Volume 9.18 | May 12

Cell Therapy News 9.18, May 12, 2008
     In this issue: Science | Policy | Business | NIH | CBER | Regulatory
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Top Stories

UC Davis Stem Researchers Demonstrate Safety of Gene Therapy Using Adult Stem Cells: A new study by UC Davis researchers provides evidence that methods using human bone marrow-derived stem cells to deliver gene therapy to cure diseases of the blood, bone marrow and certain types of cancer do not cause the development of tumors or leukemia.


In Vitro and In Vivo Bioluminescence Reporter Gene Imaging of Human Embryonic Stem Cells (VIDEO)
With the growing interest in stem cell therapies, molecular imaging techniques are ideal for monitoring stem cell behavior after transplantation. Using Luciferase reporter genes, researchers at the Stanford University School of Medicine demonstrate how to track hESC proliferation in a living mouse.

Findings Indicate How Gene Transcription is Controlled in Embryonic Stem Cells
Association determines fate in embryonic stem cells, said Baylor College of Medicine researchers in a report that appears in the current issue of the journal Nature Cell Biology.

New Technology Tests Maturity Of Stem Cells
Stem cells can differentiate into 220 different types of body cell. The development of these cells can now be systematically observed and investigated with the aid of two new machines that imitate the conditions in the human body with unprecedented accuracy.

Bone Marrow Treatments Restore Nerves
Patients who got bone marrow stem-cell transplants – similar to those given to leukemia patients – have enjoyed a mysterious remission of their multiple sclerosis.

Scientists Tackle Sport’s Achilles’ Heel
A team of Scottish researchers used stem cells to create the artificial tendon, which they believe will offer new hope of recovery to injured sportsmen and women.

Skin Flaps Deliver Cancer-Fighting Therapy
Using gene therapy, plastic surgeons have delivered cancer fighting proteins through skin flaps placed on cancerous tumors on rats with a 79 percent reduction in tumor volume, according to a study in the May issue of Plastic and Reconstructive Surgery.

Early Study Results Show New Stem Cell Treatment Successfully Treats Critical Limb Ischemia Patients
The “BONe Marrow Outcome Trial-2” is a randomized, controlled, double-blinded study treating patients with end-stage peripheral vascular disease (Critical Limb Ischemia, or CLI), using a cellular composition of autologous stem cells.

Osiris Receives Approval for Use of Prochymal (TM) Under FDA Expanded Access Treatment Program
Osiris Therapeutics, Inc. recently announced it hsa been given clearance by the U.S. Food and Drug Administration to initiate an expanded access treatment program for Prochymal, making the investigational stem cell product available to children with life-threatening Graft vs. Host Disease.


Lymphoid Enhancer Factor 1-Mediated Wnt Signaling Promotes the Initiation of Trophoblast Lineage Differentiation in Mouse Embryonic Stem Cells
Embryonic stem cells can differentiate into all three embryonic germ layers but rarely into trophectoderm lineages that contribute to the placenta, although trophectoderm differentiation can be initiated by genetic manipulation of key genes involved in trophectoderm development. The researchers demonstrate that Wnt signaling can initiate trophectoderm lineage differentiation by triggering an appropriate cue, caudal-related homeobox 2.

Reprogrammed Mouse Fibroblasts Differentiate into Cells of the Cardiovascular and Hematopoietic Lineages
Forced expression of the four transcription factors Oct4, Sox2, c-Myc, and Klf4 is sufficient to confer a pluripotent state upon the murine fibroblast genome, generating induced pluripotent stem cells.

Comparison of Reporter Gene and Iron Particle Labeling for Tracking Fate of Human Embryonic Stem Cells and Differentiated Endothelial Cells in Living Subjects
In this study, human embryonic stem cells were stably transduced with a lentiviral vector carrying a novel double-fusion reporter gene that consists of firefly luciferase and enhanced green fluorescence protein. Reporter gene expression had no adverse effects on cell viability, proliferation, or differentiation to endothelial cells (human embryonic stem cell-derived endothelial cells).


Lead Clinical Laboratory Scientist

Adult Stem Cell Biology Researcher

Operations Manager

Market Development Manager – Americas

Field Applications Specialist

Product Development Associate

Human Application Laboratory Opportunities

Cellular Therapy Laboratory Manager

Cellular Therapy Laboratory Manager

Stem Cell Laboratory Medical Technologist

Stem Cell Laboratory Supervisor

Quality Management Supervisor

Medical Director


Medical Society Takes ‘Neutral’ Position on Stem Cell Ballot Initative
In its most heated discussion, the doctors abandoned its policy supporting the expansion of embryonic stem cell research that’s been in place since 2003, take a neutral position and provide the membership with definitions, research studies and ethical considerations in educational settings over the next year.

Missouri Judge Rewrites Part of Proposed Stem Cell Amendment
Both opponents and supporters applauded a judge’s decision May 2 to rewrite part of a proposed constitutional amendment banning a particular type of embryonic stem cell research.

Minnesota State House Approves Stem Cell Measure
A bill clarifying that the University of Minnesota can use state taxpayer funds for embryonic stem cell research gained House approval Wednesday.

