model
Researchers report stable knockdown of human CCR5 by a short hairpin RNA in a humanized bone marrow/liver/thymus mouse model. [Blood]

Scl Isoforms Act Downstream of Etsrp to Specify Angioblasts and Definitive Hematopoietic Stem Cells
Data suggest that downstream of etsrp, scl-(alpha) and fli1a specify the angioblasts, while scl-(beta) further initiates hematopoietic stem cells specification from this angioblast population, and that Vegf signaling acts upstream of scl-(beta) during definitive hematopoiesis. [Blood]

Condensin Complexes Regulate Mitotic Progression and Interphase Chromatin Structure in Embryonic Stem Cells
In this study, researchers show that for Smc2 and -4, as well as an additional 49 of 62 previously identified genes required for embryonic stem cell viability, knockdown in somatic cells had minimal effects on proliferation or viability. [J Cell Biol]

Transplantation of Ciliary Neurotrophic Factor-Expressing Adult Oligodendrocyte Precursor Cells Promotes Remyelination and Functional Recovery after Spinal Cord Injury
Researchers explored whether the combination of neurotrophic factors and transplantation of adult rat spinal cord oligodendrocyte precursor cells could enhance remyelination and functional recovery after spinal cord injury. [J Neurosci]

Transplantation of Reprogrammed Embryonic Stem Cells Improves Visual Function in a Mouse Model for Retinitis Pigmentosa
Retinal pigment epithelia (RPE)-like cells derived from embryonic stem cells sequentially express multiple RPE-specific markers. [Transplantation]

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POLICY

Study Finds Stem Cell Research in the State of Maryland Supports More than 500 Local Jobs and Facilitates $71.3 Million in Business Sales Annually
A recent third party economic development impact study conducted by Sage Policy Group, Inc., entitled “Economic Benefits of Maryland's Stem Cell Program already Apparent,” found that Maryland's Stem Cell Research Fund supports 514 local jobs, with an average salary of $64,000, and facilitates $71.3 million in business sales in the state. [Maryland Stem Cell Research Fund, United States]

Idaho Senate Votes 21-13 for 'Conscience' Bill
After a long and emotional debate, Senators voted 21-13 to allow pharmacists, nurses and other health-care workers to opt out of providing assistance for abortions, stem cell therapy, emergency contraception or end-of-life care, if they tell their employers first the procedures violate their conscience. [Idaho Senate, United States]

Governor Pledges to Veto Any Restrictions on Stem Cell Research
Governor Granholm says she will veto any efforts to write new restrictions into the amendment that allows embryonic stem cell research at publicly funded research clinics. [Michigan Senate, United States]

Massachusetts Life Sciences Center Awards Worcester Polytechnic Institute $6.6 Million Grant for Next Phase of Gateway Park
The Massachusetts Life Sciences Center Board of Directors recently awarded a $6.6 million grant to Worcester Polytechnic Institute to support the next phase of life sciences related development at Gateway Park in Worcester. [Massachusetts Life Sciences Center, United States]

Center Launches 2010 Accelerator Program for Early-Stage Companies
The primary objective of the Accelerator Loan Program is to provide working capital to early stage life sciences companies that still are in the process of further developing their science/technology and have not yet raised more than $5 million in equity financing. [Massachusetts Life Sciences Center, United States]

Indian Council of Medical Research to Set Up Apex Committee to Regulate Stem Cell Research
Indian Council of Medical Research said recently it would soon set up a body to regulate the scientific community on the crucial health research of stem cell therapy. [Indian Council of Medical Research, India]



BUSINESS

Shire Announces Food and Drug Administration Approval of VPRIV™ (Velaglucerase Alfa for Injection) for the Treatment of Type 1 Gaucher Disease
Shire plc announced that the U.S. Food and Drug Administration has granted marketing approval for VPRIV, a human cell line derived enzyme replacement therapy for the long-term treatment of Type 1 Gaucher disease in pediatric and adult patients. [Shire plc Press Release]

