Volume 10.41 | Oct 19

Cell Therapy News 10.41, October 19, 2009.
     In this issue: Science | Policy | Business | NIH | CBER | Regulatory
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Top Stories

Bone Graft Grown in Exact Shape of Complex Skull-Jaw Joint: Technique could be a preferred substitute for replacing missing or damaged bones with titanium, donated bones or those harvested from elsewhere in a patient’s body. [Columbia University, New York]


Complimentary Webinar: ALDEFLUOR®-and Cancer Stem Cells

Harvard Team Reports Major Step Forward in Cell Reprogramming
Researchers have found that one chemical can replace two of the genes required in producing induced pluripotent stem cells. [Harvard Stem Cell Institute, Boston]

Research Shows Stem Cells Do Not Respond to DNA Damage
A team of researchers has demonstrated that unexpectedly the damage checkpoint in the cell cycle slows but does not prevent damaged human embryonic stem cells from replicating. [The University of Texas at San Antonio, San Antonio]

Bioengineered Stem Cells May Offer New Hope for Pancreatic Cancer Patients
Bioengineered construct were used in a treatment targeting pancreatic cancer were made of engineered, bone marrow-derived mesenchymal stem cells and a gene product toxic to tumor growth that is expressed when the tumor actively recruits the stem cells. [Massachusetts General Hospital, Boston]

What Drives Our Genes? Salk Researchers Map the First Complete Human Epigenome
Researchers at the Salk Institute provide the first detailed map of the human epigenome, the layer of genetic control beyond the regulation inherent in the sequence of the genes themselves. [Salk Institute for Biological Studies, La Jolla]

‘Spaghetti’ Scaffolding Could Help Grow Skin in Labs
Researchers at the University of Bristol have taken a novel biologically-inspired track for the production of synthetic biocompatible hydrogels, which could be used to grow new tissues tailored to the needs of individual patients. [University of Bristol, Bristol]

Wayne State Study Shows Adult Stem Cell Grafts Help Paralyzed
A recent study details the outcome of adult stem cell grafts in spinal cord injuries and how that procedure led to increased mobility and quality of life for the participating patients. [Wayne State University School of Medicine, Detroit]

New Strategy for Mending Broken Hearts?
In a series of experiments using mouse embryonic stem cells, the bioengineers used a novel mold of their own design to fashion a three-dimensional “patch” made up of heart muscle cells, known as cardiomyocytes. [Duke University, Durham]

Gene Therapy for Parkinson’s “Encouraging” in Early Trials
A gene therapy for Parkinson’s disease that has been tested on lab monkeys is showing good early results in a small-scale trial on humans. [Henri Mondor Hospital, Paris]

Stem Cells Offer New Hope for Kidney Disease Patients
The researchers found that stem cells derived from adult bone marrow are equally useful as embryonic stem cells in the treatment of Alport syndrome, a genetic kidney disease. [Harvard Medical School, Boston]

Doctors Grow Facial Bone in Groundbreaking Procedure
In a first-of-its kind procedure, physicians have used stem cells taken from the fat tissue of a 14-year-old boy and combined them with growth protein and donor tissue to grow viable cheek bones in the teen. [Cincinnati Children’s Hospital Medical Center, Cincinnati]

California Stem Cell, Inc. and Families of Spinal Muscular Atrophy Announce Completion of Pre-IND Meeting with FDA for Stem Cell-derived Therapy for the Treatment of Spinal Muscular Atrophy Type I
California Stem Cell, Inc. and Families of Spinal Muscular Atrophy announced recently that they have completed a formal pre-Investigational New Drug meeting to initiate human trials for a stem cell-derived motor neuron replacement therapy for Spinal Muscular Atrophy Type I. [California Stem Cell, Inc., Irvine]

Cardio3 BioSciences Treats Its First Patient with C-Cure(R), a Second-Generation Stem Cell Derived Therapy for Heart Failure
The patient is participating in a Phase II/III clinical study, to assess ‘cardiopoietic’ cells generated from a patient’s own bone marrow, for patients with heart failure. [Cardio3 BioSciences, Mont-Saint-Guibert]

Adipose-Derived Stem and Regenerative Cells Show Potential in First-in-Man Treatment of Stress Urinary Incontinence
Cytori was informed that stem and regenerative cells from a patient’s own fat tissue were used to treat stress urinary incontinence as part of an investigator-initiated five patient pilot study in Japan. [Cytori, San Diego]


Generation of Medaka Fish Haploid Embryonic Stem Cells
Here, the researchers generated gynogenetic medaka embryos and obtained three haploid ES cell lines, elusive for culture that retained pluripotency and competitive growth. [Science]

