Trial Outcomes & Findings for Evaluation of the Spectra Optia® Apheresis System Mononuclear Cell (MNC) Collection Procedure in Healthy Blood Donors (NCT NCT01277549)

NCT ID: NCT01277549

Last Updated: 2013-05-03

Results Overview

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
• Target enrollment: 71 participants
• Primary outcome timeframe: One day
• Results posted on: 2013-05-03

Participant Flow

Healthy adult donors were recruited at three blood collection centers to undergo a mononuclear cell collection using the experimental device, between January and September, 2011.

Participant milestones

Measure	G-CSF Mobilized Donors In this arm the donors received G-CSF (granulocyte colony stimulating factor) prior to the MNC (mononuclear cell) collection. G-CSF causes the mobilization of hematopoetic stem cells which are CD34 (cluster of differentiation 34) + to the peripheral blood. Collection efficiency of all mononuclear cells and of the CD34+ subset of mononuclear cells was assessed.	Non-mobilized Donors In this arm, donors were not mobilized prior to mononuclear cell collection. Only collection efficiency of mononuclear cells could be assessed as CD34+ cells are not present in this population.
Overall Study STARTED	41	29
Overall Study COMPLETED	15	15
Overall Study NOT COMPLETED	26	14

Reasons for withdrawal

Measure	G-CSF Mobilized Donors In this arm the donors received G-CSF (granulocyte colony stimulating factor) prior to the MNC (mononuclear cell) collection. G-CSF causes the mobilization of hematopoetic stem cells which are CD34 (cluster of differentiation 34) + to the peripheral blood. Collection efficiency of all mononuclear cells and of the CD34+ subset of mononuclear cells was assessed.	Non-mobilized Donors In this arm, donors were not mobilized prior to mononuclear cell collection. Only collection efficiency of mononuclear cells could be assessed as CD34+ cells are not present in this population.
Overall Study Failed to meet eligibility criteria	13	9
Overall Study Withdrawal by Subject	1	3
Overall Study Protocol Violation	10	1
Overall Study Physician Decision	2	1

Baseline Characteristics

Evaluation of the Spectra Optia® Apheresis System Mononuclear Cell (MNC) Collection Procedure in Healthy Blood Donors

Baseline characteristics by cohort

Measure	G-CSF Mobilized Donors n=15 Participants Donors received G-CSF prior to MNC collection	Nonmobilized Donors n=15 Participants Donors not mobilized prior to MNC collection	Total n=30 Participants Total of all reporting groups
Age Continuous	25 Years of Age n=93 Participants	33 Years of Age n=4 Participants	31 Years of Age n=27 Participants
Sex: Female, Male Female	3 Participants n=93 Participants	4 Participants n=4 Participants	7 Participants n=27 Participants
Sex: Female, Male Male	12 Participants n=93 Participants	11 Participants n=4 Participants	23 Participants n=27 Participants
Region of Enrollment United States	15 participants n=93 Participants	15 participants n=4 Participants	30 participants n=27 Participants

PRIMARY outcome

Timeframe: One day

Population: Results are given for all per protocol subjects.

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	G-CSF Mobilized Donors n=15 Participants Donors received G-CSF prior to MNC collection.	Nonmobilized Donors n=15 Participants Donors were not mobilized prior to MNC collection.
Mononuclear Cell Collection Efficiency	61 % of processed MNCs that were collected Interval 17.0 to 147.0	57 % of processed MNCs that were collected Interval 27.0 to 92.0

PRIMARY outcome

Timeframe: one day

Population: Results are given for all per protocol subjects.

The collection efficiency for CD34+ cells is defined as the percent of processed CD34+ cells that were in fact collected.

Outcome measures

Measure	G-CSF Mobilized Donors n=15 Participants Donors received G-CSF prior to MNC collection.	Nonmobilized Donors Donors were not mobilized prior to MNC collection.
CD34+ Cell Collection Efficiency	77 % of processed CD34+ cells collected Interval 43.0 to 111.0	—

SECONDARY outcome

Timeframe: One Day

Population: Per protocol

Platelet contamination of the cell product was measured as the platelet collection efficiency, that is, as the percent of platelets processed that were collected.

Outcome measures

Measure	G-CSF Mobilized Donors n=15 Participants Donors received G-CSF prior to MNC collection.	Nonmobilized Donors n=15 Participants Donors were not mobilized prior to MNC collection.
Platelet Collection Efficiency	19 % of processed platelets collected Interval 12.0 to 47.0	12 % of processed platelets collected Interval 5.0 to 21.0

SECONDARY outcome

Timeframe: One Day

Population: Per protocol

The hematocrit of the collected product was used to quantitate RBC (red blood cell) contamination.

Outcome measures

Measure	G-CSF Mobilized Donors n=15 Participants Donors received G-CSF prior to MNC collection.	Nonmobilized Donors n=15 Participants Donors were not mobilized prior to MNC collection.
Hematocrit of MNC Product	4.0 RBC % of product volume Interval 1.4 to 6.0	4.0 RBC % of product volume Interval 2.0 to 5.0

SECONDARY outcome

Timeframe: One day

Population: Results given for all per protocol subjects.

