Volume 8.05 | Feb 12

Volume 8.05, February 12, 2007
     In this issue: Science | Policy | Business | NIH | CBER | Regulatory
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Top Stories

Pre-Clinical Milestones for Sertolin Cell Replacement Technology: Insulin-Producing Cells Survive and Function without Anti-Rejection Drugs: Sernova Corp. is pleased to announce its preliminary, preclinical animal studies have demonstrated long term survival and functioning of Sertolin, the Company’s patented insulin producing cellular replacement therapy.


Master Switches Found for Adult Blood Stem Cells
Johns Hopkins Kimmel Cancer Center scientists have found a set of "master switches" that keep adult blood-forming stem cells in their primitive state. Unlocking the switches’ code may one day enable scientists to grow new blood cells for transplant into patients with cancer and other bone marrow disorders.

Brown Cancer Biologists Identify Major Player in Cell Growth
The transcription factor GABP – a member of a family of crucial gene-regulating proteins – is required to jump-start the process of cell division.

Medistem Laboratories Commences Pre-Clinical Research With Indiana University School of Medicine’s Center for Vascular Biology and Medicine Using Cord Blood in the Treatment of Critical Limb Ischemia
Initial experiments aim to position the AngioStem(TM) platform for FDA trials.

Tumor-reactive T Cells Boosted By Hematopoietic Stem Cell Transplantation
Nicholas Restifo and colleagues from the National Institutes of Health have shown that in mice, pre-treatment with more intense immune cell-depleting strategies and a hematopoietic stem cell (HSC) transplantation enabled infused tumor-reactive CD8+ T cells to increase in number more than pre-treatment with nonmyeloablative agents.

Stem Cells May Help Heal Joint Injuries
Biomedical sciences professor Dean Betts and doctoral candidate Thomas Koch are hoping to use stem cells to improve cartilage healing after joint injuries. They’re working with horses, where joint injuries are both common and costly, and say the research could be a model for helping human joint injuries.

Gene Therapy Breakthrough For Autism Condition
The British study of laboratory mice suggests a gene treatment can reverse the symptoms of Rett Syndrome, regarded as the most physically disabling of the autistic diseases.

The University of Navarra Will Test Vaccines with Dendritic Cells on Patients with Melanoma, Hepatoma and Renal Cell Carcinoma
A team from the University Hospital and the Center for Applied Medical Research (CIMA) of the University of Navarra plans to carry out tests midway through 2007 on vaccinations with dendritic cells on cancer patients with hepatoma (liver cancer), melanoma, and renal cell carcinoma.

Pluristem Announces US FDA Acceptance of its Pre-IND Application to begin Pre-clinical Studies using PLX- I in Hematological Malignancies
Pluristem Life Systems, Inc. has announced that the United States Food and Drug Administration’s (FDA) Center for Biological Evaluation and Research (CBER) accepted the Company’s proposed Pre-Investigation New Drug (PreIND) for its PLX-I product in pre-clinical studies for the treatment of hematological malignancies.

Personalized Immunotherapy Clinical Trial Initiated in HIV Patients with Argos Therapeutics’ AGS-004
Argos Therapeutics today announced the initiation of a Phase 1/2 clinical trial to test the immunologic activity and safety of its AGS-004 in HIV-infected adults.

ViaCell, Inc. Ends Umbilical Cord Blood Trials On Cancer Patients
ViaCell, Inc. has announced results of its Phase I clinical trial evaluating its investigational umbilical cord blood transplant therapy, CB001.

Opexa Announces Encouraging Clinical Data on Novel T-Cell Vaccination Therapy for Rheumatoid Arthritis
The results demonstrated that T-cell vaccination was well tolerated and, importantly, induced T-cell regulatory immune responses which collectively correlated with substantial clinical improvement in treated patients.

