Volume 10.01 | Jan 19

Cell Therapy News 10.01, January 19, 2009
     In this issue: Science | Policy | Business | NIH | CBER | Regulatory
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Top Stories

Osiris and FDA Reach Agreement on Submission of First Marketing Application for a Stem Cell Product: Osiris Therapeutics, Inc. announced recently that it has held a successful pre-Biologics License Application meeting for Prochymal used in the treatment of graft-versus-host disease.


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Cellartis Deposits Cell Lines with U.S. National Stem Cell Bank; All NIH Human Embryonic Stem Cell Registry Lines Now on Deposit at NSCB
The U.S. National Stem Cell Bank has announced that it has received deposits of two human embryonic stem cell lines from Cellartis AB, a biotechnology company based in Sweden.

Penn Researchers Unlock Molecular Origin of Blood Stem Cells
A research team at the University of Pennsylvania School of Medicine, has identified the location and developmental timeline in which a majority of bone marrow stem cells form in the mouse embryo.

University of Ottawa Heart Institute Scientists Successfully Develop Novel Biomaterial to Help Grow New Blood Vessels
Researchers at the University of Ottawa Heart Institute have successfully grown blood vessels in damaged muscle tissue by injecting a biomaterial developed specifically to attract new cells and support regeneration.

IBM Research Creates Microscope with 100 Million Times Finer Resolution than Current MRI
IBM Research scientists, in collaboration with the Center for Probing the Nanoscale at Stanford University, have demonstrated magnetic resonance imaging with volume resolution 100 million times finer than conventional MRI.

Protein’s Essential Role in Repairing Damaged Cells Revealed
University of Michigan researchers have discovered that a key protein in cells plays a critical role in two processes affecting the development of cancer.

International Stem Cell Begins Pre-Clinical Testing of Its Parthenogenetic Stem Cells for Treatment of Retinal Disease
International Stem Cell Corporation has created layered human tissue from its unique parthenogenetic stem cells and transplanted this tissue into animals in pre-clinical trials to establish a potential new treatment for human retinal diseases.

Pluristem Therapeutics Files an IND Application with the FDA to Initiate a Phase I Clinical Trial Utilizing PLX-PAD for Critical Limb Ischemia
Pluristem Therapeutics Inc. announced recently that it has filed an Investigational New Drug application with the U.S. Food and Drug Administration to begin clinical trials with its placental-derived stromal cell product, termed PLX-PAD, for the treatment of critical limb ischemia.


The Use of Human Mesenchymal Stem Cell-derived Feeder Cells for the Cultivation of Transplantable Epithelial Sheets
This report shows the efficacy of using human bone marrow derived mesenchymal stem cells as a source of feeder cells for the cultivation of transplantable corneal epithelial cell sheets.

Cell Therapy Generates a Favourable Chemokine Gradient for Stem Cell Recruitment into the Infarcted Heart in Rabbits
This study evaluated the effect of cell therapy using bone marrow stromal cells on an SDF-1 gradient in post-infarction rabbits.

Establishment and Characterization of Hepatic Stem-like Cell lines from Normal Adult Rat Liver
To investigate the mechanism of liver regeneration in vitro, the researchers established hepatic stem cell lines named HY1, HY2 and HY3, derived from a healthy liver of adult rat.

Human Embryonic Stem Cells with Maintenance under a Feeder-Free and Recombinant Cytokine-Free Condition
This paper investigated whether human embryonic stem cells could be maintained under a feeder-free condition without using recombinant cytokines if sizes and numbers of embyronic stem cell colonies were kept within an appropriate range.

Wnt3a Deficiency Irreversibly Impairs Hematopoietic Stem Cell Self-renewal and Leads to Defects in Progenitor Cell Differentiation
This paper studied a mouse deficient for a Wnt gene that seemed to play a nonredundant role in hematopoiesis.

A Forum for International Leaders

Contributing to the Future of Regenerative Medicine
February 25- 27, 2009 | San Francisco, California

– Address the topics central to the theme of regenerative medicine
– Network with prominent researchers, clinicians, businessmen, and regulators at the cutting edge of their respective fields
– Develop strategies to enable the rapidly expanding therapeutic potential of regenerative medicine
Advance registration Discount Expires Friday, January 23!

Register now and save $200! www.TheStemCellsCongress.com

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Bush Reflects on Health Policy, Defends Stem Cell Decision
In his final weeks in office, the president also acknowledges he fell short in his attempts to change the political tone in Washington.

