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
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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
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