Volume 8.13 | Apr 9

Volume 8.13, April 9, 2007
     In this issue: Science | Policy | Business | NIH | CBER | Regulatory
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Top Stories

British Researchers Grow Heart Tissue from Stem Cells: British researchers say they have grown human heart tissue from stem cells, raising hopes for the transplant of replacement valve tissue within a few years.


Penn Study Points to New Direction for Pancreas Cell Regeneration
Past studies in tissue culture have suggested that one type of pancreas cell could be coaxed to transform into insulin-producing islet cells. Now, researchers at the University of Pennsylvania School of Medicine have demonstrated that these pancreatic acinar cells do not become insulin-producing cells in an animal model. However, they did show that injured pancreatic cells readily regenerate back into healthy acinar cells, which has implications for treating cancer and inflammation of the pancreas.

National Center for Regenerative Medicine Study Shows Isolation of Cochlear Stem Cells May Lead to a Treatment for Hearing Loss
Researchers have isolated “cochlear stem cells” located in the inner ear and already primed for development into ear-related tissue due to their proximity to the ear and expression of certain genes necessary for the development of hearing.

Womb Transplant Pregnancy Success
Four sheep have become pregnant after having their wombs removed and then reconnected.

Cell Genesys Provides Final Median Survival Data From Second Phase 2 Trial of GVAX Immunotherapy for Prostate Cancer
Additional follow-up of the 22 patients who received the dose that is comparable to that being employed in the company’s ongoing Phase 3 program indicates that the median survival is 35.0 months.

LCT Reports Major Step Forward for Islet Transplantation
LCT announced it has published evidence outlining the survival and identification of live porcine islet cells and insulin production in a human patient 10 years after receiving a pig islet cell transplant.

New Therapy Stems Degeneration in Parkinson’s Patient
In a major breakthrough in the area of stem cell therapy, Manipal Hospital has successfully treated a patient of Parkinson’s disease with stem cells.

University of Minnesota Offers Another Option For Unused Embryos
After a clinic completes an agreement with the university, it will be one of two IVF clinics in the state giving patients the chance to donate embryos to university stem-cell researchers.

Dolly Creator Wants to Work With Koreans
Professor Ian Wilmut of the University of Edinburgh, who is famous for cloning the sheep “Dolly” in 1996, said he still doesn’t want to work with South Korea’s discredited scientist Hwang Woo-suk, but hopes to team up with other Korean scientists including Hwang’s colleagues.


Adipose Tissue-Derived Stromal Cells—Basic and Clinical Implications for Novel Cell-Based Therapies
It is the aim of this review to describe the preparation and isolation procedures for Adipose Tissue-Derived Stromal Cells (ADSC), to summarize the molecular characterization of ADSC, to describe the differentiation capacity of ADSC, and to discuss the mechanisms and future role of ADSC in cell therapy and tissue engineering.

Persistent Dopamine Functions of Neurons Derived from Embryonic Stem Cells in a Rodent Model of Parkinson Disease
Here, the researchers show that, after transplantation into an animal model, neurons derived from mouse ES cells survived for over 32 weeks, maintained midbrain markers, and had sustained behavioral effects.

Transplantation of Mesenchymal Stem Cells Is an Optimal Approach for Plastic Surgery
Mesenchymal stem cells (MSCs) are able to differentiate into a variety of cell types, offering promising approaches for stem cell-mediated tissue regeneration. Here, the researchers explored the potential of utilizing MSCs to reconstruct orofacial tissue, thereby altering the orofacial appearance.


Medicine Needs Hybrid Embryos, Scientists Say
The UK Government’s intention to ban experiments with hybridised animal-human embryos has come under fierce criticism from MPs, scientists and a phalanx of medical charities.

Bush May Back New Stem Cell Bill
The White House yesterday signaled support for legislation that provides federal funding for stem-cell research using embryonic cells that have no chance of surviving.

Knives Come Out on Stem Cell Bill
State-funded embryonic stem cell research may be geared to solving medical mysteries. But California’s efforts to secure affordable access to any resulting drugs – and a cut of their potential profits – are only generating more “what ifs” from bioscience firms and their attorneys.