Japanese Ministry Set to Boost Stem Cell Patent Support
The Education, Science and Technology Ministry has decided to expand support for universities and research institutions bidding to patent technologies and ideas used in their studies on induced pluripotent stem cells, officials said.

MPs to Investigate Stem Cell Funding Row
The two research councils that have turned down requests to fund stem cell studies using human-animal “hybrid” embryos are to be questioned by MPs on both sides of the House of Commons to explain why they have refused to issue the grants.


Cytori Forms Commercialization Partnership with GE Healthcare
Cytori Therapeutics recently announced the formation of a partnership with GE Healthcare to commercialize Cytori’s Celution System in select European countries.

Wyeth Pharmaceuticals and Santaris Pharma Announce Strategic Alliance to Develop RNA-based Medicines
Wyeth Pharmaceuticals and Santaris Pharma recently announced that the companies have entered into a worldwide strategic alliance to discover, develop and commercialize new medicines based on Santaris Pharma’s proprietary Locked Nucleic Acid drug platform.

VistaGen and Capsant Sign Strategic Stem Cell Technology Commercialization Agreement
VistaGen and Capsant have signed a strategic commercialization agreement under which the companies will combine their leading-edge stem cell biology and 3D cell culture platforms, respectively, to advance their mutual business interests worldwide.

Cellartis, WARF Sign License Agreement for Human Embryonic Stem Cells
Cellartis AB and the Wisconsin Alumni Research Foundation announced recently that they have signed a license for hES patents that enables Cellartis to commercialize undifferentiated hES cell products in the U.S.

Roche Stands by Dividend as Genentech Talk Swirls
Swiss drug maker Roche reaffirmed its dividend policy on Monday, dismissing talk it might sacrifice payouts to help fund a sweetened offer for the remainder of U.S. biotech giant Genentech.

Researcher Wins $1.2 Million Grant for Gene Regulation Work
Jamila Horabin, associate professor of biomedical sciences at the College of Medicine, has received a four-year, $1.2 million grant to pursue her work on RNA silencing and the genetic master switch controlling the sex determination process in fruit flies.

California Panel Warns Stem Cell Agency Board Member
A California ethics panel has chided a member of the state’s stem cell agency board for trying to influence funding for a La Jolla research institute he leads.

BioE Receives FDA 510(K) Clearance for Cord Blood Processing System
BioE Inc. announced recently it received 510(k) clearance from the U.S. Food and Drug Administration for its PrepaCyte-CB Processing System for umbilical cord blood.

Bioheart Files for Reimbursement Approval in Switzerland for MyoCell(R) Myogenic Stem Cell Therapy for Heart Failure
Bioheart, Inc. announced recently it has filed with appropriate agencies in Switzerland for reimbursement approval for its MyoCell(R) myogenic cell therapy for heart failure.


Biennial Report of the Director, National Institutes of Health, Fiscal Years 2006 & 2007

Salary Limitation on Grants, Cooperative Agreements and Contracts Under the Current Continuing Resolution (NOT-OD-09-037)

Centers of Biomedical Research Excellence (COBRE) (P20) (PAR-09-079)


Draft Guidance for Industry: Current Good Tissue Practice (CGTP) and Additional Requirements for Manufacturers of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) – 1/16/2009



Study Criticizes FDA’s Screening System
Missing information, loopholes and weak oversight hamper efforts to uncover financial conflicts involving researchers who test experimental drugs before companies seek government approval, an internal watchdog finds.

Frank Torti, Science Guy, Named Acting FDA Commissioner
The new guy, Frank Torti will take over as acting commissioner next week, when Obama’s sworn in and current commissioner Andrew von Eschenbach steps down.

FDA Announces Two Appointments
Commissioner of Food and Drugs Andrew C. von Eschenbach, M.D., recently announced the appointments of Lou Valdez as associate commissioner for international programs, and of Lori Davis as chief information officer.

Agency Information Collection Activities; Proposed Collection; Comment Request; Filing Objections and Requests for a Hearing on a Regulation or Order

Guidance for Clinical Investigators, Sponsors, and Institutional Review Boards on Adverse Event Reporting Improving Human Subject Protection; Availability , 2599–2600 [E9–683]

FDA Issues Final Guidance on Regulating Genetically Engineered Animals

Current Good Tissue Practice (CGTP) and Additional Requirements for Manufacturers of Human Cells, Tissues, and Cellular and Tissue–Based Products, 3055–3056 [E9–919]

Draft Guidance for Industry: Submission of Laboratory Packages by Accredited Laboratories; Availability

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