Volume 10.35 | Sep 7

Cell Therapy News 10.35, September 7, 2009
     In this issue: Science | Policy | Business | NIH | CBER | Regulatory
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Top Stories

New Stem Cell Treatment ‘Being Used by Patients to Avoid Hip Replacements’: Doctors in Southampton are using the pioneering technique, where a patient’s damaged bones are repaired using their own purified cells from bone marrow extracted from the pelvis. [University of Southampton, Southampton]


Complimentary Webinar: Feeder-independent growth of hESCs & hiPSCs using mTeSR(R)1

Promise of Nanodiamonds for Safer Gene Therapy
Researchers has introduced the power of nanodiamonds as a novel gene delivery technology that combines key properties in one approach: enhanced delivery efficiency along with outstanding biocompatibility. [Northwestern University, Evanston]

Clemson University Researcher Regenerates Brain Tissue in Traumatic Injuries
An injectable biomaterial gel may help brain tissue grow at the site of a traumatic brain injury, according to recent findings. [Clemson University, Clemson]

Glow-in-the-dark Stem Cells
Monash stem cell scientists have modified a human embryonic stem cell line so that it glows red when the stem cells become red blood cells. [Monash University, Melbourne]

Study Promises Faster Recovery from Life-Threatening Blood Cell Shortages
A key compound resupplies bone marrow with fast-acting stem cells that can more quickly rekindle blood cell production according to a recent study. [University of Rochester, Rochester]

Modeling Diabetes with Stem Cells
A technique that allows the insulin-producing cells that are destroyed by type 1 diabetes to be re-created in the lab could help researchers understand how the disease develops and perhaps lead to more effective treatments for the condition. [Harvard University, Boston]

Two Proteins Enable Skin Cells to Regenerate
Researchers have found that stem cells located within the skin actively generate differentiating cells that can ultimately form either the body surface or the hairs that emanate from it. [The Rockerfeller University, New York]

StemCells, Inc. Demonstrates Protection Of Neurological Function In Batten Mouse
StemCells, Inc. recently announced the publication of preclinical data demonstrating for the first time that transplantation of its proprietary, purified human neural stem cells delays the loss of motor function in a mouse model of infantile neuronal ceroid lipofuscinosis. [StemCells, Inc., Palo Alto]

Joining the Dots on Stem Cell Signaling
Transcription factors, the proteins that control the activity of genes, can be part of a hierarchy of signaling compounds in embyronic stem cells. [RIKEN, Saitama]

Stemedica Achieves Major Milestone – Company Receives License to Manufacture Clinical Grade Stem Cells
Stemedica Cell Technologies, Inc. announced recently that it has been granted a license by the State of California’s Food & Drug Branch to manufacture stem cells for human clinical trials. [Stemedica Cell Technologies, Inc., San Diego]

Safer Bone Marrow Transplants for Sick Children
For the first time, researchers have used antibodies that recognise the bone marrow to prevent rejection and create space for the donor stem cells. [Great Ormond Street Hospital for Children NHS Trust, London]

Cytopia’s CYT387 Receives FDA Clearance to Start US Clinical Trials
Cytopia Limited’s Investigational New Drug Application for CYT387, a small-molecule oral JAK1/JAK2 kinase inhibitor designed to treat various haematological disorders, has passed US Food and Drug Administration review. [Cytopia Limited, Melbourne]


Phase III Prospective Randomized Double-Blind Placebo-Controlled Trial of Plerixafor Plus Granulocyte Colony-Stimulating Factor Compared With Placebo Plus Granulocyte Colony-Stimulating Factor for Autologous Stem-Cell Mobilization and Transplantation for Patients With Non-Hodgkin’s Lymphoma
This study evaluates the safety and efficacy of plerixafor, a CXCR4 antagonist, in mobilizing hematopoietic stem cells for autologous stem-cell transplantation in non-Hodgkin’s lymphoma patients. [Journal of Clinical Oncology]

