Volume 10.23 | Jun 22

Cell Therapy News 10.23, June 22, 2009
     In this issue: Science | Policy | Business | NIH | CBER | Regulatory
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Top Stories

Johns Hopkins Researchers Edit Genes in Human Stem Cells: Researchers at the Johns Hopkins School of Medicine have successfully edited the genome of human-induced pluripotent stem cells, making possible the future development of patient-specific stem cell therapies.


VIDEO: An Introduction to a New and Innovative Way of Making Uniform, Size-controlled Embryoid Bodies

Hysterectomies a Stem Cell Source
Discarded fallopian tubes from hysterectomies could be a good source of donor stem cells, say Brazilian researchers.

Tulane Scientist to Study Limb Regeneration
With the help of a $6.25 million U.S. Department of Defense grant, Tulane University professor Ken Muneoka will lead a team to identify the genes that trigger regeneration in the axolotl, a Mexican salamander.

Researchers Suggests Gene Inhibition May Help Normalize Type 2 Diabetes
In research that could lead to new approaches for the treatment of type 2 diabetes, a Yale School of Medicine team has found that suppressing a liver enzyme that induces glucose production helped diminish the symptoms of the disease in a rat model.

Pluristem Therapeutics Receives European Regulatory Approval for Placental-Derived Stem Cell Clinical Trial
Pluristem Therapeutics Inc. announced recently the German competent authority in the European Union, has approved the Company’s Clinical Trial Application and granted approval to begin clinical trials with its placental-derived adherent stromal cell product.

Living Cell Technologies’ Accepts Proposed Revised Conditions for Diabetes Clinical Trial in New Zealand
Living Cell Technologies recently announced the Company has accepted a preliminary decision from the New Zealand Minister of Health to issue a new conditional authorization for its New Zealand Phase I/IIa clinical trial of DIABECELL(R) for insulin dependent diabetes.

Study Identifies Benefit of Donor Stem Cell Transplantation for Adults with Acute Myeloid Leukemia
A stem cell transplant from a compatible donor early in the course of disease is the best approach for the majority of young and middle-aged adult patients with acute myeloid leukemia.

FDA Removes Clinical Hold from Aastrom Phase II IMPACT-DCM Clinical Trial
Aastrom Biosciences, Inc. recently reported that the U.S. Food and Drug Administration has removed the clinical hold from the Company’s U.S. Phase II IMPACT-DCM clinical trial and that patient enrollment would resume at all five initiated clinical sites.

University of Pittsburgh Cancer Institute Joins ExCell Research Study Using Stem Cells for Leukemia and Lymphoma Patients
The phase III study is assessing the safety and efficacy of StemEx(R), an investigational product derived from stem cells, as an alternative treatment to bone marrow transplants for hematological malignancies, including leukemia and lymphoma.


CEO Pay of 2008: Who Makes What in Big Biotech?
Since biotech companies each have their own approach to reporting CEO pay, ranking were based on total compensation reported in these companies’ SEC filings.

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Stem Cell Policy May See US Companies Seeking Collaborations in India
The pro-embryonic stem cell policy of the US President Barack Obama is likely to result in Indian research organizations attracting the interest of foreign research firms for collaboration in the field.

Plan Would Regulate Michigan Stem Cell Research
The first test of how much control state lawmakers might try to exert over embryonic stem cell research in Michigan is surfacing at the Capitol.

New York Stem Cell Committee Approves Payments for Eggs
The New York Empire State Stem Cell Board has approved the use of state funds to compensate women who donate eggs for embryonic stem cell research.

South Korea to Lift 3-year Ban on Human Stem Cell Research; Catholic Group Decries Decision
South Korea will lift a three-year ban on human stem cell research, a presidential advisory committee announced Wednesday.


Connexon Creative Launches Mammary Cell News
Mammary Cell News is a weekly e-newsletter that keeps members of the mammary cell community informed by providing the latest news from all areas of the field, including its science, research and business.

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MDRNA, Inc. Gains Full Financial and Transactional Control of Its Proprietary UNA Technology
MDRNA, Inc. announced recently that it now has full financial and transactional control over the use of its proprietary UNA (Unlocked Nucleobase Analog) technology for the development of RNAi-based therapeutics.

Pfizer Looking for Mideast Acquisitions, Forecasts 10% Growth
Pfizer Inc., the world’s biggest drug maker, is seeking acquisitions in emerging markets and the Middle East, and forecasts annual “double-digit growth” in the region in the next five years, a senior executive said.

The California Institute for Regenerative Medicine Bankrolls 15 Stem Cell Research Grants with $40M
15 grants worth $40.6 million to advance stem cell research starting July 1 was approved in January but has been on standby due to financial uncertainties of the state.

Jerusalem to Begin Massive Investment in Biotech Companies
The City of Jerusalem plans to raise and invest 100 million shekels ($25 million) over the next five years in health and life science companies in a bid to create jobs and to gain a reputation for the metropolis as an international partner in the field.


NIH Extramural Loan Repayment Programs (LRP) (NOT-OD-09-107)

Extramural Loan Repayment Program for Clinical Researchers (LRP-CR): Program Specific Information (NOT-OD-09-108)

NHLBI Systems Biology Collaborations (R01) (PAR-09-214)


Clinical Investigator Status (Biologics)



FDA Commissioner Faces Formidable To-Do List
Margaret A. Hamburg, the new commissioner of the Food and Drug Administration, wants to reorient the sprawling bureaucracy and remake it into the key federal agency that protects public health.

Clinical Trials Transformation Initiative (U19) 29216–29217 [E9–14436]


Licensing Time-based Performance Measures

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