Volume 7.02 | Jan 23

Volume 7.02, January 23, 2006
     In this issue: Science | Policy | Business | NIH | CBER | Regulatory
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Top Stories

Powerful Technique for Multiplying Adult Stem Cells May Aid Therapies: Now, researchers in the lab of Whitehead Institute Member and MIT professor of biology Harvey Lodish have discovered a way to multiply an adult stem cell 30-fold, an expansion that offers tremendous promise for treatments such as bone marrow transplants and perhaps even gene therapy.

Requirements on Content and Format of Labeling for Human Prescription Drug and Biological Products; Final Rule: The Food and Drug Administration (FDA) is amending its regulations governing the content and format of labeling for human prescription drug products (including biological products that are regulated as drugs).


Cell Therapy News Introduces New Section for Cell Therapy-related Scientific Journals
Cell Therapy News, the online resource for the cell therapy community, is pleased to announce a new section in its e-newsletter.

Cloned Stem Cells Prove Identical To Fertilized Stem Cells
Scientists generally agree that all cloned animals are biologically flawed. But they don’t agree about what that means for stem cells derived from cloned embryos, the basis for therapeutic cloning.

Science Creates a Living Bandage for Broken Hearts
Merging artificially engineered products with a patient’s own heart to stop or reverse cardiac damage could be the wave of the future, researchers say.

Human Cells Applied as Patch Improve Cardiac Function After Heart Attack, According to a Report in Tissue Engineering
A three-dimensional scaffold populated with human fibroblast cells and applied as a patch to heart muscle damaged by a heart attack improved heart function and stimulated the formation of new blood vessels that supply oxygen and essential nutrients to the heart, according to a report published in the November/December issue (Volume 11, Number 11-12) of Tissue Engineering.

Study Reports Efficacy of Umbilical Cord Blood to Treat Thalassemia Patients
StemCyte discussed a new study which, it says, confirms prior research suggesting that unrelated Umbilical Cord Blood (UCB) transplants may be a promising approach for curative therapy of thalassemia.

Turning Stem Cells into Tissues
Scientists are now integrating genomics, proteomics, and other technologies in an effort to understand the two unique properties of stem cells: their ability to divide indefinitely to create more stem cells, and their ability to differentiate into any number of cell types.

Clinical Trial on Gene Therapy for Macular Degeneration Published in Human Gene Therapy
An adenoviral-based vector containing the gene for human pigment epithelium-derived factor (PEDF) showed evidence of being able to stop disease progression when injected directly into the eyes of patients with neovascular age-related macular degeneration, according to the results of a phase I clinical trial.

Gene Therapy ‘Turns Off’ Mutation Linked to Parkinson’s
A group of Northwestern University researchers is developing a novel gene therapy aimed at selectively turning off one of the genes involved in the development of Parkinson’s disease.

University of Rochester Tests Whether Stem Cells Can Heal Hearts
For the first time, the University of Rochester is testing adult stem cells in patients to see whether the cells can actually repair an organ.

Study Links Alzheimer’s Disease to Abnormal Cell Division
A new study in mice suggests that Alzheimer’s disease (AD) may be triggered when adult neurons try to divide.

Mouse Model Reveals That Oncoprotein Induces Abnormal Preleukemic Blood Cell Progenitors
Scientists have developed a novel mouse model for leukemia that reveals critical information about the mechanisms involved in leukemia progression and provides a model system for evaluation of new drugs for treatment of leukemia.

Immunotherapy May Prevent Neuroblastoma Relapse
A combined cellular and humoral immunotherapy regimen has increased survival rates in a murine model of human disseminated neuroblastoma.

Taiwan Issues Glowing Report on Pigs
Scientific team says that even the internal organs of the fluorescent swine are green


Cardiac Patch Constructed from Human Fibroblasts Attenuates Reduction in Cardiac Function after Acute Infarct
The results shos that the 3DFC as a cardiac patch functioned to attenuate further loss of LV function accompanying acute myocardial infarct and that this may be related in part to myocardial revascularization.

Activation of NK Cells by an Endocytosed Receptor for Soluble HLA-G
This unique stimulation of resting NK cells by soluble HLA-G, which is endocytosed by KIR2DL4, implies that NK cells may provide useful functions at sites of HLA-G expression, such as promotion of vascularization in maternal decidua during early pregnancy.

Identification of Pip4k2ß as a Mechanical Stimulus Responsive Gene and Its Expression During Musculoskeletal Tissue Healing
We suggest that the expression of Pip4k2ß can be used as a marker for cells receiving a suitable mechanical stimulus.


Korea Tightens Rules on Stem Cell Therapy
The Korean government is moving to make it more difficult to launch clinical tests with stem cells here as problems arise from the fast-track processing of requests to conduct experimental cell therapy.

