Volume 10.30 | Aug 3

Cell Therapy News 10.30, August 3, 2009
     In this issue: Science | Policy | Business | NIH | CBER | Regulatory
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Top Stories

United States FDA Clears the REGEN Trial to Test Bioheart’s Combination Gene and Stem Cell Therapy in Heart Failure Patients: The REGEN trial will enroll 15 patients in a multicenter, randomized, dose escalation study to assess the safety and cardiovascular effects of the implantation of MyoCell SDF-1 in congestive heart failure patients post myocardial infarction(s). [Bioheart, Inc., Sunrise]


New: Mammary Epithelial Cell Colony Interactive Tutorial

– Zoom-in and zoom out of bi-potent colonies to view details
– Highlight luminal and basal structures in 3D morphogenesis structures

Try the tutorial now

Scientists Closer to Making Implantable Bone Material
Scientists from Imperial College London have compared the ‘bone-like’ material grown from three different commonly used clinically relevant cell types and have discovered significant differences between the quality of bone-like material that these can form. [Imperial College London, London]

Researchers Rapidly Turn Bacteria into Biotech Factories
Using a novel cell programming method that retools evolution to generate genetic diversity at an unprecedented rate, a research team turned self-serving bacteria into efficient factories for making a variety of compounds. [Harvard Medical School, Boston]

Male Germ Cells Can Be Directly Converted Into Other Cell Types
Researchers have found a way to directly convert spermatogonial stem cells, the precursors of sperm cells, into tissues of the prostate, skin and uterus. [University of Illinois at Urbana-Champaign, Champaign]

Injection Reverses Heart Attack Damage
Injured heart tissue normally can’t regrow, but researchers at Children’s Hospital Boston have now laid the groundwork for regenerating heart tissue after a heart attack, in patients with heart failure, or in children with congenital heart defects. [Children’s Hospital Boston, Boston]

Reprogramming Human Cells Without Inserting Genes
A research team has discovered a novel way to turn on stem cell genes in human fibroblasts (skin cells) without the risks associated with inserting extra genes or using viruses. [Worcester Polytechnic Institute, Worcester]

Placenta-derived Stem Cells May Help Sufferers of Lung Diseases
According to Italian researchers cells delivered via intra-peritoneal transplant, regardless of the cells being allogenic or xenogenic resulted in a significant anti-fibrotic effect on the lab animals. [Centro di Ricerca E. Menni, Brescia]

Scientists Program Blood Stem Cells To Become Vision Cells
University of Florida researchers were able to program bone marrow stem cells to repair damaged retinas in mice, suggesting a potential treatment for one of the most common causes of vision loss in older people. [University of Florida, Gainesville]

United States FDA Clears the REGEN Trial to Test Bioheart’s Combination Gene and Stem Cell Therapy in Heart Failure Patients
The REGEN trial will enroll 15 patients in a multicenter, randomized, dose escalation study to assess the safety and cardiovascular effects of the implantation of MyoCell SDF-1 in congestive heart failure patients post myocardial infarction(s). [Bioheart, Inc., Sunrise]

ReNeuron Receives UK Ethics Committee Favorable Opinion for Stroke Clinical Trial
ReNeuron Group plc recently announced that the UK Gene Therapy Advisory Committee has issued a Favorable Opinion subject to conditions in respect of ReNeuron’s proposed Phase I clinical trial with its ReN001 stem cell therapy for stroke. [ReNeuron, Guildford]

Osiris Achieves Milestone Payment for Progress Developing Stem Cell Therapy for Type 1 Diabetes
Osiris Therapeutics, Inc. recently announced that it has achieved a $750,000 milestone payment from the Juvenile Diabetes Research Foundation (JDRF) for progress made on a Phase II clinical trial evaluating Prochymal, as a treatment for patients recently diagnosed with type 1 diabetes. [Osiris Therapeutics, Inc., Columbia]


Study on Sperm Made From Stem Cells Retracted for Plagiarism
A scientific journal has retracted a paper that reported researchers had created human sperm from stem cells because a section of the article was plagiarized, the editor of the journal, Stem Cells and Development, said recently.

