Volume 9.26 | Jul 7

Cell Therapy News 9.26, July 7, 2008
     In this issue: Science | Policy | Business | NIH | CBER | Regulatory
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Top Stories

Cancer Cure in Mice to be Tested in Humans; Phase II Clinical Trial of New Cancer Treatment to Begin this Summer: Scientists at Wake Forest University Baptist Medical Center are about to embark on a human trial involving transfusing specific white blood cells, called granulocytes, from select donors, into patients with advanced forms of cancer. A similar treatment using white blood cells from cancer-resistant mice has previously been highly successful, curing 100 percent of lab mice afflicted with advanced malignancies.
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Science

Salk Researchers Reprogram Adult Stem Cells in their Natural Environment
Researchers at the Salk Institute for Biological Studies have succeeded in manipulating the fate of adult stem cells cultured in the lab with adult neural stem cells still in place in the brain. They were able to coax mouse brain stem cells bound to join the neuronal network to differentiate into support cells instead.
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Researchers Link Early Stem Cell Mutation to Autism
In a breakthrough scientific study published recently in the Proceedings of the National Academy of Sciences, scientists at the Burnham Institute for Medical Research have shown that neural stem cell development may be linked to Autism. The study demonstrated that mice lacking the myocyte enhancer factor 2C protein in neural stem cells had smaller brains, fewer nerve cells and showed behaviors similar to those seen in humans with a form of autism known as Rett Syndrome.
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Stem Cells Show Promise for Repair of Macular Holes
“The technique of transplantation of bone marrow [stem] cells in the subretinal space is safe with no side effects and is a new concept.” In this study, 10 patients who had previously failed macular hole surgery underwent bone marrow aspiration from the iliac crest and intravitreal implantation of those stem cells into their retina.
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Bone Marrow Alternative: Stem Cells From Umbilical Cord May Be Used To Treat Hepatic Diseases
Scientists from the University of Granada in collaboration with the University of Leon, have confirmed that stem cells from human umbilical cord blood can be an appropriate therapy for the treatment of hepatic diseases such as hepatitis, and are therefore an effective alternative to bone marrow.
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New Technique Produces Genetically Identical Stem Cells
Adult cells of mice created from genetically reprogrammed cells-so-called induced pluripotent stem stem cells-can be triggered via drug to enter an embryonic-stem-cell-like state, without the need for further genetic alteration.
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Gene Directs Stem Cells to Build the Heart
Researchers have shown that they can put mouse embryonic stem cells to work building the heart, potentially moving medical science a significant step closer to a new generation of heart disease treatments that use human stem cells.
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Indian Scientists Develop Genetically Modified Mice Through Transgenic Sperm
Scientists at the National Institute of Immunology have been successful in inserting human genes inside the testes of male mice and integrating it with the chromosome of the germ cells to help mice give birth to genetically modified pups – an effort that is expected to boost clinical research and drug development across the world.
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VAVELTA(R) Phase II data presented at FACE
Intercytex Group plc recently announced that positive 6 month follow-up data from two Phase II trials of VAVELTA(R), its cell therapy product for damaged skin, were presented at the FACE congress on 28th June, 2008.
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Isolagen Completes Pivotal Efficacy Portion of Phase III Studies of Isolagen Therapy(TM) for Wrinkles
Isolagen(TM), Inc. announced recently the completion of the pivotal efficacy portion of its Phase III clinical studies investigating the Isolagen Therapy(TM) for the treatment of nasolabial folds, or wrinkles. The last person in each study has completed the primary efficacy follow-up visit, and collation of this data has begun.
Article

‘Designer Baby’ Free of Cancer Gene
A couple are expecting Britain’s first baby screened not to have hereditary breast cancer in a move hailed as “an exciting technological development”. They decided to screen her embryos and remove the inherited cancer-causing gene BRCA-1 because the baby’s father, his sister, mother, grandmother and cousin all had the cancer. Of the 11 embryos produced, five did not have the gene and two were implanted.
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New Probe May Help Untangle Cells’ Signaling Pathways
MIT researchers have designed a new type of probe that can image thousands of interactions between proteins inside a living cell, giving them a tool to untangle the web of signaling pathways that control most of a cell’s activities.
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CHI’s Third Annual CELLutions SUMMIT
August 11-13, 2008; Cambridge, MA
Uniquely designed to explore the evolving field of next-generation cells, engineered 3D cellular models, and therapeutic cellular-in-human use. Scientific technological progress brings fundamental understanding and provides the foundation for more rapid advances toward the clinic. CHI’s CELLutions SUMMIT will focus on a targeted topics covering this multifaceted field.
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ABSTRACTS, REVIEWS AND SPECIAL REPORTS

