Volume 8.10 | Mar 19

Volume 8.10, March 19, 2007
     In this issue: Science | Policy | Business | NIH | CBER | Regulatory
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Top Stories

Stem Cell Therapy Improves Sight of Patients Born with No Irises: Sheraz Daya, a consultant ophthalmic surgeon and director of the corneoplastic unit at Queen Victoria hospital, East Grinstead, Sussex, has treated four patients born with aniridia by transplanting into their eyes cells grown from those of dead donors. The stem cell transplants trigger production of new cells in the patients, leading to the hope that such techniques could help grow even hearts and livers.

Human Stem Cells Battle Degenerative Brain Diseases: Embryonic and adult stem cells offer similar protection against neurodegenerative disease, according to a landmark study in mice which has achieved a number of firsts with human stem cells. For the first time, rodents genetically predisposed to disease lived longer and healthier lives after receiving injections of the human cells, researchers claim.


New Cell Type Identified in Cancer Development
Scientists have discovered a new type of cell that appears to play a role in the development of cancer – a highly volatile, precancerous stem cell that can either remain benign or become malignant, depending upon environmental cues. The finding may help define the role of cancer stem cells in the growth and recurrence of the disease as well as offer new options for cancer prevention, detection and treatment.

Fountain Of Youth: Molecular Switch Holds Key To Reserve Supply Of Muscle Stem Cells
After injury, even adult muscles can heal very well because they have a reserve supply of muscle stem cells, called satellite cells, which they can utilize for repair. Until now, it was unclear how this supply of satellite and muscle progenitor cells, out of which both muscle cells as well as satellite cells develop, keeps itself “fresh”.

Chemical Cues Turn Embryonic Stem Cells into Cerebellar Neurons
For the first time, a study in mice by Rockefeller University scientists shows that embryonic stem cells implanted in the brain appear to develop into fully differentiated granule neurons, the most plentiful neuron in the cerebellum.

Scientists to ‘Grow’ Bone in the Laboratory
Damaged bones could one day be repaired using bone tissue grown in the laboratory, thanks to technology being developed through a new £310,000 grant to the University of Bath.

Study Questions ‘Cancer Stem Cell’ Hypothesis in Breast Cancer
A Dana-Farber Cancer Institute study challenges the hypothesis that “cancer stem cells” – a small number of self-renewing cells within a tumor – are responsible for breast cancer progression and recurrence, and that wiping out these cells alone could cure the disease.

First Direct Electric Link Between Neurons And Light-sensitive Nanoparticle Films Created
The world’s first direct electrical link between nerve cells and photovoltaic nanoparticle films has been achieved by researchers at the University of Texas Medical Branch at Galveston (UTMB) and the University of Michigan. The development opens the door to applying the unique properties of nanoparticles to a wide variety of light-stimulated nerve-signaling devices, including the possible development of a nanoparticle-based artificial retina.

Gene Therapy for Blindness Clears Hurdle in Mice
University of Florida researchers have used an experimental therapy in mice to shut down a gene that plays a crucial role in a leading cause of inherited blindness.

Vanderbilt Performs State’s First Stem Cell Heart Regeneration Therapy
Vanderbilt University Medical Center is the first in the state to perform a novel therapy that uses bone marrow stem cells to stimulate regeneration of the heart muscle after a heart attack.

Enzo Therapeutics Treats First Patient in Phase I/II Study of Antisense Gene Therapy for HIV-1 Infections
The study is enrolling HIV-1 infected subjects with compromised CD4+ cell counts, to determine whether the procedure will create sufficient HIV-1 resistant CD4+ cells to defer disease progression to AIDS. Enrollment is continuing under a modified protocol designed to increase the proportion of engineered stem cells that engraft in the patient’s bone marrow.

Study Compares Stem Cell Transplants for Myeloma
Younger patients diagnosed with the blood cancer myeloma survived longer if they received a stem cell transplant from themselves that was followed by one from a matched sibling – rather than receiving two transplants from themselves.

University of Wisconsin Launches Study Testing Adult Stem Cells for Heart Damage Repair
This trial is the first human Phase II adult stem cell therapy study in the U.S. Its goal is to investigate the efficacy, tolerability, and safety of blood-derived selected stem cells to improve symptoms and clinical outcomes in patients with chronic myocardial ischemia (CMI), a severe form of coronary artery disease.

Cancer Cell Therapy Trial Exceeds Expectations
Prima BioMed said the phase IIa trial of 21 patients with late stage ovarian cancer showed four had a positive clinical response or stabilisation of the disease, meeting its target of a 15 per cent success rate.


Precancerous Stem Cells Have the Potential for both Benign and Malignant Differentiation
Cancer stem cells (CSCs) have been identified in hematopoietic and solid tumors. However, their precursors – namely, precancerous stem cells (pCSCs) – have not been characterized. Here the researchers experimentally define the pCSCs that have the potential for both benign and malignant differentiation, depending on environmental cues.

