Volume 7.19 | May 22

Volume 7.19, May 22, 2006
     In this issue: Science | Policy | Business | NIH | CBER | Regulatory
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Top Stories

Bursting the Bubble on Diabetes: Research with rats points the way to delivering gene therapies for diabetes using tiny bubbles and ultrasound.


“Bubble Bassets” Cured of Genetic Disorder by In-Vivo Gene Therapy Technique
In-vivo gene therapy successfully restored the immune system in basset pups with X-linked severe combined immunodeficiency, or XSCID, a life-threatening genetic disorder that effectively disables the immune system.

Gene Therapy Role for Ulster’s Doctors
Vascular specialists at Belfast City Hospital have joined counterparts in Scotland and Germany in the European team involved in the unique research study to see whether the treatment can help patients affected by blocked leg arteries.

Researchers Find that Tumor Stem Cells are Good Models for Brain Tumor Research
Researchers at the National Cancer Institute (NCI) and the National Institute of Neurological Disorders and Stroke (NINDS), both part of the National Institutes of Health, have found that tumor stem cell lines derived directly from human glioblastoma brain tumors are a better model to study the biology and physiology of glioblastomas than are cancer cell lines that have been commonly used in cancer research laboratories.

New Study Reveals Signaling Pathways Required for Expansion of Pancreas Stem Cells
A team of scientists at The Scripps Research Institute has published a new study of important signaling pathways that are required for the expansion of pancreas stem cells, work that may lead to strategies to prevent or reverse insulin-dependent diabetes mellitus (IDDM).

UCI, Fertility Clinic to Create Stem Cell Lines
UC Irvine and an Orange County fertility clinic are teaming up to create at least five new lines of human embryonic stem cells, becoming one of the few groups in the country to try to produce fresh lines for the study of everything from spinal cord injuries to Parkinson’s disease.

Stem Cell Finding Gives Hope
University of Calgary scientists said Tuesday they have the ability to grow large quantities of breast cancer stem cells, a finding that could help researchers whose work is hampered by the small number of available cells.

Scientists Say Fetal Cells Can Correct Birth Defects
Boston researchers are preparing to fix birth defects by using a fetus’s own cells to grow replacement parts in the lab. The new parts would then be stitched into place at birth — or even before.

Stem-Cell Research Hints at Better Looking Cosmetic and Reconstructive Surgery
Stem-cell researchers have shown how cosmetic surgery, such as wrinkle removal and breast augmentation, might be improved with natural implants that keep their original size and shape better than synthetics.

New Device Shows Great Promise to Improve Islet Cell Transplantation in Patients With Diabetes
Physicians and researchers at the Diabetes Research Institute at the University of Miami Leonard M. Miller School of Medicine have successfully tested a new biomechanical device to treat diabetes in the laboratory.

The University Of Jaen Will Use Stem Cells For The Recovery Of Cartilaginous Lesions In Sports People
Researchers of the University of Jaen, Almeria and Granada, who belong to the group “Nuevas Tecnologías aplicadas a la Investigación” (CTS-107, new technologies applied to research) led by Dr. Antonia Aránega, in collaboration with the University of Malaga, are working on the recovery of cartilaginous microlesions in elite sportspeople using adult and embryonic stem cells.

‘Cloaked’ Carbon Nanotubes Become Non-Toxic
A way to cloak carbon nanotubes, making them both non-toxic and highly customisable, has been revealed. It marks a step towards using nanotubes in biological research and medicine.

Nano World: Blood-Compatible Nanomaterial
Artificial kidneys and other medical devices could soon employ carbon nanotubes and other structures only nanometers or billionths of a meter wide made highly blood compatible via anticoagulants, experts told UPI’s Nano World.

British Woman Pregnant with Cancer-Gene-Free ‘Designer Baby
British woman has become the first in the country to conceive a “designer baby” selected specifically to avoid an inherited cancer.


Correction of Canine X-Linked Severe Combined Immunodeficiency by In Vivo Retroviral Gene Therapy
This is the first demonstration that in vivo gene therapy targeting HSCs can restore both cellular and humoral immunity in a large-animal model of a fatal immunodeficiency.

Efficient Gene Delivery to Pancreatic Islets with Ultrasonic Microbubble Destruction Technology
This study describes a method of gene delivery to pancreatic islets of adult, living animals by ultrasound targeted microbubble destruction (UTMD). The researchers conclude that UTMD allows relatively noninvasive delivery of genes to pancreatic islets with an efficiency sufficient to modulate beta cell function in adult animals.


