Volume 8.07 | Feb 26

Volume 8.07, February 26, 2007
     In this issue: Science | Policy | Business | NIH | CBER | Regulatory
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Top Stories

Scientists Produce Neurons From Human Skin: Scientists from Université Laval’s Faculty of Medicine have succeeded in producing neurons in vitro using stem cells extracted from adult human skin. This is the first time such an advanced state of nerve cell differentiation has been achieved from human skin

Researchers Discover Heart Stem Cells in Animals: University researchers have discovered undeveloped adult stem cells in the hearts of animals that share many of the same characteristics of embryonic stem cells.


Mouse Stem Cell Line Advance Suggests Potential For IVF-incompetent Eggs
Researchers have found that mouse oocytes that fail to become fertilized during in vitro fertilization are nevertheless often capable of succeeding as “cytoplasmic donors” during a subsequent cloning step using so-called nuclear transfer.

How Stem Cells Are Regulated
Researchers from Biotech Research & Innovation Centre (BRIC) at University of Copenhagen have identified a new group of proteins that regulate the function of stem cells.

Xie Lab Demonstrates the Role of MicroRNA Pathway in Self-Renewal of Germline Stem Cells
Ting Xie, Ph.D., Associate Investigator, and Zhigang Jin, Ph.D., Postdoctoral Research Associate in the Xie Lab, have published results showing that the microRNA pathway is essential for controlling self-renewal of germline stem cells and somatic stem cells in the Drosophila ovary.

Lab-grown Replacement Teeth Fill the Gap
A Japanese team has successfully grown replacement teeth and implanted them into the mouths of adult mice, suggesting that a similar technique could replace missing teeth in humans.

New Way to Shut Down Viruses
Researchers have used RNAi gene therapy to turn off the viruses that cause hepatitis and HIV in mice. They are testing the technique in human trials against macular degeneration, an inherited condition, and a type of viral pneumonia.

Lab-grown Ligaments May Help Injured Sports Stars
US scientists bio-engineered anterior cruciate ligaments and used them to repair knee joints in rabbits. Eventually, the researchers hope to treat humans who suffer ruptured ligaments using the technique.

Cell Genesys, Medarex Show Combo Data
Cell Genesys, Inc. and Medarex, Inc. announced encouraging follow-up data from the ongoing Phase 1 clinical trial of Cell Genesys’ GVAX immunotherapy for prostate cancer, administered in combination with Medarex’s fully human anti-CTLA-4 antibody, ipilimumab (MDX-010).

FDA Clears First Suture That Uses DNA Technology
FDA has cleared for marketing the TephaFLEX Absorbable Suture, the first suture to be made from material created by a form of DNA technology. The product, used to hold soft tissue together for healing, is made of materials that break down in the body after a short time.


Differentiation of Human Adult Skin-derived Neuronal Precursors into Mature Neurons
This article discusses the generation of autologous neurons from an accessible adult human source, adult human skin. This technique opens many potential therapeutic applications and has a great potential for the development of experimental studies on normal human neurons.

The Adult Human Heart as a Source for Stem Cells: Repair Strategies with Embryonic-like Progenitor Cells
In this article, the researchers discuss the potential for autologous repair or even cardiac regeneration with cells that follow a developmental pathway similar to embryonic cardiac precursors but without the inherent limitations associated with undifferentiated embryonic stem cells.


Women Given All-clear to Donate Eggs for Use in Stem Cell Research
The Human Fertilisation and Embryology Authority (HFEA) has agreed that women can donate their eggs for altruistic reasons to help forward research using stem cells to tackle serious diseases.

Kuehl Wants Bigger Revenues for State’s Stem Cell Institute
A bill expected to be introduced would require companies doing business with California’s $3 billion stem-cell institute to give the state a larger portion of their revenues than the institute has proposed.


The Stem Cell Meeting
March 12 – 13 at San Francisco’s Mission Bay Conference Center at UCSF.
The only international business, policy and economic forum for science and business professionals working at the leading edge of stem cell and regenerative medicine development.  Cell Therapy News readers receive a special discount. To register, please go to www.thestemcellmeeting.com and click “Registration.”  Select “Special” from the Attendee Type drop down menu. Click “Register Now” and enter access code “2SCSPC”. If you have any questions, please contact registration at 800-549-1735; or [email protected].

University College London (UCL) and Sewon Cellontech to Work On Delivery Of Orthopaedic Treatments Using Stem Cell Therapies
UCL Business plc and the Royal National Orthopaedic Hospital NHS Trust have signed an agreement with Sewon Cellontech (SC) of South Korea to collaborate on new laboratories that will develop clinical cell therapeutic treatments for cartilage repair and bone fracture healing. The techniques use stem cells derived from the patient’s own bone marrow and cartilage tissue with the potential to alleviate the need for radical surgery.

