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Hematopoietic Growth Factor

Mobilization with G-CSF plus Mozobil for 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

Study 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 below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Toxicity as measured by bone pain, hematologic parameters, GI measures and renal parameters
Secondary outcome measures
Effects of Mobilization

Side effects data

From 2007 Phase 3 trial • 298 Patients • NCT00103610
43%
Diarrhoea
33%
Nausea
32%
Injection site erythema
27%
Fatigue
27%
Bone pain
25%
Headache
21%
Back pain
18%
Paraesthesia
17%
Hypokalaemia
15%
Arthralgia
12%
Catheter site pain
11%
Hypomagnesaemia
11%
Oedema peripheral
9%
Dizziness
8%
Injection site pruritus
8%
Pain
8%
Vomiting
7%
Night sweats
7%
Abdominal pain
7%
Flatulence
7%
Paraesthesia oral
7%
Insomnia
6%
Pyrexia
6%
Abdominal distension
5%
Anxiety
5%
Cough
5%
Hypotension
5%
Injection site irritation
5%
Muscle spasms
5%
Pain in extremity
5%
Hyperhidrosis
5%
Flushing
4%
Catheter site haemorrhage
4%
Dyspnoea
4%
Rash
3%
Erythema
3%
Hypocalcaemia
3%
Frequent bowel movements
3%
Thrombocytopenia
3%
Tachycardia
3%
Abdominal pain upper
3%
Hypoaesthesia oral
3%
Dry mouth
3%
Dyspepsia
3%
Stomach discomfort
3%
Injection site urticaria
3%
Contusion
3%
Rhinorrhoea
2%
Neck pain
2%
Central line infection
2%
Anaemia
2%
Hyperuricaemia
2%
Injection site pain
2%
Chills
2%
Hypoaesthesia
2%
Citrate toxicity
2%
Dysuria
2%
Catheter site erythema
2%
Vertigo
2%
Injection site reaction
2%
Upper respiratory tract infection
2%
Musculoskeletal pain
2%
Myalgia
2%
Hot flush
1%
Rectal haemorrhage
1%
Skin laceration
1%
Peripheral sensory neuropathy
1%
Malaise
1%
Pallor
1%
Abdominal discomfort
1%
Road traffic accident
1%
Metastases to skin
1%
Catheter bacteraemia
1%
Atrial fibrillation
1%
Hypoglycaemia
1%
Catheter site pruritus
1%
Candidiasis
1%
Oral candidiasis
1%
Excoriation
1%
Balance disorder
1%
Non-cardiac chest pain
1%
Urine analysis abnormal
1%
Catheter related complication
1%
Haematochezia
1%
Anorexia
1%
Fluid overload
1%
Gout
1%
Constipation
1%
Muscular weakness
1%
Peripheral coldness
1%
Abnormal dreams
1%
Chest discomfort
1%
Injection site swelling
1%
Limb discomfort
1%
Throat irritation
1%
Platelet count decreased
1%
Musculoskeletal chest pain
1%
Catheter site rash
1%
Blister
1%
Catheter site related reaction
1%
Erythema induratum
1%
Folliculitis
1%
Subcutaneous haematoma
1%
Convulsion
1%
Nasal dryness
1%
Viral upper respiratory tract infection
1%
Injection site rash
1%
Hyperglycaemia
1%
Retching
1%
Ventricular extrasystoles
1%
Hypothyroidism
1%
Eructation
1%
Sedation
1%
Urticaria localised
1%
Local swelling
1%
Catheter site discharge
1%
Nightmare
1%
Palpitations
1%
Mucosal inflammation
1%
Febrile neutropenia
1%
Tinnitus
1%
Extrasystoles
1%
Eye swelling
1%
Vision blurred
1%
Dysphagia
1%
Lymphadenopathy
1%
Oral mucosal blistering
1%
Supraventricular tachycardia
1%
Salivary hypersecretion
1%
Tooth disorder
1%
Periodontitis
1%
Catheter site haematoma
1%
Feeling abnormal
1%
Influenza like illness
1%
Injection site discomfort
1%
Injection site bruising
1%
Feeling cold
1%
Injection site haematoma
1%
Injection site haemorrhage
1%
Oedema
1%
Sensation of pressure
1%
Bacteraemia
1%
Herpes zoster
1%
Sinusitis
1%
Urinary tract infection
1%
Procedural pain
1%
Blood alkaline phosphatase increased
1%
Blood creatinine increased
1%
Blood magnesium decreased
1%
Blood potassium decreased
1%
Blood uric acid increased
1%
Breath sounds abnormal
1%
Weight increased
1%
Decreased appetite
1%
Hypophosphataemia
1%
Musculoskeletal discomfort
1%
Musculoskeletal stiffness
1%
Areflexia
1%
Dysgeusia
1%
Neuropathy peripheral
1%
Syncope
1%
Tremor
1%
Syncope vasovagal
1%
Depression
1%
Sleep disorder
1%
Urine odour abnormal
1%
Hallucination
1%
Pollakiuria
1%
Testicular pain
1%
Dyspnoea exertional
1%
Breast swelling
1%
Nasal congestion
1%
Paranasal sinus hypersecretion
1%
Obstructive airways disorder
1%
Pharyngolaryngeal pain
1%
Dermatitis contact
1%
Wheezing
1%
Ecchymosis
1%
Hypoaesthesia facial
1%
Pruritus
1%
Haematoma
1%
Skin irritation
1%
Urticaria
1%
Hypertension
100%
80%
60%
40%
20%
0%
Study treatment Arm
G-CSF Plus Plerixafor
G-CSF Plus Placebo

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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Mobilization of Stem Cells With G-CSF and Mozobil in Patients With End Stage Liver Disease
2012. "Mobilization of Stem Cells With G-CSF and Mozobil in Patients With End Stage Liver Disease". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01711073.
All > Liver Fibrosis
~1 spots leftby Apr 2025
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