Mobilization of Stem Cells With G-CSF and Mozobil in Patients With End Stage Liver Disease

Liver cirrhosis in humans represents the end stage of chronic liver injury. Supply of "new"
stem cells to the liver could regenerate hepatocytes and restore the lost function. Delivery
of Mesenchymal Stem Cells (MSCs) has been shown in animal models and limited clinical trials
to result in improved liver disease (MELD) score.

In preclinical studies we have demonstrated that the combination of G-CSF plus Mozobil can
effectively mobilize both hematopoietic stem cells (HSCs) and MSCs into the peripheral
circulation. While G-CSF only mobilizes HSCs.

The clinical trial will test the safety of treating patients with end stage liver disease
with G-CSF and Mozobil to mobilize MSCs into the peripheral circulation.

Inclusion Criteria:

- Patients with a clinical diagnosis of cirrhosis Age greater than or equal to 18 years
MELD score less than or equal to 12 able to provide informed consent HIV and HBsAg
seronegative Platelet count >50,000, WBC count > 2,000 No history of malignancy
within the last 5 years, except for non-melanoma skin cancer or cervical carcinoma in
situ No lesions suspicious for liver cancer on CT and/or MRI within prior 4 months

Exclusion Criteria:

Patients with acute or subacute onset of liver disease Patients who have received a liver
transplant Age < 18 MELD score >12 Patients whose MELD scores are currently less than or
equal to 12 but with history of prior deterioration with MELD score >12 Unable to provide
informed consent Patients with HIV or HBsAg seropositivity Pregnant or lactating females
Enrolled in another research protocol Any condition that precludes serial follow up
Patients with history of malignancy within the last 5 years, except for non-melanoma skin
cancer or cervical carcinoma in situ Any lesions suspicious for liver cancer on CT and/or
MRI within prior 4 months Patients with palpable splenomegaly on physical examination ANy
condition that in the investigators opinion would likely increase the risk of particpation
or would likely confound interpretation of the data