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

NCT01711073 | Unknown Phase 1 DMC

• 1 other identifier: Prot001
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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.

  12 months

Secondary Outcomes (1)

• Effects of Mobilization

  12 months

Study Arms (1)

Mobilization with G-CSF plus Mozobil

EXPERIMENTAL

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

Drug: Mobilization with G-CSF and Mozobil

Interventions

Mobilization with G-CSF and Mozobil DRUG

Treatment with drugs for mobilization of MSCs

Also known as: Filgrastim, Neupogen, Plerixafor, AMD3100

Mobilization with G-CSF plus Mozobil

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Proteonomix, Inc.: lead
• University of Medicine and Dentistry of New Jersey: collaborator
• Numoda: collaborator

Study Sites (1)

University of Medicine and Dentistry of New Jersey

Newark, New Jersey, 07101, United States

RECRUITING

MeSH Terms

Conditions

End Stage Liver Disease

Interventions

Granulocyte Colony-Stimulating Factor; plerixafor; Filgrastim

Condition Hierarchy (Ancestors)

Liver Failure; Hepatic Insufficiency; Liver Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors

Study Officials

• Baburao Koneru, MD

  University of Medicine and Dentistry of New Jersey

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 11, 2012
• First Posted: October 22, 2012
• Study Start: October 1, 2012
• Primary Completion: September 1, 2013
• Study Completion: September 1, 2013
• Last Updated: January 24, 2013

Record last verified: 2013-01

Locations

US (1)