Volume 6.48 | Nov 28

Volume 6.48, November 28, 2005
     In this issue: Science | Policy | Business | NIH | CBER | Regulatory
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Top Stories

S. Korean Stem Cell Expert Apologizes for Ethical Breach: Hwang Woo Suk, the leading stem cell expert whose South Korean team cloned the first human embryo and created the first cloned dog, publicly apologized Thursday for ethical breaches at his lab and said he would resign from all his official posts.


Adult Stem Cells Act As Construction Supervisors In Tissue Repair
“Our findings indicate a new understanding of the role played by adult stem cells,” said Thomas Skalak, chairman of the Department of Biomedical Engineering, who along with his colleague Gary Owens, professor of molecular physiology, is leading the research team.

University of Florida Scientists Say Stem Cells May Trigger Bone Cancer
The researchers are the first to identify a population of cells with characteristics of adult and embryonic stem cells in cultures derived from biopsies of patients’ bone tumors. They describe their findings in this month’s issue of the medical journal Neoplasia.

Regenerating Worms Help Elucidate Stem Cell Biology
Using a tiny flatworm best known for its extraordinary ability to regenerate lost tissue, researchers have identified a gene that controls the ability of stem cells to differentiate into specialized cells.

Laser Activates Gene Therapy in Rats’ eyes
Laser light has been used to remotely control gene therapy in rats.

S. Korea to Promote Stem Cell Treatment
With its doctors at the vanguard of pioneering stem cell therapy, South Korea is looking to become a “medical tourism” destination for foreigners unable to find cures in their own countries.


A Quantitative Matrigel Assay for Assessing Repopulating Capacity of Prostate Stem Cells
We conclude that prostate stem/progenitor cells exist and that our method is applicable to analysis of prostate stem cells, epithelial mesenchyme interactions, and prostate cancer stem cells.

Biomaterial Coatings by Stepwise Deposition of Silk Fibroin
This approach offers new options to engineer biomaterial coatings as well as bulk materials with control of both interfacial properties conducive to specific cellular or tissue responses and the potential to entrap and deliver labile molecules or other components due to the all-aqueous process described.

Cell Docking Inside Microwells within Reversibly Sealed Microfluidic Channels for Fabricating Multiphenotype Cell Arrays
The ability to position many cell types on particular regions within a two dimensional substrate could potentially lead to improved high-throughput methods applicable to drug screening and tissue engineering.


Scientists Allege U.S. Losing Lead in Stem Cell Research; Advanced Cell Technology Generated Stem Cell Embryos in 2003, but Lack of Federal Funding Hampered Progress
South Korea’s World Stem Cell Hub could become the leading center for stem cell and therapeutic cloning research, because of the chilling effect U.S. policy has had on stem cell research, according to Dr. Robert Lanza, Vice President for Medical & Scientific Development of Advanced Cell Technology, Inc. (OTCBB: ACTC), and Professor Ronald Green, Director of Dartmouth’s Ethics Institute and chair of Advanced Cell Technology’s Ethics Advisory Board, writing in the November 24th issue of the scientific journal Nature.

US Governor Perry Presents Texas Cord Blood Bank with $1.2 Million Matching Grant to Expand Programs
Three driving forces behind the establishment of the Texas Cord Blood Bank (TCBB), Texas Governor Rick Perry, Texas Railroad Commission Chairman Elizabeth Ames Jones and Texas Health and Human Services Commissioner Albert Hawkins traveled to San Antonio to acknowledge an important milestone in the collection of cord blood units and present TCBB officials with a $1.2 million matching grant to expand its programs.


Genzyme Corporation (GENZ) Acquires Cell Genesys, Inc. (CEGE) Manufacturing Site
Cell Genesys, Inc. (Nasdaq: CEGE – News) and Genzyme Corp. (Nasdaq: GENZ – News) today announced that Genzyme has acquired Cell Genesys’ manufacturing operation in San Diego, CA to support the growth of Genzyme’s gene therapy programs.

MicroIslet Inc. (MII) Announces Long-Term Supply Agreement With Mayo Foundation
MicroIslet, Inc. and Mayo Foundation for Medical Education and Research (“Mayo”) today announced that they have entered into a long-term strategic supply agreement under which Mayo will supply Designated Pathogen Free (“DPF”) Pigs to MicroIslet for use in development of MicroIslet-P(TM) — a vialed suspension of microencapsulated porcine islets for transplantation by injection into the abdominal cavity in patients with insulin-dependent diabetes.

CyGenics Ltd (CYN.AX) Announces Intention To List Tissue Banking Business “CordLife Pte Ltd”
Leading cell therapy company CyGenics Ltd. (ASX: CYN), today announced its intention to investigate the listing of its tissue banking business, predominantly held under its subsidiary, CordLife Pte Ltd, on a key Asian stock exchange.

