Volume 8.40 | Oct 15

Volume 8.40, October 15, 2007
     In this issue: Science | Policy | Business | NIH | CBER | Regulatory
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Top Stories

Mice Gene Trio Win Medicine Nobel Prize: US citizens Mario R. Capecchi and Oliver Smithies and Sir Martin J. Evans of Britain won the 2007 Nobel Prize in medicine on Monday for groundbreaking discoveries that led to a technique for manipulating mouse genes.


7th International Stem Cell Conference, Oct. 29-30, Pittsburgh, PA
The conference features top level keynotes and the latest research updates plus structured sessions facilitating networking with the FDA, NIH and leading researchers from: Wake Forest University, San-Bio, Athersys Inc., Fred Hutchinson Cancer Research Center, Progenitor Cell Therapy, OncoMed, Neuro Generation, Novocell Inc., Merck, and Genzyme Inc.
To register visit www.almevents.com/stemcell or phone 1-800-599-4950.

Stomach Stem Cell Discovery Could Bring Cancer Insights
A group of University of Michigan Medical School researchers has succeeded in finding and manipulating a population of cells that strongly resemble stem cells in the stomachs of mice.

Study Reveals How Stem Cells Decide To Become Either Skeletal or Smooth Muscle
The results not only provide insight into the development of muscle types in the human fetus, but also suggest new ways to treat atherosclerosis and cancer, diseases that involve the creation of new blood vessels from stem cell reserves that would otherwise replace worn out skeletal muscle.

Adult Stem Cells Lack Key Pluripotency Regulator
The protein Oct4, which helps to maintain embryonic stem cells, has been shown to be virtually absent in adult stem cells. Using three independent detection techniques on six tissue types where Oct4 expression had been reported, researchers found Oct4 either was not present or was present at statistically insignificant levels.

Neighborly Care Keeps Stem Cells Young
A stem cells’ immediate neighborhood, a specialized environment also known as the stem cell niche, provides crucial support needed for stem cell maintenance. But nothing lasts forever, found scientists at the Salk Institute for Biological Studies. During the aging process, the level of support drops off, diminishing the stem cells’ ability to replenish themselves indefinitely.

Xie Lab Demonstrates Dual Intrinsic and Extrinsic Control of Stem Cell Aging
The Stowers Institute’s Xie Lab has published recent findings that reveal some of the factors underlying the aging of stem cells.

Stem Cell Nuclei Are Soft ‘Hard Drives,’ Penn Study Finds
Biophysicists at the University of Pennsylvania have discovered that the nuclei of human stem cells are particularly soft and flexible, rather than hard, making it easier for stem cells to migrate through the body and to adopt different shapes, but ultimately to put human genes in the correct nuclear “sector” for proper access and expression.

Researchers Mimic Vascular System to Nourish Engineered Tissue for Transplants
The researchers have engineered tiny channels within a water-based gel that mimic a vascular system at the cellular scale and can supply oxygen, essential nutrients and growth factors to feed individual cells. The so-called gel scaffold can hold tens of millions of living cells per milliliter in a 3-D arrangement, such as in the shape of a knee meniscus, to create a template for tissue to form.

Jefferson Urologists Studying Regenerated Neo-Bladder to Help Spinal Cord Injury Patients
Urologists at Thomas Jefferson University Hospital are studying whether a neo-bladder construct grown from a patient’s own cells can improve bladder function for adult spinal cord injury patients.

BrainStorm on the Verge of a Breakthrough Towards Developing a Cure for Lou Gehrig’s Disease
BrainStorm Cell Therapeutics Inc. has announced that the Company is initiating a series of efficacy and safety studies toward a cure for Amyelotrophic Lateral Sclerosis.

One Shot of Gene Therapy Spreads Through Brain in Animal Study
By targeting a site in a mouse brain well connected to other areas, researchers successfully delivered a beneficial gene to the entire brain—after one injection of gene therapy. If these results in animals can be realized in people, researchers may have a potential method for gene therapy to treat a host of rare but devastating congenital human neurological disorders, such as Tay-Sachs disease.

