Volume 8.18 | May 14

Volume 8.18, May 14, 2007
     In this issue: Science | Policy | Business | NIH | CBER | Regulatory
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Top Stories

Dendreon Receives Complete Response Letter from FDA For Provenge(R) Biologics License Application: Dendreon Corporation has announced that it received a Complete Response Letter on May 8, 2007 from the U.S. Food and Drug Administration regarding its Biologics License Application for PROVENGE (sipuleucel-T) for the treatment of asymptomatic, metastatic, androgen-independent prostate cancer.

Precursor Cells Generated From Human Embryonic Stem Cells Show Ability to Repair Vascular Damage in Animals: New, scalable population of hemangioblast cells halves the death rate following heart attack and repairs ischemic limbs and damaged vasculature.


Cryo-Cell Isolates Maternal Stem Cell With New Therapeutic Potential for Advancing Women’s Healthcare
Researchers at Cryo-Cell International Inc. have isolated a new type of adult stem cell with potential for treating a broad range of diseases in the future. The stem cell, called a maternal placental stem cell, is taken from the discarded placental tissue immediately after childbirth and is maternal in origin.

Students Invent Protective Pouch to Enhance Cell Therapy
Johns Hopkins undergraduates have invented a device to improve cell therapy for diabetes patients by anchoring transplanted insulin-producing cells inside a major blood vessel.

Master Regulatory Gene of Epithelial Stem Cells Identified
This master regulator of epithelial stem cells turns out to be the p63 gene, a close relative to the well-known tumor-suppressing p53 gene. Without p63, mutant mice run out of the regenerative epithelial stem cells.

New Technique Dissects Stem Cells’ Picky Likes, Dislikes
Researchers have described a system that can quickly and systemically screen hundreds of individual molecules for their ability to influence stem cell fates.

Clinical Study Finds BioE’s PrepaCyte-CB Significantly Improves Cell Recoveries from Cord Blood
BioE(R), Inc. has announced its PrepaCyte(TR)-CB Umbilical Cord Blood Processing System significantly improves the recovery of therapeutically important total nucleated cells and white blood cells from human umbilical cord blood when compared to traditional hetastarch-based cord blood processing methods, according to the results of a multi-site, comparative, in-vitro clinical study.

Grant Awarded for Stem Cell Therapy
The Queensland government is getting behind a project aimed at easing the development of stem cell therapies through the use of synthetic materials.

The Stem Cells That Weren’t There: Surprising Finding May Lead To New Diabetes Treatments
Diabetes researchers, investigating how the body supplies itself with insulin, discovered to their surprise that adult stem cells, which they expected to play a crucial role in the process, were nowhere to be found.

Tissue Engineered Scaffolding Allows Reproduction Of Cartilage Tissue
A new study examines the use of tissue-engineered scaffolding made of cartilage cells, which have a limited ability to heal naturally, to replace defective cartilage tissue.

Columbia Researchers Repair Heart Damage in Mice By Activating Gene to Make Adult Heart Stem Cells Regenerate
Adult heart cells usually lack the ability to regenerate, preventing the heart from repairing itself after a heart attack. But in a recent study, Columbia researchers have successfully turned on a gene in adult mice that makes stem cells in the heart divide and allows them to repair potentially deadly heart damage.

CureDuchenne Funds Dr. Giulio Cossu’s Adult Stem Cell Study
CureDuchenne will sponsor a one-year research program that will validate Dr. Giulio Cossu’s stem cell research under GMP conditions. Dr. Cossu’s long-term objective is to conduct phase I/II clinical trials in Duchenne muscular dystrophy pediatric patients with this novel cell therapy protocol based on intra-arterial delivery of donor mesoangioblasts.

Embryonic Stem Cells Trial on Track to Start
The first clinical trial of embryonic stem cells is on track to start early next year on patients with spinal cord injury. Geron will carry out the study on accident victims in six trauma centres across the US.

Surgeons Hail Bone Stem Cell Breakthrough
Fifteen patients have so-far been treated in a ground-breaking clinical trial at the Robert Jones and Agnes Hunt Orthopaedic Hospital in Oswestry.

Amorcyte Cardiac Cell Therapy Trial Completes Second of Four Phases
Amorcyte, Inc. has announced the completion of the second of four dose cohorts in its phase I clinical trial.

Experts to Train Immune Cells to Kill Nose Cancer
Scientists in Hong Kong and Australia will soon test an experimental treatment for nose and throat cancer which “trains” the patient’s own white blood cells to fight the disease.

Phase I Trial for ImmunoCellular Therapeutics Brain Tumor Vaccine Commences
The vaccine trial, which is being conducted at the newly dedicated Johnny L. Cochran, Jr. Brain Tumor Center at Cedars-Sinai Medical Center in Los Angeles, is designed to evaluate safety/toxicity, feasibility and biological activity.

Cell Genesys Provides Update On Clinical Program For GVAX Immunotherapy For Leukemia
Cell Genesys, Inc. has reported that three new clinical trials for GVAX immunotherapy for leukemia are now under way. The new trials are based on encouraging results in an initial Phase 2 study of the product in patients with chronic myelogenous leukemia.


