Patent ID: 7994144

Claim:
A process of making a composition 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 isolated CD34 + hematopoietic cells of step c) in the presence of a mixture of cytokines and growth factors; e) subjecting the CD34 + hematopoietic cells of step d) to a transduction process with a viral vector containing a gene of interest in the presence of an agent that colocalizes the cells with the gene of interest; f) recovering the CD34 + hematopoietic cells of step e); g) determining the number of transduced CD34 + hematopoietic cells and the total number of CD34 + hematopoietic cells present in the product of step f); and h) if the number of transduced CD34 + hematopoietic cells of step g) is at least 0.52×10 6 cells per kg of body weight of the human subject, based on a determination by competitive PCR of the CD34 + hematopoietic cells, and the total number of CD34 + hematopoietic cells is at least 1.63×10 6 cells per kg of body weight of the human subject, then formulating the composition to be ready for delivery into a human subject, otherwise again performing steps a)-f) and combining the recovered CD34 + hematopoietic cells prior to step g).