Volume 9.17 | May 5

Cell Therapy News 9.17, May 5, 2008
     In this issue: Science | Policy | Business | NIH | CBER | Regulatory
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Top Stories

Gene Therapy Improves Vision in Patients with Congenital Retinal Disease: In a clinical trial at The Children’s Hospital of Philadelphia, researchers from The University of Pennsylvania have used gene therapy to safely restore vision in three young adults with a rare form of congenital blindness.


Last Chance to Recruit Top Talent at the 2008 ISCT Annual Meeting
Deadline extended to May 9, 2008
Click http://www.celltherapynews.com/post_a_job/ to advertise with the joint ISCT Cell Therapy News Job Posting Program. 

Looking At Neurons From All Sides
A new technique that marries a fast-moving laser beam with a special microscope that looks at tissues in different optical planes will enable scientists to get a three-dimensional view of neurons or nerve cells as they interact.

New Artificial Liver Tests: HepaLife’s ‘PICM-19’ Demonstrate Advantages Over Today’s Best-Available Liver Cells
HepaLife Technologies, Inc. recently announced that results from new tests of the Company’s patented PICM-19 liver cells show the highest levels of important liver-specific metabolic activity key to mimicking human liver function, and further demonstrate the PICM-19’s ability to perform equivalent to freshly harvested adult porcine hepatocytes, traditionally regarded the best available liver cell source for bioartificial liver support.

Tissue-Specific Blood Stem Cell Line Established From Embryonic Stem Cells
A research team at the Umea Center for Molecular Medicine in Sweden, led by Professor Leif Carlsson, has managed to specifically establish and isolate the tissue-specific stem cell that produces blood cells by using genetically modified embryonic stem cells.

Scientists Find Stem Cells For the First Time in the Pituitary
A team of researchers led by scientists at Cold Spring Harbor Laboratory have for the first time identified stem cells that allow the pituitary glands of mice to grow even after birth.

New Model for Embryonic Limb Development
A study led by USC researcher Francesca V. Mariani has found a new model to explain how signals between cells in the embryo control limb development.

Mouse Skin Cells Reprogrammed to Act Like Embryonic Stem Cells
Functioning cardiac cells have been created from mouse skin cells reprogrammed to have the same unlimited differentiation characteristics of embryonic stem cells, say researchers at the University of California, Los Angeles.

The Blind Can See
Dr. Awatramani and other neuroscientists developed a strategy to restore visual functions in mice with retinal degenerative diseases, a major advancement in retinal disease research.

New Findings Published in Nature Biotechnology Demonstrate Use of "Lipidoids" to Achieve Systemic Delivery of RNAi Therapeutics in Multiple Pre-Clinical Models
The studies showed successful delivery of lipidoid formulations of small interfering RNAs, the molecules that mediate RNAi, in multiple animal species including mice, rats, and non-human primates that together demonstrate potent, specific, and durable effects on gene expression in multiple tissues, including liver, lung, and peritoneal macrophages.

BioCardia and the University of Miami Receive FDA Clearance to Initiate Co-Sponsored Heart Failure Stem Cell Clinical Trial Comparing Two Cell Populations
BioCardia, Inc. and the University of Miami recently announced that the United States Food and Drug Administration approved a clinical investigation of two adult stem cell populations in the setting of heart failure.

Studies Test New Approaches to Islet Transplantation
Researchers from 11 medical centers in the United States, Canada, Sweden, and Norway have begun testing new approaches to transplanting clusters of insulin-producing islets in adults with difficult-to-control type 1 diabetes.

Cell-Based Therapy Shows Promise in Patients with Parkinson’s Disease
A novel cell therapy using retinal pigment epithelial cells attached to tiny gelatin bead microcarriers implanted in the brain can improve the symptoms of patients with moderate to advanced Parkinson’s disease.

Celgene Cellular Therapeutics Announces Clinical Transplant of Human Placenta-Derived Stem Cells
Celgene Cellular Therapeutics recently announced the clinical application of a human placenta-derived stem cells for hematopoietic reconstitution.

Quantum Immunologics, Inc. and the South Alabama Medical Science Foundation Announce an Early Clinical Evaluation of a Novel Immuno-therapeutic Vaccine for Treating Advanced Human Breast Carcinomas
Quantum Immunologics, Inc. announces the commencement of a Phase I/II clinical trial to assess the safety and efficacy of a novel anti-cancer vaccine/immunotherapy that will be used on patients with Stage IV advanced breast cancer.


