Volume 9.24 | Jun 23

Cell Therapy News 9.24, June 23, 2008
     In this issue: Science | Policy | Business | NIH | CBER | Regulatory
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Top Stories

Aastrom to Initiate Phase II Clinical Trial Using Cardiac Repair Cells Derived From Patient’s Own Bone Marrow for Treatment of Severe Chronic Heart Failure: Aastrom Biosciences, Inc., recently announced plans to initiate a 40 patient U.S. Phase II clinical trial to study the use of Cardiac Repair Cells, a mixture of stem and progenitor cells derived from a patient’s own bone marrow, for the treatment of dilated cardiomyopathy, a severe form of chronic heart failure.

VIDEO: Old Muscle Gets New Pep in UC Berkeley Stem Cell Study: In a new study published June 15 in an advanced online issue of the journal Nature, researchers identified two key regulatory pathways that control how well adult stem cells repair and replace damaged tissue. They then tweaked how those stem cells reacted to those biochemical signals to revive the ability of muscle tissue in old mice to repair itself nearly as well as the muscle in the mice’s much younger counterparts.


VIDEO: Adult Stem Cells Aid Fracture Healing; UNC Study Lays Groundwork for Potential Treatments
In an approach that could become a new treatment for the 10 to 20 percent of people whose broken bones fail to heal, researchers at the University of North Carolina at Chapel Hill have shown that transplantation of adult stem cells can improve healing of fractures. The study is the first to visualize the action of transplanted adult stem cells as they mend fractures in mice.

Penn Researchers Find Key Developmental Pathway Activates Lung Stem Cells
Researchers from the University of Pennsylvania School of Medicine found that the activation of a molecular pathway important in stem cell and developmental biology leads to an increase in lung stem cells.

Singapore Scientists Discover a Wealth of Genomic Hotspots in Embryonic Stem Cells Which Will Pave the Way for Important Advancements in Cell Reprogramming, Renewal and Pluripotency
A paper published in Cell on June 13, 2008 describes how Singapore scientists from the Genome Institute of Singapore and the National University of Singapore have successfully unveiled an atlas that shows the location of “genomic hotspots” of essential protein “switches” (transcription factors), which are critical for maintaining the state of embryonic stem cells.

iPS Stem Cell Method Improved
Shinya Yamanaka of Kyoto University and the Gladstone Institute of Cardiovascular Disease – who pioneered the reprogramming method in mice in 2006, then shared the breakthrough in human cells with James Thomson at the University of Wisconsin-Madison – said that he had achieved better results by combining his method with Thomson’s.

Researchers Create Molecule that Nudges Nerve Stem Cells to Mature
Inspired by a chance discovery during another experiment, researchers at UT Southwestern Medical Center have created a small molecule that stimulates nerve stem cells to begin maturing into nerve cells in culture.

Scientists Use ‘Biological Alchemy’ to Convert One Cell Type Into Another
Prof Melton told the annual meeting of the International Society for Stem Cell Research in Philadelphia how he took specialist “pancreatic exocrine cells” that secrete digestive enzymes, which make up to 95 per cent of the pancreas, and converted them directly into another cell type, called beta cells, which make the hormone insulin to control blood sugar levels.

Ability To Track Stem Cells in Tumors Could Advance Cancer Treatments
Using noninvasive molecular imaging technology, a method has been developed to track the location and activity of mesenchymal stem cells in the tumors of living organisms. This ability could lead to major advances in the use of stem cell therapies to treat cancer.

Gene Therapy Improves Survival and Quality of Life of Dogs with Cancer
A new gene therapy has helped pet dogs with cancer live longer and could potentially improve the quality of life and survival of people with cancer, said the therapy’s developers. The single treatment works by increasing muscle strength and correcting common complications of cancer such as weakness, weight loss and anemia, said principal investigator Ruxandra Draghia-Akli, MD, PhD, researcher, VGX Pharmaceuticals Inc., The Woodlands, Tex.

Patient’s Own Infection-Fighting T Cells Put Late-Stage Melanoma into Long-Term Remission – Without Chemotherapy or Radiation
Researchers describe the first successful use of a human patient’s cloned infection-fighting T cells as the sole therapy to put an advanced solid-tumor cancer into long-term remission. A team led by Cassian Yee, M.D., an associate member of the Clinical Research Division at Fred Hutchinson Cancer Research Center, reports these findings in the June 19 issue of the New England Journal of Medicine.

Intensive Induction Therapy Followed by Stem-Cell Support and Consolidation Therapy Produces High Responses in Elderly With Multiple Myeloma
Nearly 90% of elderly patients with newly diagnosed multiple myeloma responded to an intensive sequential treatment regimen of induction therapy with bortezomib, pegylated-liposomal doxorubicin, and dexamethasone followed by autologous stem-cell transplantation, and then consolidation with lenalidomide and prednisone.


Chronic Graft-Versus-Host Disease Following Umbilical Cord Blood Transplantation: Retrospective Survey Involving 1,072 Patients in Japan
The researchers investigated chronic Graft-Versus-Host Disease after cord blood transplantation’s clinical features in 1,072 Japanese patients with hematologic malignancies transplanted through the Japan Cord Blood Bank Network. The primary end point was to investigate the incidence of any chronic Graft-Versus-Host Disease.