Senate May Vote Soon on Embryonic Stem Cell Research
The United States Senate may vote before Memorial Day weekend on a bill to fund stem cell research that destroys embryos.

New Jersey Senate Approves Stem Cell Research Bill
New Jersey would spend $250 million to construct a network of stem-cell research facilities under a bill approved by the state Senate Thursday.

Send in the Clones – for a Good Cause
Outlaw cloning of humans, but not stem cell research that will help cure diseases.

Korean Minister for Science and Technology Reaffirms Future of Stem Cell Research
Korean stem cell research has been on a rollercoaster ride, with scientist Hwang Woo-suk’s alleged breakthroughs revealed as an elaborate fraud. But the government has reaffirmed it will continue to support stem cell research.


PrimeGen Biotech LLC Spins Off PrimeCell(TM) Therapeutics — Wholly Owned Subsidiary to Work Exclusively on First Human Adult Pluripotent Stem Cell
PrimeCell Therapeutics will focus solely on adult stem cell reprogramming, and preparing PrimeCell for therapeutic development and application.

Athersys, Inc. Announces Partnership With Angiotech Pharmaceuticals, Inc. To Commercialize Cell-Based Therapies For Cardiovascular Disease
Athersys Inc. today announced that the ADDVANCE division of Angiotech Pharmaceuticals, Inc. has made an investment in the company to support the development of cell-based products for treating cardiovascular disease.

AGTC and JDRF Announce Partnership to Develop Gene Therapy for Diabetic Eye Disease
The Juvenile Diabetes Research Foundation has joined in a partnership with AGTC (Applied Genetic Technologies Corp.) and Genzyme Corporation to develop a gene therapy treatment to potentially prevent blindness resulting from diabetic retinopathy.

BioE and South Eastern Sydney Illawarra Area Health Service Initiate Stem Cell Research Partnership
BioE(R), Inc., a biomedical company providing enabling human cord blood stem cells, and the South Eastern Sydney Illawarra Area Health Service announced today a joint research partnership to evaluate the potential of BioE’s cord blood-derived stem cell to form pancreatic beta cells. These cells, which are absent in Type 1 diabetes patients, are responsible for producing insulin that normalizes the body’s blood glucose levels.

Cleveland Stem-Cell Therapy Start-Up; Arteriocyte, Inc. Receives State Research Support; Third Frontier Funding to Advance Development of Adult Stem Cell-Based Therapies
Arteriocyte Inc., a Cleveland-based, biotechnology startup currently conducting a Phase I clinical trial for an adult, bone-marrow-derived stem cell therapy designed to generate new blood vessels in ischemic tissues, has received a $600,000 grant from the State of Ohio to further the development of its technology.

New Jersey Senate Approves $250 Million Stem-Cell Research Plan
The New Jersey State Senate approved a $250 million borrowing plan to create three stem-cell research centers, moving one step forward in the race against California to find funding and scientists for the controversial science.

Project A.L.S. Opens Privately-Funded Stem Cell Research Laboratory, The First To Focus Exclusively On ALS And Related Diseases
Project A.L.S. opened the first privately-funded lab to focus exclusively on the study of stem cells to treat ALS (amyotrophic lateral sclerosis) and related motor neuron diseases.

Center for Stem Cell & Regenerative Medicine Receives $8 million from Third Frontier Program
The Biomedical Research and Commercialization Program of the State of Ohio Third Frontier Program has announced that Case Western Reserve University and its partners, University Hospitals of Cleveland, Cleveland Clinic, and Athersys, Inc., will receive $8 million to continue clinical commercialization programs in the Center for Stem Cell and Regenerative Medicine for the next three years.

Celgene Patents Stem Cell Technology
New Jersey-based biotech gets legal protection for method of placental-derived stem cell recovery.

Tourism Gains with Stem Cell
Thousands of dollars were earned last year by hotels and the hospitality sector when patients and their loved ones traveled to Barbados for stem cell treatment at the Institute of Regenerative Medicine.

Clinical Cell Culture Ltd. Appoints New CEO
Clinical Cell Culture Ltd announced that it has appointed Bob Atwill as its new Chief Executive Officer and a Director of the Company.



