Trial Outcomes & Findings for An Evaluation of the Spectra Optia CMNC Collection Procedure (NCT NCT02253160)
NCT ID: NCT02253160
Last Updated: 2015-09-24
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
23 participants
Primary outcome timeframe
within 5 minutes upon completion of procedure
Results posted on
2015-09-24
Participant Flow
Subjects were recruited from the specialized donor population of blood centers from August 2014 through January 2015.
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.
Participant milestones
| Measure |
Lead-in Donor
Subjects screened and enrolled for the purpose of training on the investigational procedure only. Included in safety analysis only.
|
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.
|
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.
|
|---|---|---|---|
|
Overall Study
STARTED
|
1
|
12
|
10
|
|
Overall Study
COMPLETED
|
1
|
12
|
10
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
An Evaluation of the Spectra Optia CMNC Collection Procedure
Baseline characteristics by cohort
| Measure |
Lead-in Donor
n=1 Participants
Subjects screened and enrolled for the purpose of training on the investigational procedure only. Included in safety analysis only.
|
Spectra Optia CMNC First, Then COBE Spectra MNC
n=12 Participants
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.
|
COBE Spectra MNC First, Then Spectra Optia CMNC
n=10 Participants
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.
|
Total
n=23 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
32 years
STANDARD_DEVIATION NA • n=5 Participants
|
35.4 years
STANDARD_DEVIATION 7.32 • n=7 Participants
|
34.8 years
STANDARD_DEVIATION 8.44 • n=5 Participants
|
35.0 years
STANDARD_DEVIATION 7.51 • n=4 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
20 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
23 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Weight
|
110 kilograms
STANDARD_DEVIATION NA • n=5 Participants
|
115.23 kilograms
STANDARD_DEVIATION 28.921 • n=7 Participants
|
97.08 kilograms
STANDARD_DEVIATION 26.654 • n=5 Participants
|
107.11 kilograms
STANDARD_DEVIATION 28.124 • n=4 Participants
|
|
Height
|
60 inches
STANDARD_DEVIATION NA • n=5 Participants
|
70.8 inches
STANDARD_DEVIATION 2.45 • n=7 Participants
|
69.4 inches
STANDARD_DEVIATION 4.06 • n=5 Participants
|
69.7 inches
STANDARD_DEVIATION 3.83 • n=4 Participants
|
|
BMI
|
47.36 kg/m^2
STANDARD_DEVIATION NA • n=5 Participants
|
35.82 kg/m^2
STANDARD_DEVIATION 9.413 • n=7 Participants
|
30.88 kg/m^2
STANDARD_DEVIATION 6.050 • n=5 Participants
|
34.17 kg/m^2
STANDARD_DEVIATION 8.579 • n=4 Participants
|
PRIMARY outcome
Timeframe: within 5 minutes upon completion of procedureThe 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.
Outcome measures
| Measure |
Treatment Assignment 1
n=12 Participants
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.
|
Treatment Assignment 2
n=10 Participants
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.
|
|---|---|---|
|
CD34+ Collection Efficiency (CE1 %)
Spectra Optia
|
87.7 percent
Standard Deviation 20.18
|
81.4 percent
Standard Deviation 10.24
|
|
CD34+ Collection Efficiency (CE1 %)
COBE Spectra
|
66.6 percent
Standard Deviation 20.26
|
65.8 percent
Standard Deviation 6.40
|
SECONDARY outcome
Timeframe: within 5 minutes upon completion of procedureComparison 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.
Outcome measures
| Measure |
Treatment Assignment 1
n=12 Participants
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.
|
Treatment Assignment 2
n=10 Participants
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.
|
|---|---|---|
|
CD34+ Collection Efficiency (CE2 %)
Spectra Optia
|
64.7 percent
Standard Deviation 14.61
|
59.6 percent
Standard Deviation 6.17
|
|
CD34+ Collection Efficiency (CE2 %)
COBE Spectra
|
47.0 percent
Standard Deviation 14.86
|
50.2 percent
Standard Deviation 4.20
|
SECONDARY outcome
Timeframe: within 5 minutes upon completion of procedurePopulation: One subject was not included in MNC CE1 because of missing MNC lab results post-collection, therefore CE1 could not be calculated.
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.
