Volume 9.19 | May 19

Cell Therapy News 9.19, May 19, 2008
     In this issue: Science | Policy | Business | NIH | CBER | Regulatory
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Top Stories

Embryonic Pathway Delivers Stem Cell Traits: Whitehead Institute for Biomedical Research scientists in the Weinberg lab have shown that both normal and cancer cells that are induced to follow one of these pathways may gain properties of adult stem cells, including the ability to self-renew.


Scientist Uses Chemicals To Create iPS Cells
Sheng Ding, associate professor at the Scripps Research Institute in California revealed Sunday at a science conference in Kyoto that he had succeeded in creating induced pluripotent stem cells of both mice and humans after replacing one or two of the four genes used in creating iPS cells with synthetic chemicals.

Stem Cells Might Contribute to Vascular Disease
A team of scientists – led by Dr. K. Craig Kent, Greenberg-Starr Professor and professor of surgery at Weill Cornell Medical College and chief of the Division of Vascular Surgery at NewYork-Presbyterian – are currently studying how stem cells implant themselves in the wall of arteries and grow out of control.

UC Davis Children’s Hospital Researchers Identify Candidate Adult Bladder Stem Cells
Researchers at UC Davis Children’s Hospital have identified the potential stem cells that become the bladder, adding to the body of research that already has identified stem cells that can regenerate many of the body’s other organs.

Decoding Muscle Stem Cell Development
Muscle stem cells can’t grow into mature muscle cells if there aren’t enough nutrients, according to a study that offers new insight into how developing muscle cells sense and respond to nutrient levels.

How Embryonic Stem Cells Develop Into Tissue-Specific Cells Demonstrated by Hebrew University and Other Researchers
Researchers at the Hebrew University of Jerusalem and elsewhere have succeeded in graphically revealing the mechanism of how embryonic stem cells’s develop into any kind of tissue-specific cells, resolving a long-standing question as to whether the stem cells achieve their development through selective activation or selective repression of genes.

UC Davis Stem Cell Researchers Demonstrate Safety of Gene Therapy Using Adult Stem Cells
A new study by UC Davis researchers provides evidence that methods using human bone marrow-derived stem cells to deliver gene therapy to cure diseases of the blood, bone marrow and certain types of cancer do not cause the development of tumors or leukemia.

MIT Researchers Find Novel Way to Repair Airway Injuries
The new technique heals airway injuries by placing new tracheal cells around the injury site. Two types of tracheal cells, embedded within a three-dimensional gelatin scaffold, take over the functions of the damaged tissue.

FDA Places Geron’s GRNOPC1 IND on Clinical Hold
Geron Corporation announced recently that the company received verbal notice recently from the FDA that the company’s Investigational New Drug submission for GRNOPC1, a cell therapy for spinal cord injury, has been placed on clinical hold.

Argos Therapeutics Initiates Phase 2 Proof-of-Concept Trial for its Arcelis(TM) Personalized Immunotherapy Platform in HIV
Argos Therapeutics recently announced the initiation of a Phase 2a proof-of-concept clinical trial to test the efficacy of its AGS-004 therapy in improving immune control of viral replication in HIV-infected adults. AGS-004 is a product of the Company’s Arcelis(TM) technology, a personalized, RNA-loaded dendritic cell-based immunotherapy that is perfectly matched to each patient’s unique HIV viral burden.

Mesoblast’s Cells Show Long-Lasting and Sustained Effect in Knee Osteoarthritis
Mesoblast Limited recently announced succesful long-term results in its osteoarthritis preclinical trials. A single injection of its propiretary allogeneic, or “off-the-shelf”, adult stem cells into arthritic knees provided sustained protection against cartilage destruction and degeneration for up to nine months.

Mesenchymal Stem Cells Can Suppress Life-Threatening Immune Reaction
Treatment with mesenchymal stem cells has shown to be an effective therapy for patients with severe graft-versus-host disease, a life-threatening complication after allogeneic transplantation with haemopoietic stem cells.

NewYork-Presbyterian/Weill Cornell Gene Therapy Clinical Trial Yields Promising Results for Batten Disease, Fatal Neurological Condition
Promising results from a team of NewYork-Presbyterian Hospital/Weill Cornell Medical Center physician-scientists show that gene therapy is both safe and effective at slowing the progression of Batten disease, or Late Infantile Neuronal Ceroid Lipofuscinosis, a rare, genetic, degenerative neurological disorder that usually becomes fatal in children by the age of 8 to 12.

