An Evaluation of the Spectra Optia CMNC Collection Procedure

Not Applicable

Completed

Conditions: Healthy Apheresis Donors
Mononuclear (MNC) Cell Donors

Interventions: Device: Spectra Optia CMNC
Device: COBE Spectra MNC
Drug: Granulocyte-colony stimulating factor (G-CSF)

Registration Number: NCT02253160

Lead Sponsor: Terumo BCT

Brief Summary: 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.

Detailed Description: 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 23

Inclusion Criteria

≥ 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
1. If male, be willing to use a condom during sexual relations with a female partner until 48 hours following the last G-CSF injection
2. 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

Exclusion Criteria

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Spectra Optia CMNC first, then COBE Spectra MNC	Spectra Optia CMNC	Spectra Optia CMNC collection procedure followed by COBE Spectra MNC collection procedure.
Spectra Optia CMNC first, then COBE Spectra MNC	Granulocyte-colony stimulating factor (G-CSF)	Spectra Optia CMNC collection procedure followed by COBE Spectra MNC collection procedure.
COBE Spectra MNC first, then Spectra Optia CMNC	COBE Spectra MNC	COBE Spectra MNC collection procedure followed by Spectra Optia CMNC collection procedure.
COBE Spectra MNC first, then Spectra Optia CMNC	Granulocyte-colony stimulating factor (G-CSF)	COBE Spectra MNC collection procedure followed by Spectra Optia CMNC collection procedure.
Spectra Optia CMNC first, then COBE Spectra MNC	COBE Spectra MNC	Spectra Optia CMNC collection procedure followed by COBE Spectra MNC collection procedure.
COBE Spectra MNC first, then Spectra Optia CMNC	Spectra Optia CMNC	COBE Spectra MNC collection procedure followed by Spectra Optia CMNC collection procedure.

Primary Outcome Measures

Name	Time	Method
CD34+ Collection Efficiency (CE1 %)	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.

Secondary Outcome Measures

Name	Time	Method
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	The produced unit of MNCs collected into the blood bag.
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	A small amount of plasma typically used for processing was collected in a sub-set of collection procedures.
MNC Collection Efficiency (CE2%)	within 5 minutes upon completion of procedure	Comparison of collection efficiencies associated with the CMNC Collection Procedures on the Spectra Optia and COBE Spectra Apheresis Systems for MNCs. CE2 is a measurement of device performance calculated using donor blood counts immediately before and blood product counts immediately after the collection procedure and does not average the donor pre- and post-collection counts. 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.
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	Comparison of collection efficiencies associated with the CMNC Cell Collection Procedures on the Spectra Optia and COBE Spectra Apheresis Systems. CE is a measurement of device performance calculated using donor blood counts immediately before and blood product blood counts immediately after the 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.
MNC Collection Efficiency (CE1%)	within 5 minutes upon completion of procedure	Comparison of collection efficiencies associated with the CMNC Collection Procedures on the Spectra Optia and COBE Spectra Apheresis Systems for MNCs. CE1 is a measurement of device performance calculated using donor and blood product blood counts collected immediately before and after the 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.
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	Comparison of collection efficiencies associated with the CMNC Collection Procedures on the Spectra Optia and COBE Spectra Apheresis Systems for platelets. CE1 is a measurement of device performance calculated using donor and blood product blood counts collected immediately before and after the 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.
Procedure Time (Minutes)	within 5 minutes upon completion of procedure