Volume 7.07 | Feb 27

Volume 7.07, February 27, 2006
     In this issue: Science | Policy | Business | NIH | CBER | Regulatory
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Top Stories

Functioning Prostate Grown from Embryonic Stem Cells: The study published in the March edition of Nature Methods describes how human embryonic stem cells were developed into human prostate tissue equivalent to that found in a young man, in just 12 weeks.

Scientists Agree Global Stem Cell Guidance: Scientists from around the world have come up with a set of global guidelines to ensure the ethical practice of stem cell research, it was revealed today.


Geron Announces Studies Demonstrating That Cardiomyocytes Derived From Human Embryonic Stem Cells Engraft And Prevent Heart Failure In The Infarcted Rodent Heart
Geron Corporation (Nasdaq: GERN) announced today the presentation of studies showing that cardiomyocytes differentiated from human embryonic stem cells (hESCs) survive, engraft and prevent heart failure when transplanted into an infarcted rat heart.

Man-made Heart Tissue Improves Cardiac Performance
Researchers have developed a method to engineer blood vessels within the tissue of previously engineered heart muscle.

Find Weeds Out Cancerous Stem Cells
Australian scientists have overcome a hurdle in the evolution of embryonic stem cell technology by devising a means of weeding out cells that are potentially cancerous.

Common Reovirus Purges Cancer Cells From Stem Cell Transplants Following Chemotherapy
Medical studies show that a common virus may be able to eliminate cancer cells from autologous stem cell transplants.

Adult Human Pancreas Stem Cells Transformed Into Insulin-Producing Cells
Researchers collaborating at the Burnham Institute for Medical Research and the Rebecca and John Moores Cancer Center at the University of California at San Diego have shown that endocrine progenitor stem cells exist in the adult human pancreas, and they have demonstrated that these stem cells can be transformed into insulin-producing cells.

University of Minnesota Reaches Milestone in Diabetes Research Using Pig Islets
Researchers at the University of Minnesota’s Diabetes Institute for Immunology and Transplantation have successfully reversed diabetes in monkeys using transplanted islet cells from pigs.

Liver Transplants From Non-heart Beating Donors Have The Potential To Increase The Supply Of Organs By As Much As 20%
Like most other solid organ transplants, liver transplantation has become a victim of its own success with more patients now on the waiting list as the number of donors declines.

Living Taste Cells Produced Outside the Body
Researchers from the Monell Chemical Senses Center have succeeded in growing mature taste receptor cells outside the body and for the first time have been able to successfully keep the cells alive for a prolonged period of time.

4 Indicted in Stolen Human Tissue Case Likened to ‘Cheap Horror Movie’
Michael Mastromarino, owner of Biomedical Tissue Services of Fort Lee, N.J., was charged along with Brooklyn funeral home owner Joseph Nicelli.

Applied Genetic Technologies Corporation Announces Initiation of Phase 1 Clinical Study on Safety of AGTC-0106
Applied Genetic Technologies Corporation (AGTC), a private clinical-stage biotechnology company, announced today the initiation of a Phase 1 clinical study to test the safety of AGTC-0106, its investigational gene therapy product for patients with Alpha-1 Antitrypsin deficiency (“Alpha-1”).

Norwood Immunology Starts BMT Phase II Clinical Trial
Norwood Immunology Limited said Tuesday that it has commenced Phase II clinical trial in cancer patients undergoing autologous (self-derived) bone marrow transplant (BMT).


In Vivo Conditioning of Tissue-engineered Heart Muscle Improves Contractile Performance
This study describes a relatively simple in vivo model, which promotes the neovascularization of tissue-engineered heart muscle and subsequent improvement in contractile performance.

Purification and Unique Properties of Mammary Epithelial Stem Cells
Here we report the use of multi-parameter cell sorting and limiting dilution transplant analysis to demonstrate the purification of a rare subset of adult mouse mammary cells that are able individually to regenerate an entire mammary gland within 6 weeks in vivo while simultaneously executing up to ten symmetrical self-renewal divisions.


France Oks Domestic Stem Cells
Earlier this month, France passed a decree specifying the conditions under which researchers will be able to work on stem cell lines derived domestically from unused embryos from in vitro fertilization, a decision French scientists say they hope will enable France to catch up on some other countries in stem cell research.

Chinese Government Not Enforcing Legal Requirement To Test Blood, HIV/AIDS Advocate Says
The Chinese government is not enforcing a nationwide mandate that requires HIV testing for blood used in transfusions, Wan Yanhai, head of the Beijing Aizhixing Institute of Health Education, said on Tuesday at a news briefing in Beijing.

