ISCT 2011 Annual Meeting Presentations
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Academic Program

Corporate Guide


Please note: Only those presentations where permission has been received for posting are available to meeting delegates. A large number of speakers are in the process of providing ISCT with revised slides and as a result, these presentations will be gradually uploaded to the website as they are received.

Reference to these materials will be useful but not comprehensive in developing appropriate standards of care. Their use does not confer any professional qualification or standard. Publication of these materials does not constitute an endorsement of ISCT. ISCT has not reviewed these materials to ensure consistency with acceptable practices. The views expressed in these materials represent the opinion of the authors. ISCT expressly disclaims any liability arising from any inaccuracy or misstatement. Each facility and/or individual referring to these materials should analyze the information, practices and procedures outlined therein to determine their acceptability for use in the context of their own obligations and within their own facility's standards and procedures.

Speakers for the following presentations have given authorization to post their materials.


Thursday, May 19


Technical Session 1- Imaging Cell Therapy

Chair: Hervé Petite (France)
Hervé Petite (France) – Use of bioluminescence imaging for monitoring mesenclhymal stem cell survival
Mariann Gyöngyösi (Austria) – Non-invasive tracking of the cardially injected stem cell

Technical Session 2 - Practical Considerations in Cell Selection for Cellular Therapy

Chair: Ruud Hulspas (USA)
Bruce Levine (USA) – Aspects of magnetic and centrifugal-based cell sorting for clinical trials
Ruud Hulspas (USA) – Practical Considerations in Cell Selection for Cellular Therapy

Strategies for Commercialization Track 1 - Positioning for Phase III Manufacturing

Chair: Ian Harris (USA)
Ian Harris (USA) – What is needed for the manufacture of pivotal batches of cell based products
Wouter van’t Hoff (USA) – Characterization and potency assay development for MultiStem: An adult bone marrow derived adherent stem cell therapy product

Technical Applications Track 1- Quality and Technical Agreements for Cell Therapy Facilities

Chair: Shirley Bartido (USA)
Shirley Bartido (USA) – Quality and Technical Agreements for Cell Therapy Facilities
Andrea Jochheim-Richter(Germany) – Quality and Technical Agreements for Cell Therapy Facilities

Plenary Session 1 – Presidential Plenary on Mesenchymal Stem Cells

Chair: Ed Horwitz (USA)
Armand Keating (Canada) – MSCs: Current Clinical Applications and Future Challenges
Luc Sensebé(France) – MSC from genetic stability to controls of safety
Marc Dalhke (Germany) – MISOT – Mesenchymal Stem Cells in Solid Organ Transplantation

Oral Abstract Presentations 1 – Regenerative Medicine and Tissue Engineering

Co-Chairs: Ineke Slaper-Cortenbach (The Netherlands) and Ivan Martin (Switzerland)

Inositol Hexaphosphate-Loaded Red Blood Cells As Preventive therapy in Sickle Cell Disease (Abstract # 1)
Speaker:Vanessa Bourgeaux(France)
24 hr Bone Tissue Formation using Mesenquimal Stem Cells Combined with Effector T Cells and Platelet Enriched Plasma on a Matrix of Hydroxyapatite. Feasibility and Animal Proof of Principles. (Abstract # 2)
Speaker: Gustavo Moviglia(Argentina)
Autologous Tenocyte injection (Ati) For the Treatment of Lateral Epicondylitis: Phase I/II Study in Perth (Abstract # 3)
Speaker:Paul Anderson (USA)
Intramuscolar injection of Mesenchymal Stromal Cells in A Preclinical Model of Lower Esophageal Sphincter injury (Abstract # 4)
Speaker: Benedetta Mazzanti(Italy)
Development of Pharmacologically Active Microcarriers Transporting Stem Cells and Releasing Growth Factors For Cardiac Stem Cell Regeneration (Abstract # 5)
Speaker: Jean-Pierre Karam (France)