Sox2 is Dispensable for the Reprogramming of Melanocytes and Melanoma Cells into Induced Pluripotent Stem Cells
Here, the researchers show that both human and mouse melanocytes give rise to iPSCs at higher efficiencies than fibroblasts, and mouse malignant melanoma cell line remains equally amenable to reprogramming into iPSCs. [Journal of Cell Science]

Generation and Characterization of Functional Cardiomyocytes using Induced Pluripotent Stem Cells derived from Human Fibroblasts
This paper describes the successful development of both spontaneous and inductive cardiomyocyte differentiation of iPS cells reprogrammed from human foreskin fibroblasts. [Cell Biology International]

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Research and Development Scientist – Stem Cell Biology

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Safety Call Over Stem Cell Trips
A clampdown on unproven and potentially unsafe stem cell research is being called for by an expert group.

How Will Science Fare?
This year, there is a new twist in the Japanese education ministry’s budget requests: The newly elected Democratic Party now has responsibility for finalizing the budget, and no one knows how R&D will fare.

Ethics scrutiny needed for Chinese–European projects
Biomedical research collaborations between Europe and China need greater ethical oversight to combat unregulated stem-cell therapies and prevent the exploitation of clinical-trial participants according to experts.

The 2nd Annual Maryland Stem Cell Research Symposium, September 21 2009


Connexon Creative Launches Mesenchymal Cell News
Mesenchymal Cell News is a free, weekly e-newsletter that keeps the mesenchymal cell community informed by providing the latest news from all areas of the field, including its science, policy, and business.

STEMCELL Technologies Inc. to Host Stem Cell Training Courses
STEMCELL Technologies has announced the schedule for their fall training program including mesenchymal, mammary, neural, hematopoietic, human embryonic and induced pluripotent stem cell biology. [STEMCELL Technologies Inc., Vancouver]

BrainStorm Cell Therapeutics Enters into Agreement for Clinical-Grade Stem Cell Production for ALS
BrainStorm Cell Therapeutics Inc. announced recently that it has entered into an agreement with Protein Production Services Ltd. to start Good Manufacturing Practice production of its stem cell therapeutic product. [BrainStorm Cell Therapeutics, Petach Tikvah]

NIH Awards Nearly $6M in RNAi, miRNA Grants with Stimulus Money
The National Institutes of Health has awarded almost $6 million in new grants to support RNAi- and microRNA-related research projects during 2009, of which more than $2 million has been handed out to finance therapeutic RNAi research.

University of Missouri Licensing Revenue Hits $10 Million
The University of Missouri’s technology transfer program topped $10 million in licensing income for the first time ever. [University of Missouri, St.Louis]

Biotech Startup Hopes Light-activated Nerve Cells will Make it a Northeast Ohio Star
LucCell Inc.’s light switches, which sprang from research at Case Western Reserve University, allow neurons silenced by a spinal cord injury or brain cells malfunctioning due to disease might someday resume working when triggered by flashes of laser light. [LucCell Inc., Cleveland]

BloodStor(TM) Stem Cell Biopreservation Media Platform Launched by BioLife Solutions
BioLife Solutions, Inc. recently announced the launch of its BloodStor biopreservation media product platform. [BioLife Solutions, Inc., Bothwell]

Californian Budget Deficit Poses “Real Risk” to Biotech Investment
Biotech has played a large role in shaping California over the past 30 years but the new financial frugality has created a difficult relationship between the industry and the state.


Clarification of NOT-OD-08-014 Regarding Obtaining Assistance from NIH for Registration and Reporting of Results in ClinicalTrials.gov (NOT-OD-09-147)

Enhancing Peer Review: The NIMH Announces Consolidation of Review Criteria for NIMH Career Opportunities in Research (COR) Honors Undergraduate Research Training Grant (T34) Submitted for FY 2010 Funding (NOT-MH-09-018)


2009 Meeting Materials, Vaccines and Related Biological Products Advisory Committee



FDA Study Indicates Most Industry Postmarketing Studies Meet Timelines
Makers of approved drugs and biologics generally are meeting their regulatory obligations and complete their postmarketing studies in a timely manner, according to a recent study.

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