Volume 6.40 | Oct 3

Volume 6.40, October 3, 2005
     In this issue: Science | Policy | Business | NIH | CBER | Regulatory
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Cell Therapy News Launches New Website Portal: Cell Therapy News is pleased to announce the launch of a new website portal in combination with a redesign of its weekly digital e-newsletter.

NHLBI Funds New Centers for Cell-Based Therapy: The National Heart, Lung, and Blood Institute (NHLBI) of the National Institutes of Health has awarded the first three grants in a new research program on cell-based therapy of heart, lung, and blood diseases.


New Marrow Transplant Method Developed at Standford May Eliminate Fatal Side Effects
Researchers at the Stanford University School of Medicine have developed a technique that can virtually eliminate this life-threatening complication, known as graft-versus-host disease, without compromising the transplanted cells’ effectiveness against cancer.

Transplanted Insulin-producing Cells Survive Better when the Activation of NKT Cells are Blocked
Scientists in Japan have found a way to improve on a promising diabetes treatment. In the October 3 issue of The Journal of Experimental Medicine, Masaru Taniguchi and colleagues report that transplanted insulin-producing cells survive better when the activation of a specific type of immune cell is blocked.

Hope for Type 1 Diabetes Breakthrough
A team from Rosalind Franklin University of Medicine and Science have described a “reversibly immortalized” cell line that can supply large amounts of insulin-producing human beta-cells.

Adult Stem Cells Aid Recovery in Animal Model of Cerebral Palsy
Adult stem cell therapy quickly and significantly improves recovery of motor function in an animal model for the ischemic brain injury that occurs in about 10 percent of babies with cerebral palsy, researchers report.

First Patients in Parkinson’s Gene Therapy Doing Well
A New Zealand-developed gene therapy for Parkinson’s disease has produced significant improvements in motor function and significant decreases in abnormal brain metabolism, according to an early study.
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First-Ever Gene Therapy Success for Muscular Dystrophy Achieved Using Mini-Gene, New Systematic Approach
Pitt researchers have reported the first study to achieve success with gene therapy for the treatment of congenital muscular dystrophy (CMD) in mice, demonstrating that the formidable scientific challenges that have cast doubt on gene therapy ever being feasible for children with muscular dystrophy can be overcome.

Gene Therapy to Lower Blood Pressure Just Enough
A newly developed virus that introduces a blood pressure-lowering gene into cells and enables that gene to maintain blood pressure at healthy levels for four months promises to take gene therapy for the disorder a step closer to reality, said researchers at Baylor College of Medicine in a report released online in the Proceedings of the National Academy of Sciences.

Going Bald: Worry Not as Hair Raising Gene Therapy is in the Offing
Researchers from the Kennedy Krieger Research Institute and Johns Hopkins University believe that balding could be reversed by genetic manipulations in the hair cells and have published their study on mice in the Proceedings of the National Academy of Sciences.

Stem Cells Help Regenerate Cartilage and Bone
UK scientists are working on new methods to regenerate cartilage and bone by delivering genes to stem cells within the body to instruct them to turn into bone cells.

Discarded Placentas Could Provide Source of Therapeutic Stem Cells
Routinely discarded as medical waste, placental tissue could feasibly provide an abundant source of cells with the same potential to treat diseases and regenerate tissues as their more controversial counterparts, embryonic stem cells, suggests a Pitt study published in the journal Stem Cells.

Modified Collagen Could Could Help Deliver Drugs And Shape The Growth Of Engineered Tissue
Collagen often pops up in beauty products and supermodel lips. But by mating collagen with a molecular hitchhiker, materials scientists at Johns Hopkins hope to create some important medical advances.

Colostrinin Increases Cell Lifespan
The colostrum-based product increased the lifespan of cells isolated from mice predisposed to premature ageing and therefore, death, researchers will report today at the 21st International Conference of Alzheimer’s Disease International taking place in Istanbul.

Kidney Transplant Patients Face Higher Cancer Risk
People who receive a kidney transplant are nearly four times more likely to develop melanoma, a rare but deadly form of skin cancer, according to a study in the November 1, 2005 issue of CANCER, a peer-reviewed journal of the American Cancer Society.

Intermediate Doses of Interferon Do Not Reduce Recurrences in Early Melanoma
According to a recent article published in The Lancet, intermediate doses of interferon administered over a short interval do not appear to improve survival over no treatment in patients with stages IIB or III melanoma.

Engineered Molecule Amplifies Body’s Immune Response
By altering a molecule called Stat1, which is involved in cellular immune signaling, scientists have succeeded in making the molecule more responsive and thus more efficient. This old protein with a new twist may eventually be used to improve the body’s defense against infection.

