Recruiting
Phase 1

G-CSF & Mozobil

Sponsor:

Proteonomix, Inc.

Code:

NCT01711073

Conditions

End Stage Liver DIsease

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Mobilization with G-CSF and Mozobil

Study Details

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.

Conditions

End Stage Liver DIsease

Study ID

NCT01711073

Start date

Oct, 2012

Status verified date

Jan, 2013

Completion date

Sep, 2013

Anticipated

Primary completion date

Sep, 2013

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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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Study Design

Enrollment

15 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Mobilization with G-CSF plus Mozobil

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

Interventions

Mobilization with G-CSF and Mozobil

Treatment with drugs for mobilization of MSCs

Primary outcome measure

  • Toxicity as measured by bone pain, hematologic parameters, GI measures and renal parameters [ Time Frame: 12 months ]

Central Contacts and Locations

Locations

University of Medicine and Dentistry of New Jersey

Recruiting

Newark, New Jersey, United States, 07101

Contacts

Baburao Koneru, MD

koneruba@umdnj.edu

More Information

Sponsor

Proteonomix, Inc.

Last update posted

Jan 24, 2013

Last verified

Jan, 2013

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Proteonomix, Inc. on 2013-01-24.