Granulocyte contamination of the MNC product was quantitated as the percent of total product WBC (white blood cell) that were segmented granulocytes or bands.

Outcome measures

Measure	G-CSF Mobilized Donors n=15 Participants Donors received G-CSF prior to MNC collection.	Nonmobilized Donors n=15 Participants Donors were not mobilized prior to MNC collection.
Granulocyte % of MNC Product	15.0 percentage of WBCs collected Interval 0.0 to 48.0	1.7 percentage of WBCs collected Interval 0.3 to 9.0

SECONDARY outcome

Timeframe: One day

Population: Per Protocol

The viability of the collected white blood cells was assessed using the 7-AAD (7-amino actinomycin D) viability dye in a flow cytometric assay. Viability assessment is incorporated into the CD34 assay. This assay was only performed on G-CSF mobilized donors as nonmobilized donor have too few CD34+ cells to detect. Thus viability of the collected WBCs is reported only for the G-CSF mobilized arm.

Outcome measures

Measure	G-CSF Mobilized Donors n=15 Participants Donors received G-CSF prior to MNC collection.	Nonmobilized Donors Donors were not mobilized prior to MNC collection.
Viability of the Collected MNC Product	99 percentage of total WBCs collected Interval 90.0 to 100.0	—

Adverse Events

G-CSF Mobilized Donors

Serious events: 0 serious events

Other events: 19 other events

Deaths: 0 deaths

Nonmobilized Donors

Serious events: 0 serious events

Other events: 8 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	G-CSF Mobilized Donors n=25 participants at risk Donors received G-CSF prior to MNC collection	Nonmobilized Donors n=16 participants at risk Donors not mobilized prior to MNC collection. Note that some Adverse Events (Flu-like symptoms, Muscle Aches, and Bone Pain) apply only to G-CSF mobilized donors. Nonmobilized donors were not assessed for these adverse events as they were not "at risk".
General disorders Arm numbness/stiffness	0.00% 0/25 • For the Nonmobilized Arm, adverse events were collected during the leukapheresis procedure itself and for one week following the procedure. For the G-CSF mobilized arm, adverse events were also collected during the 5 days of mobilization. All subjects who underwent a leukapheresis procedure were included in the adverse event analysis. This includes the categories "COMPLETED" and "NOT COMPLETED--Protocol Violation" on the Participant Flow section above. Thus 15+10=25 Mobilized and 15+1+16 Nonmobilized subjects are included for a total of 41 subjects.	12.5% 2/16 • Number of events 2 • For the Nonmobilized Arm, adverse events were collected during the leukapheresis procedure itself and for one week following the procedure. For the G-CSF mobilized arm, adverse events were also collected during the 5 days of mobilization. All subjects who underwent a leukapheresis procedure were included in the adverse event analysis. This includes the categories "COMPLETED" and "NOT COMPLETED--Protocol Violation" on the Participant Flow section above. Thus 15+10=25 Mobilized and 15+1+16 Nonmobilized subjects are included for a total of 41 subjects.
Musculoskeletal and connective tissue disorders Bone Pain	20.0% 5/25 • Number of events 5 • For the Nonmobilized Arm, adverse events were collected during the leukapheresis procedure itself and for one week following the procedure. For the G-CSF mobilized arm, adverse events were also collected during the 5 days of mobilization. All subjects who underwent a leukapheresis procedure were included in the adverse event analysis. This includes the categories "COMPLETED" and "NOT COMPLETED--Protocol Violation" on the Participant Flow section above. Thus 15+10=25 Mobilized and 15+1+16 Nonmobilized subjects are included for a total of 41 subjects.	— 0/0 • For the Nonmobilized Arm, adverse events were collected during the leukapheresis procedure itself and for one week following the procedure. For the G-CSF mobilized arm, adverse events were also collected during the 5 days of mobilization. All subjects who underwent a leukapheresis procedure were included in the adverse event analysis. This includes the categories "COMPLETED" and "NOT COMPLETED--Protocol Violation" on the Participant Flow section above. Thus 15+10=25 Mobilized and 15+1+16 Nonmobilized subjects are included for a total of 41 subjects.
General disorders Citrate reaction	24.0% 6/25 • Number of events 6 • For the Nonmobilized Arm, adverse events were collected during the leukapheresis procedure itself and for one week following the procedure. For the G-CSF mobilized arm, adverse events were also collected during the 5 days of mobilization. All subjects who underwent a leukapheresis procedure were included in the adverse event analysis. This includes the categories "COMPLETED" and "NOT COMPLETED--Protocol Violation" on the Participant Flow section above. Thus 15+10=25 Mobilized and 15+1+16 Nonmobilized subjects are included for a total of 41 subjects.	31.2% 5/16 • Number of events 5 • For the Nonmobilized Arm, adverse events were collected during the leukapheresis procedure itself and for one week following the procedure. For the G-CSF mobilized arm, adverse events were also collected during the 5 days of mobilization. All subjects who underwent a leukapheresis procedure were included in the adverse event analysis. This includes the categories "COMPLETED" and "NOT COMPLETED--Protocol Violation" on the Participant Flow section above. Thus 15+10=25 Mobilized and 15+1+16 Nonmobilized subjects are included for a total of 41 subjects.