Second Human Cloning Failure for Controversial Fertility Expert
Speaking at a press conference in London, Dr Zavos said the latest procedure took place in a Middle Eastern country, which he refused to identify. He would not reveal the identity and nationality of the woman, either.

John Hopkins to Study How Stem Cells Could Help Hearts
The Johns Hopkins Heart Institute announced Thursday it will receive more than $12 million in federal research funding over five years to study how stem cell therapy can aid damaged hearts.

Madison to Store US’s Stem Cells
UW Madison will be home to the nation’s first bank of embryonic stem cells.


Recovery of Stem Cells from Cryopreserved Periodontal Ligament
The present study demonstrates that human post-natal stem cells can be recovered from cryopreserved human periodontal ligament, thereby providing a practical clinical approach for the utilization of frozen tissues for stem cell isolation.

Side Population Cells Derived from Adult Human Liver Generate Hepatocyte-like Cells In Vitro
We conclude that hepatic SP cells derived from the nonparenchymal portion of human liver are a potential source of human hepatocytes irrespective of their CD45 status, and further animal studies will be required to assess their regenerative potential.

Successful Nonmyeloablative Cord Blood Transplantation for an Infant with Malignant Infantile Osteopetrosis
Because of the urgent need, CBT can be considered as one of the SCT sources for MIOP, especially in a severe, life-threatening setting.

Cardiac Neural Crest Cells Contribute to the Dormant Multipotent Stem Cell in the Mammalian Heart
These results suggest that cardiac neural crest-derived cells migrate into the heart, remain there as dormant multipotent stem cells-and under the right conditions-differentiate into cardiomyocytes and typical neural crest-derived cells, including neurons, glia, and smooth muscle.

Innate Anti-breast Cancer Immunity of Apoptosis-resistant Human Gammadelta-T cells
As apoptosis-resistant human gammadelta-T cells can now readily be expanded to large numbers (clinical scale), these findings must be considered in the context of developing adoptive immunotherapy strategies to exploit gammadelta-T cell innate immune responses for the primary or adjuvant treatment of breast cancer.


Minnesota Invests $2 million in Company that Researches Stem Cells
Jamie Thomson, who founded the company earlier this year with two University of Wisconsin-Madison colleagues and a venture capital firm, flatly predicted Monday it would become the first to profit from human embryonic stem cell research.

Illinois Offers up Jobs to Lure Missouri Stem Cell Scientists
Fifty Missouri scientists and institutions, including several Washington University researchers, received a letter from Illinois Gov. Rod Blagojevich in late August encouraging them to “explore the possibility of moving to Illinois and the promise of stem cell research.”


Stem Cell Therapeutics Corp. and Medicon A/S Sign Contract to Perform Phase I Clinical Study
The contract encompasses submission of SCT’s Phase I clinical trial protocol, screening,conduct and reporting of trial results. This agreement follows the successful clinical trial feasibility assessment and positive regulatory response that Medicon and SCT have achieved to date.

Chemicon International Announces Agreement with Axordia for Exclusive Co-Development of Human Embryonic Stem Cell Antibody Markers
Serologicals Corporation (NASDAQ: SERO) announced today that Chemicon International, Inc., its wholly-owned subsidiary, and Axordia Ltd. have signed an exclusive agreement to co-develop new antibody markers from Axordia’s proprietary human embryonic stem (ES) cell lines.

Pervasis Therapeutics Closes $12 Million Series B Financing; Cell Therapy Company Developing Next-Generation Combination Treatments
Pervasis Therapeutics, Inc., a biotechnology company founded to develop the next generation of medical therapies that integrate biomaterials with cells and drugs, today announced that it has secured $12 million in Series B financing.

Building a Better Stem Cell
Cellerant Therapeutics Inc., which has developed a means for purifying stem cells removed from the blood, plans to begin clinical trials of its therapy for sickle cell disease early next year.

Agency Takes a Preliminary Step to Revoke a Genentech Patent
The Patent and Trademark Office has taken a step toward revoking a Genentech patent that was expected to bring hundreds of millions of dollars in royalties each year until 2018.

Cytori Therapeutics Demonstrates Human Adipose-Derived Adult Stem Cells Have the Potential to Differentiate into Spinal Disc
“Our research demonstrates the potential for using human adipose-derived stem cells in treating patients with degenerative disc disease,” stated Christopher J. Calhoun, Chief Executive Officer for Cytori Therapeutics. “We are encouraged by these early findings and have initiated preclinical animal studies to further evaluate the effect of these cells, in vivo, on injured discs.”

Bioheart, Inc. Completes $15 Million Private Placement
The private placement was oversubscribed by $4 million due to additional investor interest, bringing the total amount raised in the round to $19 million.

GenVec Completes $15.2 Million Financing
GenVec, Inc. (Nasdaq:GNVC) today announced that it has closed its previously announced registered direct offering of common stock.