Oral Abstract Presentations 2 – Hematopoietic Stem Cells

Co-Chairs: Fred Falkenburg (The Netherlands) and Christian Chabannon (France)

19F Mri Cellular Tracer Preserves the Differentiation Potential of Hematopoietic Stem Cells (Abstract # 6)
Speaker:Brooke Helfer (USA)
Automation of the Colony-Forming Cell Assay For Measuring Hematopoietic Progenitors in Cord Blood (Abstract # 7)
Speaker:Bert Wognum (Canada)
MT1-MMP Is involved in the Mobilization and Homing of Hematopoietic Stem/Progenitor Cells (Abstract # 8)
Speaker: Anna Janowska-Wieczorek (Canada)
High Definition Flow Cytometry Markers Provide Clear Resolution of Different Hsc and Mk-P Populations and their Subsets in Normal and Disease States (Abstract # 9)
Speaker: Varda Deutsch (Israel)

Oral Abstract Presentations 3 – Laboratory Practices/Legal & Regulatory Affairs

Co-Chair: Martino Introna (Italy) and Martin Hildebrandt (Germany)

Implementing ISBT 128 Standards as a Traceability Tool in a Cellular Therapy Facility: the Experience of the Ulice Program (2006-2010) (Abstract # 11)
Speaker:Olivier Giet (Belgium)
Comparison and Validation of Chimerism in Pediatrics Recipients of Hematopoietic Stem Cell Transplantation (Hsct ) A Comparison Between Two Methods: Real-Time Pcr (Qrt -Pcr ) Vs. Variable Number Tandem Repeats (VNTR) (Abstract # 12)
Speaker:Morris Kletzel (USA)
Post Thaw Cd34 Recovery and Viability of Hematopoietic Progenitor Cells Using A Simplified Dilution Method and a Modified Gating and Analysis Strategy (Abstract # 13)
Speaker:Nicole Prokopishyn (Canada)
Development of A Process to Determine the Effect of Dmso On Microbiology Culture Samples (Abstract # 14)
Speaker: Lizette Caballero (USA)
Conducting Affordable Cell Therapy Clinical Trials in India - Competency of the Cro to meet Regulatory Guidelines (Abstract # 15)
Speaker: Kenneth Harris (USA)

Strategies for Commercialization Track 2 - Cell Characterization, Potency, and Comparability Studies

Chair: Scott Burger (USA)
Scott Burger (USA) – US FDA Expectations for Cell Therapy Potency Testing
Janet Glassford (UK) – Potency Assays for Cell Therapies: A European Regulator’s Perspective
Anne Plant (USA) – Assurance in Cell Measurements

Plenary Session 2 – Regenerative Medicine and Tissue Engineering

Chair: Ivan Martin (Switzerland)
Anthony Hollander (UK) – Cartilage tissue engineering: are we ready to translate into the clinic?
Ivan Martin(Switzerland) – Challenges in 3D tissue graft manufacturing
Matthias Lutolf (Switzerland) – Smart materials for programming stem cell fate in situ

Workshop 1 - Ex-Vivo Expansion (Joint Session with EBMT)

Co-Chairs: Christian Chabannon (France), Alejandro Madrigal (UK)
Luc Douay (France) – From Stem Cells to Red Blood Cells in vitro: Perspectives for Transfusion Medicine
Anthony Boitano(USA) – Aryl hydrocarbon receptor antagonists promote expansion of human hematopoietic stem cells
Arnon Nagler (Israel) – Novel strategies for ex vivo expansion of human umbilical cord blood for clinical transplantation

Workshop 2 - Mesenchymal Stem/Stromal Cells and Tumors

Chair: Massimo Dominici (Italy)
Jacques Galipeau (USA) – MSCs Bite Back – MSCs as antigen presenting cells for cancer immunotherapy
Massimo Dominici (Italy) – Transforming MSC from regenerative tools in killer cells for cancer: the Mesenkillers

