Volume 11.06 | Feb 22

Cell Therapy News 11.06, February 22, 2010.
In this issue:  Science  |  Policy  |  Business  |  NIH  |  CBER  |  Regulatory  |  Events Unsubscribe


Penn Researchers Present Phase II HIV Gene Therapy Trial Data at the Conference on Retroviruses and Opportunistic Infections (CROI) 2010
The current study examined the effect of Lexgenleucel-T infusions in HIV-1 infected individuals prior to being taken off their antiretroviral treatment regimens as part of the study design’s scheduled treatment interruption. [University of Pennsylvania School of Medicine Press Release]



Induced Pluripotent Stem Cells from Patients with a Premature Aging Disorder Bring Surprises
In a study that ties stem cell research together with research on aging and cancer, investigators have used genetic reprogramming to create cells from patients with a rare premature-aging disorder that are able to rebuild their telomeres. [Press release from the Children's Hospital Boston discussing the online prepublication in Nature]

McGill Discovery Offers Hope in Diabetes
The team discovered mutations in RFX6 and found that these mutations are the cause of a rare syndrome of neonatal diabetes involving the complete absence of islets of Langerhans. [Press release from McGill University discussing the online prepublication in Nature]

'Blindfold Handshake' in the Cell Prevents Diseases
Researchers have uncovered how cells ensure inheritance of their genetic information in order to prevent diseases. [Press release from University of Dundee discussing the online prepublication in Developmental Cell]

Scientists Discover Molecular Pathway for Organ Tissue Regeneration and Repair
Scientists have discovered a molecular pathway that works through the immune system to regenerate damaged kidney tissues and may lead to new therapies for repairing injury in a number of organs. [Press release from the Cincinnati Children's Hospital Medical Center discussing the online prepublication in the Proceedings of the National Academy of Sciences USA]

'Death' Proteins Help Stem Cells Develop: Study
Stem cells that can repair and regenerate tissues may need to get their DNA chopped up as a normal part of growing up and turning into specialized cells like muscle cells, Ottawa researchers have found. [Press release from the Canadian Broadcasting Corporation discussing the online prepublication in the Proceedings of the National Academy of Sciences USA]

Induced Pluripotent Stem Cells Not Yet Reliable for Clinical Use
A new study comparing the ability of induced cells and embryonic cells to morph into the cells of the brain has found that induced cells – even those free of the genetic factors used to program their all-purpose qualities – differentiate less efficiently and faithfully than their embryonic counterparts. [Press release from the University of Wisconsin School of Medicine discussing the online prepublication in the Proceedings of the National Academy of Sciences USA]

Stem Cell Capsules to Target Broken Bones
A new way of delivering stem cells could one day lead to a single injection to mend broken or diseased bones and joints, French and Australian scientists say. [Press release from the Australian Broadcasting Corporation discussing the online prepublication in the Proceedings of the National Academy of Sciences USA]

Gene Transfer: Stick-On Protection
A research team has now designed a new polymer coating that protects viral vectors – making them resistant to serum within the body. [Press release from the Institute of Bioengineering and Nanotechnology of A*STAR discussing the online prepublication in Biomaterials]

Personalized Blood Tests for Cancer Using Whole Genome Sequence
Scientists have used data from the whole genome sequencing of cancer patients to develop individualized blood tests they believe can help physicians tailor patients' treatments. [Press release from the Johns Hopkins Kimmel Cancer Center discussing the online prepublication in Science Translational Medicine]

Athersys Announces Completion of Patient Enrollment in Phase I Study of Multistem® in Acute Myocardial Infarction
Athersys, Inc. announced that it has completed patient enrollment for its phase I clinical trial of MultiStem®, its allogeneic stem cell therapy product, administered to individuals following acute myocardial infarction. [Athersys, Inc. Press Release]

Vascular Endothelial Growth Factor Trap-Eye Shows Positive Results in Phase II Study in Patients with Diabetic Macular Edema
Bayer HealthCare AG and Regeneron Pharmaceuticals, Inc. announced that vascular endothelial growth factor Trap-Eye showed positive results in a Phase II study in patients with Diabetic Macular Edema. [Bayer HealthCare AG Press Release]


Telomere Elongation in Induced Pluripotent Stem Cells from Dyskeratosis Congenita Patients
Researchers show that reprogrammed dyskeratosis congenita cells overcome a critical limitation in telomerase RNA component levels to restore telomere maintenance and self-renewal. [Nature]

Rfx6 Directs Islet Formation and Insulin Production in Mice and Humans
Studies demonstrate a unique position for Rfx6 in the hierarchy of factors that coordinate pancreatic islet development in both mice and humans. [Nature]