Outcome measures
| Measure |
Treatment Assignment 1
n=11 Participants
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.
|
Treatment Assignment 2
n=10 Participants
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.
|
|---|---|---|
|
MNC Collection Efficiency (CE1%)
Spectra Optia CE1
|
62.06 percent
Standard Deviation 17.220
|
63.75 percent
Standard Deviation 18.900
|
|
MNC Collection Efficiency (CE1%)
COBE Spectra CE1
|
45.46 percent
Standard Deviation 6.483
|
48.58 percent
Standard Deviation 14.685
|
SECONDARY outcome
Timeframe: within 5 minutes upon completion of procedureOutcome measures
| Measure |
Treatment Assignment 1
n=12 Participants
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.
|
Treatment Assignment 2
n=10 Participants
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.
|
|---|---|---|
|
CD34+ Per kg of Body Weight
Spectra Optia
|
5.14 cells/kg
Standard Deviation 3.756
|
3.75 cells/kg
Standard Deviation 1.506
|
|
CD34+ Per kg of Body Weight
COBE Spectra
|
3.50 cells/kg
Standard Deviation 2.732
|
3.68 cells/kg
Standard Deviation 1.546
|
SECONDARY outcome
Timeframe: within 5 minutes upon completion of procedureOutcome measures
| Measure |
Treatment Assignment 1
n=12 Participants
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.
|
Treatment Assignment 2
n=10 Participants
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.
|
|---|---|---|
|
MNC Product Contamination/Purity (%) - Hematocrit (%)
Spectra Optia Hematocrit
|
6.1 % of red blood cells
Standard Deviation 2.12
|
3.7 % of red blood cells
Standard Deviation 0.95
|
|
MNC Product Contamination/Purity (%) - Hematocrit (%)
COBE Spectra Hematocrit
|
4.5 % of red blood cells
Standard Deviation 1.54
|
5.7 % of red blood cells
Standard Deviation 1.71
|
SECONDARY outcome
Timeframe: within 5 minutes upon completion of procedureOutcome measures
| Measure |
Treatment Assignment 1
n=12 Participants
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.
|
Treatment Assignment 2
n=10 Participants
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.
|
|---|---|---|
|
MNC Product Contamination/Purity (%) - Granulocyte Concentration (10^3/mL)
Spectra Optia
|
51.689 cells*10^3/mL
Standard Deviation 35.5970
|
63.338 cells*10^3/mL
Standard Deviation 44.9682
|
|
MNC Product Contamination/Purity (%) - Granulocyte Concentration (10^3/mL)
COBE Spectra
|
83.792 cells*10^3/mL
Standard Deviation 58.9491
|
70.944 cells*10^3/mL
Standard Deviation 72.4223
|
SECONDARY outcome
Timeframe: within 5 minutes upon completion of procedureOutcome measures
| Measure |
Treatment Assignment 1
n=12 Participants
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.
|
Treatment Assignment 2
n=10 Participants
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.
|
|---|---|---|
|
MNC Product Contamination/Purity (%) - Platelet Concentration (10^3/µL)
Spectra Optia
|
3724.9 cells*10^3/µL
Standard Deviation 962.42
|
2022.9 cells*10^3/µL
Standard Deviation 674.91
|
|
MNC Product Contamination/Purity (%) - Platelet Concentration (10^3/µL)
COBE Spectra
|
2857.4 cells*10^3/µL
Standard Deviation 467.44
|
3736.0 cells*10^3/µL
Standard Deviation 1200.88
|
SECONDARY outcome
Timeframe: within 5 minutes upon completion of procedurePopulation: One subject was not included in MNC CE1 because of missing MNC lab results post-collection, therefore CE1 could not be calculated.
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.
Outcome measures
| Measure |
Treatment Assignment 1
n=11 Participants
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.
|
Treatment Assignment 2
n=10 Participants
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.
|
|---|---|---|
|
MNC Product Contamination/Purity (%) - Platelet Collection Efficiency (CE1 %)
Spectra Optia
|
28.7 percent
Standard Deviation 14.08
|
23.5 percent
Standard Deviation 8.62
|
|
MNC Product Contamination/Purity (%) - Platelet Collection Efficiency (CE1 %)
COBE Spectra
|
27.9 percent
Standard Deviation 9.19
|
30.3 percent
Standard Deviation 9.85
|
SECONDARY outcome
Timeframe: within 5 minutes upon completion of procedureThe produced unit of MNCs collected into the blood bag.
