Umbilical Cord Mesenchymal Stem Cells for Patients With Liver Cirrhosis
Recruitment status was: Recruiting
|Liver Cirrhosis||Drug: conventional plus MSC treatment Drug: conventional plus placebo treatment||Phase 1 Phase 2|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||Phase 1/2 Study of UC-MSC Treatment for the Evaluation the Efficacy and Safety in Patients With Liver Cirrhosis|
- ascites volume [ Time Frame: 48 weeks ]
- the patient number of liver function worsening [ Time Frame: 48 weeks ]
- the number of patients with ascites after 12-week treatment [ Time Frame: 48 weeks ]
- The levels of serum alanine aminotransferase [ Time Frame: 48 weeks ]
- The levels of serum total bilirubin [ Time Frame: 48 weeks ]
- The levels of INR [ Time Frame: 48 weeks ]
- The levels of serum prothrombin activity [ Time Frame: 48 weeks ]
- liver function evaluation using MELD-Na score model [ Time Frame: 48 weeks ]
- plasma albumin level [ Time Frame: 48 weeks ]
- plasma HBV load [ Time Frame: 48 weeks ]
- complications [ Time Frame: 48 weeks ]
- blood routine examination [ Time Frame: 48 weeks ]
- renal function tests [ Time Frame: 48 weeks ]
|Study Start Date:||May 2009|
|Estimated Study Completion Date:||December 2013|
|Estimated Primary Completion Date:||December 2013 (Final data collection date for primary outcome measure)|
Experimental: conventional plus MSC treatment
participants will receive conventional treatment plus a dose of MSC from day 0 through the week 8 study visit. Participants will then be followed until the week 48 study visit.
Drug: conventional plus MSC treatment
received conventional treatment and taken i.v., once per 4 week, at a dose of 0.5*10E6 MSC/kg body for 8 weeks.
Experimental: conventional plus placebo treatment
participants will receive conventional plus placebo treatment from day 0 through the week 8 study visit. Participants will then be followed until the week 48 study visit.
Drug: conventional plus placebo treatment
received conventional treatment and taken i.v., once per 4 week, at 50 ml saline for 8 weeks.
Liver cirrhosis (LC) represents a late stage of progressive hepatic fibrosis characterized by distortion of the hepatic architecture and formation of regenerative nodules. The liver transplantation is one of the only effective therapies available to such patients. However, lack of donors, surgical complications, rejection, and high cost are it`s serious problems.
The potential for stem cells to differentiate into hepatocytes cells was recently confirmed. In particular, bone marrow-derived mesenchymal stem cell (BM-MSC) transplantation has been applicated in the clinic for treat several human diseases such as GVHD, cardiac injury and brain injury, and displayed good tolerance and efficiency. BM-MSC has also been used to treat human liver diseases such as liver failure and liver cirrhosis. In a phase 1 study, autologous BM-MSC transplantation has potential to decrease MELD score and increase serum albumin in 4 of patients with decompensated liver cirrhosis.
The purpose of this study is to learn whether and how umbilical cord-derived MSCs (UC-MSC) can improve the disease conditions in patients with liver cirrhosis. This study will also look at how well BM-MSC is tolerated and its safety in LC patients.
Participants in the study will be randomly assigned to one of two treatment arms:
Arm A: Participants will receive 8 weeks of conserved treatment plus UC-MSC treatment.
Arm B: Participants will receive 8 weeks of conserved treatment plus saline.
UC-MSC will be prepared according to standard procedures and is collected in plastic bags containing anti coagulant. MSCs are given via i.v. under sonography monitoring. After cell therapy, patients are followed up at week 4, 8, 12, 24, 36 and 48. The evaluation of some clinical parameters such as the level of ascites volume and ascites disappearance rate, serum alanine aminotransferase (ALT), total bilirubin (TB),prothrombin time (PT), albumin (ALB), prealbumin(PA), the rountin blood test, renal function test are detected at these timepoints. MELD-Na scores and clinical symptoms as well as complication were also observed simultaneously.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01220492
|Contact: Fu-Sheng Wang, Professor||86-10-63879735 ext firstname.lastname@example.org|
|Beijing 302 Hospital||Recruiting|
|Beijing, Beijing, China, 100039|
|Contact: Zheng Zhang, Doctor 86-10-63879735 ext 2015.12 email@example.com|
|Principal Investigator: Fu-Sheng Wang, Professor|
|Principal Investigator:||Fu-Sheng Wang, Professor||Beijing 302 Hospital|