Kinetochores Generate Microtubules with Distal Plus Ends: Their Roles and Limited Lifetime in Mitosis
Researchers provide evidence that, during early mitosis in budding yeast, microtubules are generated at kinetochores with distal plus ends. [Dev Cell]

Macrophage Wnt7b is Critical for Kidney Repair and Regeneration
Researchers show, using the kidney as a model, that the Wnt pathway ligand Wnt7b is produced by macrophages to stimulate repair and regeneration. [Proc Natl Acad Sci U S A]

Caspase 3/Caspase-Activated DNase Promote Cell Differentiation by Inducing DNA Strand Breaks
Inhibition of caspase 3 or reduction of caspase-activated DNase expression leads to a dramatic loss of strand-break formation and a block in the myogenic program. [Proc Natl Acad Sci U S A]

Neural Differentiation of Human Induced Pluripotent Stem Cells follows Developmental Principles but with Variable Potency
Researchers have shown that human induced pluripotent stem cells use the same transcriptional network to generate neuroepithelia and functionally appropriate neuronal types over the same developmental time course as human embryonic stem cells in response to the same set of morphogens; however, they do it with significantly reduced efficiency and increased variability. [Proc Natl Acad Sci U S A]

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United States “Tweaks” Stem Cell Policy
The United States government broadened the definition of a human embryonic stem cell on Friday, helping qualify several corporate and academic experiments for federal funding. [National Institutes of Health, United States]

Bills to Modify Stem Cell Amendment Held Up in Senate
A package of six bills to modify Michigan's constitutional amendment that permits embryonic stem cell research appears to be stalled in the Senate because Majority Leader Mike Bishop is concerned the changes could lead to job losses and may not reflect voters' intent in voting for the amendment. [Michigan Senate, United States]

National Institutes of Health Guidelines for Stem Cell Research and Gamete Donors
Investigators argue that dispositional authorization after disclosure regarding human embryonic stem cell research should be obtained from third-party gamete donors, but that the requirements may be more flexible and less complex than for informed consent. [Science Policy Forum]


Printing Body Parts – Making a Bit of Me
The ability to make organs as they are needed would not only relieve suffering but also save lives. And that possibility may be closer with the arrival of the first commercial 3D bio-printer for manufacturing human tissue and organs. [The Economist]

Thermo Fisher Said to Offer $6 Billion for Millipore
Thermo Fisher Scientific Inc. made an unsolicited takeover offer of about $6 billion for Millipore Corp., according to a person close to the situation. [Bloomberg Business Week]

ReNeuron and Schepens Eye Research Institute Receive Unrestricted Industrial Grant to Support United States Retinal Stem Cell Collaboration
ReNeuron Group plc announced that its ongoing United States collaboration with the Schepens Eye Research Institute at Harvard Medical School will benefit from an unrestricted grant to advance retinal research at Schepens from a leading United States specialty healthcare company. [ReNeuron Group plc Press Release]

Neuralstem Completes $5.25 Million Financing
Neuralstem, Inc. announced that it has raised a total of $5,228,000 since the beginning of the year, comprised of a previously disclosed $1.5 million private placement of 646,551 common shares at $2.32, priced at a 30 percent premium over the market on the closing, and approximately $3.7 million from warrant exercises. [Neuralstem, Inc. Press Release]

Sanofi-Aventis Enters French Research Partnership
French drugmaker Sanofi-Aventis said recently that it has formed a research partnership with France's National Alliance for Life Sciences and Healthcare to boost research in areas such as aging, infectious diseases and regenerative medicine. [Forbes]

Dutch Groups Team on Personalized Medicine Project
Three Dutch institutes have joined forces in a public-private partnership to invest 28 million euros in personalized medicine projects. [eBioNews]

Stem Cell Firm Cellular Dynamics Raises $40.6 million
Madison-based Cellular Dynamics Inc. has raised $40.6 million, according to a filing the company made with the Securities and Exchange Commission. [Journal Sentinel]

University of California, Irvine Seeks $15 Million for ‘Mouse House’
University of California, Irvine says it has asked the federal government for $15 million to create a major vivarium – or rodent housing facility – in the $66 million stem cell research institute that’s scheduled to open on campus in July. [The Orange County Register]


NIH Stem Cell Guidelines Should Be Modified, University of California, San Francisco Team Reports
A University of California, San Francisco team, led by bioethicist Bernard Lo, MD, recommends that the National Institutes of Health ethics guidelines for embryonic stem cell research be modified to better protect the rights of individuals donating egg or sperm to patients undergoing in vitro fertilization.

NIH Grants to Children's Hospital Will Advance Novel Stem Cell Treatments for Blood Disorders
Two large federal grants recently awarded to The Children’s Hospital of Philadelphia will advance the frontiers of research into cellular therapies.

