Webinar: Immune Response in Stem Cell-based Therapy

Presentations from FDA and Leading Experts

Date: September 27, 2012 from 10 am to 12 noon (Pacific)

Please accept our sincere apologies for the technical difficulties experienced with the September 27th webinar. Below are links to recordings of the webinar as well as the speakers' slides:

Links to recordings of the webinar:

• Introduction by moderator, Ellen Feigal, MD, Senior VP of Research and Development, CIRM
• Recording of Webinar
• Transcript of Question and Answer Section
   

Links to the webinar speakers' presentation slides:

• Theresa Chen
• Heike Daldrup-Link
• Amitabh Gaur
   

Moderator: Ellen Feigal, MD, Senior Vice President of Research and Development, CIRM

Speakers:
 

• Theresa Chen, Ph.D., Pharmacology/Toxicology Reviewer, Office of Cellular, Tissue and Gene Therapies (OCTGT), Center for Biologics Evaluation and Research (CBER), U.S. Food and Drug Administration (FDA)
• Heike Daldrup-Link, M.D., Associate Professor of Radiology, Stanford University School of Medicine
• Amitabh Gaur, Ph.D., Director of Custom Technology, BD Biosciences
   

Topics covered:
 

• Presentation by FDA - regulatory perspective on immune rejection concerns in the preclinical assessment of human cellular therapy products
• Assessing immune response to stem cell transplants with clinically applicable imaging techniques
• Assessing the immunogenicity of stem cells
• Overcoming the immune rejection challenge
• Questions and Answers
   

Background material:
 

• CIRM held a Roundtable meeting on Immune Response with the FDA in October of 2011. Materials from that meeting are here.
• In June 2010 CIRM committed $25 million to overcome immune rejection of stem cell transplantation therapies. More information on the 19 awards in RFA 09-03, CIRM Stem Cell Transplantation Immunology Awards, can be found on our press release.
• CIRM recently approved new awards related to the immune system:
  • Immune-Matched Neural Stem Cell Transplantation for Pediatric Neurodegenerative Disease
  • A monoclonal antibody that depletes blood stem cells and enables chemotherapy free transplants
  • Mechanisms to protect hESC-derived cells from allogenic immune rejection
• CIRM Video: Jeffrey Bluestone Talks About Immune Rejection of Stem Cell-Based Therapies
• The American Association of Immunologists - Immunology 2012 Annual Meeting