Volume 9.38 | Sep 29

Cell Therapy News 9.38, September 29, 2008
     In this issue: Science | Policy | Business | NIH | CBER | Regulatory
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Top Stories

Safer Embryonic-Like Stem Cells Created by Harvard Researchers: The Harvard researchers using a type of virus called an adenovirus, commonly employed in gene therapy, ferried certain genes into ordinary cells and endowed them with the power to act like embryonic stem cells.


Pittsburgh Researchers Identify Population of Adult Stem Cells Found in Blood Vessels With Broad Ability To Regenerate Other Tissues
In a promising finding for the field of regenerative medicine, stem cell researchers at Children’s Hospital of Pittsburgh of University of Pittsburgh Medical Center have identified a source of adult stem cells found on the walls of blood vessels with the unlimited potential to differentiate into human tissues such as bone, cartilage and muscle.

Findings Show RNA Interference has much Larger Role in Cellular Functions and Processes than Previously Thought
A team of scientists at IBM and the Genome Institute of Singapore, have discovered that microRNAs – small molecules that are an important regulatory component in the machinery of living cells – actually regulate the differentiation of stem cells and have roles that go way beyond what was previously thought.

New Technology Paves the Way for the Future of Identifying Proteins Inside Cells
The new research outlines how an imaging technique known as coherent two-dimensional infrared spectroscopy, 2DIR, has been used to successfully identify proteins in laboratory tests.

Bioheart Reports Promising Results From Preclinical Study of Adipose-Derived Acute Cell Therapy
A preclinical study involving the injection of adipose-derived stem cells into the myocardium of infarcted rats, showed evidence of regeneration of cardiomyocytes subsequent to injection of dipose-derived stem cells following heart attack.

Gene Therapy for Chronic Pain Enters First Human Trial
Recently, University of Michigan scientists began a phase 1 clinical trial for the treatment of cancer-related pain, using a novel gene transfer vector injected into the skin to deliver a pain-relieving gene to the nervous system.

NIH Fast Track Grant Awarded to Arteriocyte for Critical Limb Ischemia Research
The NANEX technology involves electrospun nanofibers that create a synthetic bone marrow “niche” environment, allowing stem cells to rapidly proliferate while maintaining their undifferentiated “stem” property.


Interleukin-1 Mediated Hematopoietic Cell Regulation in the Aorta-Gonad-Mesonephros Region of the Mouse Embryo
The study’s results suggest that IL-1 is an important homeostatic regulator at the earliest time of HSC development, acting to limit the differentiation of some HSCs along the myeloid lineage.

Rescue of Salivary Gland Function after Stem Cell Transplantation in Irradiated Glands
The researchers’ approach is the first proof for the potential use of stem cell transplantation to functionally rescue salivary gland deficiency.

Differences in Lymphocyte Developmental Potential Between Human Embryonic Stem Cell and Umbilical Cord Blood–Derived Hematopoietic Progenitor Cells
This study’s results demonstrate fundamental differences between hESC-derived hematopoietic progenitors and analogous primary human cells.

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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Appeal Plan is Proposed for Stem Cell Panel Grants
When the state stem cell institute’s board meets soon in San Diego, it will consider creating a formal process for scientists to appeal reviews of grant applications that may contain errors that wrongly prevent them from receiving funding.


Cellerant Therapeutics Awarded $13.5 Million Contract for Treatment of Acute Radiation Syndrome from the Biomedical Advanced Research and Development Authority
Cellerant Therapeutics Inc. announced recently that it has been awarded a contract valued at $13.5 million dollars from the Biomedical Advanced Research and Development Authority of the Department of Health and Human Services for the development of a treatment for acute radiation syndrome.

Biotechs Scavenge for Funds as IPO Well Stays Dry
With little chance of raising money in the public markets, biotechnology companies are increasingly accepting funds from sources they might once have disdained – and giving up more of their profits to get it.

Histogen Launches BioNuesis(TM), the All-Human Stem Cell Culturing Kit 
Histogen, Inc. recently launched BioNuesis(TM), the only soluble human extracellular matrix developed as a culturing kit for stem cell growth.

Celprogen Introduces Stem Cells in Syringes for In Vivo Applications 
Celprogen Inc. recently announced that they have successfully validated shipment of embryonic and adult stem cells at room temperature within United States research facilities for in vivo applications.

WiCell Research Institute Launches New Stem Cell Bank
The WiCell Research Institute is launching its own stem cell bank to distribute cell lines beyond the 21 lines eligible for federal funding and distribution through the National Stem Cell Bank.

Invitrogen Launches Stem Cell Culture Services
Invitrogen Corporation has introduced its custom PD-Direct(R) Bioprocess Services optimized for clinically compliant stem cell culture systems.

Australia Likely to Grant Hwang Stem Cell Patent
Australian patent authorities will likely grant a patent to disgraced Korean stem cell researcher Hwang Woo-suk for a cloned human embryonic stem cell.

Patent Wars Hit Life Sciences, Says Study
The drive to accumulate and defend patents is stifling innovation, particularly in biotechnology and healthcare, according to a Canadian-led international study.


NIH Extends Its Commitment to Transformative Research with $138 Million for Director’s Pioneer and New Innovator Awards in 2008

Elias A. Zerhouni to End Tenure as Director of the National Institutes of Health 
Elias A. Zerhouni, M.D., the director of the National Institutes of Health, recently announced his plans to step down at the end of October 2008 to pursue writing projects and explore other professional opportunities.

Announcing Transition Schedule for NIH/AHRQ/CDC/NIOSH/FDA to Adobe-based forms for SF424 Research and Related (R&R) Electronic Submissions through Grants.gov

Reminder Concerning Grantee Compliance with Public Access Policy and Related NIH Monitoring Activities

Encouraging Early Transition to Research Independence: Modifying the NIH New Investigator Policy to Identify Early Stage Investigators

Termination of PAR-06-504: Enabling Technologies for Tissue Engineering and Regenerative Medicine (R01)


Approval Information: Blood Grouping Reagent Anti-e (Monoclonal) Corrected Approval Letter

PDUFA – User Fee Billable Products Approved Under Section 351 of the PHS Act – Updated

Substantially Equivalent 510(k) Device – HEMERUS LEUKOSEP HRC-600-C Leukocyte Reduction Filtration System – Hemerus Medical, LLC



FDAAA Delays: Hurry Up and Wait
After alerting industry earlier this year to the fact that it would start missing approval deadlines, FDA is now warning members of Congress that it will miss implementation deadlines under the FDA Amendments Act.


Characterizing and Validating Cardiomyocytes Derived from Human Embryonic Stem Cells; Second Call-for-Proposals

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