Human Menstrual Blood-derived Mesenchymal Stem Cells for Patients With Liver Cirrhosis
NCT01483248 · Status: UNKNOWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 50
Last updated 2012-06-07
Summary
Orthotopic liver transplantation (OLT) is currently the most effective method for end-stage liver diseases. However, the critical shortage of donor organs, high cost, and the problem of immune rejection limit its clinical application, and even some patients on the waiting list will never survive to receive a matched liver. Stem cell transplantation instead of conventional medical therapy or orthotopic liver transplantation will be a promising alternate approach to regenerate damaged hepatic mass. Adult mesenchymal stem cells (MSCs) are generally thought of as an autologous source of regenerative cells in previous studies.In this study, the safety and efficacy of menstrual blood-derived stem cells transplantation for patients with liver cirrhosis will be evaluated.
Conditions
- Liver Cirrhosis
- Fibrosis
- Liver Disease
- Digestive System Disease
Interventions
- BIOLOGICAL
-
conventional therapy plus MenSC transplantation
patients will receive conventional treatment,such as antiviral drugs, lowering aminotransferase and jaundice medicine. MenSCs transplantation: taken i.v., twice per week, at a dose of 1\*10E6 MSC/kg body for 2 weeks.
- DRUG
-
Conventional therapy plus placebo treatment
25 of the enrolled patients were assigned to receive comprehensive treatment including antiviral drugs, lowering aminotransferase and jaundice medicine.
Sponsors & Collaborators
-
Zhejiang University
collaborator OTHER -
Zhejiang General Hospital of Armed Police
collaborator OTHER -
Zhenjiang First People's Hospital
collaborator OTHER -
Wuhan General Hospital of Guangzhou Military Command
collaborator OTHER -
S-Evans Biosciences Co., Ltd.
lead INDUSTRY
Principal Investigators
-
Charlie Xiang, Professor · S-Evans Biosciences Co., Ltd.
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 20 Years
- Max Age
- 50 Years
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2010-10-31
- Primary Completion
- 2013-10-31
- Completion
- 2015-10-31
Countries
- China
Study Locations
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