Volume 7.41 | Oct 23

Volume 7.41, October 23, 2006
     In this issue: Science | Policy | Business | NIH | CBER | Regulatory
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Top Stories

Embryonic Stem Cells Capable of Becoming Insulin Producers: NovoCell has reported that they had developed a process to turn human embryonic stem cells into pancreatic cells that can produce insulin and other hormones.
Article

Human Stem Cells Delay Start Of Lou Gehrig’s Disease In Rats: Researchers at Johns Hopkins have shown that transplanting human stem cells into spinal cords of rats bred to duplicate Lou Gehrig’s disease delays the start of nerve cell damage typical of the disease and slightly prolongs life.
Article

Science

Low Oxygen Preserves Usefulness of Stem Cells
Low levels of oxygen, or hypoxia, may help preserve the unique undifferentiated nature of stem or progenitor cells.
Article

Placenta Expanded Cell Therapy Product Increases Umbilical Cord Blood Engraftment up to 500% in Bone Marrow Transplants
The Pre-Clinical results document that adding Pluristem’s PLX-I to UCB stem cells during the Bone Marrow Transplant (BMT) human cell engraftment in NOD SCID mice showed up to a 500% increased engraftment after irradiation and Chemotropic treatment.
Article

New Stem Cell Research Targets Myocardial Ischemia
University of Iowa Hospitals and Clinics leaders announced that it is one of the first medical centers in the country participating in a novel clinical trial investigating if a patient’s own stem cells can treat a form of severe coronary artery disease.
Article

Partial-match Cell Transplants For Children With Most Resistant Leukemia
St. Jude technique allows partial-match cell transplants for children with most resistant leukemia, boosting chance for cure while avoiding previous harsh forms of treatment
Article

New University of Iowa Therapy May Help Prostate Cancer Patients
A team of University of Iowa Health Care researchers has launched an important clinical trial of a novel therapeutic that may eventually lead to new treatments for men diagnosed with prostate cancer.
Article

Arteriocyte Inc. Completes Phase I Stem Cell Clinical Trial Enrollment
The study is evaluating the safety of ACY001, an adult stem cell therapy harvested from bone marrow to treat chronic ischemia, a serious form of heart disease. 
Article

Neurologix Announces Successful Completion of First Ever Phase I Gene Therapy Trial for Parkinson’s Disease
Neurologix, Inc. announced that it has successfully completed its landmark Phase I trial of gene therapy for Parkinson’s disease with statistically significant results.
Article

Osiris Therapeutics Reports Positive Phase II Results Using PROCHYMAL(TM) in Treatment-Resistant Crohn’s Disease
This outpatient stem cell treatment resulted in a statistically significant reduction in disease severity of patients who had failed to respond to standard care. 
Article

Seven Plead Guilty in New York Body-parts Scandal
Seven New York funeral directors have quietly pleaded guilty since the summer to charges that they helped a biomedical company plunder cadavers for body parts that could be sold for huge profits.
Article

ABSTRACTS, REVIEWS AND SPECIAL REPORTS

Human Neural Stem Cell Grafts Ameliorate Motor Neuron Disease in SOD-1 Transgenic Rats
The researchers found that Neural Stem Cell grafts can survive well in a neurodegenerative environment and exert powerful clinical effects and that at least a portion of these effects may be related to the ability of these grafts to express and release motor neuron growth factors delivered to host motor neurons via graft-host connections.
Abstract

Production of Pancreatic Hormone–expressing Endocrine Cells from Human Embryonic Stem Cells
The searchers have developed a differentiation process that converts human embryonic stem (hES) cells to endocrine cells capable of synthesizing the pancreatic hormones insulin, glucagon, somatostatin, pancreatic polypeptide and ghrelin.
Abstract

Policy

Stem Cell Bill Makes it to Australian Parliament
A private member’s bill clearing the way for an expansion of embryonic stem cell research was introduced to federal parliament today.
Article

Bracks to Emulate Arnie on Stem Cell Laws
Victoria will follow in the footsteps of Arnold Schwarzenegger and go it alone on stem cell research if the federal Government votes to ban therapeutic cloning.
Article

Maryland Stem Cell Panel Aims for March
After three meetings, the new Maryland Stem Cell Research Commission is on a timetable to award the first chunks of its $15 million fund to researchers in March, well after this year’s elections and more than halfway through the next legislative session.
Article

Maryland-funded Stem Cell Lines Must be Shared
Scientists receiving state grants to conduct stem cell research will be required to share any stem cell lines developed using Maryland public funds with other scientists – a requirement that may deter private biotech firms looking to make a profit off new stem cell lines from applying for state research money.
Article

