CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 266 enrolled
Drug / intervention
conventional plus MSC treatment +1 moredrug
Likely dose
conventional plus placebo treatment 50 mlfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01220492
NCT01220492Phase 2Completed

Phase 1/2 Study of UC-MSC Treatment for the Evaluation the Efficacy and Safety in Patients With Liver Cirrhosis

Beijing 302 Hospital·interventional·Posted Oct 14, 2010·Updated Aug 8, 2018

In Brief

A Phase 2 clinical trial evaluating conventional plus MSC treatment and conventional plus placebo treatment for Liver Cirrhosis. Completed, enrolled 266 participants across 1 site.

Detailed Summary

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. Particularly, autologous bone marrow-derived mesenchymal stem cell (BM-MSC) has been demonstrated to decrease MELD score and increase serum albumin in the patients with decompensated liver cirrhosis. Therefore, the investigators propose a hypothesis that umbilical cord-derived MSCs (UC-MSC) can also improve the disease conditions of LC patients, particularly reducing the decompensated conditions in these patients.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLiver Cirrhosis
CountriesChina
Collaborators--

Timeline

Phase 2CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedOct 14, 2010
Enrollment StartMay 1, 2009
Primary CompletionApr 1, 2016
TodayJul 2, 2026
Enrollment to primary: 6.9 yearsPosted 15.7 years ago

Interventions

conventional plus MSC treatmentdrug

received conventional treatment and taken i.v., once per 4 week, at a dose of 0.5\*10E6 MSC/kg body for 8 weeks.

conventional plus placebo treatmentdrug

received conventional treatment and taken i.v., once per 4 week, at 50 ml saline for 8 weeks.