Microfabrication of Chip-Sized Scaffolds for Three-Dimensional Cell Cultivation
Dr. Stefan Geiselbrecht of the Institute of Biological Interfaces,  presents two processes for the microfabrication of porous polymer chips for three-dimensional cell cultivation.


Efficient Production of Mice from Embryonic Stem Cells Injected Into 4- or 8- Cell Embryos by Piezo Micromanipulation
In this study, researchers report a simple method for producing F0 ES cell- germline competent mice by Piezo injection of ES cells into 4- or 8-cell embryos, making this procedure more efficient and economical in laboratories.

Disturbance of Pro-oxidative/Antioxidative Balance in Allogeneic Peripheral Blood Stem Cell Transplantation
The aims of the study were to determine the effect of allogeneic HSCT on plasma concentrations of antioxidants and oxidative stress biomarkers, and to investigate their relationships with graft-versus-host disease, conditioning regimens, and transplant-related mortality in patients with hematological malignancies.

Functional Recovery in T13–L1 Hemisected Rats Resulting From Peripheral Nerve Rerouting: Role of Central Neuroplasticity
Neurotized SCI animals demonstrated multiparameters of neural reorganization in the distal lumbar cord, including enhanced proliferation of endogenous neural stem cells, increased immunoreactivity of serotonin and synaptophysin, and neurite growth/sprouting, suggesting that anastomosing functional nerves with the nerve stump emerging distal to the hemisection stimulates neuroplasticity in the dysfunctional spinal cord.

Development of a Novel Assay to Evaluate the Functional Potential of Umbilical Cord Blood Progenitors
Although the colony-forming cell assay provides the most relevant information regarding the functional potential of progenitors in a unit of umbilical cord blood, technical challenges associated with this assay have made it difficult to standardize the assay among testing laboratories. The purpose of this study was to assess the reproducibility of a newly developed functional assay (HALO SPC-QC [HALO], HemoGenix, Inc.).


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

Cellular Therapy Laboratory Manager

Cellular Therapy Laboratory Manager

Stem Cell Laboratory Medical Technologist

Stem Cell Laboratory Supervisor

Quality Management Supervisor

Medical Director


New York Governor Paterson Announces Nearly $109 Million in New Stem Cell Research Funding
Governor David A. Paterson recently announced that nearly $109 million in new state funding is being made available to support stem cell research initiatives in New York. The nearly $109 million represents the second round of available funding from the state’s 11-year, $600 million stem cell research initiative that was approved as part of last year’s state budget.

CIRM Bridges to Stem Cell Research Awards
To engage students from California State Universities and other public and private California colleges, CIRM proposes “Bridges to Stem Cell Research Awards,” a program that will provide funds to candidates for certificate, undergraduate, and master’s degree programs in their home institutions to become engaged in stem cell research via internships and associated training activities particularly at research-intensive host institutions carrying out CIRM-sponsored research.

California Institute for Regenerative Medicine Passes Audit
State Controller John Chiang said an audit of the state’s stem cell grant program found its conflict-of-interest policies, grant administration, administrative expenses and expenditures conform with the voter-approved ballot measure that created it.

Biotech Sees Massachusetts Lawmakers as Friends, Foes
Massachusetts’s biotech industry is rebelling against Gov. Deval Patrick, House Speaker Salvatore DiMasi and Senate President Therese Murray because of a provision in a separate health care cost-control bill being pushed by the Senate president.The provision would ban gifts of any kind from pharmaceutical manufacturers to doctors, their family members or their employees – even those pens with the brand names of drugs on them.

Maryland Stem Cell Research Commission Recommends 62 Projects for Funding
The board of directors of the Maryland Technology Development Corporation reviewed the Maryland Stem Cell Research Commission’s recommendations recently and approved 62 projects for funding through the Maryland Stem Cell Research Fund under the Maryland Stem Cell Research Act of 2006.

Curbs to be Relaxed on Stem Cell Consent
Consent provisions that would have banned stem cell research on childhood genetic disease are to be dropped from the Human Fertilisation and Embryology Bill.

Rift Grows as Embryo Laws Nudge Ethical Boundaries
The Human Fertilisation and Embryology Bill was never likely to have an easy passage. With its second reading planned for Monday, the Bill is intended to make the existing legislation, which has been in place for 18 years, “fit for purpose in the 21st century”.


STEMCELL Technologies, Inc. Licenses Geron Intellectual Property for the Development of Media and Matrices for Stem Cell Growth
The non-exclusive license provides STEMCELL with rights under certain Geron patents to develop, manufacture and sell cell culture media and matrix surfaces for research use only.  Geron will receive license payments and is entitled to royalties on sales of products developed under the license. Financial terms of the deal were not disclosed.

