Volume 11.16 | May 3

Cell Therapy News 11.16, May 3, 2010.
In this issue:  Science  |  Policy  |  Business  |  NIH  |  CBER  |  Regulatory  |  Events Unsubscribe


Scientists Provide Groundbreaking New Understanding of Stem Cells
In findings that could one day lead to new therapies, researchers from The Scripps Research Institute have described some striking differences between the biochemistry of stem cells versus mature cells. [Press release from PhysOrg discussing online prepublication in Nature Chemical Biology]

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Embryonic Stem Cells Reveal Oncogene's Secret Growth Formula
A comprehensive new gene expression study in embryonic stem cells has uncovered a transcription control mechanism that is not only more pervasive than once thought but is also heavily regulated by the cancer-causing gene c-Myc. [Press release from EurekAlert! discussing online prepublication in Cell]

Stem Cells from Surgery Leftovers Could Repair Damaged Hearts
Scientists have for the first time succeeded in extracting vital stem cells from sections of vein removed for heart bypass surgery. Researchers found that these stem cells can stimulate new blood vessels to grow, which could potentially help repair damaged heart muscle after a heart attack. [Press release from the University of Bristol discussing online prepublication in Circulation]

Technique Triggers Rapid Regrowth in Damaged Bone
Researchers stimulated rapid bone growth by injecting a protein called Wnt, known to be involved in the growth of many types of tissues in animals like salamanders, zebrafish and mice. [Press release from Stanford University School of Medicine discussing online prepublication in Science Translational Medicine]

New Engineering Technique Reinforces Immune Cells that Seek and Destroy Cancer, Says Researcher
In what could be a shot in the arm for adoptive immunotherapy, new Stanford University research shows promise in enhancing and controlling the growth of T cells in living mice and in human cell cultures, potentially overcoming one of the therapy’s drawbacks. [Press release from Stanford University School of Medicine discussing online prepublication in the Proceedings of the National Academy of Sciences U S A]

Researchers Attack Stem Cells that Cause Colon Cancer
Many of the colon cancer cells that form tumors can be killed by genetically short-circuiting the cells' ability to absorb a key nutrient, a new study has found. [Press release from PhysOrg discussing research presented at the Experimental Biology 2010 Conference]

Cell Study Finds Receptor Can Fight Tamoxifen-Resistant Breast Cancer Cells
A receptor that is present in the nucleus of cells can, when activated, slow the growth of tamoxifen-resistant breast cancer cells, a new study found. [Press release from NewsWise discussing research presented at the Experimental Biology 2010 Conference]

Immune System 'Reboot' Aids MS Patient
A couple of Ottawa doctors working with multiple sclerosis (MS) patients are drawing hope from their patients in long-term remission after experimental bone marrow stem cell transplant treatment. “The inflammatory nature of the disease has virtually ceased in everyone who has received this transplant,” said neurologist Dr. Mark Freedman, a lead investigator with bone marrow transplant specialist Dr. Harold Atkins. [The Windsor Star Press Release]

Leukaemia Busters Scientists Make Research Breakthrough
Scientists have discovered that molecules called saponins extracted from the plant known as Baby’s Breath (Gypsophila paniculata L) are able to enhance the killing activity of antibody-based immunotoxins for certain types of human leukaemia and lymphoma. [Press release from The Simon Flavell Leukaemia Research Laboratory discussing research presented at the American Association for Cancer Research 101st Annual Meeting 2010]

FDA Approves a Cellular Immunotherapy for Men with Advanced Prostate Cancer
The U.S. Food and Drug Administration approved Provenge (sipuleucel-T), a new therapy for certain men with advanced prostate cancer that uses their own immune system to fight the disease. Provenge is indicated for the treatment of asymptomatic or minimally symptomatic prostate cancer that has spread to other parts of the body and is resistant to standard hormone treatment. [U.S. Food and Drug Administration Press Release]


PU.1-Mediated Upregulation of CSF1R is Crucial for Leukemia Stem Cell Potential Induced by MOZ-TIF2
Using an acute myeloid leukemia (AML) model induced by the leukemia-associated monocytic leukemia zinc finger (MOZ)-TIF2 fusion protein, researchers show here that AML can be cured by the ablation of leukemia stem cells. [Nat Med]

Metabolic Oxidation Regulates Embryonic Stem Cell Differentiation
Using MS-based metabolomics, researchers show that embryonic stem cells are characterized by abundant metabolites with highly unsaturated structures whose levels decrease upon differentiation. [Nat Chem Biol]

