Volume 9.28 | Jul 21

Cell Therapy News 9.28, July 21, 2008
     In this issue: Science | Policy | Business | NIH | CBER | Regulatory
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Top Stories

Stem Cell Study Offers Transfusion Hope: University scientists have used blood stem cells from mice to mimic how we produce blood stem cells and were able to multiply them by 150-times.
Article

Science

Researchers Map Cells’ Inner Landscapes
A team of researchers at the Broad Institute has helped break new ground in stem cell research by mapping regions of cells’ genomes marked by DNA methylation – one of several so-called ‘epigenetic’ modifications.
Article

ReNeuron Announces New Data Regarding its ReNcell(R) Neural Stem Cell Lines
The study undertaken by Dr Alison Wood-Kaczmar, Dr Sarah Tabrizi, Professor Nick Wood and their colleagues at the Institute of Neurology in London, demonstrate how the ReNcell(R)VM cell line can be used to model the pathogenesis of certain inherited forms of Parkinson’s disease.
Article

Mouse miRNA Library to Open
The collection, an initiative of the Sanger Institute in Cambridge, UK, is the first to tackle the nearly 500 miRNAs that scientists have identified in the mouse genome.
Article

Cancer Drug Shows Promise Against Graft-Versus-Host Disease
A new University of Michigan study in mice suggests that a drug recently approved to fight cancer tumors is also able to reduce the effects of graft-versus-host disease, a common and sometimes fatal complication for people who have had bone marrow transplants.
Article

Stem Cell Transplant for Sickle Cell Disease Subject of Clinical Trial
Researchers at Washington University School of Medicine in St. Louis are leading a nationwide, multicenter clinical trial to determine the effectiveness of transplanting blood stem cells from unrelated donors into children with severe sickle cell disease.
Article

Stem Cell Researchers at University of Miami Enrolling Patients in Heart Failure Study
The University of Miami has received approval from the Food and Drug Administration for a study using a Helical Infusion catheter system to inject stem cells into the heart.
Article

FDA Approves ThermoGenesis’ MarrowXpress Device
ThermoGenesis Corp. has received authorization from the U.S. Food and Drug Administration to begin selling a device for separating and storing adult stem cells from bone marrow.
Article

Allen Institute for Brain Science Unveils World’s First Genome-Wide Spinal Cord Atlas
The Allen Institute for Brain Science recently unveiled the groundbreaking Allen Spinal Cord Atlas, the world’s first genome-wide map of the mouse spinal cord. Researchers can immediately access the free online data to advance their research surrounding spinal cord diseases and disorders.
Article

ABSTRACTS, REVIEWS AND SPECIAL REPORTS

Differences in Lymphocyte Developmental Potential Between Human Embryonic Stem Cell and Umbilical Cord Blood-Derived Hematopoietic Progenitor Cells
Here, the researchers demonstrate that despite expressing functional Notch-1, CD34+ cells from hESCs did not derive T cells when co-cultured with OP9 cells expressing Delta-like 1, or in fetal thymus organ culture. hESC-derived CD34+ cells also did not produce B cells in vitro. In contrast, CD34+ cells isolated from UCB routinely generated T and B cells when cultured in the same conditions.
Article

A Multicenter Prospective Phase II Randomized Study of Extracorporeal Photopheresis for Treatment of Chronic Graft-versus-Host Disease
The safety and efficacy of extracorporeal photopheresis for 12 -24 weeks, together with standard therapy was compared to standard therapy alone in patients with cutaneous manifestations of chronic graft-versus-host disease that could not be adequately controlled by corticosteroid treatment.
Article

Standards in Stem Cell Research
Standards in stem cell research help both scientists and regulators to manage uncertainty and the unknown. Efforts to standardise practices across different labs is, however, a balancing act where the autonomy of scientists and fragility of living material need to be weighed against the need for comparable data.
Article

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Policy

Umbilical Cord Stem Cell Ban May be Lifted
Official policy banning the retrieval of cord blood stem cells at Dublin’s three main maternity hospitals could be set to come to an end under new Department of Health plans.
Article

Rules on Use of Human Tissue Stifle Research, Say Scientists
Rules introduced after the Alder Hey hospital scandal to control scientists’ use of human tissue are stifling research, according to a science thinktank whose director describes the regulations as like a “sledgehammer to crack a nut”.
Article

Business

Gamida Cell Signs Collaboration Agreement with Biologics Delivery Systems
Gamida Cell Ltd. announced recently a collaboration agreement with Biologics Delivery Systems Group, Cordis Corporation. Under the terms of the agreement, Biologics Delivery Systems will supply catheters for the upcoming Phase I/II clinical trial of Gamida Cell’s CardioCure product for the treatment of post-myocardial infarction (heart attack) patients.
Article

