Volume 8.01 | Jan 15

Volume 8.01, January 15, 2007
     In this issue: Science | Policy | Business | NIH | CBER | Regulatory
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Top Stories

Osiris Therapeutics Receives FDA Fast Track Status for Its Crohn’s Disease Stem Cell Therapy and Clearance to Start Phase III Clinical Trial: Osiris Therapeutics, Inc. announced today that PROCHYMAL(TM) has received Fast Track designation from the U.S. Food and Drug Administration, expediting the development of the stem cell treatment for Crohn’s Disease that does not respond to standard therapies.


Liver Cell Created From Subcutaneous Fat
A team of doctors has succeeded in creating a hepatic cell out of subcutaneous fat, a development that might lead to a regenerative medicine technique that would enable patients with hepatitis or cirrhosis to have their livers repaired.

Researchers Report Alternative Stem Cell Source in Amniotic Fluid
Researchers at Wake Forest and Harvard report they have drawn stem cells from amniotic fluid donated by pregnant women. They say those cells were successfully turned into several different tissue cell types, including brain, liver and bone.

Scientists Discover Stage at Which an Embryonic Cell is Fated to Become a Stem Cell
Cambridge scientists have discovered the stage at which some of the cells of a fertilised mammalian egg are fated to develop into stem cells and why this occurs.

Modified Skin Cells Resist Bugs
US scientists say they have made germ-resistant skin that could one day save the lives of severe burns victims.

University of Southern California Study Supports a Stem Cell Origin of Cancer
According to the study’s findings, genes that are reversibly repressed in embryonic stem cells are over-represented among genes that are permanently silenced in cancers; this link lends support to the increasingly discussed theory that cancer is rooted in small populations of stem cells.

Cell Therapy For Parkinson’s
To directly combat the decline in dopamine levels associated with Parkinson’s, researchers at the company NeuroProgen have developed a new drug on the basis of stem cells which is now being adapted to the regulatory standards of the pharmaceutical industry in partnership with the Fraunhofer Institute for Cell Therapy and Immunology IZI.

Dramatic Results from Combo Therapy Surprises Krabbé-disease Researchers
A combination of bone marrow transplantation and gene therapy greatly lengthened the lives of laboratory mice doomed by a rapidly progressing, fatal neurodegenerative disorder also found in people.

Pluristem Submits Pre-Investigational New Drug Document to FDA
An innovative adjuvant cell therapy product based on PLacenta eXpanded Mesenchymal cells, PLX- I is expected to be used to improve the engraftment of Umbilical Cord Blood when treating blood cancer and blood disorders. Approval of the Pre-IND document by the FDA precedes initiation of Phase I trials.

Stem-cell Hope Put on Hold by US Regulator
ReNeuron recently suffered a setback when a US regulator put the group’s first clinical trial on hold.

Takara Bio Obtains Clinical Trial Approval of Gene Therapy Treatment for Chronic Granulomatosis
Bio affiliate ViroMed Co., Ltd., based in Korea, announced the Korea Food & Drug Administration approval of their clinical trial of VM106, gene therapy treatment drug, for chronic granulomatosis.

Ark Therapeutics Holds Positive End Of Phase II Meeting With FDA On Trinam(R) Gene Therapy
Ark Therapeutics Group plc has announced that it has held a positive “end of Phase II” meeting with the US Food and Drug Administration regarding Trinam(R), its novel gene therapy to prevent blood vessels blocking in kidney dialysis patients who have undergone vascular access graft surgery.

Stem Cell Device Could Have Role in Cancer Treatment
Researchers at the University of Rochester and StemCapture have unveiled a new device technology that makes it possible to harvest stem cells from the blood, bypassing the controversial use of stem cells sourced from embryos.

Womb Transplants May One Day Be a Reality
Current organ donor networks appear able to supply human wombs, or uteruses, for transplantation as a possible approach to treating infertility.

Odds Favor Hawaiian’s Return to Health with Stem Cell Therapy
Placed beyond hope by medical professionals in his own country, a US man takes his chances with adult stem therapy to treat his heart disease.


Haematopoietic Stem Cell Transplantation Trends in Children Over the Last Three Decades: A Survey By the Paediatric Diseases Working Party of the European Group for Blood and Marrow Transplantation
This paper describes the trends in haematopoietic stem cell transplantation (HSCT) activity for children in Europe over the last three decades. It shows that indications for paediatric HSCT have changed considerably during the last seven years and that these changes provide tools for decision making in health-care planning and counselling.

Efficient Non-Viral Ocular Gene Transfer with Compacted DNA Nanoparticles
This article discusses a treatment strategy that appears to be clinically viable and provides a highly efficient non-viral technology to safely deliver and express nucleic acids in the retina and other ocular tissues.


Stem Cell Research Passes U.S. House
Following an emotional day of debate in which lawmakers invoked their own medical tragedies and those of families, friends and constituents, the House voted Thursday to expand federally funded embryonic stem cell research.

Fertility Watchdog Delays Ruling on Animal-Human Embryo Research
The Government’s advisory committee on fertility has decided to delay its decision on whether to allow the creation of human-animal embryos. 