Millipore Corporation Confirms It is Evaluating Strategic Alternatives
Millipore Corporation confirmed that its Board of Directors is evaluating strategic alternatives to enhance shareholder value, including by pursuing a process with potential bidders to explore a possible merger or sale of the Company. [Millipore Corporation Press Release]

University of Minnesota Awarded $8.6 Million Contract to Manufacture Stem Cell Therapies
The University of Minnesota has been awarded an $8.6 million contract to speed the development of novel stem cell and immune cell-based therapies from the laboratory to clinical trials. [University of Minnesota Press Release]

$1.9 Billion in Research to Focus on Protecting Soldiers
The Army's fiscal 2011 science and technology budget that recently went forward for approval tops out at $1.9 billion and includes funding for advanced medical and force-protection research efforts. [United States Army Press Release]

Oklahoma Tobacco Settlement Endowment Trust Provides $5.5 million in Seed Money for Adult Stem Cell Research
The Board of Directors of the Oklahoma Tobacco Settlement Endowment Trust during its quarterly meeting approved a proposal creating a virtual research center to be known as the Oklahoma Center for Adult Stem Cell Research. [Oklahoma Tobacco Settlement Endowment Trust Press Release]

Celgene Opens European Research & Development Hub for Translational Science
The collaboration's main objective is to minimize the gap between basic scientific research and clinical results, so that patients benefit sooner from laboratory discoveries. [New Statesman]

Cheap DNA Sequencing will Drive a Revolution in Health Care
The dream of personalized medicine was one of the driving forces behind the 13-year, $3 billion Human Genome Project. [Technology Review]



NIH

National Institutes of Health Director Goes Shopping
Francis Collins, the new leader of National Institutes of Health, announced that he will spend more than $200 million out of the Common Fund over the next five years on seven programmes in areas ranging from global health to how to speed therapies to the clinic.

National Institutes of Health Director Ruffles Feathers Again With New Religion Book
National Institutes of Health Director Francis Collins is again riling some scientists by publicly sharing his religious beliefs — this time by publishing a new book about faith.

National Institute of Arthritis and Musculoskeletal and Skin Diseases Accelerating Research Translation in Musculoskeletal and Skin Tissue Engineering and Regenerative Medicine Competitive Revision Award (R01) (RFA-AR-11-004)

National Institute of Arthritis and Musculoskeletal and Skin Diseases Accelerating Research Translation in Musculoskeletal and Skin Tissue Engineering and Regenerative Medicine Competitive Revision Award (P01 and P50) (RFA-AR-11-005)

Large Scale Production of Perturbagen-Induced Cellular Signatures (U54) (RFA-RM-10-003)

Notice from the John E. Fogarty International Center with Corrections Made to PAR-10-065: Independent Scientist in Global Health Award (ISGHA) (K02) (NOT-TW-10-002)

Advancing Regulatory Science through Novel Research and Science-Based Technologies (U01) (RFA-RM-10-006)

Production Of Human Proteins To Be Used For Generating Affinity Reagents (U01) (RFA-RM-10-007)

Status of Certain Human Embryonic Stem Cell Lines (NOT-OD-10-063)

Review Considerations for Applications and Awards under the New NIH Guidelines for Human Stem Cell Research (NOT-OD-10-056)

UPDATE TO RFA-OD-10-009: OS Recovery Act Limited Competition: Methodology Development in Comparative Effectiveness Research (RC4) Announcement of Non-Applicability of Requirement to Attend Meetings (NOT-OD-10-062)

National Heart, Lung, and Blood Institute Will Provide Limited Supplemental Support to the National Institute of General Medical Sciences Medical Scientist Training Program in FY 2010 (NOT-HL-11-103)

Delays in Grant Application Submission to Agency for Healthcare Research and Quality due to Recent Winter Storm (NOT-HS-10-013)

Ruth L. Kirschstein National Research Service Awards for Individual Predoctoral MD/PhD and Other Dual Doctoral Degree Fellows (Parent F30) (PA-10-107)