Outcome measures
| Measure |
Treatment Assignment 1
n=12 Participants
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.
|
Treatment Assignment 2
n=10 Participants
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.
|
|---|---|---|
|
MNC Blood Product Volume (mL)
Spectra Optia
|
144.8 mL
Standard Deviation 32.99
|
141.3 mL
Standard Deviation 30.82
|
|
MNC Blood Product Volume (mL)
COBE Spectra
|
140.8 mL
Standard Deviation 28.36
|
137.7 mL
Standard Deviation 28.64
|
SECONDARY outcome
Timeframe: within 5 minutes upon completion of procedurePopulation: Five collections also collected plasma for this sub-study.
A small amount of plasma typically used for processing was collected in a sub-set of collection procedures.
Outcome measures
| Measure |
Treatment Assignment 1
n=2 Participants
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.
|
Treatment Assignment 2
n=3 Participants
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.
|
|---|---|---|
|
Purity of Plasma Collected for Laboratory Processing of MNC Product - Platelet Concentration in Plasma (10^3/µL)
Spectra Optia
|
32.5 cells*10^3/µL
Standard Deviation 30.41
|
8.7 cells*10^3/µL
Standard Deviation 5.86
|
|
Purity of Plasma Collected for Laboratory Processing of MNC Product - Platelet Concentration in Plasma (10^3/µL)
COBE Spectra
|
147.5 cells*10^3/µL
Standard Deviation 4.95
|
179.3 cells*10^3/µL
Standard Deviation 72.47
|
SECONDARY outcome
Timeframe: within 5 minutes upon completion of procedureOutcome measures
| Measure |
Treatment Assignment 1
n=12 Participants
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.
|
Treatment Assignment 2
n=10 Participants
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.
|
|---|---|---|
|
Procedure Time (Minutes)
Spectra Optia
|
153.8 minutes
Standard Deviation 30.90
|
151.4 minutes
Standard Deviation 27.55
|
|
Procedure Time (Minutes)
COBE Spectra
|
151.1 minutes
Standard Deviation 31.92
|
146.7 minutes
Standard Deviation 27.35
|
SECONDARY outcome
Timeframe: within 5 minutes upon completion of procedureComparison 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.
Outcome measures
| Measure |
Treatment Assignment 1
n=12 Participants
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.
|
Treatment Assignment 2
n=10 Participants
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.
|
|---|---|---|
|
MNC Collection Efficiency (CE2%)
Spectra Optia CE2
|
50.99 percent
Standard Deviation 16.590
|
52.98 percent
Standard Deviation 17.528
|
|
MNC Collection Efficiency (CE2%)
COBE Spectra CE2
|
37.77 percent
Standard Deviation 5.297
|
39.72 percent
Standard Deviation 13.972
|
SECONDARY outcome
Timeframe: within 5 minutes upon completion of procedureOutcome measures
| Measure |
Treatment Assignment 1
n=12 Participants
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.
|
Treatment Assignment 2
n=10 Participants
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.
|
|---|---|---|
|
MNC Product Contamination/Purity - RBC Concentration (10^6/µL)
Spectra Optia RBC Concentration
|
1.029 RBC*10^6/µL
Standard Deviation 0.4740
|
0.526 RBC*10^6/µL
Standard Deviation 0.1990
|
|
MNC Product Contamination/Purity - RBC Concentration (10^6/µL)
COBE Spectra RBC Concentration
|
0.653 RBC*10^6/µL
Standard Deviation 0.2786
|
0.857 RBC*10^6/µL
Standard Deviation 0.2501
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 24-hours after last collection procedurePopulation: All pivotal subjects (n=22) received both the Spectra Optia and the COBE Spectra per the crossover design. The lead-in subject only received the Spectra Optia. Both lead-in and pivotal subjects are included in any safety analysis.
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.
Outcome measures
| Measure |
Treatment Assignment 1
n=23 Participants
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.
|
Treatment Assignment 2
n=22 Participants
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.
|
|---|---|---|
|
Device Deficiencies
|
1 events
|
0 events
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 24-hours after last collection procedureThe percent change from pre-collection platelet count to post-collection subject platelet count.
