NCT01711073

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

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 15 (estimated)
• Sponsor: Proteonomix, Inc. · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DRUG	Mobilization with G-CSF and Mozobil	Treatment with drugs for mobilization of MSCs

Timeline

• Start date: 2012-10-01
• Primary completion: 2013-09-01
• Completion: 2013-09-01
• First posted: 2012-10-22
• Last updated: 2013-01-24

Locations

1 site across 1 country: United States