Volume 7.49 | Dec 18

Volume 7.49, December 18, 2006
     In this issue: Science | Policy | Business | NIH | CBER | Regulatory
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Top Stories

Mesoblast Received FDA Clearance For Phase 2 Stem Cell Clinical Trial: Australia’s adult stem cell company, Mesoblast Limited has announced that the United States Food and Drug Administration (US FDA) has cleared its Investigational New Drug Submission (IND) to commence a Phase 2 clinical trial for spinal fusion in the US.


A New Approach to Growing Heart Muscle
A University of Michigan team has reported success of a rapid 3-D cell-growth technique that produces pulsing, organized tissue.

“Inkjet” Printer Helps Organize Stem Cells
A team of bioengineers at Carnegie Mellon University’s Robotics Institute in Pittsburgh joined forces with stem cell biologists at the University of Pittsburgh School of Medicine to create an “inkjet”-style printer system for stem cells, which they eventually hope will help them make stem cells grow into complex tissues.

Virgin Process Can Produce Stem Cells
Mouse embryos created through a “virgin birth” process called parthenogenesis show that egg cells can be a source of valued embryonic stem cells, researchers said on Thursday.

Healtheuniverse Announces Intellectual Property Development Utilizing Fat Cells to Regenerate Stem Cells
The development of unique cell lines offers an alternative to human embryonic stem cells for medical treatments avoiding destruction of embryos.

Stem Cells Found in Adult Hair Follicles May Provide Alternative to Embryonic Stem Cells 
Having recently identified the molecular signature of these epidermal neural crest stem cells in the mouse, their research resolves conflicting scientific opinions by showing that these cells are distinctly different from other types of skin-resident stem cells/progenitors. Their work provides a valuable resource for future mouse neural crest stem cell research. 

Embryonic Stem Cells do Better on Bumpy Nanoscale Mattress
Unlike the princess kept awake by the pea, human embryonic stem (HES) cells do better when cultured on a substrate deliberately printed with nanoscale grooves and ridges, according to researchers from the University of Wisconsin–Madison.

Aggressive Stem Cells Might Improve Transplant Outcome
Investigators at St. Jude Children’s Research Hospital have demonstrated in mice a way that might reduce the time it takes for a bone marrow transplant to rebuild a child’s immune system, and so reduce the risk of potentially fatal virus infections that can occur during this time.

University of California, San Francisco (UCSF) Stem Cell Study Reveals Cells’ Capability In Mouse Brain Tissue Repair
UCSF scientists have determined that adult stem cells in a specific region of the mouse brain have a built-in mechanism that allows the cells to participate in the repair and remodeling of damaged tissue in the region.

Cellerant Therapeutics Presents Positive Preclinical Data on Purified Blood-Forming Stem Cells at ASH
The study demonstrated that by providing HSC treatment to therapeutic mouse models of lupus, without fully ablating their bone marrow cells prior to treatment, lupus symptoms were reversed or stabilized and the mice had significantly greater survival than comparison groups who were not transplanted or just received the conditioning therapy alone.

Northern Therapeutics and MaxCyte Initiate Landmark Engineered Cell Therapy Trial for Fatal Lung Disease
Northern Therapeutics, Inc., a Canadian biotechnology company, and MaxCyte, Inc., a U.S. therapeutics company, announced today the commencement of the first-ever human trial of a novel, engineered cell-based therapy for the treatment of idiopathic (primary) pulmonary arterial hypertension (PAH), a rare but fatal cardiovascular disease that can strike in the prime of a person’s life.

Breakthrough for “Bubble Boy” Disease
Researchers believe stem cell transplants could effectively treat and potentially cure a form of SCID caused by a deficiency of the adenosine deaminase gene, or ADA-SCID.

LCT Investigates Possible Prevention of Type 1 Diabetes
Living Cell Technologies announced today that early stage research of its NeurotrophinCell (NtCell) product may hold the potential to prevent or delay the onset of Type I diabetes.

Osiris Therapeutics Provides Update on Phase II Trial Evaluating PROCHYMAL(TM) for the Treatment of Acute Graft vs. Host Disease
The study found that patients were twice as likely to have total clinical resolution of their disease when PROCHYMAL was added to steroid therapy, compared to reported results for steroids alone.

Genvec Announces Completion of Interim Safety Data Analysis for Phase II/III Trial with TNFerade(TM) in Pancreatic Cancer
GenVec, Inc. announced today that an independent data safety monitoring board (DSMB) has completed a planned interim analysis of safety data from the ongoing Phase II/III clinical trial with TNFerade(TM) in locally advanced pancreatic cancer.

