Trial Outcomes & Findings for Procurement of Leukapheresis Products From End Stage Liver Disease (ESLD) Patients for Immunological Studies (NCT NCT02447926)
NCT ID: NCT02447926
Last Updated: 2019-09-25
Results Overview
Number of regulatory CD4+CD25+ T cells after 21 days in culture from leukapheresis product (150 ml of processed blood) from ESLD patient.
TERMINATED
NA
1 participants
21 days
2019-09-25
Participant Flow
Recruitment of the study subjects will be made from the End Stage Liver disease patients attending the outpatient pre-transplant clinics of the Northwestern Comprehensive Transplant Center.
Participant milestones
| Measure |
Single Arm Intervention
Leukapheresis. All subjects will be assigned to the the same intervention arm.
Leukapheresis: Catheter placement will occur for about 1 hour. The research nurse will schedule leukapheresis on the next day following catheter placement.
On the day of leukapheresis, a blood draw will monitor blood counts, kidney function, liver function, and blood clotting ability. Vital signs will be checked three times over the course of intervention.
During the procedure, blood is mixed with anticoagulant and separated (i.e. red blood cells, white blood cells, platelets, and plasma). 1-1.5 cups of white blood cells will be collected. Leukapheresis will last 3-6 hours.
Remaining components, except for 100-200 ml of plasma, are returned through the catheter. Two teaspoons of blood will be drawn to determine when catheter removal can occur. This part of intervention lasts about 2.5-4 hours.
|
|---|---|
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Overall Study
STARTED
|
1
|
|
Overall Study
COMPLETED
|
1
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Procurement of Leukapheresis Products From End Stage Liver Disease (ESLD) Patients for Immunological Studies
Baseline characteristics by cohort
| Measure |
Single Arm Study
n=1 Participants
Leukapheresis. All subjects will receive the same treatment arm.
|
|---|---|
|
Age, Continuous
|
70 years
STANDARD_DEVIATION 0 • n=5 Participants
|
|
Sex: Female, Male
Female
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0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 21 daysNumber of regulatory CD4+CD25+ T cells after 21 days in culture from leukapheresis product (150 ml of processed blood) from ESLD patient.
Outcome measures
| Measure |
Single Arm Intervention
n=1 Participants
Leukapheresis. All subjects will be assigned to the the same intervention arm.
Leukapheresis: Catheter placement will occur for about 1 hour. The research nurse will schedule leukapheresis on the next day following catheter placement.
On the day of leukapheresis, a blood draw will monitor blood counts, kidney function, liver function, and blood clotting ability. Vital signs will be checked three times over the course of intervention.
During the procedure, blood is mixed with anticoagulant and separated (i.e. red blood cells, white blood cells, platelets, and plasma). 1-1.5 cups of white blood cells will be collected. Leukapheresis will last 3-6 hours.
Remaining components, except for 100-200 ml of plasma, are returned through the catheter. Two teaspoons of blood will be drawn to determine when catheter removal can occur. This part of intervention lasts about 2.5-4 hours.
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|---|---|
|
Number of Regulatory CD4+CD25+ T Cells Obtained From 150 ml of Peripheral Blood in an ESLD Patient
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10000000000 Tregs/150ml
|
PRIMARY outcome
Timeframe: 21 daysAssay testing - Suppressive function of expanded cells will be assessed using in vitro assays of alloreactivity (mixed lymphocyte culture). The in vitro assays will test whether the expanded Tregs will retain their suppressive function.
Outcome measures
| Measure |
Single Arm Intervention
n=1 Participants
Leukapheresis. All subjects will be assigned to the the same intervention arm.
Leukapheresis: Catheter placement will occur for about 1 hour. The research nurse will schedule leukapheresis on the next day following catheter placement.
On the day of leukapheresis, a blood draw will monitor blood counts, kidney function, liver function, and blood clotting ability. Vital signs will be checked three times over the course of intervention.
During the procedure, blood is mixed with anticoagulant and separated (i.e. red blood cells, white blood cells, platelets, and plasma). 1-1.5 cups of white blood cells will be collected. Leukapheresis will last 3-6 hours.
Remaining components, except for 100-200 ml of plasma, are returned through the catheter. Two teaspoons of blood will be drawn to determine when catheter removal can occur. This part of intervention lasts about 2.5-4 hours.
|
|---|---|
|
Suppressive Function of Expanded Cells Will be Assessed Using in Vitro Assays of Alloreactivity (Mixed Lymphocyte Culture)
|
50 percentage of Treg inhibition
|
Adverse Events
Single Arm Treatment
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place