Volume 8.41 | Oct 22

Volume 8.41, October 22, 2007
     In this issue: Science | Policy | Business | NIH | CBER | Regulatory
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Top Stories

Osiris Therapeutics Receives FDA Clearance to Initiate Phase III Pivotal Trial for Prochymal(TM) as a First Line Treatment for Acute Graft vs. Host Disease: Strong data from a Phase II trial supports remission and survival endpoints in life threatening condition.


Quantum Dot Imaging Could Benefit Embryonic Stem Cell Therapy
have now used QDs for in vivo imaging of embryonic stem cells in mice.

The Inkjet Approach to Building Life
If you print over and over on a single piece of paper, the ink layers will eventually build up a three-dimensional structure. What if, scientists are asking, you use that same inkjet technology to print layers of cells on a tissue matrix? Can you eventually build up a living structure like a heart or a kidney?

Herpes Virus Can Be Used As Nanomachines For Cancer Treatment
Researchers at the LSU School of Veterinary Medicine are using the virus to potentially fight breast cancer.

Gene Therapy Breakthrough at Penn
Ina Dobrinski, associate professor and the director of the Center for Animal Transgenesis and Germ Cell Research, led the study, which used a harmless gene therapy process to transfer a genetic modification to male reproductive cells of mice and goats. The virus then was passed on naturally to offspring.

Biotech Patch Offers No-risk Birth Control
The fresh approach to contraception will use a revolutionary technique for switching off genes to disable eggs without affecting future fertility or any other body systems.

Independent Study by Fraunhofer Institute in Germany, Using Pluristem’s PLX Cells, Shows Promise in the Treatment of Ischemic Stroke
Fraunhofer Institute’s scientists systemically injected PLX cells into spontaneously hypertensive rats that had undergone middle cerebral artery occlusion, a commonly accepted ischemic stroke model. At the current stage, this animal trial shows a significant advantage in functional recovery over a control group that did not receive PLX cells.

Stem Cell Growth ‘May Help Hip Replacements’
British scientists are to test a promising way to harvest a patient’s stem cells in the hope it can boost the success rate of “revision hip replacements”.

Alnylam and Collaborators Publish New Pre-clinical Results on RNAi Therapeutics for the Treatment of Huntington’s Disease
New findings demonstrate potent and durable therapeutic silencing of the gene responsible for Huntington’s Disease.

Muscular Dystrophy Trial to Start
A gene therapy trial for the fatal disorder Duchenne muscular dystrophy is about to begin in London.

Aastrom Stem Cell Therapy Demonstrates Positive Results in Severe Long Bone Non-Union Fracture Trial
Phase I/II study results presented at the Orthopaedic Trauma Association Annual Meeting show a healing rate of 91 percent in patients with non-union tibia, humerus or femur fractures who failed to heal after one or more medical procedures.

OMRIX Biopharmaceuticals Announces Positive Phase I Results with Fibrin Patch
OMRIX Biopharmaceuticals, Inc. has announced the results of its prospective, open label, Phase I study of its novel Fibrin Patch. The results show that the Fibrin Patch appears to be safe as an adjunct to hemostasis.

Stem Cell Therapy Gives Dogs a New Leash on Life
Man’s best friend is benefiting from stem-cell therapy. Procedures that began experimentally with horses four years ago were expanded to dogs and cats in May.

Swarthmore College Students Use Mice Stem Cells in New Biology Class Course Believed to Be Only One of Its Kind in Country
In a new biology class at Swarthmore College this fall, students are able to conduct research using embryonic stem cells from mice. Taught by Visiting Assistant Professor of Biology William Anderson, “Stem Cells and Cloning” is believed to be the first and only course of its kind in the country.


Preparing Clinical Grade Ag-specific T Cells for Adoptive Immunotherapy Trials
In this review we address salient issues related to the technical, immunologic, practical and regulatory aspects of manufacturing these advanced T-cell products for clinical use.

Has Stem Cell Transplantation Come of Age in the Treatment of Sickle Cell Disease?
Currently, hematopoietic SCT is the only intervention that can restore normal hematopoiesis to provide a ‘cure’ in sickle cell disease. Yet, this treatment modality is used sparsely.