Workshop 3- Antigen Specific T Cells

Chair: Catherine Bollard (USA)
Catherine Bollard (USA) – Priming and Expanding Virus-Specific T Cells from Naïve Cord Blood
John Barrett (USA) – Approaches to Generating Leukemia Antigen Specific T Cells
Inge Jedema (The Netherlands) – Priming and Isolation of Virus and mHag-specific T Cells from Adult Naïve T Cell Compartments

Strategies for Commercialization Track 3- Advanced Automation for Autologous Processing

Chair: Jon Rowley (USA)
Rosemary Drake (UK) – Challenges in ex-vivo expansion of cell therapy products and automated manufacturing
Simon Mauch (Germany) – Integrated automation for the development and manufacturing of cellular therapies
David James (Australia) – Automation is critical but only part of the solution

Technical Applications Track 2- Safety Testing for Cell Therapy Products: Requirements, Relevance, and New Technologies

Chair: Mark Bonyhadi (USA)
Scott Burger (USA) – Regulatory Requirements for Safety Testing
Marianna Sabatino (USA) – Determining if Mesenchymal Stromal Cells Have Passed (Passaged) Their Prime
Mark Bonyhadi (USA) – Technologies for Rapid Testing

Friday, May 20th


Technical Session 3 - Potency Assays in Stem Cell Based Therapeutics

Chair: Rosaria Giordano (Italy)
Jan de Boer (The Netherlands) – An in vitro diagnostic marker for the efficacy of human MSC-based bone tissue engineering
Monica Moro (Italy) – How we can see them

Technical Session 4- ES/iPS Cells

Chair: Harald Mikkers (The Netherlands)
Harald Mikkers (The Netherlands) – iPS cells for treating blood disorders
Lyn Healy (UK) – Banking of hESC and iPS cell lines for research and clinical use

Strategies for Commercialization Track 4 - Risk Assessments

Chair: Christopher Bravery (UK)
Christopher Bravery (UK) – The EU risk-based approach: what does it mean?
Jean Stanton (USA) – Application of Quality Risk Management Tools for Cell Therapy Manufacturing

Technical Applications Track 3 - Environmental Monitoring: How much is enough

Chair: Kasper Westinga (The Netherlands)
Philip de Vries (The Netherlands) – Environmental Monitoring in a Dutch University Hospital GMP Production Facility
Lynn O’Donnell(USA) – Environmental Monitoring: How much is enough? A U.S. Perspective

Plenary Session 3 – Cardiovascular Cell Therapy

Chair: Stefanie Dimmeler (Germany)
Massimiliano Gnecchi (Italy) – Stem cell therapy for heart disease revisited: The paracrine paradigm
Jason Lam (Germany) – Human iPSC models of cardiac disease
Stefanie Dimmeler (Germany) – microRNAs in cardiovascular repair

Oral Abstract Presentations 4 – Basic Biology of Non-Hematapoietic Stem Cells/Non-Hematapoietic Stem Cells towards the Clinic

Co-Chairs: Massimo Dominici (Italy) and Luc Sensebé (France)
A Novel Strategy to Enhance Mesenchymal Stem Cell Migration and Therapeutic Efficacy (Abstract # 16)
Speaker: Christodoulos Xinaris (Italy)
The Role of Cd44 in the Participation of Mesenchymal Stem/Stromal Cell (Msc) to the Tumor Microenvironment (Abstract # 17)
Speaker: Frank Marini (USA)
Tumour-Derived Stromal Cells Share Immunomodulatory Properties with Multipotent Mesenchymal Stromal Cells (Abstract #18)
Speaker: Friederike Gieseke (Germany)
Treatment of Steroid Resistant Grade II to IV Acute GVHD By infusion of Mesenchymal Stromal Cells Expanded with Platelet Lysate – A Phase I/II Study (Abstract # 19)
Speaker: Ineke Slaper-Cortenbach(The Netherlands)
Repeated infusions of Allogeneic Msc’s Maintain Accelerated Growth in Children with Severe Osteogenesis Imperfecta (Abstract # 20)
Speaker: Ed Horwitz (USA)
A Short Pretreatment with Bortezomib Circumvents the Limitations of Mesenchymal Stem Cells’ in Vivo Performance, Providing Significant Clinical Benefit in Experimental Arthritis (Abstract # 21)
Speaker: Anastasia Papadopoulou (Greece)