First Gene Therapy Trial for Duchenne MD Moves Ahead
The first U.S. human gene therapy trial targeting Duchenne Muscular Dystrophy (DMD), launched in March at Columbus Children’s Hospital (Ohio), will soon move to a second stage, thanks to an unprecedented $2.5 million grant from the Muscular Dystrophy Association (MDA) and matching funds from Asklepios BioPharmaceutical Inc. (AskBio) of Chapel Hill, N.C., the Association announced.

Child Stem Cell Recipient Heads Home
Last month in Portland, Ore., doctors for the first time transplanted stem cells from aborted fetuses into a child’s head in a desperate bid to reverse, or at least slow, a rare genetic disorder called Batten disease. The so-far incurable condition normally results in blindness and paralysis before death.

Scientists Racing to Catch Gene-doping Athletes
Scientists are racing to develop a test to catch athletes who may attempt to boost performance by manipulating their genes.

New Jersey Doctor, Her Aide Convicted of Stem Cell Fraud
A New Jersey doctor and her assistant were found guilty yesterday of taking thousands of dollars from patients by promising to cure them of Lou Gehrig’s disease with a stem-cell therapy they did not, and could not, deliver.

Ukraine Babies in Stem Cell Probe
Healthy new-born babies may have been killed in Ukraine to feed a flourishing international trade in stem cells, evidence obtained by the BBC suggests.


An Epidermal Neural Crest Stem Cell (EPI-NCSC) Molecular Signature
The researchers report the first transcriptome for mouse epidermal neural crest stem cells (EPI-NCSC, formerly eNCSCs) and resolve conflicting opinions in the literature by showing that EPI-NCSC are distinct from other types of skin-resident stem cells/progenitors.


Connecticut Takes a Lead in Stem-Cell Research Aid
Doling out $20 million to 21 research projects, Connecticut is moving faster and further than other states to take the most controversial form of stem-cell research, that involving tissue from human embryos, from the political arena to the laboratory. The money will flow beginning next year, and is just a start: the state has allocated $100 million over the next decade.

Maryland Stem Cell Commission Extends Funding Application Deadline
The Maryland Stem Cell Commission, a new group overseeing $15 million in state funding for research into the controversial science, said Wednesday it has received 89 initial funding requests, a response the group describes as strong.


Carle Foundation, the University of Illinois and iCyt Mission Technology Team Up to Better Isolate Adult Stem Cells
The group hopes to isolate adult stem cells from bone marrow for use in treating cardiovascular disease, heart attacks and cancer and in developing new bone tissue.

Stem Cell Innovations and Amyotrophic Lateral Sclerosis Association Announce Colloboration
Stem Cell Innovations will develop human motor neuron models based on its proprietary PluriCell(TM) technology that can be used for high-throughput screening. Subsequently, the cell models will be used by alliance partner Galapagos to discover novel drug targets for ALS.

AlloSource and Osiris Therapeutics Partner to Bring New Allograft Technology to AlloSource Donor Communities
Under the terms of the agreement, AlloSource will provide bone matrix to Osiris for use in the production of its Osteocel product line. Osteocel will be available from AlloSource to patients in all of AlloSource’s donor areas across the country.

Third Stem Cell Company Spun Off from University of Wisconsin-Madison
The former head of UW- Madison’s stem-cell patenting arm has teamed up with a stem-cell scientist on campus to launch a company using stem cells to develop tests for diseases.

Stem Cell Therapeutics Corp. Announces Appointment of New President and CEO
Stem Cell Therapeutics Corp announces that Dr. Alan Moore, the Company’s Chief Clinical and Regulatory Officer, has been appointed as the new President and Chief Executive Officer of SCT effective December 13, 2006.


NIH Fiscal Policy for Grant Awards – FY 2007 (NOT-OD-07-030)

Request for Information (RFI): Tools and Resources for Human Embryonic Stem Cell Research in the Nervous System (Neuroscience Blueprint) (NOT-DC-06-004)

Muscular Dystrophy: Pathogenesis and Therapies (R01) (PA-07-125)


Society of Clinical Research Associates Meeting: FDA Clinical Trial Requirements: Regulations, Compliance, and GCP – Slide Presentations

Working with Center for Biologics Evaluation and Research and Suggestions for Successful Clinical Trials


The Inspection is Over – What Happens Next? Possible FDA Enforcement Actions


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



Industry Exchange Workshop on Food and Drug Administration Clinical Trial Requirements; Public Workshop


Quarterly Report of the Therapeutic Goods Administration Against the 2006-2007 Business Plan, July – September 2006

Therapeutic Goods Administration Strategic Plan 2006-2008


Call for Abstracts
On-line abstract submission for the 2007 ISCT Annual Meeting is now available through the ISCT 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 8-9