Cytori Forms Stem Cell Therapy Distribution Partnership in Spain, Italy and Portugal
Cytori Therapeutics entered into an agreement with MBA Grupo, a European healthcare distributor, who will distribute the Celution(TM) System in Spain, Italy and Portugal starting early 2008 for reconstructive surgery applications. MBA Grupo will oversee product sales, education and training for breast reconstruction following partial mastectomy initially, and for other reconstructive applications in the futaure.

Stem Cell Sciences Licenses Neural Stem Cell Technology to Merck & Co., Inc.
Stem Cell Sciences plc has licensed the use of their novel mouse neural stem cell technology to Merck & Co., Inc. for research use. Financial terms were not disclosed, but include a signing fee and milestone payments.

Pluristem Life Systems, Inc. Announces First Licensing Agreement and Stock Swap With Stem Cell Innovations, Inc.
Pluristem Life Systems, Inc. announced a licensing agreement and stock swap with Stem Cell Innovations, Inc. (Stem Cell) for certain marketing rights of Pluristem’s PLX I product in Asia, excluding Japan and 3-D stem cell expansion capability. The licensing agreement provides Stem Cell with certain rights to Pluristem’s PLX I product and 3-D stem cell expansion capability, in exchange for an upfront fee of 23 million shares of Stem Cell’s common stock, milestone payments and royalties.

Apollo Signs Memorandum of Understanding (MoU) for Stem Cell Therapy
Apollo Hospital Group today signed an MoU with StemCyte, a umbilical cord blood stem cell transplantation company, for collaboration in the use of stem cell therapy in the treatment of blood disorders.


Healtheuniverse and C.I.C.R.S. Expand Clinical Trial Collaboration Agreement for Commercialization of Adult Stem Cell Therapies
The strategic alliance is focused on the expansion of both Companies’ individual strengths leveraging Healtheuniverse’s patented stem cell technology and research and development capabilities, and C.I.C.R.S.’s clinical trial capabilities in a joint effort to commercialize the first non-embryonic stem cell therapy in the field of plastic, reconstructive, and cosmetic surgery.

BioLife Solutions Appoints Funakoshi Co. As Exclusive Distributor In Japan
This decision supports the Company’s strategic plan to capture a significant share of the worldwide market for preservation media.


Notice of Intent to Publish a Request for Applications for the NIH Director’s New Innovator Awards (NOT-OD-07-047)


Implementation of NIH Fiscal Policy for Non-Competing Grant Awards – FY 2007 (NOT-OD-07-049)

Notice of Legislative Mandates in Effect for FY 2007 (NOT-OD-07-050)

Salary Limitation on Grants, Cooperative Agreements, and Contracts (NOT-OD-07-051)

Ruth L. Kirschstein National Research Service Award (NRSA) Stipend and Other Budgetary Levels Effective for Fiscal Year 2007 (NOT-OD-07-052)

NHLBI Creates A New Clinical Research Guide (NOT-HL-07-002)

Notice of a FAQ Website for RFA-HL-07-009, NHLBI Ancillary Studies in Clinical Trials (R01) (NOT-HL-07-007)

Molecular Probes for Microscopy of Cells (R01) (PAR-07-234)

Continued Development and Maintenance of Software (R01) (PAR-07-235)


ASBMT/CIBMTR BMT Tandem Meetings – Slide Presentation

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


FOOD AND DRUG ADMINISTRATION (Untited States of America)

Withdrawal of Approval of 128 Suitability Petitions


New Guidance on Reporting Breaches of Good Clinical Practice (GCP) or the Trial Protocol


ISCT 2007 Abstract Deadline Extended to March 2!

ISCT 2007-Register Now!
13th ISCT Annual Meeting
June 24-27, 2007
Sydney, Australia

Register by clicking here.
View the Program at a Glance by clicking here.

ISCT Membership
Renew your ISCT Membership for 2007 now!
Not a member?  Visit the ISCT website to learn about the benefits of membership.

Profiled Journal

Robert Weinstein, MD
Chief, Division of Transfusion Medicine, UMass Memorial Medical Center, Worcester, MA.

The Journal of Clinical Apheresis provides the world’s premier source of current information in the field of apheresis. The Journal presents work in all aspects of basic and clinical research, practical applications, emerging technologies and regulation in apheresis and related fields including hematology, nephrology, neurology, rheumatology, transplantation, cellular therapies, blood banking, transfusion medicine, and others.

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