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CD133+ vs MNC Stem Cells in Decompensated Cirrhosis
NCT01120925Phase 2
Key facts
- Status
- Completed
- Start
- May 2010
- Primary completion
- Jul 2013
- Countries
- 1
- Sponsor
- Royan Institute
- Modality
- Stem Cell Therapies
- Conditions
- Liver cirrhosis (LC)
01
Overview
Phase 2, randomised, double-blind trial of bone marrow mononuclear cells in Liver cirrhosis (LC) (3 arms), sponsored by Royan Institute. Primary endpoint: Liver function test (MELD score) at 6 months. Started May 2010; status: completed.
02
Design
3 arms- Study design
- RandomizedDouble-blind
MNC
Bone marrow derived MNC (2-3 x 10^9 cells)
CD133
CD133 derived from Bone marrow (5-15 x 10^6 cells)
Control
Normal saline with 5% Human Serum Albumin
03
Who it enrols
Patients with decompensated cirrhosis (MELD score >= 12 or Child-Pugh B/C) aged 16-65.
04
Endpoints
Primary
Liver function test (MELD score)
Secondary
Cirrhosis Mortality
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