Comparison of Two Automated Mononuclear Collection Systems in Patients Undergoing Extracorporeal Photochemotherapy. A Cross-over Equivalence Study. (MNC_CMNC)

PHASE3CompletedINTERVENTIONAL
Enrollment

51

Participants

Timeline

Start Date

August 31, 2015

Primary Completion Date

November 30, 2015

Study Completion Date

January 31, 2016

Conditions
GvHDLung Graft Dysfunction
Interventions
DEVICE

Spectra Optia

"The Spectra Optia® Apheresis System is an automated centrifugal system that separates whole blood into its cellular and plasma components. The device is comprised of three major sub-systems, 1) the apheresis machine itself, 2) a sterile, single-use, disposable blood tubing set, and 3) embedded software.~Terumo BCT developed a completely automated apheresis system: the Spectra Optia MNC and CMNC based on an automatic interface-controlled technology that allows MNCs collection without the intervention of an operator. The optical sensors continuously control and adjust the buffy coat layer by adjusting the plasma flow.~The Spectra Optia MNC collects MNCs by intermittent flow: MNCs accumulate and are flushed from a secondary chamber at intervals during the procedure. On the other hand, the very recently released Spectra Optia CMNC (developed especially to collect stem cells that reside in the MNCs layer) is able to collect MNCs by continuous flow."

Trial Locations (1)

27100

IRCCS Policlinic San Matteo Foundation, Pavia

All Listed Sponsors
lead

Fondazione IRCCS Policlinico San Matteo di Pavia

OTHER

NCT02490163 - Comparison of Two Automated Mononuclear Collection Systems in Patients Undergoing Extracorporeal Photochemotherapy. A Cross-over Equivalence Study. (MNC_CMNC) | Biotech Hunter | Biotech Hunter