Volume 8.02 | Jan 22

Volume 8.02, January 22, 2007
     In this issue: Science | Policy | Business | NIH | CBER | Regulatory
Cell Therapy News on Facebook  Cell Therapy News on Twitter

Top Stories

Blood Stem Cells Make Mouse Bone Marrow, Brain Cells: Stem cells taken from bone marrow replenished the radiation-ravaged immune systems and bone marrow of mice and can also make brain and liver cells.
Article

Osiris Therapeutics Receives European Orphan Drug Designation for PROCHYMAL(TM): Osiris Therapeutics, Inc. has announced that it has received Orphan Drug designation from the European Medicines Agency (EMEA) for PROCHYMAL(TM), an adult stem cell product in Phase III pivotal trials for the treatment of acute Graft vs. Host Disease or GVHD.
Article

Science

Stem Cell Marker Identified in Head and Neck Cancer
Researchers have found a marker on head and neck tumor cells that indicates which cells are capable of fueling the cancer’s growth. The finding is the first evidence of cancer stem cells in head and neck tumors.
Article

Studies Show Geron’s Stem Cell Therapeutic For Spinal Cord Injury Produces Nerve Growth Factors
Geron Corporation today reported that studies show GRNOPC1, the company’s human embryonic stem cell (hESC)-based oligodendroglial progenitor therapeutic, produces multiple nerve growth factors, proteins that stimulate the survival and regeneration of neurons damaged during spinal cord injury.
Article

Researchers First To Map Gene That Regulates Adult Stem Cell Growth
Researchers genetically mapped a stem cell gene and its protein product.
Article

Brain Stem Cells Against Cancer?
Gliomas are a group of brain tumors where the most common type is also the most aggressive one. Chemotherapy and radiation have little effect on malignant gliomas, and patients survive only about a year after being diagnosed. But research at Lund University in Sweden provides hope that it may be possible in the future to develop stem cells from the brain into a new way to treat gliomas.
Article

Will Synthetically Engineered Immune Cells Stop AIDS?
Twenty years after its introduction, gene therapy still holds great promise as a way to harness the insidious power of viruses such as human immunodeficiency syndrome (HIV). But scientists have yet to solve a vexing problem: developing an efficient transport system that is capable of delivering therapeutic payloads to specific cells.
Article

Genetic Signature Predicts Recurrence of Breast, Prostate and Other Cancers
Researchers working with breast cancer stem cells at the Stanford University School of Medicine have found 186 genes that together can predict the risk of recurrence in breast cancer patients. Additionally, the same genes predict the recurrence of prostate cancer, lung cancer and medulloblastoma, the most common form of childhood brain cancer.
Article

Daughter Cells Generated from Embryonic Stem Cells May Provide a Safer Way to Develop Clinical Stem Cell Therapies
Scientists at the Genome Institute of Singapore and the National University of Singapore have found a way of manipulating embryonic stem cells (ESCs) that could allow stem cells to be produced in a safe and efficient manner for use in clinical treatments.
Article

University of Minnesota Finds Cell in Adult Heart with Embryonic Stem Cell Capability
Researchers at the University of Minnesota have found a cell type in adult rat heart tissue that can make all types of cardiac cells.
Article

Dual Gene Therapy Suppresses Lung Cancer in Preclinical Test
Combination gene therapy delivered in lipid-based nanoparticles drastically reduces the number and size of human non-small cell lung cancer tumors in mice, researchers at The University of Texas M. D. Anderson Cancer Center and the University of Texas Southwestern Medical Center have reported.
Article

Donor Mesenchymal Cell Infusion May Reduce Established Graft-Versus-Host Disease
Researchers affiliated with the European Bone Marrow Transplant Mesenchymal Stem Cell (MSC) expansion group have reported that the infusion of MSC is effective treatment of refractory acute graft-versus-host disease (GVHD) among patients who have received an allogeneic stem cell transplant.
Article

Aastrom Treats Patients in Adult Stem Cell Clinical Trial for Osteonecrosis
Aastrom Biosciences, Inc. today announced that the first two patients have been treated in a pivotal clinical trial utilizing the Company’s Tissue Repair Cells (TRCs) for the treatment of osteonecrosis (also known as avascular necrosis) of the femoral head.
Article

Potential for Adult Stem Cells to Repair Hearts Damaged by Severe Coronary Artery Disease Investigated by Rush Cardiologists
Rush University Medical Center is one of the first medical centers in the country, and currently the only site in Illinois, participating in a novel clinical trial to determine if a subject’s own stem cells can treat a form of severe coronary artery disease.
Article

AnGes MG, Vical to Start Phase III Clinical Trial of Allovectin for Gene Therapy
AnGes MG Inc. and the U.S. based Vical Inc. has announced the start of phase III of their clinical trial of Allovectin-7, a gene therapy treatment drug for progressive melanoma patients. Allovectin was assigned as an orphan drug, and is aiming to monopolize the market after its sales and distribution have been approved.
Article

