Intra-hepatic Artery Bone Marrow Derived Stem Cells Infusion for the Treatment of Advanced Liver Cirrhosis
Recruitment status was: Not yet recruiting
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.
|End Stage Liver Disease||Biological: Stem cell transplant||Phase 1 Phase 2|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
- Improvement of liver function measured by improvement in the model for end-stage liver disease (MELD) score. [ Time Frame: 2 years ]
|Study Start Date:||September 2011|
|Estimated Study Completion Date:||September 2013|
|Estimated Primary Completion Date:||September 2012 (Final data collection date for primary outcome measure)|
|Experimental: Stem cell transplant||
Biological: Stem cell transplant
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.
|No Intervention: Control|
Please refer to this study by its ClinicalTrials.gov identifier: NCT01412593
|Contact: Ayman Abdo, Associate Professorfirstname.lastname@example.org|
|King Khalid University Hospital||Not yet recruiting|
|Riyadh, Saudi Arabia, 11461|