Trial Outcomes & Findings for Safety Study of Liver Natural Killer Cell Therapy for Hepatoma Liver Transplantation (NCT NCT01147380)
NCT ID: NCT01147380
Last Updated: 2016-03-10
Results Overview
Side effect of cadaveric donor liver NK cell infusion We will measure the occurence of the side effect of the liver NK cell infusion. We will monitor the patient condition clinically. If any side effect are noticed, we will record them and report to the data safety monitoring comittee.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
18 participants
Primary outcome timeframe
1 year
Results posted on
2016-03-10
Participant Flow
Participant milestones
| Measure |
Small Dose
The number of inoculation cells is between 10 and 100 million cells.
Liver NK cell inoculation: Liver transplant recipients will receive liver NK cell inoculation several days after liver transplantation.
|
Large Dose
The number of inoculation cells is between 100 and 1000 million cells
Liver NK cell inoculation: Liver transplant recipients will receive liver NK cell inoculation several days after liver transplantation.
|
|---|---|---|
|
Overall Study
STARTED
|
6
|
12
|
|
Overall Study
COMPLETED
|
6
|
12
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Safety Study of Liver Natural Killer Cell Therapy for Hepatoma Liver Transplantation
Baseline characteristics by cohort
| Measure |
Small Dose
n=6 Participants
The number of inoculation cells is between 10 and 100 million cells.
Liver NK cell inoculation: Liver transplant recipients will receive once liver NK cell inoculation several days after liver transplantation.
|
Large Dose
n=12 Participants
The number of inoculation cells is between 100 and 1000 million cells
Liver NK cell inoculation: Liver transplant recipients will receive once liver NK cell inoculation several days after liver transplantation.
|
Total
n=18 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
5 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Age, Continuous
|
59.5 years
n=5 Participants
|
55.6 years
n=7 Participants
|
56.9 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
6 participants
n=5 Participants
|
12 participants
n=7 Participants
|
18 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 1 yearSide effect of cadaveric donor liver NK cell infusion We will measure the occurence of the side effect of the liver NK cell infusion. We will monitor the patient condition clinically. If any side effect are noticed, we will record them and report to the data safety monitoring comittee.
Outcome measures
| Measure |
Small Dose
n=6 Participants
The number of inoculation cells is between 10 and 100 million cells.
Liver NK cell inoculation: Liver transplant recipients will receive once liver NK cell inoculation several days after liver transplantation.
|
Large Dose
n=12 Participants
The number of inoculation cells is between 100 and 1000 million cells
Liver NK cell inoculation: Liver transplant recipients will receive once liver NK cell inoculation several days after liver transplantation.
|
|---|---|---|
|
Side Effect of Cadaveric Donor Liver NK Cell Infusion
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: 1 yearPopulation: Participants were devided two group( small and large dose) as described based on the dose of infused cell numbers.
To assess NK cell infusion -related toxicity at the bedside. We will monitor the patient and check the vital sign. If any side effect are noticed, we will record and report to the data safety monitoring comittee.
Outcome measures
| Measure |
Small Dose
n=6 Participants
The number of inoculation cells is between 10 and 100 million cells.
Liver NK cell inoculation: Liver transplant recipients will receive once liver NK cell inoculation several days after liver transplantation.
|
Large Dose
n=12 Participants
The number of inoculation cells is between 100 and 1000 million cells
Liver NK cell inoculation: Liver transplant recipients will receive once liver NK cell inoculation several days after liver transplantation.
|
|---|---|---|
|
NK Cell Infusion-related Toxicity
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: 2 yearOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 2 yearOutcome measures
Outcome data not reported
Adverse Events
Small Dose
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Large Dose
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Small Dose
n=6 participants at risk
The number of inoculation cells is between 10 and 100 million cells.
Liver NK cell inoculation: Liver transplant recipients will receive once liver NK cell inoculation several days after liver transplantation.
|
Large Dose
n=12 participants at risk
The number of inoculation cells is between 100 and 1000 million cells
Liver NK cell inoculation: Liver transplant recipients will receive once liver NK cell inoculation several days after liver transplantation.
|
|---|---|---|
|
General disorders
fatigue
|
0.00%
0/6 • 2 years
Adverse events will be graded according to the Common terminology criteria for Adverse Events Guide. A Data Safety Monitoring Committee will be constituted to analyze safety and preliminary evidence of efficacy of the trial. Adverse events will be reported to the IRB and DSMB. Serious adverse events will be reported to the DSMB within 24 hours.
|
0.00%
0/12 • 2 years
Adverse events will be graded according to the Common terminology criteria for Adverse Events Guide. A Data Safety Monitoring Committee will be constituted to analyze safety and preliminary evidence of efficacy of the trial. Adverse events will be reported to the IRB and DSMB. Serious adverse events will be reported to the DSMB within 24 hours.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place