Volume 7.10 | Mar 20

Volume 7.10, March 20, 2006
     In this issue: Science | Policy | Business | NIH | CBER | Regulatory
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Top Stories

Uterine Lining Stem Cells ‘Act Like Heart Cells’: Japanese researchers have harvested stem cells from human menstrual blood.

Insulin-producing Cells Grown in Lab: A bioengineering team announced today that they have developed a way of growing pancreatic cells in their laboratory.


First Lung Stem Cells Discovered
Not only is this the first time anyone has found stem cells in the lung, but the team claims that these cells could be the precursor for lung cancer, the cancer that causes the greatest number of deaths in the U.S. each year.

Hwang Cloned Stem Cells
Korea’s top experts on unisexual reproductions claim the country’s disgraced scientist Hwang Woo-suk indeed created cloned human embryonic stem cells.

Stem Cell Researcher’s License Revoked
South Korea’s government on Thursday revoked permission for disgraced scientist Hwang Woo-suk to conduct embryonic stem cell research, the latest blow since revelations that his most high-profile work was based on forged evidence.

Woman with MS Shows Remarkable Progress in Stem Cell Trial
A woman near Ottawa has surpassed all expectations after risking her life to take part in a medical experiment for multiple sclerosis.

Adult Stem Cells Improve Cardiac Function And Blood Flow In Patients With Heart Disease, New Study Finds
Bone marrow-derived adult stem cells administered within the heart (intramyocardial) and coronary artery (intracoronary) tissues of heart disease patients improved patients’ heart function and blood flow, according to a pilot study.

Uncovering How Bone Marrow Stomal Cells Can Potentially Regenerate Brain Tissue
Japanese researchers have found a piece of the “missing link” about how bone marrow stromal cells restore lost neurologic function when transplanted into animals exhibiting central nervous system disorders, according to a study in the March issue of the Journal of Nuclear Medicine.

Nanotechnology May Repair Damaged Brains
Rodents blinded by brain damage had their vision partially restored within weeks after being treated with nanotechnology developed by bioengineers and neuroscientists at the Massachusetts Institute of Technology.

UCR Researchers Grow Bone Cells on Carbon Nanotubes
Researchers at the University of California, Riverside have published findings that show, for the first time, that bone cells can grow and proliferate on a scaffold of carbon nanotubes.

Gene Therapy Gives Hope to Haemophiliacs
Scientists have injected a blood-clotting gene into an Australian doctor with severe haemophilia, giving him temporary respite from bleeding episodes.

Study Analyzes Gene Therapy for Patients at High Risk for Amputation
A new randomized study presented today at the American College of Cardiology’s 55th Annual Scientific Session investigates an innovative treatment for critical limb ischemia, or lack of arterial blood supply and oxygen to the legs, using a therapeutic approach to generate new blood vessels.

Israeli Researchers Close in on Vaccine for Autoimmune Diseases
A revolutionary approach developed in Israel which uses the body’s own cells as a vaccine for treating autoimmune diseases is showing tremendous potential in human trials.

Arbios Expands Indications for SEPET(TM) Feasibility Trial
Arbios Systems, Inc. (OTC: ABOS – News), a biomedical device and cell therapy company developing proprietary liver assist products for the treatment of liver failure, today announced that the Food & Drug Administration (FDA) has allowed expansion of the clinical feasibility trial of its SEPET(TM) liver assist device via broadened patient eligibility criteria.

ThermoGenesis AXP AutoXpress(TM) Platform Is Launched By GE Healthcare As The First Automated Functionally Closed Sterile System For The Processing Of Cord Blood Stem Cells
GE Healthcare has introduced the AXP AutoXpress™ Platform (AXP Platform), the first automated, functionally closed, sterile system that harvests stem cells from umbilical cord blood samples with high yield and at high throughput.

Adipose-Derived Stem Cells Improved Left Ventricle Wall Thickness and Capillary Density in Pigs Following Myocardial Infarction in Pre-Clinical Study
Cytori Therapeutics, Inc. (NASDAQ:CYTX) (Frankfurt:XMPA) announced today that adipose-derived stem cells improved left ventricle wall thickness and capillary density following myocardial infarction in a randomized, placebo-controlled preclinical study.

ViaCell Reveals Encouraging Preclinical Findings Of Unrestricted Somatic Stem Cells From Cord Blood – Quick Facts
ViaCell, Inc. (VIAC | charts | news | Powerrating) said Monday that preclinical findings evaluating Unrestricted Somatic Stem Cells, pluripotent stem cells cultivated from human cord blood, in a small animal model of myocardial infarction, showed a dose-dependent response and result in functional recovery in an animal model of acute myocardial infarction four weeks post transplantation.

Four Research Institutes To Build A Human Embryonic Stem Cell Research Facility In California
Four research institutes are discussing plans to request Proposition 71 funds from the San Diego Consortium for Regenerative Medicine to build a facility for human embryonic stem cell research.


Beta-cell Differentiation from Nonendocrine Epithelial Cells of the Adult Human Pancreas
Nonendocrine-to-endocrine differentiation of NEPECs supports the existence of endocrine stem or progenitor cells within the epithelial compartment of the adult human pancreas.

