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| ID | Type | Description | Link |
|---|---|---|---|
| CIV-13-10-011663 | Other Identifier | EUDAMED |
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| Name | Class |
|---|---|
| Terumo BCT | INDUSTRY |
| Chugai Pharma USA | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Spectra Optia® IDL-Set | Device | Peripheral blood progenitor cell apheresis in G-CSF mobilized allogeneic donors using the Spectra Optia® cell separator |
|
| Measure | Description | Time Frame |
|---|---|---|
| Throughput (TP) | Efficiency of peripheral blood progenitor cell collection measured as throughput (collection rate (CR) per minute) | Day 1 |
| Measure | Description | Time Frame |
|---|---|---|
| CR per total blood volume (TBV) | Efficiency of peripheral blood progenitor cell collection measured as CR per TBV | Day 1 |
| Collection efficiency (CE) 1 | Percentage of harvested cells per processed cells (calculated by use of the peripheral blood progenitor cell counts pre and post apheresis) |
| Measure | Description | Time Frame |
|---|---|---|
| levels of electrolytes before and after apheresis | sodium, potassium and calcium are measured before and after apherese and 30 days after collection | day 1, day 30 |
| kinetics of peripheral blood cell count |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Johannes C Fischer, MD | Heinrich Heine University Hospital Duesseldorf | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cellex GmbH / Zentrum für Zellgewinnung (Standort Köln) | Cologne | 50670 | Germany | |||
| Institut für Transplantantionsdiagnostik und Zelltherapeutika |
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| Spectra Optia® Collection Set | Device | Peripheral blood progenitor cell apheresis in G-CSF mobilized allogeneic donors using the Spectra Optia® cell separator |
|
| Day 1 |
| CE2 | Percentage of harvested cells per processed cells (calculated by use of the peripheral blood progenitor cell count pre apheresis) | Day 1 |
| Product T cells | % T cells as a definition of the cellular composition of the product | Day 1 |
| Product NK cells | % NK cells as a definition of the cellular composition of the product | Day 1 |
measurement of the peripheral blood cell count before and after apheresis and 30 days after collection
| day 1, day30 |
| Peripheral blood CD62P before and after apheresis | Percentage of CD62P positive platelets as a measure of platelet activation during apheresis | day 1 |
| Düsseldorf |
| 40225 |
| Germany |