Forward Programming of Pluripotent Stem Cells Towards Distinct Cardiovascular Cell Types
Here the scientists demonstrate that forced expression of Nkx2.5 similar to MesP1 is sufficient to enhance cardiogenesis in murine embryonic stem cells. [Cardiovasc Res]

Short-Term Thalidomide Incorporated into Double Autologous Stem-Cell Transplantation Improves Outcomes in Comparison With Double Auto-transplantation for Multiple Myeloma
To assess potential benefits with thalidomide incorporated into double autologous stem-cell transplantation for younger patients with newly diagnosed multiple myeloma. [Am J Clin Oncol]

Inhibition of Caspase-mediated Anoikis is Critical for bFGF-sustained Culture of Human Pluripotent Stem Cells
By using the defined mTeSR1 medium and collecting freshly detached cells, the researchers found here that human pluripotent stem cells including embryonic stem cells and induced pluripotent stem cells are subject to constant anoikis in culture. [JBC]


Technical Support Representative – France (STEMCELL Technologies)

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Manager, Market Segment Regenerative Medicine (Sigma-Aldrich Corporation)

Technical Specialist (AABB)

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A Clear Line on Stem Cells
The Stem Cell Research Enhancement Act of 2009 will be introduced shortly codify Mr. Obama’s executive order permitting federal funding of such research within guidelines established by the NIH.

Court Asked to Overturn Obama’s Decision to Fund Embryonic Stem Cell Research
A hearing was held Wednesday to reinstate a ban on taxpayer funds being used for embryonic stem cell research.

Nebraska University Regents Won’t be Pressured to Act on Stem Cells
Members of the University of Nebraska Board of Regents are under increasing pressure to decide whether NU’s medical scientists should be able to go along with newly relaxed federal rules on embryonic stem-cell research.


STEMCELL Technologies Inc. Announces Release of Defined, Animal-Protein Free Maintenance Medium for hESCs and hiPSCs
STEMCELL Technologies Inc. (STEMCELL) is pleased to announce the release of TeSR™2, a defined, animal-protein free maintenance medium for human embryonic and induced pluripotent stem cells.

DARA BioSciences and America Stem Cell Enter Into Amendment to Material Transfer Agreement
Under the Material Transfer Agreement, the Company is providing ASC with dipeptidylpeptidase inhibitors from its proprietary library which ASC is using to further its research and development program related to hematopoietic stem cell transplants.

Case Western Reserve University School of Medicine Researchers Receive $1.25M from NIMH to Study Schizophrenia
Case Western Reserve University School of Medicine has received $1.25 million from the National Institutes of Mental Health using iPS induced neural cells to study Schizophrenia.

New BioTime Subsidiary, OncoCyte Corporation, Receives $2 Million Equity Financing to Develop Cancer Treatments Using Stem Cell Technology
OncoCyte plans to develop genetically modified stem cells capable of homing to malignant tumors based upon human embryonic stem cell technology.

Bio-Matrix Scientific Group, Inc. to Aggressively Pursue Private and Public Grants to Fund Research for Development of Stem Cell Treatment of Chronic Obstructive Pulmonary Disease
Bio-Matrix Scientific Group announced recently that it has retained a private grant research and development firm to aggressively pursue both private and public sector grant funding of research in the area of Stem Cell Therapy for Chronic Obstructive Pulmonary Disease.

Stemedica Completes Meeting with the FDA
Stemedica Cell Technologies, Inc. announced that it completed its pre-IND meeting with the U.S. Food and Drug Administration regarding a proposed Investigative New Drug to evaluate the safety and efficacy of its high potency proprietary allogeneic mesenchymal bone marrow-derived stem cells as a treatment for ischemic stroke.

Amsterdam Molecular Therapeutics Receives EMEA Orphan Drug Designation for Duchenne Muscular Dystrophy
The European Medicines Agency has granted Orphan Drug Designation to AMT’s gene therapy product AMT-080 for the treatment of Duchenne muscular dystrophy. [Amsterdam Molecular Therapeutics, Amsterdam]

Biotechs Back From the Dead
The financial crisis was supposed to annihilate small companies, but many survived.


NIH Awards Grants to Examine Factors Influencing Women’s Careers in Science
The National Institutes of Health announced today that it will fund 14 grants focusing on factors that influence the careers of women in biomedical and behavioral science and engineering.

Amendment to the Institutional Eligibility Criteria for Ruth L. Kirschstein National Research Service Award (NRSA) Individual Fellowships (NOT-OD-10-004)

Bioengineering Research Grants (BRG)(R01) (PA-10-009)

Exploratory/Developmental Bioengineering Research Grants (EBRG) [R21] (PA-10-010)


Public Workshop: FDA Regulation and Licensure of Whole Blood and Blood Components



2009 Meeting Materials, Vaccines and Related Biological Products Advisory Committee

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