Oral Abstract Presentations 5 – Immunotherapy & Dendritic Cells

Co-Chairs: John Barrett (USA) and Derek Hart (Australia)
Multi-Center Clinical Trial of Adoptive Immunotherapy with Autologous Cd3/Cd28-Costimulated T-Cells After Fludarabine-Based Chemotherapy in Patients with Chronic Lymphocytic Leukemia (Abstract # 22)
Speaker: Zhaohui Zheng (USA)
Dendritic Cell Vaccination in Leukemia and Aids: An Update (Abstract # 23)
Speaker:Zwi Berneman (Belgium)
Autologous Cellular therapy Open Label Phase I Study in Chronic Active Crohn’s Disease (Cacd ) with Type 1 Regulatory (Tr1) Lymphocytes (Cats 1) (Abstract #24)
Speaker: Nathalie Chossat-Clerget (France)
Selective Graft Versus Leukemia Reactions After Donor Lymphocyte infusion Coincide with Minor Histocompatibility Antigen Responses in Graft Versus Host Disease Free Patients (Abstract # 25)
Speaker: Cornelis A.M. van Bergen (The Netherlands)
Allogeneic Cytokine-induced Killer Cells Demonstrate Anti-Tumour Activity in Patients Who Relapse After Allogeneic Haemopoietic Stem Cell Transplant For Haematological Malignancies (Abstract # 26)
Speaker: Yeh-ching Linn (Singapore)
Tolerogenic Dendritic Cells For Type 1 Diabetes Immunotherapy (Abstract # 27)
Speaker: Jaroslav Michalek (Czech Republic)

Strategies for Commercialization Track 5 - Decreasing Corporate Risk for Cell Therapy Programs

Chair: Dawn Driscoll (Australia)
Natalie Mount (UK) -Using excellence in clinical program design to mitigate corporate risk for cell therapy products
David James (Australia) – The manufacturing investment dilemma
Paul Anderson (Australia) – Portfolio Diversification in Regenerative Medicine – Strategies for Decreasing Risk

Technical Applications Track 4 - CD34 enumeration, how and when 2011

Chair: Varda Deutsch (Israel)
Frank Preijers (The Netherlands) – Prerequisites for a reliable CD34 determination
Joanne Kurtzberg (USA) – Enumeration of CD34 from fresh and cryopreserved human cord blood
Lubomir Arseniev (Germany) – Cellular quality control of haematopoietic grafts: regulatory environment, validation and justification of chosen methods

Plenary Session 4 – T Cell Immunotherapy

Chair: Fred Falkenburg (The Netherlands)
Fred Falkenburg(The Netherlands) – Alloreactive T cells for the treatment of leukemia
Ton Schumacher (The Netherlands) – Dissection of cell therapy-induced cytotoxic T cell responses in melanoma
Emma Morris (UK) – Translation of immunotherapy using WT-1 and CMV specific TCR gene transfer into the clinic

Workshop 4 - How to improve in vivo vascularisation (Joint Session with TERMIS-EU)

Co-Chairs: Ineke Slaper-Cortenbach (The Netherlands), Gerjo van Osch (The Netherlands)
Gerjo van Osch (The Netherlands) – The importance of vascularisation and different ways to obtain vascularisation
Sabine Fuchs (Germany) – Neovascularization strategies in tissue engineering based on natural cell to cell interactions

