Volume 8.43 | Nov 5

Volume 8.43, November 5, 2007
     In this issue: Science | Policy | Business | NIH | CBER | Regulatory
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Top Stories

Stem Cells Can Improve Memory After Brain Injury: In the study, mice with brain injuries experienced enhanced memory – similar to the level found in healthy mice – up to three months after receiving a stem cell treatment.


Jefferson Researchers Find Elusive Stem Cells in Intervertebral Disc, Giving New Hope to Restore Painful, Degenerate Discs in the Spine
Orthopedic researchers at Jefferson Medical College have for the first time found stem cells in the intervertebral discs of the human spine, suggesting that such cells might someday be used to help repair degenerating discs and remedy lower back and neck pain.

Newt Protein May Offer Clues for Human Regeneration
Scientists have found a key protein that helps newts regrow severed limbs and which may guide future research into human regenerative medicine.

Intravenous Gene Therapy Protects Normal Tissue of Mice During Whole-body Radiation
Gene therapy administered intravenously could be an effective agent to protect vital organs and tissues from the effects of ionizing radiation in the event of large-scale exposure from a radiological or nuclear bomb.

Sangamo BioSciences/Sigma-Aldrich Demonstrate Stem Cell Technology
Sigma-Aldrich Corp. and Sangamo BioSciences Inc. said data was published that showed positive results from the use of Sangamo’s ZFP Nucleases, or ZFNs, for ‘gene-editing’ in human stem cells.

Gene, Stem Cell Therapy Only Needs To Be 50 Percent Effective To Create A Healthy Heart
According to a new study, recently published in Circulation Research, a journal of the American Heart Association, University of Missouri-Columbia researchers have demonstrated that a muscular dystrophy patient should be able to maintain a normal lifestyle if only 50 percent of the cells of the heart are healthy.

Carnegie Mellon Biomedical Engineering Researcher Works To Develop New Drug Delivery System by Using Adult Neural Stem Cells
Researchers are creating genetically engineered adult neural stem cells for delivery to patients’ brains, where they will be programmed to produce an essential missing protein.

Oncophage Cancer Vaccine Study Shows Positive Results
Antigenics Inc. said Thursday that Phase I/II data from a trial of its investigational cancer vaccine, Oncophage, in recurrent, high-grade glioma showed that 11 out of 12 patients exceeded the historical median benchmark of 6.5 months survival from time of recurrence.

New Gene Therapy Brings Hope to Cancer Patients
A radical plan to genetically modify the bone marrow of cancer patients to reduce the side-effects of chemotherapy is a step closer to reality at the Children’s Hospital at Westmead.

Therapy for ‘Lorenzo’s Oil’ Boys
Doctors have for the first time used gene therapy to treat two boys with the rare nervous disorder made famous through the film “Lorenzo’s Oil”.

University of Minnesota Performs First Systemic Therapy for Fatal Childhood Disease
University of Minnesota Children’s Hospital, Fairview physicians have performed the first bone marrow and cord blood transplant to treat recessive dystrophic epidermolysis bullosa.

Epicel(TM) Wins Marketing Approval for Severe Burn Victims
Genzyme Corporation has announced that the U.S. Food and Drug Administration has granted Epicel(TM) (cultured epidermal autografts) marketing approval under the Humanitarian Device Exemption for the treatment of life-threatening wounds resulting from severe burns.

StemCor Systems Receives FDA Clearance for Bone Marrow Harvesting System
StemCor Systems, Inc. has announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market its MarrowMiner(TM) for the harvest of bone marrow.

Cytori Receives European Approval for 2nd Generation Celution(TM) Stem & Regenerative Cell Processing System
The Celution(TM) System is the only device approved in Europe to extract and concentrate a patient’s own stem and regenerative cells from within fat tissue in order to be delivered back to the same patient in the same procedure.

Next Step in Stem Cells: Human Tests
Companies are planning to submit applications for FDA approval to begin human testing of treatments based on embryonic stem cell research.


Isolation and Characterization of Cells from Human Term Placenta: Outcome of the First International Workshop on Placenta Derived Stem Cells
The aim of this review is to summarize and provide the state of the art of research in this field, addressing aspects including cell isolation protocols and characteristics of these cells, as well as providing preliminary indications of the possibilities for use of these cells in future clinical applications.


Cell Therapeutics Supervisor
Philadelphia, PA (AppTec)

Postdoc Fellow
Sweden (Wallenberg Neuro Center Neuronal Survival Unit)

Manager, Manufacturing
Memphis, TN (Cognate Bioservices)


EU Approves Rules Regulating Gene Therapies, Other Advanced Disease Treatments
Gene therapies and other advanced treatments for diseases such as cancer and Parkinson’s will have to be authorized by European Union regulators under rules approved by EU governments Tuesday.

New California Laws Boost Cord Blood Plans
State will encourage collection, research and storage of umbilical fluid that is rich in healing stem cells.

Patrick: State is Losing Edge in Biotech
Massachusetts Governor Deval Patrick urged the Legislature to act quickly on his 10-year, $1 billion life-sciences initiative, saying the state is losing its grip on one of its most important industries.

Corzine Spends $150,000 to Back Stem Cell Question
Multimillionaire New Jersey Governor Jon S. Corzine is putting his own money toward getting voters to approve borrowing $450 million for stem cell research.


Genzyme and Sunway to Collaborate on Gene Therapy Program in China
Genzyme Corp. and Sunway Biotech Co. Ltd. announced that they will collaborate to manufacture, develop, and commercialize the experimental gene therapy Ad2/HIF-1a in China. The product is Genzyme’s most advanced gene therapy candidate and is currently in Phase 2 clinical testing in the United States and Europe.

Thermo Fisher Scientific Announces Stem Cell Alliance with Primogenix
The agreement will cover the marketing of murine embryonic stem cells and media used to grow these cells. This partnership was formed in response to growing demand among researchers for high-quality murine embryonic stem cells.

Cryo-Cell Launches C’elle, First-Ever Proprietary Menstrual Stem Cell Service
Cryo-Cell International Inc. has announced its discovery of breakthrough stem cell technology and its launch of the world’s first-ever service provided for women to store their own menstrual stem cells.

Advanced Cell Technology Announces Executive Promotions
Advanced Cell Technology, Inc. has announced that it has appointed Jonathan H. Dinsmore, Ph.D. to the position of Senior Vice President – Regulatory and Clinical and Ivan Wolkind to the position of Senior Vice President – Finance, Administration & Chief Accounting Officer.

Former Johnson & Johnson Vice Chairman Joins Angioblast Board of Directors
Australia’s adult stem cell company, Mesoblast Limited, has announced that Robert E. Campbell, the former Chief Financial Officer and Vice Chairman of Johnson & Johnson, has been appointed to the Board of Directors of its United States-based sister company, Angioblast Systems Inc.


Request for Information (RFI): Public Meeting to Request Information and Comment from Industry concerning the use of RNAi Technologies in the NIH Intramural Laboratories (Solicitation Number: NIH-RNAi-01) (NOT-OD-08-012)

2008 NIH Director’s Pioneer Award Program (DP1) (RFA-RM-08-013)

NHLBI Ruth L. Kirschstein National Research Service Awards for Individual Predoctoral MD/PhD Fellows (F30) (PA-08-021)


Consumer Update: Human Gene Therapies, Novel Product Development: Q & A with Celia Witten, PhD., M.D.

ISBT Label Checklist for Licensed Establishments



Draft Guidance for the Public, FDA Advisory Committee Members, and FDA Staff: Public Availability of Advisory Committee Members’ Financial Interest Information and Waivers


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