valuation of Safety and Preliminary Effectiveness of Point-of-Care Cell Processing System: An Observational Study

Abstract

The potential of cell therapy in treating incurable and irreversible diseases has been proven to be safe and feasible with varying degrees of success in medical fraternity. In the past decade, there has been a steady increase in the development of advanced point-of-care cell processing technologies and intra-operative procedures that integrate autologous cell-based therapy with conventional surgical procedure in a single sitting, have emerged as an exciting approach in regenerative medicine and cell therapy field. Point-of-care (POC) cell processing devices are automatic, closed systems that allow rapid processing of whole tissue to the desired cell population at the patient's bedside, at an affordable cost. This observational study evaluates the safety and feasibility of a rapid point-of-care technology, the Res-Q™ 60 system used for processing bone marrow and/or peripheral blood intraoperatively for treating patients with various clinical indications who were administered the cell therapy product either as a standalone treatment or in conjunction with standard-of-care treatment. The data from 254 patients treated using either Bone Marrow Concentrate (BMC) or Platelet Rich Plasma (PRP) produced by Res-Q™ 60 devices was observed and analysed for device performance including cellularity, sterility and safety. The cellular output from Res-Q™ 60 BMC and PRP devices showed a significantly high MNC recovery of 71.35% ± 2.10 (SD) and platelet recovery of 78.3% ± 3.0 (SD), respectively. All the samples were sterile with no bacterial or fungal growth and all the patients tolerated the device output i.e. BMC or PRP well with no related adverse events (SAEs/ AEs). Therefore, the Res-Q™ 60 BMC and PRP devices were found to be safe, feasible and preliminary effective for autologous cellular therapy at the point-of-care.