Bone Cell Proliferation on Carbon Nanotubes
We explored the use of carbon nanotubes (CNTs) as suitable scaffold materials for osteoblast proliferation and bone formation.

Self-illuminating Quantum Dot Conjugates for In Vivo Imaging
Here we present quantum dot conjugates that luminesce by bioluminescence resonance energy transfer in the absence of external excitation.


European Union Fails to Agree on Common Embryo Research Policy
The European Union was unable to agree on Monday on a common approach to human embryonic stem cell research, banned in some member states, and is set to keep a piecemeal approach to funding such work, officials said.


Hadasit invests $3 million in CellCure
Biotechnology company CellCure Ltd has completed a financing round, in which it raised $3 million from Hadasit Bio Holdings Ltd. (TASE:HDST) , a subsidiary of Hadasit Medical Research Services and Development Ltd.

MorphoSys and Japanese Pharmaceutical Group Daiichi Sankyo Form Broad Alliance to Develop Novel Antibody Therapies
MorphoSys AG (Frankfurt: MOR; Prime Standard Segment, TecDAX) today announced that Sankyo Company, Limited, a wholly owned subsidiary of Daiichi Sankyo Company, Limited, and MorphoSys AG have entered into a license agreement and therapeutic antibody collaboration for an initial two-year term with the option of an extension of up to three more years.

AlloSource and U.S. Tissue and Cell Join Forces; Availability of Allografts from Non-Profit Provider Will Increase
The joined entity will combine the resources and services of two leading non-profit allograft providers to create a single, synergistic source for allograft products and services.

Medistem Appoints Accomplished Physician and Medical Entrepreneur Roger M. Nocera, MD, as Executive VP and CMO
Medistem Laboratories, Inc. (OTCBB:MDSM) (FWB:S2U), committed to the ethical development of next-generation medical therapies from non-controversial adult stem cell sources, has named veteran physician and medical entrepreneur, Roger M. Nocera, M.D., as its Executive Vice President and Chief Medical Officer.



NIH Provides $24 Million to Support Research Network
The National Center for Research Resources (NCRR), a part of the National Institutes of Health (NIH), announced today it will provide $24.29 million over five years to the University of California, Irvine (UCI) for continued support to the Biomedical Informatics Research Network (BIRN).

Updated Instructions Regarding Inclusion of Publications as Appendix Materials (NOT-OD-06-051)

Pre-Application Meeting for Cancer Genome Characterization Centers RFA-CA-07-014 (NOT-CA-06-016)

The Secretory Pattern of Senescent Cells (R21) (PA-06-138)

NHLBI Innovative Research Grant Program (R21) (PA-06-239)


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

Guidance for Industry: Using a Centralized IRB Review Process in Multicenter Clinical Trials

Cooperation on Medicines Regulation Intensified

2006 Biological Approvals – Update

Clinical Investigator Information – Updated with link to Introduction to the Regulatory Process for Clinical Investigators


Food and Drug Administration (United States of America)

Bush Nominates Von Eschenbach for Top FDA Job
Senate Democrats are threatening to hold up the nomination of Andrew von Eschenbach to be the permanent head of the FDA over delays in the agency’s decision on whether to allow the controversial Plan B contraceptive to be sold without a prescription.

Guidance for Industry on Nonclinical Safety Evaluation of Drug or Biologic Combinations; Availability

Medsafe (New Zealand)

GMP Certified Contract Testing Laboratories

Medicines and Healthcare Regulatory Agency (United Kingdom)

Future of the European Medicines Regulatory Network- Public Consultation

Medical Device Alert- Baxter Haemodialysis Instruments: System 1000 Tina, Aurora and Arena


ISCT2006. May 4-7. Berlin.
Click here for the preliminary program or registration information.

AABB-ISCT Cellular Therapy Audioconference Series

Somatic Cell Therapy Symposium Survey
Representatives from FDA, ISCT, and AABB are once again working on developing an outstanding program for the Annual Somatic Cell Therapy Meeting. The 6th Annual Somatic Cell Therapy Symposium, which ISCT expects will be co-sponsored again by the FDA and AABB, is the premier forum for discussing current issues around cell therapy regulations. The meeting is an interactive, panel-based meeting meant to educate and foster dialogue between the industry and those in the Agency. As representatives in the cell therapy liaison meeting stakeholder group, we ask your assistance in completing a very brief survey and circulating the survey to your various organizations and constituencies as a way of assisting the organizing committee in ensuring the meeting addresses the topics of most interest and priority.
For the survey, click here.
For more information about the meeting, click here.

Profiled Journal

Robert Weinstein, MD
Chief, Hematology and Transfusion Medicine, Caritas St. Elizabeth’s Medical Center, Tufts University School of Medicine, Boston, MA

The Journal of Clinical Apheresis provides the world’s premier source of current information in the field of apheresis. The Journal presents work in all aspects of basic and clinical research, practical applications, emerging technologies and regulation in apheresis and related fields including hematology, nephrology, neurology, rheumatology, transplantation, cellular therapies, blood banking, transfusion medicine, and others.

A subscription to the journal is a key benefit of ASFA membership, which ranges from $120-145 annually. To become a member please contact:

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