A Long-Term Follow-Up Study of Participants Treated With A2 Biotherapeutics (A2Bio) Gene Therapy (GT) Products
A Long-Term Follow-Up Study of Participants Treated With A2 Biotherapeutics (A2Bio) Gene Therapy (GT) Products
This protocol is to ensure consistent long-term follow-up for delayed safety events in participants who received A2 Bio gene therapy (GT) products.
This is a long-term follow-up study designed to evaluate delayed safety events and long-term efficacy of A2 Bio GT products for participants who received any amount of A2 Bio GT products in a previous interventional study. No further interventional treatment is administered in this study.
Participants will enroll in this long-term follow-up study upon completion of 2 years of follow-up in the assigned interventional study in which they received treatment. Participants will be followed for up to 15 years after administration of A2 Bio GT product. This study will collect long-term safety and efficacy data as outlined by the FDA guidance for long-term follow-up for GT products.
Inclusion Criteria:
Exclusion Criteria:
1. There are no specific exclusion criteria for this study