Volume 9.23 | Jun 16

Cell Therapy News 9.23, June 16, 2008
     In this issue: Science | Policy | Business | NIH | CBER | Regulatory
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Top Stories

More Than One Kind of Adult Stem Cell in Guts: A single organ may contain more than one type of adult stem cell – a discovery that complicates prospects for using the versatile cells to replace damaged tissue as a treatment for disease, according to a new study from the laboratory of geneticist Mario Capecchi, the University of Utah’s Nobel Laureate.

Adult Stem Cell Findings Offer New Hope for Parkinson’s Cure: The Griffith University study published in the journal Stem Cells found that adult stem cells harvested from the noses of Parkinson’s patients gave rise to dopamine-producing brain cells when transplanted into the brain of a rat.


VIDEO: From MEFs to Matrigel I: Passaging hESCs in the Presence of MEFs
This video demonstrates how to grow human embryonic stem cells on mouse embryonic fibroblast feeder cells.

Stem Cell Discovery Sheds Light on Placenta Development
University of Florida Researchers studying embryonic stem cells have explored the first fork in the developmental road, getting a new look at what happens when fertilized eggs differentiate to build either an embryo or a placenta.

Geron Presents Data at ISSCR Showing That Its Embryonic Stem Cell Therapeutic for Heart Failure Evades Direct Attack by the Human Immune System
Geron Corporation recently announced the presentation of research studies indicating that GRNCM1, the company’s human embryonic stem cell–based therapeutic for the treatment of heart failure, evades direct attack by the human immune system in vitro.

Shear Stress Improves Stem Cell Attachment to Vascular Surfaces
A new study about how shear stress improves adult stem cell attachment to vascular surfaces moves researchers closer to the development of a unique tissue-engineered stem cell vascular bypass graft.

ImmuneRegen(R) BioSciences Confirms Adult Stem Cell Activity of Homspera(R) in Human Bone Marrow
ImmuneRegen(R) BioSciences, Inc., announces additional study results that confirm the effects of its compound Homspera(R) in stimulating the development of human adult stem cells. The results, also found in earlier studies, document Homspera’s ability to enhance formation of early-stage blood cells from adult hematopoietic (blood-forming) stem cells.

Researchers Create New PET-Scan Probe to Monitor Immune System
Researchers at UCLA’s Jonsson Comprehensive Cancer Center have modified a common chemotherapy drug to create a new probe for positron emission tomography, an advance that will allow them to model and measure the immune system in action and monitor its response to new therapies.

Engineer Develops Detergent to Promote Peripheral Nerve Healing; 100 Patients Treated Successfully in First Year of Use
A detergent solution developed at The University of Texas at Austin that treats donor nerve grafts to circumvent an immune rejection response has been used to create acellular nerve grafts now used successfully in hospitals around the country. Research also shows early promise of the detergent solution having possible applications in spinal cord repair.

Autologous Haematopoietic Stem Cell Transplantation After Immunosuppressive Therapy Effective and Safe in Multiple Sclerosis
In patients with multiple sclerosis, immunosuppressive therapy followed by autologous haematopoietic stem cell transplantation elicited high response rates and improved quality of life for up to 6 years.

AMT prepares for submission of Marketing Authorization Dossier for AMT-011 (Glybera(R))
Amsterdam Molecular Therapeutics, a leader in the field of human gene therapy, announced recently that it has concluded enrollment and treated the last patient in the pivotal trial for it’s lead product AMT-011 (Glybera(R)) for Hyperlipoproteinemia, a seriously debilitating and potentially lethal disease. After recent preparatory meetings with the rapporteur countries Germany and the United Kingdom of the European Medicines Agency, AMT expects to file the Marketing Authorization Dossier with EMEA not later than the fourth quarter of 2008.


Efficient Differentiation of Functional Hepatocytes from Human Embryonic Stem Cells
The researchers report here a robust and highly efficient process for the generation of high-purity (70%) hepatocyte cultures from hESCs that parallels sequential hepatic development in vivo. Highly enriched populations of definitive endoderm were generated from hESCs and then induced to differentiate along the hepatic lineage by the sequential addition of inducing factors implicated in physiological hepatogenesis.

Inhalable siRNA: Potential as a Therapeutic Agent in the Lungs
Targeted, local delivery of RNAi to the lungs via inhalation offers a unique opportunity to treat a range of previously untreatable or poorly controlled respiratory conditions. In this timely review the researchers look at the potential applications of RNAi in the lungs for the treatment of a range of diseases including inflammatory and immune conditions, cystic fibrosis, infectious disease and cancer.

Nuclear Pore Composition Regulates Neural Stem/Progenitor Cell Differentiation in the Mouse Embryo
Here the researchers report that a null allele of mouse nucleoporin Nup133, a structural subunit of the NPC, disrupts neural differentiation. We find that expression of Nup133 is cell type and developmental stage restricted, with prominent expression in dividing progenitors.

Scientific Information Largely Ignored When Forming Opinions About Stem Cell Research
When forming attitudes about embryonic stem cell research, people are influenced by a number of things. But understanding science plays a negligible role for many people.


