Volume 8.00 | Jan 8

Volume 8.0, January 8, 2007
     In this issue: Science | Policy | Business | NIH | CBER | Regulatory
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Top Stories

Amorcyte Cardiac Cell Therapy Trial Passes First Stage and Opens Two New Sites: Amorcyte, Inc. has announced that its phase I clinical trial is now open in two new clinical sites and the data safety monitoring board has approved the trial going forward to the second stage using, as per the approved protocol, an increased number of stem cells.
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Tengion Launches First Phase II Clinical Trial of Regenerated Human Organ: Tengion, Inc. has announced that it has initiated a Phase II multi-center clinical study for its urinary neo- bladder construct. The study is being conducted in pediatric patients with spina bifida who have failing bladders that predispose them to a risk of kidney failure and incontinence even when they receive optimal medical therapy.
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Science

A 3-D Replacement for the Petri Dish 
For modeling cell growth and behavior in the body, scientists are turning to three-dimensional culture systems that create more lifelike environments. 
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Researchers ‘Grow’ Heart Arteries
Scientists are to use an £84,000 grant to try and “grow” test tube arteries for use in heart bypass operations.
Article

Stem Cells Used to Create Critical Brain Barrier in Lab
Researchers have described an experiment in which nascent rat neural stem cells were used to prod blood vessel cells to assume properties of the blood-brain barrier.
Article

Stem Cell Activity Deciphered in the Aging Brain
Neurobiologists have discovered why the aging brain produces progressively fewer new nerve cells in its learning and memory center. The scientists said the finding, made in rodents, refutes current ideas on how long crucial “progenitor” stem cells persist in the aging brain.
Article

Cancer-Killing Invention Also Harvests Stem Cells
Associate Professor Michael King of the University of Rochester Biomedical Engineering Department has invented a device that filters the blood for cancer and stem cells. 
Article

Researchers Find Stem Cell Therapy Effective in Targeting Metastatic Cancer
Researchers at City of Hope and St. Jude Children’s Research Hospital may have found a way to treat cancers that have spread throughout the body more effectively. They used modified neural stem cells to activate and concentrate chemotherapeutic drugs predominately at tumor sites, so that normal tissue surrounding the tumor and throughout the body remain relatively unharmed.
Article

Scientists Discover Gene Therapy for Depression
Scientists have discovered a new gene that makes mice happy, a finding that suggests another avenue of drugs for improving depression in humans.
Article

Stem Cells Used To Regenerate Parts Of Teeth By USC-Led Researchers
A multi-national research team has successfully regenerated tooth root and supporting periodontal ligaments to restore tooth function in a swine model. The breakthrough holds significant promise for clinical application in human patients.
Article

Weizmann Institute Scientists Demonstrate How Tissues Transplanted from Pig Embryos Might Present a Solution to Genetic Diseases
Previous attempts to treat genetic disease by transplanting (mother to daughter) a spleen, an organ that can manufacture a number of the missing proteins in some such diseases, had made little headway due to the fact that the spleen is home to the immune system’s T cells – cells responsible for the severe immune responses against the recipient known as graft-versus-host disease (GVHD). Reisner and his team revived the idea, with a twist.
Article

Cytori to Begin Stem Cell Trial for Heart Disease
Cytori Therapeutics received approvals to initiate a clinical trial in Spain to investigate the use of adipose-derived stem and regenerative cells for the treatment of cardiovascular disease.
Article

Stem Cell Technique Could Help Kids Avoid Root Canal
A new, less-invasive treatment leaves the soft inner pulp intact, allowing the young tooth’s stem cells to continue tooth formation.
Article

Living Cell Technologies Ltd Granted Approval to Manufacture Xeno Products for Human Use
The New Zealand regulator MedSafe issued a formal letter to LCT recommending a Licence to Manufacture Medicines be issued which will allow the use of its xenotransplant products in human patients.
Article

Gene-engineered Cattle Resist Mad Cow Disease
The cattle are engineered to lack the nervous system prions, a type of protein, that cause BSE and other related diseases such as scrapie in sheep and Creutzfeldt-Jakob disease, known as CJD, in humans.
Article

New Stem Cell Skin Therapy Gives Skin Fresh Appearance
A new skin rejuvenation therapy—using stem cells from the amniotic fluid of pregnant cows—is now used to hydrate and firm facial skin in humans.
Article

CorCell, Inc. Announces First Autologous Cord Blood Transplant For Childhood Leukemia Worldwide
CorCell announced that cord blood collected and stored by one of its private, family customers was used in what is believed to be the first autologous cord blood transplant for childhood leukemia anywhere in the world.
Article

ABSTRACT, REVIEWS AND SPECIAL REPORTS

Gene Therapy in Wound Healing: Present Status and Future Directions
This article aims to review the research on gene therapy in wound healing and possible future directions in this exciting field.
Abstract

Policy

Britain Considers Restricting Stem Cell Research
British scientists warn that an impending government decision that may ban research to create human embryos from animal eggs will jeopardize finding a cure for diseases such as Alzheimer’s and spinal muscular atrophy.
Article

New Debate on Using Embryos for Stem Cell Research in Canada
Debate has re-erupted over whether to allow donations of “fresh” human embryos for stem cell research.
Article

Americans’ Support for Embryonic Stem Cell Research Declines
Americans’ support for stem cell research has declined slightly, reversing a three-year trend, but an overwhelming majority paradoxically supports the use of such cells in pursuit of treatment for themselves or family members.
Article

Business

StemCell Technologies’ Contract Services Presents an Educational Webinar on the Use of Hematopoietic Stem Cell Assays in the Detection and Characterization of Chemokine and Cytokine Activity
“Cytokines and Chemokines In Hematopoiesis”, will be presented by Dr. Jackie Damen on January 17, 2007.
Article