Clinical Trials for Blindness and Hemophilia Gene Transfer Underway 
One gene transfer approach under investigation, which was developed by University of Pennsylvania investigator Jean Bennett, M.D., Ph.D., uses adeno-associated viral vector to deliver the gene for RPE65 into the eye. Catherine Manno, M.D., Division of Hematology, leads the center’s second gene transfer clinical trial. This trial focuses on hemophilia B, a bleeding disorder that results from a deficiency of blood coagulation factor IX.

Positive Preliminary Data on DiabeCell Phase I/IIa Clinical Trial
Living Cell Technologies Ltd is releasing this announcement concerning positive results of its Russian diabetes transplant trial to ensure that clinical information is available to all shareholders.

Blood Vessels Grown From Patient’s Skin
From a snippet of a patient’s skin, researchers have grown blood vessels in a laboratory and then implanted them to restore blood flow around the patient’s damaged arteries and veins.

FDA Approves Knee-injury Device For Humans
A new knee-surgery device investigated by University of Missouri-Columbia researchers that will help to repair meniscus tears, which were previously defined as irreparable, has been approved by the FDA for use in humans.

Cytori’s Celution(TM) System Approved in Japan for Stem Cell Collection & Preservation
Cytori Therapeutics received approval in Japan on the Celution(TM) System for use in medical laboratories for stem cell collection and preservation procedures.

FDA Approves ThermoGenesis’ Cord Blood Processing System
ThermoGenesis Corp.’s AXP AutoXpress Platform has been approved by the U.S. Food and Drug Administration, a critical step in the Rancho Cordova company’s effort to process, store and administer adult stem cells for the treatment of injuries and diseases.

Human-Animal Cybrids
Biologist Ian Wilmut talks about his cloning plans for the future.


Oct4 Expression Is Not Required for Mouse Somatic Stem Cell Self-Renewal
The researchers employed a genetic approach to determine whether Oct4 is important for maintaining pluripotency in the stem cell compartments of several somatic tissues, including the intestinal epithelium, bone marrow (hematopoietic and mesenchymal lineages), hair follicle, brain, and liver. Oct4 gene ablation in these tissues revealed no abnormalities in homeostasis or regenerative capacity.


Cell Therapeutics Supervisor
Philadelphia, PA (AppTec)

Postdoc Fellow
Sweden (Wallenberg Neuro Center Neuronal Survival Unit)

Manager, Manufacturing
Memphis, TN (Cognate Bioservices)


California Institute for Regenerative Medicine OKs Two New Research Programs
Two new research programs – to find new types of human pluripotent stem cells and to support teams of scientists targeting specific diseases – were approved by the California Institute for Regenerative Medicine.

Massachusetts Health Panel Set to Reverse Romney-Backed Stem Cell Rules
A state health panel appointed by Gov. Deval Patrick is poised to undo stem cell regulations created under former Gov. Mitt Romney that scientists said put a chill on their work and undermined a 2005 law intended to encourage the controversial research.

Specter Steering $1.5 Million to Tissue Lab
Mr. Specter then announced a $1.5 million Department of Defense grant he’s ushering through Congress for Pittsburgh Tissue Engineering Initiative to launch programs for hand transplantation, tissue regeneration and burn-injury technology.

New Jersey Acts on Third Stem Cell Research Center
The facilities are being funded through a $270 million stem cell initiative lawmakers approved last year.

Queensland Stem Cell Vote Reflects Community Support
Parliament has passed amendments paving the way for cloning of human embryos specifically for stem cell research in line with Commonwealth laws.

UK Government Publish Response To Scrutiny Committee Report On Human Tissue And Embryos Bill
Public Health Minister Dawn Primarolo set out the way ahead for the Human Tissue and Embryology bill by publishing the Government’s response to the Scrutiny Committee report on the bill. The bill represents a major overhaul of the law on assisted human reproduction and embryo research.


