Human Fetal Liver Cell Transplantation in Chronic Liver Failure
Recruitment status was Recruiting
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Liver Cirrhosis |
Other: Human Fetal Liver Cell Transplantation |
Phase 1 Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Human Fetal Liver Cell Transplantation for Treatment of Chronic Liver Failure - Transplant Experimentation |
- 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 ]
- 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 ]
| Estimated Enrollment: | 30 |
| Study Start Date: | February 2007 |
| Estimated Primary Completion Date: | February 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Human Fetal Liver Cell Transplantation |
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. |
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
Eligibility| Ages Eligible for Study: | 18 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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).
Contacts and Locations| Italy | |
| ISMETT | Recruiting |
| Palermo, Italy, 90120 | |
| Contact: Bruno Gridelli, MD 0039.091.21.92.442 ddonato@ismett.edu | |
| Contact: Giada Pietrosi, MD 0039.091.21.92.601 gpietrosi@ismett.edu | |
| Principal Investigator: Bruno Gridelli, MD | |
More Information
No publications provided
| Responsible Party: | Bruno Gridelli, ISMETT |
| ClinicalTrials.gov Identifier: | NCT01013194 History of Changes |
| Other Study ID Numbers: | IRRB/01/06 |
| Study First Received: | November 11, 2009 |
| Last Updated: | November 12, 2009 |
| Health Authority: | Italy: Ethics Committee |
Keywords provided by The Mediterranean Institute for Transplantation and Advanced Specialized Therapies:
|
Liver cirrhosis Fetal stem cells Stem cell transplantation Liver transplant candidates |
Additional relevant MeSH terms:
|
Liver Cirrhosis Fibrosis Liver Failure End Stage Liver Disease Liver Diseases Digestive System Diseases Pathologic Processes |
Hepatic Insufficiency Liver Extracts Hematinics Hematologic Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 22, 2013