NeoStem Announces Five-Year Agreement with Hemacare for Adult Stem Cell Collection Services
NeoStem, Inc. has announced a five-year agreement with HemaCare Corporation to provide NeoStem with collection services for the procurement of adult stem cells from peripheral blood for the purpose of long-term storage.
Article

MOLOGEN AG Out-licenses Marketing Rights for India and Receives Further Upfront Payment
The Berlin-based biotechnology company MOLOGEN AG announced today that licensing and marketing rights for MOLOGEN´s innovative cell-based gene-therapy for India were granted to ONCO Life Sciences, Pvt., Ltd.
Article

Medistem Laboratories Executes Agreement to License Its Intellectual Property to Rio Valley Medical Clinic
In exchange for the rights granted under the License Agreement, Medistem will receive a royalty of 90% of the monthly net revenue in excess of $20,000 resulting from the Licensee’s sale of any product derived from or involving infusion quality adult stem cells.
Article

RheoGene Inc. Announces Plan to Merge Intrexon Corp
The combined company will be called Intrexon and will be based in Blacksburg, Va., with some “supporting facilities” in Norristown.
Article

Norwegian Stem Cell Company Comes to Madison
CellCura, a Norwegian biotechnology company, is opening a location in Madison, Wisconsin, in order to facilitate collaboration with WiCell Research Institute on stem cell-related research equipment and products.
Article

Stem Cell Sciences (SCS) Opens State of the Art, Large-Scale Stem Cell Production Facility in Cambridge, UK
SCS’ new facility will enable the Company to grow and supply its novel stem cell based drug screens and assays for the world pharmaceutical industry using state of the art robotic cell culture equipment.
Article

Military College to Set Up Stem Cell Research Centre
Asia’s biggest state-of-the-art stem cell research centre is being planned at the Pune-based Armed Forces Medical College (AFMC) campus to treat diseases, a general says.
Article

NeuralStem Inc. Receives Notice Of Intention To Grant Core Patent From European Patent Office
Neuralstem, Inc. has announced that it has received notice from the European Patent Office that it intends to grant European Patent Application No. 97923569.4 Titled: “Isolation, Propagation and Directed Differentiation of Stem Cells From Embryonic and Adult Central Nervous System of Mammals.”
Article

Patent Protest Erupts Over Human Stem Cell Research
This month, a German court partially reversed approval for a patent to a German scientist for his stem cell research methods.
Article

U.S. Patent Office Reaffirms PharmaStem Patent
PharmaStem Therapeutics, Inc. announced today that the United States Patent and Trademark Office has issued a ruling confirming the validity of PharmaStem Therapeutics, Inc.’s pioneering patent about the Isolation and Preservation of Fetal and Neonatal Hematopoietic Stem and Progenitor Cells of the Blood and Methods of Therapeutic Use.
Article

Cytonome Announces New CEO
Cytonome, Inc. has announced that Dr. Lydia Villa-Komaroff has been appointed Chief Executive Officer.
Article

NIH

Stem Cells and Cancer (R01) (PA-07-187)
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Characterization, Behavior and Plasticity of Pluripotent Stem Cells (R01) (PA-07-201)
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Interactions Between Stem and Progenitor Cells and the Microenvironment in Vivo (R01) (PAS-07-189)
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Interim Guidance on Salary Limitation for Grants, Cooperative Agreements and Contracts (NOT-OD-07-033)
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Selection of Appropriate Funding Opportunity Announcements (FOAs) for the Continuation of the Innovative Technologies for Molecular Analysis of Cancer (IMAT) Program (NOT-CA-07-005)
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Innovative Technologies for Molecular Analysis of Cancer (R21) (RFA-CA-07-033)
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Innovative Technologies for Molecular Analysis of Cancer (R33) (RFA-CA-07-034)
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Application of Emerging Technologies for Cancer Research (R21) (RFA-CA-07-035)
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Application of Emerging Technologies for Cancer Research (R33) (RFA-CA-07-036) 
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Innovations In Cancer Sample Preparation (R21) (RFA-CA-07-037)
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Innovations In Cancer Sample Preparation (R33) (RFA-CA-07-038)
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Innovative Technologies for Molecular Analysis of Cancer (SBIR [R43/R44]) (RFA-CA-07-039) 
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Innovative Technologies for Molecular Analysis of Cancer (STTR [R41/R42]) (RFA-CA-07-040)
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Application of Emerging Technology For Cancer Research (SBIR [R43/R44]) (RFA-CA-07-041)
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Application of Emerging Technologies for Cancer Research (STTR [R41/R42]) (RFA-CA-07-042)
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Innovations In Cancer Sample Preparation (SBIR [R43/R44]) (RFA-CA-07-043)
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Innovations In Cancer Sample Preparation (STTR [R41/R42]) (RFA-CA-07-044)
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Nanoscience and Nanotechnology in Biology and Medicine (R01) (PAR-07-270)
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Nanoscience and Nanotechnology in Biology and Medicine (R21) (PAR-07-271)
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Ancillary Studies in Clinical Trials (R01) (RFA-HL-07-009)
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CBER

Exceptions and Alternative Procedures Approved Under 21 CFR 640.120 – Update
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Vaccines and Related Biological Products Advisory Committee – January 25, 2007
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CBER Advisory Committee Meetings 2007 Tentative Schedule
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Clinical Investigator Inspection List – Update
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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 Issues Draft Documents on the Safety of Animal Clones
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Advisory Committees Annual Reports
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ISCT

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
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ISCT Membership
Renew your ISCT Membership for 2007 now!
Not a member?  Visit the ISCT website to learn about the benefits of membership.
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AABB-ISCT Cellular Therapy Audioconference Series
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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.



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