Back to resultsIntra-hepatic Artery Bone Marrow Derived Stem Cells Infusion for the Treatment of Advanced Liver Cirrhosis
Primary Purpose
End Stage Liver Disease
Status
Unknown status
Phase
Phase 1
Locations
Saudi Arabia
Study Type
Interventional
Intervention
Stem cell transplant
Sponsored by
About this trial
This is an interventional treatment trial for End Stage Liver Disease
Eligibility Criteria
Inclusion Criteria:
- 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 Criteria:
- 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
Sites / Locations
- King Khalid University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Stem cell transplant
Control
Arm Description
Outcomes
Primary Outcome Measures
Improvement of liver function measured by improvement in the model for end-stage liver disease (MELD) score.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01412593
Brief Title
Intra-hepatic Artery Bone Marrow Derived Stem Cells Infusion for the Treatment of Advanced Liver Cirrhosis
Study Type
Interventional
2. Study Status
Record Verification Date
May 2011
Overall Recruitment Status
Unknown status
Study Start Date
September 2011 (undefined)
Primary Completion Date
September 2012 (Anticipated)
Study Completion Date
September 2013 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
King Saud University
4. Oversight
Data Monitoring Committee
No
5. Study Description
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 HBV patients undergoing liver biopsy from Saudi centers have cirrhosis. Of these 3-5% would decompensate yearly thereby requiring liver transplantation. Based on the most recent national census figures, and a 1-2% prevalence rate of HBV and HCV nationwide, an estimated 1,000 patients would require liver transplantation on a yearly basis for decompensated cirrhosis.
Liver transplantation is the only available life saving treatment for patients with end stage liver disease. Unfortunately less than 100 liver transplantations are performed in Saudi Arabia in three centers. Around 100 other patients travel abroad for transplantation annually while all other patients progressively deteriorate and eventually die from the complications of decompensated liver cirrhosis.
In addition, even in patients who are listed for liver transplantation, often patients are too sick to wait on the transplant list that often takes more than a year and the on-list mortality is high. A procedure or an intervention that may help to stabilize liver function in order to help patients survive on the transplant list while awaiting liver transplantation would be of immense benefit. Examples of such interventions are already approved and used in some centers like the MARS system.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
End Stage Liver Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Stem cell transplant
Arm Type
Experimental
Arm Title
Control
Arm Type
No Intervention
Intervention Type
Biological
Intervention Name(s)
Stem cell transplant
Intervention Description
Patients randomized to the intervention arm will be admitted to the Liver Care Unit. Granulocyte colony-stimulating factor (G-CSF; 300mcg/mL) will be administered for 1 day as a single daily subcutaneous dose. This dose is sufficient to induce 10 folds enrichment for bone marrow cells.
Primary Outcome Measure Information:
Title
Improvement of liver function measured by improvement in the model for end-stage liver disease (MELD) score.
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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 Criteria:
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ayman Abdo, Associate Professor
Phone
+96614670810
Email
aabdo@ksu.edu.sa
Facility Information:
Facility Name
King Khalid University Hospital
City
Riyadh
ZIP/Postal Code
11461
Country
Saudi Arabia
12. IPD Sharing Statement
Learn more about this trial
Intra-hepatic Artery Bone Marrow Derived Stem Cells Infusion for the Treatment of Advanced Liver Cirrhosis
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