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

This study has been completed.
Sponsor:
Collaborator:
UPMC
Information provided by (Responsible Party):
The Mediterranean Institute for Transplantation and Advanced Specialized Therapies
ClinicalTrials.gov Identifier:
NCT01013194
First received: November 11, 2009
Last updated: October 2, 2015
Last verified: October 2015
Results First Received: October 29, 2014  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Liver Cirrhosis
Intervention: Other: Human Fetal Liver Cell Transplantation

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
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

Participant Flow:   Overall Study
    Treated Patients     Control Group  
STARTED     9     16  
COMPLETED     9 [1]   16 [2]
NOT COMPLETED     0     0  
[1] Consecutive patients
[2] Retrospectively contemporary matched-pair group



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Treated Patients 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 Patients with end-stage chronic liver disease on standard therapy in waiting list for liver transplantation.
Total Total of all reporting groups

Baseline Measures
    Treated Patients     Control Patients     Total  
Number of Participants  
[units: participants]
  9     16     25  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     9     16     25  
>=65 years     0     0     0  
Gender  
[units: participants]
     
Female     3     3     6  
Male     6     13     19  
Region of Enrollment  
[units: participants]
     
Italy     9     16     25  



  Outcome Measures
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1.  Primary:   Patient Survival   [ Time Frame: 1 year ]

2.  Secondary:   Analysis of Child-Pugh Score From Baseline to 1 Year Follow-up   [ Time Frame: Baseline and 1 year Follow-up ]

3.  Secondary:   Analysis of Meld Score From Baseline to 1 Year Follow-up   [ Time Frame: Baseline and 1 year Follow-up ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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.


  More Information
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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
e-mail: gpietrosi@ismett.edu



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
Study First Received: November 11, 2009
Results First Received: October 29, 2014
Last Updated: October 2, 2015
Health Authority: Italy: Ethics Committee