Stem Cell Grants Come with Dash of Criticism
Public criticisms of scientists by other scientists are rare. But that’s part of the price for anyone obtaining a grant from California’s new $3 billion stem cell research program.

New York State Budget Approves Money for Stem Cell Research
State lawmakers approved $600 million to be used towards stem cell research over 11 years as part of the budget enacted this weekend. $100 million of that will be used this year.

Senate Passes Delaware Stem Cell Bill
Legislation to regulate stem cell research in Delaware passed the Senate 13-7 last week after a grueling four-hour debate that centered not only on the merits of the bill but the very nature of life itself, and when it begins.


Key Stem Cell Patents Rejected
The U.S. Patent and Trademark Office has upheld challenges by consumer advocates to three over-reaching patents on human embryonic stem cells and rejected patent claims by the Wisconsin Alumni Research Foundation (WARF).

PharmaStem Patents Confirmed after Reexamination by Patent Office
PharmaStem Therapeutics, Inc. announced that the United States Patent and Trademark Office has confirmed all the claims in its pioneering patents regarding umbilical cord blood stem cells.

Completion of the Acquisition Of CellCyte Genetics Corporation
CellCyte Genetics Corporation announces the Closing of its previously announced Share Exchange Agreement with CellCyte Genetics Corporation and CellCyte Genetics, Inc. in connection with the acquisition by the Company from the Vendors of all of the issued and outstanding shares of CellCyte.

New Stem Cell Treatments on the Way
Cytori could be the first company to launch a stem cell-based medical device, while Osiris hopes to launch the first stem cell drug.

Center for Regenerative Therapies Inaugurated
The Berlin-Brandenburg Centre for Regenerative Therapies, a joint research institute of the Charité University Hospital in Berlin and Germany’s largest research association, the Helmholtz Association, has commenced work.

University of Rochester President Sees Great Future for Stem Cell Research
Money just approved from the state allows University of Rochester researchers to move forward with stem cell research.

NeoStem Announces Launch of Government Affairs Initiative
NeoStem, Inc. has announced the launch of a “Government Affairs” initiative to lobby key members of the federal government on the growing threat to the thousands of first responders from radiation exposure following a possible nuclear assault.

Regenerative Medicine Journal Accepted For Coverage In MEDLINE(R)
Future Medicine Ltd announced today that its journal Regenerative Medicine has been selected for coverage in MEDLINE. Maintained by the U.S. National Library of Medicine(R), MEDLINE (Medical Literature Analysis and Retrieval System Online) is a premier bibliographic database containing approximately 13 million references to journal articles in life sciences.


Barbara Alving Named Director of NIH’s National Center for Research Resources
As Acting Director of NCRR, Alving has overseen the launch of the Clinical and Translational Science Awards (CTSA) program — a new national consortium of academic health centers that will transform the conduct of clinical and translational research to ensure that biomedical discoveries are rapidly translated into prevention strategies and clinical treatments for rare and common diseases.

Continuation of the Extension of the NIH Pilot Study to Shorten the Review Cycle for New Investigator R01 Applications (NOT-OD-07-058)

Notice of Change in Submission Dates for NHLBI NRSA Institutional Research Training Grant (T32) Application (NOT-HL-07-109)

Short-Term Research Education Program to Increase Diversity in Health-Related Research (R25) (RFA-HL-07-013)

Bioengineering Research Partnerships (BRP)[R01] (PAR-07-352)


Exceptions and Alternative Procedures Approved Under 21 CFR 640.120 – Update

Licensed Products and Establishments List – Update

Approved Biological NDA and ANDA Applications – Update

Blood Products Advisory Committee Meeting

Workshop: Immune Globulins for Primary Immune Deficiency Diseases: Antibody Specificity, Potency and Testing – Agenda

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)

Draft Animal Cloning Risk Assessment; Proposed Risk Management Plan; Draft Guidance for Industry; Availability; Extension of Comment Period


WHO Proposes Global Agenda on Transplantation
This week, at the second Global Consultation on Transplantation the World Health Organization (WHO) presented countries and other stakeholders with a blueprint for updated global guiding principles on cell, tissue and organ donation and transplantation.


Exposure Draft of the Australian Therapeutic Products Bill Released for Stakeholder Consultation


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