Stem Cell Institute Seeks Small Facility Grant Proposals
The California Institute for Regenerative Medicine said Thursday it is taking requests for grants for building shared stem cell research space.


Stem Cell Sales to Top $35 Million
Sales of adult stem cell products will more than double in 2007, exceeding $35 million and in the process opening the door for embryonic stem cell therapies, according to a medical industry analyst.

Firm Pioneers ‘Banking’ Blood For Future
By the end of this month patients in London and other areas of England will also be able to take advantage of the potential life-saving treatment, which has been described as a form of "biological life insurance".

ViaCell Implements Automation Technology at ViaCord Processing Laboratory
The automation technology is the SEPAX Cord Blood Processing System from Biosafe SA, a closed and sterile processing system that efficiently harvests stem cells from cord blood in a large-scale processing environment.

Immuno-Biological Laboratories Co., Ltd. and Intellect Neurosciences, Inc. Enter into Humanized Monoclonal Antibodies Development Agreement for the Treatment of Alzheimer’s Disease
Immuno-Biological Laboratories Co., Ltd.  and Intellect Neurosciences, Inc. have announced that Intellect has purchased from IBL the rights to manufacture, develop and commercialize two therapeutic, beta-amyloid specific, humanized monoclonal antibodies for the treatment of Alzheimer’s disease.

CytRx Corporation Establishes RNAi Subsidiary, RXi Pharmaceuticals
CytRx Corporation has announced that it has contributed its RNA interference (RNAi) assets to RXi Pharmaceuticals Corporation (RXi), which is co-owned by CytRx and several world leaders in RNAi technology.

CytRx Corporation Subsidiary, RXi Pharmaceuticals, Licenses "Nanotransporters" and Other RNAi Discoveries from the University of Massachusetts Medical School
CytRx Corporation has announced that RXi Pharmaceuticals Corporation (RXi), a majority-owned subsidiary of CytRx, has entered into significant new agreements with the University of Massachusetts Medical School (UMMS) to license RNA interference (RNAi) intellectual property for all therapeutic applications.

Genentech and Seattle Genetics In Deal
Biotechnology companies Genentech Inc. and Seattle Genetics Inc. have said that they have entered an exclusive worldwide license agreement for the development and commercialization of a humanized monoclonal antibody, SGN-40.

National Stem Cell Applies for $1,725,000 Grant From State of Maryland
National Stem Cell will be conducting its research at Johns Hopkins University School of Medicine, with whom the company maintains sponsored research agreements.

Stem Cell Centre Plan Confirmed
A world-leading centre in stem cell science and regenerative medicine is to be built in Edinburgh, ministers have confirmed.

Stem Cell Innovations Announces Issuance of Fundamental Human Stem Cell Patent
“The patent provides a broad blocking position for the pluripotent cells of interest to Stem Cell Innovations as it covers isolated human primordial germ cell derived pluripotent cells,” said Stem Cell Innovations CEO Dr. James Kelly.

GammaCan Files Additional Patent Applications Covering the Treatment of Malignant Melanoma and Colorectal Cancer with the United States Patent and Trademark Office
The first CIP is titled “Administration of Gamma Globulins to Treat Metastatic Melanoma” and builds on the pre-clinical work conducted at GammaCan and substantiates these findings with data from ongoing clinical trials.


Extension of NIH Pilot Study to Shorten the Review Cycle for New Investigator R01 Applications (NOT-OD-07-034)

Findings of Research Misconduct (NOT-OD-07-035)

Request for Community Input for the Nomination and Prioritization of Genes to be Targeted in the Knockout Mouse Project (KOMP) (NOT-HG-07-004)

Clinical Trials in Organ Transplantation in Children (U01) (RFA-AI-07-006)

Bioengineering Research Grants (BRG)(R01) (PA-07-279)


Warning Letter – INCELL Corporation, LLC

Fast Track Designation Request Performance – Update

Approved Biological NDA and ANDA Applications – Update

Licensed Products and Establishments List – Update



Vaccines and Related Biological Products Advisory Committee; Notice of Meeting


Overview of the Proposal to Establish a Trans-Tasman Regulatory Scheme for Therapeutic Products

Structure, Governance and Accountability Arrangements for the New Authority

What Are Therapeutic Products and How Would They Be Regulated Under the Proposed Joint Scheme?

Questions and Answers About Good Manufacturing Practice


The International Cellular Therapy Coding and Labeling Advisory Group would like to know your current labeling practice. Are you completely automated, completely manual or somewhere in between? Please complete the brief survey accessed at http://www.surveymonkey.com/s.asp?u=959303138614. The information gathered will be valuable as we move toward global standardization for labeling of cellular therapy products. Your participation is greatly appreciated. For more information about this project, please visit: http://www.iccbba.org/cellulartherapy_home.html

Call for Abstracts
On-line abstract submission for the 2007 ISCT Annual Meeting is now available through the ISCT Website. 
Submission deadline: February 16, 2007

ISCT Membership
Renew your ISCT Membership for 2007 now!
Not a member?  Visit the ISCT website to learn about the benefits of membership.

AABB-ISCT Cellular Therapy Audioconference Series

Profiled Journal

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

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