Outcome measures
| Measure |
Treatment Assignment 1
n=12 Participants
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.
|
Treatment Assignment 2
n=10 Participants
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.
|
|---|---|---|
|
Post-collection Platelet Loss in Subject
COBE Spectra
|
27.2 percent change
Standard Deviation 9.42
|
30.7 percent change
Standard Deviation 6.18
|
|
Post-collection Platelet Loss in Subject
Spectra Optia
|
27.2 percent change
Standard Deviation 9.88
|
23.9 percent change
Standard Deviation 8.04
|
Adverse Events
Pre-collection
Serious events: 0 serious events
Other events: 22 other events
Deaths: 0 deaths
Spectra Optia
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
COBE Spectra
Serious events: 0 serious events
Other events: 16 other events
Deaths: 0 deaths
Follow up
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Pre-collection
n=23 participants at risk
Subjects screened and received G-CSF.
|
Spectra Optia
n=23 participants at risk
Subject who received Spectra Optia CMNC collection procedure.
|
COBE Spectra
n=22 participants at risk
Subjects who received COBE Spectra MNC collection procedure.
|
Follow up
n=23 participants at risk
Subjects who completed cross-over design and were followed for at least 1 day.
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
thrombocytopenia
|
0.00%
0/23 • AEs were captured per protocol from the first dose of G-CSF until final follow up, which was typically 1 day after the last CMNC Collection Procedure for a total of 7 days.
|
21.7%
5/23 • AEs were captured per protocol from the first dose of G-CSF until final follow up, which was typically 1 day after the last CMNC Collection Procedure for a total of 7 days.
|
22.7%
5/22 • AEs were captured per protocol from the first dose of G-CSF until final follow up, which was typically 1 day after the last CMNC Collection Procedure for a total of 7 days.
|
4.3%
1/23 • AEs were captured per protocol from the first dose of G-CSF until final follow up, which was typically 1 day after the last CMNC Collection Procedure for a total of 7 days.
|
|
General disorders
fatigue
|
21.7%
5/23 • AEs were captured per protocol from the first dose of G-CSF until final follow up, which was typically 1 day after the last CMNC Collection Procedure for a total of 7 days.
|
4.3%
1/23 • AEs were captured per protocol from the first dose of G-CSF until final follow up, which was typically 1 day after the last CMNC Collection Procedure for a total of 7 days.
|
0.00%
0/22 • AEs were captured per protocol from the first dose of G-CSF until final follow up, which was typically 1 day after the last CMNC Collection Procedure for a total of 7 days.
|
4.3%
1/23 • AEs were captured per protocol from the first dose of G-CSF until final follow up, which was typically 1 day after the last CMNC Collection Procedure for a total of 7 days.
|
|
Investigations
hemoglobin decreased
|
8.7%
2/23 • AEs were captured per protocol from the first dose of G-CSF until final follow up, which was typically 1 day after the last CMNC Collection Procedure for a total of 7 days.
|
13.0%
3/23 • AEs were captured per protocol from the first dose of G-CSF until final follow up, which was typically 1 day after the last CMNC Collection Procedure for a total of 7 days.
|
9.1%
2/22 • AEs were captured per protocol from the first dose of G-CSF until final follow up, which was typically 1 day after the last CMNC Collection Procedure for a total of 7 days.
|
0.00%
0/23 • AEs were captured per protocol from the first dose of G-CSF until final follow up, which was typically 1 day after the last CMNC Collection Procedure for a total of 7 days.
|
|
Investigations
platelet count decreased
|
0.00%
0/23 • AEs were captured per protocol from the first dose of G-CSF until final follow up, which was typically 1 day after the last CMNC Collection Procedure for a total of 7 days.
|
0.00%
0/23 • AEs were captured per protocol from the first dose of G-CSF until final follow up, which was typically 1 day after the last CMNC Collection Procedure for a total of 7 days.
|
22.7%
5/22 • AEs were captured per protocol from the first dose of G-CSF until final follow up, which was typically 1 day after the last CMNC Collection Procedure for a total of 7 days.
|
0.00%
0/23 • AEs were captured per protocol from the first dose of G-CSF until final follow up, which was typically 1 day after the last CMNC Collection Procedure for a total of 7 days.
|
|
Musculoskeletal and connective tissue disorders
back pain
|
43.5%
10/23 • AEs were captured per protocol from the first dose of G-CSF until final follow up, which was typically 1 day after the last CMNC Collection Procedure for a total of 7 days.
|
4.3%
1/23 • AEs were captured per protocol from the first dose of G-CSF until final follow up, which was typically 1 day after the last CMNC Collection Procedure for a total of 7 days.