RenaMed Biologics And Genzyme Corporation (GENZ) Announce Worldwide Collaboration To Advance Investigational Treatment For Acute Renal Failure
The product utilizes physiologically active renal epithelial cells, administered ex vivo in a hollow-fiber cartridge, intended to treat a sudden loss of kidney function with the ultimate goal of improving survival rate.

SAFC Biosciences and Chromos Announce Strategic Alliance to Co-Market ACE System
SAFC Biosciences, a member of the Sigma-Aldrich Group (Nasdaq: SIAL), and Chromos Molecular Systems Inc. (“Chromos”; TSX:CHR), have entered into a non-exclusive co-marketing arrangement whereby SAFC Biosciences and Chromos will jointly market and offer Chromos’ proprietary ACE System for cell line engineering for protein production applications.

Sirna Therapeutics Granted Broad Patent Covering RNAi-Mediated Inhibition of Gene Expression
The patent claims, which are not limited to a specific siRNA sequence or structure, broadly cover any siRNA molecule which targets conserved sequences within a virus or a gene.

StemCells, Inc. Moves to Nasdaq National Market
StemCells, Inc. (NASDAQ: STEM) today announced that the Nasdaq Stock Market has approved its application to transfer the listing of its common stock to the National Market from the Capital Market. The Company’s stock will continue to trade under its current symbol, STEM.

Pluristem Life Systems Inc. Board Appoints Zami Aberman As Chief Executive Officer
Pluristem Life Systems, Inc. (OTC BB:PLRS), a biotechnology company dedicated to the expansion of stem cells from umbilical cord blood to address a myriad of fatal illnesses, today announced that the Board of Directors appointed Zami Aberman as Chief Executive Officer. Shai Meretzki will resume his position as Chief Technology Officer.


NIH Guide for Grants and Contracts – Week Of September 30, 2005

NIH Awards a National Stem Cell Bank and New Centers of Excellence in Translational Human Stem Cell Research
National Institutes of Health (NIH) Director, Elias A. Zerhouni, M.D., announced today that the NIH has awarded $16.1 million over four years to fund a National Stem Cell Bank and $9.6 million to fund two new Centers of Excellence in Translational Human Stem Cell Research for four years.

2005 NIH Director’s Pioneer Award Recipients Announced
The 2005 awardees work in diverse areas, including neuroscience, genetics, epidemiology, chemistry, stem cell biology, behavioral science, infectious diseases, and technology development.

Bioengineering Nanotechnology Initiative (SBIR/STTR) Program Announcement


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

Implementation of 21 CFR Part – 1271 Martha A. Wells, MPH, Division of Human Tissues, CBER, AATB Annual Meeting

Update on Donor Screening for TSEs Melissa A. Greenwald, MD, Division of Human Tissues, Office of Cellular, Tissue and Gene Therapies AATB 29th Annual Meeting

Draft Guidance for Industry and FDA Review Staff: Collection of Platelets by Automated Methods

ICH; Guidance for Industry: E2B(R) Clinical Safety Data Management:Data Elements for Transmission of Individual Case Safety Reports

Exceptions and Alternative Procedures Approved Under 21 CFR 640.120- Update



Besieged FDA Chief Abruptly Resigns
Lester Crawford, the embattled head of the Food and Drug Administration, abruptly resigned Friday, telling his staff that at age 67 it was time to step aside.

International Conference on Harmonisation Workshop on Oncolytic Viruses; Public Workshop


2005 Cell Therapy Audioconference Series

Profiled Journal

Join ISCT($130) and receive the journal as a benefit of membership.

Cytotherapy now incorporates “Cytokines, Cellular & Molecular Theory”.

Cytotherapy/Telegraft Advertising Offer
Cytotherapy- the official journal of the International Society for Cellular Therapy (6x annually) – and Telegraft –ISCT’s global cell therapy newsletter (4 x annually) – are offering an integrated advertisement rates package enabling even more effective coverage of your products, services and recruitment vacancies to the industry at large. The combined reach is impressive, comprising as it does your target audience core.

Here’s how the deal works:

Display advertising / print: book an advertisement, any size, in both publications and we will apply a full 30% discount off the combined ratecard price. Plus, we’ll allow any earned volume discount too!

Recruitment advertising / online: postings on the ISCT website are $1,000 for 2 months. But we’ll reduce that by 50% to $500 only if the posting is taken in addition to a print advertisement in Telegraft or Cytotherapy. ISCT web site receives over 125,000 hits per months, guaranteeing your posting industry wide exposure.

All we ask is that you make your first insertion before the end of 2005 but we’ll be pleased to extend this deal with full rate protection into 2006 on anything booked before December 31st 2005. For more information and advertising rates, click here.

Current Volume:
Volume 7, Number 4 / September 2005

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.