Status of Certain Human Embryonic Stem Cell Lines (NOT-OD-10-063)

Review Considerations for Applications and Awards under the New NIH Guidelines for Human Stem Cell Research (NOT-OD-10-056)

UPDATE TO RFA-OD-10-009: OS Recovery Act Limited Competition: Methodology Development in Comparative Effectiveness Research (RC4) Announcement of Non-Applicability of Requirement to Attend Meetings (NOT-OD-10-062)

National Heart, Lung, and Blood Institute Will Provide Limited Supplemental Support to the National Institute of General Medical Sciences Medical Scientist Training Program in FY 2010 (NOT-HL-11-103)

Delays in Grant Application Submission to Agency for Healthcare Research and Quality due to Recent Winter Storm (NOT-HS-10-013)

Ruth L. Kirschstein National Research Service Awards for Individual Predoctoral MD/PhD and Other Dual Doctoral Degree Fellows (Parent F30) (PA-10-107)

Ruth L. Kirschstein National Research Service Awards for Individual Predoctoral Fellows (Parent F31) (PA-10-108)

Ruth L. Kirschstein National Research Service Awards for Individual Predoctoral Fellowships to Promote Diversity in Health-Related Research (Parent F31 – Diversity) (PA-10-109)

Ruth L. Kirschstein National Research Service Awards (NRSA) for Individual Postdoctoral Fellows (Parent F32) (PA-10-110)

Ruth L. Kirschstein National Research Service Awards (NRSA) for Individual Senior Fellows (Parent F33) (PA-10-111)

Recovery Act Limited Competition: Program to Enhance National Institutes of Health-Supported Global Health Research Involving Human Subjects (S07) (RFA-OD-10-006)

Institutional Clinical and Translational Science Award (U54) (RFA-RM-10-001)

Notice of Intent to Establish a New National Institutes of Health Common Fund Program: Library of Integrated Network-Based Cellular Signatures (LINCS) (NOT-RM-10-002)

Investigator Initiated Multi-Site Clinical Trials (Collaborative R01) (PAR-10-096)


2010 Meeting Materials, Vaccines and Related Biological Products Advisory Committee – Draft Agenda, Member Roster, Posted

U.S. Food and Drug Administration Statement: The Impact of February’s Inclement Weather on Prescription Drug User Fee Act and Medical Device User Fee Act Deadlines



The 13th US-Japan Cellular and Gene Therapy Conference on Systems Biology in Cell Cycle Regulation

2009 Ask the Food and Drug Administration and Clinical Laboratory Improvement Amendments Transcript

Office of the Commissioner Reorganization; Statement of Organizations, Functions, and Delegations of Authority


Expressions of Interest for Membership of the Therapeutic Goods Committee


14th Annual Hilton Head Workshop
March 10-14, 2010
Hilton Head Island, United States

12th Biennial Canadian Blood and Marrow Transplant (CBMT) Consortium Meeting
April 7-10, 2010
Vancouver, Canada

American Association for Cancer Research (AACR) 101st Annual Meeting 2010
April 17-21, 2010
Washington, DC, United States

Institut National de la Santé et de la Recherche Médicale (INSERM) Induced Pluripotent Stem Cell Workshop: Human Induced Pluripotent Stem Cells, Reprogramming and Differentiation
April 21-23, 2010
St-Raphaël, France

Society for Biological Engineering's (SBE) 2nd International Conference on Stem Cell Engineering
May 2-5, 2010
Boston, United States

Select BioSciences' 4th Annual RNAi & miRNA World Congress
May 5-7, 2010
Boston, United States

World Stem Cells & Regenerative Medicine Congress 2010
May 11-13, 2010
London, United Kingdom

16th International Society for Cellular Therapy (ISCT) Meeting
May 23-26, 2010
Philadelphia, United States

ESTOOLS International Scientific Symposium
May 26-28, 2010
Lisbon, Portugal

International Society for Stem Cell Research (ISSCR) 8th Annual Meeting
June 16-19, 2010
San Francisco, United States

United Kingdom National Stem Cell Network (UKNSCN) 3rd Annual Scientific Conference
July 12-14, 2010
Nottingham, United Kingdom

2nd International Conference on Cellular and Molecular Bioengineering (ICCMB2)
August 2-4, 2010
Singapore City, Singapore

Select BioSciences' 3rd Annual Stem Cells Europe Conference
August 24-25, 2010
Edinburgh, Scotland

International Society of Cell Therapy (ISCT) Annual Meeting – Europe
September 11-14, 2010
Belgirate, Italy

2010 World Stem Cell Summit
October 4-6, 2010
Detroit, United States

Hydra VI: The European Summer School on Stem Cells & Regenerative Medicine
September 11-17, 2010
Hyrda, Greece

5th World Congress on Preventive & Regenerative Medicine (WCRM)
October 5-7, 2010
Hannover, Germany



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