NCT01901458

Brief Summary

The study will determine the advantage of the Spectra Optia® IDL set compared to the standard collection set for collection of peripheral blood progenitor cells using the Spectra Optia® apheresis system. The study will assess the reduction of apheresis time to obtain the required amount of hematopoietic progenitor cells.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2014

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 10, 2013

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 17, 2013

Completed
8 months until next milestone

Study Start

First participant enrolled

March 1, 2014

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2014

Completed
Last Updated

March 19, 2015

Status Verified

March 1, 2015

Enrollment Period

8 months

First QC Date

July 10, 2013

Last Update Submit

March 18, 2015

Conditions

Healthy Allogeneic DonorsGranulocyte Colony-stimulating Factor (G-CSF) Mobilized

Keywords

apheresisperipheral blood progenitor cellsperipheral blood stem cells

Outcome Measures

Primary Outcomes (1)

  • Throughput (TP)

    Efficiency of peripheral blood progenitor cell collection measured as throughput (collection rate (CR) per minute)

    Day 1

Secondary Outcomes (5)

  • CR per total blood volume (TBV)

    Day 1

  • Collection efficiency (CE) 1

    Day 1

  • CE2

    Day 1

  • Product T cells

    Day 1

  • Product NK cells

    Day 1

Other Outcomes (3)

  • levels of electrolytes before and after apheresis

    day 1, day 30

  • kinetics of peripheral blood cell count

    day 1, day30

  • Peripheral blood CD62P before and after apheresis

    day 1

Study Arms (2)

IDL-Set

EXPERIMENTAL

Peripheral blood progenitor cell apheresis in G-CSF mobilized allogeneic donors using the Spectra Optia® IDL-Set in combination with the Spectra Optia® cell separator and the WBC-D program

Device: Spectra Optia® IDL-Set

MNC-Set

ACTIVE COMPARATOR

Peripheral blood progenitor cell apheresis in G-CSF mobilized allogeneic donors using the Spectra Optia® Collection Set in combination with the Spectra Optia® cell separator and the MNC program

Device: Spectra Optia® Collection Set

Interventions

Spectra Optia® IDL-SetDEVICE

Peripheral blood progenitor cell apheresis in G-CSF mobilized allogeneic donors using the Spectra Optia® cell separator

IDL-Set
Spectra Optia® Collection SetDEVICE

Peripheral blood progenitor cell apheresis in G-CSF mobilized allogeneic donors using the Spectra Optia® cell separator

MNC-Set

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • ability to give informed consent to participate in the study
  • meets german eligibility criteria (ZKRD-Standards, hemotherapy guidelines) for peripheral blood stem cell donation
  • has been treated with G-CSF 10 µg per kg per day for 5 days

You may not qualify if:

  • demand of concurrent plasma

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Cellex GmbH / Zentrum für Zellgewinnung (Standort Köln)

Cologne, 50670, Germany

Location

Institut für Transplantantionsdiagnostik und Zelltherapeutika

Düsseldorf, 40225, Germany

Location

Study Officials

  • Johannes C Fischer, MD

    Heinrich Heine University Hospital Duesseldorf

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 10, 2013

First Posted

July 17, 2013

Study Start

March 1, 2014

Primary Completion

November 1, 2014

Study Completion

November 1, 2014

Last Updated

March 19, 2015

Record last verified: 2015-03

Locations

DE(2)