Phase 1 N=9 Randomized Treatment

Safety and Efficacy Study of Peripheral Blood Mononucleated Cells for Treatment of Liver Cirrhosis

Liver Cirrhosis

Bottom Line

View on ClinicalTrials.gov: NCT01503749 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Dec 2014

Primary outcome: Primary: Number of Participants With Severe Adverse Events — 0; 0; 0 participants

Study Design & Population

Study type: Interventional
Phase: Phase 1
Interventions: G-colony stimulating factor (Drug); Infusion of the mobilized monocyte cells (Other)
Age: Adult, Older Adult · 20+ yrs
Sex: All
Sponsor: Seoul National University Hospital
Primary completion: Jul 2013

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Participants With Severe Adverse Events	0; 0; 0	—
SECONDARY Mean Change in Child-Pugh Score and Model For End-Stage Liver Disease (MELD) Score	9; 10; 9; 9.5; 10; 8.3	>0.05

Summary

The investigators aim to investigate the safety and efficacy of peripheral blood monocyte for the treatment of patients with advanced liver cirrhosis.

Eligibility Criteria

Inclusion Criteria

20 = 1.5 x normal upper limit or creatinine clearance <60 ml/min
Presence of signs of malignant tumors or tumor suspected symptoms, or history of malignant tumors with recurrence rate greater than 20% within two years
Gastrointestinal bleeding within the last 3 months or if there is a history of spontaneous bacterial peritonitis
Presence of portal vein thrombosis
Presence of acute infections

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01503749). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.