Dendreon Corporation’s PROVENGE Granted FDA Priority Review For The Treatment Of Asymptomatic, Metastatic, Androgen-Independent Prostate Cancer
Dendreon Corporation today announced that the U.S. Food and Drug Administration (FDA) has accepted for filing and has assigned priority review status to the Company’s Biologics License Application (BLA) for PROVENGE(R) (sipuleucel-T), its investigational active cellular immunotherapy for the treatment of asymptomatic, metastatic, androgen-independent (also known as hormone refractory) prostate cancer.
Article

Stem Cell Transplant for Eye Repair Raises Concern
An international team of ophthalmologists has expressed grave concern over stem cell transplant procedures used by doctors in India and some other countries for preventing blindness.
Article

GenesisBPS Announces The North American Distribution And FDA 510K Clearance Of The SEPAX Cell Separation System For Cord Blood Processing
GenesisBPS has announced that the SEPAX Cell Separation System, developed and manufactured by Biosafe SA has received 510(k) marketing clearance from the U.S. Food and Drug Administration’s Center for Biologics Evaluation & Research (CBER) for use as a cord blood-processing device.
Article

ABSTRACT, REVIEWS AND SPECIAL REPORTS

Multipotent Mesenchymal Stromal Cells in Blood
In this review, current studies and knowledge about peripheral blood-derived multipotent mesenchymal stromal cells are summarized.
Abstract

Policy

Payment for Stem Cell Eggs Debated
For stem cell research, getting human eggs is a challenge: Should women be paid for them?
Article

NIH Official Says Stem Cell Policy is Delaying Cures
The National Institutes of Health official overseeing the implementation of President Bush’s embryonic stem cell policy has suggested that the controversial program is delaying cures, an unusually blunt assessment for an executive branch official.
Article

Critics Say California Stem Cell Initiative is Unconstitutional
A state appeals court yesterday set Feb. 14 as the date for oral arguments in a case challenging the constitutionality of California’s $3 billion stem cell initiative.
Article

Spitzer Wants New York to Enter Stem Cell Race
In his first address to the Legislature, Gov. Eliot Spitzer called this month for passage of a $2 billion 10-year bond initiative for research and development, at least half of which would be set aside to pay for stem cell research.
Article

Business

Progenitor Cell Therapy LLC and Invitrogen Corp. Enter Into Strategic Comarketing & Development Agreement
The collaboration will comprise co-marketing, co-referrals, joint proposals, and technical consulting services provided by PCT to Invitrogen and its customers.
Article

Invitrogen to Partner with Wave Biotech, LLC to Supply Media-Filled Disposable Bioreactor Bags
Invitrogen Corporation and Wave Biotech, LLC have announced they entered into a partnership to supply media-filled disposable bioreactors. Under the agreement, Invitrogen Corporation will offer its GIBCO(R) brand cell culture media products to Wave Bioreactor(R) users in filled Cellbag(R) brand disposable bioreactor bags.
Article

Cytonet and Vesta Therapeutics Collaborate on Liver Cell Therapy
Cytonet and Vesta Therapeutics signed a mutual strategic collaboration agreement that involves the construction of a GMP facility, in accordance with European standards, on the premises of Vesta Therapeutics in Durham, NC. Liver cell products for Cytonet’s clinical trials will be produced at the facility in the future.
Article

Cellartis Establishes Collaboration in Scotland
The Gothenburg, Sweden, based biotech company Cellartis AB and its partners ITI Life Sciences and University of Glasgow today announced an extensive £9.5 million R&D programme to develop human stem cells for pharmaceutical research.
Article

Advanced Cell Technology Awarded Federal Grant from National Institutes of Health to Accelerate Embryonic Stem Cell Research
Advanced Cell Technology Inc., an Alameda biotechnology company researching treatments made from human embryonic stem cells, received a U.S. $204,439 small-business grant to develop colored tags to track the cells’ development.
Article

BioE Awarded Patent for Cell Separation Compositions Used to Obtain Company’s Category Defining Cord Blood Stem Cell
BioE(R), Inc. announced today the U.S. Patent and Trademark Office (USPTO) recently awarded it U.S. Patent 7,160,723. This patent – combined with related U.S. Patent 6,933,148 — protects the cell separation compositions for isolating BioE’s Multi-Lineage Progenitor Cell(TM) (MLPC(TM)) stem cell.
Article

Stem Cell Research Institute for Bangalore
Bangalore is likely to get the ambitious Stem Cell Research Institute envisaged by the Department of Biotechnology of the Government of India, with the University of Agricultural Sciences, Bangalore, having agreed in principle to grant 10 acres of land on its Gandhi Krishi Vignana Kendra campus here.
Article