National Academy Of Sciences To Create Privately Funded Embryonic Stem Cell Research Committee
The committee would update guidelines on the research, which were issued by NAS in April 2005, and provide guidance to local groups on a variety of related issues.


Bioheart, Inc. And Cleveland Clinic Foundation Sign Major Patent Licensing Agreement
Bioheart, Inc., a leader in developing cell therapies for heart repair, announced today a patent licensing agreement with Cleveland Clinic of Cleveland, Ohio, to further develop its innovative cell-based technology.

U.S. BioDefense, Inc. (UBDF.OB) Wholly Owned Portfolio Company Stem Cell Research Institute, Inc. Successfully Completes Evaluation And Validation Of Human Neural Crest Stem Cell Line
U.S. BioDefense is pleased to announce today that it has successfully completed the evaluation and validation of its human neural crest stem cells as a part of its agreement with the University of British Columbia.

FDA Gives OK for Use of Durham Firm’s Technology in Stem Cell Trial
Texas doctors will utilize stem cell technology from Durham-based Aldagen as part of an effort to help advanced heart failure patients.

Cytori Therapeutics, Inc. (CYTX) Enters Exclusive Negotiating Rights Agreement With Olympus For Therapeutic Commercialization Collaboration
Cytori Therapeutics, Inc. (NASDAQ: CYTX) (Frankfurt: XMPA) announced today it has granted Olympus Corporation an exclusive right to negotiate a commercialization collaboration for the use of adipose stem and regenerative cells for a specific therapeutic area outside of cardiovascular disease.

Prima Biomed’s Ovarian Cancer Trial: Patient Recruitment Completed
Prima Biomed Limited (ASX: PRR) today announced that its Phase IIa clinical trial for ovarian cancer has completed recruitment allowing clinical investigators to prepare the analysis of the trial.

Stem Cells Bring New Business Models: BrainStorm Beefs Up Revenue-Sharing With Hospitals
“We are planning to partner with medical centers in a way that will provide them with major new sources of revenue,“ says Yoram Drucker, COO and Principal Executive at BrainStorm which is developing stem cell therapies for the treatment of Parkinson`s disease, ALS, Multiple Sclerosis and other neurodegenerative conditions.

Cambrex Licenses Cell Line to Chugai Pharmaceutical Co.
Cambrex Bio Science Walkersville, Inc., a subsidiary of Cambrex (NYSE: CBM) and the world’s leading provider of cell systems, announced today that its client Chugai Pharmaceutical Co., Ltd. completed their assessment of certain of its Clonetics(R) Conditionally Immortalized Cell Lines under the previously announced evaluation license and signed a one-year renewable license agreement to use a cell line in Chugai pharmaceutical drug discovery programs.

CryoCor to Slash Jobs and Reduce Research Work
On Feb. 3, the company announced that the Food and Drug Administration had ruled that clinical trial data would not support approval of CryoCor’s device, which allows doctors to freeze heart tissue that is suspected of causing an irregular heartbeat.



NIH Guide for Grants and Contracts – Week Of February 24, 2006


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

Substantially Equivalent 510(k) Device – BD HLA-B27 System – BD Biosciences


The Food & Drug Administration (United States of America)

Request for Nominations of Members to the Advisory Committee on Blood Safety and Availability


ISCT2006. May 4-7. Berlin.
Click here for the preliminary program or registration information.

AABB-ISCT Cellular Therapy Audioconference Series

Profiled Journal

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

Current Volume: Volume 8 Number 1/February 2006

This issue contains:

Can we use monoclonal antibodies to help T cells fight tumors?

CTLA-4 blockade by a human MAb enhances the capacity of AML-derived DC to induce T-cell responses against AML cells in an autologous culture system

The apoptotic and proliferative fate of cytokine-induced killer cells after redirection to tumor cells with bispecific Ab

Expression of aberrantly glycosylated tumor mucin-1 on human DC after transduction with a fiber-modified adenoviral vector

Transduction with a fiber-modified adenoviral vector is superior to non-viral nucleofection for expressing tumor-associated Ag mucin-1 in human DC

General safety guidances in stem cell bank installations

Novel cryoprotectant significantly improves the post-thaw recovery and quality of HSC from CB

Introduction of a validation concept for a PCR-based Mycoplasma detection assay

SCF modulates organ distribution and hematopoietic engraftment of CB-derived pluripotent HPC transplanted in NOD/SCID mice

Quality assessment of autografting by probability evaluation: model estimation by clinical end-points in newly diagnosed multiple myeloma patients

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.