Delays in Grant Application Submission Due to Spring Flooding (NOT-OD-06-070)

Mentored Specialized Clinical Investigator Development Award (NOT-HD-06-104)

Circulating Cells in Cancer Detection (R21) (PA-06-423)


All new CBER information can be reached from the What’s New page at What’s New Page

Advisory Committee on Blood Safety and Availability – Slide Presentation


Food and Drug Administration (United States of America)

Agency Information Collection Activities; Proposed Collection; Comment Request; Guidance on Informed Consent for In Vitro Diagnostic Device Studies Using Leftover Human Specimens That are Not Individually Identifiable

MedSafe (New Zealand)

Joint Australia and New Zealand Therapeutic Products Authority Planned for Next Year

Australia and New Zealand Therapeutic Products Authority Stakeholder Information Meetings


AABB-ISCT Cellular Therapy Audioconference Series

For more information on the Somatic Cell Therapy Symposium, see www.celltherapysociety.org.

Profiled Journal

Current Volume: Volume 15, No. 2



Pig-to-Nonhuman Primate Islet Xenotransplantation: A Review of Current Problems
P. P. M. Rood, L. H. Buhler, R. Bottino, M. Trucco, and D. K. C. Cooper

Coinhibitory T-Cell Signaling in Islet Allograft Rejection and Tolerance
Wayne Truong, Wayne W. Hancock, Colin C. Anderson, Shaheed Merani, and A. M. James Shapiro

Original Contributions

Viability and Functionality of Bovine Chromaffin Cells Encapsulated Into Alginate-PLL Microcapsules With a Liquefied Inner Core
T. Moustafa, S. Girod, F. Tortosa, R. Li, J. C. Sol, F. Rodriguez, R. Bastide, Y. Lazorthes, and B. Sallerin

One-Step Induction of Neurons From Mouse Embryonic Stem Cells in Serum-Free Media Containing Vitamin B12 and Heparin
Hironori Yamazoe, Masato Kobori, Yoshinobu Murakami, Keiichi Yano, Mitsuo Satoh, Kenji Mizuseki, Yoshiki Sasai, and Hiroo Iwata

Engrafted Neural Progenitor Cells Express a Tissue-Restricted Reporter Gene Associated With Differentiated Retinal Photoreceptor Cells
Thien N. Sam, Jing Xiao, Heidi Roehrich, Walter C. Low, and Dale S. Gregerson

Subnormothermic Preservation Maintains Viability and Function in a Porcine Hepatocyte Culture Model Simulating Bioreactor Transport
M.-P. van de Kerkhove, R. Hoekstra, F. C. van Nooijen, F. O. B. Spoelstra, B. M. Doorschodt, A. C. W. A. van Wijk, P. P. C. Poyck, R. A. F. M. Chamuleau, and T. M. van Gulik

Quantitative Assay for Quality Assurance of Human Cells for Clinical Transplantation
Steven T. Boyce, Benjamin A. Anderson, and Horacio L. Rodriguez-Rilo

Comparison of Cooling Systems During Islet Purification
Sue Swift, Tatsuya Kin, Mohammadreza Mirbolooki, Richard Wilson, and Jonathan R. T. Lakey

Estimation of Pancreas Weight From Donor Variables
Tatsuya Kin, Travis B. Murdoch, A. M. James Shapiro, and Jonathan R. T. Lakey

Ameliorating Injury During Preservation and Isolation of Human Islets Using the Two-Layer Method With Perfluorocarbon and UW Solution
Payam Salehi, Mohammadreza Mirbolooki, Tatsuya Kin, Toshiaki Tsujimura, A. M. James Shapiro, Thomas A. Churchill, and Jonathan R. T. Lakey

Functional MR Microimaging of Pancreatic \GK\b-Cell Activation
Barjor Gimi, Lara Leoni, Jose Oberholzer, Mark Braun, Jose Avila, Yong Wang, Tejal Desai, Louis H. Philipson, Richard L. Magin, and Brian B. Roman

Brief Communication

Size-Dependent Revascularization of Transplanted Pancreatic Islets
Caroline Kampf, Göran Mattsson, and Per-Ola Carlsson

Cell Transplantation publishes original, peer-reviewed research and review articles on the subject of cell transplantation and its application to human diseases. To ensure high-quality contributions from all areas of transplantation, separate section editors and editorial boards have been established. Articles deal with a wide range of topics including physiological, medical, preclinical, tissue engineering, and device-oriented aspects of transplantation of nervous system, endocrine, growth factor-secreting, bone marrow, epithelial, endothelial, and genetically engineered cells, among others. Basic clinical studies and immunological research papers are also featured. To provide complete coverage of this revolutionary field, Cell Transplantation will report on relevant technological advances, and ethical and regulatory considerations of cell transplants.