Invitrogen Introduces Multiplex Kit for Stem Cells
Invitrogen Corporation has announced the launch of a new kit that allows researchers to quickly and reliably monitor the state of human embryonic stem cells. The STEMPRO(R) EZChek(TM) Multiplex PCR Kit allows scientists to monitor hESCs with one reaction, using fewer sample cells than ever before.

MultiCell Technologies Signs Worldwide Exclusive License Agreement With Corning Incorporated
MultiCell Technologies, Inc. entered into a worldwide exclusive license and technology purchase agreement with Corning Incorporated of Corning, NY concerning the Company’s Fa2N-4 immortalized adult human liver cell lines.

Inovio Biomedical Redirects Strategic Emphasis toward DNA Vaccines and DNA Delivery
Inovio Biomedical Corporation has announced it is focusing its research and development efforts on its electroporation-mediated DNA delivery technology and DNA vaccines with the objective of further building potential downstream value to existing and prospective partners.

NeoStem Announces Opening of Las Vegas Adult Stem Cell Collection Center and Further Market Penetration in Western United States
NeoStem, Inc. has announced that the newest adult stem cell collection facility in its network has opened in Las Vegas, Nevada. The opening of the new Las Vegas center signals the latest successful milestone in the Company’s business strategy to establish a nationwide network of specialized adult stem cell facilities.

NeoStem Announces Further Expansion in Northeastern U.S. with Strategic Alliance with New England Cryogenic Center, Inc.
NeoStem, Inc. has announced that the Company has entered into a strategic alliance with New England Cryogenic Center, Inc. to provide extensive processing and storing capacity as the Company continues to expand its services in the United States.

Cord Blood Service to Debut
Women giving birth in Pittsburgh will have the option to make an altruistic decision with life-saving potential starting today.

Third Option for Stem Cell Storage
Delhi-based Cryobanks International India launched its Calcutta operations on Saturday, joining the recent rush for cord blood stem cells storage.

BioTime Names Dr. Michael D. West as CEO and Announces Entry Into Stem Cell Research and Regenerative Medicine
BioTime, Inc. has announced that Michael D. West, Ph.D. has become BioTime’s new Chief Executive Officer. Dr. West will help spearhead BioTime’s entry into the field of regenerative medicine by developing advanced human stem cell products and technology for diagnostic, therapeutic and research use.

Millipore Corporation Announces Appointment of Karen Marinella Hall as Director, Corporate Communications
Millipore Corporation has announced that Karen Marinella Hall has joined the organization as Director, Corporate Communications.

Rami Efrati, Former VP Business Development and Marketing for NICE SYSTEMS’ Government Division, Joins BrainStorm as CEO
Efrati’s appointment is paramount as Brainstorm approaches the crucial clinical phases of its research; at the same time the company is ramping up for its pre IND FDA approval process as indicated through the recent addition of key advisors with substantial FDA experiences.

Advanced Cell Technology Announces the Promotion of Dr. Robert Lanza to Chief Scientific Officer
Dr. Michael West is transitioning to non-executive director.Dr. Lanza will continue to work closely with Dr. Pedro Huertas, M.D., Ph.D., ACT’s Chief Development Officer, to drive these hESC therapies to the clinical development stage.


NIH Announces Plans to Eliminate Paper Notification of Notice of Award (NoA) Letters (NOT-OD-08-002)

Human Tissue and Organ Research Resource (Limited Competition U42) (RFA-RR-07-006)


PDA/FDA Joint Regulatory Conference – Slide Presentation

American Association of Tissue Banks Annual Meeting – Slide Presentations

CBER Organizational Information – Update

Fast Track Designation Request Performance – Update

Licensed Products and Establishments List – Update



Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Patent Term Restoration, Due Diligence Petitions, Filing, Format, and Content of Petitions

Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Focus Groups as Used by the Food and Drug Administration


Oman Gives the Nod to Stem Cell Therapy
Stem cell therapy, that has virtually revolutionised the world of medicine in recent years, is now within their reach after the Health Ministry yesterday gave the go-ahead for an Indian hospital, which has done pioneering research in the field, to set up a referral centre in Muscat.



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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