California Stem Cell Agency, Donors and 12 California Institutions Commit $1.1 Billion to Increase the Capacity for Stem Cell Research in California
The governing board of the California Institute for Regenerative Medicine voted recently to distribute $271 million to 12 institutions to build steam cell research facilities throughout California.

UK Second Reading of Human Fertilisation and Embryology Bill (STREAMING)
Follow the Second Reading of the Human Fertilisation and Embryology Bill in the House of Commons live at 3:30pm on Monday 12th May.


StemSoft Gains ISBT 128 Vendor Certification
StemSoft Software Inc, a company dedicated to providing software solutions that meet the needs of researchers and clinicians involved in cell-based processing, manipulation, and therapies is pleased to announce that the next release of StemLab, version 3.3, will include the ability to read and generate ISBT 128 Identification Numbers and bar codes.

Invitrogen and WARF Sign License Agreement for Human Embryonic Stem Cells
Invitrogen Corporation, a provider of essential life science technologies for research, production and diagnostics, and the Wisconsin Alumni Research Foundation, the private, non-profit patenting and licensing organization for the University of Wisconsin-Madison, announced recently that they have signed a license for human embryonic stem cell patents for the development of research tools.

Osiris and NuVasive Enter into Definitive Agreement for Osteocel(R)
Osiris Therapeutics, Inc. recently announced that it has entered into a definitive agreement with NuVasive, Inc. to sell Osiris’ Osteocel business for up to $85 million in upfront and milestone payments.

New Venture for Therapy with Cord Blood and Adult Stem Cells
Professor Colin McGuckin, Chair in regenerative medicine at Newcastle University and the Fondation Jerome Lejeune in Paris has announced the formation of a new venture ‘Novussanguis’ to promote responsible research on cord blood and adult stem cells.

Stratatech Awarded $1,186,000 NIH Grant
Stratatech Corporation has received a $1,186,000 Phase II STTR Grant from the National Institute of Aging.  Under this Grant, Stratatech will continue its work to develop cell-based gene therapy products for the use in the treatment of chronic skin ulcers, such as venous stasis and pressure ulcers, which are particularly problematic for the aged population. 

Scientists to Develop Stem Cell Therapies to Mend Livers and Bones
The research is the one of two projects at the University of Edinburgh receiving a total of £3.6 million from Scottish Enterprise, the Medical Research Council, in collaboration with the UK Stem Cell Foundation. The second, which also involves embryonic stem cells, will look at new ways to repair damaged bone and cartilage.

BioLife Solutions Announces FDA Master File Acceptance for CryoStor(TM) Pre-formulated Cryopreservation Media
BioLife Solutions Inc. recently announced that its Master File for CryoStor cryopreservation media has been accepted by the United States Food and Drug Administration.

Secure Medical CEO John Rao Joins Histogen Board of Directors
Histogen, Inc. has announced that John Rao, founder and CEO of Secure Medical Inc., a medical technology company, has joined Histogen’s Board of Directors.

ImmuneRegen(R) Appoints Renowned Hematologist Ivan N. Rich, Ph.D. to Advisory Board 
ImmuneRegen BioSciences, Inc., a wholly owned subsidiary of IR BioSciences Holdings, Inc. has announced it has appointed Ivan N. Rich, Ph.D., to its advisory board.

Neuralstem Sues StemCells, Inc. Over New Patent
Stem cell company Neuralstem, Inc. is filing suit against StemCells, Inc. stating, among other things, that StemCells intentionally withheld crucial information highly material to the patentability of StemCells’ “new” patent (US Pat No. 7,361,505) and that this was done with the intent to deceive the United States Patent Office in order to get the ‘505 patent allowed.

Living Cell Technologies Prepares to List on the International OTCQCX in the USA
Living Cell Technologies Limited recently announced it has applied to list its American Depository Receipt program on the International OTCQX to increase the Companys exposure to U.S. investors.


Limited Competition:  Renewal of Centers of Biomedical Research Excellence (COBRE)[P20] 
The objective of the Centers of Biomedical Research Excellence initiative is to strengthen an institution’s biomedical research infrastructure through the establishment of a thematic, multi-disciplinary center and to enhance the ability of investigators to compete independently for National Institutes of Health individual research grant or other external peer-reviewed support.


Licensed Products and Establishments List – Update

Safety Surveillance for Licensed Biological Products at FDA’s Center for Biologics Evaluation & Research

CBER Safety Initiatives: Tissue Safety Team

Blood Safety Team



Agency Information Collection Activities: Proposed Collection;Comment Request; Guidance for Industry: Fast Track Drug Development Programs: Designation, Development, and Application Review

Guidance for Industry and Food and Drug Administration Staff; Administrative Procedures for CLIA Categorization; Availability

FDA Official Sees Push for Clinical Trial Rules
The FDA and the HHS Office for Human Research Protections are working on a final rule for registering institutional review boards, the first of the FDA’s efforts to issue regulations instead of guidances for clinical trials.


14th ISCT Annual Meeting

May 17-20, 2008
Downtown Miami, Florida

Full details at: www.celltherapysociety.org

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