General disorders Flu-like symptoms	40.0% 10/25 • Number of events 10 • For the Nonmobilized Arm, adverse events were collected during the leukapheresis procedure itself and for one week following the procedure. For the G-CSF mobilized arm, adverse events were also collected during the 5 days of mobilization. All subjects who underwent a leukapheresis procedure were included in the adverse event analysis. This includes the categories "COMPLETED" and "NOT COMPLETED--Protocol Violation" on the Participant Flow section above. Thus 15+10=25 Mobilized and 15+1+16 Nonmobilized subjects are included for a total of 41 subjects.	— 0/0 • For the Nonmobilized Arm, adverse events were collected during the leukapheresis procedure itself and for one week following the procedure. For the G-CSF mobilized arm, adverse events were also collected during the 5 days of mobilization. All subjects who underwent a leukapheresis procedure were included in the adverse event analysis. This includes the categories "COMPLETED" and "NOT COMPLETED--Protocol Violation" on the Participant Flow section above. Thus 15+10=25 Mobilized and 15+1+16 Nonmobilized subjects are included for a total of 41 subjects.
General disorders Muscle Aches	48.0% 12/25 • Number of events 12 • For the Nonmobilized Arm, adverse events were collected during the leukapheresis procedure itself and for one week following the procedure. For the G-CSF mobilized arm, adverse events were also collected during the 5 days of mobilization. All subjects who underwent a leukapheresis procedure were included in the adverse event analysis. This includes the categories "COMPLETED" and "NOT COMPLETED--Protocol Violation" on the Participant Flow section above. Thus 15+10=25 Mobilized and 15+1+16 Nonmobilized subjects are included for a total of 41 subjects.	— 0/0 • For the Nonmobilized Arm, adverse events were collected during the leukapheresis procedure itself and for one week following the procedure. For the G-CSF mobilized arm, adverse events were also collected during the 5 days of mobilization. All subjects who underwent a leukapheresis procedure were included in the adverse event analysis. This includes the categories "COMPLETED" and "NOT COMPLETED--Protocol Violation" on the Participant Flow section above. Thus 15+10=25 Mobilized and 15+1+16 Nonmobilized subjects are included for a total of 41 subjects.
General disorders Nausea	0.00% 0/25 • For the Nonmobilized Arm, adverse events were collected during the leukapheresis procedure itself and for one week following the procedure. For the G-CSF mobilized arm, adverse events were also collected during the 5 days of mobilization. All subjects who underwent a leukapheresis procedure were included in the adverse event analysis. This includes the categories "COMPLETED" and "NOT COMPLETED--Protocol Violation" on the Participant Flow section above. Thus 15+10=25 Mobilized and 15+1+16 Nonmobilized subjects are included for a total of 41 subjects.	12.5% 2/16 • Number of events 2 • For the Nonmobilized Arm, adverse events were collected during the leukapheresis procedure itself and for one week following the procedure. For the G-CSF mobilized arm, adverse events were also collected during the 5 days of mobilization. All subjects who underwent a leukapheresis procedure were included in the adverse event analysis. This includes the categories "COMPLETED" and "NOT COMPLETED--Protocol Violation" on the Participant Flow section above. Thus 15+10=25 Mobilized and 15+1+16 Nonmobilized subjects are included for a total of 41 subjects.
General disorders Venous infiltration/hematoma	8.0% 2/25 • Number of events 2 • For the Nonmobilized Arm, adverse events were collected during the leukapheresis procedure itself and for one week following the procedure. For the G-CSF mobilized arm, adverse events were also collected during the 5 days of mobilization. All subjects who underwent a leukapheresis procedure were included in the adverse event analysis. This includes the categories "COMPLETED" and "NOT COMPLETED--Protocol Violation" on the Participant Flow section above. Thus 15+10=25 Mobilized and 15+1+16 Nonmobilized subjects are included for a total of 41 subjects.	12.5% 2/16 • Number of events 2 • For the Nonmobilized Arm, adverse events were collected during the leukapheresis procedure itself and for one week following the procedure. For the G-CSF mobilized arm, adverse events were also collected during the 5 days of mobilization. All subjects who underwent a leukapheresis procedure were included in the adverse event analysis. This includes the categories "COMPLETED" and "NOT COMPLETED--Protocol Violation" on the Participant Flow section above. Thus 15+10=25 Mobilized and 15+1+16 Nonmobilized subjects are included for a total of 41 subjects.

Additional Information

Jerome R Bill, M.D.

Terumo BCT

Phone: 303-231-4729

Email: jerry.bill@terumobct.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: LTE60