Volume 8.47 | Dec 3

Volume 8.47, December 3, 2007
     In this issue: Science | Policy | Business | NIH | CBER | Regulatory
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Osiris Therapeutics Announces Positive One Year Data from Chondrogen Trial for Knee Repair: Osiris Therapeutics, Inc. announced positive one-year interim results in the evaluation of Chondrogen, a preparation of adult stem cells formulated for direct injection into the knee.


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University of California Davis Researchers Find Evidence of Mature Heart Cell Potential in Embryonic Stem Cells
In a new study, UC Davis researchers report the first functional evidence that heart cells derived from human embryonic stem cells exhibit one of the most critical properties of mature adult heart cells, an important biological process called excitation-contraction coupling.

Stem Cell Therapies For Brain More Complicated Than Thought
In a study published in the Public Library of Science Biology on Nov. 13, MIT scientists report that adult stem cells produced in the brain are pre-programmed to make only certain kinds of connections – making it impossible for a neural stem cell originating in the brain to be transplanted to the spinal cord, for instance, to take over functions for damaged cells.

Blood Stem Cells Fight Invaders
Researchers have discovered that blood stem cells are capable of patrolling the body’s organs where they seek out, and respond to, pathogens. They appear to be proactive participants in our innate immune response.

Repairing the Heart with Stem Cells
Stem cells can prove an effective method of repairing the heart after a myocardial infarction. By replacing the damaged tissue with stem cells, doctors will be able to reduce the risk of heart failure.

Stem Cells Target Paralysis
Neuralstem Inc. is poised to launch its first trials on severe spinal cord conditions in humans.

Gene Therapy Study Is Allowed to Resume
The Food and Drug Administration has given a Seattle company permission to resume its human tests of an experimental, gene-based arthritis treatment whose safety came into question this summer after a 36-year-old study participant died.

Insulin-producing Islets from Living Donors May Revolutionise Diabetes Treatment
The shortage of pancreatic cells that create insulin for transplantation can be dealt with by obtaining islet cells from living donors, according to a study in Clinical Transplantation.

Adult Stem Cell Product to be Tested in Stroke Trial
Biocompatibles is pleased to announce that the Paul Ehrlich Institute, the regulatory agency of the German Ministry of Health, has granted permission for the start of a clinical trial for the treatment of patients immediately following a haemorrhagic stroke.

BioE Submits 510(K) Application to FDA for Umbilical Cord Blood Processing System
BioE(R), Inc. has announced it submitted a 510(k) pre-market notification application to the U.S. Food and Drug Administration requesting regulatory and marketing clearance for its PrepaCyte(R)-CB Processing System for umbilical cord blood.

Radical New Treatment Could End Transplant Crisis by Stopping Bodies Rejecting New Organs
A radical treatment that "rinses" organs and then implants them with patients’ DNA is being hailed as a solution to the transplant crisis.


In Vitro and In Vivo Induced Transgene Expression in Human Embryonic Stem Cells and Derivatives
Using GFP as an indicator, the researchers demonstrated that the tet-on system allowed a tight control of the gene expression in both undifferentiated hESCs and differentiated cells of the three germ layers. More importantly, after the cells were transplanted into animals the gene expression remained to be regulated by an orally administered drug.


Biomedical Equipment Technician
Los Angeles, CA (Cedars-Sinai Medical Center)

Quality Manager
Singapore (Singapore Cord Blood Bank)

Clinical Development Research Associate
Poway, California (VetStem)

Islet Cell Associate Research Director
Irvine, CA (University of California, Irvine)


UK Research Funders Ask Public What They Really Think About Stem Cell Research
The UK’s two biggest public funders of stem cell research have today launched a year-long national dialogue programme that aims to find out what the public really think about stem cell science.

Japan to Boost Study on Nonembryonic Stem Cells
The Japanese government will spend 65.4 million U.S. dollars over the next five years to boost study on nonembryonic stem cells, following a breakthrough by local scientists earlier this week.

State Auditor to Review Stem Cell Institute Finances
California Controller John Chiang has directed his office to conduct a financial audit of the California Institute of Regenerative Medicine and how its grants are allocated.

Suddenly, Connecticut Is Stem Cell Central
Last year, when $20 million was available, the state received 70 research proposals, mostly from University of Connecticut and Yale University. This year, with half that amount available, the state has received 87 proposals.

Senator Clinton Appoints DeGette as Adviser on Stem Cell Research
Democrat Hillary Clinton added the House’s leading advocate for embryonic stem cell research to her presidential campaign on Monday when she named Colorado Representative Diana DeGette as a health adviser.

Should Fertilized Eggs Have Rights?
If Colorado for Equal Rights for Human Life and other anti-abortion groups can wrangle 76,000 signatures in the next six months, theirs could be the first state in the nation to vote on whether a fertilized egg should legally be considered a person.


Fate Therapeutics Created by Leading Stem Cell Scientists to Pursue New Approaches to Stem Cell Therapies
A group of the nation’s most respected leaders in stem cell biology today announced formation of Fate Therapeutics, a new biotechnology company developing drugs to control cell fate. Fate will harness the healing power of adult stem cells by using small molecule drugs to modulate cells in vivo (in the body) and by reprogramming mature adult cells into stem cells.

San Diego Company Formed around Breakthrough in Embryonic Stem Cell Research
Cascade LifeSciences is the exclusive worldwide licensee of Dr. Mitalipov’s technology related to SCNT reprogramming as well as a second method of generating embryonic stem cells using an approach known as parthenogenesis.

