Volume 9.12 | Mar 31

Cell Therapy News 9.12, March 31, 2008
     In this issue: Science | Policy | Business | NIH | CBER | Regulatory
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Top Stories

Therapeutic Cloning Treats Parkinson’s Disease in Mice: Research led by investigators at Memorial Sloan-Kettering Cancer Center has shown that therapeutic cloning, also known as somatic-cell nuclear transfer, can be used to treat Parkinson’s disease in mice.


Self-Assembled Materials From Mini Stem Cell Lab
Imagine having one polymer and one small molecule that instantly assemble into a flexible but strong sac in which you can grow human stem cells, creating a sort of miniature laboratory. And that sac, if used for cell therapy, could cloak the stem cells from the human body’s immune system and biodegrade upon arriving at its destination, releasing the stem cells to do their work.


Identifying the Genes that Put the “Stem” in Cell
A team led by Howard Hughes Medical Institute researchers has identified a network of hundreds of genes that keep embryonic stem cells in their characteristic malleable state, able to develop into any cell type when the time comes.

Protein Protects Embryonic Stem Cells’ Versatility and Self-Renewal
A protein known as REST blocks the expression of a microRNA that prevents embryonic stem cells from reproducing themselves and causes them to differentiate into specific cell types, scientists at The University of Texas M. D. Anderson Cancer Center report in the journal Nature.

UCLA Stem Cell Researchers Use High Resolution Technology to Examine the Genome of Human Embryonic Cells
Stem cell researchers from UCLA used a high resolution technique to examine the genome, or total DNA content, of a pair of human embryonic stem cell lines and found that while both lines could form neurons, the lines had differences in the numbers of certain genes that could control such things as individual traits and disease susceptibility.

Umbilical Cord Blood Cell Therapy Reduces Pathology in Animal Model of Alzheimer’s Disease
Targeted immune suppression using human umbilical cord blood cells may improve the pathology associated with Alzheimer’s disease, a new study in a mouse model of this currently untreatable neurodegenerative condition reports.

Gene Silencing Therapies Could Have Harmful Side Effects, Research Suggests
A dramatic new study published in the most recent issue of Nature questions some of the mechanisms underlying a new class of drugs based on Nobel Prize-winning work designed to fight diseases ranging from macular degeneration to diabetes.

Deadly Genetic Disease Prevented Before Birth in Zebrafish
By injecting a customized “genetic patch” into early stage fish embryos, researchers at Washington University School of Medicine in St. Louis were able to correct a genetic mutation so the embryos developed normally.

Anticancer siRNA Therapy Advances, Thanks to Nanoparticles
Small pieces of nucleic acid, known as short interfering RNAs, can turn off the production of specific proteins, a property that makes them one of the more promising new classes of anticancer drugs in development. Indeed, at least two siRNA-based anticancer therapies, both delivered to tumors in nanoparticles, have begun human clinical trials.

Oxford Biomedica Report Encouraging New Phase II Trial Results with TROVAX(R) in Prostate Cancer
Oxford BioMedica has announced encouraging new data from its first Phase II trial of TroVax in prostate cancer.

Neurologix Receives FDA Clearance to Initiate Phase 2 Trial in Parkinson’s Disease Subjects
Neurologix, Inc., announced recently that the U.S. Food and Drug Administration has allowed the company to proceed with its planned Phase 2 clinical trial in subjects with advanced Parkinson’s disease.


High Incidence of Leukemia in Large Animals After Stem Cell Gene Therapy with a HOXB4-Expressing Retroviral Vector
Retroviral vector–mediated HSC gene therapy has been used to treat individuals with a number of life-threatening diseases. However, some patients with SCID-X1 developed retroviral vector–mediated leukemia after treatment. Our data thus suggest the continued need for caution in genetic manipulation of repopulating cells, particularly when the transgene might impart an intrinsic growth advantage.