Original Contributions

Autologous Bone Marrow Transplantation in Patients With Subacute and Chronic Spinal Cord Injury
Eva Syková, Aleš Homola, Radim Mazanec, Hynek Lachmann, Šimona Langkramer Konrádová, Petr Kobylka, Radek Pádr, Jiří Neuwirth, Vladimír Komrska, Vladimír Vávra, Jan Štulík, and Martin Bojar

Transplantation of Bioreactor-Produced Neural Stem Cells Into the Rodent Brain
M. McLeod, M. Hong, A. Sen, D. Sadi, R. Ulalia, L. A. Behie, and I. Mendez

Murine Brain Progenitor Cells Have the Ability to Differentiate Into Functional Neurons and Integrate Into the CNS
Singhua Ding, Conrad A. Messam, Peiying Li, Michael E. Selzer, Marc A. Dichter, and Philip G. Haydon

Immunologic Consequences of Multiple, High-Dose Administration of Allogeneic Mesenchymal Stem Cells to Baboons
Kristin J. Beggs, Alex Lyubimov, Jade N. Borneman, Amelia Bartholomew, Annemarie Moseley, Robert Dodds, Michael P. Archambault, Alan K. Smith, and Kevin R. McIntosh

Human Bone Marrow Mesenchymal Stem Cells Seeded on Modified Collagen Improved Dermal Regeneration In Vivo
Marta Markowicz, Eva Koellensperger, Sabine Neuss, Sarah Koenigschulte, Christine Bindler, and Norbert Pallua

Establishment of Cocultures of Osteoblasts, Schwann Cells, and Neurons Towards a Tissue-Engineered Approach for Orofacial Reconstruction
Kirsten Haastert, Nicole Semmler, Maike Wesemann, Martin Rücker, Nils-Claudius Gellrich, and Claudia Grothe

The Use of the BD Oxygen Biosensor System to Assess Isolated Human Islets of Langerhans: Oxygen Consumption as a Potential Measure of Islet Potency
Chris Fraker, Mark R. Timmins, Richard D. Guarino, Perry D. Haaland, Hirohito Ichii, Damaris Molano, Antonello Pileggi, Raffaella Poggioli, Sharon C. Presnell, Luca Inverardi, Mitra Zehtab, and Camillo Ricordi

Adenovirus-Mediated Expression of the Anticoagulant Hirudin in Human Islets: A Tool to Make the Islets Biocompatible to Blood
Sanja Cabric, Graciela Elgue, Bo Nilsson, Olle Korsgren, and Peter Schmidt

Survival of an Islet Allograft Deficient in iNOS After Implantation Into Diabetic NOD Mice
Andreas Börjesson, Annika K. Andersson, and Stellan Sandler

The Effects of Immunosuppressive Agents on the Function of Human Hepatocytes In Vitro
Trinidad Serrano, Ragai R. Mitry, Claire Terry, Sharon C. Lehec, Anil Dhawan, and Robin D. Hughes

Microencapsulation of Engineered Cells to Deliver Sustained High Circulating Levels of Interleukin-6 to Study Hepatocellular Carcinoma Progression
Diarmuid M. Moran, Leonidas G. Koniaris, Elizabeth M. Jablonski, Paul A. Cahill, Craig R. Halberstadt, and Iain H. McKillop

Enhanced Functional Maturation of Fetal Porcine Hepatocytes in Three-Dimensional Poly-L-lactic Acid Scaffolds: A Culture Condition Suitable for Engineered Liver Tissues in Large-Scale Animal Studies
Hongyun Huang, Sanshiro Hanada, Nobuhiko Kojima, and Yasuyuki Sakai

In Vitro Functionality of Human Fetal Liver Cells and Clonal Derivatives Under Proliferative Conditions
Tanja Deurholt, Lysbeth ten Bloemendaal, Aniska A. Chhatta, Albert C. W. A. van Wijk, Kees Weijer, Jurgen Seppen, Ronald P. J. Oude Elferink, Robert A. F. M. Chamuleau, and Ruurdtje Hoekstra

Development, Characterization, and Use of a Fetal Skin Cell Bank for Tissue Engineering in Wound Healing
Anthony S. De Buys Roessingh, Judith Hohlfeld, Corinne Scaletta, Nathalie Hirt-Burri, Stefan Gerber, Patrick Hohlfeld, Jan-Olaf Gebbers, and Lee Ann Applegate

Induction of Tolerance Across Fully Mismatched Barriers by a Nonmyleoablative Treatment Excluding Antibodies or Irradiation Use
Lionel Stephan, Christophe Pichavant, Manaf Bouchentouf, Philippe Mills, Geoffrey Camirand, Saloua Tagmouti, David Rothstein, and Jacques P. Tremblay

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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