GMP Facility Quality Assurance

Product Manager

Lead Clinical Laboratory Scientist

Adult Stem Cell Biology Researcher

Operations Manager

Market Development Manager – Americas

Field Applications Specialist

Product Development Associate

Human Application Laboratory Opportunities


Australia to Enter the Race to Clone Human Embryo Cells for Stem Cell Research
Melbourne’s Monash University may be granted the first licence in Australia to clone human embryo cells for stem cell research.

Bush Backs Adding $275 Million to U.S. FDA Budget
President George W. Bush added $275 million to his budget request for the U.S. Food and Drug Administration after lawmakers said the administration didn’t seek enough funding to protect against tainted products.

Massachusetts Push $1 Billion Biotech Bill
The Legislature’s economic development committee put the finishing touches on the $1 billion life sciences bill recently. The action comes just days before state political and life science industry leaders travel to California for a major biotechnology conference. The House is expected to approve the measure, and the Senate later in the week.


Invitrogen and Applied Biosystems to Combine
Invitrogen Corporation and Applera Corporation recently announced that their Boards of Directors have approved a definitive merger agreement, under which Invitrogen will acquire all of the outstanding shares of Applera’s Applied Biosystems Group in a cash and stock transaction valued at $6.7 billion.

Q Therapeutics Collaborates with Johns Hopkins to Study Use of Neural Cells in Treatment of ALS
Q Therapeutics, Inc. announced recently that it and Nicholas Maragakis, MD of Johns Hopkins University had received notification of an $800,000 grant to be awarded from the Maryland Stem Cell Research Fund to enable study of Q’s human neural cell product Q-Cells(R) in preclinical models of Amyotrophic Lateral Sclerosis (ALS or Lou Gehrig’s Disease).

RNL Bio Exports Stem Cell Technology to Japan
RNL Bio Co Ltd. has signed a licensing agreement with Seems, Inc. for RNL’s stem cell technology. Under the terms of the agreement, Seems, Inc. will pay 6 million dollars up front with 5% royalties of related sales revenue for the right to use RNL’s stem cell technology to establish stem cell banks and to sell the stem cell therapeutics developed by RNL Bio, in Japan. This deal is the first technology export to Japan from the Korean stem cell industry.

Amsterdam Molecular Therapeutics Makes Advance in the Development of its Gene Therapy for Hemophilia B – Company Accesses Technology to Prevent Immune Response
Amsterdam Molecular Therapeutics, a leader in the field of human gene therapy, recently announced that it obtained a license from ‘TIGET’ San Raffaele Telethon Institute For Gene Therapy, to use their micro-RNA technology to prevent immune responses against gene therapy for Hemophilia B. This technology enables AMT to accelerate the development of AMT-060 (AMT’s AAV-based gene therapy for this seriously debilitating disease).

Nastech Initiates New Corporate Direction with Name Change to MDRNA, Inc. and Appointment of J. Michael French as Chief Executive Officer
Nastech Pharmaceutical Company Inc. Announced that having acquired shareholder approval, effective June 11, 2008 the Company has changed its name to MDRNA, Inc. MDRNA will leverage its scientific and intellectual property position surrounding the research, development and delivery of Dicer substrates and “Meroduplex” RNA interference drug candidates to build an industry-leading position in the development and commercialization of RNAi-based therapeutics.


OLAW IO Outreach Program
OLAW has developed an educational outreach program to help IOs at Assured Institutions explore their responsibilities in the oversight of PHS-funded research that involves the use of live vertebrate animals.

OLAW IACUC Staff Outreach Program
OLAW has developed an educational outreach program to help IACUC staff at Assured Institutions explore their responsibilities in the oversight of PHS-funded research that involves the use of live vertebrate animals.


Draft Guidance for Industry: Providing Regulatory Submissions in Electronic Format – Postmarketing Individual Case Safety Reports

Public Workshop: Blood Establishment Computer Software
The purpose of the public workshop is to examine information technology issues at blood facilities in order to keep blood centers at the forefront of technology while assuring the continued safety and quality of the blood supply.

Blood Products Advisory Committee Charter – Updated


The United States Industry Consensus Standard for the Uniform Labeling of Cellular Therapy Products using ISBT 128, Version 1, DRAFT G
This US Cellular Therapy Document is the result of the collaborative efforts of AABB, ASBMT, ASFA, FACT, ICCBBA, ISCT, and NMDP.  It is available for public comment until August 1, 2008.  All comments will be taken into consideration prior to the final publication of the document.

Stem Cell Experts Offer Guide to Fight “Snake Oil”
The International Society for Stem Cell Research said it wants to counter “snake oil” treatments that claim to provide cures using stem cells with a set of guidelines for researchers and the public alike, in part to preserve the reputation of the field.


UK Clinical Trial Authorisation Assessment Performance
From 1 November 2007, letters from the MHRA relating to clinical trial submissions will not be signed. The wording and format of letters from the MHRA relating to clinical trial submissions will also be modified from this date. This is in line with MHRA policy.

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