Back to results

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

Primary Purpose

End Stage Liver DIsease

Status

Unknown status

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

Mobilization with G-CSF and Mozobil

About this trial

This is an interventional treatment trial for End Stage Liver DIsease

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

University of Medicine and Dentistry of New JerseyRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Mobilization with G-CSF plus Mozobil

Arm Description

Patients will receive G-CSF (Filgrastim) plus Mozobil (Plerixafor)

Outcomes

Primary Outcome Measures

Toxicity as measured by bone pain, hematologic parameters, GI measures and renal parameters

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

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.

Full Information

NCT ID

NCT01711073

First Posted

October 11, 2012

Last Updated

January 23, 2013

Sponsor

Proteonomix, Inc.

Collaborators

University of Medicine and Dentistry of New Jersey, Numoda

1. Study Identification

Unique Protocol Identification Number

NCT01711073

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2013

Overall Recruitment Status

Unknown status

Study Start Date

October 2012 (undefined)

Primary Completion Date

September 2013 (Anticipated)

Study Completion Date

September 2013 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Proteonomix, Inc.

Collaborators

University of Medicine and Dentistry of New Jersey, Numoda

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

End Stage Liver DIsease

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

15 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Mobilization with G-CSF plus Mozobil

Arm Type

Experimental

Arm Description

Patients will receive G-CSF (Filgrastim) plus Mozobil (Plerixafor)

Intervention Type

Drug

Intervention Name(s)

Mobilization with G-CSF and Mozobil

Other Intervention Name(s)

Filgrastim, Neupogen, Plerixafor, AMD3100

Intervention Description

Treatment with drugs for mobilization of MSCs

Primary Outcome Measure Information:

Title

Toxicity as measured by bone pain, hematologic parameters, GI measures and renal parameters

Description

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.

Time Frame

12 months

Secondary Outcome Measure Information:

Title

Effects of Mobilization

Description

Time Frame

12 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility 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 -

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Baburao Koneru, MD

Organizational Affiliation

University of Medicine and Dentistry of New Jersey

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Medicine and Dentistry of New Jersey

City

Newark

State/Province

New Jersey

ZIP/Postal Code

07101

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Baburao Koneru, MD

koneruba@umdnj.edu

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs