An Evaluation of the Spectra Optia CMNC Collection Procedure (CMNC)

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

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.

Study Overview

• Status: Completed
• Conditions: Healthy Apheresis Donors; Mononuclear (MNC) Cell Donors
• Intervention / Treatment: Device: Spectra Optia CMNC; Device: COBE Spectra MNC; Drug: Granulocyte-colony stimulating factor (G-CSF)

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.

• Study Type: Interventional
• Enrollment (Actual): 23
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Cincinnati, Ohio, United States, 45267-0055
      • Hoxworth Blood Center
  • Tennessee
    • Memphis, Tennessee, United States, 38104
      • Key Biologics, LLC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 48 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. ≥ 18 and ≤ 50 years of age

2. 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

3. Adequate dual peripheral venous access

4. 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.

5. Liver function: alanine aminotransferase (ALT) < 1.5 times the upper limit of normal

6. 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
7. Given written informed consent

Exclusion Criteria:

1. Previous MNC collection failure
2. Known hypersensitivity or condition that prevents the use of anticoagulants
3. Known hypersensitivity or condition that prevents the use of G-CSF
4. Known hemoglobinopathy including sickle cell trait or disease
5. History of use in the past week or anticipated need for lithium
6. Concurrent enrollment in another clinical study that could impact the results or participation in this study
7. Active infection or any serious underlying medical condition that contraindicates apheresis
8. Women who are pregnant or lactating
9. Known history of significant head trauma

Study Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Spectra Optia CMNC first, then COBE Spectra MNC; Spectra Optia CMNC collection procedure followed by COBE Spectra MNC collection procedure.	Device: Spectra Optia CMNC; The Spectra Optia® Apheresis System is an automated centrifugal system that separates whole blood into its cellular and plasma components. The device is comprised of three major sub-systems, 1) the apheresis machine itself (centrifuge, centrifuge filler, pumps, valves, computerized safety and control systems, etc.), 2) a sterile, single-use, disposable blood tubing set, and 3) embedded software. The Spectra Optia system's investigational CMNC procedure will be used to collect MNC from the peripheral blood.; Other Names: Spectra Optia Apheresis System CMNC collection procedure; Device: COBE Spectra MNC; It is also a centrifugal system that separates whole blood into its cellular and plasma components. The COBE Spectra MNC collection procedure is chosen as the comparator device because it is the reference after which design of the Spectra Optia CMNC collection procedure was modeled.; Other Names: COBE Spectra Apheresis System MNC collection procedure; Drug: Granulocyte-colony stimulating factor (G-CSF); Each subject received an injection of the G-CSF approximately equivalent to 10 ug/kg body weight subcutaneous per day for 5 days prior to the MNC collection procedure.; Other Names: Mobilization Procedure
Experimental: COBE Spectra MNC first, then Spectra Optia CMNC; COBE Spectra MNC collection procedure followed by Spectra Optia CMNC collection procedure.	Device: Spectra Optia CMNC; The Spectra Optia® Apheresis System is an automated centrifugal system that separates whole blood into its cellular and plasma components. The device is comprised of three major sub-systems, 1) the apheresis machine itself (centrifuge, centrifuge filler, pumps, valves, computerized safety and control systems, etc.), 2) a sterile, single-use, disposable blood tubing set, and 3) embedded software. The Spectra Optia system's investigational CMNC procedure will be used to collect MNC from the peripheral blood.; Other Names: Spectra Optia Apheresis System CMNC collection procedure; Device: COBE Spectra MNC; It is also a centrifugal system that separates whole blood into its cellular and plasma components. The COBE Spectra MNC collection procedure is chosen as the comparator device because it is the reference after which design of the Spectra Optia CMNC collection procedure was modeled.; Other Names: COBE Spectra Apheresis System MNC collection procedure; Drug: Granulocyte-colony stimulating factor (G-CSF); Each subject received an injection of the G-CSF approximately equivalent to 10 ug/kg body weight subcutaneous per day for 5 days prior to the MNC collection procedure.; Other Names: Mobilization Procedure

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
CD34+ Collection Efficiency (CE1 %)	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.	within 5 minutes upon completion of procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
CD34+ Collection Efficiency (CE2 %)	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.	within 5 minutes upon completion of procedure
MNC Collection Efficiency (CE1%)	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.	within 5 minutes upon completion of procedure
CD34+ Per kg of Body Weight		within 5 minutes upon completion of procedure
MNC Product Contamination/Purity (%) - Hematocrit (%)		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 Concentration (10^3/µL)		within 5 minutes upon completion of procedure
MNC Product Contamination/Purity (%) - Platelet Collection Efficiency (CE1 %)	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.	within 5 minutes upon completion of procedure
MNC Blood Product Volume (mL)	The produced unit of MNCs collected into the blood bag.	within 5 minutes upon completion of procedure
Purity of Plasma Collected for Laboratory Processing of MNC Product - Platelet Concentration in Plasma (10^3/µL)	A small amount of plasma typically used for processing was collected in a sub-set of collection procedures.	within 5 minutes upon completion of procedure
Procedure Time (Minutes)		within 5 minutes upon completion of procedure
MNC Collection Efficiency (CE2%)	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.	within 5 minutes upon completion of procedure
MNC Product Contamination/Purity - RBC Concentration (10^6/µL)		within 5 minutes upon completion of procedure

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Device Deficiencies	Any time a device or disposable does not function as described in the Operator's Manual or Package Insert, a Device Deficiency must be reported. This includes those instances wherein Operator Error led to a malfunction/deficiency. A device deficiency is any inadequacy in the identity, quality, durability, reliability, safety or performance of an investigational device, including malfunction, use errors or inadequacy in the information supplied by the manufacturer. Device malfunctions and device incidents should be reported in the same manner.	24-hours after last collection procedure
Post-collection Platelet Loss in Subject	The percent change from pre-collection platelet count to post-collection subject platelet count.	24-hours after last collection procedure

Collaborators and Investigators

• Sponsor: Terumo BCT
• Investigators: Study Director: Raymond Goodrich, PhD, Terumo BCT

Study record dates

Study Major Dates

• Study Start: September 1, 2014
• Primary Completion (Actual): January 1, 2015
• Study Completion (Actual): January 1, 2015

Study Registration Dates

• First Submitted: September 23, 2014
• First Submitted That Met QC Criteria: September 26, 2014
• First Posted (Estimate): October 1, 2014

Study Record Updates

• Last Update Posted (Estimate): September 24, 2015
• Last Update Submitted That Met QC Criteria: August 24, 2015
• Last Verified: August 1, 2015

More Information

Terms related to this study

• Keywords: Apheresis; Mononuclear Cells; MNCs; Spectra Optia
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Immunologic Factors; Adjuvants, Immunologic; Lenograstim
• Other Study ID Numbers: CTS-5038