Trial Outcomes & Findings for Human Fetal Liver Cell Transplantation in Chronic Liver Failure (NCT NCT01013194)
NCT ID: NCT01013194
Last Updated: 2015-11-03
Results Overview
Assessment of treated and control patients survival at 1 year follow-up
COMPLETED
PHASE1/PHASE2
25 participants
1 year
2015-11-03
Participant Flow
Participant milestones
| Measure |
Treated Patients
Cell source: Non-purified and non-selected fetal liver cells from fetuses aborted between the 16th and 26th week of gestation.
Infusion technique: Isolation and incannulation of the femoral artery.Splenic artery infusion under radiological guidance.
Cell infusion: between 5x10\^8 and 10x10\^8 cells. Number of sessions: up to 2.
|
Control Group
Cirrhotic patients in waiting list for Liver Transplantation on standard therapy
|
|---|---|---|
|
Overall Study
STARTED
|
9
|
16
|
|
Overall Study
COMPLETED
|
9
|
16
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Human Fetal Liver Cell Transplantation in Chronic Liver Failure
Baseline characteristics by cohort
| Measure |
Treated Patients
n=9 Participants
Patients with end-stage chronic liver disease in waiting list for liver transplantation treated with non-purified and non-selected fetal liver cells.
|
Control Patients
n=16 Participants
Patients with end-stage chronic liver disease on standard therapy in waiting list for liver transplantation.
|
Total
n=25 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
|
9 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Region of Enrollment
Italy
|
9 participants
n=5 Participants
|
16 participants
n=7 Participants
|
25 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 1 yearAssessment of treated and control patients survival at 1 year follow-up
Outcome measures
| Measure |
Treated Patients
n=9 Participants
Patients with end-stage chronic liver disease in waiting list for Liver Transplantation treated with hFLCTx
|
Control Patients
n=16 Participants
Patients with end-stage chronic liver disease in waiting list for Liver Transplantation on standard therapy
|
|---|---|---|
|
Patient Survival
Patient survival
|
5 participants
|
6 participants
|
|
Patient Survival
Death/Transplant
|
4 participants
|
10 participants
|
SECONDARY outcome
Timeframe: Baseline and 1 year Follow-upPopulation: Baseline Child-Pugh score vs Follow-up
Assessment of the efficacy of human fetal liver progenitor cell transplantation on Child-Pugh score. The Child-Pugh (CP) classification is a scoring system used for the classification of the severity of cirrhosis. It includes three continuous variables (bilirubin, albumin and INR) and two discrete variables (ascites and encephalopathy). Each variable is scored 1-3 with 3 indicating most severe derangement. The determination of CP score may range from 5 to 15 and the final score allows to categorize patients in Child-Pugh A (5-6 points), B (7-9 points) and C (10-15 points). The highest is the score the sickest is the patient.
Outcome measures
| Measure |
Treated Patients
n=9 Participants
Patients with end-stage chronic liver disease in waiting list for Liver Transplantation treated with hFLCTx
|
Control Patients
n=16 Participants
Patients with end-stage chronic liver disease in waiting list for Liver Transplantation on standard therapy
|
|---|---|---|
|
Analysis of Child-Pugh Score From Baseline to 1 Year Follow-up
Baseline Child-Pugh score
|
10.11 units on a scale
Standard Deviation 1.54
|
10.00 units on a scale
Standard Deviation 1.26
|
|
Analysis of Child-Pugh Score From Baseline to 1 Year Follow-up
Follow-up Child-Pugh score
|
9.11 units on a scale
Standard Deviation 1.45
|
11.13 units on a scale
Standard Deviation 1.63
|
SECONDARY outcome
Timeframe: Baseline and 1 year Follow-upAssessment of the efficacy of human fetal liver progenitor cell transplantation on Meld score. The Model for End-stage Liver Disease (MELD) scoring system aims at stratifying recipients by their disease severity according to a score estimating the 3-month probability of death on the waiting list. The calculation of an individual's MELD score is based on three objective lab parameters (bilirubin, serum creatinine and prothrombin time expressed as international normalized ratio, INR) and it includes logarithmic transformations and multiplication by several factors. It ranges between 6 and 40. The highest is the score the lower is the patient's survival.
Outcome measures
| Measure |
Treated Patients
n=9 Participants
Patients with end-stage chronic liver disease in waiting list for Liver Transplantation treated with hFLCTx
|
Control Patients
n=16 Participants
Patients with end-stage chronic liver disease in waiting list for Liver Transplantation on standard therapy
|
|---|---|---|
|
Analysis of Meld Score From Baseline to 1 Year Follow-up
Baseline Meld score
|
16.00 units on a scale
Standard Deviation 2.96
|
15.31 units on a scale
Standard Deviation 2.50
|
|
Analysis of Meld Score From Baseline to 1 Year Follow-up
Follow-up Meld score
|
15.67 units on a scale
Standard Deviation 3.84
|
19.06 units on a scale
Standard Deviation 5.70
|
Adverse Events
Treated Patients
Control Group
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