A Randomized, Crossover Trial to Characterize the Performance of the Spectra Optia Apheresis System Versus the COBE Spectra Apheresis System for Collection of Mononuclear Cells in Healthy Adult Donors
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 23
- 试验地点
- 2
- 主要终点
- CD34+ Collection Efficiency (CE1 %)
研究概览
简要总结
The purpose of this prospective, randomized, cross-over, multi-center study is to evaluate the performance of the Spectra Optia Apheresis System's CMNC Collection Procedure, compared to the COBE Spectra Apheresis System's MNC Procedure in mobilized healthy donors. Subject safety will be evaluated beginning with mobilization, throughout the collection procedure and for the day following the last collection.
详细描述
This is a prospective, randomized, cross-over, multi-center study to evaluate the performance of the Spectra Optia system's CMNC Collection Procedure, compared to the COBE Spectra system's MNC Procedure in mobilized healthy donors.
Up to 60 subject may be consented to meet the the enrollment target of 20 complete subjects. Eligible subjects will be randomized to receive either the Spectra Optia CMNC or the COBE Spectra MNC collection procedure first, followed by the opposite on the following day.
Study participation will be up to 14 days: a 7-day screening period, four days for mobilization, one day for the first MNC collection with additional dose of mobilization, one day for the second MNC collection, and safety follow-up the following day.
Subject safety will be evaluated beginning with mobilization, throughout the collection procedure and for the day following the second collection.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •≥ 18 and ≤ 50 years of age
- •Healthy blood donor criteria as defined by the American Associate of Blood Banks (AABB)
- •a) Note: Subjects who are deferred from volunteer donations because of travel restrictions, piercings or tattoos may participate in the study
- •Adequate dual peripheral venous access
- •Acceptable prescreening laboratory results prior to MNC mobilization as specified below:
- •a) WBC 3,500 - 10,800/µL
- •b) Hematocrit 38% - 56%
- •c) Platelets 150,000 - 400,000/µL
- •d) Coagulation tests:
- •i. PT 9.0 - 13.0 seconds
- •ii. PTT 23.4 - 41.8 seconds
- •e) Serum electrolytes:
- •i. Potassium 3.6 - 5.1 mmol/L
- •ii. Serum Calcium 8.5 mg/dL - 10.3 mg/dL
- •f) Renal function: Serum creatinine ≤ 1.5 mg/dL
- •NOTE: up to two laboratory results may fall out of the ranges listed above if, in the judgment of the investigator, they do not constitute a significant risk to the subject.
- •Liver function: alanine aminotransferase (ALT) < 1.5 times the upper limit of normal
- •Willing to avoid pregnancy until at least 48 hours following last G-CSF injection
- •If male, be willing to use a condom during sexual relations with a female partner until 48 hours following the last G-CSF injection
- •If female and of childbearing potential, be willing to use a medically acceptable contraceptive until 48 hours following the last G-CSF injection
- •Given written informed consent
排除标准
- •Previous MNC collection failure
- •Known hypersensitivity or condition that prevents the use of anticoagulants
- •Known hypersensitivity or condition that prevents the use of G-CSF
- •Known hemoglobinopathy including sickle cell trait or disease
- •History of use in the past week or anticipated need for lithium
- •Concurrent enrollment in another clinical study that could impact the results or participation in this study
- •Active infection or any serious underlying medical condition that contraindicates apheresis
- •Women who are pregnant or lactating
- •Known history of significant head trauma
研究组 & 干预措施
Spectra Optia CMNC first, then COBE Spectra MNC
Spectra Optia CMNC collection procedure followed by COBE Spectra MNC collection procedure.
干预措施: Spectra Optia CMNC (Device)
Spectra Optia CMNC first, then COBE Spectra MNC
Spectra Optia CMNC collection procedure followed by COBE Spectra MNC collection procedure.
干预措施: COBE Spectra MNC (Device)
Spectra Optia CMNC first, then COBE Spectra MNC
Spectra Optia CMNC collection procedure followed by COBE Spectra MNC collection procedure.
干预措施: Granulocyte-colony stimulating factor (G-CSF) (Drug)
COBE Spectra MNC first, then Spectra Optia CMNC
COBE Spectra MNC collection procedure followed by Spectra Optia CMNC collection procedure.
干预措施: Spectra Optia CMNC (Device)
COBE Spectra MNC first, then Spectra Optia CMNC
COBE Spectra MNC collection procedure followed by Spectra Optia CMNC collection procedure.
干预措施: COBE Spectra MNC (Device)
COBE Spectra MNC first, then Spectra Optia CMNC
COBE Spectra MNC collection procedure followed by Spectra Optia CMNC collection procedure.
干预措施: Granulocyte-colony stimulating factor (G-CSF) (Drug)
结局指标
主要结局
CD34+ Collection Efficiency (CE1 %)
时间窗: within 5 minutes upon completion of procedure
The primary endpoint is the CD34+ cell collection efficiency (CE) associated with the Mononuclear Cell (CMNC) Collection Procedures on the Spectra Optia and COBE Spectra Apheresis Systems. CE is a measurement of device performance calculated using donor and blood product blood counts collected immediately before and after the CMNC collection procedure. The collection efficiency for a given cell type is defined as the percent of processed cells of that cell type that are in fact collected.
次要结局
- CD34+ Per kg of Body Weight(within 5 minutes upon completion of procedure)
- MNC Blood Product Volume (mL)(within 5 minutes upon completion of procedure)
- MNC Product Contamination/Purity (%) - Hematocrit (%)(within 5 minutes upon completion of procedure)
- MNC Product Contamination/Purity (%) - Platelet Concentration (10^3/µL)(within 5 minutes upon completion of procedure)
- Purity of Plasma Collected for Laboratory Processing of MNC Product - Platelet Concentration in Plasma (10^3/µL)(within 5 minutes upon completion of procedure)
- MNC Collection Efficiency (CE2%)(within 5 minutes upon completion of procedure)
- MNC Product Contamination/Purity - RBC Concentration (10^6/µL)(within 5 minutes upon completion of procedure)
- CD34+ Collection Efficiency (CE2 %)(within 5 minutes upon completion of procedure)
- MNC Collection Efficiency (CE1%)(within 5 minutes upon completion of procedure)
- MNC Product Contamination/Purity (%) - Granulocyte Concentration (10^3/mL)(within 5 minutes upon completion of procedure)
- MNC Product Contamination/Purity (%) - Platelet Collection Efficiency (CE1 %)(within 5 minutes upon completion of procedure)
- Procedure Time (Minutes)(within 5 minutes upon completion of procedure)