|
0.00%
0/22 • AEs were captured per protocol from the first dose of G-CSF until final follow up, which was typically 1 day after the last CMNC Collection Procedure for a total of 7 days.
|
0.00%
0/23 • AEs were captured per protocol from the first dose of G-CSF until final follow up, which was typically 1 day after the last CMNC Collection Procedure for a total of 7 days.
|
|
Musculoskeletal and connective tissue disorders
bone pain
|
39.1%
9/23 • AEs were captured per protocol from the first dose of G-CSF until final follow up, which was typically 1 day after the last CMNC Collection Procedure for a total of 7 days.
|
0.00%
0/23 • AEs were captured per protocol from the first dose of G-CSF until final follow up, which was typically 1 day after the last CMNC Collection Procedure for a total of 7 days.
|
0.00%
0/22 • AEs were captured per protocol from the first dose of G-CSF until final follow up, which was typically 1 day after the last CMNC Collection Procedure for a total of 7 days.
|
0.00%
0/23 • AEs were captured per protocol from the first dose of G-CSF until final follow up, which was typically 1 day after the last CMNC Collection Procedure for a total of 7 days.
|
|
Nervous system disorders
paraesthesia
|
4.3%
1/23 • AEs were captured per protocol from the first dose of G-CSF until final follow up, which was typically 1 day after the last CMNC Collection Procedure for a total of 7 days.
|
4.3%
1/23 • AEs were captured per protocol from the first dose of G-CSF until final follow up, which was typically 1 day after the last CMNC Collection Procedure for a total of 7 days.
|
9.1%
2/22 • AEs were captured per protocol from the first dose of G-CSF until final follow up, which was typically 1 day after the last CMNC Collection Procedure for a total of 7 days.
|
0.00%
0/23 • AEs were captured per protocol from the first dose of G-CSF until final follow up, which was typically 1 day after the last CMNC Collection Procedure for a total of 7 days.
|
|
Cardiac disorders
palpitations
|
0.00%
0/23 • AEs were captured per protocol from the first dose of G-CSF until final follow up, which was typically 1 day after the last CMNC Collection Procedure for a total of 7 days.
|
0.00%
0/23 • AEs were captured per protocol from the first dose of G-CSF until final follow up, which was typically 1 day after the last CMNC Collection Procedure for a total of 7 days.
|
4.5%
1/22 • AEs were captured per protocol from the first dose of G-CSF until final follow up, which was typically 1 day after the last CMNC Collection Procedure for a total of 7 days.
|
0.00%
0/23 • AEs were captured per protocol from the first dose of G-CSF until final follow up, which was typically 1 day after the last CMNC Collection Procedure for a total of 7 days.
|
|
Gastrointestinal disorders
hypoaesthesia oral
|
0.00%
0/23 • AEs were captured per protocol from the first dose of G-CSF until final follow up, which was typically 1 day after the last CMNC Collection Procedure for a total of 7 days.
|
4.3%
1/23 • AEs were captured per protocol from the first dose of G-CSF until final follow up, which was typically 1 day after the last CMNC Collection Procedure for a total of 7 days.
|
4.5%
1/22 • AEs were captured per protocol from the first dose of G-CSF until final follow up, which was typically 1 day after the last CMNC Collection Procedure for a total of 7 days.
|
0.00%
0/23 • AEs were captured per protocol from the first dose of G-CSF until final follow up, which was typically 1 day after the last CMNC Collection Procedure for a total of 7 days.
|
|
Gastrointestinal disorders
abdominal distension
|
4.3%
1/23 • AEs were captured per protocol from the first dose of G-CSF until final follow up, which was typically 1 day after the last CMNC Collection Procedure for a total of 7 days.
|
0.00%
0/23 • AEs were captured per protocol from the first dose of G-CSF until final follow up, which was typically 1 day after the last CMNC Collection Procedure for a total of 7 days.
|
0.00%
0/22 • AEs were captured per protocol from the first dose of G-CSF until final follow up, which was typically 1 day after the last CMNC Collection Procedure for a total of 7 days.
|
0.00%
0/23 • AEs were captured per protocol from the first dose of G-CSF until final follow up, which was typically 1 day after the last CMNC Collection Procedure for a total of 7 days.
|
|
Gastrointestinal disorders
abdominal pain lower
|
4.3%
1/23 • AEs were captured per protocol from the first dose of G-CSF until final follow up, which was typically 1 day after the last CMNC Collection Procedure for a total of 7 days.