Workshop 5 - Dendritic Cells

Chair: Gunner Kvalheim (Norway)
Gunner Kvalheim (Norway) – DC vaccines targeting the tumors stem cells
Delores Schendel(Germany) – Young, TLR-activated DCs display optimal characteristics for vaccine use
Derek Hart (Australia) – Dendritic cell subsets and cross-presentation: the potential benefits of receptor targeted antigen loading

Strategies for Commercialization Track 6 - Challenges of Commercial Development of Pluripotent hES

Chair: Ralph Brandenberger (USA)
Ralph Brandenberger (USA) – Development of Human Embryonic Stem Cell-Derived T herapeutics Manufacturing to Support Future Commercialization
James Lawford Davies (UK) and Alexander Denoon (UK) – Negotiating the Regulatory and IP Hurdles
Howard Levine(USA) – Challenges in the GMP manufacturing of pluripotent hES: Lessons learned from monoclonal antibodies

Technical Applications Track 5 - Establishing GMP Facilities with QA Oversight in Academic Centers for Phase I/II Clinical Trials

Co-Chairs: Shirley Bartido (USA), Martin Hildebrandt (Germany)
Shirley Bartido (USA) – GMP Facilities in US Academic Centers: their Trials and Tribulations
Martin Hildebrandt (Germany) – Academic GMP – Industry standards in a non-industry environment
Martino Introna (Italy) – Feasibility of a GMP Facility inside a Public Hospital in Italy
Sven Becker (Germany) – A surprisingly big step: from an academic scientist to a pharmaceutical entrepreneur

Saturday, May 21st


Technical Session 5 - Adipose Mesenchymal Progenitors

Chair: Louis Casteilla (France)
Louis Casteilla (France) – Isolation and Biology of Adipose derived stromal cells: comparison with bone marrow mesenchymal stem cells
Jeffrey Gimble (USA) – Adipose-derived cells: How does that translate?
Christian Dani (France) – Human adipocyte progenitors: Maintenance ex vivo and regulation of their self-renewal and differentiation

Technical Session 6 - Ancillary Materials

Chair: Fouad Atouf (USA)
Fouad Atouf(USA) – Ancillary Materials Used in Cell Manufacturing: Qualification Programs and Quality Attributes
Ralf Sanzenbacher(Germany) – Manufacture of Somatic Cell T herapy and T issue-engineered Products: Considerations on Quality Aspects

Strategies for Commercialization Track 7 - Personalized Approach to Cell and Gene Therapy

Chair: Philippe Leboulch (France)
Philippe Leboulch (France) – Lentiviral therapies for genetic disorders: illustration with adrenoleukodystrophy and the betahemoglobinopathies
Ronnda L. Bartel (USA) – Ixmyelocel-T - A New Therapy for Severe Chronic Cardiovascular Disease

Technical Applications Track 6 - The Essentials of Validation, Qualification and Verification

Chair: Lizette Caballero (USA)
Lizette Caballero (USA) – Qualification and Validation of new freezing containers: our experience
Ulrike Köhl(Germany) – Validation and flow cytometric quality control for CD3/CD19 depleted grafts

Plenary Session 5 – Cancer Stem Cells

Chair: Sir Walter Bodmer (UK)
Sir Walter Bodmer (UK) – Cancer stem cells from colorectal cancer cell lines
Marc van de Wetering (The Netherlands) – Lgr5 Intestinal Stem Cells in self-renewal and cancer
Calvin Kuo (USA) – Modeling Colon Stem Cells and Neoplasia Using Primary Explant Cultures Containing an Endogenous Wntdependent Niche

Oral Abstract Presentations 6 – Cell and Gene therapy/Cellular Gene Transfer

Chair: Paolo Madeddu (UK) and Philippe Leboulch (France)

