Webinar: Clinical Trials: Moving Stem Cell based Therapies to the Clinic

 

 

WEBINAR

Clinical Trials: Moving Stem Cell based

Therapies to the Clinic

Presentations from FDA and Leading Experts

This webinar was held on April 15th at 10:00 am PT

 

You can watch the introduction and the speaker's presentations here.

Moderator

Ellen Feigal, M.D., Senior Vice President of Research and Development, CIRM

Speakers

Topics

The focus of this webinar is on the Lessons Learned from IND/Phase I trials including overcoming the challenges, and addressing the regulatory issues, as stem cell based therapies move towards the clinic.

  • Presentation by FDA - Considerations for Early Phase Clinical Trial Design in Cellular Therapies- issues the FDA considers in evaluating the risks vs. benefits of early phase trial proposals
  • Lumbar Intraspinal Injection of Neural Stem Cells in Patients with ALS:  Results of a Phase I Trial in 12 Patients
  • Lessons learned from Phase I trial of autologous cardiosphere-derived stem cell product for myocardial infarction and comparison to new allogeneic trial with the same indication
  • Questions and Answers

Background Information

© 2013 California Institute for Regenerative Medicine