Phase 1/2 Study of Human Menstrual Blood-derived Mesenchymal Stem Cells Transplantation for the Evaluation of the Efficacy and Safety in Patients With Liver Cirrhosis
Trial Snapshot
- Phase
- Phase 1
- Sponsor
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- Overall Survival
Study Overview
Brief 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.
Detailed Description
The purpose of this study is to show whether menstrual blood-derived stem cells can improve the disease conditions in patients with liver cirrhosis.
One of two treatment arms will be assigned to the patients. One group will receive 2 weeks of conventional therapy plus MenSCs treatment; The other group will receive 2 weeks of conventional therapy plus placebo treatment.
MenSCs will be cultured and collected in a GMP lab. Patients were strictly monitored after the cells injection via i.v.. Patients are followed up at intervals up to at least 2 years.Clinical parameters such as ascites volume,serum alanine aminotransferase,total bilirubin,prothrombin time,albumin,MELD score,and Child-Pugh score will be evaluated at each timepoint.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 20 Years to 50 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Written informed consent
- •Aged 20 to 50years
- •Liver cirrhosis
- •Negative pregnancy test
Exclusion Criteria
- •Pregnant or lactating women
- •Malignancies
- •Vital organs failure
- •Severe bacteria infection
- •Vascular thromboses in the portal or hepatic veins
Arms & Interventions
Intervention
Conventional therapy plus MenSCs treatment
Intervention: conventional therapy plus MenSC transplantation (Biological)
No intervention
Conventional therapy plus placebo treatment:
Oral or intravenous administration
Intervention: Conventional therapy plus placebo treatment (Drug)
Outcomes
Primary Outcomes
Overall Survival
Time Frame: 48 weeks
Secondary Outcomes
- Liver function improvement(48 weeks)
- Complications(48 weeks)
- The improvement of ascites after 12-week treatment(48 weeks)
- Child-Pugh score(48 weeks)
- MELD score(48 weeks)
- SF36-quality of life(48 weeks)