Mobilization of Stem Cells With G-CSF and Mozobil in Patients With End Stage Liver Disease
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|ClinicalTrials.gov Identifier: NCT01711073|
Recruitment Status : Unknown
Verified January 2013 by Proteonomix, Inc..
Recruitment status was: Recruiting
First Posted : October 22, 2012
Last Update Posted : January 24, 2013
|Condition or disease||Intervention/treatment||Phase|
|End Stage Liver DIsease||Drug: Mobilization with G-CSF and Mozobil||Phase 1|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||15 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Mobilization of Stem Cells With G-CSF and Mozobil in Patients With End Stage Liver Disease|
|Study Start Date :||October 2012|
|Estimated Primary Completion Date :||September 2013|
|Estimated Study Completion Date :||September 2013|
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
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|