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Completed

NCT Number: NCT01901458

Two Different Collection Sets for Peripheral Blood Progenitor Cell Apheresis With Spectra Optia®

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.

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cellex GmbH / Zentrum für Zellgewinnung (Standort Köln), Cologne, Germany

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About this study

Peripheral blood progenitor cells (PBPC) collected by apheresis are the most common stem cell source for allogeneic hematopoietic stem cell transplantation.

Recently, Terumo BCT introduced a novel automated apheresis system for PBPC collection. The Spectra Optia® apheresis system uses the Spectra Optia® Collection set and the MNC software for PBPC collection. This system combines continuous centrifugation (high g) and subsequent cellular collection into an elutriation chamber, where the platelets are elutriated from mononuclear cells. An optical sensor detects when red blood cells begin to be elutriated and subsequently triggers the collection of the buffy coat into the product bag by flushing the chamber with donor plasma. Thus PBPCs are harvested intermittently. In contrast, the same apheresis systems in combination with the Spectra Optia® IDL set and the WBC-D software, which has been designed to perform leukodepletion procedures, permits continuous PBPC centrifugation (low g) and harvesting.

The investigators hypothesis is that the use of the IDL set with manual adaption of the WBC-D-software allows a more efficient PBPC collection compared to the collection set which is recommended for PBPC collection. The apheresis time to collect the same amount of target cells dependent on the donors peripheral blood count will be shortened. In addition, the investigators want to compare both systems with respect to the cellular composition of the apheresis product and the donors platelet loss and coagulation parameters during apheresis.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • demand of concurrent plasma

Treatment and study plan

Spectra Optia® IDL-Set

Device

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

Spectra Optia® Collection Set

Device

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

Primary outcomes

  1. Throughput (TP)

    Time frame: Day 1

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

Secondary outcomes

  1. CR per total blood volume (TBV)

    Time frame: Day 1

    Efficiency of peripheral blood progenitor cell collection measured as CR per TBV

  2. Collection efficiency (CE) 1

    Time frame: Day 1

    Percentage of harvested cells per processed cells (calculated by use of the peripheral blood progenitor cell counts pre and post apheresis)

  3. CE2

    Time frame: Day 1

    Percentage of harvested cells per processed cells (calculated by use of the peripheral blood progenitor cell count pre apheresis)

  4. Product T cells

    Time frame: Day 1

    % T cells as a definition of the cellular composition of the product

  5. Product NK cells

    Time frame: Day 1

    % NK cells as a definition of the cellular composition of the product

Other outcomes

  1. levels of electrolytes before and after apheresis

    Time frame: day 1, day 30

    sodium, potassium and calcium are measured before and after apherese and 30 days after collection

  2. kinetics of peripheral blood cell count

    Time frame: day 1, day30

    measurement of the peripheral blood cell count before and after apheresis and 30 days after collection

  3. Peripheral blood CD62P before and after apheresis

    Time frame: day 1

    Percentage of CD62P positive platelets as a measure of platelet activation during apheresis

Sponsors and collaborators

Lead sponsor

Heinrich-Heine University, Duesseldorf

Other

Collaborators

  • Chugai Pharma USA
  • Terumo BCT

Registry information

Official study title

Prospective Randomized Trial Comparing Efficiency of Peripheral Blood Progenitor Cell Collection in Allogeneic Donors Using the Spectra Optia® IDL Set in Comparison With the Spectra Optia® MNC Collection Set

Acronym: optiMaL

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Jul 17, 2013
Registry last updated
Mar 19, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.