Acid Cleavable PEG-Lipids For Applications in a Ternary Gene Delivery Vector
Gene therapy has significant potential as treatment strategies for inherited or aquired diseases, however, an efficient vector system is required to deliver the gene of interest into target cells. To improve the efficacy and selectivity of synthetic vectors, targeting to cell-surface receptors using peptides, polysaccharides or antibodies has been carried out.

Bone Marrow–Derived Mesenchymal Stem Cells Facilitate Engineering of Long-Lasting Functional Vasculature
Vascular tissue engineering requires a ready source of endothelial cells and perivascular cells. Here, the researchers evaluated human bone marrow–derived mesenchymal stem cells for use as vascular progenitor cells in tissue engineering and regenerative medicine.

Localization and Characterization of STRO-1+ Cells in the Deer Pedicle and Regenerating Antler
Studying antler regeneration can provide a deeper insight into the mechanisms that prevent limb regeneration in humans and other mammals, and, with regard to medical treatments, may possibly even show ways how to overcome these limitations. The researchers results support the view that the annual process of antler regeneration might depend on the periodic activation of mesenchymal progenitor cells located in the pedicle periosteum.


Quality Management Supervisor

Reform Zones in Japan to Be Set Up for Medicine Development
Designed to promote research and development in the field of advanced medicine, the structural reform zones will receive favorable treatment in terms of budgetary allocations and the screening of new drugs.

New Rules For Cord Blood Collection
Collection of cord blood at birth will be regulated for the first time in the UK under new rules announced to ensure safety and traceability.


University of San Diego California Enters Stem Cell Research Partnership
Four major research institutions are joining to form a cutting-edge San Diego Consortium on Regenerative Medicine, which will draw together a number of major resources in the field in an attempt to further develop regenerative science.

International Stem Cell Gains Rights from CellSystems to Human Skin Model for Toxicity Testing
International Stem Cell inked an exclusive deal with CellSystems Biotechnologie to distribute laboratory-cultured models of human skin within the U.S. and Canada.

Rutgers Research Partner Stemcyte, Inc., Expands to New Jersey
Collaborative research environment triggers move of umbilical cord stem cell company.

BioCardia Completes $7.4 Million Private Equity Financing Following Successful Phase I Clinical Trial Enrollment and Two Year Followup Data
BioCardia, Inc. recently announced the completion of a new round of financing, raising $7.4 million from existing and new investors. This follows the completion of BioCardia’s Phase 1 clinical trial enrollment and its two year followup data publication on the trial’s first cohort.

Histogen Announces Initial Close of Series A Financing Round
Histogen, Inc. recently announced the initial close of Series A financing at $5.35 million. The round was completed by private and corporate investors, including Secure Medical Inc., CellCeuticals Skin Care Inc., and Leonard H. Lavin, founder and Chairman Emeritus of the Alberto-Culver Company.

Stem Cell Pioneer Thomson Elected to National Academy of Sciences
He is among 72 new fellows admitted to the 145-year old academy this year in recognition of their distinguished achievements and ongoing contributions to original research. Election to the National Academy of Sciences is considered one of the most prestigious honors that can be bestowed upon an American scientist.


Change in Procedure for Requests to NCCAM for Administrative Research Supplements to Promote Diversity and Re-entry in Health-Related Research (PA-05-015 and PA-04-126) and CAM Practitioner Supplements (NOT-AT-07-005)

Stem Cells and Cancer (R21) Funding Opportunity


Human Subject Protection; Foreign Clinical Studies Not Conducted Under an Investigational New Drug Application



FDA Embarks on Major Hiring Initiative for its Public Health Mission
Agency will fill more than 1,300 positions within the next several months.

Not All Device, Drug and Biologic Submissions Need Certification
Some device, drug and biological product applications and submissions to the FDA that are not related to clinical trials may not need the certification specified in the Food and Drug Administration Amendments Act of 2007 (FDAAA), the agency says in a draft guidance.


14th ISCT Annual Meeting

May 17-20, 2008
Downtown Miami, Florida

Full details at: www.celltherapysociety.org

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