Volume 9.09 | Mar 10

Cell Therapy News 9.09, March 10, 2008
     In this issue: Science | Policy | Business | NIH | CBER | Regulatory
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Top Stories

Study Shows Blood Stem Cells Originate, Are Nurtured in the Placenta: Solving a longstanding biological mystery, UCLA stem cell researchers have discovered that blood stem cells – the cells that later differentiate into all the cells in the blood supply – originate and are nurtured in the placenta.
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Science

Penn Researchers Engineer First System of Human Nerve-Cell Tissue
Researchers at the University of Pennsylvania School of Medicine have demonstrated that living human nerve cells can be engineered into a network that could one day be used for transplants to repair damaged to the nervous system.
Article

Stem Cell Therapy Breakthrough
Researchers in San Francisco have discovered a new way to nudge human embryonic stem cells to form specialized cells – a potentially huge step toward the development of stem cell therapies to repair damaged hearts, nerves and other organs.
Article

Scientists Shed Light on Molecular Alliance Between Key Proteins that Play a Role in Sustaining the Embryonic Stem Cell State
One of the four ingredients in the genetic recipe that scientists in Japan and the U.S. followed last year to persuade human skin cells to revert to an embryonic stem cell state, is dispensable in ES cells, thanks to the presence of a molecular alliance between a specific group of key proteins known as transcription factors, a research team led by the Genome Institute of Singapore (GIS) under the Agency for Science, Technology and Research (A*STAR) reports in Nature Cell Biology.
Article

New Stem Cell Technique Improves Genetic Alteration
UC Irvine researchers have discovered a dramatically improved method for genetically manipulating human embryonic stem cells, making it easier for scientists to study and potentially treat thousands of disorders ranging from Huntington’s disease to muscular dystrophy and diabetes.
Article

Pluristem Submits Pre-IND Application in Germany to Initiate Clinical Trials of PLX-PAD for Peripheral Artery Disease
Pluristem Therapeutics, Inc. has announced that it has filed a Pre-Investigational New Drug application with the Paul Ehrlich Institute in Germany for PLX-PAD, the Company’s product for the treatment of Peripheral Artery Disease.
Article

Doctors Looks to Biologics to Repair Joints
The orthopedics industry is using more biology and less metal to repair injured and diseased joints.
Article

Lifetime Probability of Needing a Stem Cell Transplant is Much Higher Than Previously Reported, Data Shows
New data published in the March issue of Biology of Blood and Marrow Transplantation indicate the probability of an individual in the U.S. needing a stem cell transplant, using either one’s own stem cells or those from a donor, is much higher than previously stated.
Article

Cheek Swab Kits Successful in Recruiting Bone Marrow Donors
A B.C. pilot project using free, Web mail-order cheek swab kits to recruit young and ethnically diverse bone marrow stem cell donors, is being deemed such a whopping success that it’s now being rolled out across Canada.
Article

ABSTRACTS, REVIEWS AND SPECIAL REPORTS

Defining Molecular Cornerstones during Fibroblast to iPS Cell Reprogramming in Mouse
Several groups have demonstrated the reprogramming of differentiated cells to primitive, pluripotent populations, at low efficiency, by expressing a selection of transcription factors. In this study, these factors are provided transiently in order to study the intermediate steps during the generation of induced pluripotent stem (iPS) cells.
Article

A Comparison of Protocols used to Generate Insulin-producing Cell Clusters from Mouse Embryonic Stem Cells
Three protocols for the ES cell based generation of IPCCs were modified and evaluated for (i) their ability to express pancreatic islet genes and proteins and (ii) their capacity to function.
Article

JOB OPPORTUNITIES

Cell Therapy Business Development Leader
Portland, OR (Invitrogen)
Link

Policy

Brazil Court Puts Off Stem Cell Ruling
Brazil’s Supreme Court postponed a decision on whether to permit embryonic stem cell research in Latin America’s largest country after one justice asked Wednesday for more time to study the matter.
Article

Senate Slashes Stem Cell Funds
State senators slashed Gov. Martin O’Malley’s spending plan for stem-cell research to less than one-fourth of last year’s funding level, eliciting an outcry from advocates, who say that such a budget cut would cripple the pioneering work in Maryland.
Article

UK Scientists Urge Bundestag to Legalise Embryonic Stem Cell Research
The directors of a leading British stem cell research group are urging the German Parliament to legalise the use embryonic stem cells for research in their country.
Article

Business

StemCells, Inc. Terminates Its Discussions to Acquire Progenitor Cell Therapy, LLC
StemCells, Inc. has announced it is no longer pursuing a possible acquisition of Progenitor Cell Therapy, LLC, a leading provider of cGMP-quality cell processing services headquartered in Hackensack, NJ.
Article

PrimeGen Biotech LLC and Unidym, Inc. Form Alliance to Optimize Development of Induced Pluripotent Stem Cells
PrimeGen Biotech LLC and Unidym Inc. has announced a corporate alliance focused on exploring new applications for carbon nanotubes in stem cell medicine.
Article

StemCyte Announces Joint Venture With Two Leading Healthcare and Pharmaceutical Companies in India
The creation of a new venture, StemCyte India, continues StemCyte’s international expansion and utilizes the strengths and regional expertise of Apollo Hospitals and Cadila Pharmaceuticals.
Article