Human Adult Vena Saphena Contains Perivascular Progenitor Cells Endowed with Clonogenic and Proangiogenic Potential
Saphenous vein–derived progenitor cells generated from human vein CD34-positive/CD31-negative progenitor cells might represent a new therapeutic tool for angiogenic therapy in ischemic patients. [Circulation]

Wnt Proteins Promote Bone Regeneration
Researchers found that bone healing after injury is accelerated in Axin2LacZ/LacZ mice, a consequence of more robust proliferation and earlier differentiation of skeletal stem and progenitor cells. [Sci Transl Med]

Stem Cell Mobilization with G-CSF Induces Type-17 Differentiation and Promotes Scleroderma
This study provides a logical explanation for the propensity of allogeneic stem cell transplantation to invoke sclerodermatous graft-versus-host disease and suggests a therapeutic strategy for intervention. [Blood]

Induced Pluripotent Stem Cells Derived from Mouse Models of Lysosomal Storage Disorders
Researchers report the generation of disease-specific induced pluripotent stem cells from mouse models of Fabry disease, globoid cell leukodystrophy, and mucopolysaccharidosis VII. The study demonstrates the unique promise of induced pluripotent stem cells for studying the pathogenesis and treatment of lysosomal storage diseases. [Proc Natl Acad Sci U S A]

Combining CD19 Redirection and Alloanergization to Generate Tumor-Specific Human T Cells for Allogeneic Cell Therapy of B-Cell Malignancies
Data support the application of CD19 redirection and subsequent alloanergization to generate allogeneic donor T cells for clinical use possessing increased antitumor activity but limited capacity to mediate graft-versus-host disease. Immunotherapy with such cells could potentially reduce disease relapse after allogeneic transplantation without increasing toxicity, thereby improving the outcome of patients undergoing allogeneic transplantation for high-risk B-cell malignancies. [Cancer Res]

An Elastomeric Patch Derived from Poly(Glycerol Sebacate) for Delivery of Embryonic Stem Cells to the Heart
Researchers conclude that poly(glycerol sebacate) is a suitable biomaterial for stem cell-based regeneration strategies to restore cardiomyocyte function, and the hybrid heart patch engineered under optimal conditions would be a promising support device for the cardiac repair. [Biomaterials]

Enhancement of Bone Regeneration by Gene Delivery of BMP2/Runx2 Bicistronic Vector into Adipose-Derived Stromal Cells
Researchers hypothesize that adipose-derived stromal cells could be induced to efficiently differentiate into osteocytes by the co-expression of the BMP2 and Runx2 genes. To prove this hypothesis, researchers constructed a bicistronic vector encoding the BMP2 and Runx2 genes linked to the ‘self-cleaving’ 2A peptide sequence. [Biomaterials]

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Obama Staffing Health Care Reform Implementation Team
The Obama administration continues the critical process of hiring health care experts to help carry out and sell the policy it passed into law. [Obama Administration, United States]

Science Panel Cuts Authorization Levels for Three COMPETES Agencies
The House of Representatives Science and Technology Committee scaled back proposed funding levels for three key science agencies as part of its reauthorization of the America COMPETES Act. [The House of Representatives Science and Technology Committee, United States]

Commission to Boost Research and Innovation by Making it Easier to Apply for and Manage European Union Grants
The European Commission has unveiled a plan to simplify the procedures for taking part in European Union-funded research projects. [European Research, Innovation and Science Commission, European Union]

$11.5M for Stem Cell Therapy Research
Ontario's provincial government has announced $11.5 million in funding support for researchers at McMaster University, who are developing stem cell-based therapies. [Global Leadership Round in Genomics & Life Sciences, Canada]

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CIRM Awards $28 Million to Answer Fundamental Questions in Stem Cell Biology
At a meeting at the City of Hope, the governing board of the California Institute for Regenerative Medicine (CIRM), the state stem cell agency created by Proposition 71, approved funding $28 million to support 16 Basic Biology II Awards that answer fundamental questions about stem cell biology and one Leadership Award. [California Institute for Regenerative Medicine Press Release]

