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

King Saud University

Status and phase

Unknown

Phase 2

Phase 1

Conditions

End Stage Liver Disease

Treatments

Biological: Stem cell transplant

Study type

Interventional

Funder types

Other

Identifiers

NCT01412593

LDRC001SC

Details and patient eligibility

About

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.

Enrollment

50 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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