Volume 7.00 | Jan 9

Volume 7.0, January 9, 2006
     In this issue: Science | Policy | Business | NIH | CBER | Regulatory
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Top Stories

Stem-cell Work ‘Very Exciting’: Canadians and Australians isolate mouse breast cells that can regenerate a milk-making mammary gland.
Article

US House And Senate Approve Umbilical Cord Blood Bill; Measure Sent To White House: The purpose of the Stem Cell Therapeutic and Research Act of 2005 is to provide for the collection and maintenance of human cord blood stem cells for the treatment of patients and research, and to amend the Public Health Service Act to authorize the C.W. Bill Young Cell Transplantation Program.
Article

Science

Researchers Derive Animal-free Stem Cells
Scientists working at the WiCell Research Institute, a private laboratory affiliated with UW-Madison, have developed a precisely defined stem cell culture system free of animal cells and used it to derived two new human embryonic stem cell lines.
Article

UPMC Affiliate Gets $4.2 million Grant to Develop Gene Therapy for Parkinson’s
A foundation established by actor Michael J. Fox is giving $4.2 million to a University of Pittsburgh Medical Center affiliate called RheoGene Inc. to develop gene therapy for Parkinson’s disease.
Article

Sickle Cell Disease Corrected in Human Models Using Stem Cell-Based Gene Therapy
In a study to be published in the January 2006 issue of Nature Biotechnology, researchers led by a team of scientists at Memorial Sloan-Kettering Cancer Center have devised a novel strategy that uses stem cell-based gene therapy and RNA interference to genetically reverse sickle cell disease (SCD) in human cells.
Article

Penn Study Finds Hyperbaric Oxygen Treatments Mobilize Stem Cells
According to a study to be published in the American Journal of Physiology-Heart and Circulation Physiology, a typical course of hyperbaric oxygen treatments increases by eight-fold the number of stem cells circulating in a patient’s body.
Article

Could Knee Stem Cells Offer New Hope on Arthritis?
Article

Altered Cells Deliver Parkinson’s Therapy to Brain
Genetically modified nerve ‘progenitor’ cells can be used as mini-pumps to deliver nerve growth factor to the brain, a new study in animals shows.
Article

MIT Researcher Finds Neuron Growth in Adult Brain
Despite the prevailing belief that adult brain cells don’t grow, a researcher at MIT’s Picower Institute for Learning and Memory reports in the Dec. 27 issue of Public Library of Science (PLoS) Biology that structural remodeling of neurons does in fact occur in mature brains.
Article

Gene Therapy Trials in the Works to Treat Hereditary Blood Diseases
Scientists in New York have developed a gene therapy they say may cure two pervasive blood disorders, and the first round of human trials is expected to begin within six months.
Article

Bare Metal Stents Deliver Gene Therapy To Animal Heart Vessels
Improved materials may allow stents, tiny metal scaffolds inserted into blood vessels, to better deliver beneficial genes to patients with heart disease, by reducing the risk of inflammation that often negates initial benefits.
Article

Cedars-Sinai Researchers Demonstrate a New Way to Switch Therapeutic Genes ‘On’ and ‘Off’
A gene therapy research team at Cedars-Sinai Medical Center has developed a new method of signaling therapeutic genes to turn “off” or “on,” a mechanism that could enable scientists to fine-tune genetic- and stem cell-based therapies so that they are safer, more controllable and more effective.
Article

New Blow to S. Korea Clone Work
South Korea’s disgraced human cloning scientist did not produce any stem cells tailored to individual patients as claimed, a panel has concluded.
Article

The Center for Gene Therapy at Tulane University Health Sciences Center to Offer Autologous Stem/Progenitor Cells (MSCs) for Clinical Trials
The Center for Gene Therapy at Tulane University Health Sciences Center is pleased to announce that it is preparing to offer stem/progenitor cells (MSCs) for use in Phase I/II clinical trials.
Article


ABSTRACT, REVIEWS, & SPECIAL REPORTS

An Alternative and Effective HIV Vaccination Approach Based on Inhibition of Antigen Presentation Attenuators in Dendritic Cells
This study represents the first, to our knowledge, attempt to elicit HIV-specific T cell and antibody responses by inhibiting a host’s antigen presentation attenuator, which may open a new and alternative avenue to develop effective therapeutic and prophylactic HIV vaccines.
Abstract

A Novel Method of Modifying Immune Responses By Vaccination With Lipiodol-siRNA Mixtures
This simple method of in vivo modification of immune response possesses therapeutic potential in Th1-mediated diseases such as multiple sclerosis and autoimmune diabetes.
Abstract

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.
Abstract

Policy

FACT and JACIE Issue Public Review
The Foundation for the Accreditation of Cellular Therapy (FACT) in collaboration with the Joint Accreditation Committee ISCT & EBMT (JACIE) have issued for public review and comment the Third Edition, FACT-JACIE International Standards for Cellular Therapy Product Collection, Processing and Administration. You are invited to review and comment on the proposed standards through January 31, 2006. Standards can be viewed online at www.factwebsite.org.

