Phase 1
Completed N=9
Safety and Efficacy Study of Peripheral Blood Mononucleated Cells for Treatment of Liver Cirrhosis
Source: ClinicalTrials.gov NCT01503749 ↗Enrolled (actual)
9
Serious AEs
0.0%
Results posted
Dec 2014
Primary outcomePrimary: Number of Participants With Severe Adverse Events — 0; 0; 0 participants
Summary
The investigators aim to investigate the safety and efficacy of peripheral blood monocyte for the treatment of patients with advanced liver cirrhosis.
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 |
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
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. Informational only — not medical advice.