Ruth L. Kirschstein National Research Service Awards for Individual Predoctoral Fellows (Parent F31) (PA-10-108)

Ruth L. Kirschstein National Research Service Awards for Individual Predoctoral Fellowships to Promote Diversity in Health-Related Research (Parent F31 – Diversity) (PA-10-109)

Ruth L. Kirschstein National Research Service Awards (NRSA) for Individual Postdoctoral Fellows (Parent F32) (PA-10-110)

Ruth L. Kirschstein National Research Service Awards (NRSA) for Individual Senior Fellows (Parent F33) (PA-10-111)

Notice of Intent to Establish a New National Institutes of Health Common Fund Program: Library of Integrated Network-Based Cellular Signatures (LINCS) (NOT-RM-10-002)



CBER

2010 Biological Device Application Approvals

2010 Meeting Materials, Vaccines and Related Biological Products Advisory Committee Meeting – Draft Agenda, Member Roster

U.S. Food and Drug Administration Statement: The Impact of February’s Inclement Weather on Prescription Drug User Fee Act and Medical Device User Fee Act Deadlines



REGULATORY

FOOD AND DRUG ADMINISTRATION (United States)

Health and Human Services Announces New Partnership Between the National Institutes of Health and the Food and Drug Administration

Agency Information Collection Activities; Proposals, Submissions, and Approvals: Human Tissue Intended for Transplantation, 9226–9227 [FDA-2010-N-0066]

Draft Guidance for Industry: Adaptive Design Clinical Trials for Drugs and Biologics; Availability, 8968–8970 [FDA-2010-D-0090]

Office of the Commissioner Reorganization; Statement of Organizations, Functions, and Delegations of Authority

THERAPEUTIC GOODS ADMINISTRATION (Australia)

Expressions of Interest for Membership of the Therapeutic Goods Committee



EVENTS

14th Annual Hilton Head Workshop
March 10-14, 2010
Hilton Head Island, United States

12th Biennial Canadian Blood and Marrow Transplant (CBMT) Consortium Meeting
April 7-10, 2010
Vancouver, Canada

American Association for Cancer Research (AACR) 101st Annual Meeting 2010
April 17-21, 2010
Washington, DC, United States

Institut National de la Santé et de la Recherche Médicale (INSERM) Induced Pluripotent Stem Cell Workshop: Human Induced Pluripotent Stem Cells, Reprogramming and Differentiation
April 21-23, 2010
St-Raphaël, France

Society for Biological Engineering's (SBE) 2nd International Conference on Stem Cell Engineering
May 2-5, 2010
Boston, United States

Select BioSciences' 4th Annual RNAi & miRNA World Congress
May 5-7, 2010
Boston, United States

World Stem Cells & Regenerative Medicine Congress 2010
May 11-13, 2010
London, United Kingdom

16th International Society for Cellular Therapy (ISCT) Meeting
May 23-26, 2010
Philadelphia, United States

ESTOOLS International Scientific Symposium
May 26-28, 2010
Lisbon, Portugal

International Society for Stem Cell Research (ISSCR) 8th Annual Meeting
June 16-19, 2010
San Francisco, United States

United Kingdom National Stem Cell Network (UKNSCN) 3rd Annual Scientific Conference
July 12-14, 2010
Nottingham, United Kingdom

2nd International Conference on Cellular and Molecular Bioengineering (ICCMB2)
August 2-4, 2010
Singapore City, Singapore

Select BioSciences' 3rd Annual Stem Cells Europe Conference
August 24-25, 2010
Edinburgh, Scotland

International Society of Cell Therapy (ISCT) Annual Meeting – Europe
September 11-14, 2010
Belgirate, Italy

2010 World Stem Cell Summit
October 4-6, 2010
Detroit, United States

Hydra VI: The European Summer School on Stem Cells & Regenerative Medicine
September 11-17, 2010
Hyrda, Greece

5th World Congress on Preventive & Regenerative Medicine (WCRM)
October 5-7, 2010
Hannover, Germany


 

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