Volume 9.46 | Nov 24

Cell Therapy News 9.46, November 24, 2008
     In this issue: Science | Policy | Business | NIH | CBER | Regulatory
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Top Stories

First Tissue-Engineered Trachea Successfully Transplanted: The first tissue-engineered trachea, utilizing the patient’s own stem cells, has been successfully transplanted into a young woman with a failing airway.


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VIDEO: Breakthrough in Cell-Type Analysis Offers New Ways to Study Development and Disease
Researchers at The Rockefeller University have developed a method to reveal translational profiles by isolating the genetic messages that govern protein production in different cell types.

‘Femtomolar Optical Tweezers’ May Enable Sensitive Blood Tests
The National Institute of Standards and Technology has licensed a patented “optical tweezers” technique for detecting and measuring very small concentrations of a biological substance – such as a virus on a surface.

“Jet Injection” for Gene Therapy – First Clinical Trial Evaluates Feasibility
For the first time in a clinical study, researchers have tested a new technology enabling them to transfer genetic material directly into a tumor by means of high pressure.

A*STAR and NUS Researchers Score Breakthrough in Developing Unlimited Number of Pure Insulin-Producing Cells
The researchers found that these pure insulin-producing cells, which according to electron microscopy studies, have the same sub-cellular structures as the insulin-producing cells naturally found in the pancreas, were highly effective in treating diabetes in the mouse model.

Pluripotent Stem Cells Shown to Generate New Retinal Cells Necessary for Vision
Pluripotent stem cells can be converted into the different classes of retinal cells necessary for vision, according to a new study from researchers at Syracuse University of New York Upstate Medical University.

Neurons Derived from Embryonic Stem Cells Restore Muscle Function after Injury
Dalhousie Medical School researchers have discovered that embryonic stem cells may play a critical role in helping people with nerve damage and motor neuron diseases, such as amyotrophic lateral sclerosis, regain muscular strength.

Jefferson Researchers Define Ideal Time for Stem Cell Collection for Parkinson’s Disease Therapy
Researchers have identified a stage during dopamine neuron differentiation that may be an ideal time to collect human embryonic stem cells for transplantation to treat Parkinson’s disease.

First Trial in the U.S. to Treat Both Ischemic & Non-Ischemic Heart Failure to be Performed by University of Utah Researchers Using Patient’s Own Stem Cells
Researchers at the University of Utah are enrolling people in a new clinical trial that will look at the safety of injecting Cardiac Repair Cells and their ability to improve heart function.

Histogen Announces Start of Hair Regrowth Clinical Evaluation
Histogen, Inc. recently announced the start of the Company’s first human clinical evaluation to evaluate the safety in the clinical application of the ReGenica product.

Aastrom Announces Treatment of First Patient in U.S. Phase II IMPACT-DCM Trial
The U.S. Phase II clinical trial is designed to evaluate the surgical delivery of the Company’s Cardiac Repair Cells directly into human heart muscle for the treatment of dilated cardiomyopathy, a severe form of chronic heart failure.


Hepatocyte Growth Factor/c-MET Axis-mediated Tropism of Cord Blood-derived Unrestricted Somatic Stem Cells for Neuronal Injury
An under-agarose chemotaxis assay was used to investigate whether unrestricted somatic stem cells that were recently characterized in human cord blood are attracted by neuronal injury in vitro.

The Na+/H+ Exchanger Isoform 1 Facilitates Cardiomyocyte Embryonic Stem Cell Differentiation
To gain insights into improving cardiomyocyte development from stem cells we examined the role of the Na+/H+ exchanger isoform 1 in cardiomyocyte differentiation.

Novel Cryopreservation Method for Dissociated Human Embryonic Stem Cells in the Presence of a ROCK Inhibitor
One of the major challenges regarding the application of human embryonic stem cells is the development of an efficient cryopreservation protocol, since current methods, which include slow-freezing–rapid thawing and vitrification of colonies in suspension, present poor viability and high differentiation rates.

Transplanted Mouse Embryonic Stem-Cell-Derived Motoneurons Form Functional Motor Units and Reduce Muscle Atrophy
In this study, the researchers ask whether transplanted embryonic stem cells differentiated into motor neurons can form functional synapses with host muscle, and if so what effects do they have on the muscle.


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Obama Should Tap Personalized Medicine Tools, Leavitt Says
President-elect Barack Obama should explore tools of personalized medicine, such as genetic tests and online health records, to mend the U.S. health-care system, said Michael Leavitt, the outgoing health secretary.


Stem Cell Sciences Signs Service Agreement with Pfizer to Provide Access to Proprietary Technologies and Methods
Stem Cell Sciences plc has signed a Master Service Agreement of up to five years with Pfizer Limited to provide research services, cell lines, media and reagents to support Pfizer’s R&D efforts in this important field.

StemCells, Inc. Closes $20 Million Equity Financing
StemCells, Inc. announced recently that it has closed the sale of 13,793,104 units to certain institutional investors at a price of $1.45 per unit, for gross proceeds of $20.0 million.

Tengion Announces Second Closing of Series C Financing
Tengion Inc. recently announced that it has completed a second closing of its Series C financing, receiving a total of approximately $21 million in additional equity capital from the company’s existing institutional equity investor base along with new investor, Safeguard Scientifics, Inc.

Tissue Genesis Applies CE Mark to Its Adult Stem Cell Isolation System
Tissue Genesis, Inc. recently announced that effective immediately, its Tissue Genesis Cell Isolation System will be available to the European marketplace.


Reminder and Clarification on NIH/AHRQ/CDC/FDA Transition to Adobe-Based Forms for SF424 Research and Related Electronic Submissions Through Grants.gov

Implementing the Early Stage Investigator Policy: Updating eRA Commons Profiles to Include Degree and Residency Completion Dates


Draft Guidance for Industry on Process Validation: General Principles and Practices

Importing CBER Regulated Products into the United States – FAQs

Substantially Equivalent 510(k) Device – MEDITECH Client Server Blood Bank module v5.6 – MEDITECH Medical Information Technology, Inc

Blood Products Advisory Committee – Update



Industry on Process Validation, Draft Guidance; Availability: General Principles and Practices, 68431–68432 [E8–27321]

HHS Opens Offices of the Food and Drug Administration in China
As part of an ongoing strategy to continually improve import safeguards to meet the changing demands of a global economy, the U.S. Department of Health and Human Services is this week officially opening offices of its Food and Drug Administration in Beijing, Guangzhou and Shanghai in the People’s Republic of China.

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