Virginia House Of Delegates Committee Passes Legislation Establishing Cord Blood Bank, USA
The Virginia House of Delegates’ Health, Welfare and Institutions Committee on Tuesday by voice vote passed a bill (HB 413) that would establish a statewide umbilical cord blood bank system

California Institute for Regenerative Medicine Official on Hot Seat
The Oakland-based Center for Genetics and Society said in a report that the new state agency overseeing $3 billion in taxpayer funds over the next 10 years for basic science is not accountable to the public and is going back on campaign promises of affordable cures.


Dendreon Announces Strategic Realignment to Focus on PROVENGE BLA and Commercialization
Dendreon Corporation (Nasdaq: DNDN) announced today the Company has realigned its resources to focus on advancing PROVENGE(R) (sipuleucel-T), its lead investigational active cellular immunotherapy for the treatment of prostate cancer, toward the market as expeditiously as possible.

MicroIslet Inc. (MII) Appoints Dr. James R. Gavin III Interim President And CEO
MicroIslet, Inc. today announced that it has appointed James R. Gavin III, M.D., Ph.D., as its interim President and CEO, effective January 20, 2006. Dr. Gavin has been a member of MicroIslet’s Board of Directors since March 2001.

Vitro and PhosphoSolutions Collaborate to Study Stem Cell Proteomics
Vitro Diagnostics, Inc. (OTC BB: VODG), dba Vitro Biopharma, announced establishment of research collaboration with PhosphoSolutions, LLC (Aurora Colorado) to characterize intracellular signaling mechanisms involved with regulation of stem cell growth and differentiation.

Aniara Corporation Growth Driven by Global Presence and Extensive Product Offering for Medical Exploration and Discovery
Aniara Corporation, a multi-national distributor of diagnostic and research agents, as well as screening tools, has strengthened its commitment to meeting today’s highest standards for porduct quality and cost-efficient delivery.



Directed Stem Cell Differentiation for Cell Based Therapies for Heart, Lung, Blood, and Aging Diseases (SBIR [R43/R44]) (PA-06-124)

Directed Stem Cell Differentiation for Cell Based Therapies for Heart, Lung, Blood, and Aging Diseases (STTR [R41/R42]) (PA-06-125)

Specialized Cooperative Centers Program in Reproduction and Infertility Research (U54)

Sarcoidosis: Research into the Cause of Multi-organ Disease and Clinical Strategies for Therapy (R01) (PA-06-123)


All new CBER information can be reached from the What’s New page at What’s New Page

Cellular, Tissue and Gene Therapies Advisory Committee; Notice of Meeting

Current Good Manufacturing Practice Regulation and Investigational New Drugs; Direct Final Rule
The Food and Drug Administration (FDA) is amending its current good manufacturing practice (CGMP) regulations for human drugs, including biological products, to exempt most investigational “Phase 1” drugs from complying with the requirements in FDA’s regulations.

Requirements on Content and Format of Labeling for Human Prescription Drug and Biological Products; Final Rule

Guidance for Industry: Adverse Reactions Section of Labeling for Human Prescription Drug and Biological Products – Content and Format

Guidance for Industry: Clinical Studies Section of Labeling for Human Prescription Drug and Biological Products – Content and Format

Draft Guidance for Industry: Warnings and Precautions, Contraindications, and Boxed Warning Sections of Labeling for Human Prescription Drug and Biological Products – Content and Format

Draft Guidance for Industry: Labeling for Human Prescription Drug and Biological Products – Implementing the New Content and Format Requirements

Draft Guidance for Industry: INDs – Approaches to Complying with CGMP During Phase 1

Biological Product Deviation Reporting – Codes for Human Tissues and Cellular & Tissue-Based Products – Update

2005 Biological Approvals – Update

Approved Biological NDA and ANDA Applications – Update

Cleared Biological 510(k) Device Applications – Update

Approved Biological Premarket Approval (PMA) Device Applications – Update

Licensed Products and Establishments List – Update

Regulatory SOPP 8407 – Compliance Status Checks

Approval Information – Immune Globulin Subcutaneous (Human) (Vivaglobin) – ZLB Behring, L.L.C


TGA- Therapeutic Goods Administration (Australia)

Therapeutic Goods Order No. 74 Standards for Blood Components


ISCT2006. May 4-7. Berlin.
Click here for the Call for Abstracts and preliminary program or registration information.

