Volume 8.24 | Jun 25

Volume 8.24, June 25, 2007
     In this issue: Science | Policy | Business | NIH | CBER | Regulatory
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Top Stories

Scientists Move Closer to Human Therapeutic Cloning: Human therapeutic cloning has moved a step closer after U.S. researchers announced they had successfully created embyonic stem cells from monkey embryos.
Article

Science

Advanced Cell Technology Develops First Human Embryonic Stem Cell Line without Destroying an Embryo
Advanced Cell Technology, Inc. has successfully produced a human embryonic stem cell line without destroying an embryo.
Article

Scientists Announce Stem Cell Line from New Source
Scientists have created a new stem cell line from a clinically unusable human egg.
Article

ReNeuron Scientists Generate Pancreatic Cell Lines for Treatment of Diabetes
ReNeuron Group plc announces that it has taken a major step forward with its ReN002 diabetes programme with the generation of new data concerning its pancreatic cell lines for the treatment of Type 1 diabetes.
Article

Embryonic Stem Cells Grow Kidneys in Mice
Researchers at the University of Tokyo used stem cells from a mouse embryo to grow kidneys in mice lacking the organs.
Article

Blood Vessels in Rats Made from Stem Cells
Researchers grew stem cells on elastic biodegradable tubes to engineer new blood vessels for rats within days of extracting the cells.
Article

Discovery in Fish May Aid Human Blood Cell Transplants
The discovery that zebrafish produce natural chemicals that enhance production of blood-forming stem cells may translate rapidly into new treatments to increase the success of bone marrow or cord blood transplants in humans.
Article

Genes Show Promise to Correct Hearing
A new method involves transferring genes into diseased tissue of the inner ear.
Article

Research Brings Hope of Curing Brain Disease
Researchers have used RNA interference to silence faulty genes or viruses that cause brain diseases.
Article

Single Injection Targets Alcohol Cravings
Chilean researchers discovered that rats treated with gene therapy via an injection were less likely to crave alcohol than those without.
Article

Advanced Cell Technology Announces Critical Advancements in Its RPE Program for the Treatment of Macular Degeneration and Other Retinal Degenerative Diseases
The company commences GLP safety studies with MPI Research for RPE cells manufactured under GMP compliant conditions.
Article

Mesoblast Announces Strong Interim Results in Fracture Repair Trial
Mesoblast has released positive interim results from a clinical trial of its proprietary adult stem cell technology for patients suffering from non-healing, long bone fractures.
Article

StemCells, Inc. Announces Important Milestone in Batten Disease Clinical Trial
StemCells, Inc. announced that the Phase I clinical trial of its proprietary HuCNS-SC(TM) product candidate has successfully completed enrollment of the low-dose cohort and will proceed to the high-dose cohort.
Article

Promising Results from First Gene Therapy Clinical Trial for Parkinson’s Disease Reported
A team led by physician-scientists at NewYork-Presbyterian Hospital/Weill Cornell Medical Center has completed the first-ever phase 1 clinical trial using gene therapy to battle Parkinson’s disease.
Article

Stem Cells to Repair Damaged Heart Muscle
In the first trial of its kind in the world, 60 patients who have recently suffered a major heart attack will be injected with selected stem cells from their own bone marrow during routine coronary bypass surgery.
Article

Opexa Therapeutics Reports Positive Top-line Data in Phase I/II Extension Trial with Tovaxin(TM) for Multiple Sclerosis
In this one-year, 8-subject extension clinical trial of relapsing remitting and secondary progressive subjects, Tovaxin therapy was shown to be safe and effective.
Article

ABSTRACTS, REVIEWS AND SPECIAL REPORTS

Characterization of Human Embryonic Stem Cell Lines by the International Stem Cell Initiative
The International Stem Cell Initiative has characterized 59 human embryonic stem cell lines from 17 laboratories worldwide.
Abstract