Stem Cells Act Through Multiple Mechanisms to Benefit Mice with Neurodegenerative Metabolic Disease
Intracranial transplantation of neural stem cells (NSCs) delayed disease onset, preserved motor function, reduced pathology and prolonged survival in a mouse model of Sandhoff disease, a lethal gangliosidosis.


$75 Million Boost for California Stem Cell Scientists
Just a month after approving nearly $45 million for embryonic stem cell research, California’s stem cell agency authorized another $75.7 million in additional funds for established scientists at 12 non-profit and academic institutions.

Victorian Treasurer Offers Clone Bill Support
Victorian Treasurer John Brumby has spoken out in support of a proposed move to allow cloning of human embryos for research purposes in the state’s medical facilities.

Senate Narrowly Approves New Mexico Stem Cell Bill
A bill to allow certain types of research on embryonic stem cells in New Mexico gained narrow approval from the Senate after a debate over medical ethics.


NeoStem Announces Las Vegas Facility to Expand Nationwide Network of Cutting-Edge Adult Stem Cell Collection Centers
NeoStem, Inc. has announced that the Company has entered into an agreement to open an Adult Stem Cell Collection Center in Las Vegas, Nevada.

Oxxon Therapeutics to be Acquired by Oxford BioMedica
Oxxon Therapeutics Limited has announced today that it has entered into an agreement to be acquired by Oxford BioMedica. Oxford BioMedica is focused on the development of novel gene-based therapeutics particularly in oncology, including therapeutic vaccines, and neurotherapy.

Vietnam to Establish Stem Cell Bank
Vietnam will establish a repository for stem cells from umbilical cord blood and umbilical cord membrane for the treatment of serious diseases, said a leading scientist.

New Stem Cell Production Facility Installs CompacT SelecT(TM) To Provide Rapid Delivery of Consistently High Quality Stem Cells
The CompacT SelecT at SCS will be used to culture several different human and mouse stem cell lines to supply the world’s top pharmaceutical companies with the right quantity, as well as quality of cells in assay ready plates.

Stem Cell Business Challenges
Unlike biotech, the stem cell industry faces a tough crowd.

Capital Markets Remain Chilly for Stem Cell Companies
Though market downturns such as the current one usually leave no industry untouched, their effect can be most pronounced – and lasting – in nascent, early-stage niche industries such as stem cells.

ThermoGenesis Granted Three Additional Patents by the U.S. Patent & Trademark Office
ThermoGenesis Corp. has announced that the U.S. Patent and Trademark Office has granted the Company notice of allowance of claims for the first two patents for the AutoXpress(TM) System and has granted an additional patent that extends coverage on the CryoSeal System.

StemCell Technologies’ Contract Services Launches Re-designed Website
New features of the website include: news, events and educational webcasts presented by the STI Contract Services team.

Stem Cell Innovations Names Ian Lyons, Ph.D., U.S. Chief Scientific Officer
Stem Cell Innovations, Inc. has announced that Ian Lyons, Ph.D., has been appointed Chief Scientific Officer, U.S. Dr. Lyons joins Helmuth van Es, Ph.D., Chief Scientific Officer, Europe, as co-leader of Stem Cell Innovation’s scientific programs.

NeoStem Hires Experienced Marketing Executive Arlene Graime to Direct Government Affairs and Raise Nationwide Consumer Awareness
In her new position, Ms. Graime will spearhead initiatives aimed at working with key federal and state agencies, and crucial Congressional committees in order to raise awareness for the benefits of adult stem cell therapy as a treatment option.


Announcing the NIH Director’s Bridge Awards (NOT-OD-07-056)

Revision: Ruth L. Kirschstein National Research Service Award (NRSA) Stipend and Other Budgetary Levels Effective for Fiscal Year 2007 (NOT-OD-07-057)

Correction for PAR-07-024: Ancillary Studies to Major Ongoing NIDDK and NHLBI Clinical Research Studies (R01) (NOT-DK-07-006)

NOTICE: Administrative Supplements for Making Knockout Mice (NOT-HG-07-011)

Notice of Intent to Issue a PA on Investigator-Initiated Multi-Site Clinical Trials (NOT-HL-07-108)

NINDS Institutional Center Core Grants to Support Neuroscience Research PAR-05-070 – Resumption of Receipt Dates (NOT-NS-07-008)


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

SOPP 8401: Administrative Processing of Biologics License Applications (BLA) – Updated

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)

Blood Vessels Recovered With Organs and Intended for Use in Organ Transplantation; Final Rule

Immune Globulins for Primary Immune Deficiency Diseases: Antibody Specificity, Potency and Testing; Public Workshop


Publication: Guidelines on Submission of Applications to the MHRA


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Profiled Journal

Robert Weinstein, MD
Chief, Division of Transfusion Medicine, UMass Memorial Medical Center, Worcester, MA.

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