Pluripotent Stem Cells Induced from Adult Neural Stem Cells by Reprogramming with Two Factors
Scientists of the Max Planck Institute for Molecular Biomedicine in Munster have succeeded in resetting cells of adult mice into their embryonic state in a more gentle and safer manner needing only two genes instead a “cocktail” of four genes. Scholer and his colleagues furthermore report that they could markedly bring down the use of viruses which would avert one of the largest risks of future stem cell therapies: a derailment of injected cells to tumours.
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Unrelated Donor Umbilical Cord Blood Transplantation for Inherited Metabolic Disorders in 159 Pediatric Patients from a Single Center: Influence of Cellular Composition of the Graft on Transplant Outcomes
The researchers present results of 159 young patients with inherited metabolic disorders transplanted with partially HLA-mismatched unrelated donor UCB grafts and the impact of graft and patient characteristics on engraftment, overall survival and graft versus host disease. In multivariate analysis, favorable factors for overall survival were high pre-transplant performance status, matched donor/recipient ethnicity, and higher infused colony forming units.
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Recasting the Federal Debate on Stem Cells
Bush Administration Revisits Embyronic Stem Cell Stance by Encouraging Funding for Pluripotent Stem Cells
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Research: Three Technologies That Could Transform Patient Care
Three mouthfuls of letters – RNAi, IPSCs and GWAS – encompass the hottest research topics in biomedical science today. The three technologies could revolutionise healthcare in the coming decades, although they are at different stages of development.
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JOB OPPORTUNITIES

GMP Facility Quality Assurance

Product Manager

Lead Clinical Laboratory Scientist

Adult Stem Cell Biology Researcher

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Market Development Manager – Americas

Policy

Human-Pig Hybrid Embryos Given Go Ahead
A licence to create human-pig embryos to study heart disease has been issued by the fertility watchdog. The effort at the University of Warwick is led by Professor Justin St John. “This new license allows us to attempt to make human pig clones to produce embryonic stem cells.”
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Lawsuit Asks Court to Clarify Missouri Stem Cell Limits
An embryonic stem cell critic is suing to delay spending from a state life-sciences research fund.
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Stanford Researchers Get Stem Cell Grants for $5.6 Million
The CIRM’s $1.4 million awards support two types of research. One is the creation of new human embryonic stem cell lines from excess or discarded early-stage human embryos created by in vitro fertilization. Another is the derivation of new pluripotent human stem cell lines either through a technique called somatic cell nuclear transfer or by modifying neonatal or adult cells to render them pluripotent. Grant reviewers gave special consideration to those types of research unlikely to receive federal funding.
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CIRM Grants Awarded to UC San Diego Researchers
Three grants were awarded recently to the University of California, San Diego School of Medicine researchers to fund new approaches to generating stem cell lines from human skin, and to fighting leukemia and Alzheimer’s disease.
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Business

Introgen Submits ADVEXIN(R) Regulatory Applications in the U.S. and Europe
An Austin biotechnology company on Monday became the first to apply for U.S. Food and Drug Administration approval of a gene therapy drug to treat recurring head and neck cancers.
Article

Lonza and Osiris Therapeutics Enter Strategic Product Supply Agreement
Lonza, recently announced a clinical and commercial manufacturing agreement with Osiris Therapeutics, Inc. for the production of Prochymal(R), their leading adult stem cell therapy.
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Bioheart, Inc., Board Appoints Howard J. Leonhardt Chief Executive Officer
Bioheart, Inc. recently announced that its Board of Directors appointed Howard J. Leonhardt, Bioheart’s co-founder, Chairman of the Board and Chief Technology Officer, to serve as Chief Executive Officer effective as of July 1, 2008. This follows the resignation of William M. Pinon as the Company’s President and CEO and as a member of the Board of Directors as of the same date.
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NIH

NIH Implementation of Government-wide Standard Terms and Conditions for Research Grants
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Corrections and Additional Information for RFA HL-08-012, NHLBI Progenitor Cell Biology Consortium Planning Awards (R03)
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Notice of NIH Office of Rare Diseases Opportunities for Researchers to Translate New Genetic Tests from Laboratory to Clinical Testing: Collaboration, Education, and Test Translation (CETT) Program
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Research Supplements to Promote Re-Entry into Biomedical and Behavioral Research Careers
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CBER

Exceptions and Alternative Procedures Approved Under 21 CFR 640.120 of the Code of Federal Regulations Regarding Blood, Blood Components or Blood Products
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Medical Device Notification – Sunquest Laboratory Blood Bank and Blood Donor Modules
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BIO, International Convention, San Diego, California – Slide Presentation
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Licensed Products and Establishments List – Update
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Regulatory

MEDICINES AND HEALTHCARE PRODUCTS REGULATORY AGENCY (United Kingdom)

Commission on Human Medicines Summary Minutes
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