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

NCT02490163 | Completed Phase 3

• 1 other identifier: doc20150414113301_CDF
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

Brief Summary

In a study performed in 2012, the investigators demonstrated that in ECP setting , the new automated device (Spectra Optia-MNC) released by Terumo BCT for MNCs collection based on intermittent flow is safe and ensures high-quality MNC collection and yield.(5, 6) More recently (in 2013), Terumo BCT released another automated system that allows to collect stem cells and MNCs basing on a continuous collection flow.(7, 8) The aim of this cross-over study is to compare yield (i.e. collection efficiency, CE) and quality (i.e. purity and contamination) of MNCs collected from patients undergoing ECP with two different automated systems: MNC and CMNC (Terumo BCT) processing 1.5 blood volumes during every collection procedure.

Conditions

GvHD; Lung Graft Dysfunction

Outcome Measures

Primary Outcomes (1)

• Yield of MNCs

  absolute number of MNC/ml in bag

  on average at 1 month from ECP start

Secondary Outcomes (3)

• Collection efficiency (%)

  on average at 1 month from ECP start

• purity

  on average at 1 month from ECP start

• safety as change in platelet count in peripheral blood

  single timepoint point: 10 minutes after MNC collection

Other Outcomes (1)

• Yield of MNCs in GvDH vs CLAD

  on average at 1 month from ECP start

Study Arms (2)

CMNC

EXPERIMENTAL

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.

Device: Spectra Optia

MNC

ACTIVE COMPARATOR

The Spectra Optia MNC collects MNCs by intermittent flow: MNCs accumulate and are flushed from a secondary chamber at intervals during the procedure.

Device: Spectra Optia

Interventions

Spectra Optia DEVICE

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.

Also known as: Terumo BCT

CMNC; MNC

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

Sponsors & Collaborators

• Fondazione IRCCS Policlinico San Matteo di Pavia: lead

Study Sites (1)

IRCCS Policlinic San Matteo Foundation

Pavia, 27100, Italy

Location

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: May 28, 2015
• First Posted: July 3, 2015
• Study Start: August 1, 2015
• Primary Completion: November 1, 2015
• Study Completion: January 1, 2016
• Last Updated: January 11, 2016

Record last verified: 2016-01

Locations

IT (1)