Human Fetal Liver Cell Transplantation in Chronic Liver Failure

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2009 by The Mediterranean Institute for Transplantation and Advanced Specialized Therapies.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
University of Pittsburgh
UP
Information provided by:
The Mediterranean Institute for Transplantation and Advanced Specialized Therapies
ClinicalTrials.gov Identifier:
NCT01013194
First received: November 11, 2009
Last updated: November 12, 2009
Last verified: November 2009

November 11, 2009
November 12, 2009
February 2007
February 2011   (final data collection date for primary outcome measure)
Assess the therapeutic efficacy of human fetal liver progenitor cell transplantation by monitoring standard and specific liver function parameters [ Time Frame: 6 months, 1 year ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01013194 on ClinicalTrials.gov Archive Site
Assess the safety of human fetal liver progenitor cell transplantation on the clinical course of chronic liver failure patients Assess the development of ectopic liver tissue in the spleen by means of serial imaging studies. [ Time Frame: 6 months, 1 year ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Human Fetal Liver Cell Transplantation in Chronic Liver Failure
Human Fetal Liver Cell Transplantation for Treatment of Chronic Liver Failure - Transplant Experimentation

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.

One of the major clinical problems in transplantation medicine is the discrepancy between the growing number of liver chronic disease patients and the lack of organs. Research and development of new liver failure treatments thus have a high clinical significance. Regenerative medicine and results recently achieved in the field of stem cell biology may provide a remedy to this emerging problem.

Our project aims at developing new generation cell transplantation methodologies through an interdisciplinary research project created from a collaboration between ISMETT, Palermo and the University of Pittsburgh (UPMC-USA).

Adult hepatocyte transplantation has been in use for several years already and has proved to be safe for patients and able, especially in pediatric patients, to improve liver function indices and delay the need for liver transplantation. Studies have been limited until now by the use of already differentiated hepatocytes and therefore unable to proliferate and develop a suitable liver mass to support a decompensated liver.

The hypothesis of our project, supported by in vitro studies and studies on experimental animal models, is based on the possibility to generate an ectopic liver system in the spleen through the experimental use of hepatic cell progenitors obtained from human fetal liver tissues. Human fetal liver cell transplantation will be performed in the spleen through arterial injection.

The final endpoint of the project is to develop an innovative and safe treatment for patients with end-stage chronic liver failure

Interventional
Phase 1
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Liver Cirrhosis
Other: 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 1x108 and 5x108 cells during each session. Number of sessions: up to 4 sessions.

Experimental: Human Fetal Liver Cell Transplantation
Intervention: Other: Human Fetal Liver Cell Transplantation
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
30
Not Provided
February 2011   (final data collection date for primary outcome measure)

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 (Appendix 1) 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 < 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
  • 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).
Both
18 Years to 70 Years
No
Italy
 
NCT01013194
IRRB/01/06
Yes
Bruno Gridelli, ISMETT
The Mediterranean Institute for Transplantation and Advanced Specialized Therapies
  • University of Pittsburgh
  • UP
Not Provided
The Mediterranean Institute for Transplantation and Advanced Specialized Therapies
November 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP