Volume 9.39 | Oct 6

Cell Therapy News 9.39, October 6, 2008
     In this issue: Science | Policy | Business | NIH | CBER | Regulatory
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Top Stories

The Role of Stem Cells in Renewing the Cornea: Using mouse models, the researchers have demonstrated that everyday wear and tear on the cornea is repaired from stem cells residing in the corneal epithelium, and that more serious repair jobs require the involvement of other stem cells that migrate from the limbus.


Regenerating Torn Cartilage
A new biomaterial developed by Cartilix could dramatically improve the success rate of knee-cartilage repair surgery, making the procedure more accessible to patients with bad knees.

Scientists Identify New Bone Protecting Protein
Researchers at the Universities of Manchester and Oxford have identified a naturally occurring protein molecule that not only protects against inflammation but also actively inhibits bone erosion in those affected by disease.

A New Cell Therapy Technique with Demonstrated Efficacy in Chronic, Localized and Stable Forms of Vitiligo
Specialists at the University Hospital of Navarra have managed to repigment certain areas of the body affected by vitiligo by transplanting epidermal cells from a pigmented area of the patient’s skin to other areas of the same patient which are depigmented.

Pioneering Heart Disease Trials Call for More Patients
Doctors at Barts and The London are calling for more patients to come forward to take part in the UK’s first large scale adult stem cell trial for heart disease.

Utah Tests May Lead to Stem Cell Treatment of Kidney Failure
Intermountain Medical Center and AlloCure, a Utah-based biotech company, have teamed up to test AlloCure’s patented cells in patients who have had open-heart surgery.

Stratatech Successfully Completes Clinical Trial of StrataGraft(R) Skin Substitute
Stratatech Corp. recently announced that it has successfully completed the multi-center, 15-patient clinical trial of its StrataGraft(R) living human skin substitute.

Bioheart Announces 35 Leading U.S. Heart Failure Centers Engaged in Phase II/III Marvel Trial of Myogenic Cells for Treating Advanced Heart Failure
Bioheart, Inc. recently announced that 35 of the leading U.S. Heart Failure Centers have engaged in Bioheart’s Phase II/III MARVEL(1) Trial of myogenic cells for treating advanced heart failure.


MUC1* Mediates the Growth of Human Pluripotent Stem Cells
This study reports that MUC1*, a transmembrane cleavage product, acts as a growth factor receptor on undifferentiated human embryonic stem cells.

Wnt3a Deficiency Irreversibly Impairs Hematopoietic Stem Cell Self-Renewal and Leads to Defects in Progenitor Cell Differentiation
This study shows that Wnt3a signaling not only provides proliferative stimuli, such as for immature thymocytes, but also regulates cell fate decisions of HSC during hematopoiesis.

What to Do with Leftover Embryos in Fertility Clinics?
The majority of infertility patients are in favor of using left-over embryos for stem cell research and would also support selling left-over embryos to other couples, according to a recent survey.


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Review of the California Institute for Regenerative Medicine Approved
The state’s Little Hoover Commission, an advisory body to the governor and Legislature, said recently that it will examine the structure and governance of the state stem cell institute.

Schwarzenegger Vetoes Stem Cell Bill
In vetoing the bill, Schwarzenegger said SB 1565 would have undermined “the express intent of Proposition 71, which funds embryonic stem cell research that the federal government [does not]”.

Maryland Stem Cell Commission Issues Requests for Applications
Per the Maryland Stem Cell Commission meeting on Sept. 10, 2008, the Commission has issued recently three official Requests for Applications for funding through the Maryland Stem Cell Research Fund under the Maryland Stem Cell Research Act.


Genentech, Glycart and Roche Enter Into Collaboration Agreement for Potential Cancer Therapy
Genentech, Inc., GlycArt, and Roche have entered into a collaboration agreement, including a license from GlycArt to Genentech, for the joint development and commercialization of GlycArt’s GA101 molecule.

MacroGenics Raises $25M in Series D-2 Financing
MacroGenics expects to use the proceeds from this financing to fund the cancer stem cell program it acquired through its acquisition of Raven Biotechnologies in July.

StemCells, Inc. Receives NIH Grant to Pursue Cell-Based Therapeutic for Hepatitis C
StemCells, Inc. announced recently that it has been awarded a $305,000 grant from the National Institute of Diabetes and Digestive and Kidney Diseases to research and develop a potential cell-based therapeutic for liver disease arising from infection by the hepatitis C virus.

New Head Aims to Salvage Australian Stem Cell Centre
The new head of the Australian Stem Cell Centre, Graham Macdonald, has identified cost-cutting as a potential strategy as an interim board tries to secure the financial future of the troubled centre.


NIH Announces Funding for New Epigenomics Initiative

NIH Announces Initial Implementation Timeline For Enhancing Peer Review Activity

NIH Announces a New Business Process for Reporting an Identified Financial Conflict of Interest for Grants and/or Cooperative Agreements beginning October 10, 2008 (NOT-OD-09-001)

Non-Competing Grant Awards under the Current Continuing Resolution (NOT-OD-09-002)

Correction of NIMH Program Contact Information for: RFA-GM-09-008 – Exceptional, Unconventional Research Enabling Knowledge Acceleration (EUREKA) (R01)


Public Workshop: Workshop to Consider Approaches to Reduce the Risk of Transfusion-Transmitted Babesiosis in the United States – Transcript



FDA Nets Nearly $300M More Funding for 2009
Congress has assured increased funding for the FDA in fiscal year 2009, with the passage of the continuing resolution by the House of Representatives last Wednesday and by the Senate on Saturday.

Agency Information Collection Activities; Proposed Collection; Comment Request; Requirements on Content and Format of Labeling for Human Prescription Drug and Biological Products

Preparation for International Conference on Harmonization Meetings in Brussels, Belgium; Public Meeting; Correction

Memorandum of Agreement Between the Food and Drug Administration, the National Cancer Institute, a Part of the National Institutes of Health, and the CRIX International Association

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