Human Umbilical Cord-derived Mesenchymal Stem Cells for Decompensated Cirrhosis (MSC-DLC-2)
ConditionDecompensated Cirrhosis
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorBeijing 302 Hospital
About this trial
Decompensated cirrhosis has a high overall mortality rate. There is a large unmet need for safe and alternative therapeutic potions. This clinical trial is to inspect the efficiency and safety of mesenchymal stem cells (MSCs) therapy for decompensated cirrhosis.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Willing to provide written informed consent;
Aged 18 to 75 years (including 18 and 75 years), male or female;
Patients diagnosed with decompensated liver cirrhosis based on clinical findings, laboratory tests, imaging findings and/or representative pathological findings (decompensated liver cirrhosis is defined as the occurrence of at least one serious complication, including esophageal and gastric varices bleeding, hepatic encephalopathy, ascites, spontaneous bacterial peritonitis and other serious complications);
The Model for End-stage Liver Disease (MELD) score 15 to 30 points.
Disqualifiers
Appearance of active variceal bleeding, overt hepatic encephalopathy (HE), refractory ascites or hepatorenal syndrome within 1 month prior to screening visit.
Uncontrolled severe infection within 2 weeks of screening.
Patients with hepatitis B virus-related decompensated liver cirrhosis may discontinue antiviral therapy during the study, or those who with antiviral therapy for HBV for less than 12 months, or hepatitis B virus (HBV) DNA ≥ detection limit at the time of screening.
Patients with hepatitis C virus-related decompensated liver cirrhosis may discontinue antiviral therapy during the study, or those who with antiviral therapy for HCV for less than 12 months, or hepatitis C virus (HCV) RNA ≥ detection limit at the time of screening (except HCV RNA< detection limit without any antiviral treatment).
Trial design
Design model
Parallel
Treatments tested in this trial
UC-MSCs
Biological/Vaccine3 doses of UC-MSCs intravenously at day 1, day 8, day 15.
Placebo(solution without UC-MSCs)
Biological/Vaccine3 doses of placebo intravenously at day 1, day 8, day 15.
Treatment groups
140 Participants
are divided into 2 treatment groupsGroup A: Human Umbilical Cord-Mesenchymal Stem Cells (UC-MSCs)Experimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Change in Model for End-Stage Liver Disease (MELD) score from baseline to 28th day
The Model for End-stage Liver Disease (MELD) is a scoring system that evaluates the liver function reserve and prognosis of patients with chronic liver disease by creatinine, international normalized ratio (INR), and bilirubin-conjugated cirrhosis etiology.
Time frame
Baseline, 28th daySecondary outcomes
1
Change in MELD score from baseline to 24 months
Time frame
up to 24 months2
Incidence of each complication associated with decompensated cirrhosis
Time frame
up to 24 months3
Liver transplant-free survival
Time frame
month 12 and 244
Incidence of liver failure
Time frame
month 12 and 24Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Beijing 302 Hospital
Lead sponsor
Chinese PLA General Hospital
Collaborator
Shanghai Changzheng Hospital
Collaborator
LanZhou University
Collaborator
Jin Yin-tan Hospital
Collaborator
Hainan General Hospital
Collaborator
Vcanbio Cell and Gene Engineering Corp., Ltd.
Collaborator
Third Affiliated Hospital, Sun Yat-Sen University
Collaborator
Xinjiang Kashi Area Number 1 Hospital
Collaborator
Source ClinicalTrials.gov