UK To Invest in Stem Cell Research
The UK needs to invest an extra GBP350mn (US$609.38mn) in stem cell research if it wishes to retain its international standing, claims a recent report by the UK Stem Cell Initiative (UKSCI).
Article

Dying Patients ‘Can Aid Stem Cell Research’
Professor Ian Wilmut, creator of Dolly the sheep, today said experimental stem cell therapy should be carried out on terminally ill patients to speed up the pace of research.
Article

Business

Cambrex to Stop Acquisition Plan, CEO to Leave
Cambrex Corp. on Wednesday said Chief Executive and President John Leone will leave the company effective Jan. 15 and it would discontinue its acquisition plan.
Article

Terumo Ends Partnership with Boston Scientific
Japanese device firm Terumo has announced it is ending a 15-year relationship with Boston Scientific and will launch a new direct sales, marketing, and distribution strategy in the U.S. and Latin America for its vascular interventional products.
Article

Enzon Pharmaceuticals, Inc. (ENZN) Returns Rights To Transplantation Product To Fresenius Biotech GmbH
Enzon Pharmaceuticals, Inc. (Nasdaq: ENZN) today announced that it is returning its rights to ATG-Fresenius S to Fresenius Biotech GmbH, a subsidiary of the health care company Fresenius AG.
Article

MultiCell Technologies In-Licenses Phase IIb/III Drug for the Treatment of Fatigue in Multiple Sclerosis from Amarin Corporation
MultiCell Technologies, Inc. (OTCBB: MCET) and Amarin Corporation plc (NasdaqSC: AMRN) announced today that MultiCell has exclusively licensed LAX-202 from Amarin for the treatment of fatigue in patients suffering from multiple sclerosis (MS).
Article

Cerus Submits IND Application for CRS-100 to FDA
Cerus Corporation (NASDAQ: CERS) today announced that it has submitted an investigational new drug (IND) application to the U.S. Food and Drug Administration (FDA) to initiate a Phase 1 safety trial for CRS-100, a Listeria-based immunotherapeutic designed to treat patients with cancer that has metastasized to the liver.
Article

GenVec Completes Previously Announced Sale of Myoblast Cell Therapy Program
GenVec, Inc. (NASDAQ:GNVC) announced today the sale of its myoblast cell therapy program to Mytogen, Inc., a newly-formed private biotechnology company specializing in the development of cell therapy products, in exchange for potential future milestone and royalty payments to GenVec.
Article

Osiris Therapeutics, Inc. Gets Another $19 Million To Fund Stem-Cell Trials
The money will fund the company’s five ongoing clinical trial programs using their proprietary adult stem cell technology platform.
Article

Osiris Receives Orphan Drug Status from FDA for Lead Stem Cell Drug
Osiris Therapeutics, Inc. announced today that it has received orphan drug designation from the U.S. Food and Drug Administration (FDA) for PROCHYMAL(TM), an adult stem cell product under investigation for the treatment of acute Graft vs. Host Disease (GVHD).
Article

Living Cell Technologies Awarded $480,000 Grant by NZTE
New Zealand Trade & Enterprise (NZTE) today announced it had awarded a NZ$480,000 grant to Living Cell Technologies Ltd (ASX:LCT) to help progress the development of cell based therapeutic products.
Article

Living Cell Technologies awarded $100,000 grant by Cure Kids New Zealand
Living Cell Technologies (ASX:LCT) today announced Cure Kids New Zealand had awarded the cell therapy company a NZ$100,000 grant to pursue its program of liver cell transplantation treatment of the inherited bleeding disorder, haemophilia.
Article

Aastrom Biosciences, Inc. (ASTM) To Begin Seeking New CEO
Aastrom Biosciences, Inc. (Nasdaq: ASTM – News) today announced that at the request of Chairman and Chief Executive Officer, R. Douglas Armstrong, Ph.D., Aastrom’s Board of Directors’ Corporate Governance and Nominating Committee will initiate a process to identify potential candidates to succeed Dr. Armstrong as Chief Executive Officer, allowing him to transition out of day-to-day management.
Article

MultiCell Technologies Announces Appointment of Chief Financial Officer
MultiCell Technologies, Inc. (OTCBB: MCET) announced today that Gerard A. Wills has joined the company as its Chief Financial Officer.
Article

NIH


NATIONAL INSTITUTES OF HEALTH

Career Enhancement Award for Stem Cell Research (K18) (PAR-06-115)
Link

CBER

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

Safety Alert: Rho(D) Immune Globulin Intravenous (Human) (WinRho SDF)
Link

Substantially Equivalent 510(k) Device – BacT/ALERT BPA Culture Bottle – bioMerieux, Inc
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Workshop on Behavior-Based Blood Donor Deferrals in the Era of Nucleic Acid Testing (NAT)
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Draft Guidance for Clinical Trial Sponsors: Establishment and Operation of Clinical Trial Data Monitoring Committees
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Variances for Collection of Blood and Blood Products from Patients with Hemochromatosis – Update
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Recall of Baxter ALYX Red Kit Disposables – Baxter Healthcare Corp
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Important Safety Alert: BacT/ALERT BacT/VIEW Users – Biomerieux
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Substantially Equivalent 510(k) Device – TANGO Automated Blood Bank Analyzer System (HW Version 02/SW Version 3.0) – Olympus America Inc
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Blood Products Advisory Committee Charter Update
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Vaccines and Related Biological Products Advisory Committee Charter Update
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Regulatory

Food & Drug Administration (United States of America)

Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Current Good Manufacturing Practices and Related Regulations for Blood and Blood Components; and Requirements for Donor Testing, Donor Notification, and “Lookback”
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Pediatric Oncology Subcommittee of the Oncologic Drugs Advisory Committee; Notice of Meeting
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Oncologic Drugs Advisory Committee; Notice of Meeting
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Cellular, Tissue and Gene Therapies Advisory Committee; Notice of Meeting
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Medsafe (New Zealand & Australia)

Description of the Joint Regulatory Scheme for the Advertising of Therapeutic Products
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ISCT

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

2005 Cell Therapy Audioconference Series
Link



Profiled Journal

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

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Current Volume: Volume 7, Number 6 / December 2005

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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