ARTICLE | Clinical News

Ceprate SC stem cell concentration system data

December 6, 1993 8:00 AM UTC

Results of the Phase III trial in 94 patients were to be presented at the ASH meeting in St. Louis, showing a significant reduction in cardiovascular side effects. Engraftment of the CD34+ enriched marrow by day 20 was equivalent to that of a standard marrow transplant. Engraftment by day 20 and reduction in cardiovascular side effets were the primary end points of the trial. The company will file a PMA by the end of the month.

Patients were randomized to receive either their own stored marrow or their marrow after it had been processed by the Ceprate system, which separates CD4+ stem cells. After chemotherapy and infusion of the stored marrow, both groups (42 patients each) showed neutrophil recovery of at least 500 cells/mm3by day 20, while the incidence of hypertension or slowed heart rate after the infusion was cut in half in the group that received CD34+ enriched marrow (p < 0.005). ...