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

Sponsor

King Saud University (Other)

Overall Status

Unknown status

CT.gov ID

NCT01412593

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

2.1

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
End Stage Liver Disease	Biological: Stem cell transplant	Phase 1/Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

50 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Study Start Date :

Sep 1, 2011

Anticipated Primary Completion Date :

Sep 1, 2012

Anticipated Study Completion Date :

Sep 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
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

Arm

Intervention/Treatment

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

Outcome Measures

Primary Outcome Measures

Improvement of liver function measured by improvement in the model for end-stage liver disease (MELD) score. [2 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	King Khalid University Hospital	Riyadh		Saudi Arabia	11461

Sponsors and Collaborators

King Saud University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

, ,

ClinicalTrials.gov Identifier:

NCT01412593

Other Study ID Numbers:

LDRC001SC

First Posted:

Aug 9, 2011

Last Update Posted:

Aug 9, 2011

Last Verified:

May 1, 2011

Additional relevant MeSH terms:

Liver Diseases

End Stage Liver Disease

Study Results

No Results Posted as of Aug 9, 2011