Volume 9.43 | Nov 3

Cell Therapy News 9.43, November 3, 2008
     In this issue: Science | Policy | Business | NIH | CBER | Regulatory
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Top Stories

Geron Scientists and Collaborators Demonstrate Activity of Pancreatic Islet-like Cells Derived from Human Embryonic Stem Cells in Diabetes: Geron Corporation recently announced the publication of data showing the successful engraftment of human embryonic stem cell-derived pancreatic islet-like clusters in diabetic mice.


Stem Cell Therapies for Heart Disease – One Step Closer
New research from the University of Bristol reveals that our bodies’ ability to respond to an internal ‘mayday’ signal may hold the key to success for long-awaited regenerative medicine.

Stanford Researchers Discover Pervasive Network Driving Protein Production and Placement in Cells
Stanford University School of Medicine researchers have uncovered what appears to be an extensive, but until now barely noticed, network of regulatory interactions that influence what proteins are made inside a cell, and when and where.

Immortalizing a Piece of Yourself
Stem cells derived from volunteers for the Personal Genome Project will be disseminated globally.

Scientist Clears Hurdles for Muscular Dystrophy Therapy
University of Missouri-Columbia scientist proves therapy can be beneficial for the heart in new studies demonstrating effective gene therapy deliver.

StemCells, Inc. Announces Preclinical Results Showing its Proprietary Human Neural Stem Cells Can Prevent Vision Loss
StemCells, Inc. reported recently that its proprietary HuCNS-SC (R) product candidate (purified human neural stem cells), when transplanted into a well-established animal model, can protect the retina from progressive degeneration.

Singaporean Development of Cell Therapy Treatment for Cancer
Explaining the ground-breaking nature of this trial, Dr Toh says, “What we’re doing is to extract T-cells from the patient’s own blood, then ‘educate’ these cells to recognize certain viral proteins. These T-cells will be expanded into large numbers in the lab and returned back to the patients to fight the cancer.”

C. Difficile Infection Often Seen in Leukemia Patients after Stem Cell Therapy
The results of a small study suggest that nearly a third of patients who undergo allogeneic hematopoietic stem cell transplantation will develop Clostridium difficile infection, and that those with leukemia are at much greater risk than patients with lymphoma.

University of Miami Health Cardiologists Are First in the U.S. to Use a Novel Catheter to Inject Stem Cells
Cardiologists at the University of Miami Health System injected stem cells into the heart using a novel, corkscrew-shaped catheter, using bone marrow cell therapy in an effort to treat heart failure.


The Growth Factor Environment Defines Distinct Pluripotent Ground States in Novel Blastocyst-Derived Stem Cells
This paper explores how the developmental stage of the tissue of origin, and culture growth factor conditions, affect the stem cell pluripotent state.

In Situ Tissue Regeneration Using a Novel Tissue-Engineered, Small-Caliber Vascular Graft Without Cell Seeding
In this the researchers investigated in situ tissue regeneration in small-diameter arteries using a novel tissue-engineered biodegradable vascular graft that did not require ex vivo cell seeding.

Hyperthermia Induced Targeting of Thermosensitive Gene Carriers to Tumors
This study shows that locoregional hyperthermia can be utilized for site directed activation of macromolecular drug delivery systems.


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Australian Embryonic Stem Cell Debate to Begin
State Parliament will begin debating a bill to allow embryonic stem cell research in South Australia.

Britain Widens Scope for Stem Cell Research
British plans to allow scientists to use hybrid animal-human embryos for stem cell research won final approval from lawmakers in a sweeping overhaul of sensitive science laws.

Cuba Seeks Stronger Economic Ties with Malaysia through Biotechnology
Cuba is seeking for more long-term partnerships with Malaysia in research and development in the biotechnology sector to further strengthen its economic ties with the country.


StemCor Signs Agreement with Hospira to Market New Medical Device to Oncologists and Hematologists
StemCor Systems, Inc. announced recently that it has signed an agreement with Hospira, to develop and commercialize StemCor’s proprietary System for the harvest of bone marrow.

BioLife Solutions HypoThermosol(R) Adopted by MicroIslet for Processing Pancreatic Islet Cells to Treat Diabetes
BioLife Solutions Inc. recently announced that MicroIslet Inc. has adopted HypoThermosol for preserving, transporting, and storing pancreatic source material.

Northeast Baptist Hospital Becomes a Texas Cord Blood Collection Site
The Texas Cord Blood Bank, a publicly and privately funded non-profit program established to create a public supply of umbilical cord blood, announced today that it has begun collecting the life-saving resource from Northeast Baptist Hospital.

Osteotech Receives FDA Clearance for its Next Generation Grafting Material
Osteotech received 510(k) clearance from the United States Food and Drug Administration for its bone graft substitute, and bone void filler, for use in the spine, pelvis and extremities.

RGK Foundation provides ALS Therapy Development Institute with $1 Million Grant
The grant, to be awarded over 18 months, will support the institute’s on-going efforts to utilize the latest gene therapy technology to develop an effective therapeutic to slow or stop the progression of amyotrophic lateral sclerosis, commonly known as Lou Gehrig’s disease.

Promoting the Healing Process after a Heart Attack
The European Research Council has granted 2.4 million Euros to support research into vascular disease and cell aging.

Aastrom Biosciences Receives Notification That NASDAQ Issued Temporary Suspension of Certain Continued Listing Requirements
Aastrom has until March 20, 2009 to regain compliance with the $1.00 minimum closing bid price rule due to NASDAQ suspending enforcement given the current extraordinary market conditions.


NIH Director’s Council of Public Representatives Welcomes Six New Members
The National Institutes of Health has selected six outstanding individuals to serve as members of the Director’s Council of Public Representatives, the advisory committee to the NIH Director on issues important to the public.

Announcing 2009 NIH Regional Seminars on Program Funding and Grants Administration

Revised New and Early Stage Investigator Policies

Requests for Applications Intestinal Stem Cell Consortium (U01)

Requests for Applications 2009 NIH Director’s Pioneer Award Program (DP1)

Requests for Applications 2009 NIH Director’s New Innovator Award Program (DP2)


CBER – Annual Report

Exceptions and Alternative Procedures Approved Under 21 CFR 640.120 – Update



The US Government Accountability Office Critical of FDA’s Overseas Inspections
The US Government Accountability Office has released a report, which accuses the FDA of failing to keep accurate data about overseas drug facilities and not following up warning letters with inspections.

HHS Preparing to Open FDA Offices in China, India, Europe, and Latin America this Year
The U.S. Department of Health and Human Services will send the first U.S. Food and Drug Administration staff to China, India, Europe, and Latin America before the end of 2008.

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