Intra-hepatic Artery Bone Marrow Derived Stem Cells Infusion for the Treatment of Advanced Liver Cirrhosis

End Stage Liver Disease Clinical Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01412593
• Other study ID #: LDRC001SC
• Status: Not yet recruiting
• Phase: Phase 1/Phase 2
• First received: August 8, 2011
• Last updated: August 8, 2011
• Start date: September 2011
• Est. completion date: September 2013

Study information

• Verified date: May 2011
• Source: King Saud University
• Contact: Ayman Abdo, Associate Professor
• Phone: +96614670810
• Email: aabdo[@]ksu.edu.sa
• Is FDA regulated: No
• Health authority: Saudi Arabia: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: September 2013
• Est. primary completion date: September 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• End Stage Liver Disease
• Liver Diseases

Intervention

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.

Locations

Country	Name	City	State
Saudi Arabia	King Khalid University Hospital	Riyadh

Sponsors (1)

Lead Sponsor	Collaborator
King Saud University

Country where clinical trial is conducted

Saudi Arabia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improvement of liver function measured by improvement in the model for end-stage liver disease (MELD) score.		2 years	Yes