Volume 8.22 | Jun 11

Volume 8.22, June 11, 2007
     In this issue: Science | Policy | Business | NIH | CBER | Regulatory
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Top Stories

New Stem Cell Breakthrough Avoids Destroying Human Embryos: Adult mouse skin cells were “reprogrammed” back to a stem cell-like state using a kind of genetic deception.


CHI’s Second Annual CELLutions SUMMIT – August 20 23, 2007  Boston, MA
CHI’s CELLutions SUMMIT provides in-depth scientific coverage of stem cell science and business strategies to achieve the necessary funding and collaborations for research. Join us for invaluable networking and learning opportunities.

A Long, Uncertain Path for New Cell Technique
While intriguing, a new approach for producing embryonic stem cells faces considerable hurdles before it can be used to develop medical treatments, executives from stem cell and other biotechnology companies have said. 

Genetically Modified Stem Cells May Have Therapeutic Application to X-SCID
Using new technology, the scientists showed gene correction or precise addition of a gene in human stem cells at unprecedented levels.

Stanford Researchers Track Human Stem Cells Transplanted Into Rat Brain
Researchers at the Stanford University School of Medicine have illuminated the path taken by human neural stem cells that were transplanted into the brains of rats and mice, and found that the cells successfully navigate toward areas damaged by stroke.

New Platform for Regulating the Expression of Therapeutic Genes
Researchers have provided a demonstration that their new design can enable delivered genes to become highly responsive to a cell’s identity.

Sleeping Beauty “Jumping Gene” Shows Promise For Sickle Cell Gene Therapy
The Sleeping Beauty tranposon (SB-Tn) system, a gene therapy technology that avoids the pitfalls of transferring genes with viruses, shows promise in laboratory experiments for correcting the gene defect responsible for sickle cell disease.

Gene Therapy Delivery of Nerve Growth Factors Reverses Erectile Dysfunction in Animal Model
Rats with erectile dysfunction, or ED, that were injected with a gene therapy vector containing either of two nerve growth factors were able to regain normal function after four weeks.

Human Stem Cell Treatment Restores Motor Function in Paralyzed Rats
Rats paralyzed due to loss of blood flow to the spine returned to near normal ambulatory function six weeks after receiving grafts of human spinal stem cells. 

Umbilical Cord Blood Cells May Replace Bone Marrow Transplants for Children
He found that umbilical cord blood cells work just as well at fighting a deadly form of childhood leukemia with fewer side effects than bone-marrow transplants.

Stem Cells to Provide Blindness Cure
An anonymous American philanthropist, who saw his father go blind, has given a London based team almost £4 million towards the overall £8 million cost of a stem cell therapy, where eye cells derived from an embryo are used for repair, which would mark a world first.

Harvest Technologies Announces FDA Approval to Begin the First Randomized, Placebo-Controlled Clinical Trial in the United States Using Autologous Adult Stem Cells to Treat Patients With End-Stage Critical Limb Ischemia
Harvest Technologies Corp. has announced that the Food and Drug Administration has granted Investigational Device Exemption approval to commence a 48-patient ‘feasibility’ clinical trial using the company’s BMAC System to treat patients with Critical Limb Ischemia.

Lentiviral Vector Assists Gene Therapy
VRX496 uses a lentiviral vector to deliver a payload to block the replication of HIV. In a recent Phase I trial, VRX496 suppressed viral loads and restored the immune system responses in chronic HIV patients.

Cell Genesys and Medarex Report Follow-Up Data From a Phase 1 Combination Therapy Trial With GVAX Immunotherapy for Prostate Cancer and Ipilimumab (MDX-010) Antibody
Cell Genesys, Inc. and Medarex, Inc. announced follow-up data from the ongoing Phase 1 clinical trial in patients with advanced prostate cancer receiving Cell Genesys’ GVAX immunotherapy for prostate cancer administered in combination with ipilimumab, a fully human anti-CTLA-4 antibody that is being jointly developed by Medarex and Bristol-Myers Squibb Company.

Cell Genesys Reports Additional Data From Phase 2 Clinical Trial of GVAX Immunotherapy for Pancreatic Cancer
Cell Genesys, Inc. has announced follow-up data from a Phase 2 clinical trial of GVAX immunotherapy for pancreatic cancer which was conducted by the Johns Hopkins Sidney Kimmel Cancer Center.

