Human Menstrual Blood-derived Mesenchymal Stem Cells for Patients With Liver Cirrhosis
Recruitment status was: Enrolling by invitation
|Liver Cirrhosis Fibrosis Liver Disease Digestive System Disease||Biological: conventional therapy plus MenSC transplantation Drug: Conventional therapy plus placebo treatment||Phase 1 Phase 2|
|Study Design:||Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||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|
- Overall Survival [ Time Frame: 48 weeks ]
- Liver function improvement [ Time Frame: 48 weeks ]
- Complications [ Time Frame: 48 weeks ]such as fever,anaphylaxis,cough,chest distress,and dyspnea,et al.
- The improvement of ascites after 12-week treatment [ Time Frame: 48 weeks ]
- Child-Pugh score [ Time Frame: 48 weeks ]
- MELD score [ Time Frame: 48 weeks ]
- SF36-quality of life [ Time Frame: 48 weeks ]
|Study Start Date:||October 2010|
|Estimated Study Completion Date:||October 2015|
|Estimated Primary Completion Date:||October 2013 (Final data collection date for primary outcome measure)|
Conventional therapy plus MenSCs treatment
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.
Active Comparator: No intervention
Conventional therapy plus placebo treatment:
Oral or intravenous administration
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.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01483248
|the First Affiliated Hospital of Zhejiang University-IRB|
|Hangzhou, Zhejiang, China, 310003|
|Principal Investigator:||Charlie Xiang, Professor||S-Evans Biosciences Co.,Ltd.|