Phase 2 N=25 Treatment

Human Fetal Liver Cell Transplantation in Chronic Liver Failure

Liver Cirrhosis

Bottom Line

View on ClinicalTrials.gov: NCT01013194 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Nov 2015

Primary outcome: Primary: Patient Survival — 5; 6; 4; 10 participants — p=0.4340

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Human Fetal Liver Cell Transplantation (Other)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: The Mediterranean Institute for Transplantation and Advanced Specialized Therapies
Primary completion: Apr 2011

Outcome Measures

Outcome	Result	p-value
PRIMARY Patient Survival	5; 6; 4; 10	0.4340
SECONDARY Analysis of Child-Pugh Score From Baseline to 1 Year Follow-up	10.11; 10.00; 9.11; 11.13	0.0076 sig
SECONDARY Analysis of Meld Score From Baseline to 1 Year Follow-up	16.00; 15.31; 15.67; 19.06	0.0437 sig

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.

Eligibility Criteria

Inclusion Criteria

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.

Exclusion Criteria

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 2 mg/dl and/or creatinine clearance 35 mmHg)
History of neoplasia
Pregnancy
Non Sicilian residency
HBV DNA positive
HIV infection
Drug addiction
Age < 18 years
Transjugular intrahepatic portosystemic shunt (TIPS) placed in the previous month
Contraindications to the procedure (e.g., related to the splenic artery: aneurysm, kinking, thrombosis, splenic-renal shunt; related to the spleen: large angioma).

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01013194). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.