Production of ex vivo expanded hematopoietic cells and progenitors in a closed bioreactor, starting with a small volume marrow collection: A feasibility study in patients with poor-risk breast cancer and receiving high-dosesof cyclophosphamide

We report a clinical pilot study conducted in 6 women with poor-prognosis b reast cancer. The goal was to evaluate the feasibility and safety of produc ing hematopoietic progenitors and cells from a small marrow sample, for cli nical use after high-dose cyclophosphamide. A small volume marrow collectio n was obtained, using local anesthesia and conscious sedation, before the f irst of two chemotherapy cycles. Cells were cryopreserved, and later thawed to inoculate two Aastrom Biosciences Inc Replicell(R) bioreactors, on time to reinfuse ex vivo expanded cells after the second chemotherapy cycle. Pa tients recovered neutrophils and platelets at similar times after the first and second chemotherapy cycles, and showed comparable clinical events. Thi s pilot study prepares future randomized trials, designed to evaluate clini cal benefits associated with the use of ex vivo expanded cells in the setti ng of multicycle high-dose chemotherapy.