Volume 7.45 | Nov 20

Volume 7.45, November 20, 2006
     In this issue: Science | Policy | Business | NIH | CBER | Regulatory
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Top Stories

Doernbecher Children’s Hospital Team Completes First-Ever Stem Cell Transplant in Human Brain: Researchers in Doernbecher Children’s Hospital at Oregon Health & Science University will begin a Phase I clinical trial using stem cells in infants and children with a rare neurodegenerative disorder that affects infants and children.

Gene Therapy Inhibits Epilepsy in Animals: By using gene therapy to modify signaling pathways in the brain, researchers found that they could significantly reduce the development of epileptic seizures in rats.


Stem Cell Cure Hope for Diabetes
Scientists have used stem cells from human bone marrow to repair defective insulin-producing pancreatic cells responsible for diabetes in mice.

Seaweed Extract Makes Embryonic Stem Cells Safer for Injecting
Australian researchers say they have developed a treatment that provides a solution to an obstacle often cited in treating people with embryonic stem cells – the development of tumors.

Amniotic Stem Cells Offer Hope Against Congenital Heart Defects
If findings from a Swiss study prove true, in the future doctors will be able to use a simple procedure to extract stem cells from the mother’s amniotic fluid and use them to make a new heart valve, ready to place in the baby as soon as it is born.

Researchers Spur Growth of Adult Brain Stem Cells
Researchers have found a way to spur the growth of neural stem cells in the brains of adult mice with an eye toward harnessing the brain’s innate capacity for repair to help people with diseases such as Alzheimer’s.

Stem Cell Therapy Promises Hope for Muscular Dystrophy Victims
Italian scientists, by using new stem cell therapy on dogs with muscular dystrophy, have improved the dogs condition to such an extent that the dogs were able to walk and even jump again.

Adult Pig Stem Cells Show Promise in Repairing Animals’ Heart Attack Damage
Scientists have successfully grown large numbers of stem cells taken from adult pigs’ healthy heart tissue and used the cells to repair some of the tissue damage done to those organs by lab-induced heart attacks. 

Advanced BioHealing Initiates Celaderm(TM) Clinical Trial
Advanced BioHealing, Inc. has announced that it has received conditional clearance from the United States Food and Drug Administration (FDA) to begin enrolling patients in a pilot trial of Celaderm(TM), the Company’s next generation bioengineered tissue product.

Initial Trials Indicate Reduced Intensity Stem Cell Transplant Safe For Scleroderma Patients
A phase I trial of non-myeloablative or reduced intensity hematopoietic stem cell transplantation (HSCT) in patients with systemic sclerosis (scleroderma) has proven safe and well tolerated.

Enrollment Completed Utilizing Cytori’s Adipose-Derived Stem Cell Technology for Treatment of Breast Cancer Complications
Cytori Therapeutics, Inc. was informed of the completion of enrollment of the 11 patient investigator-initiated RESTORE study in Japan using adipose-derived stem cells to treat the complications of surgery and radiation damage following partial mastectomy for the treatment of breast cancer.

Bioheart, Inc. Expands Clinical Trials of Adult Myogenic Stem Cell Treatment for Heart Attack and Advanced Heart Failure Patients
Bioheart, Inc. is expanding its United States and European clinical trials of its MyoCell(TM) adult myogenic (muscle) stem cell composition and MyoCath(R) needle-injection catheter product candidates.

Pervasis Therapeutics Announces Successful Initial Safety Results of Phase I Trials of Vascugel(TM) Cell-Based Gel to Repair Arteries
The trials were designed to study the safety of Vascugel(TM) in maintaining vascular patency in patients with arteriovenous access fistulas (AVF) and arteriovenous access grafts (AVG) for dialysis treatment of end-stage renal disease (ESRD).

Dendreon Completes Submission of Biologics License Application to FDA for PROVENGE in Hormone Refractory Prostate Cancer
Dendreon Corporation has announced the final portion of the Biologics License Application (BLA) for PROVENGE(R) (sipuleucel-T) has been electronically submitted to the U.S. Food and Drug Administration (FDA), which completes its rolling submission that began in August 2006.

King’s Scientists Submit Stem Cell Research Licence Application
Scientists from King’s submitted a licence application on November 6, 2006 to the Human Fertilisation and Embryology Authority (HFEA) to allow them to fuse human cells with animal eggs.


Isolation of an Adult Blood-derived Progenitor Cell Population Capable of Differentiation into Angiogenic, Myocardial and Neural lineages
The simple and rapid method of synergetic cell population (a novel human cell population derived from the peripheral blood) and the resulting considerable quantities of lineage-specific precursor cells makes it a potential source of autologous treatment for a variety of diseases.


Election Outcome Boosts Embryonic Stem Cell Work
Missouri voters endorsed the controversial field in last week’s elections. With some $2 billion in private funding, and a team of international scientists already at work, the Stowers Institute for Medical Research now sees mostly clear sailing as it seeks stem-cell treatments for illnesses ranging from Alzheimer’s disease to multiple sclerosis.