Ccr5 Disrupted Cd4+ T Cells Can Be Consistently Manufactured At Clinical Scale From Hiv+ Patients with Suboptimal Cd4+ Counts (250-500 Cells/mm3) (Abstract # 28)
Martin Giedlin (USA)
Immune Responses to Transgene and Retroviral Vector in Patients Treated with Ex Vivo Engineered T-Cells (Abstract # 29)
Cor Lamers (The Netherlands)
Clinical Scale Electroporation of T Cells with Rna Encoding a Chimeric Antigen Receptor (Car) Mediates Regression of Human Metastatic Mesothelioma at a Fraction of the Cost and Regulatory Burden of Viral Vectors (Abstract # 30)
Speaker: Andrea Brennan (USA)
Redirected Autologous T Cells Engineered to Contain Anti-Cd19 Attached to TCRzeta and 4-1Bb Signaling Domains: in Vivo Expansion, Persistence and Anti-Tumor Activity in Patients with Chemotherapy Resistant or Refractory Cll (Abstract # 31)
Speaker: Bruce Levine (USA)

Oral Abstract Presentations 7 – Translational Process Development/ Cardiovascular Regeneration

Chair: Tracey Lodie (USA) and Francesco Lanza (Italy)

From Concept to Patient Treatment: A Clinical Trial of Mesenchymal Stromal Cells for Amyotrophic Lateral Sclerosis (Abstract # 32)
Speaker: Allan Dietz (USA)
Cell Characterization: Developing Assays to Address the Biological Parameters of Identity and Potency (Abstract # 33)
Speaker: Jessica Carmen (USA)
Combined Transcriptomic and Proteomic Approach Identifies Several Putative Paracrine Factors of Fetal Mesenchymal Stem Cells (Abstract # 35)
Speaker:Patrizia Danieli (Italy)

Technical Applications Track 7- ISBT 128 Labeling: We’ve implemented, and so can you!

Chair: Ineke Slaper-Cortenbach (The Netherlands)
Boris Calmels (France) – Implementation of ISBT 128 through the development of an ISBT 128-compliant software for labeling CT products
Giovanna Cameron (Canada) – Implementing ISBT 128 for a Multisite BMT Program

Workshop 6 - New Gene Transfer Technologies (Joint Session with ESGCT)

Co-Chairs: Cor Lamers (The Netherlands), Paolo Madeddu (UK)
Zsuzsanna Izsvák (Germany) – Translating transposons into cellular therapies: victories and challenges
Shamim Rahman (Germany) – Cut & Paste – Designer Nucleases for Targeted Genome Editing
Axel Rethwilm (Germany) – New developments in viral gene transfer

Workshop 7 - Lung Regeneration

Chair: Dan Weiss (USA)
Dan Weiss (USA) – Cell Therapy and Bioengineering Approaches for Lung Repair and Regeneration
Sam Janes (UK) – Cell Therapy for Lung Cancer and the Roadmap Ahead

Strategies for Commercialization Track 8 - Strategies for Allogeneic Cell Therapy Commercialization

Chair: Stewart Abbot (USA)
Kilian Kelly (Australia) – Commercialization of Allogeneic Mesenchymal Precursor Cells
Frida Grynspan (Israel) – Commercialization strategies for the development of PLX-PAD; placental expanded adherent stromal cells, an "off the shelf” product

Technical Applications Track 8 - Process Development: Optimization and qualification of processes for maintaining quality parameters of therapeutic cells

Chair: Jon Rowley (USA)
Miguel Carrion (USA) – Developing and transferring cell culture processes into manufacturing
Ryan Guest (UK) – Post-culture processing of a personalised cellular therapeutic product
Erik Woods (USA) – Packaging Considerations and Cryopreservation of Cell Therapy Products

Plenary Session 6 – Embryonic to Adult Stem Cells

Chair: Elaine Dzierzak (The Netherlands)

Derk ten Berge (The Netherlands) - Regulation of self-renewal and differentiation of pluripotent stem cells by Wnt proteins
Takumi Era (Japan) – Origin of mesenchymal stem cell
Elaine Dzierzak (The Netherlands) – the development of hematopoietic stem cells: Endothelial to hematopoietic transition

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