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

Study Status: Completed
Recruit Status: Unknown status
Study Type: Interventional

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

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 Summary:

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.


Sponsor: Proteonomix, Inc.

Current Primary Outcome: Toxicity as measured by bone pain, hematologic parameters, GI measures and renal parameters [ Time Frame: 12 months ]

The primary end point for this study is the safety of mobilization of stem cells in patients with end stage liver disease. Adverse events will be documented to assess safety.


Original Primary Outcome: Same as current

Current Secondary Outcome: Effects of Mobilization [ Time Frame: 12 months ]

The secondary objective is to study the mobilization of stem cells, including MSCs, to the peripheral circulation and the effect on liver function. Functional assays will define the levels of heamtopoietic stem cells (CD34+ cells) and MSCs (CFU-F) in the circulation of patients.


Original Secondary Outcome: Same as current

Information By: Proteonomix, Inc.

Dates:
Date Received: October 11, 2012
Date Started: October 2012
Date Completion: September 2013
Last Updated: January 23, 2013
Last Verified: January 2013