An Evaluation of the Spectra Optia CMNC Collection Procedure

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02253160

Acronym

CMNC

Enrollment

Registered

2014-10-01

Start date

2014-09-30

Completion date

2015-01-31

Last updated

2015-09-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Apheresis Donors, Mononuclear (MNC) Cell Donors

Keywords

MNCs, Mononuclear Cells, Apheresis, Spectra Optia

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.

Interventions

DEVICESpectra 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.

DEVICECOBE 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.

DRUGGranulocyte-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.

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 50 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.
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 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	—
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.
MNC Blood Product Volume (mL)	within 5 minutes upon completion of procedure	The produced unit of MNCs collected into the blood bag.
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.
Procedure Time (Minutes)	within 5 minutes upon completion of procedure	—

Other

Measure	Time frame	Description
Device Deficiencies	24-hours after last collection procedure	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.
Post-collection Platelet Loss in Subject	24-hours after last collection procedure	The percent change from pre-collection platelet count to post-collection subject platelet count.

Countries

United States

Participant flow

Recruitment details

Subjects were recruited from the specialized donor population of blood centers from August 2014 through January 2015.

Pre-assignment details

A lead-in phase was used to allow for investigational device training. One subject consented the lead-in phase and was included in the safety analysis only. After a screening period to evaluate and confirm eligibility criteria prior to enrollment & randomization to treatment assignment (Arm 1 or Arm 2) 22 subjects enrolled in the pivotal study.

Participants by arm

Arm	Count
Lead-in Donor Subjects screened and enrolled for the purpose of training on the investigational procedure only. Included in safety analysis only.	1
Spectra Optia CMNC First, Then COBE Spectra MNC Spectra Optia CMNC collection procedure followed by COBE Spectra MNC collection procedure. 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. 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.	12
COBE Spectra MNC First, Then Spectra Optia CMNC COBE Spectra MNC collection procedure followed by Spectra Optia CMNC collection procedure. 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. 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.	10
Total	23

Baseline characteristics

Characteristic	Lead-in Donor	Spectra Optia CMNC First, Then COBE Spectra MNC	COBE Spectra MNC First, Then Spectra Optia CMNC	Total
Age, Continuous	32 years	35.4 years STANDARD_DEVIATION 7.32	34.8 years STANDARD_DEVIATION 8.44	35.0 years STANDARD_DEVIATION 7.51
BMI	47.36 kg/m^2	35.82 kg/m^2 STANDARD_DEVIATION 9.413	30.88 kg/m^2 STANDARD_DEVIATION 6.05	34.17 kg/m^2 STANDARD_DEVIATION 8.579
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants	12 Participants	10 Participants	23 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	0 Participants	0 Participants	0 Participants	0 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants	0 Participants	0 Participants	0 Participants
Height	60 inches	70.8 inches STANDARD_DEVIATION 2.45	69.4 inches STANDARD_DEVIATION 4.06	69.7 inches STANDARD_DEVIATION 3.83
Race (NIH/OMB) American Indian or Alaska Native	0 Participants	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Asian	0 Participants	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Black or African American	1 Participants	5 Participants	6 Participants	12 Participants
Race (NIH/OMB) More than one race	0 Participants	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants	1 Participants	0 Participants	1 Participants
Race (NIH/OMB) White	0 Participants	6 Participants	4 Participants	10 Participants
Sex: Female, Male Female	0 Participants	1 Participants	2 Participants	3 Participants
Sex: Female, Male Male	1 Participants	11 Participants	8 Participants	20 Participants
Weight	110 kilograms	115.23 kilograms STANDARD_DEVIATION 28.921	97.08 kilograms STANDARD_DEVIATION 26.654	107.11 kilograms STANDARD_DEVIATION 28.124

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk	EG002 affected / at risk	EG003 affected / at risk
deaths Total, all-cause mortality	— / —	— / —	— / —	— / —
other Total, other adverse events	22 / 23	13 / 23	16 / 22	2 / 23
serious Total, serious adverse events	0 / 23	0 / 23	0 / 22	0 / 23

Outcome results

Primary

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.