|
0.00%
0/23 • AEs were captured per protocol from the first dose of G-CSF until final follow up, which was typically 1 day after the last CMNC Collection Procedure for a total of 7 days.
|
0.00%
0/22 • AEs were captured per protocol from the first dose of G-CSF until final follow up, which was typically 1 day after the last CMNC Collection Procedure for a total of 7 days.
|
0.00%
0/23 • AEs were captured per protocol from the first dose of G-CSF until final follow up, which was typically 1 day after the last CMNC Collection Procedure for a total of 7 days.
|
|
Gastrointestinal disorders
nausea
|
4.3%
1/23 • AEs were captured per protocol from the first dose of G-CSF until final follow up, which was typically 1 day after the last CMNC Collection Procedure for a total of 7 days.
|
0.00%
0/23 • AEs were captured per protocol from the first dose of G-CSF until final follow up, which was typically 1 day after the last CMNC Collection Procedure for a total of 7 days.
|
0.00%
0/22 • AEs were captured per protocol from the first dose of G-CSF until final follow up, which was typically 1 day after the last CMNC Collection Procedure for a total of 7 days.
|
0.00%
0/23 • AEs were captured per protocol from the first dose of G-CSF until final follow up, which was typically 1 day after the last CMNC Collection Procedure for a total of 7 days.
|
|
Gastrointestinal disorders
vomiting
|
4.3%
1/23 • AEs were captured per protocol from the first dose of G-CSF until final follow up, which was typically 1 day after the last CMNC Collection Procedure for a total of 7 days.
|
0.00%
0/23 • AEs were captured per protocol from the first dose of G-CSF until final follow up, which was typically 1 day after the last CMNC Collection Procedure for a total of 7 days.
|
0.00%
0/22 • AEs were captured per protocol from the first dose of G-CSF until final follow up, which was typically 1 day after the last CMNC Collection Procedure for a total of 7 days.
|
0.00%
0/23 • AEs were captured per protocol from the first dose of G-CSF until final follow up, which was typically 1 day after the last CMNC Collection Procedure for a total of 7 days.
|
|
General disorders
infusion site extravasation
|
0.00%
0/23 • AEs were captured per protocol from the first dose of G-CSF until final follow up, which was typically 1 day after the last CMNC Collection Procedure for a total of 7 days.
|
4.3%
1/23 • AEs were captured per protocol from the first dose of G-CSF until final follow up, which was typically 1 day after the last CMNC Collection Procedure for a total of 7 days.
|
0.00%
0/22 • AEs were captured per protocol from the first dose of G-CSF until final follow up, which was typically 1 day after the last CMNC Collection Procedure for a total of 7 days.
|
0.00%
0/23 • AEs were captured per protocol from the first dose of G-CSF until final follow up, which was typically 1 day after the last CMNC Collection Procedure for a total of 7 days.
|
|
General disorders
injection site pain
|
4.3%
1/23 • AEs were captured per protocol from the first dose of G-CSF until final follow up, which was typically 1 day after the last CMNC Collection Procedure for a total of 7 days.
|
0.00%
0/23 • AEs were captured per protocol from the first dose of G-CSF until final follow up, which was typically 1 day after the last CMNC Collection Procedure for a total of 7 days.
|
0.00%
0/22 • AEs were captured per protocol from the first dose of G-CSF until final follow up, which was typically 1 day after the last CMNC Collection Procedure for a total of 7 days.
|
0.00%
0/23 • AEs were captured per protocol from the first dose of G-CSF until final follow up, which was typically 1 day after the last CMNC Collection Procedure for a total of 7 days.
|
|
Metabolism and nutrition disorders
decreased appetite
|
0.00%
0/23 • AEs were captured per protocol from the first dose of G-CSF until final follow up, which was typically 1 day after the last CMNC Collection Procedure for a total of 7 days.
|
0.00%
0/23 • AEs were captured per protocol from the first dose of G-CSF until final follow up, which was typically 1 day after the last CMNC Collection Procedure for a total of 7 days.
|
4.5%
1/22 • AEs were captured per protocol from the first dose of G-CSF until final follow up, which was typically 1 day after the last CMNC Collection Procedure for a total of 7 days.
|
0.00%
0/23 • AEs were captured per protocol from the first dose of G-CSF until final follow up, which was typically 1 day after the last CMNC Collection Procedure for a total of 7 days.