Advanced Cell Technology Announces Catheter Supply Agreement with Biologics Delivery Systems Group
Advanced Cell Technology, Inc. has announced that it has reached a supply agreement with Biologics Delivery Systems Group, Cordis Corporation, in which Biologics Delivery Systems will supply catheters for the Phase II human clinical trial of ACT’s myoblast therapy for the treatment of heart failure.
Article

Osteotech Signs Agreement To Distribute Harvest Technologies’ BMAC(TM) System
Osteotech, Inc. has announced that it has entered into a three-year agreement with Harvest Technologies Corporation to distribute the BMAC(TM) (Bone Marrow Aspirate Concentrate) System.
Article

Millipore and Guava Technologies Team Up to Create New Solutions for Fast Growing Cell Biology Market
Millipore Corporation and Guava Technologies, Inc. have announced a long-term partnership to deliver integrated flow cytometry solutions to scientists conducting research in cell biology, including stem cell research.
Article

Millipore Expands Portfolio of Animal-Free Cell Culture Supplements through Partnership with Solabia
Millipore Corporation has announced an agreement with Solabia S.A.S. to distribute animal-free hydrolysates to its biopharmaceutical customers.
Article

Exactech Signs License Agreement for Cartilage Repair Technology, Patent Rights
Exactech, Inc. has announced that its Taiwanese subsidiary, Exactech Taiwan, has entered into an exclusive license agreement with the Industrial Technology Research Institute and the National Taiwan University Hospital for the rights to technology and patents related to the repair of cartilage lesions.
Article

World-first Stem Cell Screening Facility to Target Brain Tumours
More effective treatments for brain cancer will be developed at a tumour-cell testing facility opened on Wednesday, March 5, at The University of Queensland’s Queensland Brain Institute.
Article

First Umbilical Cord Blood Bank to Be Set Up
The first umbilical cord blood bank will start its operation in Vietnam in late April.
Article

Stem Cell Funding for Parkinson’s Disease
The Parkinson’s Disease Society has announced funding of 170k to the University of Bristol for research into how to make stem cells produce dopamine and live longer after they have been transplanted into animals.
Article

TxCell Completes a 10.5 Million Second Round and Initiates Clinical Trials
This round of financing confirms the significant potential of TxCell’s innovative approach and will enable the company to determine the clinical efficacy of treatment with autologous Tr1 cells.
Article

Alnylam Announces Grant of Tuschl II Patent in Japan
Alnylam Pharmaceuticals, Inc. has announced that the Japanese Patent Office has sent notification of an intent to grant a patent (JP Application Number 2002/546670) for the Tuschl II patent series, entitled “RNA Interference Mediating Small RNA Molecules.”
Article

MicroIslet Announces New Scientific Advisory Board
The Company named John B. Buse, M.D., Ph.D., David W. Scharp, M.D., Christopher L. Marsh, M.D., F.A.C.S, Bassam Damaj, Ph.D., Miguel Carlos Riella, M.D., Ph.D., and John Logan, Ph.D. as members.
Article

NIH

NIH to Lighten Up Heavy Peer Review Process
Researchers applying to the US National Institutes of Health for research grants could find the complicated peer-review process easier to navigate in the future under new proposals designed to revamp the outdated system.
Article

Notice of Amendment to the Number of Applications per Applicant Organization and Clarification of Page Limitation for RFA-OD-08-001 “Rare Diseases Clinical Research Consortia (RDCRC) for Rare Diseases Clinical Research Network (U54)” (NOT-OD-08-051)
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Registration Open for the Tenth Annual NIH SBIR/STTR Conference – July 22-23, 2008 (NOT-OD-08-053)
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Hot Topics for Institutional Officials – March, 2008 in Atlanta, GA (NOT-OD-08-056)
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Notice of Public Meeting: Seeking Comments on Implementation of the NIH Public Access Policy (NOT-OD-08-057)
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Correction to Notice-HG-08-002, Administrative Supplements for Making Knockout Mice (NOT-HG-08-003)
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NHLBI Does Not Accept R21 Applications Primarily Related to Cancer Research (NOT-HL-08-113)
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CBER

Approved Biological NDA and ANDA Applications – Update
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Licensed Products and Establishments List – Update
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Importing Biological Specimens for Clinical Testing or Research Use Only (FAQs) – Update
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Guidance for Industry and FDA Staff: Interactive Review for Medical Device Submissions: 510(k)s, Original PMAs, PMA Supplements, Original BLAs, and BLA Supplements
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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 (United States)

Draft Guidance for Industry on Diabetes Mellitus: Developing Drugs and Therapeutic Biologics for Treatment and Prevention; Availability
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Agency Information Collection Activities; Proposed Collection; Comment Request; Certification to Accompany Drug, Biological Product, and Device Applications or Submissions (Form FDA 3674)
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EUROPEAN MEDICINES AGENCY (Europe)

EU Proposes New Regulations for Advanced Therapies
A new framework for advanced therapy products or ATPs is being formulated and the new EU rules are expected to come into effect by the end of 2008, according to PJB news.
Article

ISCT

14th ISCT Annual Meeting

May 17-20, 2008
Downtown Miami, Florida

Full details at: http://www.celltherapysociety.org



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