Bayer HealthCare launches ADVIA Centaur® CP Immunoassay System
Bayer HealthCare, Diagnostics Division, a member of the Bayer Group (NYSE:BAY), announced today the approval for sale of the new ADVIA Centaur® CP Immunoassay System.

Gene Therapy Is Respectable Again
Researchers have learned to mix optimism with caution, and some of their results are demonstrating definite promise

New Pharmaceutical Company in The Woodlands Has a Handle on Effectively Treating MS
PharmaFrontiers is a cellular therapy company with two technology platforms. The first is a T-cell therapy for treating MS, which Tim received, and the second is stem cell therapy that enables the extraction of large quantities of stem cells from the blood.

CalbaTech, Inc.’s Subsidiary, LifeStem Inc., Selects Leading Physician As Chief Medical Officer CalbaTech, Inc. , an emerging life sciences company concentrating on providing products and platforms to the research market for biotech and pharmaceutical companies and to academic institutions, announced today that its wholly owned subsidiary LifeStem, Inc., has selected Dr. Jason R. Van Tassel as its Chief Medical Officer.

Osteotech (OSTE) Says CEO To Retire Sooner Than Planned
Osteotech, Inc. (Nasdaq: OSTE – News) announced today that Richard W. Bauer, Osteotech’s Chief Executive Officer, has decided to accelerate his previously disclosed retirement plans and will retire at the end of December 2005.

Cardium Therapeutics, Inc. Announces Addition Of Vice President – Regulatory Affairs To Advance Commercial Development Of Generx(TM)
Cardium Therapeutics Inc., a wholly-owned subsidiary of Aries Ventures Inc. , announced today the addition of Jennifer A. Spinella as Vice President – Regulatory Affairs.



NIH Guide for Grants and Contracts – Week Of November 25, 2005

Request for Information (RFI): Tools and Resources for Neurodegeneration Research (Neuroscience Blueprint) (NOT-MH-05-023)


All new CBER information can be reached from the What’s New page at What’s New Page

Investigational New Drugs: Export Requirements for Unapproved New Drug Products; Final Rule

Recall of LCG2 Leukoreduction System for Red Blood Cells- MacoProductions S.A.S.

Anticoagulant Citrate Phosphate Dextrose Solution (CPD) with an integral container of Additive Solution (AS-1) and an integral Leukoflex MTL1-WB Leukocyte Reduction Filter for Whole Blood – MacoProductions SAS

Tissue Reference Group Annual Report – FY2005 Update

Regulatory Considerations for Combination Products with Biological Material — the U.S. Perspective (Slides)


For country-specific and international regulatory resources, including regulatory agencies such as the FDA, EMEA, and more, please visit the Regulatory page on the Cell Therapy News website at http://www.celltherapynews.com/regulatory/

2005 Cell Therapy Audioconference Series

Profiled Journal

Join ISCT($130) and receive the journal as a benefit of membership.

Cytotherapy now incorporates “Cytokines, Cellular & Molecular Theory”.

Cytotherapy/Telegraft Advertising Offer
Cytotherapy- the official journal of the International Society for Cellular Therapy (6x annually) – and Telegraft –ISCT’s global cell therapy newsletter (4 x annually) – are offering an integrated advertisement rates package enabling even more effective coverage of your products, services and recruitment vacancies to the industry at large. The combined reach is impressive, comprising as it does your target audience core.

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Current Volume: Volume 7, Number 6 / December 2005

This issue contains:

An ex vivo model of hematopoietic stem cell mobilization

Ex vivo expansion of neutrophil precursor cells from mobilized peripheral blood cells: similar results in cancer patients and normal donors

BM micrometastases and circulating tumor cells in breast cancer patients: where have we been, where are we now and where does the future lie?

BM-derived cells restore expression of peroxiredoxin V in the airways following acute naphthalene injury in mice

Long-lasting improvement of myocardial perfusion and chronic refractory angina after autologous intramyocardial PBSC transplantation

An improved definition of mouse mammary epithelial side population cells

Outgrowth of a transformed cell population derived from normal human BM mesenchymal stem cell culture

Differentiation of transplanted mesenchymal stem cells in a large osteochondral defect in rabbit

Roadmap to approval: use of an automated sterility test method as a lot release test for Carticel®, autologous cultured chondrocytes

Cytotherapy publishes original research, reviews, meeting reports, special focus issues and letters in the general field of cell therapy. The scope of the journal includes basic and applied research with hematopoietic and non-hematopoietic stem cells, immune cells, and antigen-presenting cells. Therapeutic topics within the scope of Cytotherapy include ex-vivo and in-vivo aspects of gene therapy, immunotherapy, stem cell transplantation and tissue regeneration. Cytotherapy particularly welcomes contributions from researchers, clinicians, technicians and individuals involved in regulatory aspects of cell therapy.

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