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

NCT ID: NCT01711073

Last Updated: 2013-01-24

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-10-31
• Study Completion Date: 2013-09-30

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.

Conditions

End Stage Liver DIsease

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Mobilization with G-CSF plus Mozobil

Patients will receive G-CSF (Filgrastim) plus Mozobil (Plerixafor)

Group Type: EXPERIMENTAL

Mobilization with G-CSF and Mozobil

Intervention Type: DRUG

Treatment with drugs for mobilization of MSCs

Interventions

Mobilization with G-CSF and Mozobil

Treatment with drugs for mobilization of MSCs

Intervention Type: DRUG

Other Intervention Names

Filgrastim; Neupogen; Plerixafor; AMD3100

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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• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Medicine and Dentistry of New Jersey

OTHER

Sponsor Role: collaborator

Numoda

INDUSTRY

Sponsor Role: collaborator

Proteonomix, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Baburao Koneru, MD

Role: PRINCIPAL_INVESTIGATOR

University of Medicine and Dentistry of New Jersey

Locations

University of Medicine and Dentistry of New Jersey

Newark, New Jersey, United States

Site Status: RECRUITING

Countries

United States

Facility Contacts

Baburao Koneru, MD

Role: primary

koneruba@umdnj.edu

Other Identifiers

Prot001

Identifier Type: -

Identifier Source: org_study_id