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

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

History of Changes

Tracking Information
First Received Date ^ICMJE	November 11, 2009
Last Updated Date	November 12, 2009
Start Date ^ICMJE	February 2007
Estimated Primary Completion Date	February 2011 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: November 12, 2009)	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 ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01013194 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: November 12, 2009)	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 ]
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Human Fetal Liver Cell Transplantation in Chronic Liver Failure
Official Title ^ICMJE	Human Fetal Liver Cell Transplantation for Treatment of Chronic Liver Failure - Transplant Experimentation
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.
Detailed Description	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
Study Type ^ICMJE	Interventional
Study Phase	Phase 1 Phase 2
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Condition ^ICMJE	Liver Cirrhosis
Intervention ^ICMJE	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.
Study Arm (s)	Experimental: Human Fetal Liver Cell Transplantation Intervention: Other: Human Fetal Liver Cell Transplantation
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Recruiting
Estimated Enrollment ^ICMJE	30
Completion Date	Not Provided
Estimated Primary Completion Date	February 2011 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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).
Gender	Both
Ages	18 Years to 70 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Not Provided
Location Countries ^ICMJE	Italy

Administrative Information
NCT Number ^ICMJE	NCT01013194
Other Study ID Numbers ^ICMJE	IRRB/01/06
Has Data Monitoring Committee	Yes
Responsible Party	Bruno Gridelli, ISMETT
Study Sponsor ^ICMJE	The Mediterranean Institute for Transplantation and Advanced Specialized Therapies
Collaborators ^ICMJE	University of Pittsburgh UP
Investigators ^ICMJE	Not Provided
Information Provided By	The Mediterranean Institute for Transplantation and Advanced Specialized Therapies
Verification Date	November 2009
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

To Top