Volume 7.01 | Jan 16

Volumes 7.01, January 16, 2006
     In this issue: Science | Policy | Business | NIH | CBER | Regulatory
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Top Stories

Scientist Admits Cloned Stem Cells Faked: South Korean scientist Hwang Woo-suk has admitted that embryonic stem cells he purportedly cloned last year were faked.
Article

Administering Stem Cells Leads To A Reduction Of Myocardial Infarcts: This week, doctors at the Catholic University of Leuven, connected with the University Hospital – Gasthuisberg, the Stem Cell Institute Leuven (SCIL), and the Flanders Interuniversity Institute for Biotechnology (VIB), are publishing a major breakthrough in the treatment of patients with acute myocardial infarction.
Article

Science

Insulin Secreted by Embryonic Stem Cells Is Derived From External Sources, Concludes a Study in Cloning and Stem Cells
Cultured embryonic stem cells induced to form insulin-producing Islet-like cell clusters–intended to replace the insulin production lost in diabetes–do not produce detectable amounts of new insulin, according to a report in the December 2005 (Volume 7, Number 4) issue of Cloning and Stem Cells.
Article

Molecule Dictates How Stem Cells Travel
The discovery by researchers at the Massachusetts General Hospital Center for Regenerative Medicine and the Harvard Stem Cell Institute may help improve bone marrow stem cell transplantation and the treatment of several blood disorders.
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Animal-human Embryos to be Used for Stem Cell Research
Scientists in Scotland are planning to create animal-human embryos cloned from human skin cells and unfertilized rabbit eggs.
Article 1 Article 2

Intense Bone Marrow Transplantation Protocol Not Useful for Severe MS
“The lack of efficacy, together with some serious side effects, does not favor the use of similar rigorous T cell depleting protocols in the future,” senior author Dr. R. Q. Hintzen, from Erasmus Medical Center in Rotterdam, the Netherlands, and colleagues note.
Article

Boosting Stem Cells to Treat Diabetes
For diabetes patients, who can’t produce their own insulin, human stem cell-based transplants that produce insulin would be a major breakthrough.
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Stem Cells Used to Correct Sickle Cell
Scientists say they have found a way to use embryonic stem cells to correct the mutation that causes sickle cell disease in mice.
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New Jersey Commission Awards $5 Million in Stem Cell Grants
The New Jersey Commission on Science and Technology awarded a total of $5 million through its Stem Cell Research Grant program, available immediately to 17 researchers at university, nonprofit institution and corporate labs in New Jersey.
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ABSTRACT, REVIEWS, & SPECIAL REPORTS

Creatine Kinase, a Magnetic Resonance-Detectable Marker Gene for Quantification of Liver-Directed Gene Transfer
Use of the ck reporter would facilitate the clinical translation of gene therapy by providing a nondestructive readout of the level and duration of therapeutic gene expression.
Abstract

Derivation of Human Embryonic Stem Cells in Defined Conditions
Here we report feeder-independent human ES cell culture that includes protein components solely derived from recombinant sources or purified from human material. We describe the derivation of two new human ES cell lines in these defined culture conditions.
Abstract

Origin of Insulin Secreted from Islet-Like Cell Clusters Derived from Murine Embryonic Stem Cells
Despite the presence of at least some level of de novo, synthesized insulin in ILCCs, the majority of insulin released by ILCCs was sequestered from the exogenous medium.
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.

Invitation to Comment – FACT/NETCORD Cord Blood Standards
The Foundation for the Accreditation of Cellular Therapy (FACT) in collaboration with NETCORD have issued for public review and comment the Third Edition, NETCORD-FACT International Standards for Cord Blood Collection, Processing, Testing, Banking, Selection and Release. You are invited to review and comment on the proposed cord blood standards through February 9, 2006.
Standards can be viewed online at www.factwebsite.org.

Business

Human Genome Grants Gene Rights to Amgen
Biotech company Human Genome Sciences Inc. said Monday that it licensed rights for the development of therapeutics and medical tests for a gene it discovered to Amgen Inc.
Article

Pluristem Life Systems Inc. Announces Advanced Engineered Cell Graft To Improve Resurgence Of The Hematopoietic Stem Cells In Bone Marrow For Cancer Patients
Pluristem Life Systems, Inc. (OTC BB:PLRS), a biotechnology company dedicated to the commercialization of cell therapy products, today announced that the Company has formulated a cell graft to provide an efficient alternative to the standard procedure of bone marrow transplantation (BMT).
Article

Gamida Cell Ltd. Announces New Supporting Evidence That An Ex-Vivo Expanded Population Of Human Bone Marrow Stem Cells May Help Treat Heart Disease
Data to Be Presented at The Second International Conference on Cell Therapy for Cardiovascular Diseases at the New York Academy of Medicine, January 19, 2006. Gamida Cell Ltd., developer of expanded stem cell therapeutics, announced today that its technology for the ex-vivo expansion of bone marrow-derived stem cells for the treatment of cardiovascular diseases will be presented at The Second International Conference on Cell Therapy for Cardiovascular Diseases at The New York Academy of Medicine, located at 1216 Fifth Avenue, in New York, New York.
Article

Inex Pharmaceuticals Court Hearing Completed
Inex Pharmaceuticals Corporation (“INEX”; TSX:IEX) announced today that the Supreme Court of British Columbia hearing to discuss INEX’s proposed Plan of Arrangement to spin out its Targeted Immunotherapy assets into a new company has been completed.
Article

Chromos Molecular Systems Inc. (CHR.TO) Announces Expansion Of Pfizer Inc. (PFE) Collaboration
Under the expanded agreement, Chromos will use its ACE System to develop a cell line for a Pfizer therapeutic protein product candidate. The parties will also initiate a collaborative program to genetically engineer production cell lines.
Article

NIH


NATIONAL INSTITUTES OF HEALTH

NIH Financial Policy for Grant Awards – FY 2006
The NIH appropriation for FY 2006 includes an across-the-board reduction to non-emergency, discretionary programs, which has a direct impact on NIH’s budget. The NIH share of this adjustment is approximately $286 million. NIH has established the following financial polices consistent with this appropriation.
Article

CBER

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

Cellular, Tissue and Gene Therapies Advisory Committee; Notice of Meeting
Link

Draft Guidance for Industry: INDs – Approaches to Complying with CGMP During Phase 1
Link

Guidance for Industry: Formal Dispute Resolution: Scientific and Technical Issues Related to Pharmaceutical CGMP
Link

Regulatory

Ministry of Health (New Zealand)

Guidelines on Using Cells from Established Human Embryonic Stem Cell Lines for Research
Link

ISCT

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

AABB-ISCT Cellular Therapy Audioconference Series
Link

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.

Here’s how the deal works:

Display advertising / print: book an advertisement, any size, in both publications and we will apply a full 30% discount off the combined ratecard price. Plus, we’ll allow any earned volume discount too!

Recruitment advertising / online: postings on the ISCT website are $1,000 for 2 months. But we’ll reduce that by 50% to $500 only if the posting is taken in addition to a print advertisement in Telegraft or Cytotherapy. ISCT web site receives over 125,000 hits per months, guaranteeing your posting industry wide exposure.

All we ask is that you make your first insertion before the end of 2005 but we’ll be pleased to extend this deal with full rate protection into 2006 on anything booked before December 31st 2005. For more information and advertising rates, click here.

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.
http://journalsonline.tandf.co.uk/link.asp?id=107693