Volume 8.11 | Mar 26

Volume 8.11, March 26, 2007
     In this issue: Science | Policy | Business | NIH | CBER | Regulatory
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Top Stories

‘Gene Therapy for Foetuses’ Hope: UK scientists believe in the future they will be curing babies in the womb of serious diseases with the use of gene therapy.

Small Molecule Maintains Human ES Cells’ Growth and Potency Indefinitely: USC scientists believe that IQ-1 could lead to elimination of the feeder layer of mouse fibroblast cells.


B.C. Cancer Researchers’ Mice Stem Cell Find Could Help Leukemia Treatment
A B.C. Cancer Agency team led by Dr. Connie Eaves discovered the blood stem cells in fetal and adult mice are markedly different and switch dramatically to the adult type from the fetal type between three and four weeks after birth.

Novel Peptide Could Boost Availability and Success of Islet Cell Transplant for Type-1 Diabetes
A peptide developed by scientists at Weill Cornell Medical College may expand the availability and durability of islet cell transplant for patients with type-1 diabetes, which is characterized by a lack of these insulin-producing cells.

A New Look into Cancer’s Roots
Advances in molecular biology and the current boom in stem cell research have spurred renewed interest in the idea that stem cells are at the root of cancer – and renewed skepticism.

Protein Found to Shield Pancreatic Cancer Cells from Self-Destruction
An overexpressed protein protects human pancreatic cancer cells from being forced to devour themselves, removing one of the body’s natural defenses against out-of-control cell growth.

DNA Nanoparticles Hold Promise In Gene Therapy For Parkinson’s Disease
Researchers are testing the feasibility of using a novel technology to condense DNA plasmids into nanoparticles and deliver them to the brain as a means to halt or prevent the neurodegenerative process.

Advanced Cell Technology hESC lines to be used in CIRM-Funded Study To Test Development of New Therapies For Heart Disease
Preclinical studies using hESCs derived from Advanced Cell Technology, Inc.’s proprietary ACTcellerate technology (a means of accelerating the discovery of products from hESC) will be used as part of a study to determine if hESCs are safe and effective in animal models for heart attacks and heart failure.

Mice See New Hue With Added Gene
Providing a kaleidoscopic upgrade to creatures that are largely colorblind, scientists have endowed mice with a human gene that allows the rodents to see the world in full Technicolor splendor.

ViaCell Announces Commencement of ViaCyte Pivotal Trial
ViaCell, Inc. has announced it has initiated a clinical trial to evaluate the safety and efficacy of ViaCyteSM, an investigational product being studied for the cryopreservation and thawing of human oocytes for use during assisted reproductive technology.

Brain Tumor Vaccine Developed by Stanford Researcher to Be Tested at 20 Sites Nationally
Originally developed by Albert Wong, MD, professor of neurosurgery and member of the Stanford Comprehensive Cancer Center, results so far have been promising enough to spur a 20-center trial sponsored by Celldex, the New Jersey-based company developing the therapy.

Potential for Adult Stem Cells to Repair Hearts Damaged by Severe Coronary Artery Disease Investigated in Ongoing Study
The Autologous Cellular Therapy CD34-Chronic Myocardial Ischemia (ACT34-CMI) trial is the first Phase II adult stem cell therapy study in the U.S. designed to investigate the efficacy, tolerability and safety of blood-derived selected CD34+ stem cells to improve symptoms and clinical outcomes in patients with chronic myocardial ischemia (CMI), a severe form of coronary artery disease.

Sports Medicine Turns to Stem Cell ‘Repair Kits’
Doctors and researchers say that in a few years the use of primitive stem cells from infants’ umbilical cord blood could grow new knee ligaments or elbow tendons, creating a therapy that becomes the vanguard of sports injury repair.

Umbilical Cord Cells: Godsend or Gimmick?
As the trend of banking cord blood continues to grow, critics say those who bank umbilical cord cells at private banks will most likely never use it.

Fresh Questions on Stem Cell Findings
Fresh questions surround some of the highest-profile research on adult stem cells. For the second time, New Scientist has discovered apparently duplicated data being used to describe results from different experiments in work published by a group of scientists at the University of Minnesota, Minneapolis.

New Trend in Organ Donation Raises Questions
The number of kidneys, livers and other body parts surgeons are harvesting through a controversial approach to organ donation has started to rise rapidly, a trend that is saving the lives of more waiting patients but, some say, risks sacrificing the interests of the donors.


Plasmid-based Gene Therapy of Diabetes Mellitus
This review shows that gene transfer of immunoregulatory molecules can prevent Type I diabetes mellitus and other autoimmune diseases.

Wnt/Beta-catenin/CBP Signaling Maintains Long-term Murine Embryonic Stem Cell Pluripotency
Using a high-throughput, cell-based assay, the researchers identified the small molecule IQ-1 that allows for the Wnt/-catenin-driven long-term expansion of mouse ESCs and prevents spontaneous differentiation.


Australian Ethical Guidelines for Cloning Approved
Australian scientists are a step closer to being allowed to clone human embryos after a federal health agency approved guidelines governing ethics of the research.

Australian Guidelines for Organ Harvesting
The Australian body charged with setting health standards, the National Health and Medical Research Council (NHMRC), met last week to discuss the guidelines and expects to release them publicly in the next few weeks.

South Korean Panel Allows Partial Study of Embryonic Stem Cells
A presidential panel decided Friday to partially allow research on embryonic stem cells, opening the way for South Korean scientists to resume their studies in the field.

NIH Chief Calls for More Stem Cell Research 
Elias Zerhouni charges that a ban on federal funding of research on new embryonic stem cell lines hurts science and the nation.

Court Refuses to Rehear Stem Cell Case
The 1st District Court of Appeal in San Francisco that recently ruled in favor of California’s stem cell institute denied two requests March 20 for rehearing the case that charged Proposition 71 was unconstitutional.


NeoStem Announces Expansion of Nationwide Network with Launch of Third Cutting-Edge Stem Cell Collection Center
The new Pennsylvania location will be among the first such centers to target a projected $8.5 billion adult stem cell industry.

Bio Stem, Inc. to Acquire One of the Largest Stem Cell Inventories in the World Through Merger
Bio Stem, Inc. has announced that through their planned acquisition of Cryobanks International, Inc., BioStem will acquire nearly 9,000 internationally registered cord blood stem cell units presently being inventoried at their Altamore Springs, FL location.

CytRx RNAi Subsidiary, RXi Pharmaceuticals, Announces Worldwide Research and Therapeutic RNAi Licensing Agreement with Cold Spring Harbor Laboratory
CytRx Corporation has announced that its majority-owned subsidiary, RXi Pharmaceuticals Corporation (RXi), has secured a non-exclusive, worldwide research and therapeutic license from Cold Spring Harbor Laboratory to their short hairpin RNAi technology (shRNAi).

International Stem Cell Corporation Subsidiary Lifeline Cell Technology Enters into Agreement with University of California to Study Macular Degeneration and Retinitis Pigmentosa
The project with the University of California is entitled “Characterization of New Human Embryonic Stem Cell Lines and the Differentiation into Retinal Progenitor Cell” and will be under the direction of Dr. Hans Keirstead of the Reeve-Irvine Research Center at the University’s Irvine Campus.

Bio-Matrix Scientific Group Achieves Progress for its Planned Facility
Bio-Matrix Scientific Group Inc. has issued an update on the Company’s progress towards opening its 15,000 square foot Stem Cell Bank and Laboratories.

Ireland Set to Be Major Player in Stem Cell Research
Ireland is set to play a significant role in field of stem cell research
Gary Culliton looks at progress in the field of stem cell research and finds that Ireland could be a major player as developments unfold over the next five years, particularly in NUI Galway’s Regenerative Medicine Institute


Institutional Clinical and Translational Science Award (U54) (RFA-RM-07-007)

Development of Animal Models and Related Biological Materials For Research (R21) (PA-07-336)


Cellular, Tissue and Gene Therapies Advisory Committee March 29 & 30, 2007 Meeting

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


FOOD AND DRUG ADMINISTRATION (Untited States of America)

FDA Proposes New, Tougher Procedures for Membership on Advisory Committees
The U.S. Food and Drug Administration (FDA) today announced new draft guidance that would implement a more stringent approach for considering potential conflicts of interest for its advisory committee members and for recommending eligibility for meeting participation. FDA is accepting public comments on the proposal for the next 60 days.

Draft Guidance for the Public, FDA Advisory Committee Members, and FDA Staff on Procedures for Determining Conflict of Interest and Eligibility for Participation in FDA Advisory Committees; Availability

Request for Nominations for Voting Members on Public Advisory Committees


Feds Unveil Strict New Transplant Rules
The agency believes enforcement of the regulations will cut patient deaths.


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