Volume 7.25 | Jul 4

Volume 7.25, July 4, 2006
     In this issue: Science | Policy | Business | NIH | CBER | Regulatory
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Top Stories

‘Virgin Birth’ Stem Cells Bypass Ethical Objections: Early human embryos grown from unfertilised eggs are not viable, but this means that their stem cells could be used to treat disease without upsetting religious sensibilities.


Stroke Study Demonstrates The Promise Of Stem Cells
By activating neural stem cells in a rat’s brain, scientists helped restore movement in animals who suffered from simulated strokes.

Different Stem Cell Treatments Both Produce Results for Two Similar Patients in China
Shenzhen Beike Biotechnology Co., Ltd. announced the successful treatment of two similar spinal cord injury patients using two different procedures that involved umbilical cord stem cells.

Bioengineered Tissue Implants Regenerate Damaged Knee Cartilage
Demonstrating that engineered cartilage tissue can grow and mature when implanted into patients with a knee injury, a study published in Tissue Engineering describes how a novel tissue engineering strategy can lead to cartilage regeneration even in knees affected by osteoarthritis.

Dendreon Announces Publication of Pivotal Phase 3 Study Highlighting Survival Benefit and Safety Profile of Provenge in Men with Advanced Prostate Cancer
It is the first cancer immunotherapy to demonstrate a survival benefit in a randomized Phase 3 study.

Key Molecule Puts Brakes on Stem Cell Differentiation
Howard Hughes Medical Institute researchers have identified a protein that could aid development of methods to grow new skin to treat patients with burns or skin ulcers. The protein maintains hair follicle stem cells in their immature, undifferentiated state.

Brain Chip Made With Rat Neurons
A uniform neural net of brain cells – a brain chip – has been created by a team of scientists lead by Yael Hanein of Tel Aviv University in Israel.

Disgraced South Korean Scientist Heads Back to Lab
Disgraced South Korean scientist Hwang Woo-suk will open a laboratory in Seoul next month to resume his work on animal cloning, and perhaps restart research on human embryonic stem cells, his lawyer said on Tuesday.

Stem Cell Research to Lead to Clinical Applications Soon
Scientists are said to be making advances in understanding how to cause embryonic stem cells to become heart cells, and believe the cells from embryos hold more promise than adult stem cells.


Notch Signalling Regulates Stem Cell Numbers in Vitro and in Vivo
The article shows that transient administration of Notch ligands to the brain of adult rats increases the numbers of newly generated precursor cells and improves motor skills after ischaemic injury.

Potential of Stem Cell Based Therapies for Heart Disease
The article discusses the headway scientists are making in exploring the potential future use of stem cells to treat heart disease.


Stem Cell Bill Heads to Senate Floor
A controversial bill that would lift federal restrictions on embryonic stem cell research is headed to the Senate floor for a vote next month along with two related bills favored by social conservatives.

Canadian Government Approves Use of Fresh Embryos in Stem Cell Research
The governing council of the Canadian Institutes of Health Research (CIHR) has given conditional approval for a controversial project to use “fresh” as well as frozen human embryos for stem cell research.

New Jersey Senate Committee Approves Sending Stem Cell Research to Voters
A New Jersey state Senate committee has approved a measure that would put a stem cell research proposal in front of state voters. It would ask them to support a bond issue which requires the state to borrow $230 million for embryonic stem cell research, even though New Jersey faces a fiscal crisis.

Vatican Aide Urges Excommunication for Stem Cell Scientists
Scientists who engage in stem cell research using human embryos should be subject to excommunication from the Catholic Church, according to a senior Vatican official.

EU Funding for Embryonic Stem Cell Research in Jeopardy With Second Vote
In addition to the parliament vote, the Framework Programme 7 (FP7) budget, which funds all EU science projects, must also be approved by the EU member states.

Australians Back Stem Cell Research
Many adults in Australia believe stem cells from human embryos should be extracted and used to treat injuries and disease, according to a poll by Roy Morgan International.


Bioheart, Inc. to Receive Funds From a Grant Awarded by the State of Ohio to Further Develop Adult Stem Cell Therapies
Bioheart will collaborate with Cleveland Clinic under the grant in order to accelerate the development of cell therapies for congestive heart failure and heart attack patients.