BIO Chief Talks About Industry’s Concerns
The biotechnology industry considers funding for the Food and Drug Administration and the National Institutes of Health, as well as rules for making generic drugs, as its top political issues this year, said James Greenwood, who heads the national Biotechnology Industry Organization.

Stem Cell Field Grows Despite Controversy: Experts
Political controversy may have slowed the pace of stem cell science, but the field is still promising enough to attract many talented researchers, stem cell experts said on Saturday.


GMP Facility Quality Assurance

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Lead Clinical Laboratory Scientist

Adult Stem Cell Biology Researcher

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Market Development Manager – Americas

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Human Application Laboratory Opportunities


International Committee Recommends Stringent Guidelines for Translating Stem Cell Therapies from the Lab Bench to the Bedside
At the sixth annual meeting of the International Society for Stem Cell Research, a task force of leaders in the field announced a draft set of guidelines to ensure that rigorous best practices are applied to the clinical translation of stem cell research from the laboratory to human subjects.

Bishops Condemn Stem Cell Research
Catholic bishops on Friday condemned the destruction of human embryos for stem cell research as a “gravely immoral act” in the organization’s first formal statement on the issue.

Maryland Joins Sprint to Lead in Biotechnology
Gov. Martin O’Malley Monday unveiled a proposal to invest $1.1 billion over the next decade to cement Maryland’s status as a pre-eminent hub for biotechnology research, including stem cell studies aimed at finding breakthrough medical advances.

Massachusetts to Spend $1 Billion on Biotechnology
Massachusetts Gov. Deval Patrick signed a bill on Monday that will direct $1 billion of state funds toward biotechnology over 10 years, aiming to fill a federal funding shortfall caused by White House opposition to embryonic stem cell research.

Canadian Stem cell Research Gets a $1M boost
Ontario grant will fund Toronto lab, U.S. partner doing cutting-edge work on skin reprogramming.

California Stem Cell Effort Receives Help From Australia, Canada
Australia and Canada pledged their support to California’s stem cell initiative June 18 with partnerships intended to spur innovative stem cell research. Canada said it would donate an initial $100 million over three years to the Canadian Cancer Stem Cell Consortium, which will work in tandem with the California Institute for Regenerative Medicine, an initiative established in 2004 after voters approved Proposition 71.


Cytori Selected by Fraunhofer Society to Develop New Stem and Regenerative Cell-Based Treatments for Stroke
Cytori Therapeutics and the Fraunhofer Institute for Cell Therapy and Immunology formed collaboration to develop adipose-derived stem and regenerative cell-based treatments for ischemic stroke. The Fraunhofer Society will commit $425,000 over two years in support to Cytori’s already planned research and development.

MedCell and NovaThera Combine Forces for Musculoskeletal Regeneration
MedCell Bioscience Ltd, recently announced its merger with NovaThera Ltd. NovaThera brings two key platform technologies to the new company: TheraGlass(R) a novel bioactive glass: and the NovaPod(TM), a revolutionary rotating bio-processor. MedCell will continue to further develop its MS-Ten programme. This technology harnesses the plasticity of autologous mesenchymal stem cells to promote tendon and ligament regeneration, in humans.

The Gladstone Institutes and iZumi Bio Announce Broad Partnership in Regenerative Medicine and Cardivascular Disease
iZumi Bio, Inc. and The J. David Gladstone Institutes, have announced a major research collaboration and licensing agreement to focus on applications for induced pluripotent stem cells.

Israeli Government Chief Scientist Office Awards $870,000 Grant to BrainStorm Cell Therapeutics for the Second Consecutive Year
BrainStorm Cell Therapeutics Inc. announced recently that the company has been awarded a grant from Israel’s prestigious Chief Scientist Office.  The company will receive approximately $870,000 over the remainder of the current fiscal year to fund the continuing development of treatments for ALS and Parkinson’s disease.

Stem Cell Sciences Licenses-In Fluorescent Protein Technology to Enhance Stem Cell Research Tools and Services Offerings
Stem Cell Sciences plc, recently announced the licensing of certain rights to green fluorescent protein technology from Prolume Ltd.

Court Determines That University of Pittsburgh and Artecel Have Sole Rights to Adipose-Derived Stem Cell Patent
Artecel, Inc., announced recently that the patent inventorship litigation concerning the foundational, composition-of-matter patent covering stem cells isolated from adipose tissue has been decided in favor of Artecel’s licensor, the University of Pittsburgh and against Cytori Therapeutics’ licensor, the University of California.


NIGMS National Centers for Systems Biology (P50) (RFA-GM-09-009)

Integrative Systems Biology Approaches to Auditory Hair Cell Regeneration (R21) (PA-08-176)


Impact of Severe Weather Conditions on Biological Products



Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; State Petitions for Exemption From Preemption

FDA Hopes to Open China Offices by Year End
China has granted diplomatic approval for the U.S. Food and Drug Administration to open three inspections offices in China that also will help increase China’s capacity for safe foods, drugs and medical devices, a top Bush cabinet official said on Tuesday.