Full results & analysis
Available in the Gosset platform where reported.
Trial intelligence / Profile preview
Multiple Infusions of Mononuclear Bone Marrow Cells in Chronic Liver Diseases
NCT02171949Phase 2
Key facts
- Status
- Unknown
- Start
- Apr 2015
- Primary completion
- Dec 2018
- Countries
- 1
- Sponsor
- Hospital São Rafael
- Modality
- Stem Cell Therapies
- Conditions
- Liver cirrhosis (LC)chronic hepatitis
01
Overview
Phase 2, randomised, open-label trial of bone marrow mononuclear cells in Liver cirrhosis (LC) and chronic hepatitis (2 arms), sponsored by Hospital São Rafael. Primary endpoints: Child-Pugh Score at 12 months and Model for End-Stage Liver Disease Score at 12 months. Status: unknown.
02
Design
2 arms- Study design
- RandomizedOpen-label
Bone marrow mononuclear cell therapy
Infusion of bone marrow mononuclear cells on Days 1, 30, and 60 + Standard of Care
Control group
Standard of Care only
03
Who it enrols
Patients with chronic decompensated liver disease (Child-Pugh B or C) and confirmed cirrhosis (Metavir F3/F4), excluding those with HCC, severe coagulopathy, renal failure, or HIV coinfection.
04
Endpoints
Primary
Child-Pugh Score
Model for End-Stage Liver Disease Score
Secondary
Degree of muscle strength
Hepatic fibrosis
Quality of Life
Functional capacity
Serum bilirubin levels
Serum albumin levels
Prothrombin time
Serum levels of cytokines
Beyond the preview
Go deeper on NCT02171949.
Full results, competitive context and analysis are in the Gosset platform.
Competitive context
Available in the Gosset platform where reported.
Bring the full picture into focus.
See how Gosset can support your research on NCT02171949.