Policy

Bush Vetoes Stem Cell Research Legislation
President Bush has vetoed legislation to expand federally funded embryonic stem cell research, saying that scientific advances now allow researchers to pursue the potentially lifesaving work without destroying human embryos.
Article

Bush Likely to See More Stem Cell Legislation From Democratic Congress
Supporters are answering his veto with an effort to add to an appropriations bill permission to use taxpayer dollars for new lines of embryonic stem cells.
Article

Survey Sees Support for Embryos in Stem Cell Work
About 60 percent of people with frozen embryos stored at U.S. fertility clinics would be willing to donate them for use in human stem cell research.
Article

Assembly Passes ‘New Jersey Stem Cell Research Bond Act’
Legislation Assembly members Neil M. Cohen, John F. McKeon, Joan Voss, and Mike Panter sponsored to authorize the sale of $450 million in general obligation bonds for the purpose of supporting stem cell research in New Jersey passed today in the General Assembly.
Article

Stem Cell Research Bill Dies on Oregon House Floor
Anti-abortion groups scored a rare victory in a legislative session that’s been dominated by Democratic priorities, by derailing a bill that would have put Oregon among the growing number of states exploring public funding for stem cell research.
Article

British Body Backs Inter-species Clones
Making human-animal embryos for scientific experiments should be allowed because of the benefits to science and medicine, British experts said in a recent report.
Article

Business

ThermoGenesis, UC Davis Partner for Stem Cell Treatments
Researchers at UC Davis will use ThermoGenesis blood processing systems to develop treatments for artery disease, myocardial infarction and skin wounds.
Article

Baxter Signs Agreements to Evaluate TISSEEL Use with New, Innovative Therapies
Fibrin sealant will be used in combination with investigational treatments for chronic back pain and wound repair.
Article

Stem Cell Sciences In-Licenses Breakthrough Discovery for the Production of Human Stem Cells
This discovery overcomes the key challenge in the effective scale-up of stem cell technologies – cell death.
Article

Ceregene and Genzyme Announce Partnership for the Development and Commercialization of CERE-120 for Parkinson’s Disease
Ceregene, Inc. and Genzyme Corporation has announced that they have entered into a partnership for the development and commercialization of CERE-120, Ceregene’s proprietary lead program for the treatment of Parkinson’s disease.
Article

Stem Cell Licensing Deal Positions Toronto as World Leader in the Technology
Under the agreement, Tissue Regeneration Therapeutics Inc. will exclusively license its human umbilical cord perivascular cell technology to Stem Cell Authority Ltd. for family stem cell banking in the U.S.
Article

Applied Genetic Technologies Corporation Receives $2 Million Milestone from Genzyme after Successful Transfer of Novel Production Technology
Applied Genetic Technologies Corporation has announced that it has received a $2 million milestone payment from Genzyme Corporation as a result of having successfully transferred AGTC’s proprietary Adeno-Associated Virus vector production technology to Genzyme.
Article

Biotechs Brace for Patent Reform, High Court Impacts
While large pharmaceutical companies have been the industry mouthpiece about controversial patent reforms, local legal experts say it’s actually small biotech companies whose value is most affected by their patents.
Article

NIH

Extension of Expiration Date and Clarification of Eligibility for Reentry Supplement (NOT-OD-07-068)
Link

NIH/AHRQ/NIOSH Announce Change in Electronic Submission Process – Federal Holidays Excluded from Application Viewing Window (NOT-OD-07-070)
Link

CBER

Human Cells, Tissues, and Cellular and Tissue-Based Products; Donor Screening and Testing, and Related Labeling; Final Rule
Link

Cellular, Tissue and Gene Therapies Advisory Committee
Link

Supplement Approval (Revised Package Insert) – Autologous Cultured Chondrocytes (Carticel) – Genzyme Biosurgery
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All new CBER information can be reached from the What’s New page at What’s New Page

Regulatory

FOOD AND DRUG ADMINISTRATION (Untited States of America)

Licensure of Apheresis Blood Products; Public Workshop
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Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Guidance for Industry on Special Protocol Assessment
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ISCT

ISCT Membership
Renew your ISCT Membership for 2007 now!
Not a member?  Visit the ISCT website to learn about the benefits of membership.
Link

Profiled Journal

Cytotherapy is the Official Journal of the International Society for Cellular Therapy (ISCT). Coverage encompasses important new therapies emerging from the manipulation of cytokines and cells, as well as bringing readers the very latest developments news and opinion in the fast-moving field of vaccines, cytokine and cellular therapy.