Generating Neuron-like Cells from BM-derived Mesenchymal Stromal Cells In Vitro
The researchers investigated the efficacy of different growth factors in inducing MSC differentiation into neurons.

Generation of Functional Hemangioblasts from Human Embryonic Stem Cells
The researchers describe an efficient and reproducible method for generating large numbers of bipotential progenitors—known as hemangioblasts—from human embryonic stem (hES) cells using an in vitro differentiation system. Injection of the cells also reduced the mortality rate after myocardial infarction and restored blood flow in hind limb ischemia in mouse models.


The Student Society for Stem Cell Research (SSSCR)
SSSCR is an international network dedicated to advancing scientific research for cures. Our network spans over 15 countries, 100 institutions, and 35 U.S. states. Our network includes students, professionals, and patient advocates. We are a special project of the Genetics Policy Institute and a member of the Coalition for the Advancement of Medical Research. Get plugged-in and be a part of the future of stem cell research. Join today, http://www.ssscr.org/main/join_now.

Massachusetts Proposes Stem Cell Research Grants
Governor Deval Patrick on Tuesday unveiled a $1.25 billion proposal intended to help the state maintain its status as a pre-eminent place for stem cell research and other life sciences.

Responsible Oversight of Human Stem Cell Research: The California Institute for Regenerative Medicine’s Medical and Ethical Standards
California voters recently approved $3 billion over 10 years for public funding of stem cell research through the California Institute for Regenerative Medicine (CIRM). Geoffrey Lomax and colleagues discuss the principles that guided the CIRM regulations.

House Committee Passes Stem Cell Bill
A bill regulating embryonic stem cell research in Delaware will get a chance at full House support this year when it reaches the House floor for debate.


Odds High, Funds Sparse for Stem Cell Researchers
Neither the federal government nor private investors provide much support and small firms with limited funding are struggling to figure out how to harness stem cells’ extraordinary power.

Cord Blood Banking Called ‘Biological Insurance’ – But is it Worth the Cost?
Many experts believe that some in the industry are playing fast and loose with parental fears in order to sell pricey biological insurance that only an estimated one in 20,000 children would ever need.

Dendreon Drug Delayed; Layoffs May be Coming
Seattle-based Dendreon could face layoffs now that the approval of its prostate-cancer drug has been delayed for as long as three years.

Invitrogen Partners with Cytori to Offer Adipose Stem Cell Research Products
Invitrogen will offer Cytori’s stem cell products to broaden the understanding of adult stem cells and to discover and accelerate development of preclinical applications for adipose derived stem cells.

Stem Cell Innovations Signs Compound Validation Collaboration with H. Lundbeck A/S
Stem Cell Innovations, Inc. has announced that it had entered into an agreement to examine hepatic metabolism of a set of Lundbeck compounds using its proprietary C3A human liver cell-line.

BioLife Solutions Announces HypoThermosol Supply and License Agreement With Intercytex
Terms of the 10-year agreement include an intellectual property escrow provision which guarantees Intercytex access under certain conditions to BioLife’s HypoThermosol storage and preservation media when used in the production of Intercytex’ VAVELTA, a facial rejuvenation product and ICX-TRC, a hair regeneration product, as well as annual license fees payable to BioLife.

NovaThera and Gamida Cell Announce a Collaboration Agreement to Develop Cell Therapeutics for Lung Disease
Under the terms of the agreement, NovaThera and Gamida Cell will pool technology and expertise and work together with the clinical team at Papworth Hospital in the U.K. towards advancing cell therapy approaches for treating lung disease.

Spa Joins Stem Cell Line
A township medical spa that specializes in skin care and anti-aging programs is now collecting and storing adult stem cells through a new procedure used in only two other clinics nationwide.

Dundee Joins £9.5M Stem Cell Research Collaboration Programme
ITI Life Sciences is very pleased to announce that it has reached its first technical milestone in its Stem Cell Technologies R&D programme, and as a result Dundee University has joined the £9.5 million programme, which started in January 2007.

Q Therapeutics Announces New Stem Cell Patent
Q Therapeutics, Inc. has announced that it was awarded Patent Number 7,214,372, titled “Methods Using Lineage Restricted Glial Precursors from the Central Nervous System,” by the United States Patent and Trademark Office.


Clarification on Page Limits and Budget Submissions for Bioengineering Research Partnerships (PAR-07-352)


2007 Biological Approvals – Update

Approved Biological NDA and ANDA Applications – Update

Licensed Products and Establishments List – Update

SOPP 8101.1: Scheduling and Conduct of Regulatory Review Meetings with Sponsors and Applicants – Update

SOPP 8104: Documentation of Telephone Contacts with Regulated Industry – Update

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


FOOD AND DRUG ADMINISTRATION (Untited States of America)

Vaccines and Related Biological Products Advisory Committee; Amendment of Notice

Draft Guidance for Industry on Protecting the Rights, Safety, and Welfare of Study Subjects – Supervisory Responsibilities of Investigators; Availability

Guidance for Industry: Computerized Systems Used in Clinical Investigations


Consultation Paper: The Regulation of Human Cellular and Tissue Therapies (HCTs)


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Profiled Journal

Senior Editor:
John Barrett, MD, FRCP, FRCPath
National Institutes of Health Bethesda, MD, USA

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