Mobilization of Stem Cells With G-CSF and Mozobil in Patients With End Stage Liver Disease
Recruitment status was: Recruiting
|End Stage Liver DIsease||Drug: Mobilization with G-CSF and Mozobil||Phase 1|
|Study Design:||Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||Mobilization of Stem Cells With G-CSF and Mozobil in Patients With End Stage Liver Disease|
- 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.
- 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.
|Study Start Date:||October 2012|
|Estimated Study Completion Date:||September 2013|
|Estimated Primary Completion Date:||September 2013 (Final data collection date for primary outcome measure)|
Experimental: Mobilization with G-CSF plus Mozobil
Patients will receive G-CSF (Filgrastim) plus Mozobil (Plerixafor)
Drug: Mobilization with G-CSF and Mozobil
Treatment with drugs for mobilization of MSCs
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01711073
|United States, New Jersey|
|University of Medicine and Dentistry of New Jersey||Recruiting|
|Newark, New Jersey, United States, 07101|
|Contact: Baburao Koneru, MD email@example.com|
|Principal Investigator:||Baburao Koneru, MD||University of Medicine and Dentistry of New Jersey|