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 ]
Original Primary Outcome: Same as current
Current Secondary Outcome: Effects of Mobilization [ Time Frame: 12 months ]
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