A paired study comparing mononuclear cell collection using a new in-line system with an off-line extracorporeal photopheresis apheresis system.

Abstract

Background: Extracorporeal photopheresis (ECP) product characteristics are not well established. The aim of this study was to compare mononuclear cells (MNCs) collection using the new Amicus blue (AB) In-line ECP system to our standard Off-line ECP system using the Optia apheresis device and the MacoGenic G2 inactivation system (OM).

Study design and methods: We assessed the ECP products and procedure parameters, patient characteristics, and adverse events for both AB and OM systems in paired patients. Comparisons were made with t-test for paired samples.

Results: Thirteen patients underwent 15 double, paired procedures using both ECP protocols and processing the same blood volume of 4000 mL. Total MNC collected in the product were 51.6 × 10⁸ (95% CI 30.0-73.1) and 42.2 × 10⁸ (95% CI 22.4-62.0) for the AB and OM, respectively (not significant). Both products were also similar regarding volume, MNC concentration, purity, and hematocrit. However, total platelet count (×10¹¹) was significantly lower in the AB products: 0.25 (95% CI 0.15-0.36) versus 1.2 (95% CI 0.9-1.5). The new AB system reduced significantly also the time invested and anticoagulant used per procedure compared with OM, albeit with similar collection efficiency and percentage of MNC captured per procedure. Hypocalcemia was the commonest adverse event with both systems, but it was not severe.

Conclusions: The new AB system collected MNC products comparable to our current experience with OM, although in a significantly shorter time, with a reduced use of anticoagulant and lower contamination with platelets, which are all valuable advantages of the new system.