Oxford Biomedica and Sanofi-Aventis Report new TroVax(R) Phase II Trial Results in Renal Cancer
Oxford BioMedica and sanofi-aventis announce new data from two Phase II trials of TroVax(R) in renal cancer. TroVax(R) is Oxford BioMedica’s lead cancer immunotherapy product, which is being developed in collaboration with sanofi-aventis.

A Stem-Cell Heretic Makes His Case
Embryonic stem-cell researchers are prone to touting the potential of their work to treat all sorts of ailments, from diabetes to Parkinson’s disease. Don’t bet on it, says James Sherley, a stem-cell specialist himself, who has become a notable heretic in the field.

Refrigerated Stem Cells Survive 12 Times Longer with ProtoKinetix’s AAGP(TM)
ProtoKinetix has recently finished a set of trials designed to determine whether AAGP(TM) treated cells could survive after preservation in refrigeration (4°C).


Comparison of Proliferative and Multilineage Differentiation Potential of Human Mesenchymal Stem Cells Derived from Umbilical Cord and Bone Marrow
Human umbilical cord perivascular cells showed a higher proliferative potential than bone marrow mesenchymal stromal cells and were capable of osteogenic, chondrogenic, and adipogenic differentiation. 

In Vitro Reprogramming of Fibroblasts into a Pluripotent ES-cell-like State
This research shows that the biological potency and epigenetic state of in-vitro-reprogrammed induced pluripotent stem cells are indistinguishable from those of ES cells.


Stem Cell Bill Passes, Faces New Veto
The Democratic-controlled Congress passed legislation Thursday to loosen restraints on federally funded embryonic stem cell research, but the bill’s supporters lacked the votes needed to override President Bush’s threatened veto.

Australian State Approves Therapeutic Cloning
Lawmakers in Australia’s most populous state voted Thursday to overturn a ban on the use of cloned human embryos for stem cell research despite strong opposition from the Catholic church.

More Grants Approved for Stem Cell Research
The California Institute for Regenerative Medicine approved grants Tuesday morning for 13 California institutions to build shared facilities for human embryonic stem cell research and to create courses to teach scientists how to create new human embryonic stem cell lines.


Stem Cell Industry Set to Break Out
With California finally free to spend $3 billion on embryonic research, the stage could be set for a hot new biotech sector.

On Heels of Life Sciences Initiative, Governor Patrick Announces Organogenesis to Expand in Massachusetts
The world’s first profitable regenerative medicine company will grow in Massachusetts due to state’s newly unveiled life science initiative.

Cryobanks International Prepares to Launch Cord Blood Bank in Thailand; Over 4,000 Units Estimated During Initial 12-Month Operation
The new laboratory, processing, and storage center will be the third CI licensee to open in overseas markets. Currently, two other facilities operate in Athens, Greece and Delhi, India with eight more banks scheduled to open in other international locations.

Vadodara to Get First Stem Cell Bank
Stem cell banking has already taken off in the country and many parents have started sending cord blood cells collected immediately after birth to distant places like Mumbai, Chennai and New Delhi to preserve them, but one need not have to look that far any more with a facility coming up at Savli near here.

Canadian Blood Services Wants $5 Million To Start Umbilical Cord Bank
Canadian Blood Services will be asking the government for $5 million in the next month to start the country’s first public umbilical cord bank.

Student Society for Stem Cell Research (SSSCR) Expands Coast to Coast
The Student Society for Stem Cell Research has announced its recognition of 9 new chapters.


NIH Establishes Working Groups to Examine Peer Review
National Institutes of Health (NIH) Director Elias A. Zerhouni, M.D., announced today the formation of two working groups – one external, the other internal – to examine the NIH peer review process, with the goal of maximizing its effectiveness.

Notice of Correction of Receipt Date on PAR-06-504, Enabling Technologies for Tissue Engineering and Regenerative Medicine (NOT-EB-07-008)


Draft Guidance for Industry: Providing Regulatory Submissions in Electronic Format – Receipt Date

FDA Workshop on Licensure of Apheresis Blood Products – Updated Fax Number for Meeting Registration

Approved Biological NDA and ANDA Applications – Update

Licensed Products and Establishments List – Update

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)

Request for Nominations for Voting Members on a Public Advisory Committee; Risk Communication Advisory Committee

Advisory Committee; Risk Communication Advisory Committee; Establishment


Russia to Set Blood Export Rules
Russia will soon set new rules governing the export of human blood and tissue, the Russian media cited the health minister as saying Tuesday, suggesting a sudden ban that has sparked criticism would be lifted or eased.


Proposed Voluntary Accreditation Scheme for Phase 1 Clinical Trial Units


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