Cytotherapy’s impact factor is rising steadily: 0.8 in 2003, 1.4 in 2004, and 1.8 in 2005 (Thomson © 2005) and 2.2 in 2006 (*© Thomson ISI Journal Citation Reports 2007).  Now is your chance to purchase this excellent source of cutting edge research at a 25% discounted rate.

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Forthcoming Issue: Volume 9, Number 4, 2007

Review
BM-derived cell therapies for cardiovascular disease
RO Cannon III, CE Dunbar

Original Papers

Mesenchymal stromal cells
Surface Characterization & Chondrogenic Differentiation of Mesenchymal Stromal Cells Derived from Synovium. CH JO, HJ AHN, HJ KIM, SC SEONG, MC LEE.

The Influence of Freezing and Storage on Characteristics and Functions of Human Mesenchymal Stromal Cells Isolated for Clinical Use. M HAACK-SORENSEN, L BINDSLEV, S MORTENSEN, T FRIIS, J KASTRUP.

Co-culture of Cord Blood CD34+ Cells with Human Bone Marrow Mesenchymal Stromal Cells Enhances Short-Term Engraftment of Cord Blood Cells in NOD/SCID Mice. XM FEI, YJ WU, Z CHANG, KR MIAO, Y TANG, XY ZHOU, LX WANG, QQ PAN, CY WANG.

Hematopoietic stem cells
Adverse Events After Infusions of Cryopreserved Hematopoietic Stem Cells Depend on Non-Mononuclear Cell in Infused Suspension and on Patient Age. G MILONE, S MERCURIO, A STRANO, S LEOTTA, V PINTO, K BATTIATO, S COPPOLETTA, P MURGANO, B FARSACI, A PRIVITERA, R GIUSTOLISI.

Peripheral Blood Stem Cell Collection in Extremely Low Weight Infants: Single Center Experience. J SEVILLA, SF PLAZA, M GONZALEZ-VINCENT, A LASSALETTA, M RAMIREZ, L MADERO, MA DIAZ.

Umbilical Cord cells
In Vitro Differentiation of Human Cord Blood Derived Unrestricted Somatic Stem Cells (USSC) Towards in Endodermal Pathway. S SENSKEN, S WACLAWCZYK, AS KNAUPP, T TRAPP, J ENCZMANN, P WERNET, G KOGLER.

Cytokines
Bovine Dialyzable Leukocyte Extract Modulates Cytokines and Nitric Oxide Production in LPS-simulated Human Blood Cells. MA FRANCO-MOLINA, E MENDOZA-GAMBOA, P CASTILLO-TELLO, CE ISAZA-BRANDO, ME VERA GARCIA, L CASTILLO-LEON, RS TAMEZ-GUERRA, C RODRIGUEZ-PADILLA.

Tumor immunotherapy
Induction of Potent Antitumor Immunity by Direct Injection of Ad-LIGHT at the Site of Tumor Inoculation. J ZHANG, Q WANG, D ZHAO, X CAO.

Meeting Report
Progress in Characterization, Preparation and Clinical Applications of Non-hematopoietic Stem Cells. R SCHÄFER, M DOMINICI, I MÜLLER, F DAZZI, K BIEBACK, K GODTHARDT, K LEBLANC, R MEISEL, R POCHAMPALLY, R RICHTER, T SKUTELLA, G STEINHOFF, M MITTERBERGER, HP WENDEL, J WISKIRCHEN, R HANDGRETINGER, H NORTHOFF.

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