The Wanderings of Hematopoietic Stem Cells
The Rho GTPase family member Rac1 functions in the migration of hematopoietic stem/progenitor cells in the embryo and is required for the emergence of intraembryonic hematopoiesis.


UK Prime Minister to Allow Partial Free Embryo Vote
Gordon Brown said on Tuesday that Labour MPs will have a free vote on three “ethical” parts of proposed legislation on embryo research after reports said some cabinet ministers could resign over the issue.

Patent Law Changes Could Alter Rules for Life Sciences
A “perfect storm” in Washington is currently building against biomedical patent protection.

Nebraska Governor Signs Stem Cell Bill
A major compromise on medical research involving human cloning and embryonic stem cells now is part of Nebraska law.


STEMCELL Technologies Delivers a New Method for Identifying and Quantifying Neural Stem and Progenitor Cells In Vitro
The NeuroCult(R) Neural Colony-Forming Cell Assay increases accuracy of studying neural stem cells in vitro and therefore, the evaluation of the therapeutic potential of neural stem cells.

Medistem Enters Into Collaborative Agreement With TriCell
Under the terms of the agreement, which is subject to Indian government approval, Medistem Laboratories will receive cash and equity in TriCell. TriCell will receive access to Medistem’s intellectual property portfolio along with its know-how in the area of stem cell culturing and expansion for use in India and certain jurisdictions.

The Wistar Institute Collaborates with the Coriell Institute to Distribute Cell Lines
Cell lines developed by scientists at The Wistar Institute in Philadelphia have recently been made available to researchers around the globe through the catalog collection at the Coriell Institute for Medical Research of Camden, N.J.

Biolife Solutions Expands Presence in Cell Therapy and Cord Blood Banking Market Segments
BioLife announced that Oncolix, Inc. is developing a potential lifesaving treatment for stage IV melanoma and has adopted CryoStor for the cryopreservation of the Company’s proprietary dendritic cell-based cancer therapy.

Isolagen, Inc. Sells Switzerland Facility for about $6.4M
Isolagen(TM), Inc. recently announced the sale of its facility located in Switzerland for approximately $6.4 million, net. $5.85 million of the sale amount was paid at the time of closing and the remaining proceeds are expected within the next six weeks.

Sydney Clinic in Stem Cell First
Sydney clinic the Stem Cell Company will become the first company in the world to sell made-to-order stem cells generated from women’s unwanted IVF embryos.

Renowned Stem Cell Researcher Jeanne F. Loring Heads New Center at The Scripps Research Institute
Professor Jeanne F. Loring, Ph.D., has been named founding director of the newly created Center for Regenerative Medicine at The Scripps Research Institute in La Jolla, California.


222 NIH Grants: 22 Researchers
A whopping 200 scientists received six or more grants each from the US National Institutes of Health (NIH) in 2007, according to data analysed by Nature. One principal investigator was awarded 32 grants, the data reveal, and many others got eight or nine.

NIH Council of Councils Members Named

Tumor Stem Cells in Cancer Biology, Prevention, and Therapy (P01) (RFA-CA-08-020)


Procedures for Handling Adverse Reaction Reports Related to "361" Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)

Identification of Drug and Biological Products Deemed to Have Risk Evaluation and Mitigation Strategies for Purposes of the Food and Drug Administration Amendments Act of 2007

All new CBER information can be reached from the What’s New page at WHAT’S NEW PAGE



FDA Identifies First Steps in Requirements for Safety Plans for Certain Drugs and Biologics
The U.S. Food and Drug Administration has identified 25 drugs and biologic products that will be required to submit safety plans called Risk Evaluation and Mitigation Strategy, the FDA said in a Federal Register notice published recently.


Consultation on Draft Guidance for Sponsors: Information and Submission Requirements for Subsequent Entry Biologics (SEBs)


14th ISCT Annual Meeting

May 17-20, 2008
Downtown Miami, Florida

Full details at: http://www.celltherapysociety.org

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