Volume 9.45 | Nov 17

Cell Therapy News 9.45, November 17, 2008
     In this issue: Science | Policy | Business | NIH | CBER | Regulatory
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Top Stories

A Doctor, a Mutation and a Potential Cure for AIDS: The startling case of an AIDS patient who underwent a bone marrow transplant to treat leukemia is stirring new hope that gene-therapy strategies on the far edges of AIDS research might someday cure the disease.


Stem Cells with Potential to Regenerate Injured Liver Tissue Identified by Penn Researchers
A novel protein marker has been found that identifies rare adult liver stem cells, whose ability to regenerate injured liver tissue has the potential for cell-replacement therapy.

Plastic Additives Leach into Medical Experiments, Research Shows
A group of scientists warned Thursday that disposable plastic laboratory equipment – things like test tubes and pipette tips – may exude compounds that can interact with solutions or cells placed in them, leading to skewed results.

Umbilical Cord Blood May Help Build Heart Valves
In what is called a concept study, researchers showed it was possible to collect blood from the umbilical cord at birth, harvest the stem cells and then make a heart valve that is ready when the baby needs it.

Yerkes Researchers Find Stem Cells from Monkey Teeth Can Stimulate Growth and Generation of Brain Cells
Rhesus monkey dental stem cells show the ability to produce different types of cells, illustrating the potential for cell therapy and regenerative medicine.

Intraspinal Implant of Mesenchymal Stem Cells May Not Heal the Demyelinated Spinal Cord
Researchers from the University of Cambridge conducted experiments using animal models to see if the direct implantation of multipotent mesenchymal stem cells into the demyelinated rat spinal cord would be therapeutic and remyelinate the sheath surrounding the nerve fibers of the spinal cord in multiple sclerosis.

Engineered Killer T-Cell Recognizes HIV-1’s Lethal Molecular Disguises
Researchers at the University of Pennsylvania School of Medicine and colleagues in the United Kingdom have engineered T cells able to recognize HIV-1 strains that have evaded the immune system.

Researchers have Identified a Novel Mechanism in the Regulation and Differentiation of Neural Stem Cells.
University of Southern California researchers found that the protein receptor Ryk has a key role in the differentiation of neural stem cells, and demonstrated a signaling mechanism that regulates neuronal differentiation as stem cells begin to grow into neurons.

Celgene Cellular Therapeutics Receives FDA Clearance for First Placenta-Derived Stem Cell Clinical Study
Celgene Cellular Therapeutics recently announced the U.S. Food and Drug Administration has accepted the company’s investigational new drug application to initiate a clinical trial using PDA001, an immunomodulatory therapy utilizing human placenta-derived stem cells obtained via CCT’s proprietary processes.

Children’s Hospital of Pittsburgh’s Study Demonstrates Unique Form of Bone Marrow Transplant Can Cure Sickle Cell Disease
A unique approach to bone marrow transplantation pioneered in part by a Children’s Hospital of Pittsburgh physician has proven to be the only safe and effective cure for sickle cell disease, according to a new study.

Celladon Announces Presentation of Clinical Data from First-in-Human Mydicar Trial for Advanced Heart Failure
Celladon Corporation announced recently results from the first nine patients treated with MYDICAR, showing the product was safe and demonstrating improvement across a number of key parameters.


Induction of Pluripotent Stem Cells from Primary Human Fibroblasts with only Oct4 and Sox2
Here this study reports that valproic acid, a histone deacetylase inhibitor, enables reprogramming of primary human fibroblasts with only two factors, Oct4 and Sox2, without the need for the oncogenes c-Myc or Klf4.

Efficient and Rapid Generation of Induced Pluripotent Stem Cells from Human Keratinocytes
This paper shows that reprogramming of juvenile human primary keratinocytes by retroviral transduction with OCT4, SOX2, KLF4 and c-MYC is at least 100-fold more efficient and two-fold faster compared with reprogramming of human fibroblasts.

Multipotent Adult Germline Stem Cells and Embryonic Stem Cells have Similar MicroRNA Profiles
Despite the differences regarding time and extent of differentiation observed between embryonic stem cells and multipotent adult germline stem cells, expression profiles of both miRNA families showed similarities between these two cell types.


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Massachusetts Cuts $10M from Biotech’s Billion
The state has cut $10 million from this year’s disbursement of its ambitious $1 billion in biotech industry and research incentives.

Missouri Judge Dismisses Stem Cell Research Lawsuit
A state trial judge dismissed a lawsuit Wednesday filed by critics of embryonic stem cell research who wanted to block $21 million in state funds from going to life sciences research.

Obama Reviewing Bush Orders on Stem Cells
US president-elect Barack Obama is reviewing President George W. Bush’s executive orders on oil drilling and stem cell research and could reverse them, his transition chief said Sunday.


Strategic Alliance with Cenegenics
AssureImmune LLC, recently announced a strategic alliance with an age management company, Cenegenics.

Stem Cell Sciences Enters into Services Agreement with Huntington’s Research Group, CHDI Foundation Inc.
Stem Cell Sciences plc recently announced that it has entered into an agreement with CHDI Foundation, Inc., to support the standardisation of CHDI’s novel mouse embryonic stem cell lines.

SpineSmith Partners Collaborates with University of Texas Biomedical Engineering Students to Develop Innovative Products
SpineSmith Partners is collaborating with several senior design teams in The University of Texas Biomedical Engineering Department to help educate students on the design, engineering, and commercialization process of medical devices.

Sigma-Aldrich Enters Distribution Agreement With AlphaGenix, Inc.
Sigma-Aldrich recently announced a distribution agreement with AlphaGenix, Inc. and will now be the exclusive supplier of AlphaGenix-developed antibodies and research tools for the fields of regenerative medicine and stem cell biology.

Pfizer Launches Global Regenerative Medicine Research Unit
Scientists at Pfizer Regenerative Medicine will explore the use of stem cells to develop future treatments that may prevent disability, repair failing organs and treat degenerative diseases.

Stem Cell Sciences Reinforces its International Patent Position in Stem Cell Technologies
Stem Cell Sciences plc announced that European patent no. 0695361 covering its IRES technology was upheld by the European Patent Office, and that the UK Intellectual Property Office granted UK Patent 2428041 for obtaining cells by episomal expression.

New Patent Granted for HA-Mediated Cell Mobilization
Orcrist Bio Inc. announced recently that the U.S. Patent and Trademark Office has approved the issuance of a patent relating to the company’s ORC-HYC750 drug candidate for the treatment of chemotherapy-related blood cell depletion and other underserved clinical indications.


Extension of Expiration Date for PA-06-042 Academic Research Enhancement Award (AREA): Parent R15 (NOT-OD-09-018)

Request for Information (RFI): Acquisition, Processing, Preservation, and Distribution of Human Tissues to Advance Understanding and Treatment of Developmental Disabilities (NOT-HD-09-005)


Fatalities Reported to FDA Following Blood Collection and Transfusion Annual Report – FY 2007



Agency Information Collection Activities; Proposals, Submissions, and Approvals, 66901–66906 [E8–26863] – Current Good Manufacturing Practices and Related Regulations for Blood and Blood Components; and Requirements for Donor Testing, Donor Notification, and “Lookback”


Blood/Fluid Warming Systems: Blood/Fluid Warmer Unit – The Surgical Company International BV – Fluido SA 200


Standards for Blood, Blood Components and Plasma for Fractionation

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