Patent ID: 7776595

Claim:
A method for determining whether transduced CD34 + hematopoietic progenitor (HP) cells undergo T-lymphocyte development for more than 12 months in a human subject comprising: a) mobilizing CD34 + hematopoietic progenitor cells into the blood of a human subject by administering to the subject an amount of one or more cytokines sufficient to mobilize the hematopoietic cells; b) isolating by apheresis leukocytes from the blood of the subject of step a); c) isolating the CD34 + hematopoietic cells from the isolated leukocytes of step b); d) culturing the CD34 + cells in the presence of at least one cytokine; e) transducing the CD34 + cells with a viral construct which comprises a gene of interest in the presence of an agent which enhances colocalization of the cells and the viral construct to form a composition of cells having a minimum dose of 0.52×10 6 transduced CD34 + hematopoietic progenitor cells per kg body weight of the subject in a total CD34 + cell population of at least 1.63×10 6 cells per kg of body weight of the subject, wherein the number of transduced CD34 + hematopoietic cells is based on a determination by competitive PCR of the CD34 + hematopoietic cells; f) delivering to the subject the composition of cells; g) at least 12 months later, isolating blood from the subject; h) determining whether T-lymphocytes in the blood comprise the gene of interest, thereby determining whether transduced CD34 + hematopoietic progenitor cells undergo T-lymphocyte development for more than 12 months in the human subject.