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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01412593
Recruitment Status : Unknown
Verified May 2011 by King Saud University.
Recruitment status was:  Not yet recruiting
First Posted : August 9, 2011
Last Update Posted : August 9, 2011
Information provided by:
King Saud University

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : September 2011
Estimated Primary Completion Date : September 2012
Estimated Study Completion Date : September 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Liver Diseases

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

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01412593

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Contact: Ayman Abdo, Associate Professor +96614670810

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

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Responsible Party: Dr Ayman Abdo, King Saud University Identifier: NCT01412593     History of Changes
Other Study ID Numbers: LDRC001SC
First Posted: August 9, 2011    Key Record Dates
Last Update Posted: August 9, 2011
Last Verified: May 2011

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