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Human Fetal Liver Cell Transplantation in Chronic Liver Failure (hFLCTx)

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ClinicalTrials.gov Identifier: NCT01013194
Recruitment Status : Completed
First Posted : November 13, 2009
Results First Posted : November 3, 2015
Last Update Posted : November 3, 2015
Sponsor:
Collaborator:
University of Pittsburgh
Information provided by (Responsible Party):
The Mediterranean Institute for Transplantation and Advanced Specialized Therapies

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Liver Cirrhosis
Intervention Other: Human Fetal Liver Cell Transplantation
Enrollment 25
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Treated Patients Control Group
Hide Arm/Group Description

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.

Cirrhotic patients in waiting list for Liver Transplantation on standard therapy
Period Title: Overall Study
Started 9 16
Completed 9 [1] 16 [2]
Not Completed 0 0
[1]
Consecutive patients
[2]
Retrospectively contemporary matched-pair group
Arm/Group Title Treated Patients Control Patients Total
Hide Arm/Group Description Patients with end-stage chronic liver disease in waiting list for liver transplantation treated with non-purified and non-selected fetal liver cells. Patients with end-stage chronic liver disease on standard therapy in waiting list for liver transplantation. Total of all reporting groups
Overall Number of Baseline Participants 9 16 25
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 9 participants 16 participants 25 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
9
 100.0%
16
 100.0%
25
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 9 participants 16 participants 25 participants
Female
3
  33.3%
3
  18.8%
6
  24.0%
Male
6
  66.7%
13
  81.3%
19
  76.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Italy Number Analyzed 9 participants 16 participants 25 participants
9 16 25
1.Primary Outcome
Title Patient Survival
Hide Description Assessment of treated and control patients survival at 1 year follow-up
Time Frame 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treated Patients Control Patients
Hide Arm/Group Description:
Patients with end-stage chronic liver disease in waiting list for Liver Transplantation treated with hFLCTx
Patients with end-stage chronic liver disease in waiting list for Liver Transplantation on standard therapy
Overall Number of Participants Analyzed 9 16
Measure Type: Number
Unit of Measure: participants
Patient survival 5 6
Death/Transplant 4 10
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Treated Patients, Control Patients
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4340
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
2.Secondary Outcome
Title Analysis of Child-Pugh Score From Baseline to 1 Year Follow-up
Hide Description

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.

Time Frame Baseline and 1 year Follow-up
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Hide Analysis Population Description
Baseline Child-Pugh score vs Follow-up
Arm/Group Title Treated Patients Control Group
Hide Arm/Group Description:
Cirrhotic patients in waiting list for Liver Transplantation treated with non-purified and non-selected fetal liver stem cells
Cirrhotic patients in waiting list for Liver Transplantation on standard therapy
Overall Number of Participants Analyzed 9 16
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline Child-Pugh score 10.11  (1.54) 10.00  (1.26)
Follow-up Child-Pugh score 9.11  (1.45) 11.13  (1.63)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Treated Patients, Control Group
Comments Comparison at 1 year Follow-up
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0076
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
3.Secondary Outcome
Title Analysis of Meld Score From Baseline to 1 Year Follow-up
Hide Description

Assessment 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.

Time Frame Baseline and 1 year Follow-up
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treated Patients Control Patients
Hide Arm/Group Description:
Cirrhotic patients in waiting list for Liver Transplantation treated with non-purified and non-selected fetal liver stem cells.
Cirrhotic patients in waiting list for Liver Transplantation on standard therapy
Overall Number of Participants Analyzed 9 16
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline Meld score 16.00  (2.96) 15.31  (2.50)
Follow-up Meld score 15.67  (3.84) 19.06  (5.70)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Treated Patients, Control Patients
Comments Comparison at 1 year Follow-up
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0437
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Time Frame 1 year
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Treated Patients Control Group
Hide Arm/Group Description Patients with end-stage chronic liver disease in waiting list for liver transplantation treated with non-purified and non-selected fetal liver cells from fetuses aborted between the 16th and 26th week of gestation. Patients with end-stage chronic liver disease in waiting list for liver transplantation.
All-Cause Mortality
Treated Patients Control Group
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Treated Patients Control Group
Affected / at Risk (%) Affected / at Risk (%)
Total   0/9 (0.00%)   0/16 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Treated Patients Control Group
Affected / at Risk (%) Affected / at Risk (%)
Total   0/9 (0.00%)   0/16 (0.00%) 
Using a single gynecology unit we had only a 22% rate of fetal donation, necessarily limiting the availability of hFLCs. Our strict inclusion criteria limited the pool of potential patients to enroll.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Dr Giada Pietrosi
Organization: ISMETT-UPMC
Phone: +390912192111
Responsible Party: The Mediterranean Institute for Transplantation and Advanced Specialized Therapies
ClinicalTrials.gov Identifier: NCT01013194     History of Changes
Other Study ID Numbers: IRRB/01/06
First Submitted: November 11, 2009
First Posted: November 13, 2009
Results First Submitted: October 29, 2014
Results First Posted: November 3, 2015
Last Update Posted: November 3, 2015