Cellular Dynamics Raises $40.6 MM to Revolutionize Pharma Drug Research with Industrial Manufacture of Human Heart and Other Cells
Cellular Dynamics International, Inc. has closed on a $40.6 million Series B private equity round. This financing enables the company to increase production capacity for its iCell™ Cardiomyocytes, human heart cells derived from induced pluripotent stem cells, and to launch additional human tissue cell products for biomedical and pharmaceutical drug development and safety research. [Cellular Dynamics International, Inc. Press Release]

BioTime, Inc. Announces Completion of ES Cell International Pte Ltd Acquisition
BioTime, Inc. announced that it has completed its acquisition of the Singapore company ES Cell International Pte Ltd. [BioTime, Inc. Press Release]

The New York Stem Cell Foundation and the Johns Hopkins University School of Medicine to Collaborate on Stem Cell Research
The Johns Hopkins University School of Medicine and The New York Stem Cell Foundation are establishing a collaborative program to advance the development and use of stem cells in therapies for a wide range of diseases. [The New York Stem Cell Foundation Press Release]

Cipla Ties Up with Stempeutics for Stem Cell Therapies
Cipla, the largest domestic drug manufacturer, has tied up with the Manipal Group-promoted Stempeutics Research to market stem cell-based therapies. [Business Standard]

Vitro Forms Strategic Alliance with a Leading Stem Cell Company
Vitro Diagnostics, Inc. announced that it signed a contract to jointly manufacture and distribute stem cell analysis tools with HemoGenix®, Inc., a leading firm known for its pioneering analysis of stem cells. [Vitro Diagnostics, Inc. Press Release]

ProBioGen Signs Therapeutic Protein Process Development Contract with Virdante Pharmaceuticals
ProBioGen will contribute producer cell line development and process engineering for one of Virdante’s proprietary therapeutic proteins. [ProBioGen AG Press Release]

Pluristem Therapeutics Announces Interim Top-Line Results from PLX–PAD Clinical Trials
Pluristem Therapeutics Inc. announced interim top-line results from its Phase I clinical trials utilizing its placenta-derived cell therapy product, PLX-PAD, for the treatment of critical limb ischemia, the end-stage of peripheral artery disease. [Pluristem Therapeutics, Inc. Press Release]

Advanced Cell Technology’s Studies to Support Phase I Multicenter Trial of Patients with Stargardt’s Macular Dystrophy Demonstrate Excellent Safety Profile
Advanced Cell Technology, Inc. announced that it has completed key animal studies in connection with its Phase I multicenter study using embryonic stem cell derived Retinal Pigment Epithelium cells to treat patients with Stargardt’s Macular Dystrophy. [Advanced Cell Technology, Inc. Press Release]

Kiadis Pharma Provides ATIR™ Update: Two Year Follow-Up Data Show No Cases of Transplant Related Mortality
FDA grants ATIR™ orphan drug status as a medicinal cell based therapy to reduce transplant related mortality. [Kiadis Pharma Press Release]

Bristol-Myers Squibb Receives Complete Response Letter from FDA for Belatacept
Bristol-Myers Squibb Company announced that the U.S. Food and Drug Administration (FDA) has issued a complete response letter regarding the Biologics License Application for belatacept in kidney transplantation. [Bristol-Myers Squibb Company Press Release]

NeoStem, Inc. Officially Launches Adult Stem Cell Collection Center and R&D Laboratory in Cambridge, Massachusetts
NeoStem, Inc. announced the official launch of the Company's Adult Stem Cell Collection Center and Research & Development laboratory at the Company's 8,000 square foot facility at the Riverside Technology Center in Cambridge, Massachusetts. [NeoStem, Inc. Press Release]

Opexa Strengthens Management Team with Hire of Cell Therapy Expert
Opexa Therapeutics, Inc. announced the hiring of an experienced cell therapy immunologist to lead the Company's research and development efforts including the further development of Tovaxin. [Opexa Therapeutics, Inc. Press Release]

UNMC Researcher Begins Work on New Embryonic Stem Cell Line
A University of Nebraska Medical Center (UNMC) researcher has obtained one of the first new human embryonic stem cell lines approved for use by the National Institutes of Health since President Obama ordered an update of the federal stem cell research guidelines. [University of Nebraska Medical Center Press Release]

Geron Comments on Decision by U.S. PTO on Wisconsin Alumni Research Foundation Patent
Geron Corporation announced today that the Board of Patent Appeals and Interferences of the U.S. Patent Office has reversed an earlier decision from the Patent Office reexamination division that had upheld the claims of U.S. Patent Number 7,029,913. [Geron Corporation Press Release]

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Statement of NIH Director on Federal Funding for Embryonic Stem Cell Lines
National Institutes of Health Director Francis S. Collins, M.D., Ph.D., announced that 13 additional human embryonic stem cell lines have been approved for federal funding and added to the NIH Stem Cell Registry.

