Status:
UNKNOWN
Intra-hepatic Artery Bone Marrow Derived Stem Cells Infusion for the Treatment of Advanced Liver Cirrhosis
Lead Sponsor:
King Saud University
Conditions:
End Stage Liver Disease
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
PHASE2
Brief Summary
Liver disease is a common medical problem in Saudi Arabia. Early studies indicated that around 10% of the Saudi population is either infected with hepatitis B or C. An estimated 12% of chronic HCV and...
Eligibility Criteria
Inclusion
- Age \>18 years
- Clinically diagnosed liver cirrhosis by any of the following: ultrasound/MRI/ CT/ + tissue biopsy.
- MELD score ≥ 18 and \<35
- Ability to sign an informed consent
- Refused by liver transplant program or labeled as not a liver transplant candidate, decided by at least 3 transplant physicians
Exclusion
- On a liver transplantation waiting list
- Questionable diagnosis of cirrhosis
- Prior history of organ transplantation
- Past history of malignancy within the 2 years prior to inclusion
- Probable or diagnosis of hepatocellular carcinoma
- Major hepatic vascular thrombosis (hepatic artery, or portal or hepatic veins)
- Serious cardiovascular or respiratory disease, or other medical condition with a high anticipated mortality within twelve months
- Current or recent (within the past 4 weeks) use of vasoactive drugs (Epinephrine, Norepinephrine, Vasopressin, Dopamine, terlipressin)
- Type-1 (acute) hepatorenal syndrome
- Levels of serum creatinine \>150 µmol/ml and/or creatinine clearance \<30 ml/min (as calculated by MDRD system)
- Documented or suspected ongoing infection
- Active or recent gastrointestinal bleeding episode (in the previous 4 weeks)
- Active alcohol abuse extending to within the previous six months
- Pulmonary hypertension (PAP \> 35 mmHg), porto-pulmonary hypertension or hepatopulmonary syndrome
- Pregnancy
- HIV infection
- Active or past drug addiction within the preceding 6 months
- History of serious or uncontrolled psychiatric disease or depression
- Contraindications to the angiography procedures (e.g. arterial aneurysm, kinking, thrombosis)
- Contraindications for bone marrow biopsy (e.g. bleeding diathesis)
- Prior shunt operative shunt procedure
Key Trial Info
Start Date :
September 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2013
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT01412593
Start Date
September 1 2011
End Date
September 1 2013
Last Update
August 9 2011
Active Locations (1)
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1
King Khalid University Hospital
Riyadh, Riyadh Region, Saudi Arabia, 11461