SR Pharma PLC Announces Start Of Phase I Trial With Novel RNAi Therapeutic RTP-801i In Age-Related Macular Degeneration (AMD)
RTP-801i is based on Atugen’s proprietary siRNA technology and modifies the expression or function of one specific gene target, which is involved in the progression of Age-related Macular Degeneration (AMD).

Stem Cells from Fat Tissue Transplanted Into Heart
Doctors have implanted adult stem cells extracted from a man’s fat tissue through liposuction into his heart, in an experimental treatment for angina and heart disease.
Article 1    Article 2


Therapeutic Strategies for Parkinson Disease Based on the Modulation of Adult Neurogenesis
This review discusses neurorestorative or neuroregenerative therapies based on gene and stem cell therapy.

Pig Liver Gene Therapy by Noninvasive Interventionist Catheterism
These data presented in this article suggest that retrovenous injection by noninvasive interventionist catheterism could become an efficient procedure for hepatic gene transfer with potential clinical applications.


Animal-human Hybrid Embryos Get Go-ahead
UK government plans to ban the creation of human-animal hybrids in the laboratory have been dealt a serious blow after the regulatory body on embryos backed the research.

Australian University in Stem Cell Land Row
One of Australia’s leading universities is facing increasing criticism from academics across the country for agreeing not to do stem cell research on land it bought from a Roman Catholic college.

Debate on Embryonic Stem Cells is Ticklish Situation for University of Minnesota
The debate over stem cells is putting the University of Minnesota in an uneasy spot, forcing leaders to navigate between Republican Gov. Tim Pawlenty’s ethical reservations and eagerness among Democrats to expand a promising field of study.

Stem Cell Institute Issues Evaluation of Grant Applications
The California Institute for Regenerative Medicine has released its first public evaluation of early-stage stem cell research grant applications.


The Stem Cell Meeting
March 12 – 13 at San Francisco’s Mission Bay Conference Center at UCSF.
The only international business, policy and economic forum for science and business professionals working at the leading edge of stem cell and regenerative medicine development.  Cell Therapy News readers receive a special discount. To register, please go to www.thestemcellmeeting.com and click “Registration.”  Select “Special” from the Attendee Type drop down menu. Click “Register Now” and enter access code “2SCSPC”. If you have any questions, please contact registration at 800-549-1735; or [email protected].

Cambrex Corporation Completes Sale Of Bio Businesses
Cambrex Corporation has announced that it has completed the sale of its Bioproducts and Biopharma subsidiaries to Lonza Group AG. The sale was approved by an overwhelming majority at a Special Meeting of Shareholders held yesterday.

Laureate Pharma Announces Collaboration With Boehringer Ingelheim
Laureate Pharma, Inc. is pleased to announce a preferred partnership agreement with Boehringer Ingelheim, one of the leading companies in biopharmaceutical development and manufacturing. With this collaboration, Laureate’s clients will gain access to Boehringer Ingelheim’s comprehensive manufacturing technology platform for biopharmaceutical products produced by mammalian cell culture.

Advanced Cell Technology Announces Collaboration with the Casey Eye Institute at Oregon Health and Science University
The research team is conducting a dosage study utilizing the Company’s RPE cells in the Royal College of Surgeons rat model and plans to conduct similar studies in other rodent models of retinal degenerative disease.

Stem Cell Patents Granted for Cardiac Disease and New Clinical Opportunities
Mesoblast Limited has announced that two key patents have been granted by IP Australia relating to the adult stem cell technology platform to which Mesoblast and its US-based sister company, Angioblast Systems Inc; have exclusive commercial rights. These new patents protect and expand the commercial opportunities of both companies.

Advanced Cell Technology Acquires Intellectual Property Assets of Infigen, Inc.
Advanced Cell Technology, Inc. announced today that it has acquired the intellectual property assets of its former competitor Infigen, Inc. relating to somatic cell nuclear transfer (SCNT), parthenogenesis, and other related technologies.


