Phase I/II Clinical Trials Using Gene-Modified Adult Hematopoietic Stem Cells for HIV: Lessons Learnt

Figure 2

The figure shows the prototypic phase I trial design in which CD34+ HSC were obtained from post G-CSF apheresis product that is CD34+ selected. The CD34+ cells were then transduced with either control or OZ1-containing vector and both transduced populations (control and OZ1) mixed and infused into the individual. (1) Subjects are injected with a course of G-CSF to mobilize CD34+ HSC from the bone marrow to the peripheral blood. (2) Apheresis product is obtained. (3) The mononuclear cell fraction is applied to a CD34+ isolation system. (4) CD34+ cells are obtained. (5) These are transduced with either control or OZ1-containing vector (50% of each) to obtain (6) A mixed population of control and OZ1 transduced cells. (7) This mixed population is infused back into the individual.