Cell Therapeutics Supervisor
Philadelphia, PA (AppTec)

Postdoc Fellow
Sweden (Wallenberg Neuro Center Neuronal Survival Unit)

Manager, Manufacturing
Memphis, TN (Cognate Bioservices)


Going Against Bush, NIH Director Urges Expanded Stem Cell Research
National Institutes of Health Director Elias A. Zerhouni suggests that embryonic stem cell research should be expanded.

Senate Democrats Drop Plan to Challenge Stem Cell Restrictions
Senate Democrats, yielding to a veto threat, have dropped provisions from a spending bill that would have loosened President George W. Bush’s restrictions on embryonic stem-cell research.

Planned Stem Cell Referendum Up in Air
A proposed November 6 public referendum on a $450 million stem-cell research program could be in jeopardy after a state appeals court agreed to hear a lawsuit challenging it.

New Head of Stem Cell Agency Not Affected by Tainted Research
A Melbourne laboratory headed by Alan Trounson, the acclaimed researcher tapped to run California’s $3 billion stem cell agency, is embroiled in an investigation of alleged irregularities in a government-funded experiment, according to news accounts in Australia.

China to Continue Actively Developing Stem Cell Research, GM Crops
China will pay close attention to ethical issues as it continues to support stem cell research and the development of GM crops, a senior official from the Ministry of Science and Technology said.


NeoStem Announces Multi-Territory Development Agreement With Stem Cell Collect, LLC to Accelerate Growth of Nationwide Collection Center Network
Stem Cell Collect has purchased the right to open six adult stem cell collection facilities with an option to develop significantly more territories. According to the agreement, Stem Cell Collect is entitled to begin by expanding the NeoStem network throughout most of California and to launch the Colorado market.

NeoStem Announces Agreement with ProHEALTH to Open Adult Stem Cell Collection Center in the New York Metropolitan Area
ProHEALTH, one of the largest and most prominent multi specialty practices in the New York metropolitan area, has over 100 providers in its network and provides care for over 250,000 patients in one of the most populous and affluent markets in the nation.

Merck & Co., Inc. Licenses SNALP Technology from Protiva
Under the terms of the broader agreement Protiva will receive a one-time payment from Merck with the potential for milestone and royalty payments based upon the developmental progress of future RNAi-based product candidates.

Immunomedics’ Cancer Therapy Gets Patent
Immunomedics Inc. said Tuesday the biopharmaceutical company received a patent for its product candidate hPAM4 to treat pancreatic cancer, sending its stock sharply higher.

National Stem Cell Holding Announces Patent Application for Newly Discovered Cellular Derived Biomaterials for Anti-Aging Applications
National Stem Cell Holding, Inc. today announced the filing of a provisional patent application for a newly discovered group of biomaterials, derived from the company’s stem cell and progenitor cell lines, that may stimulate a variety of naturally occurring physiological mechanisms that are involved with the skins ability to preserve and repair itself .

IVF ‘Cell Bank’ Plan Criticised 
A US firm’s controversial proposition to store stem cells from spare IVF embryos has angered UK scientists. 


New Features in eRA Commons (NOT-OD-08-007)

Continued Development and Maintenance of Software (R01) (PAR-08-010)


Applications for Food and Drug Administration Application Approval to Market a New Drug; Revision of Postmarketing Reporting Requirements; Final Rule

ISCT 7th Annual Somatic Cell Therapy Symposium – Slide Presentation



Training Program for Regulatory Project Managers; Information Available to Industry

Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Guidance for Industry on Special Protocol Assessment

Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Information Program on Clinical Trials for Serious or Life-Threatening Diseases: Maintaining a Data Bank


Good Clinical Practice (GCP) in Today’s Changing Environment



In response to increasing calls for smaller, more regionalized meetings, ISCT is pleased to announce the launch of its first Regional Meeting.

Date: November 2-4, 2007
Location: Texas Children’s Hospital  The Feigin Center  Houston, TX
Target Audience: Laboratory practitioners and technicians working in cellular therapy laboratories
Learning Objectives:
To provide an overview of the biology of cellular therapy 
To provide education on cell processing laboratory procedures and issues

Click here for more information, including program, speakers, accommodation and registration. 

Space is limited! Register now!

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