Clinical trial NCT01711073: Mobilization of Stem Cells With G-CSF and Mozobil in Patients With End Stage Liver Disease
Official title: Mobilization of Stem Cells With G-CSF and Mozobil in Patients With End Stage Liver Disease
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: End Stage Liver DIsease
Lead sponsor: Proteonomix, Inc.
Sponsor class: INDUSTRY
Collaborators: name: University of Medicine and Dentistry of New Jersey
name: Numoda
First posted: 2012-10-22
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: A phase I trial to study the safety of mobilization of stem cells with G-CSF and Mozobil in patients with chronic liver disease.

Detailed description: 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.

Eligibility criteria: 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

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Primary outcomes:
measure: Toxicity as measured by bone pain, hematologic parameters, GI measures and renal parameters
timeFrame: 12 months
Secondary outcomes:
measure: Effects of Mobilization
timeFrame: 12 months
Other outcomes:
Locations:
city: Newark
country: United States
facility: University of Medicine and Dentistry of New Jersey
state: New Jersey
Study officials:
affiliation: University of Medicine and Dentistry of New Jersey
name: Baburao Koneru, MD
role: PRINCIPAL_INVESTIGATOR
References: