Volume 9.44 | Nov 10

Cell Therapy News 9.44, November 10, 2008
     In this issue: Science | Policy | Business | NIH | CBER | Regulatory
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Japanese Researchers Make Brain Tissues from Stem Cells: Japanese researchers said Thursday they had created functioning human brain tissues from stem cells, a world first that has raised new hopes for the treatment of disease.


Simple Chemical Procedure Augments Therapeutic Potential of Stem Cells
By attaching a molecule called SLeX to the surface of human cells extracted from bone marrow, researchers have enabled the cells to more effectively travel through vessels and reach sites of injury and replace damaged tissue.

Technical Advance Moves Stem Cells Closer to Clinic
Recently, Michael Shamblott, an assistant professor in the Department of Gynecology and Obstetrics at the Hopkins School of Medicine, and his colleagues were able to successfully culture hESC cell lines on tissue isolated from human umbilical cord blood.

Scientists Confirm a Molecular Clipping Mechanism Behind Stem Cell Development
New research from Rockefeller University scientists now shows that during specific stages of differentiation in mouse embryonic stem cells, crucial marks can be removed by cutting off the end of the histone’s tail.

Tiny Backpacks for Cells
MIT engineers have outfitted cells with tiny “backpacks” that could allow them to deliver chemotherapy agents, diagnose tumors or become building blocks for tissue engineering.

Mice Frozen 16 Years Ago “Resurrected” by Cloning
Generating lines of embryonic stem cells in a novel cloning procedure, a team of Japanese geneticists has successfully created healthy clones of dead animals.

Accordion-like, Biodegradable Scaffold Aids Engineering of New Heart Tissue
The accordion-like honeycomb scaffold is the first to be explicitly designed to match the structural and mechanical properties of native heart tissue, and then living heart cells or stem cells seeded onto such a scaffold would develop into a patch of cardiac tissue

Stanford Research Sheds Light on Key Trigger of Embryonic Stem Cell Differentiation
The researchers found that embryoid bodies have hallmarks of gastrulation and that this process is initiated by a single signaling pathway in embryoid bodies and in real embryos.

Silencing Growth Inhibitors Could Help Recovery from Brain Injury
Silencing natural growth inhibitors may make it possible to regenerate nerves damaged by brain or spinal cord injury, finds a study from Children’s Hospital Boston.

More Alzheimer Patients Receive ‘Protein Factory’ Brain Implants
Clinical testing of implanting small capsules containing protein-producing cells into the brain to treat Alzheimer’s disease, have now been implanted in six patients.

Aldagen Receives Orphan Drug Designation for ALD-101
The designation was granted for the use of ALD-101 to improve patient outcomes by decreasing time to platelet and neutrophil engraftment in patients with inherited metabolic disorders undergoing umbilical cord blood transplantation.

Bone Marrow Transplant Trial Using Proprietary Cell Therapy Receives United States FDA Clearance and Institutional Ethics Approval
Mesoblast Limited recently announced the commencement of a Phase I/II clinical trial in the United States using the patented allogeneic Mesenchymal Precursor Cells in up to 30 patients with haematologic malignancies undergoing bone marrow transplantation.

Clinical Trial Looks to Use Stem Cells to Combat Diabetes
The University of Minnesota is set to begin the first phase-II clinical trial to use stem cells to combat diabetes in the United States.


Menin Regulates the Function of Hematopoietic Stem Cells and Lymphoid Progenitors
This paper reveals a novel and essential role for menin in hematopoietic stem cells homeostasis that was most apparent during situations of hematopoietic recovery, suggesting that menin regulates molecular pathways that are essential during the adaptive hematopoietic stem cells response to stress.

Generation of T Lineage Cells from Human Embryonic Stem Cells in a Feeder Free System
In this report, the researchers show that T cell progenitors can be derived from hESC cultured as embryoid bodies and that they give rise to phenotypically and functionally normal cells of the T lineage when transferred into human thymic tissue implanted in immunocompromised mice.

Differentiation Potential of Multipotent Progenitor Cells Derived from War-Traumatized Muscle Tissue
The site of injury is also the site of healing, and we propose that derided muscle tissue contains cells with robust reparative and regenerative potential.

Induction of Pluripotent Stem Cells from Mouse Embryonic Fibroblasts by Oct4 and Klf4 with Small-Molecule Compounds
This study demonstrates that small molecules identified through a phenotypic screen can compensate for viral transduction of critical factors, such as Sox2, and improve reprogramming efficiency.

De Novo DNA Methylation Promoted by G9a Prevents Reprogramming of Embryonically Silenced Genes
The pluripotency-determining gene Oct3/4 (also called Pou5f1) undergoes postimplantation silencing in a process mediated by the histone methyltransferase G9a.


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Michigan Voters Approve Stem Cell Research Measure
Michigan voters on Tuesday approved Proposal 2, which changes state law to allow people to donate embryos left over from fertility treatments for scientific research.

More Universities Plan Stem Cell Research
The Irish government is coming under increasing pressure to legislate on stem cell research as two more Irish colleges are expected to follow University College Cork and carry out trials.


Genzyme and Osiris Partner to Develop and Commercialize First-in-Class Adult Stem Cell Products
Genzyme Corp. and Osiris Therapeutics announced recently that they have entered a strategic alliance for the development and commercialization of Prochymal and Chondrogen, two novel, late-stage adult stem cell treatments that hold significant potential to treat a wide range of diseases.

BioLife Solutions to Supply CryoStor(TM) to Cryobanks International as Standard Media for Preservation and Storage of Umbilical Cord Blood Stem Cells
BioLife Solutions Inc. recently announced that it will supply its CryoStor biopreservative freezing media to Cryobanks International for long-term storage of stem cells isolated from umbilical cord blood.

NeoStem, Inc. to Enter the Regenerative Medicine Market in Asia
NeoStem announced recently that it has agreed to acquire a Hong Kong corporation, whose wholly-owned subsidiary, Beijing HuaMeiTai Bio-technology Limited Liability Company, has a series of contracts with Shandong New Medicine Research Institute of Integrated Traditional and Western Medicine LLC.

Aldagen and University of California Davis Form Collaboration Related to Neural Diseases
Aldagen and UC Davis Health System will collaborate to explore the activity of Aldagen’s unique adult stem cell population in a preclinical model of ischemic stroke.

Ceregene Phase 2 Clinical Trial for Alzheimer’s Disease to be Funded by $5.4 Million Grant from National Institutes of Health
The University of California, San Diego has received a $5.4 million grant from the National Institute of Aging at the National Institutes of Health to support a Phase 2 clinical study of Ceregene’s CERE-110, a gene therapy product designed to deliver nerve growth factor for the treatment of Alzheimer’s disease.

Osiris Leads Stem Cell Field as First Company to Turn Profit 
Osiris Therapeutics Inc. became the first developer of stem cell therapies to turn a profit after selling an implantable stem-cell product used in fractures to another company and earning $5.3 million in the third quarter.

MOLOGEN AG Receives Patent for Cell Based Gene Therapy
The Berlin biotech company MOLOGEN AG announced recently that the Russian patent office will issue a patent for its cell based gene therapy against cancer (MGN1601).


New NIH Policy Establishes Goals to Support Scientists Early in Their Careers
The National Institutes of Health announced recently a new policy establishing goals to encourage funding for scientists new to NIH and those who are at an early stage in their careers.

NIH Announces the Opportunity for Funded Extensions and/or One-Time Administrative Supplements to Grants Located in Galveston, Texas Affected by Hurricane Ike

Error Correction Window Extended to November 14, 2008 for NIH, AHRQ and NIOSH Grant Applications Due November 3-10, 2008

Notice of Clarification of Eligibility Criteria for NIH Director’s New Innovator Award


Notice to HCT/P Establishments: FDA Form 3356 Annual Tissue Establishment Registration/Listing – 2008

Current Licensed Establishments and Products by Establishment – Update

Current Licensed Establishments and Products by Product – Update



Agency Information Collection Activities; Proposals, Submissions, and Approvals – Guidance for Industry on Formal Dispute Resolution; Appeals Above the Division Level

Vaccines and Related Biological Products Advisory Committee; Notice of Meeting

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