Human Menstrual Blood-derived Mesenchymal Stem Cells for Patients With Liver Cirrhosis
|ClinicalTrials.gov Identifier: NCT01483248|
Recruitment Status : Unknown
Verified June 2012 by S-Evans Biosciences Co.,Ltd..
Recruitment status was: Enrolling by invitation
First Posted : December 1, 2011
Last Update Posted : June 7, 2012
|Condition or disease||Intervention/treatment||Phase|
|Liver Cirrhosis Fibrosis Liver Disease Digestive System Disease||Biological: conventional therapy plus MenSC transplantation Drug: Conventional therapy plus placebo treatment||Phase 1 Phase 2|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||October 2010|
|Estimated Primary Completion Date :||October 2013|
|Estimated Study Completion Date :||October 2015|
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.
- 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 ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01483248
|the First Affiliated Hospital of Zhejiang University-IRB|
|Hangzhou, Zhejiang, China, 310003|
|Principal Investigator:||Charlie Xiang, Professor||S-Evans Biosciences Co.,Ltd.|