In Vitro Derivation of Human Sperm from Embryonic Stem Cells
The researchers in this stud developed an in vitro strategy for establishing of male GSCs from human embryonic stem cells. [Stem Cells and Development]

Protein Kinase C{gamma} Mediates Regulation of Proliferation by the Serotonin 5-Hydroxytryptamine Receptor 2B
Activation of the 5-hydroxytryptamine receptor 2B (5-HT2B), a Gq/11 protein-coupled receptor, results in proliferation of various cell types. [Journal of Biological Chemistry]

Cultivated Human Conjunctival Epithelial Transplantation for Total Limbal Stem Cell Deficiency
The purpose of this study was to determine the feasibility of cultivated conjunctiva as a viable epithelial sheet for transplantation and corneal resurfacing in eyes with limbal stem cell deficiency. [Investigative Ophthalmology and Visual Science]

Characterization in Vitro and Engraftment Potential in Vivo of Human Progenitor T Cells Generated from Hematopoietic Stem Cells
Human umbilical cord blood hematopoietic stem cells were induced to differentiate to the T lineage in OP9-DL1 co-cultures to elucidate molecular and cellular events occurring at early stages of human T-cell development. [Blood]

Muscle Stem Cell Behavior is Modified by MicroRNA-27 Regulation of Pax3 Expression
The researchers identified microRNA-27b (miR-27b), which directly targets the 3′-UTR of Pax3 mRNA, as a regulator of skeletal muscle stem cells are regulation. [Proceedings of the National Academy of Sciences]

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Research and Development Scientist – Stem Cell Biology

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Obama Enacts New U.S. Stem Cell Research Rules
U.S. President Barack Obama directed federal agencies on Thursday to enact new rules governing federally funded research on human embryonic stem cells.

Germany Tightens Law on Stem Cell Treatments
Treatments in Germany involving adult stem cells will be more closely regulated after revision of Germany’s medical products law received final approval by the Bundesrat, the upper house of parliament.


Connexon Creative Launches Cord Blood News
Cord Blood News is a weekly e-newsletter that keeps members of the cord blood community informed by providing the latest news from all areas of the field, including its science, research, policy, and business.

Developing Gene Therapy to Fight Blindness
An international team of scientists and clinicians from the United States and Saudi Arabia are working to develop gene therapy for treating a rare, hereditary retinal disease. [University of California, San Diego School’s Shiley Eye Center, San Diego]

North Carolina Mayors to Talk Biotech
North Carolina Mayors agreed to pursue priorities in several areas, including support for funding of innovation, educating citizens about biotech job opportunities and benchmarking best practices from communities around the state, according to an announcement that followed the closed-door session.

Living Cell Technologies Raises A$4.2m from a Placement of Shares to Fund Clinical Trials of DIABECELL(R)
Living Cell Technologies Limited announced that it has closed a private placement of share capital raising A$4.2m. [Living Cell Technology, Sydney]

Pennsylvania Researchers Win Fight Over Stem Cell Patent
Two University of Pittsburgh researchers won a patent ruling over their discovery that stem cells gleaned from liposuctioned fat could be used to produce bone, cartilage and muscle. [University of Pittsburgh, Pittsburgh]


Recovery Act of 2009: Information on Quarterly Reporting Requirements for NIH Award Recipients (NOT-OD-09-129)

Corrections to the Instructions in SF424 (R&R) Individual Fellowship Application Guide for NIH and AHRQ (NOT-OD-09-131)


Guidance for Industry: Nucleic Acid Testing (NAT) to Reduce the Possible Risk of Parvovirus B19 Transmission by Plasma-Derived Products

Exceptions and Alternative Procedures Approved Under 21 CFR 640.120



Wisconsin Law Professor Tapped for FDA Job
A University of Wisconsin-Madison law professor, Alta Charo, will work as a senior adviser in the Office of the Commissioner starting Aug. 30.

Science Board to the Food and Drug Administration; Notice of Meeting, August 17, 2009

Agency Information Collection Activities; Class II Special Controls Guidance Document: Automated Blood Cell Separator Device Operating by Centrifugal or Filtration Separation Principle

Agency Information Collection Activities; Request for Samples and Protocols

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