Final Opportunity to Attend a 2010 NIH Regional Seminar on Program Funding & Grants Administration: Register Now for Portland, OR (June 24-25, 2010) (NOT-OD-10-092)

Frequently Asked Questions (FAQ) for: Centers of Research Translation (CORT) (P50) RFA-AR-11-002 (NOT-AR-10-035)

Ruth L. Kirschstein National Research Service Awards (NRSA) for Individual Predoctoral Fellows in PharmD/PhD Programs (F31) (PA-10-178)

Extension of Expiration Date for PA-07-277, PA-06-367, and PA-06-368: Research on Ethical Issues in Human Subjects Research (NOT-OD-10-086)


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

May 7, 2010: Vaccines and Related Biological Products Advisory Committee Meeting Announcement



FDA Conducting Safety Review of Commonly Used Prostate Cancer Drugs
Gonadotropin-Releasing Hormone (GnRH) agonists, a class of medications primarily used to treat men with prostate cancer, have been associated with a small increased risk for diabetes, heart attack, stroke, and sudden death in men treated with one of the medications, according to a preliminary and ongoing analysis of several studies.

Guidance for Industry: Requalification Method for Reentry of Blood Donors Deferred Because of Reactive Test Results for Antibody to Hepatitis B Core Antigen (Anti-HBc); Availability [Docket No. FDA-2008-D-0263]

Emerging Infectious Diseases: Evaluation to Implementation for Transfusion and Transplantation Safety and Quantitative Risk Assessment: Blood Safety and Availability; Public Workshops [Docket No. FDA-2010-N-0001]

Considerations Regarding Food and Drug Administration Review and Regulation of Articles for the Treatment of Rare Diseases; Public Hearing [Docket No. FDA-2010-N-0218]


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

European Molecular Biology Laboratory Stem Cells, Tissue Homeostasis and Cancer Conference
May 12-15, 2010
Heidelberg, Germany

American Society of Gene & Cell Therapy (ASGCT) 2010 Clinical Trials Training Course and 13th Annual Meeting
May 17-22, 2010
Washington, DC, United States

2010 Mater Medical Research Institute (MMRI) Stem Cell Symposium: Epigenetics, Transcriptomics and Nanobiotechnology of Stem Cells
May 20-21, 2010
Brisbane, Australia

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

ESTOOLS International Scientific Symposium: Stem Cells in Biology and Disease
May 26-28, 2010
Lisbon, Portugal

London Research Institute Stem Cell Club Meeting
May 31, 2010
London, United Kingdom

Regenerative Medicine in 21st Century: Managing Uncertainty at the Global Level Conference
June 9-10, 2010
Madison, United States

8th International Conference on Cell and Stem Cell Engineering
June 11-12, 2010
Dublin, Ireland

Tissue Engineering & Regenerative Medicine International Society (TERMIS) – European Union 2010
June 13-17, 2010
Galway, Ireland

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

XXXIst International Congress of the International Society of Blood Transfusion (ISBT) in joint cooperation with the 43rd Congress of the German Society for Transfusion Medicine and Immunohematology (DGTI)
June 26-July 1, 2010
Berlin, Germany

United Kingdom National Stem Cell Network (UKNSCN) 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 for Cellular Therapy (ISCT) – Europe 2nd Regional Meeting
September 11-14, 2010
Belgirate, Italy

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

Stem Cells USA & Regenerative Medicine Congress 2010
September 13-15, 2010
Philadelphia, United States

Tissue Engineering & Regenerative Medicine International Society (TERMIS) – Asia Pacific 2010
September 15-17, 2010
Sydney, Australia

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

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

American Association of Blood Banks (AABB) Annual Meeting & Cellular Therapy and Transfusion Medicine Expo (CTTXPO) 2010
October 9-12, 2010
Baltimore, United States

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

World Stem Cells & Regenerative Medicine Congress Asia 2010
October 26-29, 2010
Singapore City, Singapore

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

Stem Cell Network 10th Annual Scientific Meeting
November 22-24, 2010
Calgary, Canada

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

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



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