Actively Recruiting
A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled Trial to Evaluate the Efficacy and Safety of Human Umbilical Cord-derived Mesenchymal Stem Cells in the Treatment of Decompensated Cirrhosis Patients (MSC-DLC-2)
Led by Beijing 302 Hospital · Updated on 2024-10-18
140
Participants Needed
7
Research Sites
103 weeks
Total Duration
On this page
Sponsors
B
Beijing 302 Hospital
Lead Sponsor
C
Chinese PLA General Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of human umbilical cord-derived mesenchymal stem cells (MSCs) therapy for patients with decompensated cirrhosis, a serious liver condition with a high death rate. Liver transplantation remains the most effective treatment, but challenges like limited donor availability, high costs, and rejection restrict its use. Given these issues, this study aims to explore MSCs as a potential alternative therapy through a phase 2, multicenter, randomized, double-blind, placebo-controlled trial. Participants will be randomly assigned to receive either three intravenous doses of MSCs or a placebo at days 1, 8, and 15, alongside standard care. The trial will include 140 patients with decompensated cirrhosis, split evenly between the MSC treatment group and the placebo group. The study treatments are given through IV transfusions, and the trial will be conducted at multiple centers to assess both safety and treatment effects. During the trial, patients will undergo regular assessments including laboratory tests, clinical evaluations, and quality-of-life questionnaires over a period of up to 24 months. The main outcome measured is the change in the Model for End-Stage Liver Disease (MELD) score from baseline to day 28. Secondary outcomes include longer-term changes in MELD scores, incidence of complications, liver transplant-free survival, liver function tests, and monitoring of treatment-emergent adverse events. This comprehensive monitoring will help determine the potential benefits and risks of MSC therapy for this condition.
CONDITIONS
Brief Title
Human Umbilical Cord-derived Mesenchymal Stem Cells for Decompensated Cirrhosis (MSC-DLC-2)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Willing to provide written informed consent
- Aged 18 to 75 years, male or female
- Diagnosed with decompensated liver cirrhosis confirmed by clinical, laboratory, imaging, or pathological findings
- MELD score between 15 and 30 points
You will not qualify if you...
- Active variceal bleeding, overt hepatic encephalopathy, refractory ascites, or hepatorenal syndrome within 1 month prior to screening
- Uncontrolled severe infection within 2 weeks of screening
- Hepatitis B or C virus-related decompensated liver cirrhosis with less than 12 months of antiviral therapy or detectable viral load at screening
- Corticosteroid treatment for autoimmune hepatitis less than 6 months
- Trans-jugular intrahepatic portosystemic shunts (TIPS) insertion within 6 months prior to inclusion
- Active alcohol abuse unwilling to stop after inclusion
- Significant renal insufficiency or severe electrolyte abnormalities
- Biliary obstruction or portal vein spongiosis
- History of splenic cut-off flow surgery
- Malignant tumors within 5 years except certain treated skin cancers
- Prior major organ transplantation or significant other systemic diseases
- Drug abuse, dependence, methadone treatment, or psychosis
- Positive HIV or syphilis antibody tests
- Pregnancy, lactation, or recent fertility plans during and 6 months after the study
- Severe allergies or known allergy to the investigational drug or excipients
- History of pulmonary embolism
- Previous stem cell therapy or intolerance to cell therapy
- Planned liver transplant within three months
- Participation in other clinical trials within the last 3 months
- Any other clinical condition deemed unsuitable by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 3 weeks
Participants receive three intravenous doses of either human umbilical cord-derived mesenchymal stem cells or placebo on Day 1, Day 8, and Day 15, alongside standard of care.
3 infusion visits (in-person)
Duration - Up to 24 months
Participants are monitored for efficacy and safety outcomes, including liver function and complications, up to 24 months after treatment.
Multiple visits over 24 months for follow-up assessments
Trial Site Locations
Total: 7 locations
1
The First Hospital of Lanzhou University
Lanzhou, Gansu, China
Not Yet Recruiting
2
Third Affiliated Hospital, Sun Yat-Sen University
Guangzhou, Guangdong, China
Not Yet Recruiting
3
Hainan hospital of Chinese PLA General Hospital
Sanya, Hainan, China
Actively Recruiting
4
Jin Yin-tan Hospital
Wuhan, Hubei, China
Not Yet Recruiting
5
Shanghai Changzheng Hospital
Shanghai, Shanghai Municipality, China, 200003
Actively Recruiting
6
Xinjiang Kashi Area Number 1 Hospital
Kashgar, Xinjiang, China
Not Yet Recruiting
7
Beijing 302 Hospital
Beijing, China
Actively Recruiting
Research Team
L
Lei Shi, MD,PhD
F
Fu-Sheng Wang, MD,PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here