Volume 7.18 | May 15

Volume 7.18, May 15, 2006
     In this issue: Science | Policy | Business | NIH | CBER | Regulatory
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Top Stories

Injected Cells Cure Tumors in Mice: White blood cells from mice that are naturally immune to cancer cured tumors in other mice and provided them with lifelong immunity to the disease.


Study Says Stem Cell ‘Fusion’ Occurs In Tumors
An Oregon Health & Science University study is adding credence to an increasingly popular theory that fusion is what bonds stem cells with bone marrow cells to regenerate organ tissue.

Engineered Functional Lung Tissue Grown on 3D Hydrogel
The engineered, 3-D pulmonary tissue constructs described in a report in the April 2006 issue of Tissue Engineering represent a successful first step in the creation of functional pulmonary tissue constructs designed for therapeutic use.

Researchers Differentiate Cord Blood Stem Cells into Alveolar Cells
BioE reported that scientists at the University of Minnesota, using its stem cell isolation technology, derived the company’s Multi-Lineage Progenitor Cell™ (MLPC) from cord blood and, for the first time, differentiated it into type II alveolar cells.

Isolating Adult Mesenchymal Stem Cells From Blood
Ortec International, Inc., a company focused on development and commercialization of products applicable to regenerative medicine and stem cell therapy, today announced the results of experiments showing the ability of Fibrin Microbeads (FMB), an advanced fibrin based biomaterial, to isolate the Mesenchymal class of adult stem cells (MSC) from human peripheral blood.

Austrianova Biotechnology Starts Industrial Production of NovaCaps
Austrianova today announced that it has started industrial production of its lead product NovaCaps®. Austrianova is the first company worldwide that has been successful in developing a market scale, GMP compliant, industrial production process for encapsulated cell products.

Cell Genesys Receives Fast Track Status for GVAX(R) Immunotherapy for Prostate Cancer
Cell Genesys, Inc. today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for GVAX immunotherapy for prostate cancer, the company’s lead product candidate for the treatment of advanced prostate cancer.

M. D. Anderson Cancer Center Initiates Clinical Trial to Evaluate a Custom-Made Therapeutic Vaccine for the Treatment of Chronic Lymphocytic Leukemia
The University of Texas M. D. Anderson Cancer Center has initiated a clinical trial to evaluate the use of an idiotype active immunotherapy, also referred to as idiotype vaccine therapy, in patients with Chronic Lymphocytic Leukemia (CLL), a type of cancer affecting the blood and bone marrow.

Researchers Have Used Targeted Viral Vectors as Carriers to Attach Gold Nanoparticles to Tumors
This opens up the possibility of combining two types of treatment: heating the tumor using the gold nanoparticles, and killing the tumor using gene therapy.

Biovest’s AutovaxID(TM) Cleared for Commercial Sale; First and Only Device to Automate Production of Complex Biologics
A majority-owned subsidiary of Accentia Biopharmaceuticals, Inc. , Biovest International, Inc., has been informed by the United States Food and Drug Administration (FDA) that its patent-pending AutovaxID(TM) device requires no further review by the FDA, allowing Biovest to commence commercialization of the device.

Therapy Helps Parkinson’s Patients
More than 1.5 million Americans suffer from Parkinson’s disease. There is no cure, but now there is a new treatment that may improve patients’ quality of life.

The South Korean Cloning Scientist Who Faked His Stem Cell Research Has Been Charged with Fraud and Embezzlement
Hwang Woo-suk was also charged with using millions of dollars in grants for private purposes, as well as violating laws on bio-ethics.


Bone Marrow-Derived Cells Fuse With Normal and Transformed Intestinal Stem Cells
The findings suggest an unexpected role for Bone Marrow-Dervied Stem Cells in both regeneration and tumorigenesis of the intestine.

Isolation of Mesenchymal Stem Cells from G-CSF-Mobilized Human Peripheral Blood Using Fibrin Microbeads
The study indicates that fibrin microbeads (FMB) may have special advantage in isolating mesenchymal stem cells (MSC) from sources such as mobilized PB, where the number of such cells is scarce.


Senators Specter and Santorum Introduce Bill Requiring NIH To Research Methods Of Creating Embryonic Stem Cells Without Destroying Embryos
Senators Arlen Specter and Rick Santorum on Friday announced they introduced a bill that would require NIH to research and fund methods of creating embryonic stem cell lines without destroying human embryos, the Philadelphia Inquirer reports

Senate Unlikely To Consider Embryonic Stem Cell Legislation in Upcoming ‘Health Week’ Debates
It is unlikely there will be debate on legislation (HR 810, S 471) that would expand federal funding for human embryonic stem cell research during an upcoming week of discussion that Republicans are calling “Health Week,” the office of Senate Majority Leader Bill Frist (R-Tenn.) said.


Stem Cell Therapeutics Corp. Announces Issuance of Second US Patent
The patent, entitled “Production of Radial Glial Cells”, protects novel methods of producing radial glial cells in the brain.

Advanced Cell Technology Announces Cross License of Key Intellectual Property with Kirin
Advanced Cell Technology, Inc. has entered into exclusive and non-exclusive license agreements of key intellectual property with Kirin Brewery Company, Ltd. with offices located in Tokyo, Japan and the United States (“Kirin”) and certain other Kirin subsidiaries.

Pluristem Files Patent Application For PLX-1, Intended as an Innovative Stem Cell Solution For Improved Engraftment During Bone Marrow Transplantation
PLX-1 is intended to offer a breakthrough solution to improved engraftment during bone marrow transplant procedures that use umbilical cord blood (UCB).

Aastrom Biosciences, Inc. Receives Manufacturing License At European Pilot Facility For Production Of Proprietary Bone Marrow Stem Cell Products
Aastrom Biosciences, Inc. announced today that it has received a human pharmaceuticals manufacturing license, through its wholly owned subsidiary, for the production of the Company’s Tissue Repair Cell (TRC) products.

Biovest International Announces Addition to Senior Management Team; Company Move Strengthens Manufacturing Expertise
Biovest International, Inc. (OTCBB: BVTI.OB), a biopharmaceutical company focused on the development of patient specific immunotherapeutics and automated cell culture instrumentation, has appointed Dr. James Zabrecky as Vice President for Biologics Development of its Biovax subsidiary.

In Medicine, Small is About to Become Big
Nanotechnology is poised to make huge leaps in the treatment of disease at the cellular level.



Directed Stem Cell Differentiation for Cell-Based Therapies for Heart, Lung, and Blood, and Aging Diseases (R21) (PA-06-407)

Non-Human Primate Islet/Kidney Transplantation Tolerance (U01, U19) (RFA-AI-06-018)

Pilot and Feasibility Clinical Research Grants in Diabetes, Endocrine and Metabolic Diseases (R21) (PA-06-387)


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

Current Licensed Establishments and Products


Food and Drug Administration (United States of America)

Guidance on Informed Consent for In Vitro Diagnostic Device Studies Using Leftover Human Specimens that are Not Individually Identifiable

Industry Exchange Workshop on Food and Drug Administration Clinical Trial Requirements; Public Workshop

Draft Guidance for Clinical Investigators, Institutional Review Boards, and Sponsors; Process for Handling Pediatric Referrals to the Food and Drug Administration: Additional Safeguards for Children in Clinical Investigations


Now Available! Cellular Therapy: A Physicians Handbook, 1st Edition

International Society for Cellular Therapy – http://www.celltherapysociety.org

AABB-ISCT Cellular Therapy Audioconference Series

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.

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