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

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2013 by Proteonomix, Inc.
Sponsor:
Collaborators:
University of Medicine and Dentistry of New Jersey
Numoda
Information provided by (Responsible Party):
Proteonomix, Inc.
ClinicalTrials.gov Identifier:
NCT01711073
First received: October 11, 2012
Last updated: January 23, 2013
Last verified: January 2013
  Purpose

A phase I trial to study the safety of mobilization of stem cells with G-CSF and Mozobil in patients with chronic liver disease.


Condition Intervention Phase
End Stage Liver DIsease
Drug: Mobilization with G-CSF and Mozobil
Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Mobilization of Stem Cells With G-CSF and Mozobil in Patients With End Stage Liver Disease

Resource links provided by NLM:


Further study details as provided by Proteonomix, Inc.:

Primary Outcome Measures:
  • Toxicity as measured by bone pain, hematologic parameters, GI measures and renal parameters [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    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.


Secondary Outcome Measures:
  • Effects of Mobilization [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    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.


Estimated Enrollment: 15
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)
Arms Assigned Interventions
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
Other Names:
  • Filgrastim
  • Neupogen
  • Plerixafor
  • AMD3100

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with a clinical diagnosis of cirrhosis Age greater than or equal to 18 years MELD score less than or equal to 12 able to provide informed consent HIV and HBsAg seronegative Platelet count >50,000, WBC count > 2,000 No history of malignancy within the last 5 years, except for non-melanoma skin cancer or cervical carcinoma in situ No lesions suspicious for liver cancer on CT and/or MRI within prior 4 months

Exclusion Criteria:

Patients with acute or subacute onset of liver disease Patients who have received a liver transplant Age < 18 MELD score >12 Patients whose MELD scores are currently less than or equal to 12 but with history of prior deterioration with MELD score >12 Unable to provide informed consent Patients with HIV or HBsAg seropositivity Pregnant or lactating females Enrolled in another research protocol Any condition that precludes serial follow up Patients with history of malignancy within the last 5 years, except for non-melanoma skin cancer or cervical carcinoma in situ Any lesions suspicious for liver cancer on CT and/or MRI within prior 4 months Patients with palpable splenomegaly on physical examination ANy condition that in the investigators opinion would likely increase the risk of particpation or would likely confound interpretation of the data

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  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01711073

Locations
United States, New Jersey
University of Medicine and Dentistry of New Jersey Recruiting
Newark, New Jersey, United States, 07101
Contact: Baburao Koneru, MD       koneruba@umdnj.edu   
Sponsors and Collaborators
Proteonomix, Inc.
University of Medicine and Dentistry of New Jersey
Numoda
Investigators
Principal Investigator: Baburao Koneru, MD University of Medicine and Dentistry of New Jersey
  More Information

No publications provided

Responsible Party: Proteonomix, Inc.
ClinicalTrials.gov Identifier: NCT01711073     History of Changes
Other Study ID Numbers: Prot001
Study First Received: October 11, 2012
Last Updated: January 23, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Liver Diseases
End Stage Liver Disease
Digestive System Diseases
Liver Failure
Hepatic Insufficiency
JM 3100
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 19, 2014