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

This study is not yet open for participant recruitment.
Verified May 2011 by King Saud University
Sponsor:
Information provided by:
King Saud University
ClinicalTrials.gov Identifier:
NCT01412593
First received: August 8, 2011
Last updated: NA
Last verified: May 2011
History: No changes posted
  Purpose

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 Intervention Phase
End Stage Liver Disease
 Biological: Stem cell transplant
 Phase 1
Phase 2

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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by King Saud University:

Primary Outcome Measures:
  • Improvement of liver function measured by improvement in the model for end-stage liver disease (MELD) score. [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 50
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)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01412593

Contacts
Contact: Ayman Abdo, Associate Professor +96614670810 aabdo@ksu.edu.sa

Locations
Saudi Arabia
King Khalid University Hospital Not yet recruiting
Riyadh, Saudi Arabia, 11461
Sponsors and Collaborators
King Saud University
  More Information

No publications provided

Responsible Party: Dr Ayman Abdo, King Saud University
ClinicalTrials.gov Identifier: NCT01412593     History of Changes
Other Study ID Numbers: LDRC001SC
Study First Received: August 8, 2011
Last Updated: August 8, 2011
Health Authority: Saudi Arabia: Ethics Committee

Additional relevant MeSH terms:
Liver Diseases
End Stage Liver Disease
Digestive System Diseases
Liver Failure
Hepatic Insufficiency

ClinicalTrials.gov processed this record on May 16, 2013