New Jersey Panel OKs $270M for Stem Cell Work
The state would invest $270 million in stem cell research under legislation advanced Thursday by an Assembly committee.
Article

US Government To Fund Umbilical Cord Banks
The federal government is moving aggressively to create the first national banking system for umbilical cord blood.
Article

Business

Malachite Management Inc. Launches Apheresis News, An E-Newsletter and Website Portal for the Apheresis Community
Malachite Management Inc. is pleased to announce the launch of Apheresis News, a digital publication that is dedicated to the field of apheresis and is endorsed by the American Society for Apheresis.
Article

Amorcyte Secures Additional Funding to Expand Clinical Program in Cardiovascular Cell Therapy
Amorcyte, Inc., a privately funded biotechnology company developing cell therapy products to treat cardiovascular disease, has secured additional funding to complete its first Phase I trial and pursue additional cell therapy opportunities for cardiac and vascular diseases.
Article

Major Stem Cell Patent Granted in United States
The patent ensures that only Mesoblast and its United States-based sister company, Angioblast Systems Inc, can commercialise the proprietary adult stem cells, termed Mesenchymal Precursor Cells, in the USA, the world’s largest market for regenerative medicines.
Article

ACell Wins Again in Federal Appeals Court
ACell, Inc., the owner of highly valued extracellular matrix (ECM) patents, along with co-defendants Dr. Stephen Badylak and Dr. Alan Spievack, today won another legal victory against Cook Biotech, Inc. (Cook) and Purdue Research Foundation (Purdue) when the Court of Appeals for the Federal Circuit denied Cook’s and Purdue’s Petition for Rehearing and Rehearing En Banc.
Article

Living Cell Technologies Granted Diabetes Patent Across the EU
Living Cell Technologies has received confirmation of the decision by the European Patent Office to grant LCT an EU patent relating to its porcine pancreatic islet cell product for type 1 diabetes.
Article

Was Stem Cell Advance ‘Obvious’?
The U.S. Patent and Trademark Office’s review of three patents held by the Wisconsin Alumni Research Foundation will ask if Thomson’s accomplishment in 1998 was "obvious" because other scientists had done similar work in species such as mice and pigs.
Article

Biotech Firms See Big Danger in Patent Regulation Changes
The proposal to limit a key portion of the patent application process, aimed at reducing the patent office’s backlog of more than 700,000 cases by limiting continuations, could go into effect before the end of the year and has raised the ire of biotech and agri-technology companies.
Article

Pluristem Upgrades Manufacturing Facilities to Enable Production of First Biological Product for Phase I Clinical Trials
The manufacturing facilities include thirteen units of 7000 square feet total and include five clean room units of 3000 square feet total. Upon FDA approval, the facilities could support production and shipping of up to 50 doses of PLX-I per day worth more than $500,000.
Article

NIH

Announcing Electronic Grant Submission Training Opportunity (NOT-OD-07-009)
Link

Delays in Grant Application Submission Due to Earthquake in Hawaii (NOT-OD-07-010)
Link

CBER

Guidance for Industry: Biological Product Deviation Reporting for Licensed Manufacturers of Biological Products Other than Blood and Blood Components
Link

Guidance for Industry: Biological Product Deviation Reporting for Blood and Plasma Establishments
Link

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

Regulatory

Food and Drug Administration (United States of America)

Debarment Orders: Butkovitz, Anne L
Link

Therapeutic Goods Administration (Australia)

Therapeutic Goods Administration and Biologics and Genetic Therapies Directorate (BGTD) of Health Canada – Parallel Review Project
Link

Australian Manufacturers Licensed to Manufacture Therapeutic Goods
Link

Australia New Zealand Therapeutic Products Authority (Australia and New Zealand)

Second Phase of ANZTPA Consultation Documents Released
Link

Ministry of Health and Family Welfare (India)

Indian Government May License Stem Cell Research
Private stem cell companies will soon have to apply for licences under the Drugs and Cosmetics Act as India plans to join a handful of countries regulating stem cells.
Article

ISCT

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

AABB-ISCT Cellular Therapy Audioconference Series
Link

Profiled Journal

Editor-in-Chief:
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:

ASFA Head Office
570 West 7th Ave, Suite 402
Vancouver, BC V5Z IB3, Canada
T 604-484-2851
F 604-874-4378
E [email protected]
www.apheresis.org

Please visit the website for all you need to know about publishing in or subscribing to the Journal of Clinical Apheresis:
http://www.interscience.wiley.com/journal/jca



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