Webinar: Immune Response in Stem Cell-based Therapy

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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)

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

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