Australia Senate Lifts Ban on Cloning
Australia’s Senate narrowly voted to end the country’s four-year ban on cloning human embryos for stem cell research, ruling that the potential for medical breakthroughs outweighed moral doubts.

German Scientists Call for Changes in Stem Cell Law
The scientists say the government must change federal laws on the production and importation of embryonic stem cells or face losing out to other countries’ research efforts.


The American Society for Apheresis Presents an Educational Webinar Series on Regulatory and Accreditation Oversight of Apheresis Programs
The American Society for Apheresis, an organization dedicated to leading the field of apheresis through patient and donor care, research, education, and advocacy, is pleased to announce a two-part educational webinar series focusing on regulatory and accreditation oversight of apheresis programs.

StemSoft Software Pleased to Release StemLab(TM) Version 3.2
This new version offers cord blood banks and cellular therapy labs many new features that ease compliance and improve the efficiency of product data management, analysis, and tracking.

Dataworks Development Launches Major Freezerworks Unlimited Upgrade
Dataworks Development, Inc. announces the release of a major new upgrade, version 3.0, to its Freezerworks Unlimited freezer inventory program.

Genzyme Completes Tender Offer for Outstanding Shares of AnorMED
Genzyme Corporation and AnorMED Inc. announced the completion of Genzyme’s tender offer to acquire all of the outstanding shares of AnorMED for $13.50 per share, or approximately $584 million.

Bio-Matrix Scientific Receives Certificate of Compliance for Class 10,000 Processing Laboratory
Bio-Matrix Scientific has completed the calibration and certification of the class 10,000 clean room and has received the ISO 14644 class 7 certificate of compliance.

$20 Million Gift to Establish Cancer Stem Cell Research Center at Stanford
The Stanford University School of Medicine has received a $20 million gift to establish a new world-class research enterprise to study cancer stem cells, which are believed to be at the heart of most cancers.

StemCellPatents.com Launches First-Ever Free Comprehensive Index of Stem Cell Related IP
StemCellPatents.com announced today the launch of a Beta Site summarizing all issued US patents in the area of stem cells, as well as their clinical applications.


Limits on Resubmission of an Application: Clarification of NIH Policy (NOT-OD-07-015)

New Limits on Appendix Materials for All NIH/AHRQ/NIOSH Grant Applications Beginning with Receipt Dates On or After January 3, 2007 (NOT-OD-07-018)

Announcing Availability of Pre-registration for the NIH Regional Seminars on Program Funding and Grants Administration (NOT-OD-07-019)


Distribution of Blood Derivatives by Registered Blood Establishments That Qualify as Health Care Entities; Prescription Drug Marketing Act of 1987; Prescription Drug Amendments of 1992; Delay of Applicability Date; Final Rule; Delay of Applicability Date

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


Therapeutic Goods Administration (Australia)

Subscribe to the ANZTPA Update Email List

Australian Manufacturers Licensed to Manufacture Therapeutic Goods 

Medicines and Healthcare Products Regulatory Agency (United Kingdom)

Field Safety Notice  – IVDs, Haematology: Software – Beckman Coulter (Beckman Instruments (UK) Ltd) – Coulter EPICS XL Flow Cytometers with EXPO 32 ADC Software

Field Safety Notice – IVDs, Haematology: Instrumentation – Beckman Coulter (Beckman Instruments (UK) Ltd) – Haematology Sample Processor (FP1000 Cell Preparation System)

Central Drug Authority (CDA) (India)

Cloning’s Out, But Stem Cell R&D Will Have Rules
Days of unregulated and unscientific stem cell research in India are numbered with government expected to issue guidelines which clearly disallow human cloning, make donor consent mandatory for embryonic stem cell research and place strict conditions on in vitro culture of human embryos. 


International Society for Cellular Therapyhttp://www.celltherapysociety.org

ISCT 13th Annual Meeting: June 24-27, 2007 in Sydney, Australia

Call for Abstracts
On-line abstract submission for the 2007 ISCT Annual Meeting is now available through the ISCT Website. 
Submission deadline: February 16, 2007

ISCT Membership
Renew your ISCT Membership for 2007 now!
Not a member?  Visit the ISCT website to learn about the benefits of membership.

AABB-ISCT Cellular Therapy Audioconference Series

Profiled Journal

Join ISCT and receive the journal as a benefit of membership.

Current Volume: Volume 8 Number 5 / November 2006

Cytotherapy publishes original research, reviews, meeting reports, special focus issues and letters in the general field of cell therapy. The scope of the journal includes basic and applied research with hematopoietic and non-hematopoietic stem cells, immune cells, and antigen-presenting cells. Therapeutic topics within the scope of Cytotherapy include ex-vivo and in-vivo aspects of gene therapy, immunotherapy, stem cell transplantation and tissue regeneration. Cytotherapy particularly welcomes contributions from researchers, clinicians, technicians and individuals involved in regulatory aspects of cell therapy.

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