Cytori Sells First European Union StemSource(R) Bank; Industry Leading Biohellenika of Greece Acquires Exclusive Rights
Cytori sold its first European Union StemSource(R) Cell Bank as part of an agreement with Biohellenika. Biohellenika will be the exclusive provider of the StemSource Cell Bank cryopreservation services in Greece, which is one of the largest markets for cell banking in Europe.
Article

Amsterdam Molecular Therapeutics Starts Collaboration With St. Jude Children’s Research Hospital on Gene Therapy for Hemophilia B
Amsterdam Molecular Therapeutics recently announced the start of a collaboration with St. Jude Children’s Research Hospital in Memphis, Tennessee, USA, on the development of a gene therapy treatment for Hemophilia B. Under the deal, AMT will receive the exclusive commercial rights to the final product.
Article

Alnylam Announces Extension of RNAi Therapeutics Collaboration with Novartis
Alnylam Pharmaceuticals, Inc. announced recently that Novartis has elected to extend the company’s RNAi therapeutics collaboration for an additional year, through October 2009.
Article

International Stem Cell Corporation and Novocell, Inc. Collaborate to Test Human Parthenogenetic Stem Cells for Production of Pancreatic Islet Cells that May be Useful in the Treatment of Diabetes
International Stem Cell Corporation announced recently a collaboration with Novocell Inc. to use ISCO’s human parthenogenetic stem cell lines for differentiation to Human pancreatic islet cells.
Article

MacroGenics Acquires Raven Biotechnologies
MacroGenics, Inc recently announced the acquisition of Raven Biotechnologies, Inc., a privately held biotechnology company focused on the discovery and development of monoclonal antibody therapeutics for oncology through its cancer stem cell program.
Article

Cellumen Spins Off Personalized Medicine Unit as Cernostics Pathology, Inc.
The objective of Cernostics Pathology, Inc. is to become the leading provider of digital imaging pathology and tissue-based diagnostics products and services applied to personalized medicine.
Article

Advanced Cell Technology Running Short of Cash
In a Securities and Exchange Commission filing Tuesday, Advanced Cell Technology Inc. warned that it doesn’t have cash to continue operating after July 31 without raising additional money or drastically slashing operations.
Article

Carolina Mayor Settles SEC Advanced Cell Technology Insider Trading Case
The mayor of Beaufort, South Carolina, has agreed to pay almost $50,000 to settle insider trading charges related to the stock of a California biotechnology company, the U.S. Securities and Exchange Commission said on Wednesday.
Article

Mesoblast Limited Is Granted Key Stem Cell Patent In The United States
Australia’s regenerative medicine company, Mesoblast Limited, recently announced that the United States Patent and Trade Mark Office has granted a key patent, US Patent 7,399,632, through to at least the year 2019.
Article

Consumer Groups File Appeal on Challenge of Human Stem Cell Patent Held by WARF
Two consumer groups recently filed an appeal in their challenge of a controversial patent on human embryonic stem cells held by the Wisconsin Alumni Research Foundation.
Article

Stem Cell Research Expert Dr. Jeanne Loring Joins Histogen Scientific Advisory Board
As founding Director of the Center for Regenerative Medicine at Scripps Research Institute in La Jolla, Calif., Dr. Loring focuses on supporting collaboration and strategic partnerships in human stem cell research, as well as training the next generation of stem cell scientists.
Article

Silence Therapeutics plc CEO Leaves Company
Silence Therapeutics plc announces that for personal reasons, Jeffery Vick, has resigned as Group CEO and left the Company.
Article

NIH

NIH Awards More Than $33 Million to Fund State-of-the-Art Research Equipment
Article

Research on Causal Factors and Interventions that Promote and Support the Careers of Women in Biomedical and Behavioral Science and Engineering (R01)
Link

Translation of Common Disease Genetics into Clinical Applications (R21) (RFA-DK-08-004)
Link

Research on Interventions that Promote Research Careers (R01) (RFA-GM-09-011)
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CBER

Guidance for Industry: Safety, Efficacy, and Pharmacokinetic Studies to Support Marketing of Immune Globulin Intravenous (Human) as Replacement Therapy for Primary Humoral Immunodeficiency
Link

Medical Device Notification (PSN-08-05) Sunquest Laboratory Blood Bank and Blood Donor Modules
Link

Violative Advertising and Promotional Labeling Letter: Coagulation Factor IX (Recombinant) (BeneFIX) – Wyeth Pharmaceuticals, Inc
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Regulatory

FOOD AND DRUG ADMINISTRATION (United States)

FDA Launches Fellowship Program to Develop Pipeline of Scientists, Other Professionals
The U.S. Food and Drug Administration recently announced it is launching a two-year fellowship program aimed at attracting scientists, engineers and health professionals to the agency.
Article

MEDICINES AND HEALTHCARE PRODUCTS REGULATORY AGENCY (United Kingdom)

Field Safety Notices for Medical Devices: Implants, Non Active, Cardiovascular Heart Valves: Biological Heart Valve – Sorin Biomedica Cardio S.r.l. – Freedom Solo
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