|
|
Musculoskeletal and connective tissue disorders
muscle spasm
|
0.00%
0/23 • AEs were captured per protocol from the first dose of G-CSF until final follow up, which was typically 1 day after the last CMNC Collection Procedure for a total of 7 days.
|
0.00%
0/23 • AEs were captured per protocol from the first dose of G-CSF until final follow up, which was typically 1 day after the last CMNC Collection Procedure for a total of 7 days.
|
4.5%
1/22 • AEs were captured per protocol from the first dose of G-CSF until final follow up, which was typically 1 day after the last CMNC Collection Procedure for a total of 7 days.
|
0.00%
0/23 • AEs were captured per protocol from the first dose of G-CSF until final follow up, which was typically 1 day after the last CMNC Collection Procedure for a total of 7 days.
|
|
Musculoskeletal and connective tissue disorders
arthralgia
|
4.3%
1/23 • AEs were captured per protocol from the first dose of G-CSF until final follow up, which was typically 1 day after the last CMNC Collection Procedure for a total of 7 days.
|
0.00%
0/23 • AEs were captured per protocol from the first dose of G-CSF until final follow up, which was typically 1 day after the last CMNC Collection Procedure for a total of 7 days.
|
0.00%
0/22 • AEs were captured per protocol from the first dose of G-CSF until final follow up, which was typically 1 day after the last CMNC Collection Procedure for a total of 7 days.
|
0.00%
0/23 • AEs were captured per protocol from the first dose of G-CSF until final follow up, which was typically 1 day after the last CMNC Collection Procedure for a total of 7 days.
|
|
Metabolism and nutrition disorders
musculoskeletal pain
|
4.3%
1/23 • AEs were captured per protocol from the first dose of G-CSF until final follow up, which was typically 1 day after the last CMNC Collection Procedure for a total of 7 days.
|
0.00%
0/23 • AEs were captured per protocol from the first dose of G-CSF until final follow up, which was typically 1 day after the last CMNC Collection Procedure for a total of 7 days.
|
0.00%
0/22 • AEs were captured per protocol from the first dose of G-CSF until final follow up, which was typically 1 day after the last CMNC Collection Procedure for a total of 7 days.
|
0.00%
0/23 • AEs were captured per protocol from the first dose of G-CSF until final follow up, which was typically 1 day after the last CMNC Collection Procedure for a total of 7 days.
|
|
Musculoskeletal and connective tissue disorders
musculoskeletal stiffness
|
4.3%
1/23 • AEs were captured per protocol from the first dose of G-CSF until final follow up, which was typically 1 day after the last CMNC Collection Procedure for a total of 7 days.
|
0.00%
0/23 • AEs were captured per protocol from the first dose of G-CSF until final follow up, which was typically 1 day after the last CMNC Collection Procedure for a total of 7 days.
|
0.00%
0/22 • AEs were captured per protocol from the first dose of G-CSF until final follow up, which was typically 1 day after the last CMNC Collection Procedure for a total of 7 days.
|
0.00%
0/23 • AEs were captured per protocol from the first dose of G-CSF until final follow up, which was typically 1 day after the last CMNC Collection Procedure for a total of 7 days.
|
|
Musculoskeletal and connective tissue disorders
pain in extremity
|
4.3%
1/23 • AEs were captured per protocol from the first dose of G-CSF until final follow up, which was typically 1 day after the last CMNC Collection Procedure for a total of 7 days.
|
0.00%
0/23 • AEs were captured per protocol from the first dose of G-CSF until final follow up, which was typically 1 day after the last CMNC Collection Procedure for a total of 7 days.
|
0.00%
0/22 • AEs were captured per protocol from the first dose of G-CSF until final follow up, which was typically 1 day after the last CMNC Collection Procedure for a total of 7 days.
|
0.00%
0/23 • AEs were captured per protocol from the first dose of G-CSF until final follow up, which was typically 1 day after the last CMNC Collection Procedure for a total of 7 days.
|
|
Nervous system disorders
headache
|
0.00%
0/23 • AEs were captured per protocol from the first dose of G-CSF until final follow up, which was typically 1 day after the last CMNC Collection Procedure for a total of 7 days.
|
0.00%
0/23 • AEs were captured per protocol from the first dose of G-CSF until final follow up, which was typically 1 day after the last CMNC Collection Procedure for a total of 7 days.
