Long-Term Follow-Up of Subjects in Gene Transfer Clinical Protocols Vector Classes with Potential for Long-Term Risks Carolyn A. Wilson, Ph.D. Division of Cellular and Gene Therapies CBER, FDA

12/5/00


Click here to start


Table of Contents

Long-Term Follow-Up of Subjects in Gene Transfer Clinical Protocols Vector Classes with Potential for Long-Term Risks Carolyn A. Wilson, Ph.D. Division of Cellular and Gene Therapies CBER, FDA

Overview

Properties of Gene Transfer Vectors with Potential for Long-term Risks

Integration into Host Genomic DNA in Somatic Cells: Biological Effects

What Is the Likelihood that Gene Transfer Vector Integration Would be Tumorigenic?

Rationale for Long-term Follow-up to Identify Risk of Vector DNA Integration

PPT Slide

PPT Slide

Long-term follow-up -- Unresolved issues

Properties of Gene Transfer Vectors with Potential for Long-term Risks

Integration into host genomic DNA in germ cells: Risks

What Is the Likelihood that Gene Transfer Vector Integration in Germ Cell DNA Would Be Deleterious?

Potential for Integration into Genome of Germ Cells

Potential for Integration into Genome of Germ Cells

Summary

PPT Slide

Author: CBER