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Hematopoietic Growth Factor
Mobilization of Stem Cells With G-CSF and Mozobil in Patients With End Stage Liver Disease
Phase 1
Waitlist Available
Led By Baburao Koneru, MD
Research Sponsored by Proteonomix, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
* 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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights
All Individual Drugs Already Approved
Approved for 5 Other Conditions
No Placebo-Only Group
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.
Eligible Conditions
- Liver Disease
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Toxicity as measured by bone pain, hematologic parameters, GI measures and renal parameters
Secondary study objectives
Effects of Mobilization
Awards & Highlights
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 5 Other Conditions
This treatment demonstrated efficacy for 5 other conditions.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Mobilization with G-CSF plus MozobilExperimental Treatment1 Intervention
Patients will receive G-CSF (Filgrastim) plus Mozobil (Plerixafor)
Find a Location
Who is running the clinical trial?
Proteonomix, Inc.Lead Sponsor
1 Previous Clinical Trials
22 Total Patients Enrolled
University of Medicine and Dentistry of New JerseyOTHER
121 Previous Clinical Trials
13,271 Total Patients Enrolled
NumodaIndustry Sponsor
2 Previous Clinical Trials
26 Total Patients Enrolled
Baburao Koneru, MDPrincipal InvestigatorUniversity of Medicine and Dentistry of New Jersey
1 Previous Clinical Trials
321 Total Patients Enrolled