Pluristem Life Systems Retains Biologics Consulting Group to Pursue FDA Approval of PLX-1
Pluristem Life Systems, Inc., a cell therapy company dedicated to the commercialization of stem cell products, announces it has engaged Biologics Consulting Group, Inc. to assist in the Company’s pursuit of FDA approval of PLX-1. Pluristem’s PLX-1 will enable umbilical cord blood to become an alternative to bone marrow transplant, eliminating the current bone marrow transplant search and match process.

Invitrogen and Geron Ink Stem Cell Deal
Invitrogen has announced that it licensed Geron’s intellectual property related to the growth of human embryonic stem cells (hESC).

Invitrogen and Cellartis Collaborate to Create hESC Multi-Lineage Reporter Lines
Invitrogen Corporation and Cellartis AB today announced a collaboration between the companies to develop novel engineered human embryonic stem cell (hESC) reporter lines.

Therion Biologics Assets to be Sold After Cancer Vaccine Trial Halted
Therion Biologics Corp., a 15-year-old Cambridge company trying to develop a new breed of vaccines to fight cancer, will be shuttered and sold after its most promising drug candidate failed a pivotal human test, the company’s chief executive said yesterday.

Cord Blood Cell Bank to be Set Up in DuBiotech
Cryo-Save, the largest and longest-established private stem cell bank in Europe, on Sunday announced that it will set up Cryo-Save Arabia, the region’s first private cord blood cell bank at the Dubai Biotechnology and Research Park (DuBiotech).

South Korea Hospital Loses Suit in Embryonic Stem Cell Research Fraud Case
A South Korean hospital that contributed to the embryonic stem cell research fraud scandal in the Asian nation lost a court case in which a woman who donated her eggs for the research was not told about the risks involved.

Stem Cell Therapy International Files Provisional Patent Application for the Compositions and Methods of Treating Severe Burns Using Cryopreserved Stem Cells
The subject of this patent application is the first of its kind to address the use of third-degree burns with human stem cells. It uses a combination of stem cells from different sources, some of which have been cryopreserved using a methodology developed in the Ukraine.

Biotech Executives Against Sharing of Stem Cell Research Profits
A proposal that would let the state share in any profits that result from its $3 billion stem-cell research grants and force researchers to freely disseminate their discoveries has riled biotech executives, who say it could deter them from working on stem-cell therapies.


NIH to Fund Mouse Gene Exploration
The National Institutes of Health says it plans to award $50 million in grants to scientists to discover the function of each of the more than 20,000 genes in a mouse as part of a five-year program to investigate human diseases.

All R18/U18, C06/UC6 and R25 Grant Applications Must Use the SF 424 (R&R) Application Form and Apply through Grants.gov for the October 1, 2006 Submission Date and Beyond (NOT-OD-06-079)


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

Exceptions and Alternative Procedures Approved Under 21 CFR 640.120 – Update

July 2006 Advisory Committee Meetings – Blood Products Advisory Committee


Food and Drug Administration (United States of America)

FDA Announces New Initiative to Modernize the Regulation of Clinical Trials and Bioresearch Monitoring

Blood Products Advisory Committee; Notice of Meeting

World Health Organization (International)

Improving World Health Through Regulation of Biological Medicines

Central Drug Authority (CDA) (India)

India’s New Drug Authority May Have FDA-Like Divisions
India’s design for a new Central Drug Authority currently includes separate divisions for its various functions, including regulation of clinical trials. New drugs, vaccines and biologicals, and medical devices also will be among the separate divisions envisioned, all patterned on the U.S. FDA model.


AABB-ISCT Cellular Therapy Audioconference Series

For more information on the Somatic Cell Therapy Symposium, see www.celltherapysociety.org.

European branch of the International Society for Cellular Therapy (ISCT-Europe) and German Society for Transfusion Medicine and Immunohematology (DGTI) Joint meeting “Regulatory Framework for Advanced Medicinal Products in Europe”

Profiled Journal

Join ISCT($130) and receive the journal as a benefit of membership.

Current Volume: Volume 8 Number 3 / May 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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