StemCells, Inc. Exploring Acquisition of Progenitor Cell Therapy, LLC
StemCells, Inc. today announced it is exploring the acquisition of privately held Progenitor Cell Therapy, LLC, a leading provider of cGMP-quality cell processing services headquartered in Hackensack, NJ.

University of California, Los Angeles Scientists’ Biotech Firm to be Acquired by Pharmaceutical Corp.
Acquisition will make the faculty-founded company one of L.A.’s largest private biotechnology firms.

Six Institutions to Focus on Stem Cells
Research institutions across Southern California have joined forces to advance stem cell research by establishing the Southern California Stem Cell Scientific Collaboration (SC3).

Genzyme, French Firm Partner on Gene Therapies
Genzyme Corp. in Cambridge said on Tuesday that it hat signed a collaboration deal with Fovea Pharmaceuticals SA in Paris.

Binex and MaxCyte Collaborate on Cancer Immunotherapy Research
Binex and MaxCyte, Inc. have announced the signing of a Sponsored Research Agreement to evaluate MaxCyte’s GMP-compliant cell loading technologyfor use in closed-system manufacturing of Binex’s cell-based cancer immunotherapies.

Millipore Announces Collaboration with Abeome Corporation Partnership to Distribute Monoclonal Antibodies for Stem Cell Research
Millipore Corporation has announced its collaboration with Abeome Corporation on the development and distribution of a novel stem cell antibody. The antibody, Human Embryonic Stem Cell Antigen-1, is a previously unidentified marker for the analysis of pluripotent stem cells in immunocytochemistry and other immunological techniques.

HepaLife(TM) Enters Into New Cooperative Research and Development Agreement with U.S. Government Agency
HepaLife Technologies, Inc. has announced that the Company has entered into a new Cooperative Research and Development Agreement with the U.S. Department of Agriculture, Agricultural Research Service for further optimization of HepaLife’s PICM-19 liver stem cell line for application in the first-of-its-kind bioartificial liver device.

University of Texas at San Antonio Tapped for Army Contract to Develop Biomed Technologies
The University of Texas at San Antonio College of Engineering has been awarded a $2 million grant to develop bone-regeneration technologies for wounded soldiers.

MicroIslet, Inc. Retains New York-Based Investor Relations Firm
MicroIslet, Inc. has engaged the Investor Relations Group, Inc., based in New York City, to serve as its new financial relations and corporate communications firm.

Pluristem’s Reverse Stock Split Effective Today
Pluristem Therapeutics Inc. has announced that its previously disclosed two hundred for one reverse stock split has become effective. The Company’s name was also changed from Pluristem Life Systems, Inc. to Pluristem Therapeutics Inc.

University of Pennsylvania Establishes Institute for Regenerative Medicine
The University of Pennsylvania is launching the Institute for Regenerative Medicine, a new cross-disciplinary endeavor to investigate and harness the therapeutic potential of stem cells in the treatment of cancer, diabetes, cardiovascular disease, degenerative diseases, wound healing and aging. Two renowned Penn scientists, Jonathan A. Epstein and Ralph L. Brinster, will lead the Institute.

Regenerative Medicine Gets £10 Million Public Support
The UK’s Technology Strategy Board has committed £10 million to support collaborative research and development projects in the field of regenerative medicine.

Arteriocyte Awarded $800,000 for Cellular Therapy for Battlefield Wounds Project as Part of Department of Defense Fiscal Year 2008 Budget
Arteriocyte has announced that the company will receive $800,000 for their Cellular Therapy for Battlefield Wounds project from the 2008 Defense Appropriations bill the President signed into law November 13th. U.S. Representative Stephanie Tubbs Jones and Senator Sherrod Brown championed the effort to secure the funding.

Alnylam Announces Grant of Broad Patent Covering RNAi Therapeutics in Germany
Alnylam Pharmaceuticals, Inc. has announced that the German Patent Office has granted a patent (DE 10080167 or “’167 patent”) for the Kreutzer-Limmer I patent series.


Notice Regarding Authentication of Cultured Cell Lines (NOT-OD-08-017)

NIH Reduces Temporary “Error Correction Window” for Electronic Grant Applications from Five Business Days to Two (NOT-OD-08-018)

Extension of the NIDDK Mentored Research Scientist Development Award (K01) Funding Opportunity Announcement (PAR-05-066) (NOT-DK-08-005)


PAR-07-420, Lymphatic Biology in Health and Disease (R01): An Addition (NOT-HL-08-107)

Deep Vein Thrombosis and Venous Disease (R01) (RFA-HL-08-002)



Medical Devices; Hematology and Pathology Devices: Reclassification of Automated Blood Cell Separator Device Operating by Centrifugal Separation Principle; Final Rule

Guidance for Industry: Providing Regulatory Submissions to the Center for Biologics Evaluation and Research in Electronic Format – Lot Release Protocols

Guidance for Industry and FDA Staff: Class II Special Controls Guidance Document: Automated Blood Cell Separator Device Operating by Centrifugal or Filtration Separation Principle



The European Union And The FDA Working Together To Create CommonApplication For Orphan Designation For Medicines
The European Commission, the European Medicines Agency and the United States Food and Drug Administration have adopted a common application form for sponsors seeking orphan designation of medicines in the European Union and US.

FDA Needs More Money and Staff, Report Finds
American lives are at risk because the Food and Drug Administration lacks the funding to keep up with scientific advances, agency advisers said.


14th ISCT Annual Meeting

May 17-20, 2008
Downtown Miami, Florida

Abstract Submission and Early Registration Deadline: January 31, 2008

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

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