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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Throughput (TP)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years(Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •demand of concurrent plasma
研究组 & 干预措施
IDL-Set
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
干预措施: Spectra Optia® IDL-Set (Device)
MNC-Set
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
干预措施: Spectra Optia® Collection Set (Device)
结局指标
主要结局
Throughput (TP)
时间窗: Day 1
Efficiency of peripheral blood progenitor cell collection measured as throughput (collection rate (CR) per minute)
次要结局
- CE2(Day 1)
- CR per total blood volume (TBV)(Day 1)
- Collection efficiency (CE) 1(Day 1)
- Product T cells(Day 1)
- Product NK cells(Day 1)
