NCT01013194

Brief Summary

The herein study consists in the transplantation of liver progenitor cells isolated from human fetal liver tissue with the aim of improving conventional liver therapy and broadening therapeutical options other than liver transplantation.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Feb 2007

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2007

Completed
2.8 years until next milestone

First Submitted

Initial submission to the registry

November 11, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 13, 2009

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2011

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2011

Completed
4.3 years until next milestone

Results Posted

Study results publicly available

November 3, 2015

Completed
Last Updated

November 3, 2015

Status Verified

October 1, 2015

Enrollment Period

4.2 years

First QC Date

November 11, 2009

Results QC Date

October 29, 2014

Last Update Submit

October 2, 2015

Conditions

Liver Cirrhosis

Keywords

Liver cirrhosisFetal stem cellsStem cell transplantationLiver transplant candidate

Outcome Measures

Primary Outcomes (1)

  • Patient Survival

    Assessment of treated and control patients survival at 1 year follow-up

    1 year

Secondary Outcomes (2)

  • Analysis of Child-Pugh Score From Baseline to 1 Year Follow-up

    Baseline and 1 year Follow-up

  • Analysis of Meld Score From Baseline to 1 Year Follow-up

    Baseline and 1 year Follow-up

Study Arms (2)

Treated patients

EXPERIMENTAL

Cirrhotic patients treated with Human Fetal Liver Cell Transplantation.

Other: Human Fetal Liver Cell Transplantation

Control patients

NO INTERVENTION

Cirrhotic patients on Standard therapy.

Interventions

Human Fetal Liver Cell TransplantationOTHER

Human Fetal Liver Cell Transplantation. 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 5 and 10x10\^8 cells. Number of sessions: up to 2.

Treated patients

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Clinical diagnosis (evidence of chronic liver disease, presence of ascites and/or esophageal varices upon superior digestive endoscopy and/or ultrasound evidence of portal hypertension) or histological diagnosis of liver cirrhosis with any etiology.
  • Serious liver failure documented by a score ≥ B8 based on the Child-Pugh-Turcotte classification and/or MELD score ≥ 14.
  • Informed consent to the study signed by the patient.

You may not qualify if:

  • MELD score ≥ 25
  • Hepatocellular carcinoma (HCC)
  • Portal vein thrombosis
  • Serious cardiovascular or respiratory disease, or other medical condition which may threaten patient's life in the subsequent three months
  • Admission to the Intensive Care Unit (ICU)
  • Hemodynamic instability (MAP \< 55 mmHg)
  • Use of vasoactive drugs (Epinephrine, Norepinephrine, Vasopressin, Dopamine, Terlipressine
  • Type-1 (acute) hepatorenal syndrome
  • Levels of serum creatinine \>2 mg/dl and/or creatinine clearance \<30-40 ml/min
  • Sepsis, active infection or spontaneous bacterial peritonitis
  • Active gastrointestinal bleeding or recent gastrointestinal bleeding episode (in the previous 4 weeks)
  • Active alcohol abuse
  • Severe alcoholic hepatitis
  • Pulmonary hypertension (PAP \> 35 mmHg)
  • History of neoplasia
  • +8 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

ISMETT

Palermo, 90127, Italy

Location

MeSH Terms

Conditions

Liver Cirrhosis

Condition Hierarchy (Ancestors)

Liver DiseasesDigestive System DiseasesFibrosisPathologic ProcessesPathological Conditions, Signs and Symptoms

Limitations and Caveats

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.

Results Point of Contact

Title
Dr Giada Pietrosi
Organization
ISMETT-UPMC
gpietrosi@ismett.edu
+390912192111

Study Officials

  • Bruno Gridelli, MD

    ISMETT-UPMC

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 11, 2009

First Posted

November 13, 2009

Study Start

February 1, 2007

Primary Completion

April 1, 2011

Study Completion

July 1, 2011

Last Updated

November 3, 2015

Results First Posted

November 3, 2015

Record last verified: 2015-10

Locations

IT(1)