Nod for Stem Cell Research with UK
A delegation of British stem cell experts has given Australian research the thumbs up, signalling a growth in commercial and public collaborations between the nations.
Article

NIH

Novel Approaches to Enhance Animal Stem Cell Research (R01) (PA-07-303)
Link

Novel Approaches to Enhance Animal Stem Cell Research (R21) (PA-07-304)
Link

Funding Opportunities for Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) Grant Programs for 2007 (NOT-OD-07-036)
Link

Delays in Grant Application Submission due to Ice Storms – January 2007 (NOT-OD-07-037)
Link

NIH/AHRQ Confirms Plans to Transition the G7, G8, G11, G13, G20, S11, S21 and S22 to Electronic Applications and Announces Delay in Transition of K, F, T and Complex Grant Programs (NOT-OD-07-038)
Link

RFA Announcement: B Cell Immunology for Protective HIV Vaccines (NOT-AI-07-020)
Link

AHRQ Interim Guidance on Salary Limitation for Grants, Cooperative Agreements, and Contracts (NOT-HS-07-001)
Link

NIAID Competing Supplements (Revisions) for B Cell Immunology and HIV-1 Neutralizing Antibody Projects (R01) (RFA-AI-07-016)
Link

PHS 2007-02 Omnibus Solicitation of the NIH, CDC, and FDA for Small Business Innovation Research Grant Applications (Parent SBIR [R43/R44])
Link

PHS 2007-02 Omnibus Solicitation of the NIH for Small Business Technology Transfer Grant Applications (Parent STTR [R41/R42]) (PA-07-281)
Link

CBER

Letter to Stem Cell Pharma Inc.
Link

FDA Issues Draft Guidance on License Applications for Certain Placental/Umbilical Cord Blood Products
Link

Draft Guidance for Industry: Minimally Manipulated, Unrelated, Allogeneic Placental/Umbilical Cord Blood Intended for Hematopoietic Reconstitution in Patients with Hematological Malignancies
Link

All new CBER information can be reached from the What’s New page at What’s New Page

Regulatory

FOOD AND DRUG ADMINISTRATION (United States of America)

FDA Warns Doctor Over Stem Cell Implants
A Las Vegas doctor has been implanting stem cells harvested from placentas into patients with multiple sclerosis, muscular dystrophy and other diseases in violation of federal law, according to a warning letter released by health officials Thursday.
Link

THERAPEUTIC GOODS ADMINISTRATION (Australia)

Therapeutic Goods Administration International Training Calendar for 2007 
Link

Further Phase 2 Australia New Zealand Therapeutic Products Authority Consultation Document (Draft Advertising Rule)
Link

ISCT

The Boards of AABB, ASBMT, ASFA, EBMT, FACT, ICCBBA Inc, ISBT, ISCT, ISCT Europe, JACIE, NMDP and WMDA agreed to develop standards for the use of ISBT 128 for coding and labeling of CT products, and established an international advisory group to take forward the development and management of terminology and label design. The International Cellular Therapy Coding and Labeling Advisory Group has been working on this project since October 2005 and a workshop was held at the ISCT meeting in Berlin in 2006.
Two draft standards have been prepared covering the aspects of terminology and labeling, together with a guidance document on implementation. These documents are now available for public comment and we value your feedback.  They may be accessed by clicking here:  http://www.iccbba.org/ctcomments.html

The International Cellular Therapy Coding and Labeling Advisory Group would like to know your current labeling practice. Are you completely automated, completely manual or somewhere in between? Please complete the brief survey accessed at http://www.surveymonkey.com/s.asp?u=959303138614. The information gathered will be valuable as we move toward global standardization for labeling of cellular therapy products. Your participation is greatly appreciated. For more information about this project, please visit: http://www.iccbba.org/cellulartherapy_home.html

Call for Abstracts
On-line abstract submission for the 2007 ISCT Annual Meeting is now available through the ISCT Website. 
Submission deadline: February 16, 2007
Link

ISCT Membership
Renew your ISCT Membership for 2007 now!
Not a member?  Visit the ISCT website to learn about the benefits of membership.
Link

AABB-ISCT Cellular Therapy Audioconference Series
Link

Profiled Journal

Join ISCT and receive the journal as a benefit of membership.

Current Volume: Volume 8 Number 6 / December 2006

Cytotherapy publishes original research, reviews, meeting reports, special focus issues and letters in the general field of cell therapy. The scope of the journal includes basic and applied research with hematopoietic and non-hematopoietic stem cells, immune cells, and antigen-presenting cells. Therapeutic topics within the scope of Cytotherapy include ex-vivo and in-vivo aspects of gene therapy, immunotherapy, stem cell transplantation and tissue regeneration. Cytotherapy particularly welcomes contributions from researchers, clinicians, technicians and individuals involved in regulatory aspects of cell therapy.



 Learn more about Cell Therapy News:  Archives  |  Events  |  Update Profile  |  Contact Us