Fall Meetings (Somatic and Stem Cell Translation)

In the fall of 2010, ISCT hosted the 2nd Annual Symposium on Stem Cell Translation Meeting.  In previous years, ISCT hosted meetings in the fall called The Somatic Cell Therapy Symposium and more recently ISCT Somatic: Innovations in Cord Blood and Mesenchymal Stem Cell Therapies.

2nd Annual Symposium on Stem Cell Translation: Strategies, Best Practices & Regulatory Considerations

September 27-28, 2010
San Francisco, CA

In partnership with CIRM and UCSF

This 2-day symposium provided education on the bench-to-bedside translation of stem cell-based therapies, with emphasis on product development and preclinical animal studies; discussion of requirements for IND submission to FDA; case studies and panel discussions and opportunities to learn from, and network with, colleagues from academia, industry, and FDA

Topics included::

  • IND Development for Stem Cell Therapies from Adult, Fetal, and Embryonic Sources
  • Stem Cell Characterization & Assay Development
  • Cell Source Selection, Qualification, Banking, and Testing
  • Preclinical Animal Studies:  Efficacy and Safety
  • Bench-to-Bedside Development Case Studies
  • Development of GMP Manufacturing Processes
  • Standardization Issues for Ancillary Reagents and Biomaterials

ISCT Somatic: Innovations in Cord Blood and Mesenchymal Stem Cell Therapies

September 14-15, 2009
Bethesda, MD
This meeting was focused on current innovations in UCB cellular therapy including generation of iPS from UCB, novel MSC applications with focus on neurologic disorders, novel T-cell therapies, and further innovations in biomaterials ideal for stem cell seeding to enhance vascular therapy. It was organized to provide laboratory investigators, clinicians, industry and technologists focused on cellular therapies and cell processing, relevant translational research and technical information for clinical applications. Six plenary sessions included:

  • iPS from UCB chaired by Jan Nolta, PhD, UC Davis
  • MSC in Neurodegenerative Disease chaired by Mercedes Serabian, MS, DABT, FDA/CBER/OCTGT
  • T cell-based Therapies chaired by Daniel Powell, PhD, University of Pennsylvania
  • Policy Session NIH chaired by David Stroncek, MD, NIH
  • Stem Cells/Biomaterials in Vascular Regenerative Medicine chaired by Ed Snyder, MD, Yale-New Haven Hospital
  • UCB Basic/Translational Science chaired by Hal E. Broxmeyer, PhD, Indiana University

Tutorials included:

  • Alternative Strategies for Gene Delivery
  • Cord Blood Graft Manipulation
  • Cord Blood Immune Cells
  • Cord Blood Stem Cells and Non-Hematopoietic Therapeutic Indications
  • Update on Current MSC Trials

MEMBER ACCESS TO MEETING PRESENTATIONS

Somatic Cell Therapy Symposium (2008 and earlier)

These meetings were designed to engage FDA, academia, and industry in an open dialogue on regulatory issues for:

  1. Translation of basic laboratory research findings into therapeutic products suitable for evaluation in clinical trials.
  2. Product manufacturing in the context of early and late phase clinical trials, and
  3. Preparation and maintenance of IND and biologics license applications for cellular therapy products.