Clinical Trial: Long-term Follow-up After Adoptive Transfer of Genetically Modified Cell Products
Study Status: Completed
Recruit Status: RECRUITING
Condition: Relapsed Hematologic Malignancy
Study Type: OBSERVATIONAL
Official Title: Long-term Follow-up After Adoptive Transfer of Genetically Modified Cell Products
Brief Summary:
Human gene therapy products are designed to achieve therapeutic effect through genetic modifications of human cells using retroviral or lentiviral vectors, resulting in permanent or long-acting changes in the human body.With this genetic modification comes risk of undesirable adverse events.Due to this risk, the Food and Drug Administration (FDA) and the Center for Biologics Evaluation and research (CBER) require long-term follow-up (15 years) of participants that receive investigational gene therapy products that…
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