|
4.5%
1/22 • AEs were captured per protocol from the first dose of G-CSF until final follow up, which was typically 1 day after the last CMNC Collection Procedure for a total of 7 days.
|
0.00%
0/23 • AEs were captured per protocol from the first dose of G-CSF until final follow up, which was typically 1 day after the last CMNC Collection Procedure for a total of 7 days.
|
|
Nervous system disorders
neuropathy peripheral
|
0.00%
0/23 • AEs were captured per protocol from the first dose of G-CSF until final follow up, which was typically 1 day after the last CMNC Collection Procedure for a total of 7 days.
|
0.00%
0/23 • AEs were captured per protocol from the first dose of G-CSF until final follow up, which was typically 1 day after the last CMNC Collection Procedure for a total of 7 days.
|
4.5%
1/22 • AEs were captured per protocol from the first dose of G-CSF until final follow up, which was typically 1 day after the last CMNC Collection Procedure for a total of 7 days.
|
0.00%
0/23 • AEs were captured per protocol from the first dose of G-CSF until final follow up, which was typically 1 day after the last CMNC Collection Procedure for a total of 7 days.
|
|
Nervous system disorders
peripheral sensory neuropathy
|
0.00%
0/23 • AEs were captured per protocol from the first dose of G-CSF until final follow up, which was typically 1 day after the last CMNC Collection Procedure for a total of 7 days.
|
0.00%
0/23 • AEs were captured per protocol from the first dose of G-CSF until final follow up, which was typically 1 day after the last CMNC Collection Procedure for a total of 7 days.
|
4.5%
1/22 • AEs were captured per protocol from the first dose of G-CSF until final follow up, which was typically 1 day after the last CMNC Collection Procedure for a total of 7 days.
|
8.7%
2/23 • AEs were captured per protocol from the first dose of G-CSF until final follow up, which was typically 1 day after the last CMNC Collection Procedure for a total of 7 days.
|
|
Nervous system disorders
tension headach
|
0.00%
0/23 • AEs were captured per protocol from the first dose of G-CSF until final follow up, which was typically 1 day after the last CMNC Collection Procedure for a total of 7 days.
|
4.3%
1/23 • AEs were captured per protocol from the first dose of G-CSF until final follow up, which was typically 1 day after the last CMNC Collection Procedure for a total of 7 days.
|
0.00%
0/22 • AEs were captured per protocol from the first dose of G-CSF until final follow up, which was typically 1 day after the last CMNC Collection Procedure for a total of 7 days.
|
0.00%
0/23 • AEs were captured per protocol from the first dose of G-CSF until final follow up, which was typically 1 day after the last CMNC Collection Procedure for a total of 7 days.
|
|
Psychiatric disorders
insomina
|
4.3%
1/23 • AEs were captured per protocol from the first dose of G-CSF until final follow up, which was typically 1 day after the last CMNC Collection Procedure for a total of 7 days.
|
4.3%
1/23 • AEs were captured per protocol from the first dose of G-CSF until final follow up, which was typically 1 day after the last CMNC Collection Procedure for a total of 7 days.
|
0.00%
0/22 • AEs were captured per protocol from the first dose of G-CSF until final follow up, which was typically 1 day after the last CMNC Collection Procedure for a total of 7 days.
|
0.00%
0/23 • AEs were captured per protocol from the first dose of G-CSF until final follow up, which was typically 1 day after the last CMNC Collection Procedure for a total of 7 days.
|
|
Psychiatric disorders
restlessness
|
4.3%
1/23 • AEs were captured per protocol from the first dose of G-CSF until final follow up, which was typically 1 day after the last CMNC Collection Procedure for a total of 7 days.
|
0.00%
0/23 • AEs were captured per protocol from the first dose of G-CSF until final follow up, which was typically 1 day after the last CMNC Collection Procedure for a total of 7 days.
|
0.00%
0/22 • AEs were captured per protocol from the first dose of G-CSF until final follow up, which was typically 1 day after the last CMNC Collection Procedure for a total of 7 days.
|
0.00%
0/23 • AEs were captured per protocol from the first dose of G-CSF until final follow up, which was typically 1 day after the last CMNC Collection Procedure for a total of 7 days.
|
Additional Information
Raymond P. Goodrich, PhD, VP, Scientific and Clinical Affairs; Chief Science Officer - BBT
Terumo BCT
Phone: 303-232-6800
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60