Space Limited for 2007 Regional Seminars in Program Funding and Grants Administration (NOT-OD-07-045)

Announcement of Participation of NCI on PA-07-279 – Bioengineering Research Grants (BRG)(R01) (NOT-CA-07-012)

Notice of Extension for Request for Information (RFI): Tools and Resources for Human Embryonic Stem Cell Research in the Nervous System (Neuroscience Blueprint) (NOT-DC-07-001)

Notice of NHLBI Participation in PA-07-303 Novel Approaches to Enhance Animal Stem Cell Research (R01) and PA-07-304 Novel Approaches to Enhance Animal Stem Cell Research (R21) (NOT-HL-07-005)


2007 Biological Approvals – Update

Licensed Products and Establishments List – Update

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


FOOD AND DRUG ADMINISTRATION (Untited States of America)

Vaccines and Related Biological Products Advisory Committee; Notice of Meeting

Requirements for Foreign and Domestic Establishment Registration and Listing for Human Drugs, Including Drugs That Are Regulated Under a Biologics License Application, and Animal Drugs; Reopening of Comment Period


The Boards of AABB, ASBMT, ASFA, EBMT, FACT, ICCBBA Inc, ISBT, ISCT, ISCT Europe, JACIE, NMDP and WMDA agreed to develop standards for the use of ISBT 128 for coding and labeling of CT products, and established an international advisory group to take forward the development and management of terminology and label design. The International Cellular Therapy Coding and Labeling Advisory Group has been working on this project since October 2005 and a workshop was held at the ISCT meeting in Berlin in 2006.
Two draft standards have been prepared covering the aspects of terminology and labeling, together with a guidance document on implementation. These documents are now available for public comment and we value your feedback.  They may be accessed by clicking here:  http://www.iccbba.org/ctcomments.html

The International Cellular Therapy Coding and Labeling Advisory Group would like to know your current labeling practice. Are you completely automated, completely manual or somewhere in between? Please complete the brief survey accessed at http://www.surveymonkey.com/s.asp?u=959303138614. The information gathered will be valuable as we move toward global standardization for labeling of cellular therapy products. Your participation is greatly appreciated. For more information about this project, please visit: http://www.iccbba.org/cellulartherapy_home.html

Call for Abstracts
On-line abstract submission for the 2007 ISCT Annual Meeting is now available through the IASCT Website. 
Submission deadline: February 16, 2007

ISCT Membership
Renew your ISCT Membership for 2007 now!
Not a member?  Visit the ISCT website to learn about the benefits of membership.

AABB-ISCT Cellular Therapy Audioconference Series

Profiled Journal

Current Issue: Volume 15, No 10


Naoya Kobayashi, Guest Editor-in-Chief


Cell Therapy for Diabetes Mellitus
Naoya Kobayashi

Functional Hepatocyte Culture and its Application to Cell Therapies
Kimiaki Tanaka, Alejandro Soto-Gutierrez, Nalu Navarro-Alvarez, Jorge David Rivas-Carrillo, Hee-Sook Jun, and Naoya Kobayashi

Original Contributions

Instant Hepatic Differentiation of Human Embryonic Stem Cells Using Activin A and a Deleted Variant of HGF
Yong Chen, Alejandro Soto-Gutierrez, Nalu Navarro-Alvarez, Jorge David Rivas-Carrillo, Tomoki Yamatsuji, Yasuhiro Shirakawa, Noriaki Tanaka, and Naoya Kobayashi

The Significant Improvement of Survival Times and Pathological Parameters by Bioartificial Liver With Recombinant HepG2 in Porcine Liver Failure Model
Shin Enosawa, Tomoyuki Miyashita, Tomohiro Saito, Takeshi Omasa, and Toshiharu Matsumura

Preservation of Rat Aortic Tissue Transplant With Green Tea Polyphenols
S.-H. Hyon, D.-H. Kim, W. Cui, K. Matsumura, J.-Y. Kim, and S. Tsutsumi

Increased Sensitivities of Peripheral Blood Mononuclear Cells to Immunosuppressive Drugs in Cirrhosis Patients Awaiting Liver Transplantation
Abuduxukuer Mijiti, Naoto Matsuno, Tohru Iwahori, Hironori Takeuchi, Takeshi Nagao, Kitaro Oka, and Toshihiko Hirano

Maintenance of Neovascularization at the Implantation Site of an Artificial Device by bFGF and Endothelial Cell Transplant
Atsushi Miki, Jorge D. Rivas-Carrillo, Nalu Navarro-Alvarez, Alejandro Soto-Gutierrez, Yong Chen, Kimiaki Tanaka, Michiki Narushima, Yasuhiko Tabata, Teru Okitsu, Hirofumi Noguchi, Shinichi Matsumoto, Noriaki Tanaka, and Naoya Kobayashi

PuraMatrix™ Facilitates Bone Regeneration in Bone Defects of Calvaria in Mice
Haruo Misawa, Naoya Kobayashi, Alejandro Soto-Gutierrez, Yong Chen, Aki Yoshida, Jorge David Rivas-Carrillo, Nalu Navarro-Alvarez, Kimiaki Tanaka, Atsushi Miki, Jiro Takei, Tadayoshi Ueda, Masato Tanaka, Hirosuke Endo, Noriaki Tanaka, and Toshifumi Ozaki

Improvement of Hepatocyte Viability After Cryopreservation by Supplementation of Long-Chain Oligosaccharide in the Freezing Medium in Rats and Humans
Yoshitaka Miyamoto, Satoshi Suzuki, Kou Nomura, and Shin Enosawa

Self-Assembling Peptide Nanofiber as a Novel Culture System for Isolated Porcine Hepatocytes
Nalu Navarro-Alvarez, Alejandro Soto-Gutierrez, Jorge D. Rivas-Carrillo, Yong Chen, Tsuyoshi Yamamoto, Takeshi Yuasa, Haruo Misawa, Jiro Takei, Noriaki Tanaka, and Naoya Kobayashi

Induction of Pancreatic Stem/Progenitor Cells Into Insulin-Producing Cells by Adenoviral-Mediated Gene Transfer Technology
Hirofumi Noguchi, Gang Xu, Shinichi Matsumoto, Hideaki Kaneto, Naoya Kobayashi, Susan Bonner-Weir, and Shuji Hayashi

Amelioration of Diabetes in Mice After Single-Donor Islet Transplantation Using the Controlled Release of Gelatinized FGF-2
Jorge David Rivas-Carrillo, Nalu Navarro-Alvarez, Alejandro Soto-Gutierrez, Teru Okitsu, Yong Chen, Yasuhiko Tabata, Haruo Misawa, Hirofumi Noguchi, Shinichi Matsumoto, Noriaki Tanaka, and Naoya Kobayashi

Double-Compartment Cell Culture Apparatus: Construction and Biochemical Evaluation for Bioartificial Liver Support
Masahiro Takahashi, Masayuki Sakurai, Shin Enosawa, Takeshi Omasa, Shuichi Tsuruoka, and Toshiharu Matsumura

Volume 15 Subject and Author Index

Cell Transplantation publishes original, peer-reviewed research and review articles on the subject of cell transplantation and its application to human diseases. To ensure high-quality contributions from all areas of transplantation, separate section editors and editorial boards have been established. Articles deal with a wide range of topics including physiological, medical, preclinical, tissue engineering, and device-oriented aspects of transplantation of nervous system, endocrine, growth factor-secreting, bone marrow, epithelial, endothelial, and genetically engineered cells, among others. Basic clinical studies and immunological research papers are also featured. To provide complete coverage of this revolutionary field, Cell Transplantation will report on relevant technological advances, and ethical and regulatory considerations of cell transplants.

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