Novartis Exercises Rights to Purchase Additional Shares of Alnylam’s Common Stock in Accordance with Terms of Existing Investor Rights Agreement
Alnylam Pharmaceuticals, Inc., announced recently that Novartis has elected to fully exercise its current right to purchase 213,888 unregistered shares of Alnylam’s common stock in accordance with the terms of the Investor Rights Agreement between Alnylam and Novartis, dated September 6, 2005.

VGX Pharmaceuticals Signs Multi-Year Production Agreement with the United Kingdom Cystic Fibrosis Gene Therapy Consortium
Under the terms of the agreement, VGX will provide the United Kingdom Cystic Fibrosis Gene Therapy Consortium multiple batches of a CFTR product to support clinical studies planned to run through 2010. If all options are exercised, several hundred grams of plasmid DNA will be provided, making this agreement one of the largest contracts for non-viral gene therapy products ever undertaken.

NuVasive Signs Definitive Agreement to Acquire Osteocel Biologics Business from Osiris Therapeutics
NuVasive, Inc. announced recently that it has signed a definitive agreement to acquire the Osteocel biologics business from Osiris Therapeutics, Inc.

International Stem Cell Corporation’s Human Parthenogenetic Stem Cells to be Used in the Development of Treatments for Liver Disease
The studies will be carried out under a Material Transfer Agreement between International Stem Cell Corporation and the University of California, San Francisco. Holger Willenbring, MD, UCSF assistant professor of surgery, will direct the research.

Invitrogen Creates Division to Concentrate on Cell Therapy Technology Development
Invitrogen is forming a new business unit that will focus meeting the needs of researchers involved in developing cell therapies. The Cell Therapy Systems segment will operate within the company.

Aldagen, Inc. Files Registration Statement for Initial Public Offering
Aldagen, Inc. recently announced that it has filed a registration statement on Form S-1 with the Securities and Exchange Commission relating to the proposed initial public offering of shares of its common stock.

Biotech: Crunch Time For UK Biotech
The turmoil in the credit markets is jeopardising research that could help millions of lives, warns Sir Chris Evans, one of Britain’s leading scientific entrepreneurs.

Invitrogen Launches New Animal Origin Free Substrate for Stem Cells
Invitrogen Corporation recently announced the launch of CELLstart(TM), the first fully defined, completely animal origin free substrate in the marketplace for the attachment and expansion of embryonic, mesenchymal and neural stem cells.


Fate Therapeutics Taps Succesful Biotech CEO Paul Grayson and John Mendlein for Leadership Team
Paul A. GRayson and John Mendlein have joined Fate Therapeutics as president and CEO and executive chairman respectively.

Stem Cell Sciences Granted Broad US Stem Cell Media Patent
Stem Cell Sciences plc recently announced that the US Patent and Trademark Office has granted its patent for technology that improves the efficiency of the culture and derivation of embryonic stem cells which leads to an increased purity of the cells.

StemCells Files Second Suit Against Neuralstem to Protect Intellectual Property
StemCells, Inc. announced recently that it has moved to protect its reputation and intellectual property rights by filing suit against Neuralstem, Inc. in U.S federal court in Northern California for patent infringement, libel and unfair competition.


NIH Implements New Procedures to Protect NIH Application Data Sent to Peer Reviewers on Compact Disks

Change in Application Receipt Date to RFA-RM-08-001
The purpose of this notice is to change the receipt date to the Funding Opportunity Announcement RFA-RM-08-001: Limited Competition: Construction of a Reference Sequence Data Set for the Human Microbiome Project (U54).


Medical Device Recall: BioArchive – Vapor Bypass Assembly
The BioArchive system is a computer-controlled, robotic liquid nitrogen cryopreservation and storage system that enables the freezing and managing of blood component samples.



FDA Official Sees Push for Clinical Trial Rules
The FDA and the HHS Office for Human Research Protections are working on a final rule for registering institutional review boards, the first of the FDA’s efforts to issue regulations instead of guidances for clinical trials.

Final Guidance on Adverse Events in Clinical Trials Due Soon
The FDA will soon issue a final guidance distinguishing between adverse events and unanticipated problems in clinical trials, clarifying when the former have to be reported to an institutional review board.

Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Adverse Experience Reporting for Licensed Biological Products; and General Records


14th ISCT Annual Meeting

May 17-20, 2008
Downtown Miami, Florida

Full details at: www.celltherapysociety.org

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