AABB-ISCT Cellular Therapy Audioconference Series

Profiled Journal

Current Volume: VOLUME 14, NUMBER 9, 2005



A Role of the Choroid Plexus in Transplantation Therapy
Dwaine F. Emerich, Stephen J. M. Skinner, Cesario V. Borlongan, and Christopher G. Thanos


Minimal Focal Steatosis of Liver After Islet Transplantation in Humans: A Long-Term Study
Paola Maffi, Enzo Angeli, Federico Bertuzzi, Carlo Paties, Carlo Socci, Carlo Fedeli, Francesca De Taddeo, Rita Nano, Valerio Di Carlo, Alessandro Del Maschio, and Antonio Secchi

Generation of Islet-Like Hormone-Producing Cells In Vitro From Adult Human Pancreas
Fouad Atouf, Yong Choi, Michael J. Fowler, Greg Poffenberger, Jan Vobecky, Malancha Ta, George B. Chapman, Alvin C. Powers, and Nadya L. Lumelsky

AN69 Hollow Fiber Membrane Will Reduce But Not Abolish the Risk of Transmission of Porcine Endogenous Retroviruses
Oleg Pakhomov, Lionel Martignat, Jiri Honiger, Béatrice Clémenceau, Pierre Saï, and Sylviane Darquy

Effective Islet Isolation Method With Extremely High Islet Yields From Adult Pigs
Yukihide Yonekawa, Shinichi Matsumoto, Teru Okitsu, Takashi Arata, Yasuhiro Iwanaga, Hirofumi Noguchi, Hideo Nagata, John J. O’Neil, and Koichi Tanaka

The Effects of Bone Marrow-Derived Mesenchymal Stem Cells and Fascia Wrap Application to Anterior Cruciate Ligament Tissue Engineering
Zigang Ge, James Cho Hong Goh, and Eng Hin Lee

Analysis of Allogeneic and Syngeneic Bone Marrow Stromal Cell Graft Survival in the Spinal Cord
Sharon A. Swanger, Birgit Neuhuber, B. Timothy Himes, Ajay Bakshi, and Itzhak Fischer

Purified Human Bone Marrow Multipotent Mesenchymal Stem Cells Regenerate Infarcted Myocardium in Experimental Rats
Shaoheng Zhang, Zhuqing Jia, Junbo Ge, Lizhong Gong, Yanling Ma, Tao Li, Jingxuan Guo, Ping Chen, Qikuan Hu, Ping Zhang, Yonggang Liu, Zhaoping Li, Kangtao Ma, Linsong Li, and Chunyan Zhou

Protection of Photoreceptor Cells From Phototoxicity by Transplanted Retinal Pigment Epithelial Cells Expressing Different Neurotrophic Factors
Toshiaki Abe, Yoko Saigo, Masayoshi Hojo, Tetsuya Kano, Ryosuke Wakusawa, Yumi Tokita, and Makoto Tamai

Synergistic Effect of Keratinocyte Transplantation and Epidermal Growth Factor Delivery on Epidermal Regeneration
So-Jung Gwak, Sang-Soo Kim, Kyungeun Sung, Joungho Han, Cha Yong Choi, and Byung-Soo Kim

Differentiation Effects by the Combination of Spheroid Formation and Sodium Butyrate Treatment in Human Hepatoblastoma Cell Line (Hep G2): A Possible Cell Source for Hybrid Artificial Liver
J. Fukuda, K. Okamura, K. Ishihara, H. Mizumoto, K. Nakazawa, H. Ijima, T. Kajiwara, and K. Funatsu

The Effect of Simulated Microgravity by Three-Dimensional Clinostat on Bone Tissue Engineering
Masataka Nishikawa, Hajime Ohgushi, Noriyuki Tamai, Koichi Osuga, Masaru Uemura, Hideki Yoshikawa, and Akira Myoui

Influence of Preservation Solution on the Isolation and Culture of Human Hepatocytes From Liver Grafts
Alfonso Serralta, Maria Teresa Donato, Amparo Martinez, Eugenia Pareja, Francisco Orbis, Jose Vincente Castell, Jose Mir, and Maria Jose Gómez-Lechón

Large-Scale Isolation of Human Hepatocytes for Therapeutic Application
Krassimira Alexandrova, Carsten Griesel, Marc Barthold, Hans-Gert Heuft, Michael Ott, Michael Winkler, Harald Schrem, Michael P. Manns, Timm Bredehorn, Marc Net, Martí Manyalich I Vidal, Sabine Kafert-Kasting, and Lubomir Arseniev


Stem Cells and Development Publishes Neural Stem Cells Compendium
Paul R. Sanberg and Cathryn R. Greene-Zavertnik


A Manual for Primary Human Cell Culture (Jan-Thorsten Schantz and Kee Woei Ng)
Gary R. Hellermann


Effects of Copper and Cross-Linking on the Extracellular Matrix of Tissue-Engineered Arteries
Shannon L. M. Dahl, Robert B. Rucker, and Laura E. Niklason

Cell Transplantation publishes original, peer-reviewed research and review articles on the subject of cell transplantation and its application to human diseases.